作者: Georges‐Philippe Pageaux , Yvon Calmus , Olivier Boillot , Christian Ducerf , Claire Vanlemmens
DOI: 10.1002/LT.20291
关键词: Regimen 、 Gastroenterology 、 Randomized controlled trial 、 Liver transplantation 、 Incidence (epidemiology) 、 Medicine 、 Prednisolone 、 Basiliximab 、 Placebo-controlled study 、 Placebo 、 Surgery 、 Internal medicine
摘要: Some clinical studies in liver transplantation have recently reported safety advantages and similar acute rejection rates with early steroid withdrawal. The aim of this study was to evaluate the efficacy an immunosuppressive regimen withdrawal at day 14. A multicenter, 1-year, comparative, double blind, placebo-controlled performed. Patients undergoing a first cadaveric were recruited all received basiliximab + cyclosporine intravenous methylprednisolone. without severe postoperative complications randomized 7 receive maintenance Neoral (cyclosporine) prednisolone (group 1) or steroids (Neoral placebo; group 2), after 7-day blinded oral tapering period. total 174 patients 1: n = 90; 2: 84). incidence biopsy-confirmed treated 6 months 38.1% 2 vs. 24.4% 1 (P .03) trend for higher Grade II / III (28.6% 18.9%; P .12). Changes from baseline regard metabolic parameters (glycemia, cholesterol, triglycerides). toward better glucose tolerance observed, as fewer antidiabetic treatment placebo (2 10). In conclusion, double-blind, 14 showed rejection, only balanced by lower need treatment.