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持续气道正压通气治疗与阻塞性睡眠呼吸暂停患者的全因死亡率和心血管死亡率:一项对随机对照试验以及经混杂因素调整的非随机对照研究的系统评价和荟萃分析

Positive airway pressure therapy and all-cause and cardiovascular mortality in people with obstructive sleep apnoea: a systematic review and meta-analysis of randomised controlled trials and confounder-adjusted, non-randomised controlled studies.

作者信息

Benjafield Adam V, Pepin Jean-Louis, Cistulli Peter A, Wimms Alison, Lavergne Florent, Sert Kuniyoshi Fatima H, Munson Sibyl H, Schuler Brendan, Reddy Badikol Shrikar, Wolfe Kelly C, Willes Leslee, Kelly Colleen, Kendzerska Tetyana, Johnson Dayna A, Heinzer Raphael, Lee Chi-Hang, Malhotra Atul

机构信息

ResMed Science Center, Sydney, NSW, Australia.

Grenoble Alpes University, Inserm U1300, CHU Grenoble Alpes, HP2, Grenoble, France.

出版信息

Lancet Respir Med. 2025 May;13(5):403-413. doi: 10.1016/S2213-2600(25)00002-5. Epub 2025 Mar 18.

Abstract

BACKGROUND

Data regarding the effect of positive airway pressure (PAP) therapy for obstructive sleep apnoea (OSA) on all-cause mortality are inconsistent. We aimed to conduct a systematic review and meta-analysis to test the hypothesis that PAP therapy is associated with reduced all-cause and cardiovascular mortality in people with OSA.

METHODS

For this systematic review and meta-analysis, we searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials, from database inception to Aug 22, 2023 (updated Sept 9, 2024), with no language or geographical restrictions. Reference lists of eligible studies and recent conference abstracts (2022-23) were also reviewed. We included outpatient studies (randomised controlled trials [RCTs] or confounder-adjusted, non-randomised controlled studies [NRCSs]) assessing the incidence of all-cause mortality, cardiovascular mortality, or both in adults (aged ≥18 years) with OSA who were treated versus not treated with PAP; other study types and studies that evaluated only PAP adherence were excluded. Abstracts of all retrieved publications were independently screened by two of three researchers (BS, SRB, and KCW), with disagreements resolved by adjudication from another researcher (SHM). The AutoLit feature of the Nested Knowledge platform was used for the review and data-extraction phases. We analysed each log-transformed hazard ratio (HR) and SE using a linear random-effects model to estimate overall HRs and 95% CIs. To evaluate the risk of bias, we used the Cochrane Risk of Bias tool for RCTs and the Newcastle-Ottawa Scale for NRCSs. This study was registered with PROSPERO, CRD42023456627.

FINDINGS

Of 5484 records identified by our search, 435 were assessed for eligibility and 30 studies were included in the systematic review and meta-analysis (ten RCTs and 20 NRCSs). These studies included 1 175 615 participants, of whom 905 224 (77%) were male and 270 391 (23%) were female (SE 1·9), with a mean age of 59·5 (SE 1·4) years and a mean follow-up of 5·1 (0·5) years. The risk of bias was low to moderate. The risk of all-cause mortality (HR 0·63, 95% CI 0·56-0·72; p<0·0001) and cardiovascular mortality (0·45, 0·29-0·72; p<0·0001) was significantly lower in the PAP group than in the no-PAP group, and the clinically relevant benefit of PAP therapy increased with use.

INTERPRETATION

Our results are consistent with a potentially beneficial effect of PAP therapy on all-cause and cardiovascular mortality in patients with OSA. Patients should be made aware of this effect of their treatment, which could result in greater acceptance of treatment initiation and greater adherence, leading to a higher likelihood of improved outcomes.

FUNDING

ResMed.

摘要

背景

关于气道正压通气(PAP)治疗阻塞性睡眠呼吸暂停(OSA)对全因死亡率影响的数据并不一致。我们旨在进行一项系统评价和荟萃分析,以检验PAP治疗与降低OSA患者的全因死亡率和心血管死亡率相关这一假设。

方法

对于这项系统评价和荟萃分析,我们检索了PubMed、Embase和Cochrane对照试验中央注册库,检索时间从数据库建立至2023年8月22日(2024年9月9日更新),无语言或地域限制。还查阅了符合条件研究的参考文献列表和近期会议摘要(2022 - 2023年)。我们纳入了评估接受PAP治疗与未接受PAP治疗的成年(≥18岁)OSA患者全因死亡率、心血管死亡率或两者发生率的门诊研究(随机对照试验[RCT]或经混杂因素调整的非随机对照研究[NRCS]);排除其他研究类型和仅评估PAP依从性的研究。三名研究人员(BS、SRB和KCW)中的两名独立筛选所有检索到的出版物的摘要,如有分歧由另一名研究人员(SHM)裁决解决。在综述和数据提取阶段使用了Nested Knowledge平台的AutoLit功能。我们使用线性随机效应模型分析每个经对数转换的风险比(HR)和标准误(SE),以估计总体HR和95%置信区间(CI)。为评估偏倚风险,我们对RCT使用Cochrane偏倚风险工具,对NRCS使用纽卡斯尔 - 渥太华量表。本研究已在PROSPERO注册,注册号为CRD42023456627。

结果

在我们检索到的5484条记录中,435条被评估是否符合纳入标准,30项研究被纳入系统评价和荟萃分析(10项RCT和20项NRCS)。这些研究共纳入1175615名参与者,其中905224名(77%)为男性,270391名(23%)为女性(标准误1.9),平均年龄59.5(标准误1.4)岁,平均随访5.1(0.5)年。偏倚风险为低到中度。PAP治疗组的全因死亡率(HR 0.63,95% CI 0.56 - 0.72;p < 0.0001)和心血管死亡率(0.45,0.29 - 0.72;p < 0.0001)显著低于非PAP治疗组,且PAP治疗的临床相关益处随使用时间增加。

解读

我们的结果与PAP治疗对OSA患者全因死亡率和心血管死亡率具有潜在有益作用一致。应让患者了解其治疗的这一效果,这可能会使患者更愿意开始治疗并提高依从性,从而更有可能改善治疗结果。

资助

瑞思迈公司。

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本文引用的文献

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Positive Airway Pressure, Mortality, and Cardiovascular Risk in Older Adults With Sleep Apnea.
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Arch Bronconeumol. 2024 Oct;60(10):627-633. doi: 10.1016/j.arbres.2024.05.029. Epub 2024 May 31.
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