Randomized placebo-controlled crossover trial of continuous positive airway pressure for mild sleep apnea/hypopnea syndrome
Randomized placebo-controlled crossover trial of continuous positive airway pressure for mild sleep apnea/hypopnea syndrome
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DOI：
10.1164/ajrccm.159.2.9803121
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发表时间：
1999-02-01
影响因子：
24.7
通讯作者：
Douglas, NJ
中科院分区：
文献类型：
--
作者：
Engleman, HM;Kingshott, RN;Douglas, NJ
尽管持续气道正压通气（CPAP）治疗的初步研究显示，睡眠呼吸暂停/低通气综合征（SAHS）患者的日间改善程度为每小时睡眠5至15次呼吸暂停+低通气（AHI），但患者从治疗中获益的最低疾病严重程度尚未得到很好的表征。因此，我们进行了第二个，更大的，随机，安慰剂对照研究，在一个前瞻性系列的34例（13名女性）轻度SAHS（AHI 5至15）和白天嗜睡。患者接受CPAP治疗4周，口服安慰剂4周，治疗顺序随机化，在每次治疗的最后一天进行日间评估。有效的CPAP使用平均为每晚2.8 +/- 2.1小时（平均值+/- SD）。与安慰剂相比，CPAP改善了症状评分（p < 0.01），主观（埃普沃思; p < 0.01）但不客观（保持清醒试验; p > 0.2）嗜睡，7项认知任务中有2项的表现（p < 0.02）、抑郁评分（p < 0.01）和SF-36健康/功能状态问卷的五个分量表（p小于或等于0.03）。34例患者中有14例首选CPAP。在14例AHI在5至10之间的患者中，症状，认知功能，心理健康和生活质量得到改善。这些结果证实了CPAP治疗轻度SAHS后对日间功能的益处，但强调了CPAP在许多此类患者中的不可接受性。
The minimal disease severity at which patients with the sleep apnea/hypopnea syndrome (SAHS) gain benefit from treatment is not well characterized, although a pilot study of continuous positive airway pressure (CPAP) therapy showed daytime improvements in patients with 5 to 15 apneas + hypopneas per hour slept (AHI). We have thus performed a second, larger, randomized, placebo-controlled study in a prospective series of 34 patients (13 female) with mild SAHS (AHI 5 to 15) and daytime sleepiness. Patients spent 4 wk on CPAP treatment and 4 wk on an oral placebo, with randomization of treatment order, and daytime assessments on the last day of each treatment. Effective CPAP use averaged 2.8 +/- 2.1 h (mean +/- SD) per night. Compared with placebo, CPAP improved symptom score (p < 0.01), subjective (Epworth; p < 0.01) but not objective (maintenance of wakefulness test; p > 0.2) sleepiness, performances on 2 of 7 cognitive tasks (p < 0.02), depression score (p < 0.01), and five subscales of the SF-36 health/functional status questionnaire (p less than or equal to 0.03). Fourteen of 34 patients preferred CPAP. In 14 patients with AHI in the range 5 to 10, symptoms, cognitive function, psychological well-being and quality of life were improved. These results confirm benefits for daytime function after CPAP treatment for mild SAHS, but highlight unacceptability of CPAP in many such patients.