妊娠期糖尿病合并阻塞性睡眠呼吸暂停患者应用持续气道正压通气治疗的随机对照试验
Continuous Positive Airway Pressure Therapy in Gestational Diabetes With Obstructive Sleep Apnea: A Randomized Controlled Trial.
机构信息
Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Excellence Center for Sleep Disorders, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.
出版信息
J Clin Sleep Med. 2018 Mar 15;14(3):327-336. doi: 10.5664/jcsm.6972.
STUDY OBJECTIVES
Obstructive sleep apnea (OSA) is associated with gestational diabetes mellitus (GDM). This study assessed the effects of continuous positive airway pressure (CPAP) in obese pregnant females with GDM and OSA.
METHODS
A randomized controlled trial was conducted (April 2014 - June 2016). Obese females at 24 to 34 weeks gestation and with diet-controlled GDM were screened for OSA. Those with OSA were randomly assigned to receive 2 weeks nightly CPAP or be part of a waitlist control group. After 2 weeks, all patients were offered CPAP. The primary outcome was glucose metabolism, obtained from an oral meal tolerance test (MTT) at baseline and 2 weeks. Pregnancy outcomes were collected.
RESULTS
Eighteen patients were randomized to CPAP and 18 to control groups. There were no significant changes between groups in fasting glucose, glucose response to MTT, and insulin sensitivity or secretion after 2 weeks. Those adherent to CPAP had significantly improved insulin secretion ( = .016) compared to the control group. When a counterfactual instrumental variable approach was applied to deal with nonadherence, the CPAP group had significantly improved insulin secretion ( = .002) and insulin sensitivity ( = .015). Lower rates of preterm delivery ( = .002), unplanned cesarean section ( = .005), and neonatal intensive care unit admissions ( < .001) were observed among those who used CPAP longer than 2 weeks.
CONCLUSIONS
Two weeks of CPAP in females with GDM and OSA did not result in improved glucose levels, but insulin secretion improved in those adherent to CPAP. Continued CPAP use was possibly associated with improved pregnancy outcomes.
CLINICAL TRIAL REGISTRATION
Registry: ClinicalTrials.gov; Title: Obstructive Sleep Apnea and Gestational Diabetes: Incidence and Effects of Continuous Positive Airway Pressure Treatment on Glucose Metabolism; Identifier: NCT02108197; URL: https://clinicaltrials.gov/ct2/show/NCT02108197.
研究目的
阻塞性睡眠呼吸暂停（OSA）与妊娠糖尿病（GDM）有关。本研究评估了持续气道正压通气（CPAP）对患有 GDM 和 OSA 的肥胖孕妇的影响。
方法
进行了一项随机对照试验（2014 年 4 月至 2016 年 6 月）。对 24 至 34 周妊娠且患有饮食控制 GDM 的肥胖女性进行 OSA 筛查。对 OSA 患者进行随机分配，接受 2 周夜间 CPAP 治疗或作为候补对照组。2 周后，所有患者均提供 CPAP。主要结局是通过基线和 2 周时的口服糖耐量试验（MTT）获得的葡萄糖代谢。收集妊娠结局。
结果
18 名患者被随机分配到 CPAP 组，18 名患者被分配到对照组。2 周后，两组之间的空腹血糖、MTT 葡萄糖反应以及胰岛素敏感性或分泌均无显着变化。与对照组相比，CPAP 组的胰岛素分泌明显改善（=.016）。当应用反事实工具变量方法来处理不依从性时，CPAP 组的胰岛素分泌明显改善（=.002），胰岛素敏感性也明显改善（=.015）。CPAP 使用时间超过 2 周的患者，早产率（=.002）、计划性剖宫产率（=.005）和新生儿重症监护病房入院率（<.001）均较低。
结论
在患有 GDM 和 OSA 的女性中，2 周的 CPAP 治疗并未导致血糖水平改善，但在依从 CPAP 治疗的患者中，胰岛素分泌得到改善。持续使用 CPAP 可能与改善妊娠结局有关。
临床试验注册
注册处：ClinicalTrials.gov；标题：阻塞性睡眠呼吸暂停和妊娠糖尿病：持续气道正压通气治疗对葡萄糖代谢的影响和发生率；标识符：NCT02108197；网址：https://clinicaltrials.gov/ct2/show/NCT02108197。
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