Simulect和OKT3诱导治疗应用于肾移植临床的疗效比较

目的评价Simulect和OKT3作为肾移植诱导治疗的有效性和安全性.方法将170例首次肾移植受者随机分为两组:Simulect组62,OKT3组108例.所有患者免疫抑制维持治疗均用环孢素A(CsA)/他克莫司(FK506) 霉酚酸酯(MMF) 泼尼松(Pred)三联.Simulect组:分别于术前2 h和术后4 d使用20mg Simulect:OKT3组:OKT3每天5 mg静滴,从术后第1天开始,连用7～10 d.观察两组在肾移植术后1年内急性排斥反应(AR)、移植肾功能延迟恢复(DGF)、毒副作用和人/肾存活情况.结果有34例发生AR,Sinulect组6例,OKT3组28例(P＜0.05),其中OKT3组5例出现2次或2次以上AR,7例AR需要ATG治疗逆转.移植肾功能延迟恢复(DGF)、细胞因子释放综合征、过敏反应等方面,Simulect组发生率明显低于OKT3组(6vs32,0vs49,0vs31,P＜0.01).Simulect组感染发生率低于OKT3组(16vs45;P＜0.05).OKT3组有2例移植肾切除,1例死于严重肺部感染.结论Simulect在肾移植免疫诱导治疗中疗效显著,副作用少,是一种强效安全的免疫抑制剂.

Effect of Simulect and OKT3 induction therapy in renal transplantation

Objective:To evaluate the efficacy and safety of Simulect and OKT3induction therapy in renal transplantation.Methods:One hundred and seventy recipients were retrospectively analyzed and divided into Simulect group and OKT3group.Maintenance immunosuppressive therapy regimen consisted of prednisone,acrolimus or cyclosporine A and mycophenolate mofetil in all recipients.Simulect group received2-dose Simulect(20mg)intravenous infusion2hours before operation and on postoperative day4.OKT3group received OKT3(5mg/d)intravenous infusion from postoperative day1to day7or10.Acute rejection,delayed graft function,side ef-fects and survival rates of grafts and recipients within1year after transplantation were observed.Results:During a follow-up1year6cases were subjected to acute rejection(AR)in Simulect group and28in OKT3group(P<0.05).In OKT3group5cases were subjected to second acute rejection,7cases of AR required ATG therapy.The inci-dences of delayed graft function,cytokine release syndrome and allergic reaction in Simulect group were significantly lower than that in OKT3group(6vs32,0vs49,0vs31;P<0.01).The incidences of delayed graft function,cy-tokine release syndrome and allergic reaction in Simulect group were significantly lower than that in OKT3group(6vs32,0vs49,0vs31;P<0.01).The incidences of infection in Simulect group was lower than that in OKT3group(16vs45;P<0.05).Conclusions:Simulect is a safe and effective induction therapeutic agent and can substitute for OKT3in renal transplantation.