贝利尤单抗治疗系统性红斑狼疮患者的疗效及安全性的meta分析

doi:10.3760/cma.j.issn.1007-1245.2023.22.019

摘要/Abstract

摘要：

目的　分析贝利尤单抗治疗系统性红斑狼疮患者的临床效果及安全性，并进行循证医学评价。方法　检索PubMed、Web of Science、Cochrane Library、EMBASE、中国知网、中国生物医学数据库、维普数据库、万方数据库中所有有关贝利尤单抗与系统性红斑狼疮研究的随机对照试验，检索时间范围自建库至2023年2月。通过纳入排除标准筛选文献，获取数据，采用RevMan5.4.1软件和Sata16软件对获取的数据进行meta分析，采用相对危险度、加权均数差表示效应指标，比较两组疗效及安全性。分析灵敏度及发表偏倚。结果　共纳入9项随机对照试验，共2 657例患者，其中贝利尤单抗组1 522例，安慰剂组1 135例。在临床疗效方面：与安慰剂组对比，贝利尤单抗持续治疗52周系统性红斑狼疮反应者指数（systemic lupus erythematosus responder index，SRI4）（RR=1.29，95%CI 1.17～1.42，P<0.001；I²=0，P=0.91）达标率明显增多，有效改善患者的临床症状，降低严重发作率（severe flare，SF）（RR=0.68，95%CI 0.58～0.79，P<0.001；I²=0，P=0.48），有效降低了患者疾病活动度，提高患者生活质量，SELENA-SLEDAI评分降低≥4分（RR=1.28，95%CI 1.17～1.40，P<0.001；I²=0，P=0.95），系统性红斑狼疮疾病活动度（systemic lupus erythematosus disease activity index，SLEDAI）评分（WMD=-4.77，95%CI -8.67～-0.86，P=0.02；I²=97%，P<0.001）。在安全性方面：两组总不良事件发生率（RR=0.99，95%CI 0.96～1.02，P=0.54；I²=0，P=0.90）和严重不良事件发生率（RR=0.85，95%CI 0.64～1.12，P=0.25；I²=57%，P=0.05）差异均无统计学意义。结论　贝利尤单抗作为附加治疗系统性红斑狼疮患者具有良好的效果，且不会增加用药后不良反应事件发生率。

关键词:

系统性红斑狼疮, 贝利尤单抗, 疗效, 不良反应事件

Abstract:

Objective　To analyze the clinical efficacy and safety of belizumab in the treatment of patients with systemic lupus erythematosus and conduct a meta-analysis. Methods　The PubMed, Web of Science, Cochrane Library, EMBASE, China National Knowledge Internet (CNKI), China Biomedical Literature Database (CBM), VIP database, and Wanfang database were searched for all the randomized controlled trials related to belizumab and systemic lupus erythematosus from their establishment to February 2023. According to the including and excluding criteria, the literatures were screened, and the data were obtained. The RevMan5.4.1 software and Sata16 software were used for the meta-analysis of the obtained data. Relative risk and weighted mean difference were used to represent the effect indicators. The efficacies and safety of the two groups were compared. The sensitivity and publication bias were analyzed. Results　A total of 9 randomized controlled trials were included, with a total of 2 657 patients, including 1 522 cases in the belizumab group and 1 135 cases in the placebo group. Clinical efficacy: compared with the placebo group, the qualified rate of the systemic lupus erythematosus responder index (SRI4) (RR=1.29, 95%CI 1.17-1.42, P<0.001; I²=0,P=0.91) of belizumab continuous treatment for 52 weeks significantly increased; the patients' clinical symptoms were effectively improved; the severe flare (SF) was reduced (RR=0.68, 95%CI 0.58-0.79, P<0.001; I²=0, P=0.48); the disease activity was effectively reduced; the patients' quality of life was improved; the decrease of the SELENA-SLEDAI score ≥4 points (RR=1.28, 95%CI 1.17-1.40, P<0.001; I²=0%, P=0.95); the systemic lupus erythematosus disease activity index (SLEDAI) score (WMD=-4.77, 95%CI -8.67--0.86, P=0.02; I²=97%, P<0.001). Safety: there were no statistical differences in the total incidence of adverse events (RR=0.99, 95%CI 0.96-1.02, P=0.54; I²=0, P=0.90) and the incidence of serious adverse events (RR=0.85, 95%CI 0.64-1.12, P=0.25; I²=57%, P=0.05) between the two groups. Conclusion　Belizumab as an additional treatment for patients with systemic lupus erythematosus has good efficacy and does not increase the incidence of adverse reactions after medication.

Key words:

Systemic lupus erythematosus, Belizumab, Efficacy, Adverse reaction events

李浩李江涛刘丹李顺华.

贝利尤单抗治疗系统性红斑狼疮患者的疗效及安全性的meta分析 [J]. 国际医药卫生导报, 2023, 29(22): 3217-3224.

Li Hao, Li Jiangtao, Liu Dan, Li Shunhua.

Efficacy and safety of belizumab in treatment of patients with systemic lupus erythematosus: a meta-analysis [J]. International Medicine and Health Guidance News, 2023, 29(22): 3217-3224.

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