重度哮喘中的支气管热成形术：桥接随机对照试验与真实世界证据——系统综述与荟萃分析。
完整摘要 · 中文译文
引言：支气管热成形术（BT）可减少气道平滑肌，可能对重症哮喘有益，但其与生物制剂联合使用时的作用仍不明确。我们评估了关于其疗效和安全性的随机对照试验及真实世界证据。方法：我们检索了PubMed、Scopus和Cochrane图书馆中关于BT在成人重症未控制哮喘患者中应用的随机对照试验和观察性研究，并对它们分别进行分析。结果：共纳入二十项研究（五项随机对照试验，十五项观察性研究）。在随机对照试验中，BT改善了哮喘相关生活质量（AQLQ；均数差，0.69；95%置信区间 0.30-1.09）、哮喘控制（ACQ；均数差，-0.64；95%置信区间，-1.10至-0.19）和清晨呼气峰流速（均数差，20.62升/分钟；95%置信区间，4.92-36.32），但未改善急救药物使用或无哮喘症状天数。BT在治疗期间增加了住院风险（相对危险度，3.50；95%置信区间，1.26-9.68），此后无显著超额风险。真实世界研究显示AQLQ（均数差，1.38；95%置信区间，0.97-1.80）、ACQ（均数差，-1.24；95%置信区间，-1.86至-0.62）和年化急性加重率（均数差，-3.79次/患者-年；95%置信区间，-6.98至-0.61）均有改善。证据提示可能存在但不一致的激素节约效应；关于生物制剂和长期安全性的数据有限。结论：BT改善了哮喘相关生活质量和控制，主要见于无假手术对照的试验中，但增加了短期住院风险。真实世界研究结果相似，但来自非对照研究。BT并非生物制剂的既定替代方案，但可能适合经仔细筛选的无法使用生物制剂或对其无反应的重症哮喘患者。
完整摘要 · 英文原文
Introduction: Bronchial thermoplasty (BT) reduces airway smooth muscle and may benefit severe asthma, but its role alongside biologics remains unclear. We assessed randomised and real-world evidence on efficacy and safety. Methods: We searched PubMed, Scopus, and Cochrane Library for RCTs and observational studies of BT in adults with severe uncontrolled asthma, analysing them separately. Results: Twenty studies were included (five RCTs, 15 observational). In RCTs, BT improved asthma-related quality of life (AQLQ;MD, 0.69; 95% CI 0.30-1.09), asthma control (ACQ; MD,-0.64; 95%CI, -1.10 to -0.19), and morning peak expiratory flow (MD, 20.62 L/min; 95% CI, 4.92-36.32), but did not improve rescue medication use or symptom-free-days. BT increased the risk of hospitalisation during the treatment period (RR, 3.50; 95%CI, 1.26-9.68), with no significant excess thereafter. Real-world studies showed improvements in AQLQ (MD,1.38; 95%CI, 0.97-1.80), ACQ (MD,-1.24; 95%CI, -1.86 to -0.62), and annualised exacerbation rates (MD, -3.79 exacerbations/patient-year; 95%CI, -6.98 to -0.61). Evidence suggested a possible, inconsistent corticosteroid-sparing effect; data on biologics and long-term safety were limited. Conclusions: BT improved asthma-related quality of life and control, mainly in trials without sham controls, but increased short-term hospitalisation risk. Real-world findings were similar but came from uncontrolled studies. BT is not an established alternative to biologics, but may suit carefully selected patients with severe asthma who cannot use or do not respond to them.