比较支气管热成形术和生物制剂治疗重度哮喘:系统综述和网络荟萃分析
2023/08/28
摘要
背景：支气管热成形术(BT)在多项随机对照试验(RCT)中显示出良好的安全性和有效性，但尚未与生物疗法进行直接比较。
方法：在PubMed、EMBASE和Cochrane Central Register of Controlled Trials上进行电子文献检索，检索BT或FDA批准的生物制剂对比对照治疗重度哮喘患者的RCT。分析6项结局指标:哮喘控制问卷(Asthma Control Questionnaire, ACQ)、哮喘生活质量问卷(Asthma Quality of Life Questionnaire, AQLQ)、哮喘发作≥1次的患者数、年发作率比(annual exacerbation rate ratio, AERR)、口服糖皮质激素减量(oral corticosteroid dose reduction, OCDR)和晨峰呼气流速(morning peak expiratory flow rate, amPEF)。采用随机效应、Frequentist网络荟萃分析(NMA)方法，采用p-评分对治疗方案进行排序。
结果：共纳入29个RCT(15,547例患者)。与对照组相比，BT组发生≥1次哮喘发作的患者较少(风险比[RR] = 0.66, 95%CI = 0.45～0.98)。BT组与对照组相比，AERR差异无统计学意义，但ACQ评分[均数差(MD) = -0.41, 95%CI = -0.63～-0.20]、AQLQ评分(MD = 0.54, 95%CI = 0.30～0.77)、amPEF和OCDR均有显著改善。在对所有研究进行的间接比较中，未观察到BT和生物制剂之间有显著差异。
结论：尽管缺乏直接比较试验，但本次NMA提示BT在生活质量评分方面不劣于生物制剂，对于重度哮喘患者是一种有前景的替代方案。
Comparing bronchial thermoplasty with biologicals for severe asthma: Systematic review and network meta-analysis
K. Y. Fong, J. J. Zhao, N. L. Syn, P. Nair, Y. H. Chan and P. Lee
Abstract
BACKGROUND: Bronchial thermoplasty (BT) has shown favorable safety and efficacy in several randomized controlled trials (RCTs), but has not been directly compared to biological therapies.
METHODS: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.
RESULTS: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.
CONCLUSIONS: 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.
背景：支气管热成形术(BT)在多项随机对照试验(RCT)中显示出良好的安全性和有效性，但尚未与生物疗法进行直接比较。
方法：在PubMed、EMBASE和Cochrane Central Register of Controlled Trials上进行电子文献检索，检索BT或FDA批准的生物制剂对比对照治疗重度哮喘患者的RCT。分析6项结局指标:哮喘控制问卷(Asthma Control Questionnaire, ACQ)、哮喘生活质量问卷(Asthma Quality of Life Questionnaire, AQLQ)、哮喘发作≥1次的患者数、年发作率比(annual exacerbation rate ratio, AERR)、口服糖皮质激素减量(oral corticosteroid dose reduction, OCDR)和晨峰呼气流速(morning peak expiratory flow rate, amPEF)。采用随机效应、Frequentist网络荟萃分析(NMA)方法，采用p-评分对治疗方案进行排序。
结果：共纳入29个RCT(15,547例患者)。与对照组相比，BT组发生≥1次哮喘发作的患者较少(风险比[RR] = 0.66, 95%CI = 0.45～0.98)。BT组与对照组相比，AERR差异无统计学意义，但ACQ评分[均数差(MD) = -0.41, 95%CI = -0.63～-0.20]、AQLQ评分(MD = 0.54, 95%CI = 0.30～0.77)、amPEF和OCDR均有显著改善。在对所有研究进行的间接比较中，未观察到BT和生物制剂之间有显著差异。
结论：尽管缺乏直接比较试验，但本次NMA提示BT在生活质量评分方面不劣于生物制剂，对于重度哮喘患者是一种有前景的替代方案。
（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）
（Respir Med 2023 Vol. 216 Pages 107302 DOI: 10.1016/j.rmed.2023.107302）
（Respir Med 2023 Vol. 216 Pages 107302 DOI: 10.1016/j.rmed.2023.107302）
Comparing bronchial thermoplasty with biologicals for severe asthma: Systematic review and network meta-analysis
K. Y. Fong, J. J. Zhao, N. L. Syn, P. Nair, Y. H. Chan and P. Lee
Abstract
BACKGROUND: Bronchial thermoplasty (BT) has shown favorable safety and efficacy in several randomized controlled trials (RCTs), but has not been directly compared to biological therapies.
METHODS: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.
RESULTS: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.
CONCLUSIONS: 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.
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