哮喘的吸入缓解疗法：系统评价和荟萃分析
2024/11/29
摘要
背景：哮喘的最佳吸入缓解疗法仍不清楚。
目的：比较单独使用短效β激动剂 （SABA） 与 SABA 联合吸入皮质类固醇 （ICS） 以及速效、长效β激动剂福莫特罗联合 ICS 治疗哮喘的疗效。
方法: 数据来源：检索时间为 2020年1月1日至2024年9月27日的 MEDLINE、Embase 和 CENTRAL 数据库，没有语言限制。研究选择： 两位评价员独立选择随机临床试验，评估（1）单独使用 SABA，（2）ICS 与福莫特罗，以及（3）ICS与SABA（组合或单独吸入器）。资料提取和综合：两名评价员独立提取资料并评估偏倚风险。随机效应荟萃分析综合结果。GRADE（Grading of Recommendations Assessment，Development，and Evaluation）用于评价证据质量。主要结局和措施：哮喘症状控制（5项哮喘控制问卷;范围，0-6分，分数越低表示哮喘控制越好;最小重要差异 [MID]，0.5 分），哮喘相关生活质量 （哮喘生活质量问卷;范围，1-7分，分数越高表示生活质量越好;MID，0.5 分）、严重恶化的风险和严重不良事件的风险。
结果: 共纳入27 项随机临床试验（N = 50 496 名成人和儿童患者;平均年龄 41.0 岁;20 288 名男性 [40%]）。与单独使用 SABA 相比，两种含 ICS 的缓解药物的严重恶化率较低（ICS-福莫特罗风险比 [RR]，0.65 [95% CI，0.60-0.72];风险差 [RD]，-10.3% [95% CI，-11.8% 至 -8.3%];ICS-SABA RR，0.84 [95% CI，0.73-0.95];RD，-4.7% [95% CI，-8.0% 至 -1.5%]），质量高。与单独使用 SABA 相比，两种含 ICS 的缓解剂都与哮喘控制的改善相关（ICS-福莫特罗 RR 总分改善 [MID]，1.07 [95% CI，1.04-1.10];RD，4.1% [95% CI，2.3%-5.9%];ICS-SABA RR，1.09 [95% CI，1.03-1.15];RD，5.4% [95% CI，1.8%-8.5%]），质量高。在与 ICS-SABA 的间接比较中，ICS-福莫特罗与较少的严重恶化相关 （RR， 0.78 [95% CI，0.66-0.92];RD，-5.5% [95% CI，-8.4% 至 -2.0%]），中等质量。与单独使用 SABA 相比，ICS-福莫特罗（RD，-0.6% [95% CI，-1.3%，0%]）与严重不良事件风险增加无关（高质量），ICS-SABA（RD，0% [95% CI，-1.1%，1.2%]）与严重不良事件风险增加无关 （中等质量）。
结论: 在这项针对哮喘患者的网络荟萃分析中，与单独使用 SABA 相比，ICS 联合福莫特罗和 ICS 联合 SABA 均与减少哮喘发作和改善哮喘控制相关。
Inhaled Reliever Therapies for Asthma: A Systematic Review and Meta-Analysis.
Daniel G, Rayner; Dario M, Ferri; Gordon H,
Abstrast
Background: The optimal inhaled reliever therapy for asthma remains unclear.
Objective: To compare short-acting β agonists (SABA) alone with SABA combined with inhaled corticosteroids (ICS) and with the fast-onset, long-acting β agonist formoterol combined with ICS for asthma.
Methods: DATA SOURCES: The MEDLINE, Embase, and CENTRAL databases were searched from January 1, 2020, to September 27, 2024, without language restrictions. STUDY SELECTION: Pairs of reviewers independently selected randomized clinical trials evaluating (1) SABA alone, (2) ICS with formoterol, and (3) ICS with SABA (combined or separate inhalers). DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data and assessed risk of bias. Random-effects meta-analyses synthesized outcomes. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to evaluate the certainty of evidence. MAIN OUTCOMES AND MEASURES: Asthma symptom control (5-item Asthma Control Questionnaire; range, 0-6, lower scores indicate better asthma control; minimum important difference [MID], 0.5 points), asthma-related quality of life (Asthma Quality of Life Questionnaire; range, 1-7, higher scores indicate better quality of life; MID, 0.5 points), risk of severe exacerbations, and risk of serious adverse events.
Results: A total of 27 randomized clinical trials (N = 50 496 adult and pediatric patients; mean age, 41.0 years; 20 288 male [40%]) were included. Compared with SABA alone, both ICS-containing relievers were associated with fewer severe exacerbations (ICS-formoterol risk ratio [RR], 0.65 [95% CI, 0.60-0.72]; risk difference [RD], -10.3% [95% CI, -11.8% to -8.3%]; ICS-SABA RR, 0.84 [95% CI, 0.73-0.95]; RD, -4.7% [95% CI, -8.0% to -1.5%]) with high certainty. Compared with SABA alone, both ICS-containing relievers were associated with improved asthma control (ICS-formoterol RR improvement [MID] in total score, 1.07 [95% CI, 1.04-1.10]; RD, 4.1% [95% CI, 2.3%-5.9%]; ICS-SABA RR, 1.09 [95% CI, 1.03-1.15]; RD, 5.4% [95% CI, 1.8%-8.5%]) with high certainty. In an indirect comparison with ICS-SABA, ICS-formoterol was associated with fewer severe exacerbations (RR, 0.78 [95% CI, 0.66-0.92]; RD, -5.5% [95% CI, -8.4% to -2.0%]) with moderate certainty. Compared with SABA alone, ICS-formoterol (RD, -0.6% [95% CI, -1.3% to 0%]) was not associated with increased risk of serious adverse events (high certainty) and ICS-SABA (RD, 0% [95% CI, -1.1% to 1.2%]) was not associated with increased risk of serious adverse events (moderate certainty).
Conclusions：In this network meta-analysis of patients with asthma, ICS combined with formoterol and ICS combined with SABA were each associated with reduced asthma exacerbations and improved asthma control compared with SABA alone.
背景：哮喘的最佳吸入缓解疗法仍不清楚。
目的：比较单独使用短效β激动剂 （SABA） 与 SABA 联合吸入皮质类固醇 （ICS） 以及速效、长效β激动剂福莫特罗联合 ICS 治疗哮喘的疗效。
方法: 数据来源：检索时间为 2020年1月1日至2024年9月27日的 MEDLINE、Embase 和 CENTRAL 数据库，没有语言限制。研究选择： 两位评价员独立选择随机临床试验，评估（1）单独使用 SABA，（2）ICS 与福莫特罗，以及（3）ICS与SABA（组合或单独吸入器）。资料提取和综合：两名评价员独立提取资料并评估偏倚风险。随机效应荟萃分析综合结果。GRADE（Grading of Recommendations Assessment，Development，and Evaluation）用于评价证据质量。主要结局和措施：哮喘症状控制（5项哮喘控制问卷;范围，0-6分，分数越低表示哮喘控制越好;最小重要差异 [MID]，0.5 分），哮喘相关生活质量 （哮喘生活质量问卷;范围，1-7分，分数越高表示生活质量越好;MID，0.5 分）、严重恶化的风险和严重不良事件的风险。
结果: 共纳入27 项随机临床试验（N = 50 496 名成人和儿童患者;平均年龄 41.0 岁;20 288 名男性 [40%]）。与单独使用 SABA 相比，两种含 ICS 的缓解药物的严重恶化率较低（ICS-福莫特罗风险比 [RR]，0.65 [95% CI，0.60-0.72];风险差 [RD]，-10.3% [95% CI，-11.8% 至 -8.3%];ICS-SABA RR，0.84 [95% CI，0.73-0.95];RD，-4.7% [95% CI，-8.0% 至 -1.5%]），质量高。与单独使用 SABA 相比，两种含 ICS 的缓解剂都与哮喘控制的改善相关（ICS-福莫特罗 RR 总分改善 [MID]，1.07 [95% CI，1.04-1.10];RD，4.1% [95% CI，2.3%-5.9%];ICS-SABA RR，1.09 [95% CI，1.03-1.15];RD，5.4% [95% CI，1.8%-8.5%]），质量高。在与 ICS-SABA 的间接比较中，ICS-福莫特罗与较少的严重恶化相关 （RR， 0.78 [95% CI，0.66-0.92];RD，-5.5% [95% CI，-8.4% 至 -2.0%]），中等质量。与单独使用 SABA 相比，ICS-福莫特罗（RD，-0.6% [95% CI，-1.3%，0%]）与严重不良事件风险增加无关（高质量），ICS-SABA（RD，0% [95% CI，-1.1%，1.2%]）与严重不良事件风险增加无关 （中等质量）。
结论: 在这项针对哮喘患者的网络荟萃分析中，与单独使用 SABA 相比，ICS 联合福莫特罗和 ICS 联合 SABA 均与减少哮喘发作和改善哮喘控制相关。
(中日友好医院呼吸与危重症医学科 万静萱 摘译 林江涛 审校)
(JAMA 2024 Oct 28;0(0)；DOI: 10.1001/jama.2024.22700；IF：45.54.)
(JAMA 2024 Oct 28;0(0)；DOI: 10.1001/jama.2024.22700；IF：45.54.)
Inhaled Reliever Therapies for Asthma: A Systematic Review and Meta-Analysis.
Daniel G, Rayner; Dario M, Ferri; Gordon H,
Abstrast
Background: The optimal inhaled reliever therapy for asthma remains unclear.
Objective: To compare short-acting β agonists (SABA) alone with SABA combined with inhaled corticosteroids (ICS) and with the fast-onset, long-acting β agonist formoterol combined with ICS for asthma.
Methods: DATA SOURCES: The MEDLINE, Embase, and CENTRAL databases were searched from January 1, 2020, to September 27, 2024, without language restrictions. STUDY SELECTION: Pairs of reviewers independently selected randomized clinical trials evaluating (1) SABA alone, (2) ICS with formoterol, and (3) ICS with SABA (combined or separate inhalers). DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data and assessed risk of bias. Random-effects meta-analyses synthesized outcomes. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to evaluate the certainty of evidence. MAIN OUTCOMES AND MEASURES: Asthma symptom control (5-item Asthma Control Questionnaire; range, 0-6, lower scores indicate better asthma control; minimum important difference [MID], 0.5 points), asthma-related quality of life (Asthma Quality of Life Questionnaire; range, 1-7, higher scores indicate better quality of life; MID, 0.5 points), risk of severe exacerbations, and risk of serious adverse events.
Results: A total of 27 randomized clinical trials (N = 50 496 adult and pediatric patients; mean age, 41.0 years; 20 288 male [40%]) were included. Compared with SABA alone, both ICS-containing relievers were associated with fewer severe exacerbations (ICS-formoterol risk ratio [RR], 0.65 [95% CI, 0.60-0.72]; risk difference [RD], -10.3% [95% CI, -11.8% to -8.3%]; ICS-SABA RR, 0.84 [95% CI, 0.73-0.95]; RD, -4.7% [95% CI, -8.0% to -1.5%]) with high certainty. Compared with SABA alone, both ICS-containing relievers were associated with improved asthma control (ICS-formoterol RR improvement [MID] in total score, 1.07 [95% CI, 1.04-1.10]; RD, 4.1% [95% CI, 2.3%-5.9%]; ICS-SABA RR, 1.09 [95% CI, 1.03-1.15]; RD, 5.4% [95% CI, 1.8%-8.5%]) with high certainty. In an indirect comparison with ICS-SABA, ICS-formoterol was associated with fewer severe exacerbations (RR, 0.78 [95% CI, 0.66-0.92]; RD, -5.5% [95% CI, -8.4% to -2.0%]) with moderate certainty. Compared with SABA alone, ICS-formoterol (RD, -0.6% [95% CI, -1.3% to 0%]) was not associated with increased risk of serious adverse events (high certainty) and ICS-SABA (RD, 0% [95% CI, -1.1% to 1.2%]) was not associated with increased risk of serious adverse events (moderate certainty).
Conclusions：In this network meta-analysis of patients with asthma, ICS combined with formoterol and ICS combined with SABA were each associated with reduced asthma exacerbations and improved asthma control compared with SABA alone.
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