Meta-analysis of efficacy and safety of belimumab in the treatment of childhood-onset systemic lupus erythematosus

YU Xin; ZHAI Wensheng; ZHANG Mengmeng; REN Xiangge

doi:10.6039/j.issn.1001-0408.2023.16.16

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Meta-analysis of efficacy and safety of belimumab in the treatment of childhood-onset systemic lupus erythematosus

更新时间：2023-08-24

- Meta-analysis of efficacy and safety of belimumab in the treatment of childhood-onset systemic lupus erythematosus
- ZHONGGUO YAOFANG Vol. 34, Issue 16, Pages: 2003-2007(2023)
- 作者机构：
  
  1.河南中医药大学儿科医学院，郑州　450099
  2.河南中医药大学第一附属医院儿科一病区，郑州　450099
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.16.16
  CLC： R979.5
- Published：30 August 2023，
  
  Received：15 March 2023，
  
  Revised：20 July 2023，
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禹欣,翟文生,张蒙蒙等.贝利尤单抗治疗儿童系统性红斑狼疮有效性和安全性的Meta分析 ^Δ[J].中国药房,2023,34(16):2003-2007.

YU Xin,ZHAI Wensheng,ZHANG Mengmeng,et al.Meta-analysis of efficacy and safety of belimumab in the treatment of childhood-onset systemic lupus erythematosus[J].ZHONGGUO YAOFANG,2023,34(16):2003-2007.
禹欣,翟文生,张蒙蒙等.贝利尤单抗治疗儿童系统性红斑狼疮有效性和安全性的Meta分析 ^Δ[J].中国药房,2023,34(16):2003-2007. DOI： 10.6039/j.issn.1001-0408.2023.16.16.

YU Xin,ZHAI Wensheng,ZHANG Mengmeng,et al.Meta-analysis of efficacy and safety of belimumab in the treatment of childhood-onset systemic lupus erythematosus[J].ZHONGGUO YAOFANG,2023,34(16):2003-2007. DOI： 10.6039/j.issn.1001-0408.2023.16.16.

摘要

目的

评价贝利尤单抗治疗儿童系统性红斑狼疮（cSLE）的有效性和安全性，为临床用药提供循证参考。

方法

计算机检索中国知网、万方数据、维普网、SinoMed、PubMed、Embase、Web of Science、Cochrane图书馆，收集贝利尤单抗或贝利尤单抗联合激素或贝利尤单抗联合激素和传统药物（试验组）对比安慰剂或激素或传统药物或传统药物联合激素等基础治疗（对照组）的随机对照试验（RCT），检索时限均为建库至2023年4月9日。筛选文献、提取资料后，采用Cochrane系统评价员手册5.1.0推荐的偏倚风险评估工具对纳入文献进行质量评价，采用RevMan 5.4软件进行Meta分析、敏感性分析。

结果

纳入7项RCT，共计510例患儿。Meta分析结果显示，试验组患儿的临床有效率显著优于对照组[OR＝6.16，95%CI（2.23，17.00），

＝0.000 4]，两组患儿的系统性红斑狼疮活动指数[MD＝－1.73，95%CI（－3.50，0.05），

＝0.06]、不良反应发生率[OR＝0.72，95%CI（0.43，1.19），

＝0.02]、补体C3水平[MD＝0.12，95%CI（－0.06，0.30），

＝0.18]、补体C4水平[MD＝0.08，95%CI（－0.07，0.24），

＝0.30]、系统性红斑狼疮反应指数4反应率[OR＝1.52，95%CI（0.94，2.44），

＝0.09]比较，差异均无统计学意义。敏感性分析结果显示，以系统性红斑狼疮活动指数、补体C3水平、补体C4水平为指标时，本研究所得结果稳健。

结论

贝利尤单抗治疗cSLE的疗效较好，且安全性与基础治疗相当。

Abstract

OBJECTIVE

To evaluate the efficacy and safety of belimumab in the treatment childhood-onset systemic lupus erythematosus （cSLE）， and to provide evidence-based references for clinical medication.

METHODS

Randomized controlled trials （RCTs） about belimumab or belimumab combined with hormone or belimumab combined with hormone and traditional drugs （test group） compared with placebo or hormone or traditional drugs or traditional drugs combined with hormone （control group） were collected by computer searching CNKI， Wanfang data， VIP， SinoMed， PubMed， Embase， Web of Science and the Cochrane Library； the search deadline was from the establishment of the databases to April 9th， 2023. After screening the literature and extracting the data， the quality of the included literature was evaluated by using the bias risk assessment tool recommended by Cochrane system evaluation manual 5.1.0； meta-analysis and sensitivity analysis were conducted by using RevMan 5.4 software.

RESULTS

A total of 510 children were included in 7 RCTs. Results of the meta-analysis showed that the clinically effective rate of test group was significantly better than the control group [OR＝6.16， 95%CI （2.23， 17.00），

＝0.000 4]. There were no statistically significant differences in SLE disease activity index （SLEDAI） [MD＝－1.73， 95%CI （－3.50， 0.05），

＝0.06]， the incidence of adverse drug reactions [OR＝0.72， 95%CI （0.43， 1.19），

＝0.02]， complement C3 levels [MD＝0.12， 95%CI （－0.06， 0.30），

＝0.18]， complement C4 levels [MD＝0.08， 95%CI （－0.07，0.24），

＝0.30] or the response rate of SLE responder index 4 [OR＝1.52， 95%CI （0.94，2.44），

＝0.09] between 2 groups. The results of sensitivity

analysis showed that when SLEDAI， the complement C3 levels and complement C4 levels were used as indicators， the results obtained in this study were robust.

CONCLUSIONS

The efficacy of belimumab in the treatment of cSLE is good， and its safety is comparable to the basic treatment.

关键词

贝利尤单抗儿童系统性红斑狼疮有效性安全性Meta分析

Keywords

childhood-onset systemic lupus erythematosusefficacysafetymeta-analysis

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