大环内酯类药物治疗哮喘：一项随机试验的系统评价与meta分析
2026/04/02
摘要
背景：大环内酯类药物用于哮喘治疗的获益与风险尚不明确。
目的：作为即将发布的美国过敏、哮喘与免疫学会/美国过敏、哮喘与免疫学院实践参数联合工作组关于重症哮喘指南的组成部分，本研究系统评价大环内酯类药物治疗哮喘的有效性与安全性。
方法：系统检索MEDLINE、Embase及CENTRAL数据库截至2025年4月12日的文献，纳入比较大环内酯类药物与安慰剂或标准治疗用于哮喘的随机对照试验。由两名研究者独立筛选文献并提取数据。采用随机效应协方差分析模型整合患者个体水平数据，评估哮喘控制水平与哮喘相关生活质量；采用随机效应meta分析评估重症急性加重与不良事件。使用GRADE方法评价证据质量。研究方案已在PROSPERO注册（CRD42023408677）。
结果：本meta分析共纳入19项试验、1825例受试者。与安慰剂相比，大环内酯类药物可改善哮喘控制（6项哮喘控制问卷，分值0~6分，分值越低控制越好；组间均数差：−0.23，95%CI：−0.32~−0.13；达到最小重要差异0.5分的改善比例：40.6% vs 21.6%，高证据质量）；可能降低重症急性加重风险（发生率比：0.75，95%CI：0.57~0.98；率差：每患者年减少0.26次事件，95%CI：减少0.45～0.02次，中等证据质量）；可能小幅改善生活质量（哮喘生活质量问卷，分值1～7分，分值越高生活质量越好；均数差：0.11，95%CI：−0.06~0.29；达到最小重要差异0.5分的改善比例：47.6% vs 42.4%，中等证据质量）；对严重不良事件与死亡率几乎无影响（高证据质量）。在2型高炎症与2型低炎症哮喘患者中，治疗相对效果相似。
结论：在2型高炎症或2型低炎症哮喘患者中，大环内酯类药物可能减少重症急性加重、改善哮喘控制与生活质量，且严重不良事件风险无明显差异。
Macrolides for asthma: A systematic review and meta-analysis of randomized trials
Ologundudu LM, Wong MM, Islam N, et al.
Abstract
BACKGROUND:The benefits and harms of using macrolides for asthma remain unclear.
OBJECTIVE:As part of upcoming Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters guidelines addressing severe asthma, we systematically reviewed the efficacy and safety of macrolides for asthma.
METHODS:We systematically searched MEDLINE, Embase, and CENTRAL to April 12, 2025, for randomized trials comparing macrolides with placebo or standard care for asthma. Paired reviewers independently screened records and extracted data. Individual patient-level data in random effects analysis of covariance models addressed asthma control and asthma-related quality of life. Random effects meta-analyses addressed severe exacerbations and harms. We used the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate certainty of evidence. Our study protocol is registered in PROSPERO (CRD42023408677).
RESULTS: Our meta-analysis comprised 19 trials enrolling 1825 participants. Compared with placebo, macrolides improve asthma control (6-item Asthma Control Questionnaire; score range 0-6, lower better; between-group mean difference: −0.23 [95% CI −0.32 to −0.13]; 40.6% vs 21.6% improving by minimally important difference of 0.5 point; high certainty), likely reduce severe exacerbations (incidence rate ratio: 0.75 [95% CI 0.57 to 0.98]; rate difference: 0.26 fewer events per patient-year [95% CI 0.45 to 0.02 fewer events]; moderate certainty), and likely modestly improve quality of life (Asthma Quality of Life Questionnaire; score range 1-7, higher better; mean difference: 0.11 [95% CI −0.06 to 0.29]; 47.6% vs 42.4% improving by minimally important difference of 0.5 points; moderate certainty) with little to no effect on serious adverse events and mortality (high certainty). Relative effects were similar among patients with type 2 high inflammation versus type 2 low inflammation asthma.
CONCLUSION:Macrolides likely reduce severe exacerbations and improve asthma control and quality of life with little to no difference in serious harms among patients with type 2 high inflammation or type 2 low inflammation asthma.
背景：大环内酯类药物用于哮喘治疗的获益与风险尚不明确。
目的：作为即将发布的美国过敏、哮喘与免疫学会/美国过敏、哮喘与免疫学院实践参数联合工作组关于重症哮喘指南的组成部分，本研究系统评价大环内酯类药物治疗哮喘的有效性与安全性。
方法：系统检索MEDLINE、Embase及CENTRAL数据库截至2025年4月12日的文献，纳入比较大环内酯类药物与安慰剂或标准治疗用于哮喘的随机对照试验。由两名研究者独立筛选文献并提取数据。采用随机效应协方差分析模型整合患者个体水平数据，评估哮喘控制水平与哮喘相关生活质量；采用随机效应meta分析评估重症急性加重与不良事件。使用GRADE方法评价证据质量。研究方案已在PROSPERO注册（CRD42023408677）。
结果：本meta分析共纳入19项试验、1825例受试者。与安慰剂相比，大环内酯类药物可改善哮喘控制（6项哮喘控制问卷，分值0~6分，分值越低控制越好；组间均数差：−0.23，95%CI：−0.32~−0.13；达到最小重要差异0.5分的改善比例：40.6% vs 21.6%，高证据质量）；可能降低重症急性加重风险（发生率比：0.75，95%CI：0.57~0.98；率差：每患者年减少0.26次事件，95%CI：减少0.45～0.02次，中等证据质量）；可能小幅改善生活质量（哮喘生活质量问卷，分值1～7分，分值越高生活质量越好；均数差：0.11，95%CI：−0.06~0.29；达到最小重要差异0.5分的改善比例：47.6% vs 42.4%，中等证据质量）；对严重不良事件与死亡率几乎无影响（高证据质量）。在2型高炎症与2型低炎症哮喘患者中，治疗相对效果相似。
结论：在2型高炎症或2型低炎症哮喘患者中，大环内酯类药物可能减少重症急性加重、改善哮喘控制与生活质量，且严重不良事件风险无明显差异。
（中日友好医院呼吸与危重症医学科 李春晓 摘译 林江涛 审校）
（J Allergy Clin Immunol. 2026 Feb 5:S0091-6749(26)00078-3.doi: 10.1016/j.jaci.2026.01.024.）
（J Allergy Clin Immunol. 2026 Feb 5:S0091-6749(26)00078-3.doi: 10.1016/j.jaci.2026.01.024.）
Macrolides for asthma: A systematic review and meta-analysis of randomized trials
Ologundudu LM, Wong MM, Islam N, et al.
Abstract
BACKGROUND:The benefits and harms of using macrolides for asthma remain unclear.
OBJECTIVE:As part of upcoming Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters guidelines addressing severe asthma, we systematically reviewed the efficacy and safety of macrolides for asthma.
METHODS:We systematically searched MEDLINE, Embase, and CENTRAL to April 12, 2025, for randomized trials comparing macrolides with placebo or standard care for asthma. Paired reviewers independently screened records and extracted data. Individual patient-level data in random effects analysis of covariance models addressed asthma control and asthma-related quality of life. Random effects meta-analyses addressed severe exacerbations and harms. We used the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate certainty of evidence. Our study protocol is registered in PROSPERO (CRD42023408677).
RESULTS: Our meta-analysis comprised 19 trials enrolling 1825 participants. Compared with placebo, macrolides improve asthma control (6-item Asthma Control Questionnaire; score range 0-6, lower better; between-group mean difference: −0.23 [95% CI −0.32 to −0.13]; 40.6% vs 21.6% improving by minimally important difference of 0.5 point; high certainty), likely reduce severe exacerbations (incidence rate ratio: 0.75 [95% CI 0.57 to 0.98]; rate difference: 0.26 fewer events per patient-year [95% CI 0.45 to 0.02 fewer events]; moderate certainty), and likely modestly improve quality of life (Asthma Quality of Life Questionnaire; score range 1-7, higher better; mean difference: 0.11 [95% CI −0.06 to 0.29]; 47.6% vs 42.4% improving by minimally important difference of 0.5 points; moderate certainty) with little to no effect on serious adverse events and mortality (high certainty). Relative effects were similar among patients with type 2 high inflammation versus type 2 low inflammation asthma.
CONCLUSION:Macrolides likely reduce severe exacerbations and improve asthma control and quality of life with little to no difference in serious harms among patients with type 2 high inflammation or type 2 low inflammation asthma.
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