Simulect和Zenapax应用于肾移植诱导治疗的5年临床观察  

Five-year clinical study of Simulect and Zenapax in renal transplantation

作　　者：方针强[1] 贾维胜[1] 黄赤兵[1] 王平贤[1] 鲁猛[2] 冯嘉瑜[1] 肖亚[1] 张艮甫[1] 叶钢[1] 

机构地区：[1]第三军医大学新桥医院泌尿外科,重庆400037 [2]四川省广元市旺苍县中医院,628200

出　　处：《重庆医学》2006年第15期1347-1349,共3页Chongqing medicine

摘　　要：目的评价2剂Simulect和5剂Zenapax在肾移植中诱导治疗预防急性排斥反应（AR）的有效性、安全性以及对近、远期人／肾存活的影响。方法选择1999年4月～2001年4月首次肾移植患者102例，分成Simulect组（54例）和Zenapax组（48例），在三联免疫抑制剂基础上（环孢素A／FK506、骁悉、皮质激素）加用Simulect（术前2h和术后第4天分别予20mg静滴）或Zenapax（1mg·kg^-1·d^-1，最大剂量100mg，首剂术前2h，此后每2周1剂，共5剂）。观察术后3个月内肾功、AR、移植肾功能延迟恢复（DGF）、急性肾小管坏死情况；术后5年内肾功、排斥反应、并发症及人／肾存活情况。结果术后3个月内AR发生率明显降低（Simulect组：14．8％；Zenapax组：14．6％）；首次AR发生时间延迟；激素治疗对大部分AR有效；5年内再次排斥反应发生率为9．3％（Simulect组）和6．3％（Zenapax组）。术后肾功能恢复明显加快，早期及远期肾功能良好。未出现细胞因子释放综合征，仅2例DGF。5年内，感染、糖尿病、高脂血症、恶性肿瘤等未见增加。5年人／肾存活良好，均达95％以上。结论2剂Simulect和5剂Zenapax预防肾移植术后AR的效果好、安全性高，有利于早期肾功能恢复和远期人／肾存活。Objective To evaluate the efficacy,safety for prevention of acute rejection（AR） and effect on long-term survival of patient/graft of two-dose Simulect and five-dose Zenapax in renal transplantation. Methods A total of 102 renal transplant recipients were randomized into 2 groups： Simlulect group （54 cases） and Zenapax group （48 cases）. All the cases received the triple therapy of cyclosporine/FK506,mycophenolate mofetil and prednisolone （CsA/FK506＋ MMF ＋ Pred） . Simlulect group received two-dose Simlulect （20 mg intravenous infusion） 2h before operation and 4d after transplantation. Zenapax group received five-dose Zenapax （50mg） at ld before operation and once per two weeks after transplantation. The renal function, AR,delayed graft function（DGF） and acute tubular necrosis（ATN） were observed within 3 months post-transplantation. The renal function, rejection, complications and patient/graft survival were observed for 5 years. Results The rate of AR was cut down significantly（Simulect group：14.8 % ; Zenapax group：14.6 %） ;the time of the first AR episodes was delayed; MP therapy was effective for most of AR; the rates of second rejection of two groups in 5 years were 9.3% （Simulect group） and 6.3% （Zenapax group）, respectively. The recovery for renal function was faster. The early and later renal function was fine. No cytokine release syndrome was observed and only 2 eases of DGF. No increase in infection, diabetes,hyperlipoidemia and malignant tumor in 5 years. The survival rates of 5- year patient/graft were above 95%. Conclusion Two-dose Simulect and five-dose Zenapax for preventing AR in renal transplantation have good therapeutic effect and safety and are beneficial to early recovery of renal function and later patient/graft survival.

关 键 词：SIMULECT ZENAPAX 肾移植 

分 类 号：R699.2[医药卫生—泌尿科学] R979.5[医药卫生—外科学]