贝利木单抗治疗系统性红斑狼疮的有效性和安全性的Meta分析

Efficacy and safety of belimumab in the treatment of systemic lupus erythematosus: a Meta-analysis

目的:系统评价贝利木单抗治疗系统性红斑狼疮的有效性与安全性。方法:计算机检索Ovid Embase、The Cochrane Library、PubMed、SinoMed、CNKI、VIP、WanFang data及ClinicalTrials.gov网站,搜集有关贝利木单抗治疗系统性红斑狼疮的随机对照试验(randomized controlled trial,RCT)。检索时间均自建库到2019年8月。针对所获得的文献,进行筛选、数据提取及质量评价后,采用RevMan 5.3统计软件进行定量分析。结果:纳入4项RCTs,共计2 235例患者。Meta分析结果显示:试验组的SRI反应率[RR=1.29, 95%CI(1.17,1.42),P<0.01]、治疗第40~52周的糖皮质激素剂量减少的患者百分率[RR=1.40, 95%CI(1.07,1.83),P=0.01]均明显高于对照组,严重耀斑发生率[RR=0.57, 95%CI(0.44,0.73),P<0.01]低于对照组,且差异具有显著性意义。安全性方面,试验组和对照组的不良事件发生率没有明显差别[RR=1.01, 95%CI(0.97,1.05),P=0.58],差异无显著性。结论:当前证据表明,贝利木单抗能够明显改善系统性红斑狼疮患者的SRI反应率,减少患者糖皮质激素的剂量并降低严重耀斑发生率,安全性较好。

OBJECTIVE To systematically review the efficacy and safety of belimumab in the treatment of Systemic Lupus Erythematosus.METHODS Ovid Embase, The Cochrane Library, PubMed, SinoMed, CNKI, VIP, WanFang data and ClinicalTrials.gov website were searched to gather randomized controlled trials(RCT) about the efficacy and safety of belimumab for the patients with Systemic Lupus Erythematosus. The search time was from inseption to August 2019. After screening, data extraction and quality evaluation of the obtained literature, quantitative analysis was conducted by RevMan5.3 statistical software.RESULTS 4 RCTs involving 2 235 patients were included. Meta-analysis showed that experiment group can increase SRI response rate[RR=1.29, 95%CI(1.17,1.42), P<0.01], decrease the percentage of patients with reduced corticosteroid dose between weeks 40 and 52[RR=1.40, 95%CI(1.07,1.83), P=0.01] and incidence of severe flares[RR=0.57, 95%CI(0.44,0.73), P<0.01], and the differences were statistically significant.The incidence of adverse events between experiment and control group [RR=1.01, 95%CI(0.97,1.05), P=0.58] was no significantly different.CONCLUSION Current evidence suggests that bevacizumab can significantly improve the SRI response rate, reduce the dose of glucocorticoids and reduce the incidence of severe flares in patients with systemic lupus erythematosus, with good safety.