肾移植后应用雷帕霉素口服液的两年临床观察

Two-year experience with rapamycin in kidney transplantation

目的观察肾移植后应用雷帕霉素(Rap)进行免疫抑制治疗的有效性和安全性。方法将接受首次尸体肾移植的患者50例随机分为两组,研究组30例,术后采用Rap、环孢素A(CsA)和泼尼松(Pred)预防急性排斥反应;对照组20例,术后采用硫唑嘌呤、CsA及Pred预防急性排斥反应。两个组CsA和Pred的用法和用量相同。密切观察和详细记录手术后发生的不良事件,并定期对实验室各项指标进行分析。结果研究组如期完成观察的例数为26例,对照组为18例。在观察的104周内,两组的人、肾存活率为100%;研究组和对照组急性排斥反应的发生率分别为3.7%(1/27)和25.0%(5/20),经激素冲击治疗后逆转;研究组在维持血CsA浓度与对照组相当的情况下,其CsA的用量低于对照组;研究组血胆固醇总量和甘油三酯的水平明显高于对照组。结论Rap用于预防肾移植后急性排斥反应是安全有效的,其与CsA合用可减少CsA的用量,Rap的副作用主要是导致血脂升高。

Objective To observe the effects and safety of rapamyein （Rap） in combination with cyclosporine A （CsA） and steroid （Pred） as triple regimen for prevention of acute rejection after renal transplantation. Methods Fifty patients with de novo cadaveric kidney allograft were randomized into two groups. In the study group there were 30 patients treated with Rap, CsA, and Pred, while in the control group there were 20 patients with conventional triple therapy of azathioprine （Aza）, CsA, and Pred. Same dosages of CsA and Pred were used in both groups. Any adverse event after treatment was observed and recorded in detail. The laboratory investigations were checked and analyzed periodically. Results The pre-protocol population included 26 patients in study group and 18 patients in control group. The 2-year patient and graft survival rates in both groups were 100 %. The incidence of acute rejection was 3. 7 % （1/27） in study group, 25 % （5/20） in control group, respectively. All episodes of acute rejection were reversed by methylprednisolone. The trough levels of CsA kept same in both groups, but CsA dose in study group was lower than that in control group. Blood concentrations of total cholesterol and triglyceride in study group were higher than those in control group. Conclusion Rap is an effective and safe immunosuppressive drug for prevention of acute rejection after renal transplantation. Rap combined with CsA allows reducing the dose of CsA. But its main side effect is hyperlipidemia.