医学治疗对成年轻中度阻塞性睡眠呼吸暂停的影响。
Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients.
机构信息
Division of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Division of Pulmonary and Sleep Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
出版信息
J Clin Sleep Med. 2019 Jul 15;15(7):979-983. doi: 10.5664/jcsm.7876.
STUDY OBJECTIVES
Patients with obstructive sleep apnea (OSA) have been shown to have high levels of inflammatory markers. Anti-inflammatory treatment with montelukast and intranasal steroids have demonstrated efficacy for mild OSA in children; this has not been fully evaluated in adults. This study investigated the response of mild OSA in adults to anti-inflammatory medical therapy.
METHODS
Adults aged ≥ 21 years with an apnea-hypopnea index (AHI) ≤ 15 events/h on polysomnography (PSG) were recruited to a prospective double-blind, randomized control trial. Patients were treated for 12 weeks with montelukast and fluticasone or placebo. All underwent a pretreatment and posttreatment PSG. Epworth Sleepiness Scale (ESS) score was obtained pretreatment and at 6 and 12 weeks posttreatment.
RESULTS
A total of 26 patients completed the study with 13 in each group. Mean age in the treatment and placebo groups were 58.3 ± 10.3 and 54.8 ± 14 years, respectively. There was no significant difference between groups reporting nasal congestion ( = .186), rhinitis ( = .666), or snoring ( = .177). There was no difference in the pretreatment ESS score ( = .077), body mass index ( = .173), or AHI ( = .535). The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( = .02) and percent of stage R sleep ( = .05). Neither group showed significant change in AHI. In patients in the treatment group, the 6- and 12-week follow-up ESS scores were not significantly different from pretreatment scores ( = .37-.46).
CONCLUSIONS
Intranasal steroids and montelukast did not decrease AHI; however, total sleep time and percent of stage R sleep significantly increased. Self-reported improvement could be explained by observed changes in sleep parameters. Larger prospective studies could help elucidate the effects of medical therapy on adult patients with OSA.
CLINICAL TRIAL REGISTRATION
Registry: ClinicalTrials.gov; Title: Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults; Identifier: NCT01089647; URL: https://clinicaltrials.gov/ct2/show/record/NCT01089647.
研究目的
患有阻塞性睡眠呼吸暂停（OSA）的患者表现出高水平的炎症标志物。孟鲁司特和鼻内皮质类固醇的抗炎治疗已证明对儿童轻度 OSA 有效；但尚未在成人中得到充分评估。本研究旨在探讨抗炎药物治疗对成人轻度 OSA 的反应。
方法
年龄≥21 岁、多导睡眠图（PSG）上呼吸暂停低通气指数（AHI）≤15 次/小时的成人患者入组前瞻性双盲、随机对照试验。患者接受孟鲁司特和氟替卡松或安慰剂治疗 12 周。所有患者均进行预处理和治疗后 PSG。在预处理和治疗后 6 周和 12 周时，采用 Epworth 睡眠量表（ESS）评分。
结果
共有 26 例患者完成了研究，每组 13 例。治疗组和安慰剂组的平均年龄分别为 58.3±10.3 岁和 54.8±14 岁。两组在鼻塞（ =.186）、鼻炎（ =.666）或打鼾（ =.177）方面无显著差异。预处理 ESS 评分（ =.077）、体重指数（ =.173）或 AHI（ =.535）均无差异。治疗组治疗后 PSG 显示总睡眠时间（ =.02）和 R 期睡眠百分比（ =.05）显著增加。两组 AHI 均无显著变化。治疗组患者的 6 周和 12 周随访 ESS 评分与预处理评分无显著差异（ =.37-.46）。
结论
鼻内皮质类固醇和孟鲁司特不能降低 AHI；然而，总睡眠时间和 R 期睡眠百分比显著增加。自我报告的改善可能可以通过观察到的睡眠参数变化来解释。更大的前瞻性研究可以帮助阐明药物治疗对 OSA 成年患者的影响。
临床试验注册
注册机构：ClinicalTrials.gov；标题：孟鲁司特和鼻内皮质类固醇治疗成人轻度阻塞性睡眠呼吸暂停；标识符：NCT01089647；网址：https://clinicaltrials.gov/ct2/show/record/NCT01089647。
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