Abstract: An important goal for cancer patients is to improve the quality of life (QOL) by maximising functions affected by the disease and its therapy. Preliminary research suggests that exercise may be an effective intervention for enhancing QOL in cancer survivors. Research has provided preliminary evidence for the safety, feasibility, and efficacy of exercise training in breast cancer survivors. The aim of this study was to assess the association between physical exercise and quality of life in a population of female breast cancer survivors, followed up from diagnosis to the off-treatment time period, and investigated about their exercise habits in pre-diagnosis.A total of 212 female breast cancer survivors consecutively registered from January 2002 to December 2006 at a Supportive Care Unit in an Italian Oncology Department were enrolled. Exercise behaviour was assessed by the Leisure Score Index (LSI) of the Godin Leisure-Time Exercise Questionnaire. Patients were asked to report their average weekly exercise for three cancer-related time periods, i.e. pre-diagnosis, during active treatment and off-treatment. Quality of life was assessed by the Italian version of the WHOQOL-BREF standardised instrument. Statistical analysis indicated significant differences across the cancer-relevant time-periods for all exercise behaviour outcomes: the exercise behaviour was significantly lower during both on- and off- treatment than during prediagnosis; exercise during active treatment was significantly lower than during off-treatment. QOL strongly decreases during active treatment. Significant correlations were found between total exercise on- and off-treatment and all QOL indicators. Strenuous exercise is strongly correlated with QOL. Absent/mild exercise seems to be inversely correlated with a positive perception of disease severity and with quality of life on all axes. Need clearly results for inclusion of physical activity programs in comprehensive, complementary treatment regimes for breast cancer patients in Italian oncology departments.
Abstract: Goal of this study was to investigate whether appropriately applied spa therapy in several indications could be associated with a subsequent fall in the need for costly health services and missed working days due to sick-leave. The Naiade project was a multicenter observational, longitudinal, questionnaire-based study comparing an "entry" inquiry addressed to patients before an entry thermal cycle, and a "return" inquiry after 1 year. Routine statistical methods were used for comparisons. The study was carried out in 297 of the 340 certified Italian spa centers. Inquiries were managed by the spa doctor(s), with the collaboration of family doctors, and when necessary, hospitals, other health services, labour offices and employers. After exclusion of regular customers and of patients with acute disease phases or severe health conditions, 39,943 patients divided into eight diseases subgroups (rheumatic, respiratory, dermatologic, gynaecologic, otorhynologic, urinary, vascular and gastroenteric) underwent entry inquiry and appropriate spa treatment. Patients who returned for treatment after 1 year ("index year") were 23,680 (59.2%) and received return inquiry. Outcomes considered were: frequency and duration of hospitalisation periods; missed working days; regular use of disease-specific drugs; and resort to "non-spa" rehabilitation therapies. The data collected at return inquiry were compared with those of entry inquiry. All the considered outcomes appeared to be significantly reduced in the index year in seven of the eight disease subgroups in comparison with the previous year. In conclusion, disease-appropriate spa treatments were followed by a reduction in the need of subsequent health interventions in most disease subgroups. The health promoting value of spa treatments should therefore undergo more rigorous assessment with randomised controlled studies.
Abstract: In the past decade, some authors have reported objective responses and prolonged median survival times using hypoxic abdominal perfusion (HAP) for the treatment of advanced pancreatic cancer. However, these promising results have not been confirmed by others, making it difficult to define the effectiveness of this loco-regional chemotherapy. The aim of this study, therefore, was to evaluate the response rate, time to disease progression and overall survival following HAP treatment of 22 consecutive patients with advanced pancreatic tumors. Within the period from 1999 to 2003, 22 patients with histological diagnosis of unresectable stage III/IV pancreatic cancer, not responsive to systemic chemotherapy, were treated with mitomycin C 30mg/m(2) and cisplatin 60mg/m(2) by HAP (stop flow technique). Immediately after perfusion, hemofiltration was performed to reduce systemic side toxic effects. Responses were assessed by CT-scan 30days from the end of treatment. Minor or partial responses were confirmed by a second CT-scan 4weeks later. Following 26 treatment cycles no death or technical complications were recorded; four patients (18.2%) achieved a partial response, 2 (9.1%) a minimal response and 13 (59.1%) stable disease. The remaining 3 patients (13.6%) showed progression of the disease. The median time to disease progression was 3 months (range 1-10). The median survival time from the start of regional chemotherapy was 6 months (range 1.9-16), with a 1-year survival rate of 9%. Our data show that HAP is a relatively effective second-line treatment for advanced stage pancreatic cancer with a low complication rate. We do not concur with the opinion of others that HAP is an inactive treatment approach. However, taking into account the invasiveness of this procedure, and associated morbidity and cost, HAP would not appear to be preferable to less invasive loco-regional chemotherapeutic alternatives.
Abstract: BACKGROUND: The rationale for combining anticancer drugs has not been applied consistently to use of intravesical agents for treatment of superficial bladder cancer, for which immunotherapeutic BCG and chemotherapeutic mitomycin seem to be a potentially effective combination. We aimed to do a prospective, randomised comparison of BCG alone with that of sequential BCG and electromotive mitomycin in patients with stage pT1 bladder cancer. METHODS: After transurethral resection and multiple biopsies, 212 patients with stage pT1 bladder cancer were randomly assigned to: 81 mg BCG infused over 120 min once a week for 6 weeks (n=105); or to 81 mg BCG infused over 120 min once a week for 2 weeks, followed by 40 mg electromotive mitomycin (intravesical electric current 20 mA for 30 min) once a week as one cycle for three cycles (n=107). Complete responders underwent maintenance treatment: those assigned BCG alone had one infusion of 81 mg BCG once a month for 10 months, and those assigned BCG and mitomycin had 40 mg electromotive mitomycin once a month for 2 months, followed by 81 mg BCG once a month as one cycle for three cycles. The primary endpoint was disease-free interval; secondary endpoints were time to progression; overall survival; and disease-specific survival. Analyses were done by intention to treat. This trial has been submitted for registration at the US National Cancer Institute website . FINDINGS: Median follow-up was 88 months (IQR 63-110). Patients assigned sequential BCG and electromotive mitomycin had higher disease-free interval than did those assigned BCG alone (69 months [95% CI 55-86] vs 21 months [15-54]; difference between groups 48 months [42-54], log-rank p=0.0012). Patients assigned sequential BCG and electromotive mitomycin also had lower recurrence (41.9% [32.7-51.5] vs 57.9% [48.7-67.5]; difference between groups 16.0% [2.7-29.3], log-rank p=0.0012); progression (9.3% [3.8-14.8] vs 21.9% [17.9-25.9]; difference between groups 12.6% [3.0-22.2], log-rank p=0.004); overall mortality (21.5% [13.5-29.5] vs 32.4% [23.4-41.4], difference between groups 10.9% [0.6-21.2], log-rank p=0.045); and disease-specific mortality (5.6% [1.2-10.0] vs 16.2% [6.1-23.3], difference between groups 10.6% [2.5-18.7], log-rank p=0.01). Side-effects were mainly localised to the bladder. INTERPRETATION: BCG-induced inflammation might increase the permeability of the bladder mucosa such that mitomycin can reach the target tissue more easily and exert its anticancer effect.
Abstract: Malignant pleural mesothelioma (MPM) is an aggressive treatment-resistant tumor with a median survival from diagnosis of 12 months. Although multimodality protocols that combine aggressive surgery and adjuvant chemotherapy or radiotherapy have shown improved survival in selected cases, the majority of patients with MPM are not suitable for radical surgery due to advanced stage and comorbid medical illness. For these patients combination chemotherapy with Pemetrex and Cisplatin should be considered for first line palliative chemotherapy. The therapeutic options available to patients with MPM resistant or refractory to systemic chemotherapy are very limited. Thoracic "stop-flow" perfusion (TSP) is a semi-invasive loco-regional drug delivery system that, limiting the circulation to the thorax during the anticancer agent's infusion, claims the advantage of reaching high drug concentration at the tumor site while maintaining a low systemic toxicity. The aim of this phase I-II study was to evaluate the toxicity profile and efficacy of two different platinum-based combined regimens--cisplatin plus mitomycin-C (MMC) and cisplatin plus melphalan (L-PAM)--administered using TSP technique in patients with advanced or recurrent MPM who had refractory disease after systemic first line chemotherapy. Patients with histologically proven unresectable stage II-III MPM entered this trial. Between January 1995 and December 2001, 27 patients were enrolled in the study and submitted to TSP using the two different chemotherapy cisplatin based regimens: 12 patients received cisplatin 100 mg/m2 plus MMC 20 mg/m2 (MMC arm) and 15 cisplatin 100 mg/m2 plus L-PAM 50 mg/m2 (L-PAM arm). Objective responses were assessed by CT-scan 30 and 60 days after the end of treatment in all 27 enrolled patients. Two patients (7.4%) achieved a complete response, 2 (7.4%) a partial response and 4 (14.8%) a minor response. The remaining 19 patients (70.3%) showed a stable disease. No patients developed progression of the disease following the first TSP. The overall median time to progression was 8.9 months (range 1-41). The median survival time for all patients from the beginning of regional chemotherapy was 16.6 months, with a 1-year survival rate of 62.9%, a 2-year survival rate of 18.5%, and a 3-year survival rate of 7.4%. Our data show that TSP is a relatively effective second-line treatment in patients with progressive disease after systemic chemotherapy, with a low rate of major complications and treatment-related toxicity.
Abstract: GOALS: The objective of this study was to assess the knowledge possessed and the attitudes held by Italian radiotherapists regarding evaluation and treatment of pain. METHODS: One hundred and twenty-six radiotherapists completed a 16-item questionnaire that was specifically designed to investigate three main topics: the attention paid to pain, the use of analgesics, and pain in children. Chi-square or Fisher's exact text was employed to evaluate differences based on position (staff/resident), age (<35 or >35 years old), availability of consultants in pain therapy and/or palliative care, colleagues with main interest in palliative care among their own staff, and region of residence (north/center/south of Italy). RESULTS: Overall percentage of correct answers was 76.6% (range 34.9-94.4%). Correct answers by groups of items were: attention paid to pain 77.3%, use of analgesics 81.5%, and pain in children 63.7%. CONCLUSION: Results of the survey demonstrate that knowledge and attitudes of Italian radiotherapists towards the approach to and treatment of pain can be considered satisfactory.
Abstract: OBJECTIVES: This work was conducted to evaluate symptoms assessment and use of patient-tailored protocols in clinical practice among Italian medical oncologists. METHODS: A questionnaire based on four topics (assessment of symptoms, assessment of a specific symptom, assessment of pain, use of patient-tailored protocols of treatment) was administered to 250 Italian medical oncologists. RESULTS: Of these oncologists, 43.7% used multiple symptoms tools and 37.9% used symptom specific tools; 58.9% used some instrument to assess pain. More than a third of the respondents (35.5%) used patient-tailored protocols. No statistical differences were found regarding region of residency, availability of consultants in pain therapy and/or palliative care, colleagues with main interest on palliative care, and beds dedicated to palliative care. Statistically significant differences were found regarding the position (staff/resident) in three out four topics. CONCLUSIONS: Among Italian medical oncologists, the instruments used for assessment of symptoms are poorly employed. Even when these instruments are used, patient-tailored protocols are rarely administered.
Abstract: An increased incidence of amyotrophic lateral sclerosis (ALS) amongst soccer players in Italy has recently been reported. A case-control study (300 cases and 300 matched controls) was conducted to explore the association between ALS and physical/sports activities, with specific reference to trauma-related risk. Neither the practice of competitive sports nor sports-related traumas were found to be associated with an increased risk of ALS. The practice of physical activities or sports is not per se a risk factor for ALS. Our results exclude sports-related microtraumas as etiopathogenic factors in the natural history of ALS.
Abstract: Repeated loads and vibration stress in professional settings are relevant risk factors for back pain. Aim of this cross-sectional study was to estimate: a) the prevalence of back pain in two high-risk professional samples (helicopter pilots and bus drivers); b) the association between physical/sports exercise and back pain subjective perception across age. Prevalence of back pain is 94% in helicopter pilots and 74% in bus drivers; prevalence of back pain significantly increases with age. The positive effect of regular physical/sports exercise on subjective back pain significantly decreases with age. Physical or sports exercise adapted to structural characteristic of patients can result effective in diminishing personal impairment in subjects at professional risk.
Abstract: This study was undertaken to determine the survival of patients with unresectable and refractory non small cell lung cancer (NSCLC) submitted to thoracic stop-flow perfusion (TSP). Forty-five patients with NSCLC confined to thoracic region entered the study. All 45 patients had been pretreated with some form of chemotherapy and had progression of disease. The cytostatic regimen was mitomycin 10 mg/m2, navelbine 25 mg/m2 and cisplatin 60 mg/m2. In 39/45 patients, immediately after TSP, hemofiltration was performed to reduce systemic side effects There were 16/45 responses to the first TSP (CR 0; PR 16): a response rate of 35.6%. Median time to progression was 4 months. Median survival was 7.5 months.1-year survival rate was 36.4%, 2-year survival rate was 14%, and 3-year survival rate was 5.7%.
Abstract: Hypoxic pelvic and limb perfusion by means of a balloon occlusion technique was evaluated in patients with recurrent melanoma of the lower limbs who were non-responders to isolated hyperthermic limb perfusion or who were not eligible for this procedure. A pilot study was performed in 17 patients, who underwent hypoxic pelvic and limb perfusion with 50 mg/m(2) of melphalan or 50 mg/m(2) of melphalan and 25 mg/m(2) of mitomycin C. Each procedure was followed by haemofiltration. A leakage monitoring study was performed in five of the 17 patients. The response rate and time to disease progression were the primary endpoints, with overall survival as the secondary endpoint. During the procedures there were no technical, haemodynamic or vascular complications, and no deaths occurred during surgery or in the postoperative period. Significant leakage (median 40%) was measured in the five patients studied. No severe systemic or regional toxicity was observed. After one course of treatment, the objective response rate was 47% (95% confidence interval 22.5-71.5%), the median time to disease progression was 10 months (range 2-40 months), and the 3 year overall survival was 20%. Hypoxic pelvic and limb perfusion seems to be a safe and effective treatment for patients with unresectable recurrent limb melanoma who are not eligible for isolated hyperthermic limb perfusion. Due to the non-homogeneity of the study, with some patients receiving a combination of melphalan and mitomycin C and others receiving only melphalan, it is not possible to make definite conclusions with regard to efficacy. Further studies are necessary to establish whether the response rates can be improved by using different drug regimens.
Abstract: AIM: The "Naiade" Project was carried out in execution of the Decree of December 1994 by the Italian Ministry of Health, with the objective of defining the therapeutic role of spa therapy in the various sectors of medicine. In this study the authors refer to the results obtained in osteoarthritis (OA). METHODS: The OA study included the observation of patients for 2 consecutive years, with the compilation of a series of clinical and socio-economic data. The initial sample was of 11437 patients suffering from primary and secondary OA, and in the 2(nd) year the total number of assessable patients was 6111 (53.4%). All patients underwent 1 annual cycle of balneotherapy and mud packs therapy for 2 consecutive years. The thermal treatments were carried out in 98 Italian spas with sulphurous water, sodium chloride-bromide-iodide water, sulphate water, and bicarbonate water. Analysis of the data collected confirmed the clinical efficacy of spa treatments for OA, particularly for localisations in the cervical and lumbar spine. The benefits of these treatments and the persistence of the therapeutic effects over time were clearly demonstrated by the collection of some socio-economic indicators relative to the year before each cycle of thermal therapy. RESULTS: In fact, the analysis of these indicators showed a significant reduction in recourse to additional treatments (hospital admissions, physical and pharmacological therapies) and absence from work. CONCLUSION: The obtained data was particularly interesting for the number of samples examined, the follow-up over a period of 2 years, and the collection of clinical and, especially, socio-economic parameters. The results of the Naiade Project confirmed the value of spa therapies in the treatment of OA.
Abstract: OBJECTIVE: This study focuses on the evaluation of some infectious diseases as risk determinants of type I diabetes mellitus (DM). METHODS: A population-based case-control study was carried out by referring to the type I DM population-based register of the Abruzzo region of Italy as it includes all type I DM cases since January 1 1990, the point at which the register became operative. The pediatric population (age: 0-14), living in the same municipalities of the cases, was selected as the control population. Data were collected through questionnaires submitted by a physician to parents of cases and controls. Conditional logistic regression models were used to evaluate association between determinants and onset of type I DM. RESULTS: The risk of diabetes for children exposed to only one infection (morbilli, parotitis, rubella, pertussis or varicella) is not statistically significant: OR: 0.778; CI: 0.427-1.370. On the contrary, when two infections are contracted statistically significant results occur: OR: 2.375; CI: 1.149-4.914; for more than two infections values are: OR: 6.786; CI: 2.881-17.877. No substantial difference in odds ratios (ORs) after adjustment for confounding variables was found. A significant decrease in OR was noted for pertussis and MMR vaccinations, respectively: OR: 0.015; CI: 0.001-0.251; OR: 0.400; CI: 0.201-0.799. CONCLUSIONS: Since the higher the number of contracted infections, the higher the risk of diabetes, contracted infections can be considered potential accelerating factors of clinical manifestation of type I DM. Therefore multiple exposures might speed up the onset of diabetes in children. This study suggests the utility of applying the risk model method to wider populations, especially if the geographical variability of standardised incidence rates of type I DM in pediatric age is taken into consideration.
Abstract: BACKGROUND: The treatment of patients with advanced or recurrent pelvic melanoma, which are often associated with lesions in the lower limbs, is still unsatisfactory and controversial. A simplified hypoxic pelvic and limb perfusion has been recently recommended to provide therapeutic options for palliation and possibly cure. METHODS: A nonrandomized and noncontrolled phase II experimental study was performed in 11 patients with symptomatic unresectable recurrent melanoma of the pelvis and limb. Patients were submitted to hypoxic pelvic and limb perfusion with 25 mg/m(2) of melphalan, 50 mg/m(2) of cisplatin, 300 mg/m(2) of dacarbazine, and 75 mg/m(2) of epirubicin by means of a simplified balloon occlusion technique. Response rate and time to disease progression were the primary endpoints; overall survival was the secondary endpoint. RESULTS: During the procedures there were no technical, hemodynamic, or vascular complications, and no deaths occurred during surgery or in the postoperative period. Response rate was 82% (95% confidence interval, 58% to 100%). Median time to disease progression was 12 months (range 9 to 30 months). Three-year overall survival was 34%. CONCLUSIONS: Hypoxic pelvic and limb perfusion is a safe and good palliative treatment for patients with unresectable recurrent melanoma. Further studies are necessary to to confirm these data and to establish if refinements can be made with acceptable toxicity.
Abstract: BACKGROUND: Chronic venous disorders carry lifelong medical and social burdens. Within conservative approaches, spa hydrotherapy is popular among patients with venous disorders in Europe, but whether the practice is associated with health or social benefits remains controversial. METHODS: The present work is a substudy of the nation-wide Italian Naiade Project, a large multicenter observational exercise on spa treatments in different disease groups. The "Chronic Phlebopathies" substudy included 2504 patients with primary or secondary varicosis or non-varicose venous insufficiency. After a first visit and administration of a detailed questionnaire, patients underwent a "thermal cycle" of 15-20 days consisting of underwater active and passive physical therapy with mineral waters. The same procedures were repeated after 1 year on the 1352 patients (54%) who spontaneously returned to the same spa. Primary endpoints of the study were some indicators of the use of health resources related to the year after the first thermal cycle, compared with the same indicators recorded at first visit using appropriate statistical methods. RESULTS: The occurrence of acute venous episodes, working days missed, number and duration of hospital admissions, consumption of drugs and physical therapies were all significantly reduced in the year after thermal therapy, thus indicating lesser use of health resources. CONCLUSIONS: The study suggests that thermal hydrotherapy in patients with chronic venous disorders is associated with health and social benefits.
Abstract: HYPOTHESIS: To evaluate the role of hypoxic pelvic perfusion in providing therapeutic options for palliation without relevant complications in a homogeneous group of patients with unresectable locally recurrent rectal cancer who are nonresponders or have disease progression after the standard treatments. DESIGN: Nonrandomized and noncontrolled phase II experimental study. SETTING: University hospital, L'Aquila, and the National Cancer Institute, Naples and Milan, Italy. PATIENTS: Eleven patients had symptomatic unresectable pelvic recurrent rectal cancer. The mean +/- SD product of the 2 maximum perpendicular diameters of the recurrent cancer was 24.2 +/- 11.0 cm(2) (range, 10-48 cm(2)). Tumor fixation to the pelvic side walls or proximal sacrum were the main criteria for unresectability. All patients were free from extrapelvic disease and had a life expectancy longer than 3 months. INTERVENTION: Patients were submitted to one course of pelvic perfusion with mitomycin C (MMC) (25 mg/m(2)) by means of a simplified balloon occlusion technique. A pharmacokinetic evaluation of the procedure was also performed. MAIN OUTCOME MEASURES: Response rate and time to disease progression were the primary endpoints; overall survival was the secondary endpoint. RESULTS: Mean +/- SD value of the ratios of pelvic MMC area under the plasma concentration curve (0 to 20 minutes) (AUC(0-20)) to systemic MMC AUC(0-20) was 13.30 +/- 6.52. During the procedures there were no technical, hemodynamic, or vascular complications, and no deaths occurred during surgery or in the postoperative period. The response rate was 36.3% (95% confidence interval [CI], 6.5%-66.1%). Pain response rate was 45.4% (95% CI, 16.6%-76.2%). Median survival was 12.2 months (range, 5.7-19.5 months). Median time to disease progression was 6 months (range, 3-8 months). Two-year overall survival was 9.1%. CONCLUSIONS: Hypoxic pelvic perfusion with MMC is a safe and good palliative treatment for patients with unresectable locally recurrent rectal cancer. Further studies are necessary to establish if a different sequence in the multimodular treatment of these patients could be more useful.
Abstract: BACKGROUND: Whilst upper gastrointestinal disturbances are frequently observed in patients with diabetes mellitus, little is known about the prevalence of Helicobacter pylori infection and peptic disease in these patients. AIM: To evaluate prevalence of Helicobacter pylori infection and peptic disease lesions in diabetics with dyspeptic symptoms. PATIENTS AND METHODS: Study population comprises 74 consecutive diabetes mellitus patients with dyspepsia and 117 consecutive non diabetic dyspeptic patients. Upon enrolment, each patient completed an interview screening questionnaire to obtain information concerning presence and severity of dyspepsia. All patients underwent upper gastrointestinal endoscopy with biopsy specimens being collected from gastric antrum and body Helicobacter pylori was evaluated in each patient by rapid urease test and histology (Giemsa). Gastritis was classified according to the Sydney System. Statistical analysis was performed by chi-square, Fisher exact or t test and logistic regression analysis. A p value <0.05 was considered significant. RESULTS: Prevalence of Helicobacter pylori infection was found to be significantly higher in diabetics than in controls. The prevalence rate of endoscopic lesions was comparable in the two groups, but the association between endoscopic lesions and Helicobacter pylori infection was significantly higher in diabetics. Overall, the presence of chronic gastritis, both non atrophic and atrophic, as well as intestinal metaplasia were comparable in the two groups of patients, whilst the association between chronic gastritis and Helicobacter pylori infection or gastritis activity were significantly higher in diabetics. In neither group, was any correlation found between severity of dyspepsia and presence of endoscopic lesions, chronic gastritis or Helicobacter pylori infection. CONCLUSIONS: These data show a higher prevalence of Helicobacter pylori infection in diabetes mellitus patients with dyspepsia. Helicobacter pylori infection was significantly associated both with the presence of endoscopic lesions and chronic gastritis in diabetic patients, but not in the controls.
Abstract: The hepatitis C virus infection (HCV) is the most frequent cause of hepatic infection in Europe. In Italy, anti-HCV positivity values are extremely variable, depending on the age and geographic location of the population being analysed. The aims of the study were: (1) evaluating positivity for anti-HCV antibodies in various age groups and determining the HBsAg in a mountainous and predominantly farming area in central Italy; (2) assessing some anamnestic and clinical variables through a questionnaire, submitted during the taking of blood samples, in order to determine HCV exposure and risk factors for the target population. 344 subjects selected by random sampling among 3308 people, older than 16, were considered as the target population. A prevalence study was carried out. The sources of data were: blood samples taken to carry out the HCV positivity test; a questionnaire including items about exposures at risk and case-historical and clinical patient data. The risk of infection was evaluated by a multiple logistic regression model. The inferred HCV+ prevalence rate is 22.4/100 (95% confidence interval (CI): 20.8-24.1). An increasing age trend is shown with a higher positive predominance among females (28.99/100 vs. 14.29/100 in males). The positive HBsAg prevalence in the examined survey is 1.2/100. Variables associated with the HCV occurrence are case history of pneumonopathy (OR: 4.9) and exposure to parenteral therapies with glass syringes (OR: 3.3). This study is consistent with literature about the hypothesis of a north-south geographic gradient in the hepatitis C occurrence in Italy. Data clearly show the effects of the inappropriate use of medical or surgery practices on the population, with particular reference to the use of glass syringes. No elements prove that the farming features of the area may be predictive of HCV infection risk. The extent of the recorded prevalence values calls for the implementation of programmes aimed at detecting clusters or population areas at risk.
Abstract: Changes in visual evoked potentials, mainly affecting the amplitude of the major positive wave, are referred to by many authors and are related to the pathophysiological basis of primary headache. We performed both transient pattern-reversal visual evoked potentials and spectral analysis by means of fast Fourier transform of 8-Hz steady-state pattern-reversal visual evoked potentials in 34 children affected with migraine (14 with aura, 20 without aura), and compared them with 14 patients with tension-type headache and 10 healthy subjects. The amplitude of the response to the transient stimulation (P100) was higher and the latency shorter in the patients with headache compared with the controls, but the difference was not statistically significant. The absolute power of the first harmonic (1F) obtained by the spectral analysis of the steady-state stimulation was increased in all the patients with headache compared with the controls, and the increase was significant in patients with migraine. These data seem to confirm the hypothesis of abnormal processing of visual input in migraineurs and could be interpreted as neurophysiological support for the theory that different headache types are related conditions. Furthermore, the spectral analysis of steady-state pattern-reversal visual evoked potentials could be proposed as a test to diagnose migraine.
Abstract: Controversy still exists about the optimal lymph node (LN) dissection for potentially curable gastric cancer. For rational LN dissection it is important to know the incidence of metastasis at each LN station. For this purpose a computer program was developed using data from 4302 primary gastric cancers treated at the National Cancer Center Hospital in Tokyo between 1969 and 1989. To evaluate the accuracy of the computer program, the differences between the individual reports generated by the computer and the stored data were investigated in 282 Italian patients submitted to curative gastrectomy and D2 or more extended LN dissections for gastric cancer. Receiver operating characteristic (ROC) analysis was used to assess the sensitivity and specificity of the program for predicting LN metastases in each of the 16 regional LN stations. The computer program showed good predictive ability for LN metastases in most of the 16 LN stations, as the areas under the curve ranged from 0.741 (station 15) to 0.944 (station 8), with a mean of 0.856. A critical cutoff point of 18% of the program's expected percentage was the value maximizing the validity of the prediction. Using an "absolute" cutoff point of 0%, the overall rate of false-negative (FN) predictions in 176 N+ patients was 11.9%; of these, 11 (6.2%) were absolute FNs, in which the program totally failed to estimate LN metastases; the remaining 10 cases (5.7%) were relative FNs because the specific prediction was positive for a different depth of stomach invasion. The low number of D3/D4 lymph-adenectomies in the historical database may affect the low estimate of metastases to N3/N4 nodes generated by the program. Based on these data, the program predicts with good accuracy the extent of LN metastases from gastric cancer, but it is not recommended for directing the surgeon to perform more extensive lymphadenectomy.
Abstract: The main objectives of type 1 diabetes mellitus (DM) management include keeping glycemia levels within the euglycemic range to prevent complications. Daily self-monitoring is an important problem for many diabetic patients, particularly for adolescents. The aim of this study was to evaluate the determinants of poor daily self-monitoring, focusing on the patients' parents' perception of the problem. In order to evaluate parents' awareness of their children's disease-monitoring status, we carried out a cross-sectional investigation of a sample of children and adolescents from a population-based register, with the corresponding population of parents. To collect our data, we used a 33-item questionnaire, separately administered by diabetologists to both parents and children. We estimated the concordance with respect to patients' and parents' answers. Adolescents followed their overall medical prescriptions more regularly (48.8%) than children (29.7%), but most frequently they forgot to use glycemic tests (adolescents 42.4%, children 29.7%). A major duration of disease affected HbA1c levels (values > 8%) of patients younger than 14 years (pFisher = 0.016). Our results indicate a worse compliance of adolescents with respect to children in attending to daily self-monitoring, not just regarding daily glycemic levels but also the course of daily activities such as going to school, studying, working, and simulating symptoms and signs of hypo-hyperglycemia. Parents mostly ignored their child's self-monitoring status and the related motivations.
Abstract: A case of juvenile polyposis is reported and 271 cases are collected from the literature. The risk for neoplasia is analyzed and the endoscopic or surgical therapy is discussed. The authors conclude that juvenile polyposis should be considered as a challenge to the surgeon with regard to familial adenomatous syndromes, and strongly recommend a close follow-up of patients with juvenile polyposis.
Abstract: Insulin resistance is a feature common to patients with diabetes and to some with hypertension. It is assumed that this feature confers the increased metabolic risk in hypertension. However, the state of the renin-angiotensin system might contribute to cardiovascular risk, although there is no clear mechanistic explanation. Our recent observation that insulin levels are increased in a specific subset of patients with normal/high-renin hypertension, the nonmodulators, provided the background for the current hypothesis: to ascertain whether abnormalities in lipid and carbohydrate metabolism are observed in the same patients in whom alterations in sodium transport, sodium homeostasis, and the renin-aniotensin system response have been identified. Exploration of a family history of cardiovascular risk was a secondary goal. Insulin sensitivity (assessed by a 75-g oral glucose load), lipid levels, and two defects in the renin-angiotensin system were assessed in 62 hypertensive and 14 normotensive subjects placed on a high (210 mmol/l) and a low (10 mmol/l) sodium intake for 2 weeks, to classify them as low-renin, nonmodulator, or modulating hypertensive subjects. Only in nonmodulators were the following cardiovascular risk factors significantly increased: fasting insulin (P < 0.01); increment in post-glucose load insulin (P < 0.01); total, LDL, and VLDL cholesterol and triglyceride levels (P < 0.05); and erythrocyte Na+/Li+ countertransport activity (P < 0.001). Both nonmodulators and low-renin hypertensive subjects had a significantly (P < 0.01) increased frequency of a family history of hypertension by questionnaire compared with subjects with intact modulation. However, only nonmodulators had a significantly (P < 0.02) higher frequency of a family history of myocardial infarction. Thus, there is a clustering of metabolic abnormalities in a discrete subset of the essential hypertensive population with a specific dysregulation of the renin-angiotensin system--nonmodulation. The absence of this cluster in low-renin hypertensive subjects may explain their relatively diminished cardiovascular risk. Its presence in nonmodulators likely contributes to the increased cardiovascular risk observed in normal/high-renin hypertension.
Abstract: We investigated the effect of angiotensin II on endothelin-1 secretion in vitro and in vivo. In vivo, angiotensin II was given intravenously to 23 essential hypertensive and 8 control subjects according to different protocols: Study A, 1.0 ng x min-1 x kg-1 and 3.0 ng x min-1 x kg-1 angiotensin II for 30 min each; Study B, 1.0 ng x min-1 x kg-1 and 3.0 ng x min-1 x kg-1 angiotensin II for 120 min each; Study C, 3.0 ng x min-1 x kg-1 angiotensin II for 30 min followed by a dose increment of 3.0 ng x min-1 x kg-1 every 30 min until mean blood pressure levels increased by 25 mmHg; Study D, 1.0 ng x min-1 x kg-1 followed by 3.0 ng x min-1 x kg-1 angiotensin II for 60 min each on two different NaCl diets (either 20 mmol NaCl/day or 220 mmol NaCl/day, both for 1 week). In all in vivo studies neither plasma nor urine endothelin-1 levels changed with angiotensin II infusion. In contrast, angiotensin II (10(-9), 10(-8), 10(-7) mol/l) stimulated endothelin-1 secretion from cultured human vascular endothelial cells derived from umbilical cord veins in a time- and dose-dependent manner. The in vitro angiotensin II effects were abolished by candesartan cilexetil, an inhibitor of the membrane-bound AT1 receptor, and also by actinomycin D, an RNA synthesis inhibitor, and cycloheximide, a protein synthesis inhibitor, indicating that endothelin-1 release depended on AT1 receptor subtype and de novo protein synthesis. Our findings indicate that angiotensin II regulates endothelin-1 release by cultured endothelial cells through an AT1 receptor-dependent pathway, but does not influence circulating endothelin-1 levels in vivo.
Abstract: Upregulation of endothelial adhesion molecules is the earliest step of atherogenesis. Whether obesity induces endothelial adhesin upregulation is unknown. To address this topic, circulating vascular cell adhesion molecule-1 (VCAM-1), intercellular adhesion molecule-1 (ICAM-1), E-selectin, and von Willebrand factor (vWF) concentrations were evaluated in 22 obese hypertensive (51.4+/-4.6 years [mean+/-SD age]), 19 obese normotensive (50.6+/-3.8 years), 18 nonobese hypertensive (52.3+/-3.9 years), and 16 nonobese normotensive (52. 4+/-3.5 years) men without other risk factors or overt atherosclerosis. All measurements were repeated in the obese subgroups after weight loss induced by 12 weeks of caloric restriction. Basal circulating VCAM-1 levels were similar between the 2 obese groups but were higher (P<0.0001) than in the 2 nonobese groups. No differences were found between nonobese hypertensives and normotensives. Serum low density lipoprotein cholesterol was weakly correlated with plasma soluble VCAM-1 levels in pooled, obese subjects (r=0.362, P=0.02). Plasma soluble adhesin and vWF concentrations decreased significantly after weight loss in obese hypertensives (VCAM-1 P=0.03, ICAM-1 P=0.004, E-selectin P<0.0001, and vWF P=0.003) and normotensives (VCAM-1 P=0.04, ICAM-1 P=0.003, E-selectin P<0.0001, and vWF P<0.0001). Body mass index was correlated with plasma E-selectin concentrations at baseline and after weight loss in obese hypertensives (r=0.501, P=0.018 and r=0. 466, P=0.03, respectively) and obese normotensives (r=0.523, P=0.021 and r=0.460, P=0.05, respectively). In conclusion, our data show that obesity per se induces early endothelial activation in hypertensive and normotensive men. Weight loss counteracted endothelial activation in both obese hypertensive and normotensive men.
Abstract: BACKGROUND: Several studies suggest that the hyperactivity of the circulating renin-angiotensin system might favor the progression of renal disease in essential hypertension. To elucidate this aspect, we investigated the relationship between plasma renin activity (PRA) and the urinary albumin excretion rate (UAER), an early marker of hypertension-related renal changes, in human essential hypertension. METHODS: Ninety nonobese, nondiabetic, nonhyperlipidemic patients with mild-to-moderate essential hypertension (67 males, 23 females; mean age 51.4 +/- 6.2 years) were divided into low renin (LR), normal renin (NR), and high renin (HR) subgroups according to individual PRA while they were on a constant NaCl intake (120 mmol NaCl/day). The UAER was assessed during the same NaCl intake. RESULTS: Data showed significantly higher UAER (31.3 +/- 12.9 microg/min) in HR (N = 30) than NR (N = 30, 22.7 +/- 14.4 microg/min, P < 0.02) and LR patients (N = 30, 21.7 +/- 10.8 microg/min, P < 0. 01). CONCLUSIONS: Our study demonstrates that the UAER is elevated in HR essential hypertensive patients, suggesting that high PRA accelerates the onset of early renal changes in human essential hypertension.
Abstract: BACKGROUND/AIMS: The value of pre-operative angiographic evaluation in patients undergoing gastric cancer surgery with extended lymphadenectomy was assessed in a prospective study comparing exposed and unexposed groups of patients. METHODOLOGY: During the period from July 1991 to October 1997, 76 patients (Group A--exposed) were pre-operatively submitted to a digital subtraction angiography (DSA) after informed consent. Concurrently, 94 patients (Group B--unexposed) were included as an unexposed reference group. All patients underwent total or subtotal gastrectomy with D2 lymphadenectomy according to the guidelines proposed by the Japanese Research Society for Gastric Cancer (JRSGC). RESULTS: In 34 (45%) exposed patients (Group A), DSA detected an atypical vascular anatomy. Major anatomical variations of the celiac axis, its branches and the superior mesenteric artery were discovered in 4 subjects (5%). Vascular anomalies affecting the surgical tactics of lymphadenectomy were detected in less than 8% of patients. Five post-operative deaths (6.6%) were registered between patients of the Group A, exposed to pre-operative angiography, 8 in the unexposed Group B (8.5%). Post-operative morbidity was significantly higher (P = 0.038) in the Group B (34%) in comparison to Group A (20%) but no difference in risk of individual complications was detected. CONCLUSIONS: Although useful in the presence of major vascular anomalies, it appears that pre-operative angiography did not significantly reduce intra- and post-operative complications associated with radical gastrectomy combined with extended lymphadenectomy. Arteriography is therefore not routinely recommendable but its use is mandatory in specific operations for gastric cancer.
Abstract: Insulin-dependent diabetes mellitus (type 1) is a common chronic disease of childhood occurring throughout the world. In the literature, its most important determinants include genetic, environmental and familial factors. We evaluated family history as a determinant of the risk of type 1 diabetes mellitus with a population-based case-control study. Information about type 1 patients was taken from the dedicated register of the Abruzzo Region; the register has been collecting incident cases in the age group 0-14 years, diagnosed between 1 January 1990 and 31 December 1996. The control group was taken from the lists of patients attending family pediatricians. The family history data for type 1 and type 2 patients was obtained by a questionnaire, administered to their parents. The risk of type 1 diabetes mellitus associated with its occurrence in first- and second-degree relatives was estimated using logistic regression methods. Our results show that the risk is indeed increased with a positive family history (OR=3.96; 95% CI 1.54-10.14). This shows that the risk of type 1 diabetes mellitus for children whose fathers are affected by the disease is 11 times higher with respect to controls. Moreover, the risk for children whose brothers are affected by the disease is 20 times higher with respect to controls. In contrast, a family history for type 2 diabetes mellitus does not influence the risk.
Abstract: PURPOSE: The objective of the study was to investigate specificity and sensitivity of bladder wall thickness in the diagnosis of bladder outlet obstruction. MATERIALS AND METHODS: The study included 174 patients referred to our prostate centers for lower urinary tract symptoms. Free uroflowmetry and pressure-flow studies were performed in duplicate as part of the diagnostic evaluation. After the 2 voiding studies were done the bladder was filled to 150 ml. and wall thickness was measured via suprapubic ultrasound. Bladder outlet obstruction was diagnosed and graded according to the Abrams-Griffiths and Schäfer nomogram as well as to the group specific urethral resistance algorithm. RESULTS: A significant correlation (r > 0.6, p < or = 0.007) was found between bladder wall thickness and all parameters of the pressure-flow study. A bladder wall thickness of 5 mm. appeared to be the best cutoff point to diagnose bladder outlet obstruction, since 63.3% of patients with bladder wall thickness less than 5 mm. were unobstructed while 87.5% of those with a bladder wall thickness 5 mm. or greater were obstructed. Bladder wall thickness out performed uroflowmetry in terms of specificity and sensitivity in the diagnosis of outlet obstruction as demonstrated by an area under curve value of 0.860 versus 0.688 in the receiver operator characteristics analysis. CONCLUSIONS: Measurement of bladder wall thickness appears to be a useful predictor of outlet obstruction with a diagnostic value exceeding free uroflowmetry although it does not represent a substitution to invasive urodynamics. These data support the hypothesis that the relationships between morphology and function are of clinical importance.
Abstract: Insulin-dependent diabetes mellitus (IDDM) is a worldwide occurrence disease of childhood with genetic, environmental and familial risk factors. Our study aims to evaluate family history as a determinant of IDDM. In a population-based case-control study informations on all incident IDDM cases, age 0-14, diagnosed between January 1st 1990 and December 31st 1996 were taken from the IDDM population-based register of the Abruzzo Region. The control group was taken from the lists of children attending family paediatricians. The family history data collection for IDDM and non insulin-dependent diabetes (NIDDM) were obtained by a questionnaire, administered to parents. Risk of IDDM associated with familiarity in first and second degree relatives was estimated using conditional regression analysis. Our results show that the risk of developing IDDM is increased by positive family history (OR = 3.99; 95% c.i. 1.56-10.23). The risk of IDDM for children whose fathers or brothers are affected by IDDM is respectively 11 and 20 times higher than for children with no family history. Family history for NIDDM does not influence the risk.
Abstract: The aim of this study, based on a prospective analysis, was to evaluate the accuracy of the TEST-yolk buffer enhanced hamster egg penetration test (HEPT) and acrosin activity in discriminating fertile from infertile males as compared with the conventional semen profile. The incidence of spontaneous pregnancies was monitored during a follow-up period ranging between 18-24 months in 62 couples without untreatable female infertility. The diagnostic accuracy of the HEPT was significantly higher than that of the conventional semen profile, as evaluated with fitted ROC curves. The best discriminatory ability was exhibited by a penetration index (penetrations/oocyte) of 2 as cut-off value. In our series it gave a positive predictive value of 77.8% and a negative predictive value of 92.3%. Acrosin activity did not show a discriminating power significantly higher than the conventional semen profile, but an acrosin activity <20 microIU/10(6) spermatozoa was found only among patients who did not achieve a pregnancy. In conclusion, this prospective analysis indicates that the TEST-yolk buffer enhanced HEPT constitutes a significant improvement over the conventional semen profile in discriminating fertile from infertile males. Acrosin activity could provide a useful adjunctive test because of the high negative predictive value of its poor results.
Abstract: OBJECTIVE: To provide incidence data of insulin dependent diabetes mellitus (IDDM) in the Abruzzo Region, Italy in 0-14 year-old children and contribute to a better understanding of IDDM geographical variability throughout Italy. SUBJECTS AND METHODS: All incident cases younger than 15 years first diagnosed with IDDM according to the WHO criteria between 1 January 1990 and 31 December 1995 and resident in the Abruzzo Region were recorded. The primary sources were divisions of pediatrics, endocrinology or medicine, diabetic centers for adult patients and the Regional Pediatric Diabetology Centre. Secondary independent sources included registered prescriptions for insulin in local district units of the National Health System and the regional IDDM association for children. RESULTS: During the six years, 117 new cases of IDDM in the age-group 0-14 were identified, with an overall standardized incidence rate of 9.34/100,000/year (95% C.I. 7.76-10.95). The crude incidence rate was highest in the 10-14 year age-group (10.64, 95% C.I. 7.66-13.62). Teramo province showed the highest standardized incidence rate, 10.30/100,000/year (95% C.I. 6.58-14.02); it is noteworthy that the IDDM rate in Teramo (15.40/100,000/year) was the highest in peninsular Italy in 1994. Abruzzo Region shows significantly higher rates than other central Italian regions. No significant difference in rates between males and females was observed. Seasonality was not observed from incidence data. CONCLUSIONS: We report the highest incidence rate for IDDM in children in the Italian mainland in the years 1990-95. Our findings confirm the need for epidemiological research to provide more information about the distribution of genetic markers and the etiologic role of environmental factors in Italian regions.
Abstract: The use of Risk Index in surgery is aimed to plan surgical strategy in order to achieve a better post-operative prognosis. This is especially true in geriatric surgery where ASA Index and, more recently, Reiss Index are widely employed. Since the mentionated Risk Indices are calculated on the basis of different factors, in this prospective study we compared the two Risk Indices with the aim of verify which index offers better prognostic indications. 125 consecutive patients, aged older 70 years, undergoing surgical treatment, were investigated. The patients were grouped according to ASA Index and Reiss Index and postoperative morbidity and mortality rate was calculated. Both Indices resulted good predictive for the postoperative prognosis (ASA: G Statistic = 31.531, p < 0.001; Reiss: G Statistic = 18.416, p < 0.001), but ASA Index sensitivity was better (Specificity = 100%, sensitivity = 28%, false negative rate = 72%) than Reiss Index (Specificity = 100%, sensitivity = 0, false negative rate = 100%). Therefore ASA Index has clinical valid role in valuing surgical risk in elderly.
Abstract: Analyses of biochemical and microbiological parameters such as pH, N-nitroso compound (NOC) concentration, carcinoembryonic antigen (CEA) level, and total viable counts (TVCs), and identification of microorganisms were carried out on 65 fasting gastric juice samples obtained at endoscopy from 45 patients previously submitted to partial gastrectomy for benign peptic ulcer disease (23 Billroth I, 22 Billroth II/Reichel-Polya) and 20 normal controls. Biopsy specimens were taken to determine histology, the Helicobacter pylori status, and both tissue CEA immunoreactivity and level. Significantly higher mean pH values, NOC and CEA concentrations, and TVCs were found in partial gastrectomies compared with normal controls. In relation to surgical methods, higher mean pH values, NOC concentrations, TVCs, and anaerobic bacterial counts were observed in the juice of patients with Billroth II compared with Billroth I gastrectomies. Mild CEA immunoreactivity and apical CEA localization were found significantly more often in Billroth II than in Billroth I stumps. Intensive CEA immunoreactivity and cytoplasmatic localization were found significantly more often in Billroth I than in Billroth II stumps. Independent of the type of surgical reconstruction, higher mean NOC levels were recorded in patients with more severe histological changes and H. pylori infection. Higher mean CEA levels in gastric juice and tissue were detected in the gastric stumps with more severe histological changes. All these data suggest that high levels of NOCs in the gastric juice could be a cofactor in gastric stump carcinogenesis and determination of CEA level in gastric juice and tissue could be included as a very useful marker in quantifying this process.
Abstract: PURPOSE: We compared manual versus computer analysis of pressure-flow tracings for diagnosing bladder outlet obstruction in patients with benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 105 patients with a clinical diagnosis of prostate enlargement and lower urinary tract symptoms was included in the study irrespective of free flow rates. Pressure-flow studies were performed in duplicate and tracings were evaluated by 2 independent investigators blinded to patients status. Manual reading of urodynamic printouts and fully computerized analysis using CLIM software were done. All urodynamic parameters relevant to the diagnosis of outlet obstruction were compared using the Abrams-Griffiths and Schäfer nomograms. Group specific urethral resistance factors were also compared. RESULTS: There was good correlation between manual and computer derived values of maximum flow (r = 0.9874, p < or = 0.0001), detrusor pressure at maximum flow (r = 0.9943, p < or = 0.0001), minimum detrusor pressure during voiding (r = 0.8816, p < or = 0.0001) and group specific urethral resistance factor (r = 0.9917, p < or = 0.0001). The diagnosis of outlet obstruction according to the group specific urethral resistance factor, and the Abrams-Griffiths and Schäfer nomograms was highly consistent using the manual and computerized approaches. CONCLUSIONS: Manual analysis of pressure-flow tracings generated by urodynamic equipment and digital data obtained by CLIM software appeared to be highly consistent and equally reliable for diagnosing and grading outlet obstruction.
Abstract: The postoperative course of 172 patients with early gastric cancer (EGC) was followed for a median 7 years to evaluate the causes of death, incidence and patterns of recurrence, and characteristic findings in the recurrent cases. The cumulative 10-year mortality rate (+/- SE) was 22 +/- 3.7%. Seven patients (4.1%) died of operative mortality, 11 (6.4%) died of a recurrence of the gastric cancer and 13 (7.6%) died of unrelated causes. Unrelated causes of death were metachronous primary cancer (n = 6), cardiovascular disease (n = 2), pneumonia (n = 3), sepsis (n = 1), and car accident (n = 1). Four patients died from gastric stump recurrence, three from liver metastases, two from lymph node metastases, and two from peritoneal dissemination. Using Cox multivariate analysis, histologic type had the most significant effect on recurrence. Although influenced by the tumor nature, the EGC prognosis is relatively good. Based on the results of this study, particularly in Western institutions, histologic examination of resection margins and lymphadenectomy should be improved. Moreover, patients must be carefully followed for late recurrence and metachronous cancer.
Abstract: BACKGROUND: This work followed a group of patients living in a psychiatric hospital in Central Italy in 1978 at the time of enforcement of the Italian reform law (No. 180) for closing down mental hospitals. The study had the following aims: a) to compare in terms of mortality patients discharged into the community with patients who did not experience deinstitutionalization; b) to determine the survival of the cohort of patients and to analyse prognostic risk factors for death; c) to analyse differences in mortality rates between psychiatric patients and the general population. METHODS: The study was designed as an historical follow-up investigation. Univariate (product limit) and multivariate (proportional hazards model) methods were used to estimate prognostic variables and related death risks. Mortality was assessed using standardized mortality ratios (SMR) on the entire cohort as well as after stratification according to age, sex, cause of death and discharge status, assuming the Abruzzo Region's population as standard. RESULTS: Length of hospitalization and discharge from hospital are prognostic variables for death risk, with relative risks respectively of 4.22 (95% confidence interval [CI]: 2.41-7.40) for a length of hospitalization of 10-25 years, and 8.13 (95% CI: 4.73-13.88) for non-discharge. The global SMR of the cohort was 2.68 (95% CI: 2.42-3.07). Non-discharged patients showed higher SMR than discharged. Excess mortality was found both in males and females for circulatory, respiratory and undefined diseases. A significantly lower mortality for cancer was observed in male patients. A strong excess mortality was observed in younger patients (20-29 years: SMRmales = 43.57; SMRfemales = 97.52). CONCLUSIONS: Longer periods of hospitalization and non-discharge from hospital are the main risk factors for death in psychiatric patients, who globally experience higher death rates than the general population for a wide spectrum of causes of death, whatever their diagnosis or gender. These findings strongly suggest positive actions in order to overcome the effects of institutionalization.
Abstract: BACKGROUND: It has been suggested that the variation of biochemical and microbiological parameters in the gastric juice may play a role in the development of gastric cancer. In the present study we concurrently assessed the presence of N-Nitroso compounds (NOC) and their precursors, bacteria and carcinoembryonic antigen (CEA) in the gastric juice of normal controls, patients with gastric resection, and advanced gastric cancer. METHODS: Detailed analyses of biochemical and microbiological parameters such as pH, nitrite (NO2) concentration, N-nitroso compounds (NOC) concentration, carcino-embryonic antigen (CEA) level, total viable counts (TVC), nitrate-reductase positive bacterial counts (NRPBC), and identification of micro-organisms were carried out. RESULTS: Significantly higher mean pH values, NO2, NOC and CEA concentrations, TVC, and NRPBC were found in partial gastrectomies compared with normal controls, and all these intragastric parameters were significantly higher in patients with gastric cancer than in those with partial gastrectomies. As far as surgical methods are concerned, higher mean pH values, NO2 and NOC concentrations, TVC, NRPBC, and anaerobic bacterial counts were observed in the juice of patients with Billroth II compared with Billroth I gastrectomies. Apart from the type of surgical reconstruction, higher mean NOC levels were recorded in patients with more severe histological changes and H. pylori infection. CONCLUSIONS: All these data suggest that the presence of high levels of NOC in the gastric juice of gastroresected patients can be considered a risk factor of gastric stump cancer.
Abstract: A total of 100 patients treated with a single session of microwave thermotherapy at 4 European centers was stratified according to 2 different types of obstruction (constrictive and compressive) and compared to clinical outcome at 6 months. Patients had a Madsen-Iversen score of 8 or more, maximum flow rate of 15 ml. per second or less and residual urine volume of 300 ml. or less at entry. The change in Madsen-Iversen score was the same in the 2 groups. Maximum flow rate increased from 8.71 +/- 2.62 to 14.73 +/- 4.04 ml. per second in the constrictive group, and from 8.54 +/- 2.26 to 10.41 +/- 4.52 in the compressive group (p < or = 0.0001). Residual urine decreased from 96.00 +/- 72.85 to 40.34 +/- 56.33 ml. in the constrictive group and from 109.86 +/- 67.09 to 84.65 +/- 81.45 ml. in the compressive group (p < or = 0.0001). Success, as defined by an increase of 50% or more in maximum flow rate and Madsen-Iversen score, was noted in 68% of the constrictive but only 15% of the compressive groups (p < or = 0.0001 chi-square test for trend). Selection by pressure-flow criteria for patients being considered for thermotherapy should improve the overall clinical results.
Abstract: OBJECTIVE: To determine the relationship between acrosome reactions and hamster egg penetration after ionophore challenge in nonteratozoospermic semen samples. SETTING: A tertiary care center, the Andrologic Clinic, Department of Internal Medicine, University of L'Aquila. PATIENTS: Twenty-five nonteratozoospermic patients with infertile marriages and nine fertile men. INTERVENTIONS: The hamster egg penetration assay and the acrosome reaction assessment were performed on capacitated sperm suspensions in basal conditions and after ionophore challenge with ionomycin. MAIN OUTCOME MEASURE: The relationship between the acrosome reactions and the hamster egg penetration was analyzed. RESULTS: Although in basal conditions the spontaneous acrosome reaction rate was not correlated with the hamster egg penetration, after ionophore challenge both the induced acrosome reaction rate and the acrosome reaction increase (induced minus spontaneous acrosome reaction rate) correlated with the hamster egg penetration. The highest correlation was observed between the induced acrosome reaction rate and the penetration index. Considering a penetration index = 2 as the threshold of a good response of the hamster egg penetration assay to the ionophore challenge, significantly lower acrosome reaction rates and increases were associated with poor hamster egg penetration. However, different penetration indexes occurred at the same level of induced acrosome reaction rate. CONCLUSIONS: The capability of sperm to react after ionophore challenge reflects to some extent the capability of the acrosome-reacted sperm to undergo the changes of the plasma membrane that are necessary for sperm-oocyte fusion. The simple evaluation of the acrosome reactions may represent a useful complement rather than a substitute for the hamster egg penetration assay in monitoring the responses of human sperm to the ionophore challenge. An impaired inducibility of the acrosome reactions may account for poor hamster egg penetrations exhibited by nonteratozoospermic semen samples.
Abstract: A new in vitro method for early detection of prostatic cancer is described. The results of tissue culture of prostatic epithelial cells harvested during digital rectal examination were compared with patient-matched biopsy findings in a double-blind study. An arbitrary combination of five culture parameters (displayed in vitro by cultured prostatic cells and related to neoplastic and differentiation features of the sample [growth capacity, proportion of epithelium and morphologic atypia of overlapping cells, multinucleated cells and vacuolized cells]), was created after two weeks of culture; this combination, referred to as the Global Tissue Culture Score (GTCS), ranged from 0 (negative result or benign behavior) to 15 (highly abnormal neoplastic behavior). The GTCS was significantly higher in biopsy-proven prostatic carcinoma than in other prostatic diseases. The combination of GTCS and patient age was highly sensitive and specific for a diagnosis of prostatic carcinoma, according to the biopsy results. Our findings indicate that the early diagnosis of prostatic carcinoma can be obtained by a tissue culture method which allows in vitro growth of epithelial cells harvested through digital rectal prostatic massage. This method is easy to perform, is non-invasive, is able to discriminate between biologically aggressive and non-aggressive neoplasms, and may be useful for mass screening of prostatic carcinoma in conjunction with digital rectal exam. Early diagnosis of prostatic carcinoma may maximize the potential curative value of radical prostatectomy or other forms of therapy for this highly prevalent cancer.
Abstract: Our aims were to design a reproducible method of measuring life-time alcohol consumption in patients with cirrhosis, and to assess the risk of liver decompensation associated with alcohol intake using a case-control design and a multivariate analysis. We studied 439 patients ("cases") with decompensated cirrhosis, and 233 with compensated cirrhosis ("controls"). Mean life-time daily amount and duration of alcohol intake were measured by a standardized questionnaire, whose reproducibility, assessed by interviewing 75 relatives, was 70% for daily alcohol intake and 84% for duration of intake. Better reproducibility was found by re-interviewing patients at discharge from hospital. Daily alcohol intake was significantly higher in males, younger patients and patients with liver decompensation. After stratification according to the average life-time daily alcohol intake, we found a significant increase in the risk of liver decompensation from 125 g ethanol intake per day onwards. No association was found between duration of alcohol intake and risk of liver decompensation. We conclude that alcohol intake can be reliably and reproducibly measured: in patients with cirrhosis, increased alcohol intake is associated with increased risk of liver decompensation, with a significant dose-effect above a daily intake of 125 g ethanol.
Abstract: The efficacy and safety of ipriflavone, a new anti-osteoporotic agent, has been evaluated in an open study in 100 agent, has been evaluated in an open study in 100 osteoporotic women. Ipriflavone was administered as oral capsules dosed at 200 mg, 3 times a day for 12 months. Ninety women completed the study, and the results indicate that the bone mineral density was increased by 2% and 5.8% after 6 and 12 months, respectively. Pain and rachis mobility seemed to be positively influenced by ipriflavone. Only three women complained of side-effects (gastralgia and nausea) and asked to stop the therapy.
Abstract: The postoperative course of 172 patients with early gastric cancer operated between 1974 and 1987 was reviewed with a median follow-up of 7 years. The survival probability at the end of 1989 was 0.916 (excluding operative mortality and other causes of death) or 0.876 when the operative mortality was included. Univariate analysis showed a significant survival difference according to the presence or absence of submucosal invasion (p = 0.02, Log-Rank test) and lymph node invasion (p = 0.04, age greater than or less than 50 years (p = 0.03) and according to the type of resection performed (total gastrectomy with gastric and perigastric lymph node dissection or subtotal gastrectomy with incomplete lymph node dissection (p = 0.05). Eleven patients died from cancer recurrence, one is still alive with a recurrence of the gastric stump. The other deaths were due to cancers of other organs (6), cardiovascular disease (2), pneumonia (3), septicaemia (1) and a car accident. Although the prognosis of early gastric cancer is relatively favourable in European countries, patients must be carefully followed for a long period because of recurrences and the high incidence of cancers in other organs.
Abstract: We carried out a hospital-based, case-control study to assess the association of both the Hepatitis B Virus (HBV) infection and the lifetime daily alcohol intake with the risk of developing hepatocellular carcinoma (HCC) in patients with liver cirrhosis (LC). Cases were 62 consecutive inpatients of a Gastroenterology Division in whom a first diagnosis of HCC superimposed on LC was made. Two control groups were used: 310 patients without liver disease, matched 1:5 with cases and randomly selected from inpatients of the same hospital, and 97 consecutive asymptomatic inpatients in whom the first diagnosis of LC was made. Alcohol intake was quantified in all subjects by a standardized questionnaire. HBV infection was associated with HCC development in cirrhotics (odds ratio = 6.8; 95% confidence interval = 1.4-32.3), whereas we observed a trend towards a decreased HCC risk at increased alcohol intake values (odds ratio from 1 for lifetime abstainers to 0.2 for drinkers of 175 g/day or more). Our results suggest that alcohol intake is not a direct determinant of HCC, but its role is mediated by LC. Cirrhotics with high alcohol intake do not usually survive long enough to develop HCC.
Abstract: A total of 198 alcoholic subjects was recruited into a treatment programme according to Hudolin's method. The programme included three steps: (1) presentation of the programme to the alcoholic family (four meetings); (2) a therapeutic community that met weekly over 4 months; and (3) attendance at an on-Treatment Alcoholic Club located close to the family's home residence (weekly self-conducted meetings). Data on the families' compliance to the treatment programme were obtained in January 1993 and the prognostic significance of 11 variables collected during the first step was determined by the proportional hazards regression model. The cumulative proportion of family compliance after 40 months was 36.4%, with similar drop-out rates at each of the three steps of the programme. The prognostic factor which was the major determinant of family compliance to treatment was the active presence of the whole family in the first step, while a good job performance was independently associated with family compliance, being a significant prognostic factor in the second step of the programme. Alcohol abstinence was obtained in 35.9% of the whole study group. This programme provided results for alcohol abstinence which are comparable with methods that require more expensive resources.
Abstract: In order to assess the interaction between alcohol intake, tobacco smoking and coffee consumption in determining the risk of liver cirrhosis we carried out a hospital-based case-control study involving 115 patients at their first diagnosis of cirrhosis and 167 control patients consecutively enrolled in the General Hospitals of the Province of L'Aquila (Central Italy). The mean life-time daily alcohol intake (as g ethanol consumed daily) was measured by direct patient interviews, whose reproducibility was > 0.80 and similar for cases and controls, as checked by interviewing the relatives of a sample of 50 cases and 73 controls. During the same patient's interview we also measured the mean consumption of coffee (daily number of cups of filtered coffee) and tobacco (life-time daily number of cigarettes smoked). A dose-effect relationship on the risk of cirrhosis was present both for alcohol intake--for which the risk was significantly increased above 100 g of daily intake--and for cigarette consumption. The latter did not however improve the goodness-of-fit of a logistic regression model including alcohol intake as covariate. By contrast, coffee consumption had a protective effect on the risk of cirrhosis and significantly improved the goodness-of-fit of such a model. Abstaining from coffee consumption determined both a significantly increased risk of cirrhosis, even for daily alcohol intake below 100 g, and a multiplicative effect with alcohol intake on this risk. In patients drinking > or = 101 g ethanol daily the relative risk increased from 5.5 (95% confidence interval: 1.4-22.0) for coffee consumers to 10.8 (95% confidence interval: 1.3-58.1) for coffee abstainers.(ABSTRACT TRUNCATED AT 250 WORDS)
Abstract: We assessed the performance of 4 methods of discriminant analysis using as independent variables the age and 16 serum tests, for correctly identifying patients with liver cirrhosis among hospitalized patients affected by chronic liver disease without signs of liver failure; 290 patients entered this study: on the basis of laparoscopy with or without liver biopsy, 152 patients had a diagnosis of liver cirrhosis and 138 were classified as chronic hepatitic patients. Due to the non-multinormal distribution of the variables used and to the unequality of the variance-covariance matrices, we compared the following 4 methods: linear discriminant function, quadratic discriminant function, non-parametric discriminant function and logistic regression. The Receiver Operating Characteristic (ROC) analysis was used to compare diagnostic ability of the assessed methods: the quadratic discriminant function was the best performing method. The predictive ability of this function was compared to that reported for percutaneous liver biopsy, showing that this simple statistical method using age and biochemical tests can efficiently identify liver cirrhosis in the setting of chronic liver disease, reducing the need for invasive diagnostic procedures.
Abstract: The postoperative course of 159 patients with early gastric cancer operated on between 1974 and 1987 was followed for a median of 7.3 years. The cumulative 10-year survival rate(s.e.) calculated using follow-up data to the end of 1989 was 90.6(2.7) per cent excluding operative death and that from causes other than gastric cancer, or 86.3(3.0) per cent when operative mortality was included. The overall 10-year survival rate(s.e.) was 77.3(3.7) per cent. Univariate analysis showed a significant difference in survival rates between cancers confined to the mucosa and those with submucosal invasion (P = 0.02), between patients with and without lymph node metastases (P = 0.05) and between those < or = 50 and > 50 years of age (P = 0.02). Using Cox multivariate analysis and a stepwise procedure for eight variables (sex, age, depth of invasion, lymph node metastases, presence of ulceration, location, histological type, type of surgery), age and histological type had the most significant effect on survival. Seven operative deaths were recorded. Eleven patients died from recurrent cancer and one is still alive with a gastric remnant recurrence. Other causes of death were metachronous primary cancer (six patients), cardiovascular disease (two), pneumonia (three), sepsis (one) and car accident (one). Although the prognosis of early gastric cancer is relatively good in western countries, patients should be carefully followed over a long period for late recurrence and for metachronous cancer, which has a high incidence.
Abstract: We carried out a hospital based case-control study involving 320 patients with symptomatic liver cirrhosis (LC) and 320 pair-matched control individuals, in order to estimate the dose-response relationship between both the daily amount and the duration of alcohol intake and the risk of LC. Lifetime alcohol consumption was measured by a standardized and reproducible questionnaire, and expressed as lifetime daily alcohol intake (LDAI) and duration of alcohol consumption (DAC). The odds ratio (OR) for LC was estimated by the conditional logistic regression. It increased from 1.0 for lifetime abstainers to 4.2 for LDAI of 225 g or more. Comparing durations of alcohol consumption of < or = 10 and > or = 30 years in the model, the ORs consistently decreased for all the LDAI categories: from 4.1 to 0.6 in the 25-50 g category; from 15.1 to 0.9 in the 75-100 g category; from 67.2 to 1.5 in the 125 g or more category. Our results suggest that the dose-dependent relationship between alcohol and LC may be mediated by the degree of individual susceptibility to the detrimental effect of alcohol to the liver.
Abstract: We carried out a population-based prevalence study to assess the association between the presence of alcohol-related problems within the family and the risk of disorders in the children's global functioning level. We enrolled 394 children attending nursery, primary and secondary schools and their parents living in two municipalities in Central Italy. Alcohol-related problems within the family were reported by registered records obtained from general practitioners and teachers, who were considered as preference raters. The children's level of functioning was assessed by teachers, who attributed to each school child a score according to the Children Global Assessment Scale (CGAS). The number of reports of alcohol-related problems within the family and the CGAS scores were considered, respectively, as independent and dependent variables in a multiple logistic regression model for ordinal outcome variables. The children's sex and age, and the age of their parents, the duration of the parents' education and family size were considered as covariates. We found a strong association between a poor level of functioning in the children in the social environment and alcohol-related problems within the family. The prevalence odds ratio (and 95% confidence interval) decreased from 0.5 (range 0.2-1.3) for children whose families were reported by one rater to 0.4 (range 0.2-0.8) for children whose families were reported by two raters, the non-reported families being the reference category, suggesting that the level of functioning of the child decreased as reports of alcohol-related problems in the family increased.
Abstract: The aim of this paper is to analyze important methodological questions in estimates of the prevalence and risk factors in erection disorders. Sampling problems, lack of standardization in epidemiological and clinical data recording, nosographic uncertainties, explain the wide variability of prevalence estimates (2-10%). Lack of standard epidemiological methods produces differences in risk estimates of reviewed factors.
Abstract: Considering the potential unification of philosophic and scientific research methods, on the basis of Popper's theory, a relevant question about the indifference of the method towards the object-event. This work illustrates the Popper-Hempel nomological-inferential model and provides a description of the relationship between psychiatry and bioethics as an example of the unity of science.
