评估慢性阻塞性肺疾病患者生物治疗的有效性和安全性的随机对照试验的meta分析。

IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Khai-Chi Hu MD , Min-Hsiang Chuang MD , Chih-Cheng Lai MD , Kuang-Ming Liao MD, PhD
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引用次数: 0

摘要

抗白介素-5 (IL-5)、抗白介素-5受体和抗白介素-4 (IL-4)已成为严重嗜酸性粒细胞哮喘的潜在治疗方法,但它们在治疗慢性阻塞性肺疾病(COPD)中的作用尚不清楚。文献综述截止到2024年5月31日。本荟萃分析仅纳入评估COPD患者生物治疗(抗il -5/抗il -5受体/抗il -4)临床疗效和不良反应的随机对照试验(RCTs)。主要结局关注COPD恶化风险,次要结局检查肺功能、生活质量和不良事件。我们分析了4篇包含6个随机对照试验的文章。2837例患者接受抗il -5/抗il -5受体治疗,468例接受抗il -4治疗,1913例接受安慰剂治疗。总体而言,与安慰剂相比,生物治疗总体上显示COPD恶化风险降低(比率比,0.88;95% ci, 0.80-0.97, i2 = 53%)。具体来说,dupilumab在统计学上显著降低恶化风险(率比0.70,95% CI 0.58-0.84)。贝纳利珠单抗显示出急性发作风险的边缘性降低(比率比,0.92;95% CI, 0.85-1.00, I2 = 0%,而Mepolizumab表现出降低急性加重风险的趋势,但无统计学意义(比率比0.90,95% CI 0.77-1.06, I2 = 62%)。亚组分析显示,接受生物治疗的慢性阻塞性肺疾病和嗜酸性粒细胞≥300 /立方毫米的患者可能会降低急性加重的风险。从基线开始,生物疗法和安慰剂对肺功能的改变没有显著差异。圣乔治呼吸问卷(SGRQ)评分分析显示,与安慰剂相比,生物疗法有显著改善(平均差异-1.30,95% CI -2.46至-0.14,I2 = 28%)。与安慰剂相比,生物疗法显示出相当的不良事件风险。这项荟萃分析表明,与安慰剂相比,生物疗法可以降低COPD患者急性加重的风险,提高患者的生活质量。然而,这些疗法并没有显示出肺功能的显著改善。未来的研究需要描述这些生物疗法在控制COPD恶化中的作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Meta-Analysis of Randomized, Controlled Trials Assessing the Effectiveness and Safety of Biological Treatments in Chronic Obstructive Pulmonary Disease Patients
Anti-interleukin-5 (IL-5), anti-IL-5 receptor and anti-interleukin-4 (IL-4) have emerged as potential treatments for severe eosinophilic asthma, yet their role in treating chronic obstructive pulmonary disease (COPD) is unclear. A literature review was conducted up to May 31, 2024. Only randomized controlled trials (RCTs) assessing the clinical efficacy and adverse effects of biological treatment (anti-IL-5/ anti-IL-5 receptor /anti-IL-4) in COPD patients were included in this meta-analysis. Primary outcomes focused on COPD exacerbation risk, with secondary outcomes examining lung function, quality of life, and adverse events. Four articles comprising 6 RCTs were analyzed. Among 2837 patients receiving anti-IL-5/anti-IL-5 receptor therapies, 468 receiving anti-IL-4 therapies, and 1913 receiving placebo. Overall, biological treatment therapies collectively demonstrated a reduced risk of COPD exacerbation compared to placebo (rate ratio, 0.88; 95% CI, 0.80–0.97, I2 = 53%). Specifically, dupilumab statistically significant reduction in exacerbation risk (rate ratio 0.70, 95% CI 0.58–0.84). Benralizumab showed a borderline reduction in exacerbation risk (rate ratio, 0.92; 95% CI, 0.85–1.00, I2 = 0%, while Mepolizumab exhibited a trend towards lower exacerbation risk that did not reach statistical significance (rate ratio 0.90, 95% CI 0.77–1.06, I2 = 62%). Subgroup analysis showed that patients with COPD and eosinophils ≥300 per cubic millimeter who received biological treatment may experience a reduced risk of acute exacerbation. Changes in lung function from baseline did not significantly differ between biological therapies and placebo. Analysis of St. George's Respiratory Questionnaire (SGRQ) scores indicated significant improvements with biological therapies compared to placebo (mean difference -1.30, 95% CI -2.46 to -0.14, I2 = 28%). Biological therapies showed comparable risks of adverse events compared to placebo. This meta-analysis suggests that biological therapies may reduce the risk of acute exacerbations and improve quality of life in COPD patients compared to placebo. However, these therapies did not demonstrate significant improvements in pulmonary function. Future studies are needed to delineate the role of these biologic therapies in managing COPD exacerbations.
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来源期刊
Clinical therapeutics
Clinical therapeutics 医学-药学
CiteScore
6.00
自引率
3.10%
发文量
154
审稿时长
9 weeks
期刊介绍: Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug and other therapies as well as in diagnostics, pharmacoeconomics, health policy, treatment outcomes, and innovations in drug and biologics research. In addition Clinical Therapeutics features updates on specific topics collated by expert Topic Editors. Clinical Therapeutics is read by a large international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings. Articles are indexed by all major biomedical abstracting databases.
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