兔抗人胸腺细胞免疫球蛋白诱导治疗在中国心脏死亡器官捐献供肾肾移植受者中的应用

Application of rabbit anti-human thymocyte immunoglobulin induction therapy in kidney transplant recipients with organ donation after cardiac death in China

  • 摘要:
    目的 评估兔抗人胸腺细胞免疫球蛋白(rATG)诱导治疗在中国心脏死亡器官捐献肾移植受者中的疗效和安全性。
    方法 这是一项在中国进行的前瞻性、多中心、单臂、干预性研究(NCT03099122)。纳入接受心脏死亡器官捐献肾移植并接受rATG诱导治疗(累积剂量为5 mg/kg)的成年患者,采用单因素和多因素逻辑回归分析探讨与急性排斥反应(AR)、移植物功能延迟恢复(DGF)、移植物失功和患者死亡相关的因素。分析不良事件的发生情况。
    结果 共115例成年患者纳入研究,其中107例患者可评估疗效。活组织检查证实的AR(BPAR)和AR的发生率分别为2.8%(95%可信区间0.6%~8.0%)和4.7%(95%可信区间1.5%~10.6%)。DGF的发生率为13.1%(95%可信区间7.3%~21.0%),移植物和患者生存率分别为97.2%(95%可信区间92.0%~99.4%)和99.1%(95%可信区间94.9%~100%)。多因素逻辑回归分析结果显示,供者血清肌酐和受者群体反应性抗体是DGF的危险因素(均为P<0.05)。常见的治疗期间出现的不良事件(发生率>5%)包括贫血(8.7%)、感染性肺炎(8.7%)和尿路感染(8.7%)。
    结论 标准剂量的rATG诱导治疗在中国心脏死亡器官捐献肾移植受者中表现出较低的BPAR、AR和DGF发生率,且耐受性良好。

     

    Abstract:
    Objective  To evaluate the efficacy and safety of rabbit anti-human thymocyte immuneglobulin (rATG) induction therapy in kidney transplant recipients from donation after cardiac death in China.
    Methods  This was a prospective, multicenter, single-arm and interventional study conducted in China (NCT03099122). Adult patients who underwent kidney transplantation from donation after cardiac death and received rATG induction therapy (cumulative dose of 5 mg/kg) were included. Univariate and multivariate logistic regression analyses were used to identify factors associated with acute rejection (AR), delayed graft function (DGF), graft failure, and patient death. The occurrence of adverse events was also analyzed.
    Results  A total of 115 adult patients were enrolled in the study, of whom 107 were evaluable for efficacy. The incidence of biopsy-proven acute rejection (BPAR) and acute rejection (AR) was 2.8% (95% confidence interval 0.6%–8.0%) and 4.7% (95% confidence interval 1.5%–10.6%), respectively. The incidence of delayed graft function (DGF) was 13.1% (95% confidence interval 7.3%–21.0%). Graft and patient survival rates were 97.2% (95% confidence interval 92.0%–99.4%) and 99.1% (95% confidence interval 94.9%–100%), respectively. Multivariate logistic regression analysis showed that donor serum creatinine and recipient panel reactive antibodies were risk factors for DGF (both P<0.05). Common treatment-emergent adverse events (incidence >5%) included anemia (8.7%), infectious pneumonia (8.7%), and urinary tract infection (8.7%).
    Conclusions  Standard-dose rATG induction therapy demonstrates low incidences of BPAR, AR, and DGF, and good safety in Chinese kidney transplant recipients from donation after cardiac death.

     

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