OBJECTIVE: To examine the factors associated with liver steatosis in severely obese subjects and to test the potential reversibility of fatty liver after weight loss. DESIGN: Retrospective clinical study. SUBJECT: 528 obese patients before bariatric surgery and 69 obese subjects of the initial cohort evaluated before and 27 AE 15 months after gastroplasty. MEASUREMENTS: Fatty deposition (scored as mild, moderate or severe) and in¯ammatory changes were evaluated in liver biopsies; clinical (body mass index (BMI), age, gender, duration of obesity) and biological (glucose, triglycerides, liver enzymes) parameters were related to histological ®ndings. RESULTS: 74% of the 528 biopsies showed fatty change, estimated as mild in 41% of cases, moderate in 32% and severe in 27%. The prevalence of steatosis was signi®cantly higher in men than in women (91% vs 70%, P 0.001) and in patients with impaired glucose tolerance or type 2 diabetes compared with nondiabetics (89% vs 69% P 0.001). The severity of the steatosis was associated with BMI (P 0.002) but not with the duration of obesity or the age of the patient. When compared with patients without fatty change, those with liver steatosis had signi®cantly higher fasting plasma glucose (5.5 mmol/l vs 5.1 mmol/l, P 0.007) and triglycerides (1.8 mmol/l vs 1.3 mmol/l, P 0.002). Mean serum liver enzyme activities (alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyl-transpeptidase (gGT) were signi®cantly (P`0.001) increased in patients with fatty change but remained within laboratory reference values. In the 69 patients who have been evaluated after a marked weight reduction (732 AE 19 kg), 45% of the biopsies were considered as normal (vs 13% before, P`0.001) while pure fatty change was still observed in 38% of the patients (vs 83% before, P 0.001). However, the severity of the steatosis was signi®cantly (P`0.001) reduced (mild: 62% vs 21%; moderate: 23% vs 37%; severe: 15% vs 42%). In addition, a signi®cant increase of hepatitis was observed in 26% of the biopsies (vs 14% before, P`0.05). CONCLUSIONS: Liver steatosis in obese subjects is associated with men, diabetic status, BMI, higher fasting glucose and hypertriglyceridaemia. Postgastroplasty weight loss reduces liver steatosis, but seems to increase the incidence of in¯ammatory lobular hepatitis.

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To our knowledge, this study is the first to demonstrate BSP expression in human prostate cancer and to highlight the protein's statistically significant prognostic value in patients with clinically confined prostate adenocarcinomas.

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In the first two documents [Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewé, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, J. Pharm. Biomed. Anal. 36 (2004) 579-586; Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewé, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, E. Rozet, J. Pharm. Biomed. Anal., in press], a recent SFSTP Commission on the validation of analytical procedure has introduced a harmonized approach for the validation of analytical procedures. In order to complete this guide, the statistical methodology allowing to correctly conclude about the validity of a procedure is proposed in this third part of the guide. Indeed all the steps to obtain the decision tool namely the accuracy profile are described and illustrated step by step by a numerical example. This tool, based on the concept of total error (bias+standard deviation) build with a beta-expectation tolerance interval, allows to easily take the right decision and simultaneously minimizing the risk of the future use of the analytical procedure.

The aim of this study was to compare prospectively the incidence of incisional hernia in two groups of patients operated on for morbid obesity, with or without intraperitoneal polyglactin mesh. From October 1990 to September 1993, a total of 288 patients were randomly assigned to the two groups. There were 144 patients in the mesh group and 144 in the no-mesh group. Altogether 240 patients (83%) were reviewed personally, 45 (16%) were interviewed by phone (n = 39) or mail (n = 6), and 3 (1%) were inaccessible for follow-up since discharge from the hospital. The mean follow-up period was 29.8 months (range 0-67 months). A total of 33 incisional hernias were observed in the mesh group and 41 in the no-mesh group. There was no significant difference in the distribution of herniation time between the two groups (p = 0.43). The two main predictive factors of herniation were age and weight. In conclusion, the use of an intraperitoneal polyglactin mesh does not prevent postoperative incisional hernias in obese patients.

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