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成人中枢性睡眠呼吸暂停的无创正压通气。

Non-invasive positive pressure ventilation for central sleep apnoea in adults.

机构信息

Cochrane Brazil, Health Technology Assessment Center, São Paulo, Brazil.

Biological and Health Sciences Department, Federal University of Amapa, Amapá, Brazil.

出版信息

Cochrane Database Syst Rev. 2022 Oct 24;10(10):CD012889. doi: 10.1002/14651858.CD012889.pub2.

Abstract

BACKGROUND

Central sleep apnoea (CSA) is characterised by abnormal patterns of ventilation during sleep due to a dysfunctional drive to breathe. Consequently, people with CSA may present poor sleep quality, sleep fragmentation, inattention, fatigue, daytime sleepiness, and reduced quality of life.

OBJECTIVES

To assess the effectiveness and safety of non-invasive positive pressure ventilation (NIPV) for the treatment of adults with CSA.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and Scopus on 6 September 2021. We applied no restrictions on language of publication. We also searched clinical trials registries for ongoing and unpublished studies, and scanned the reference lists of included studies to identify additional studies.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) reported in full text, those published as abstract only, and unpublished data.

DATA COLLECTION AND ANALYSIS

Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias of the included studies using the Cochrane risk of bias tool version 1.0, and the certainty of the evidence using the GRADE approach. In the case of disagreement, a third review author was consulted.

MAIN RESULTS

We included 15 RCTs with a total of 1936 participants, ranging from 10 to 1325 participants. All studies had important methodological limitations. We assessed most studies (11 studies) as at high risk of bias for at least one domain, and all studies as at unclear risk of bias for at least two domains. The trials included participants aged > 18 years old, of which 70% to 100% were men, who were followed from one week to 60 months. The included studies assessed the effects of different modes of NIPV and CSA. Most participants had CSA associated with chronic heart failure. Because CSA encompasses a variety of causes and underlying clinical conditions, data were carefully analysed, and different conditions and populations were not pooled. The findings for the primary outcomes for the seven evaluated comparisons are presented below.  Continuous positive airway pressure (CPAP) plus best supportive care versus best supportive care in CSA associated with chronic heart failure In the short term, CPAP plus best supportive care may reduce central apnoea hypopnoea index (AHI) (mean difference (MD) -14.60, 95% confidence interval (CI) -20.11 to -9.09; 1 study; 205 participants). However, CPAP plus best supportive care may result in little to no difference in cardiovascular mortality compared to best supportive care alone. The evidence for the effect of CPAP plus best supportive care on all-cause mortality is very uncertain. No adverse effects were observed with CPAP, and the results for adverse events in the best supportive care group were not reported. Adaptive servo ventilation (ASV) versus CPAP in CSA associated with chronic heart failure The evidence is very uncertain about the effect of ASV versus CPAP on quality of life evaluated in both the short and medium term. Data on adverse events were not reported, and it is not clear whether data were sought but not found. ASV versus bilevel ventilation in CSA associated with chronic heart failure In the short term, ASV may result in little to no difference in central AHI. No adverse events were detected with ASV, and the results for adverse events in the bilevel ventilation group were not reported. ASV plus best supportive care versus best supportive care in CSA associated with chronic heart failure In the medium term, ASV plus best supportive care may reduce AHI compared to best supportive care alone (MD -20.30, 95% CI -28.75 to -11.85; 1 study; 30 participants). In the long term, ASV plus best supportive care likely increases cardiovascular mortality compared to best supportive care (risk ratio (RR) 1.25, 95% CI 1.04, 1.49; 1 study; 1325 participants). The evidence suggests that ASV plus best supportive care may result in little to no difference in quality of life in the short, medium, and long term, and in all-cause mortality in the medium and long term. Data on adverse events were evaluated but not reported. ASV plus best supportive care versus best supportive care in CSA with acute heart failure with preserved ejection fraction Only adverse events were reported for this comparison, and no adverse events were recorded in either group. ASV versus CPAP maintenance in CPAP-induced CSA In the short term, ASV may slightly reduce central AHI (MD -4.10, 95% CI -6.67 to -1.53; 1 study; 60 participants), but may result in little to no difference in quality of life. Data on adverse events were not reported, and it is not clear whether data were sought but not found. ASV versus bilevel ventilation in CPAP-induced CSA In the short term, ASV may slightly reduce central AHI (MD -8.70, 95% CI -11.42 to -5.98; 1 study; 30 participants) compared to bilevel ventilation. Data on adverse events were not reported, and it is not clear whether data were sought but not found.

AUTHORS' CONCLUSIONS: CPAP plus best supportive care may reduce central AHI in people with CSA associated with chronic heart failure compared to best supportive care alone. Although ASV plus best supportive care may reduce AHI in people with CSA associated with chronic heart failure, it likely increases cardiovascular mortality in these individuals. In people with CPAP-induced CSA, ASV may slightly reduce central AHI compared to bilevel ventilation and to CPAP. In the absence of data showing a favourable impact on meaningful patient-centred outcomes and defining clinically important differences in outcomes in CSA patients, these findings need to be interpreted with caution. Considering the level of certainty of the available evidence and the heterogeneity of participants with CSA, we could draw no definitive conclusions, and further high-quality trials focusing on patient-centred outcomes, such as quality of life, quality of sleep, and longer-term survival, are needed to determine whether one mode of NIPV is better than another or than best supportive care for any particular CSA patient group.

摘要

背景

中枢性睡眠呼吸暂停(CSA)的特点是睡眠期间通气模式异常,这是由于呼吸驱动功能障碍所致。因此,CSA 患者可能表现出睡眠质量差、睡眠碎片化、注意力不集中、疲劳、日间嗜睡和生活质量降低。

目的

评估无创正压通气(NIPV)治疗成人 CSA 的有效性和安全性。

检索方法

我们于 2021 年 9 月 6 日在 Cochrane 对照试验中心注册库(CENTRAL)、MEDLINE、Embase 和 Scopus 中进行了检索。我们对发表语言没有任何限制。我们还检索了正在进行和未发表研究的临床试验注册处,并对纳入研究的参考文献进行了扫描,以确定其他研究。

纳入标准

我们纳入了以全文发表、仅以摘要发表和未发表数据形式报告的随机对照试验(RCT)。

数据收集和分析

两名综述作者独立选择纳入的研究,使用 Cochrane 偏倚风险工具版本 1.0 评估纳入研究的偏倚风险,并使用 GRADE 方法评估证据的确定性。如果存在分歧,则咨询第三位综述作者。

主要结果

我们纳入了 15 项 RCT,共纳入 1936 名参与者,参与者人数从 10 人到 1325 人不等。所有研究均存在重要的方法学局限性。我们评估了大多数研究(11 项研究)在至少一个领域存在高偏倚风险,所有研究在至少两个领域存在不确定偏倚风险。这些试验纳入的参与者年龄>18 岁,其中 70%至 100%为男性,随访时间从一周到 60 个月不等。纳入的研究评估了不同模式的 NIPV 和 CSA 的效果。大多数参与者患有与慢性心力衰竭相关的 CSA。由于 CSA 涵盖了多种原因和潜在的临床情况,因此对数据进行了仔细分析,并且不同的情况和人群未进行汇总。以下是对七个评估比较的主要结局的发现。持续气道正压通气(CPAP)加最佳支持治疗与慢性心力衰竭相关的 CSA 在短期内,CPAP 加最佳支持治疗可能会降低中枢性呼吸暂停低通气指数(AHI)(平均差值(MD)-14.60,95%置信区间(CI)-20.11 至-9.09;1 项研究;205 名参与者)。然而,CPAP 加最佳支持治疗可能与单独最佳支持治疗相比,对心血管死亡率的影响差异无统计学意义。CPAP 加最佳支持治疗对全因死亡率的影响证据非常不确定。CPAP 没有观察到不良反应,也没有报告最佳支持治疗组的不良事件结果。适应性伺服通气(ASV)与慢性心力衰竭相关的 CSA 与 CPAP 的比较 关于 ASV 与 CPAP 对短期和中期生活质量的影响,证据非常不确定。未报告不良事件数据,也不清楚是否有数据但未找到。ASV 与慢性心力衰竭相关的 CSA 中的双水平通气 在短期内,ASV 可能对中枢性 AHI 无显著影响。ASV 未检测到不良反应,也未报告双水平通气组的不良反应结果。ASV 加最佳支持治疗与慢性心力衰竭相关的 CSA 与最佳支持治疗的比较 在中期,与单独最佳支持治疗相比,ASV 加最佳支持治疗可能会降低 AHI(MD-20.30,95%CI-28.75 至-11.85;1 项研究;30 名参与者)。在长期,与单独最佳支持治疗相比,ASV 加最佳支持治疗可能会增加心血管死亡率(风险比(RR)1.25,95%CI 1.04 至 1.49;1 项研究;1325 名参与者)。研究结果表明,与单独最佳支持治疗相比,ASV 加最佳支持治疗可能对短期、中期和长期的生活质量以及中期和长期的全因死亡率无显著影响。不良事件数据已评估但未报告。ASV 加最佳支持治疗与急性心力衰竭伴射血分数保留的 CSA 与最佳支持治疗的比较 仅报告了这一比较的不良事件,两组均未记录不良事件。ASV 与 CPAP 维持治疗在 CPAP 诱导的 CSA 中的比较 在短期内,ASV 可能会轻微降低中枢性 AHI(MD-4.10,95%CI-6.67 至-1.53;1 项研究;60 名参与者),但对生活质量可能无显著影响。未报告不良事件数据,也不清楚是否有数据但未找到。ASV 与 CPAP 诱导的 CSA 中的双水平通气 在短期内,与双水平通气相比,ASV 可能会轻微降低中枢性 AHI(MD-8.70,95%CI-11.42 至-5.98;1 项研究;30 名参与者)。未报告不良事件数据,也不清楚是否有数据但未找到。

作者结论

与单独最佳支持治疗相比,CPAP 加最佳支持治疗可能会降低慢性心力衰竭相关 CSA 患者的中枢性 AHI。虽然 ASV 加最佳支持治疗可能会降低慢性心力衰竭相关 CSA 患者的 AHI,但与这些患者的心血管死亡率增加相关。在 CPAP 诱导的 CSA 患者中,与双水平通气和 CPAP 相比,ASV 可能会轻微降低中枢性 AHI。在没有数据显示对 CSA 患者有意义的患者为中心结局有有利影响,并确定结局的临床重要差异的情况下,需要谨慎解释这些发现。考虑到现有证据的确定性水平以及 CSA 患者的异质性,我们无法得出明确的结论,需要进一步开展高质量的临床试验,重点关注患者为中心的结局,如生活质量、睡眠质量和更长期的生存,以确定在任何特定的 CSA 患者群体中,一种 NIPV 模式是否优于另一种模式或优于最佳支持治疗。

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