阿来佐单抗行肾移植免疫诱导治疗的有效性和安全性

Efficacy and safety of Alemtuzumab induction in kidney transplantation

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.

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.