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抗白细胞介素-5 治疗在慢性阻塞性肺疾病患者中的疗效和安全性:一项随机对照试验的荟萃分析。

Efficacy and safety of anti-interleukin-5 therapy in patients with chronic obstructive pulmonary disease: A meta-analysis of randomized, controlled trials.

机构信息

School of Management, Putian University, PR China.

Department of Internal Medicine, Kaohsiung Veterans General Hospital, Tainan Branch, Tainan, Taiwan.

出版信息

J Microbiol Immunol Infect. 2022 Feb;55(1):26-35. doi: 10.1016/j.jmii.2020.11.001. Epub 2020 Dec 5.

DOI:10.1016/j.jmii.2020.11.001
PMID:33349601
Abstract

BACKGROUND

Anti-interleukin-5 (IL-5) therapy has been proposed as a novel treatment option for patients with chronic obstructive pulmonary disease (COPD). However, its efficacy for preventing COPD exacerbation remains unclear.

METHODS

A literature review was conducted to August 26th 2019. Only randomized controlled trials (RCTs) that investigated the clinical efficacy and adverse effects of anti-IL-5 therapy were included in the meta-analysis. The primary outcome was the risk of COPD exacerbation.

RESULTS

A total of 3 articles containing 5 RCTs were included in the study. Overall, 2837 and 1442 patients received anti-IL-5 therapy (mepolizumab, n = 865; benralizumab, n = 1972) and placebo, respectively. In the pooled analysis, anti-IL-5 therapy was associated with a lower risk of COPD exacerbation compared with the placebo (rate ratio, 0.92; 95% CI, 0.86-0.97, I = 0%). In addition, no significant differences in the changes in SGRQ scores and FEV from baseline were found between the anti-IL-5 therapy and placebo (SGRQ, mean difference, -0.86, 95% CI, -1.92 - 0.19, I = 0%; FEV, mean difference, 0.01, 95% CI, -0.01 - 0.03, I = 0%). Anti-IL-5 therapy had a similar risk of any adverse event (risk ratio, 1.02; 95% CI, 0.99-1.05), an event leading to treatment discontinuation (risk ratio, 1.04; 95% CI, 0.72-1.48) and any serious adverse events (risk ratio, 0.93; 95% CI, 0.85-1.01) when compared with the placebo.

CONCLUSION

Anti-IL-5 therapy was associated with a lower rate of COPD exacerbation compared with placebo. In addition, anti-IL-5 therapy was well tolerated for COPD patients.

摘要

背景

抗白细胞介素-5(IL-5)治疗已被提议作为慢性阻塞性肺疾病(COPD)患者的一种新的治疗选择。然而,其预防 COPD 加重的疗效尚不清楚。

方法

对截至 2019 年 8 月 26 日的文献进行了综述。仅纳入了评估抗 IL-5 治疗的临床疗效和不良反应的随机对照试验(RCT)进行荟萃分析。主要结局为 COPD 加重的风险。

结果

共有 3 项研究包含 5 项 RCT 被纳入本研究。总体而言,2837 名和 1442 名患者分别接受了抗 IL-5 治疗(美泊利珠单抗,n=865;贝那利珠单抗,n=1972)和安慰剂。荟萃分析结果显示,与安慰剂相比,抗 IL-5 治疗可降低 COPD 加重的风险(率比,0.92;95%CI,0.86-0.97,I²=0%)。此外,抗 IL-5 治疗与安慰剂相比,SGRQ 评分和 FEV1 自基线的变化无显著差异(SGRQ,平均差,-0.86,95%CI,-1.92-0.19,I²=0%;FEV1,平均差,0.01,95%CI,-0.01-0.03,I²=0%)。抗 IL-5 治疗的任何不良事件(风险比,1.02;95%CI,0.99-1.05)、导致治疗中止的事件(风险比,1.04;95%CI,0.72-1.48)和任何严重不良事件(风险比,0.93;95%CI,0.85-1.01)的风险与安慰剂相似。

结论

与安慰剂相比,抗 IL-5 治疗可降低 COPD 加重的发生率。此外,抗 IL-5 治疗对 COPD 患者具有良好的耐受性。

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