Kusajili – Centralise les essais cliniques mondiaux

[Functional outcomes of transvesical single-site versus extraperitoneal laparoscopic radical prostatectomy for low-risk prostate cancer]. To compare the perioperative data, pathological results and functional outcomes of transvesical single- site laparoscopic radical prostatectomy (TVSSLRP) with those of nerve-sparing extraperitoneal laparoscopic radical prostatectomy (nsELRP) in the treatment of low-risk prostate cancer (PCa). Fifty patients with low-risk organ-confined PCa were randomly assigned to two groups of equal number to receive TVSSLRP and nsELRP, respectively. Comparisons were made between the two groups of patients in such demographic and baseline data as age, comorbidity, body mass index (BMI), serum prostate-specific antigen (PSA), prostate volume, bioptic Gleason score, clinical stage, IIEF-5 score, nocturnal penile tumescence (NPT), penile brachial index (PBI), and penile arterial blood flow velocity as well as in such surgery-related parameters as operation duration, blood loss, blood transfusion, intraoperative complications, positive surgical margin, catheterization time, hospital stay, and postoperative Gleason score, pathologic stage, urinal pad use, PSA level, IIEF-5 score, NPT, PBI and PABFV. All the operations were successfully performed. There were no statistically significant differences between the two groups either in the demographic and baseline data or in intraoperative blood loss, blood transfusion rate, complications, and positive surgical margin. No intraoperative complications and positive surgical margins were found in either group. Compared with nsELRP, TVSSLRP achieved a significantly shorter operation duration ([151.46 ± 40.68] min vs [105.92 ± 26.21] min, P <0.05), catheterization time ([13.01 ± 1.64] d vs [11.24 ± 1.17] d, P <0.05), and hospital stay ([15.76 ± 4.65] d vs [12.92 ± 4.29] d, P <0.05). On the first day and at 1, 3 and 6 months after catheter removal, the urinary continence rates in the TVSSLRP and nsELRP groups were 84% vs 52% (P <0.05), 100% vs 84%, 100% vs 96%, and 100% vs 96%, respectively; and at 3, 6 and 12 months after surgery, the erectile potency rates were 48% vs 28% (P <0.05), 64% vs 52%, and 76% vs 68%, respectively, with an IIEF-5 score ≥ 18, all evidently higher in the TVSSLRP than in the nsELRP group. The penile brachial index and arterial blood flow velocity of the two groups of patients exhibited no significant differences before and after surgery, nor did postoperative complications (grade II) between the TVSSLRP and nsELRP groups (32% vs 40%, P >0.05). The Gleason score and pathologic stage were increased after surgery, but with remarkable differences between the two groups (P >0.05). No biochemical recurrence was found in either group during a 12-month follow-up. With the advantages of safety and rapid postoperative recovery, both TVSSLRP and nsELRP are feasible for the treatment of low-risk organ-confined PCa, but the former may achieve an earlier recovery of urinary continence and erectile function than the latter.

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The value of amiodarone for the treatment of unstable angina. Amiodarone is a potent coronary vasodilator; it has alpha and beta receptor-antagonist activity and is well-known for its marked antiarrhythmic efficacy. This report describes the results of a randomized study of amiodarone in unstable angina. 40 patients (33 male, 7 female; mean age: 55) with unstable angina entered the study. They were randomized into two treatment groups. In group I (20 cases), amiodarone was the first drug applied (during the first 3 days; 1500 mg/24 hours IV + 200 mg orally every 8th hour; from day 4 onwards: 200 mg orally 3 times daily). If, after 8 hours following initiation of treatment, the symptoms were still present or recurred, nifedipine was added at a dose of 10 mg 4 times daily. In case of failure of the combined medical treatment, coronary angiography and, if needed, surgery was performed after 16 hours. In group II (20 cases), nifedipine was given as the first drug and at a dose of 10 mg every 6th hour. If, after 8 hours, this therapy failed, amiodarone was added according to the scheme previously described. In case of failure of the combined therapy, coronary angiography and surgery were performed. In group I, amiodarone was successful within 8 hours in 12 cases. None of the non-responders was improved by the addition of nifedipine. In group II, nifedipine was successful within 8 hours in 6 cases (p = 0.086). Among the 14 non-responders, amiodarone controlled the anginal episodes in 11 instances (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

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Regional brain metabolism as the predictor of performance on the Trail Making Test in schizophrenia. A 18FDG PET covariation study. With the aim to indicate the functional anatomical substrate of cognitive dysfunction in schizophrenia we evaluated the relationship between resting brain metabolism and performance on the Trail Making Test (TMT). As the prerequisite analysis we compared the performance in Part A and B of the TMT between schizophrenic patients and controls. Resting brain metabolism was investigated by (18)FDG positron emission tomography (PET) as the probe for the relative regional synaptic strength and density. (18)FDG PET data were analyzed by SPM99 with TMT A and B as the covariate (p< or =0.001). Schizophrenic patients (N=42) had worse performance in both TMT A and B compared to controls (N=42). In schizophrenic subjects (18)FDG PET did not predict the performance on Part A (psychomotor speed) but predicted that for Part B (set-shifting and flexibility) of the TMT. The (18)FDG uptake in the superior, middle and inferior frontal gyruses bilaterally was associated with better performance in the TMT B. The negative covariation between 18FDG uptake and time spent in the TMT B was detected in the temporal and parietal cortices, pre- and postcentral gyruses, precuneus limbic regions (anterior cingulate, uncus) and the pons. Our data indicate that hypometabolism in the frontal lobes and hypermetabolism in the temporo-parieto-limbic regions is the neurobiological basis for deficient TMT B performance in schizophrenia.

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The relationship between ventricular electrical delay and left ventricular remodelling with cardiac resynchronization therapy. The aim of the present study was to evaluate the relationship between left ventricular (LV) electrical delay, as measured by the QLV interval, and outcomes in a prospectively designed substudy of the SMART-AV Trial. This was a multicentre study of patients with advanced heart failure undergoing cardiac resynchronization therapy (CRT) defibrillator implantation. In 426 subjects, QLV was measured as the interval from the onset of the QRS from the surface ECG to the first large peak of the LV electrogram. Left ventricular volumes were measured by echocardiography at baseline and after 6 months of CRT by a blinded core laboratory. Quality of life (QOL) was assessed by a standardized questionnaire. When separated by quartiles based on QLV duration, reverse remodelling response rates (>15% reduction in LV end systolic volume) increased progressively from 38.7 to 68.4% and QOL response rate (>10 points reduction) increased from 50 to 72%. Patients in the highest quartile of QLV had a 3.21-fold increase (1.58-6.50, P = 0.001) in their odds of a reverse remodelling response after correcting for QRS duration, bundle branch block type, and clinical characteristics by multivariate logistic regression analysis. Electrical dyssynchrony, as measured by QLV, was strongly and independently associated with reverse remodelling and QOL with CRT. Acute measurements of QLV may be useful to guide LV lead placement.

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Significance of follow-up left ventricular ejection fraction measurements in the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation trial (DEFINITE). As left ventricular ejection fraction (LVEF) may improve, worsen, or remain the same over time, patients' prognosis may also be expected to change because of the change in LVEF, among other factors. To evaluate the effect of LVEF change on outcome in the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial. Patients with nonischemic cardiomyopathy with LVEF<36%, history of symptomatic heart failure, and the presence of significant ventricular ectopic activity were enrolled in the DEFINITE trial. Follow-up LVEF measurements were obtained annually in only a minority (17%) of trial participants. This study therefore evaluated survival and arrhythmic end points in patients whose LVEF was reassessed between 90 and 730 days after enrollment. During the 90-730-day postrandomization period, 187 of 449 (42%) enrolled patients who survived at least 90 days had at least 1 follow-up LVEF measurement; these patients were younger and white; had diabetes, better 6-minute walk test results, and higher BMI; were more likely to have appropriate shocks; and had fewer deaths compared to those without follow-up LVEF measurements. Patients whose LVEF improved had reduced mortality compared to patients whose LVEF decreased (hazard ratio 0.09; 95% confidence interval 0.02-0.39; P = .001). Survival free of appropriate shocks was not significantly related to LVEF improvement during follow-up. LVEF improvement was associated with improved survival, but not with a significant decrease in appropriate shocks. These data highlight that appropriate caution should be exercised not to extrapolate the positive effect of improved LVEF to the elimination of arrhythmic events.

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Idiopathic retroperitoneal fibrosis: a role for mycophenolate mofetil. Idiopathic retroperitoneal fibrosis (IRPF) is an unusual progressive illness for which consistent therapeutic recommendations have not been devised. The present report describes a collaborative nephrology and urology approach to distinguish IRPF from secondary disease and then combine necessary acute surgical or radiological intervention with short-term corticosteroid and with mycophenolate mofetil (MM) to facilitate steroid tapering and long-term management. 21 patients have been evaluated and followed over a 7-year period, 16 with characteristic IRPF and 5 with secondary retroperitoneal disease. IRPF patients initially received high-dose corticosteroid and MM. We report clinical follow-up along with imaging studies of the retroperitoneum and related organs, serologic markers for systemic disease, and nonspecific acute-phase reactants as indicators of ongoing disease activity. Among IRPF patients, uniform success in stabilizing clinical signs and symptoms, radiological disease in the retroperitoneum and associated organs, and inflammatory indicators have been observed. Corticosteroid therapy can be limited to 6 months or less and MM to approximately 2 years, all with substantial impact on the natural history of IRPF. This is not a randomized, controlled trial, and patients were often referred with prior complications and/or treatments, however, the systematic approach and consistent results support the utility of MM as a safe and effective choice for long-term stabilization in IRPF.

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Naproxen vs. aspirin in osteoarthritis of the hip and knee. This 12-week double-blind trial compared the efficacy and tolerance of naproxen (750 mg/day) with that of aspirin (3.6 gm/day). There was no statistical difference in efficacy between the two trial drugs for any of the objective (e.g., 25-foot walking time) or subjective (e.g., overall severity of symptoms) variables measured. No side effects were experienced by 69% of the naproxen patients and 37.5% of the aspirin patients. There were a statistically greater number and more severe side effects during aspirin therapy than during naproxen therapy (p = 0.002). The results show naproxen to be a potentially useful drug for the treatment of osteoarthritis.

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[Pre-menstrual cyclic mastalgia]. To compare therapeutic effects of placebo with intake of low doses of acetyl-salysilic acid (aspirin) and a compound of retinol, pyridoxine chlorhydrate and tocopherol acetate. The study is a prospective, controlled, triple blinded, randomized trial. From 259 patients, 81 were selected in order to follow rigid criteria of inclusion. They were divided into three groups of 27 patients, taking aspirin, vitamins or placebo respectively. The number of patients in each group was considered satisfactory for statistical analysis. Pain was scored as Grade 1 (without pain), Grade II (moderate pain) and Grade III (severe pain). The Tukey test was applied for comparison of results (statistical significance 5%). Clinical parameters, age, weight, BMI, parity and lactation period were similar for each group. There was a decrease of pain intensity in all groups, that was even more pronounced for the placebo group. Emphasis was given to symptomatic treatment of cyclic premenstrual mastalgia with symptoms considered to be the expression of a physiological process that can be treated with simple drugs or placebo. Usual therapeutic approaches with several drugs are criticized, including results and contraindications. This study based upon acceptable trial methodology (randomized, triple blinded, placebo controlled, prospective) did not show significant differences in the treatment of cyclic mastalgia.

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The influence of dialyzer geometry on blood coagulation and biocompatibility. The influence of dialyzer geometry on blood coagulation, heparin requirement and complement activation was studied in fourteen chronic hemodialysis patients. Each patient was dialyzed with two different cuprophan dialyzers, hollow fiber GF 120M and parallel plate Lundia IC5N. Both dialyzers had a wall thickness of 11 microns, surface area of 1.2 m2 and both were sterilized with ethylene oxide. Heparin doses were individually titrated. The mean heparin dose was 6089 +/- 988 U. Platelet count decreased from 218 x 10(9)/l to 193 x 10(9)/l and from 235 x 10(9)/l to 197 x 10(9)/l respectively (hollow fiber/plate dialyzer, ns). The number of leucocytes decreased at 15 min after start of dialysis by 56% and 61% (hollow fiber/plate dialyzer, ns). The heparin requirement, measured as prolongation of whole blood activated coagulation time after identical doses of heparin, were the same in hollow fiber and plate dialysis sessions. The arterial fibrinopeptide A concentrations increased during dialysis from 5.4 to 7.1 nmol/l and 8.5 to 9.6 nmol/l respectively (hollow fiber/plate dialyzer, ns). The residual blood volume in the hollow fiber dialyzers was 1.3 +/- 1.1 ml and in the plate dialyzers 1.5 +/- 0.9 ml (ns). C3a activation, indicated by a marked arterio-venous difference, was observed at 15 min after start of dialysis with hollow fiber as well as plate dialyzers. The arterio-venous difference was less pronounced at the end of dialysis. There were no differences in C3a activation between hollow fiber and plate dialyzers at any timepoint. It is concluded that dialyzer geometry does not significantly influence platelet count, blood coagulation, heparin requirement or complement activation.

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Clinical and microbiological effects of daily brushing with either NaF or SnF2 gels in subjects with fixed or removable dental prostheses. 61 adults, with fixed or removable dental protheses, completed a 6-month double-blind trial comparing the clinical and microbial effects of brushing twice daily with either 0.22% NaF or 0.4% SnF2. Those subjects brushing with SnF2 had less gingivitis and fewer bleeding sites for both "total teeth" and "abutment teeth". Plaque scores between groups were only statistically different for the "abutment teeth". The microbial parameters, salivary S. mutans and subgingival plaque total CFU, were significantly reduced in the SnF2 group. In both treatment groups, there was a reduction over the course of the study in the number of subjects with recoverable A. actinomycetemcomitans and black pigmented bacteroides, yet there was no difference between groups.

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