A randomized, double-blinded comparison of thymoglobulin versus Atgam for induction immunosuppressive therapy in adult renal transplant recipients
A randomized, double-blinded comparison of thymoglobulin versus Atgam for induction immunosuppressive therapy in adult renal transplant recipients
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DOI：
10.1097/00007890-199904150-00013
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发表时间：
1999-04-15
期刊：
影响因子：
6.2
通讯作者：
Singer, GG
中科院分区：
文献类型：
--
作者：
Brennan, DC;Flavin, K;Singer, GG
背景本研究的目的是比较Thymoglobulin（兔源性多克隆抗体）Atgam（马源性多克隆抗体）诱导成人肾移植recipients.Methods的有效性和安全性，移植受体（n=72）随机2：1在一个双盲的方式接受Thymoglobulin（n=48）在1.5 mg/kg静脉注射或Atgam（n=24）在15 mg/kg静脉注射，手术中，然后每天至少6天。接受者至少随访1年。移植后1年，4%的Thymoglobulin治疗患者发生急性排斥反应，而Atgam25%的患者发生急性排斥反应Thymoglobulin组急性排斥反应发生率低于Atgam组（P=0.014）（相对危险度=0.09; P=0.009），使用Thymoglobulin的排斥反应较Atgam轻（P=0.02），Thymoglobulin组未发生复发性排斥反应，Atgam组为33%（P=NS）。患者生存率无差异，但无死亡、移植物丢失或排斥反应的复合终点，即“无事件生存期"，Thymoglobulin的不良事件发生率更上级（P = 0.013），Thymoglobulin的白细胞减少症发生率高于Atgam（56%vs.4%; P = 0.0005）。
Background. The aim of this study was to compare the efficacy and safety of Thymoglobulin (a rabbit-derived polyclonal antibody) to Atgam (a horse-derived polyclonal antibody) for induction in adult renal transplant recipients.Methods, Transplant recipients (n=72) were randomized 2:1 in a double-blinded fashion to receive Thymoglobulin (n=48) at 1.5 mg/kg intravenously or Atgam (n=24) at 15 mg/kg intravenously, intraoperatively, then daily for at least 6 days. Recipients were observed for at least 1 year of follow-up.Results. By 1 year after transplantation, 4% of Thymoglobulin-treated patients experienced acute rejection compared with 25% of Atgam-treated patients (P=0.014), The rate of acute rejection was lower with Thymoglobulin than Atgam (relative risk=0.09; P=0.009), Rejection was less severe with Thymoglobulin than Atgam (P=0.02), No recurrent rejection occurred with Thymoglobulin compared with 33% with Atgam (P=NS), Patient survival was not different, but the composite end point of freedom from death, graft loss, or rejection, the "event-free survival," was superior with Thymoglobulin (94%) compared with Atgam (63%; P=0.0005), Fewer adverse events occurred with Thymoglobulin (P=0.013), Leukopenia was more common with Thymoglobulin than Atgam (56% vs. 4%; P