Clinical research of Hangzhou domestic tacrolimus in liver transplantation / 中华器官移植杂志

ABSTRACT

ObjectiveTo demonstrate the efficacy and safety of Hangzhou tacrolimus capsule (Saishi Tac capsule,Hangzhou Zbongmei Huadong Pharmaceutical Co.Ltd,China) in Chinese liver transplant recipients.MethodsMulticenter,randomized open-labeled,prospective controlled clinical trial was performed in de novo Chinese liver transplant recipients.According to inclusive and exclusive criterion,83 liver recipients from 11transplant centers were enrolled.The recipients accepted Saishi Tac capsule,mycopheolate and steroid 48 h post-operation.The initial dose of Tac was 0.1-0.15 mg kg-1day-1and C0 was 8-12 ng/ml in the first 60 days,followed by 5-10 ng/ml until the terminal observation time poiut (12 weeks after transplantation).The efficacy and safety were estimated during the period.The primary efficacy endpoint of the study was the incidence of biopsy-confirmed acute rejection.Graft survival was the secondary endpoint.Safety was assessed by monitoring laboratory parameters and adverse events reported over the course of the study,such as infection,renal damage,hypertension,hyperlipema and diabetes mellitus and other adverse affairs.ResultsThe dose of Tac at 1st,2nd,4th and 8th week post-operation was (4.1±1.9),(4.5±2.1),(4.5±2.1),(4.4±1.8) and (4.1±2.1) mg,and correspondjng values to the C0 were (8.1±4.5),(8.9±4.5),(8.8±4.3),(8.8±4.1) and (8.0±2.8) ng/ml.During 12 weeks of follow-up,the incidence of biopsy-confirmed acute rejection was 4.8％ (4/83),and all of cases were reversed by implosive therapy.The survival rate of graft hver was 100％.The incidence of lung infection and diabetes mellitus was both 6.02％.ConclusionSaishi Tac capsule was safe and effective to Chinese liver transplant recipients.