The Study Of Efficacy And Safety Of Tacrolimus In Renal Transplantation

BackgroundRenal transplantation has been generally accepted as the main treatment for end-stage renal disease. The use of CsA is a milestone in the development process of renal transplantation in 1978. Since then, this science has entered CsA times. In 1989,A new immunosu- ppressant tacrolimus which mechanism is similar with CsA is appli- ed in the clinical trial in Starzl organ transplant center of the Univer- sity of Pittsburgh and achieved good results in the United States. FK506 was applied formally in the clinical in our country from April 1999. Clinical Practice has proved that tacrolimus is a potent immu- neosuppressants.However, the efficacy and safety is still controver- sial about the application of tacrolimus in renal transplantation.ObjectiveThe aim of this study is to evaluate the efficacy and safety of tacrolimus in renal transplantation.Methods:We retrospectively analysed the treatment of patients after cad- averic renal transplantation from March 2002 to March 2006 in this paper. The experimental group is FK506 group, the control group is CsA group. The study be divided to two parts : The first part which observe the effecacy about the application of FK506 in renal transpl- antation,have observed a one-year patient / graft survival rate,the in-cidence of AR,AR reversal rate.The second part which observe the safety about the application of cyclosporine A in renal transplanta- tion,have observed the morbidity of CMV pneumonia,the incidence of drug-induced hepatotoxicity and nephrotoxicity, the morbidity of PTDM,the morbidity of hyperlipidemia.Results1.The comparison of efficacy between tacrolimus and cyclosporineA(1)There was no significant difference in one-year patient / graft survival rate between FK506 Group and CsA Group (P >0.05).(2) The incidence of AR was significantly lower in FK506 Group than in CsA Group (P <0.05),but there was no significant difference in AR reversal rate between FK506 Group and CsA Group (P < 0.05).2.The comparison of safety between tacrolimus and cyclosporine A(1) There was no significant difference in the morbidity of CMV pneumonia between FK506 Group and CsA Group (P >0.05).(2)The morbidity of hyperlipidemia were significantly lower in FK506 Group than in CsA Group (P <0.01).(3) The incidence of drug-induced hepatotoxicity and drug-induced nephrotoxicity was significantly lower in FK506 Group than in CsA Group ,the morbidity of PTDM was significantly higher in FK506 Group than in CsA Group (P <0.05). Conclusions(1)FK506 is more effective than CsA in preventing AR.(2)FK506 is more safe than CsA ,it can significantly reduce the morbidity of hyperlipidemia, it can efficiently reduce the incidence of drug-induced hepatotoxicity and drug-induced nephrotoxicity,but it does not raise the morbidity of CMV pneumonia.(3)The morbidity of PTDM was significantly higher in FK506 Group than in CsA Group.