Electronic literature searches were performed on PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials, to retrieve RCTs of BT or FDA-approved biologicals against controls in patients with severe asthma. Six outcomes were analyzed: Asthma Control Questionnaire (ACQ), Asthma Quality of Life Questionnaire (AQLQ), the number of patients experiencing ≥1 asthma exacerbation, annualized exacerbation rate ratio (AERR), oral corticosteroid dose reduction (OCDR), and morning peak expiratory flow rate (amPEF). Random-effects, Frequentist network meta-analysis (NMA) were performed, and therapies were ranked using P-scores.
Twenty-nine RCTs (15,547 patients) were included. Fewer patients treated with BT experienced ≥1 asthma exacerbation (risk ratio [RR] = 0.66, 95%CI = 0.45-0.98) compared to control. AERR of BT versus control was non-significant, but significant improvements in ACQ score (mean difference [MD] -0.41, 95%CI -0.63 to -0.20), AQLQ score (MD = 0.54, 95%CI = 0.30-0.77), amPEF and OCDR were found. No significant differences between BT and biologics were seen across indirect comparisons of all studies.
Despite the lack of head-to-head comparative trials, this NMA suggests that BT is non-inferior to biologicals in terms of quality-of-life scores, and represents a promising alternative for patients with severe asthma.
方法:在PubMed上进行电子文献检索,EMBASE,和Cochrane中央控制试验登记册,在重度哮喘患者中检索BT或FDA批准的生物制剂对照的RCT。分析了六个结果:哮喘控制问卷(ACQ),哮喘生活质量问卷(AQLQ),经历≥1次哮喘加重的患者人数,年化恶化率比率(AERR),口服皮质类固醇剂量减少(OCDR),和早晨呼气峰流速(amPEF)。随机效果,进行了频繁网络荟萃分析(NMA),和治疗使用P评分进行排名。
结果:纳入29个RCTs(15,547例患者)。与对照组相比,接受BT治疗的患者出现≥1次哮喘加重(风险比[RR]=0.66,95CI=0.45-0.98)。BT与对照的AERR无统计学意义,但ACQ评分显著改善(均差[MD]-0.41,95CI-0.63至-0.20),AQLQ评分(MD=0.54,95CI=0.30-0.77),发现了amPEF和OCDR。在所有研究的间接比较中,BT和生物制剂之间没有显着差异。
结论:尽管缺乏头对头比较试验,这个NMA表明BT在生活质量评分方面不劣于生物制品,并代表了严重哮喘患者的有希望的替代方案。