Efficacy and safety of basiliximab and antithymocyte globulin in immune induction in kidney transplantation: a Meta-analysis
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摘要:
目的 通过系统评价和Meta分析评估巴利昔单抗(BAS)和抗胸腺细胞球蛋白(ATG)在肾移植免疫诱导治疗中的有效性和安全性。 方法 系统检索国内外数据库,筛选比较BAS和ATG在肾移植免疫诱导治疗中的前瞻性随机对照临床研究文献。采用Jadad评分量表对文献质量评价并提取数据。分析BAS和ATG对肾移植术后1年急性排斥反应发生率、移植肾存活率、受者生存率、移植肾功能延迟恢复发生率、感染率、巨细胞病毒感染率、恶性肿瘤发生率、白细胞和血小板减少发生率的影响。 结果 纳入10篇英文文献,共1 721例肾移植受者,其中883例使用ATG,838例使用BAS。ATG组和BAS组术后1年急性排斥反应发生率、移植肾存活率、受者生存率、移植肾功能延迟恢复发生率、感染率、巨细胞病毒感染率和血小板减少发生率的差异均无统计学意义(均为P > 0.05)。ATG组术后1年内恶性肿瘤发生率、白细胞减少发生率均高于BAS组,差异均有统计学意义(均为P < 0.05)。 结论 使用ATG和BAS进行肾移植免疫诱导治疗,其术后1年有效性相当,但BAS安全性较好。未来应进行不同的免疫风险分层的临床研究,以达到个体化精准治疗。 Abstract:Objective To evaluate the efficacy and safety of basiliximab (BAS) and antithymocyte globulin (ATG) in immune induction therapy in kidney transplantation by systematic review and Meta-analysis. Methods Prospective randomized controlled clinical trials screening and comparing BAS and ATG in immune induction therapy in kidney transplantation were systematically searched from global databases, screened and compared. The quality of clinical trials was evaluated by Jadad scoring system and data extraction was performed. The effects of BAS and ATG on the incidence of acute rejection, survival rate of kidney allografts, survival rate of recipients, incidence of delayed graft function, infection, cytomegalovirus infection, malignant tumor, leukopenia and thrombocytopenia at 1 year after kidney transplantation were analyzed. Results A total of 10 clinical trials in English consisting of 1 721 kidney transplant recipients were searched, including 883 cases in the ATG group and 838 cases in the BAS group. No significant differences were observed in the incidence of acute rejection, survival rate of kidney allografts, survival rate of recipients, incidence of delayed graft function, infection, cytomegalovirus infection and thrombocytopenia at postoperative 1 year between the ATG and BAS groups (all P > 0.05). The incidence of malignant tumor and leukopenia at postoperative 1 year in the ATG group were significantly higher than those in the BAS group (both P < 0.05). Conclusions The use of ATG and BAS for immune induction therapy in kidney transplantation yield equivalent efficacy at postoperative 1 year, but BAS is safer than ATG. Clinical trials related to stratified analyses of immune risk are urgently required to achieve individualized precision treatment. -
Key words:
- Basiliximab /
- Antithymocyte globulin /
- Kidney transplantation /
- Immune induction /
- Rejection /
- Delayed graft function /
- Infection /
- Cytomegalovirus
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表 1 纳入文献的基本特征
Table 1. Basic characteristics of the included articles
研究者 年份 国家、地区 研究中心 ATG组 BAS组 免疫抑制方案 Jadad评分(分) 例数(n) 年龄①(岁) 活体供肾(n) 尸体供肾(n) 例数(n) 年龄①(岁) 活体供肾(n) 尸体供肾(n) Sollinger H, et al[9] 2001 美国 多中心 65 50±12 23 42 70 45±14 28 42 CsA②+MMF③+Pred④ 3 Lebranchu Y, et al[10] 2002 法国 多中心 50 46±11 0 50 50 44±11 0 50 CsA+MMF+Pred 3 Tullius SG, et al[11] 2003 德国 单中心 62 19~71 0 62 62 16~69 0 62 Tac⑤+Pred 3 Mourad G, et al[12] 2004 法国 多中心 53 45±13 1 52 52 45±12 2 50 CsA+MMF+Pred 3 Brennan DC, et al[13] 2006 美国、欧洲 多中心 141 51±13 0 141 137 50±13 0 137 CsA+MMF+Pred 4 Kyllönen LE, et al[14] 2007 芬兰 单中心 53 22~64 0 53 58 22~65 0 58 CsA+AZA⑥+Pred 4 Pilch NA, et al[15] 2014 美国 单中心 102 52±13 19 83 98 49±14 19 79 CsA+MMF+Pred 4 Patel HV, et al[16] 2014 印度 单中心 80 36 49 31 20 45 15 5 CsA/Tac+MMF/AZA +Pred 3 Tedesco-Silva H, et al[17] 2015 巴西 单中心 85 44±14 18 67 102 45±14 36 66 Tac+EVR⑦ 4 Thomusch O, et al[18] 2016 德国 多中心 192 54±12 24 168 189 54±13 20 169 Tac+MMF+Pred 4 注:①年龄的表示方法有均数±标准差、范围、平均数。
②CsA为环孢素。
③MMF为吗替麦考酚酯。
④Pred为泼尼松。
⑤Tac为他克莫司。
⑥AZA为硫唑嘌呤。
⑦EVR为依维莫司。 -
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