贝利尤单抗治疗狼疮肾炎疗效及安全性的Meta分析

Meta-analysis of efficacy and safety of belizumab in the treatment of lupus nephritis

目的 系统评价贝利尤单抗治疗狼疮肾炎(LN)的疗效及安全性。方法 通过计算机检索PubMed、The Cochrane Library、Web of Science、中国知网、万方、维普数据库中关于贝利尤单抗治疗LN的研究文献。文献检索时间为1990年1月1日—2022年9月1日。按纳入/排除标准对文献进行筛选,对文献进行风险偏倚评价并提取文献信息,采用RevMan 5.4软件进行Meta分析。结果 纳入文献2篇,共588例患者,Meta分析结果显示,贝利尤单抗组的主要疗效肾脏应答(PERR)发生率、完全肾反应(CRR)发生率与安慰剂组比较差异有统计学意义(OR=1.67,95%CI:1.19,2.34,P=0.003;OR=1.72,95%CI:1.18,2.49,P=0.005),且使用贝利尤单抗联合霉酚酸酯基础治疗后的肾脏反应效果更佳。贝利尤单抗组与安慰剂组的治疗相关不良事件和严重不良事件发生率比较差异无统计学意义(OR=1.04,95%CI:0.75,1.44,P=0.80;OR=0.82,95%CI:0.57,1.18,P=0.29)。结论 贝利尤单抗联合基础治疗如霉酚酸酯、环磷酰胺能够提高肾脏应答效果,一定程度上缓解LN患者的肾脏损害。贝利尤单抗联合基础治疗的安全性与安慰剂联合基础治疗的安全性相当。

Objective A systematic evaluation of the efficacy and safety of beliumab in the treatment of lupus nephritis(LN).Methods Literature on beliumab in the treatment of LN was searched in the databases of PubMed,The Cochrane Library,Web of Science,CNKI,Wanfang Data and VIP database.The literature search time was from January 1,1990 to September 1,2022.The literature was screened according to the inclusion/exclusion criteria,the risk of bias in the included literature was evaluated and the data was extracted,RevMan 5.4 software was used for meta-analysis.Results Two studies(588 patients)were included.The results of meta-analysis showed that the incidence of primary efficacy renal response(PERR)and complete renal response(CRR)(OR=1.67,95%CI:1.19,2.34,P=0.003;OR=1.72,95%CI:1.18,2.49,P=0.005)in the belizumab group was significantly different from that in the placebo group.The renal response was better after the treatment with belizumab combined with mycophenolate mofetil.There were no statistically significant difference in the incidence of treatment-related adverse events and serious adverse events between belizumab group and placebo group(OR=1.04,95%CI:0.75,1.44,P=0.80;OR=0.82,95%CI:0.57,1.18,P=0.29).Conclusion Current evidence suggests that beliumab combined with basic treatment such as mycophenolate mofetil or cyclophosphamide can improve renal response and alleviate renal damage in patients with LN to a certain extent.The safety of belizumab combined with basic treatment is comparable to that of placebo combined with basic treatment.