术前单次高剂量ATG—F诱导治疗对肾移植受者的安全性及有效性

Safety and efficacy of preoperative induction therapy using a single high dose ATG-F in renal transplantation： a meta-analysis of randomized controlled trials

目的评价术前使用单次高剂量（9mg／kg）抗人类胸腺球蛋白（ATG）-F诱导治疗对肾移植患者的安全性及有效性。方法检索Cochrane图书馆，MEDLINE，EMBASE，CBM数据库。收集有关术前使用单次高剂量ATG—F诱导治疗对肾移植患者安全性及有效性影响的随机对照临床试验文献，检索文献时间截止到2015年7月。在评价纳入研究的方法学质量和提取有效数据后，采用RevMan5．2进行荟萃分析。结果共纳入5篇RCT，包括346例患者。荟萃分析结果显示：高剂量ATG—F诱导治疗组较对照组急性排斥反应发生率降低，差异有统计学意义（P〈0．0001）。随访1年及5年受者生存率、移植物存活率、巨细胞病毒（CMV）感染、泌尿系感染、新发糖尿病、恶性肿瘤的发生率在两组间差异均无统计学意义。结论术前单次高剂量ATG—F诱导治疗可以降低移植后急性排斥反应发生率，相比于术前不使用诱导治疗的患者，单次高剂量ATG—F诱导治疗组并不增加肾移植患者泌尿系感染、CMV感染以及恶性肿瘤的发生率。

Objective This study aimed to evaluate the safety and efficacy of preoperative induction therapy using a single high dose （ 9 mg/kg） of antithymocyte globulin-Fresenius S （ ATG-F ） for patients undergoing renal transplantation. Methods Randomized controlled clinical trials （RCTs） on the safety and efficacy of preoperative induction therapy using a single high dose of ATG-F for patients undergoing renal transplantation were searched in Coehrane Library, PubMed, EMBASE covering a period from the beginning of databases to July 2015. The meta-analysis was conducted using RevMan 5.2. Results Five RCTs with 346 patients were included in this study. The meta-analysis showed that the incidences of acute rejection for the patients with renal transplantation were 20. 6% （37/180） in the induction therapy group using a single high dose of ATG and 42. 8% （71/166） in the control group, with a combined relative risk （RR） of 0. 49 and 95% confidence interval （CI） of[0. 36, 0. 691 （P 〈0. 000 1 ）. The patient survival rate （ 1 year： RR = 1.02, 95% CI[0.98, 1.06], P=0.43; 5 years： RR=1.01, 95% CI[0.94, 1.08], P=0. 83） and the graft survival rate （RR= 1.04, 95% CI[0.97, 1.12], P=0.24） of the two groups were similar. The incidences of CMV infection, urinary tract infection, and malignant tumor were also similar in the two groups. Conclusion The induction therapy using a single high dose of ATG-F significantly reduced the incidence of acute rejection after transplantation and showed no increased incidence of urinary tract infection, CMV infection, or malignant tumor. The results of our meta-analysis suggest that the application of a high dose of ATG-F may be a safe and effective induction therapy.