Rogliani Paola, Beasley Richard, Cazzola Mario, Calzetta Luigino
Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome "Tor Vergata", Rome, Italy.
Medical Research Institute of New Zealand, Wellington, New Zealand.
Respir Med. 2021 Nov;188:106611. doi: 10.1016/j.rmed.2021.106611. Epub 2021 Sep 7.
A large proportion of asthmatic patients are treated with protocols resulting from data obtained by randomized controlled trials (RCTs) for which they would not have been eligible. Therefore, the aim of this study was to undertake a quantitative synthesis on real-world evidence comparing single inhaled corticosteroid (ICS)/formoterol maintenance and reliever therapy (SMART) and maintenance ICS/long-acting β-adrenoceptor agonist (LABA) + as-needed short-acting β-adrenoceptor agonist (SABA). A network meta-analysis of real-world studies was performed to compare SMART with ICS/LABA + as-needed SABA therapies in asthmatic patients. The surface under the cumulative ranking curve analysis was used to rank efficacy. The posterior probability distribution was reported as 95% credible interval (95%CrI). Data of 11,360 asthmatic patients were extracted from 6 studies. SMART including an ICS at medium-dose (MD) was more effective than MD ICS/LABA FDC + as-needed SABA (RR 0.54 95%CrI 0.42-0.69; P < 0.001) and low-dose (LD) SMART (RR 0.82 95%CrI 0.70-0.95; P < 0.05) against severe asthma exacerbation. MD SMART improved the Asthma Control Questionnaire score more than MD ICS/LABA FDC + as-needed SABA (delta effect -0.33 95%CrI -0.62 to -0.01; P < 0.05). The efficacy rank was: MD SMART > LD SMART > ICS + LABA free combination + as-needed SABA > ICS/LABA FDC + as-needed SABA > MD ICS/LABA FDC + as-needed SABA. The findings of this network meta-analysis of real-world evidence, and concordance with the effect estimates resulting from previous meta-analyses of RCTs, suggest that SMART may represent the preferred therapeutic option to reduce the risk of severe exacerbation in adults with moderate to severe asthma.
很大一部分哮喘患者接受的治疗方案是基于他们本不符合入选标准的随机对照试验（RCT）所获数据制定的。因此，本研究的目的是对真实世界证据进行定量综合分析，比较单剂量吸入糖皮质激素（ICS）/福莫特罗维持和缓解治疗（SMART）与维持使用ICS/长效β肾上腺素能受体激动剂（LABA）+按需使用短效β肾上腺素能受体激动剂（SABA）。对真实世界研究进行网络荟萃分析，以比较哮喘患者中SMART与ICS/LABA +按需使用SABA疗法。累积排序曲线下面积分析用于对疗效进行排序。后验概率分布报告为95%可信区间（95%CrI）。从6项研究中提取了11360例哮喘患者的数据。与中剂量（MD）ICS/LABA固定剂量复方制剂+按需使用SABA相比，含中剂量ICS的SMART在预防严重哮喘急性发作方面更有效（风险比0.54，95%CrI 0.42 - 0.69；P < 0.001），与低剂量（LD）SMART相比也更有效（风险比0.82，95%CrI 0.70 - 0.95；P < 0.05）。中剂量SMART在改善哮喘控制问卷评分方面比中剂量ICS/LABA固定剂量复方制剂+按需使用SABA更显著（效应差值 - 0.33，95%CrI - 0.62至 - 0.01；P < 0.05）。疗效排序为：中剂量SMART > 低剂量SMART > ICS + LABA自由联合制剂+按需使用SABA > ICS/LABA固定剂量复方制剂+按需使用SABA > 中剂量ICS/LABA固定剂量复方制剂+按需使用SABA。这项基于真实世界证据的网络荟萃分析结果，以及与先前RCT荟萃分析所得效应估计值的一致性，表明SMART可能是降低中重度哮喘成年患者严重急性发作风险的首选治疗方案。
