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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2h和术后4d使用20mgSimulect;OKT3组:OKT3每天5mg静滴,从术后第1天开始,连用7~10d。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,Simulect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。
Objective To evaluate the efficacy and safety of Simulect and OKT3 as induction therapy for renal transplantation. Methods 170 primary renal transplant recipients were randomly divided into two groups: Simulect group 62 and OKT3 group 108 cases. All patients were immunosuppressed with cyclosporine A (CsA) / tacrolimus (FK506) + mycophenolate mofetil (MMF) + prednisone triple. Simulect group: 20mgSimulect was used at 2h before surgery and 4 days after operation respectively; OKT3 group: 5mg intravenous infusion of OKT3 every day for 7-10 days from the first day after operation. The acute rejection (AR), delayed graft function (DGF), toxic and side effects and human / kidney survival were observed within 1 year after renal transplantation. Results AR occurred in 34 cases, 6 cases in Simulect group and 28 cases in OKT3 group (P <0.05). Among 5 cases in OKT3 group, there were AR more than 2 times and AR in 7 cases. The incidence of delayed renal transplant (DGF), cytokine release syndrome, allergic reaction and so on, the incidence of Simulect group was significantly lower than the OKT3 group (6vs32,0 vs49,0 vs31, P <0.01). The incidence of Simulect infection was lower in the OKT3 group (16 vs. 45; P <0.05). OKT3 group had 2 cases of grafted nephrectomy, 1 patient died of severe pulmonary infection. Conclusion Simulect is a potent and safe immunosuppressive agent with significant therapeutic effects and less side effects in the induction of renal transplantation.