达利珠单抗联合环孢素A、霉酚酸酯及糖皮质激素预防肾移植后急性排斥反应

Multi-center,open-labeled clinical trial of 2-dose daclizumab (Zenapax) in combination with MMF,CsA,and corticosteroids for the prevention of acute rejection in renal allograft recipients

目的 观察达利珠单抗联合环孢素A、霉酚酸酯和糖皮质激素预防肾移植后急性排斥反应的有效性和安全性。方法 由 15家肾移植中心参加的开放性临床试验 ,共纳入 72例首次尸肾移植受者为研究对象 ,在接受环孢素A、霉酚酸酯和糖皮质激素联合应用预防肾移植后急性排斥反应的同时 ,给予 2剂人源化达利珠单抗 ,首剂给予时间为术前 2 4h内 ,第 2剂在术后第 14d给予。对入选患者密切随访 ,评价肾移植后 3个月和 6个月时急性排斥反应的发生率、严重程度以及人、肾存活率 ;评价该治疗方法的安全性。结果 术后 3个月内有 3例患者发生 4次急性排斥反应 ,3个月及 6个月的排斥反应发生率均为 5 .5 6 % ;人 /肾 6个月和 1年的存活率分别为 95 .8% / 95 .8%和 94 .5 % /94 .5 % ;仅有 1例的腹痛可能与达利珠单抗有关。结论 2剂达利珠单抗联合环孢素A、霉酚酸酯和糖皮质激素预防肾移植后的急性排斥反应安全有效。

Objective To evaluate the efficacy and safety of 2-dose Zenapax in combination with MMF, CsA, and corticosteroids for the prevention of acute rejection in renal allograft recipients.Methods Fifteen kidney transplantation centers in China participated in this clinical trial, and 72 primary cadaveric renal allograft recipients were enrolled. 2-dose Zenapax in combination with MMF, CsA, and corticosteroids was used for the prevention of acute rejection in kidney allograft recipients. All recipients were followed up for at least 6 months; The incidence and severity of acute rejection, the patient and graft survival rate at 3rd and 6th month were observed; the incidence of infection and side-effects were also recorded. Results In the group of 2-dose Zenapax in combination with MMF, CsA, and corticosteroids, the incidence of acute rejection was 5.56?% , 5.56?% at 3rd month and 6th month respectively; the patient/graft survival rate was 95.8?% / 95.8?% and 94.5?% / 94.5?% at 6 month and 1 year after operation respectively; no clinical adverse events highly relevant with Zenapax were observed.Conclusion The efficacy and safety of 2-dose Zenapax in combination with MMF, CsA, and corticosteroids for the prevention of acute rejection in renal allograft recipients were confirmed.