达利珠单抗预防致敏受者肾移植后排斥反应的临床研究

Prevention of rejection by Simulect (basiliximab) in sensitized kidney allograft recipients

目的 探讨用达利珠单抗诱导治疗预防致敏受者肾移植后急性排斥反应的有效性与安全性。方法 将 36例群体反应性抗体为 30 %～ 5 0 %的致敏受者随机分为舒莱组和对照组 ,各 18例 ,舒莱组患者于移植术前 2h和术后第 4d接受达利珠单抗 (2 0mg/次 )诱导治疗 ,两个组术后均以环孢素A、霉酚酸酯和皮质激素预防排斥反应。结果 舒莱组术后 3个月内的急性排斥反应发生率明显低于对照组 (P <0 .0 1) ;术后 2～ 4周内对照组平均每日皮质激素用量明显高于舒莱组 ;两个组人 /肾 1年存活率的差异无显著性 ;舒莱组术后肾功能的恢复较对照组快 ,但差异无显著性 ;舒莱组术后1周内CD2 5 + 淋巴细胞数明显降低 (P <0 .0 1) ;未观察到达利珠单抗的相关不良反应。结论 在合理筛选供受者的基础上 ,致敏受者肾移植前接受达利珠单抗诱导治疗可降低术后急性排斥反应的发生率 ,且较为安全。

Objective To explore the validity and security of Simulect (basiliximab) induction immunosuppressive therapy in terms of prevention of acute allograft rejection in sensitive recipients.Methods Thirty-six adult recipients of cadaveric kidney transplant with panal reactive antibody 30 %～ 50 % were assigned randomly in a 1∶1 ratio to receive either two doses Simulect or matching placebo. Both patient groups also received baseline triple immunosuppression with the cyclosporine microemulsion, MMF and steroids. A total 40 mg Simulect was given in two doses of 20 mg eachon day 0 about 2 h before transplantation and the day 4 after transplantation respectively.Results No hyperacute rejection and delayed graft function occurred in the two groups. No apparent adverse and toxic events were recorded in the Simulect group. The incidence of acute rejection 3 months after transplantation was 11.1 % in Simulect group compared with 50 % in the placebo group ( 77.8 % reduction, P< 0.01). The mean daily dose of steroids was significantly higher in the placebo group during 2 to 4 weeks post-transplantation. No clinically meaningful differences in the mean dose of cyclosporine were observed between the two groups; in addition, there were no statistically significant differences in the rate of patient/graft survival.Conclusion On the basis of rational selection of the donor and recipient, Simulect is effective and safe for the sensitive recipients as immune induction before transplantation.