阿来佐单抗行肾移植免疫诱导治疗的有效性和安全性

目的 评价阿来佐单抗行肾移植免疫诱导治疗的有效性和安全性.方法 将89例肾移植受者随机分为试验组(43例)和对照组(46例).试验组于肾移植术前和术后24 h内分别静脉滴注阿来佐单抗15 mg,对照组不接受免疫诱导治疗.受者术后常规应用环孢素A(或他克莫司)+吗替麦考酚酯+泼尼松预防排斥反应.统计两组术后12月内的移植肾功能、急性排斥反应发生率、感染发生率、移植肾功能延迟恢复发生率、移植肾存活率及淋巴细胞计数,并用ImmuKnowTM免疫细胞功能测定法检测受者CD4+T淋巴细胞的三磷酸腺苷(ATP)值.结果 术后12个月内试验组7.0%(3/43)的受者发生病理证实的急性排斥反应,明显低于对照组的23.9%(11/46,P＜0.05).试验组和对照组总体的感染发生率为别为39.5%(17/43)和30.4%(14/46,P＞0.05),两组机会性感染的发生率分另为23.2%(10/43)和17.4%(8/46,P＞0.05).术后3个月内,试验组淋巴细胞计数低于对照组;术后6个月内,试验组CD4+T淋巴细胞ATP值低于对照组.结论 阿来佐单抗行肾移植免疫诱导治疗可维持受者的免疫抑制状态,未见严重不良反应.

Efficacy and safety of Alemtuzumab induction in kidney transplantation

Objective To evaluate the efficacy and safety of alemtuzumab in renal transplant recipients treated with induction therapy. Methods Eighty-nine cadaveric renal transplant recipients in our department were randomly divided into experimental group (n = 43) treated with alemtuzumab induction, 15 mg i. v. and control group (n = 46). Main immunosuppressive therapy regimen consisted of steroids, tacrolimus or cyclosporine and mycophenolate mofetil in all recipients. Post-transplant kidney function, acute rejection,infection, DGF, graft survival, lymphocyte counts were recorded within 1 year. ATP values in CD4+ T cells after transplantation was determined by using Cylex ImmuKnow assay. Results There was significant difference in the incidence of biopsy-proven acute rejection, but no significant difference was found in ImmuKnow ATP values during 6 months after transplantation and lymphocyte counts during 3 months, graft survival and the incidence of infections between the two groups. Conclusion Induction therapy with alemtuzumab appeared to be effective in the prevention of acute rejection.