舒莱预防肾脏移植物急性排斥反应的随机对照试验研究

目的：探讨白细胞介素2受体单克隆抗体——舒莱（Simulect）对移植肾急性排斥反应的预防作用以及用药的安全性与药物的毒副作用。方法：将我器官移植移植中心1999年3月～2002年10月共46例肾移植受者为研究对象，随机分成舒莱组（23例）和对照组（23例），两组肾移植术后均接受以Neoral为基础的三联免疫抑制剂。舒莱组术前2h和术后4d各给予舒莱20mg静脉滴注。观察急性排斥反应、Neoral、皮质激素和硫唑嘌呤用量及药物的毒副作用。实验室检测血CsA浓度和肝肾功能。结果：研究结果表明，舒莱组无1例发生急性排斥反应，对照组术后8周内发生3例4次急性排斥反应。两组均未发生明显的毒副作用。两组间Neoral用量及血CsA浓度无明显差异。对照组因发生急性排斥反应，8周内皮质激素用药量总量大于舒莱组。结论：舒莱对移植肾急性排斥反应具有明显的预防作用，且用药方法简便，疗程短，无明显的毒副作用。

Randomised trial of simulect versus placebo for control of acute rejection in renal allograft recipients

Objective:To study the efficacy and safety profile of Simulect,anti-IL-2R monoclonal antibody,and prevent the acute rejection in renal allograft recipients.Methods:46 patients were treated with Neoral-based immunosuppressive agents combined with or without Simulect in March 1999-October 2002 in our organ transplant center.The 46 patients were classified into two groups,group Simulect and group control randomly.The all patients in both groups received Neoral,Azatheoprine and steroid conventionally,but the patients in group Simulect were given Simulect additionally with the first dose of Simulect 20mg,2 hours preoperatively and the second dose of 20 mg 4 days postoperatively.Thereafter,acute rejection,dosage of Neoral,steroids and Azatheoprine as well as the toxicity of these agents and Simulect were closely monitored.In addition,the trough level of CsA in whole blood,liver and renal functions were also monitored.Results:In 8 weeks post-transplantation,3 cases of group control recipients experienced 4 episodes of acute allograft rejection,but none of group Simulect recipients had it(P<0.01).No patients in both groups were associate with toxicity,such as cytokin release syndrome,CMV infection and post-transplantation lymphoproliferative disorders(PTLD) and so on.No significant difference of dosage of Neoral and trough level of CsA were found in the patients in both groups.The total dosage of corticosteroids in the patients of the group control was higher than group Simulect because of acute rejection(P<0.05).Conclusions:Simulect prevented the recipients of kidney transplantation from acute rejection effectively,with a simple administration,short course and very well safety profile.kidney transplantation;graft rejection;Simulect