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系统文献回顾:在吸入性皮质类固醇与短效β-激动剂按需缓解剂、按需 ICS/福莫特罗或 ICS/福莫特罗维持和缓解治疗的随机对照试验中,报告的哮喘特征和结果。

Systematic literature review of traits and outcomes reported in randomised controlled trials of asthma with regular dosing of inhaled corticosteroids with short-acting β-agonist reliever, as-needed ICS/formoterol, or ICS/formoterol maintenance and reliever therapy.

机构信息

Pneumology, AP-HP Centre Université Paris Cité, Hôpital Cochin, Paris, France.

Department of Pulmonology, Celal Bayar University, Manisa, Turkey.

出版信息

Respir Med. 2024 Jan;221:107478. doi: 10.1016/j.rmed.2023.107478. Epub 2023 Nov 24.

DOI:10.1016/j.rmed.2023.107478
PMID:38008385
Abstract

INTRODUCTION

Asthma treatments based solely on diagnostic label do not benefit patients equally. To identify patient traits that may be associated with improved treatment response to regular inhaled corticosteroid (ICSs) dosing with short-acting β-agonist reliever or ICS/formoterol-containing therapy, a systematic literature review (SLR) was conducted.

METHODS

Searches of databases including MEDLINE and Embase identified randomised controlled trials (RCTs) of patients with asthma, aged ≥12 years, published 1998-2022, containing ≥1 regular ICS dosing or ICS/formoterol-containing treatment arm, and reporting patient traits and outcomes of interest. Relevant data was extracted and underwent a feasibility assessment to determine suitability for meta-analysis.

RESULTS

The SLR identified 39 RCTs of 72,740 patients and 90 treatment arms, reporting 11 traits and 11 outcomes. Five patient traits (age, body mass index, FEV, smoking history, asthma control) and five outcomes (exacerbation rate, lung function, asthma control, adherence, time to first exacerbation) were deemed feasible for inclusion in meta-analyses due to sufficient comparable reporting. Subgroups of clinical outcomes stratified by levels of patient traits were reported in 16 RCTs.

CONCLUSION

A systematic review of studies of regular ICS dosing with SABA or ICS/formoterol-containing treatment strategies in asthma identified consistent reporting of five traits and outcomes, allowing exploration of associations with treatment response. Conversely, many other traits and outcomes, although being potentially relevant, were inconsistently reported and limited subgroup reporting meant analyses of treatment response for subgroups of traits was not possible. We recommend more consistent measurement and reporting of clinically relevant patient traits and outcomes in respiratory RCTs.

摘要

简介

仅基于诊断标签的哮喘治疗方法并不能使所有患者受益。为了确定可能与常规吸入皮质类固醇(ICS)与短效β-激动剂缓解剂或 ICS/福莫特罗联合治疗的剂量改善治疗反应相关的患者特征,进行了系统文献回顾(SLR)。

方法

对包括 MEDLINE 和 Embase 在内的数据库进行了检索,以确定 1998 年至 2022 年期间发表的包含≥1 个常规 ICS 剂量或 ICS/福莫特罗联合治疗组的、≥12 岁患者的随机对照试验(RCT),并报告患者特征和相关结局。提取相关数据,并进行可行性评估,以确定是否适合进行荟萃分析。

结果

SLR 共纳入 39 项 RCT,涉及 72740 名患者和 90 个治疗组,报告了 11 个特征和 11 个结局。由于有足够的可比报告,5 个患者特征(年龄、体重指数、FEV、吸烟史、哮喘控制)和 5 个结局(恶化率、肺功能、哮喘控制、依从性、首次恶化时间)被认为适合进行荟萃分析。16 项 RCT 报告了按患者特征水平分层的临床结局亚组。

结论

对常规 ICS 与 SABA 或 ICS/福莫特罗联合治疗策略治疗哮喘的研究进行系统评价,确定了对 5 个特征和结局的一致报告,这使得可以探索与治疗反应的关联。相反,许多其他特征和结局虽然具有潜在相关性,但报告不一致,且亚组报告有限,意味着无法对特征亚组的治疗反应进行分析。我们建议在呼吸 RCT 中更一致地测量和报告与临床相关的患者特征和结局。

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