白细胞介素2受体单克隆抗体预防肾移植术后急性排斥反应

Interleukin-2-receptor monoclonal antibody for prevention of acute rejection after renal transplantation

目的:观察白细胞介素2受体单克隆抗体在预防肾移植术后急性排斥反应中的作用。方法:选择2004-01/2005-12在武装警察部队安徽省总队医院接受同种异体肾移植的患者47例,患者均知情同意。根据是否应用白细胞介素2受体单克隆抗体分为2组,白细胞介素2受体单克隆抗体组25例;对照组22例,为同期未应用白细胞介素2受体单克隆抗体的患者。两组均采用“环孢素A+霉酚酸酯+强的松”的三联免疫抑制治疗方案。白细胞介素2受体单克隆抗体组在此基础上于术前2h和术后第4天分别静脉滴注白细胞介素2受体单克隆抗体20mg。观察术后6个月移植肾急性排斥反应、药物不良反应及并发症发生情况,并通过检测血清肌酐水平评估肾功能恢复情况。结果:47例患者全部进入结果分析,无脱落。①两组患者的急性排斥反应发生率比较:白细胞介素2受体单克隆抗体组显著低于对照组(12%,41%,P<0.05)。②两组患者的不良反应及并发症发生情况:白细胞介素2受体单克隆抗体组患者发生肺部感染2例,肝功能损害1例,胃肠道反应6例;对照组发生肺部感染2例,肝功能损害3例,胃肠道反应4例,两组差异无显著性意义(P>0.05)。两组均未发生白细胞减少、切口感染、尿路感染、高血糖等并发症。③两组患者的血清肌酐水平比较:术后1,2周,白细胞介素2受体单克隆抗体组的血清肌酐水平低于对照组[(104.7±10.1,103.1±7.7;128.3±28.2,120.0±8.5)μmol/L(P<0.05)];术后1-6个月,两组间血清肌酐水平差异无显著性意义(P>0.05),提示术后2周两组移植肾功能均基本恢复正常。结论:白细胞介素2受体单克隆抗体能有效预防肾移植术后急性排斥反应的发生,且使用安全,不增加术后的不良反应。

AIM： To observe the effect of interleukin 2 receptor monoclonal antibody （Simulect） in the prevention of acute rejection after renal transplantation. METHODS： Totally 47 renal transplantation recipients were enrolled from Anhui General Forces Hospital, Chinese People＇s Armed Police Forces from January 2004 to December 2005. The patients all agreed to participate into the trial. According to whether using Simulect or not, there were 2 groups, Simulect group in 25 cases and control group in 22 cases, who were not treated with Simulect. Each group received the same immunosuppressive therapy regimen consisted of cyclosporine, mycophenolate and prednisone （CsA＋MMF＋Pred）. On this basis, the Simulect group received 20 mg Simulect at hour 2 before operation and day 4 after operation. Acute rejection, drug adverse reaction and complication were observed 6 months after operation. The recovery of renal function was evaluated by detecting creatinine level in serum. RESULTS： Totally 47 patients were involved in the result analysis, no drop-out. （1）incidence rate of acute rejection in patients of the two groups： It was significantly lower in the Simulect group than the control group （12% ,41%, P 〈 0.05）. （2）adverse reaction and complication in patients of the two groups： There were pulmonary infection in 2 cases, liver functional lesion in 1 case and gastrointestinal tract reaction in 6 cases in the Simulect group, as well as pulmonary infection in 2 cases, liver functional lesion in 3 cases and gastrointestinal tract reaction in 4 cases in the control group. There was no significant dffference between the two groups （P 〉 0.05）. No complication occurred in the two groups such as hypolekocytosis, incision infection, urinary tract infection, hyperglycemia and so on. （3）creatinine level in serum in patients of the two groups： At weeks 1 and 2, it was lower in the Simulect group than the control group [（104.7± 10.1）,（103.1±7.7）;（128.3±28.2）,（120.0±8.5） μmol/L （P〈 0.05）]. From month 1-6 after operation, there was no significant difference in creatinine level in serum between the two groups （P 〉 0.05）. It indicatedthat in the two groups the renal function recovered normally 2 weeks after operation. CONCLUSION： As a safe and effective induction therapy drug, simulect which seldom cause adverse reactions can prevent acute rejection in renal transplantation recipients.