针对2型炎症的生物制剂治疗COPD的疗效和安全性:一项系统综述和网络meta分析

IF 2.7 3区 医学 Q2 RESPIRATORY SYSTEM
Shujie Li, Baiyi Yi, Huan Wang, Xianghuai Xu, Li Yu
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引用次数: 0

摘要

目的:本研究旨在比较评价针对2型炎症的生物制剂在COPD中的疗效和安全性。方法:截至2024年9月1日,我们从多个数据库中确定并筛选了8项临床研究,评估针对2型炎症的生物制剂治疗COPD的效果。在数据提取之后,我们使用R软件进行了网络荟萃分析,间接比较了五种纳入的生物制剂的疗效和安全性,并将分析结果可视化。结果:在嗜酸性粒细胞水平升高(外周血嗜酸性粒细胞计数≥200细胞/μL)的COPD患者中,dupilumab通过以下方式显示出显著的治疗效果:(1)降低急性加重的年化率(与安慰剂相比:-0.44;95% CI -0.77 ~ -0.10),(2)降低SGRQ总分(与安慰剂相比:-3.41;95% CI -6.00至-0.82),以及(3)支气管扩张剂前FEV1增加(与安慰剂相比:0.06 L;95% CI 0.00 - 0.12)。贝纳利珠单抗在降低急性加重率方面也显示出临床益处(10 mg vs安慰剂:-0.21;95% CI -0.39 ~ -0.04)和SGRQ评分的改善(100 mg vs安慰剂:-1.70;95% CI为-3.35 ~ -0.04)。此外,在该网络荟萃分析中评估的所有五种生物制剂均显示出良好的安全性。结论:该NMA表明,dupilumab和benralizumab在COPD治疗中具有统计学显著的疗效,特别是在嗜酸性粒细胞炎症患者中。这些生物制剂保持着良好的安全性。未来的研究应侧重于大规模的多中心临床试验、基于生物标志物的患者分层、药物给药方案的优化以及多靶点联合治疗的开发。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and Safety of Biologics Targeting Type 2 Inflammation in COPD: A Systematic Review and Network Meta-Analysis.

Purpose: This study aims to comparatively evaluate the efficacy and safety profiles of biologic agents targeting type 2 inflammation in COPD.

Methods: As of September 1, 2024, we identified and screened eight clinical studies evaluating biologic agents targeting type 2 inflammation for COPD treatment from multiple databases. Following data extraction, we conducted a network meta-analysis using R software to indirectly compare the efficacy and safety profiles of the five included biologic agents, incorporating visualization of the analytical results.

Results: In COPD patients with elevated eosinophil levels (peripheral blood eosinophil count ≥200 cells/μL), dupilumab demonstrated significant therapeutic efficacy by: (1) reducing the annualized rate of acute exacerbations (versus placebo: -0.44; 95% CI -0.77 to -0.10), (2) decreasing SGRQ total scores (versus placebo: -3.41; 95% CI -6.00 to -0.82), and (3) increasing pre-bronchodilator FEV1 (versus placebo: 0.06 L; 95% CI 0.00 to 0.12). Benralizumab also showed clinical benefits in reducing acute exacerbation rates (10 mg versus placebo: -0.21; 95% CI -0.39 to -0.04) and improving SGRQ scores (100 mg versus placebo: -1.70; 95% CI -3.35 to -0.04). Furthermore, all five biologic agents evaluated in this network meta-analysis exhibited favorable safety profiles.

Conclusion: This NMA demonstrates that both dupilumab and benralizumab show statistically significant efficacy in COPD management, particularly among patients with eosinophilic inflammation. And these biological agents maintain favorable safety profiles. Future research should focus on large-scale multicenter clinical trials, biomarker-based patient stratification, optimization of drug delivery regimens, and development of multi-target combination therapies.

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来源期刊
CiteScore
4.80
自引率
10.70%
发文量
372
审稿时长
16 weeks
期刊介绍: An international, peer-reviewed journal of therapeutics and pharmacology focusing on concise rapid reporting of clinical studies and reviews in COPD. Special focus will be given to the pathophysiological processes underlying the disease, intervention programs, patient focused education, and self management protocols. This journal is directed at specialists and healthcare professionals
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