正压通气治疗阻塞性睡眠呼吸暂停对脑卒中患者的作用：一项随机对照试验。
Role of Positive Airway Pressure Therapy for Obstructive Sleep Apnea in Patients With Stroke: A Randomized Controlled Trial.
机构信息
Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.
Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
出版信息
J Clin Sleep Med. 2018 Apr 15;14(4):511-521. doi: 10.5664/jcsm.7034.
STUDY OBJECTIVES
Obstructive sleep apnea (OSA) is an independent risk factor for stroke. The objective of this study was to assess the effect of continuous positive airway pressure (CPAP) treatment on prevention of new vascular events among patients with stroke and OSA.
METHODS
Consecutive conscious patients presenting with first imaging-confirmed arterial stroke were included, 6 weeks or more after ictus. All patients underwent clinical and polysomnography (PSG) testing. Patients with an apnea-hypopnea index (AHI) of > 15 events/h were randomized to posttitration nightly CPAP treatment and non-CPAP (received best medical treatment) groups. On follow-up at 3, 6, and 12 months from randomization, evaluation was carried out for any new vascular events as the primary outcome measure, and for clinical stroke outcomes (using the Barthel Index and modified Rankin scale) and neuropsychological parameters as the secondary outcome measures.
RESULTS
Among the 679 patients with stroke who were screened, 116 reported for PSG, 83 had AHI > 15 events/h, and 70 (34 in CPAP and 36 in non-CPAP) were randomized. Thirteen patients could not be randomized because of a lack of CPAP devices. Four patients crossed over from the CPAP to the non-CPAP group. Age (mean age 53.41 ± 9.85 in CPAP versus 52.69 ± 13.23 years in non-CPAP, = .81) and sex distribution (24 males in CPAP versus 33 males in non-CPAP, = .79) were similar in both groups. At 12-month follow-up, there was 1 vascular event (3.33%) in the CPAP group and 6 events (15%) in the non-CPAP group ( = .23). Modified Rankin scale score improvement by ≥ 1 at 12-month follow-up was found in significantly more patients in the CPAP group than in the non-CPAP group (53% versus 27%).
CONCLUSIONS
These findings suggest significantly better stroke outcomes and statistically nonsignificant favorable outcomes in terms of recurrence of vascular events for patients with stroke and OSA who use CPAP treatment.
CLINICAL TRIAL REGISTRATION
Registry: Clinical Trials Registry - India, CTRI Registration No: CTRI/2016/07.007104, Title: Sleep Disordered Breathing in stroke patients: Effect of treatment trial, URL: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=8682&EncHid=&userName=sleep%20disordered%20breathing.
研究目的
阻塞性睡眠呼吸暂停（OSA）是中风的独立危险因素。本研究的目的是评估持续气道正压通气（CPAP）治疗对中风合并 OSA 患者预防新血管事件的效果。
方法
连续纳入首次影像学证实的动脉性中风患者，在中风后 6 周或以上。所有患者均进行临床和多导睡眠图（PSG）检查。呼吸暂停低通气指数（AHI）>15 次/小时的患者随机分为滴定后每晚 CPAP 治疗组和非 CPAP 组（接受最佳药物治疗）。随机分组后 3、6 和 12 个月进行随访，主要终点为新发血管事件，次要终点为临床中风结局（采用巴氏指数和改良 Rankin 量表）和神经心理学参数。
结果
在筛选的 679 例中风患者中，116 例进行了 PSG 检查，83 例 AHI>15 次/小时，70 例（CPAP 组 34 例，非 CPAP 组 36 例）被随机分组。由于缺乏 CPAP 设备，有 13 例患者无法随机分组。4 例患者从 CPAP 组交叉到非 CPAP 组。CPAP 组的平均年龄为 53.41±9.85 岁，非 CPAP 组为 52.69±13.23 岁（ =.81），两组的性别分布（CPAP 组 24 例男性，非 CPAP 组 33 例男性， =.79）相似。12 个月随访时，CPAP 组有 1 例（3.33%）血管事件，非 CPAP 组有 6 例（15%）（ =.23）。CPAP 组在 12 个月随访时改良 Rankin 量表评分改善≥1 分的患者明显多于非 CPAP 组（53%比 27%）。
结论
这些发现表明，对于中风合并 OSA 患者，使用 CPAP 治疗可显著改善中风结局，且血管事件复发的统计学无显著获益。
临床试验注册
ClinicalTrials.gov，注册号：CTRI/2016/07.007104，试验名称：睡眠呼吸紊乱与中风患者，试验网址：http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=8682&EncHid=&userName=sleep%20disordered%20breathing。
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