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持续气道正压通气(CPAP)治疗睡眠呼吸暂停/低通气综合征后日间功能的随机安慰剂对照试验。

Randomised placebo controlled trial of daytime function after continuous positive airway pressure (CPAP) therapy for the sleep apnoea/hypopnoea syndrome.

作者信息

Engleman H M, Martin S E, Kingshott R N, Mackay T W, Deary I J, Douglas N J

机构信息

Respiratory Medicine Unit, University of Edinburgh, UK.

出版信息

Thorax. 1998 May;53(5):341-5. doi: 10.1136/thx.53.5.341.

Abstract

BACKGROUND

Patients with the sleep apnoea/hypopnoea syndrome (SAHS) report improved sleepiness, cognitive function, and psychological well being after continuous positive airway pressure (CPAP) therapy, and it is for these daytime features that CPAP is usually given. However, few randomised or controlled studies exist on the effects of CPAP on daytime function.

METHODS

A prospective, randomised, single blind, placebo controlled, crossover trial of daytime function after CPAP was conducted in 23 patients with SAHS, all with > or = 15 apnoeas + hypopnoeas/hour and > or = 2 symptoms of SAHS. All patients spent four weeks on CPAP therapy and four weeks on oral placebo treatment, following randomisation to treatment order. With ethics committee approval, patients were told the placebo tablet might improve upper airway function. Average effective CPAP use was monitored using hidden time clocks. Assessments of objective and subjective sleepiness, symptoms, cognitive performance, and psychological well being were performed on the last day of each treatment and compared.

RESULTS

Objective sleepiness measured by sleep onset latency on the multiple sleep latency test improved with CPAP (mean difference from placebo +2.4 min, 95% CI 0.8 to 4.0; p < 0.001) as did subjective sleepiness on the Epworth scale (mean difference -6, 95% CI -3 to -9; p = 0.001). Symptom total score also fell with CPAP (mean difference -1.6, 95% CI -2.2 to -1.0; p < 0.001). No determinants of these changes with active treatment were identified, and no significant enhancements to cognitive function or psychosocial well being were found in this small sample.

CONCLUSIONS

These findings provide further evidence for clinically significant benefits to daytime function from CPAP.

摘要

背景

睡眠呼吸暂停/低通气综合征(SAHS)患者报告称,持续气道正压通气(CPAP)治疗后嗜睡、认知功能和心理健康状况有所改善,而CPAP通常正是因其对日间这些症状的改善作用而被采用。然而,关于CPAP对日间功能影响的随机或对照研究却很少。

方法

对23例SAHS患者进行了一项关于CPAP治疗后日间功能的前瞻性、随机、单盲、安慰剂对照、交叉试验,所有患者每小时呼吸暂停及低通气次数均≥15次,且有≥2种SAHS症状。随机分配治疗顺序后,所有患者接受4周的CPAP治疗和4周的口服安慰剂治疗。经伦理委员会批准,告知患者安慰剂片可能会改善上气道功能。使用隐蔽的计时钟监测CPAP的平均有效使用情况。在每种治疗的最后一天对客观和主观嗜睡、症状、认知表现及心理健康状况进行评估并比较。

结果

通过多次睡眠潜伏期试验中的睡眠起始潜伏期测量的客观嗜睡情况在使用CPAP后有所改善(与安慰剂相比平均差异为+2.4分钟,95%可信区间为0.8至4.0;p<0.001),Epworth嗜睡量表评估的主观嗜睡情况也是如此(平均差异为-6,95%可信区间为-3至-9;p=0.001)。症状总分在使用CPAP后也有所下降(平均差异为-1.6,95%可信区间为-2.2至-1.0;p<0.001)。未发现积极治疗导致这些变化的决定因素,且在这个小样本中未发现对认知功能或心理社会健康有显著增强作用。

结论

这些发现为CPAP对日间功能具有临床显著益处提供了进一步证据。

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