Multicentre international liver tumour study protocol of the case-control study on hepatocellular cancer

Toxicological evidence has recently shown that cyproterone acetate (CPA) is associated with increased adduct formation in liver cell cultures that was interpreted as a possible sign for genotoxicity. Likewise, a few spontaneous reports of liver cancer associated to CPA were published. This led to an alert announced by the German Drug Regulators. One reason to design a case-control study on hepatocellular cancer (HCC) and oral contraceptives (OC's) use (and specific subtypes such as CPA-containing ones) was that other clinical or pharmacoepidemiological studies were not available which dealt with this suspicion. This idea got support from the fact that most of the earlier case-control studies on HCC and OC were small, did not sufficiently control for confounding by: hepatitis B and C, exposure at work, use of other potentially hepatotoxic drugs and also did not distinguish between different types of OC's. Objectives, hypotheses, methods used and subjects studied are described in this paper. The study began in six countries (Germany, United Kingdom, France, Italy, Spain, Greece) on 1 July 1994. It will be finished by the end of June 1996, and first results can be expected by the end of 1996 or early 1997.     

Cerebrospinal fluid cyclic AMP and acid monoamine metabolites following probenecid: Studies in psychiatric patients

At probenecid levels greater than 10 g/ml, CSF cAMP was independent of CSF probenecid concentration. At these levels of probenecid, cAMP transport out of CSF is probably maximally blocked and cAMP levels reflect cAMP release into CSF. CSF cAMP was significantly higher in RDC-diagnosed schizophrenics than in other psychotics or depressives. A significant decrease in CSF cAMP was found in psychotic patients treated with chlorpromazine. No changes in CSF cAMP were observed in patients treated with tricyclic antidepressants or lithium.     

High-dose immunoglobulin therapy for Guillain−Barré syndrome in Japanese children

BACKGROUND: Guillain-Barré syndrome (GBS) is an acute acquired demyelinating polyneuropathy, presumed to be immune-mediated. Intravenous immunoglobulin (IVIg) has been used to treat GBS and was found to be effective. However, a well-controlled study of pediatric GBS has not been conducted in Japan. Therefore, to evaluate the efficacy of IVIg in the treatment of GBS, an open-labeled study was performed in pediatric patients. METHODS: Participants in the study were required to be younger than 15 years old, and diagnosed as having moderate or severe GBS. IVIg (400 mg/kg per day) was administered to patients for five consecutive days. Predefined outcome measures were defined on a seven-point scale of motor function (Hughes' functional grade [FG]). RESULTS: Eleven patients were treated with IVIg. The median time taken to improve by one grade on the FG scale was 10.0 days after initial treatment. Two weeks after initial treatment, 72.7% of patients treated with IVIg improved by one or more grades, and 36.4% improved by two or more grades, measured on the FG scale. After 4 weeks an improvement by one or more grades was observed in 81.8% of patients, and two or more grades in 63.6% of patients. These improvement rates were markedly greater than would occur with the natural course of GBS1. Adverse events (subjective symptoms or abnormal laboratory findings) were observed in four patients, although all were temporary and mild. CONCLUSIONS: The authors conclude that IVIg is a safe and effective treatment for childhood GBS, which shortens the time to recovery.     

PSA screening for prostate cancer: The current controversy - a viewpoint

Prostate cancer is an important health problem. Randomized trialshave not yet proven whether or not screening with prostate-specificantigen measurements reduces morbidity or mortality. The potentialfor overtreatment of prostate cancers not destined to causefuture mortality, the uncertainty about the benefits of aggressivetreatment of screen-detected cancers, and the relatively highcosts of prostate cancer screening programs are all areas ofconcern. A shared approach to decisions about screening individualpatients pending better evidence is one strategy for cliniciansto consider in dealing with this controversial problem. mass screening, prostatic neoplasia, prostate-specific antigen     

Factors associated with liver biopsy performance in HCV-HIV coinfected injecting drug users with HCV viremia: Results from a five-year longitudinal assessment

The last international consensus conference about hepatitis C virus (HCV) treatment emphasized the importance of treatment for persons coinfected with HCV and human immunodeficiency virus (HIV). As liver biopsy precedes treatment, we aimed to identify factors associated with the performance of liver biopsy among HIV-HCV coinfected drug users during a 5-year follow-up to study their access to HCV treatment. Of the 296 patients followed in the HIV hospital departments of Nice and Marseilles and with retrievable records about HCV diagnosis and care, 166 were eligible for analysis having had detectable HCV RNA at least once during the study period. Overall, 45.2% of patients underwent liver biopsy during follow-up. Using proportional hazard models, predictors of having had a liver biopsy were high social support, complete abstinence from drug injection, and lack of immunosuppression as well as male gender, no history of multiple incarcerations, more recent onset of drug use, and an increase of liver enzyme levels. These results suggest that specific efforts should be devoted to HIV-HCV coinfected drug users to assist with stabilizing these patients to optimize their access to HCV care whenever possible. The MANIF 2000 study group includes C. Boirot, A. D. Bouhnik, M. P. Carrieri, J. P. Cassuto, M. Chesney, P. Dellamonica, P. Dujardin, S. Duran, J. G. Fuzibet, H. Gallais, J. A. Gastaut, G. Lepeu, D. A. Loundou, C. Marimoutou, D. Mechali, J. P. Moatti, J. Moreau, M. Nègre, Y. Obadia, I. Poizot-Martin, C. Pradier, D. Rey, C. Rouzioux, A. Sobel, B. Spire, F. Trémolières, and D. Vlahov.     

Arterial intervention and reduction in amputation for chronic critical leg ischaemia

BACKGROUND: Untreated chronic critical leg ischaemia (CLI) usually leads to an amputation or death of a patient. Surgical and endovascular interventions may improve arterial flow. Long infrainguinal reconstruction may be the most useful method for preventing amputations. The value of different reconstruction methods was assessed by their impact on amputation incidence. METHODS: A nationwide 2-year analysis of the incidence of major amputations and reconstructions for CLI was done in Finland (population 5.1 million). Incidences were compared in hospital regions with more than 150 000 inhabitants. RESULTS: The overall amputation incidence was 216 per million inhabitants per year. The corresponding incidence of arterial reconstructions was 203 per million inhabitants per year. There were large variations in the incidence of amputations and reconstructions; 20-fold differences in infrapopliteal surgical reconstructions and 30-fold differences in endovascular procedures were found. There was a correlation between a high incidence of infrapopliteal surgical reconstructions and a low incidence of amputations. This correlation was found for below-knee amputations only. CONCLUSION: These results suggest that long surgical reconstructions improving perfusion directly to the ischaemic tissue can improve leg salvage.