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 β₂-adrenoceptor agonist (LABA) + as-needed short-acting β₂-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来源于他们不符合条件的随机对照试验 (RCT) 获得的数据。_{因此，本研究的目的是对比较单次吸入皮质类固醇（ICS）/福莫特罗维持和缓解治疗（SMART）和维持ICS/长效β2-}肾上腺素受体激动剂（LABA）的真实世界证据进行定量综合。按需短效_β2-肾上腺素受体激动剂（SABA）。对真实世界研究进行了网络荟萃分析，以比较 SMART 与 ICS/LABA + 按需 SABA 疗法在哮喘患者中的疗效。累积排序曲线分析下的表面用于对功效进行排序。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 11,360 名哮喘患者的数据。包含中等剂量 (MD) ICS 的 SMART 比 MD ICS/LABA FDC + 按需 SABA (RR 0.54 95%CrI 0.42–0.69; P < 0.001) 和低剂量 (LD) SMART (RR 0.82) 更有效95%CrI 0.70–0.95；P < 0.05) 对抗严重哮喘发作。MD SMART 对哮喘控制问卷评分的改善超过 MD ICS/LABA FDC + 按需 SABA（增量效应 -0.33 95%CrI -0.62 至 -0.01；P < 0.05）。疗效等级为：MD SMART > LD SMART > ICS + LABA 自由组合 + 按需 SABA > ICS/LABA FDC + 按需 SABA > MD ICS/LABA FDC + 按需 SABA。对现实世界证据的网络荟萃分析的结果，以及与先前随机对照试验荟萃分析产生的效果估计的一致性，表明 SMART 可能是降低中度至中度至成年患者严重恶化风险的首选治疗方案。严重哮喘。