Muxfeldt Elizabeth S, Margallo Victor, Costa Leonardo M S, Guimarães Gleison, Cavalcante Aline H, Azevedo João C M, de Souza Fabio, Cardoso Claudia R L, Salles Gil F
From the Department of Internal Medicine, University Hospital Clementino Fraga Filho, School of Medicine, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Hypertension. 2015 Apr;65(4):736-42. doi: 10.1161/HYPERTENSIONAHA.114.04852. Epub 2015 Jan 19.
The effect of continuous positive airway pressure (CPAP) on blood pressures (BPs) in patients with resistant hypertension and obstructive sleep apnea is not established. We aimed to evaluate it in a randomized controlled clinical trial, with blinded assessment of outcomes. Four hundred thirty-four resistant hypertensive patients were screened and 117 patients with moderate/severe obstructive sleep apnea, defined by an apnea-hypopnea index ≥15 per hour, were randomized to 6-month CPAP treatment (57 patients) or no therapy (60 patients), while maintaining antihypertensive treatment. Clinic and 24-hour ambulatory BPs were obtained before and after 6-month treatment. Primary outcomes were changes in clinic and ambulatory BPs and in nocturnal BP fall patterns. Intention-to-treat and per-protocol (limited to those with uncontrolled ambulatory BPs) analyses were performed. Patients had mean (SD) 24-hour BP of 129(16)/75(12) mm Hg, and 59% had uncontrolled ambulatory BPs. Mean apnea-hypopnea index was 41 per hour and 58.5% had severe obstructive sleep apnea. On intention-to-treat analysis, there was no significant difference in any BP change, neither in nocturnal BP fall, between CPAP and control groups. The best effect of CPAP was on night-time systolic blood pressure in per-protocol analysis, with greater reduction of 4.7 mm Hg (95% confidence interval, -11.3 to +3.1 mm Hg; P=0.24) and an increase in nocturnal BP fall of 2.2% (95% confidence interval, -1.6% to +5.8%; P=0.25), in comparison with control group. In conclusion, CPAP treatment had no significant effect on clinic and ambulatory BPs in patients with resistant hypertension and moderate/severe obstructive sleep apnea, although a beneficial effect on night-time systolic blood pressure and on nocturnal BP fall might exist in patients with uncontrolled ambulatory BP levels.
持续气道正压通气(CPAP)对难治性高血压合并阻塞性睡眠呼吸暂停患者血压的影响尚未明确。我们旨在通过一项随机对照临床试验对其进行评估,并对结果进行盲法评估。对434例难治性高血压患者进行了筛查,将117例中度/重度阻塞性睡眠呼吸暂停患者(定义为呼吸暂停低通气指数≥每小时15次)随机分为6个月CPAP治疗组(57例患者)或不治疗组(60例患者),同时维持抗高血压治疗。在6个月治疗前后测量诊室血压和24小时动态血压。主要结局指标为诊室血压、动态血压以及夜间血压下降模式的变化。进行了意向性分析和符合方案分析(仅限于动态血压未得到控制的患者)。患者的24小时平均(标准差)血压为129(16)/75(12)mmHg,59%的患者动态血压未得到控制。平均呼吸暂停低通气指数为每小时41次,58.5%的患者患有重度阻塞性睡眠呼吸暂停。在意向性分析中,CPAP组和对照组之间在任何血压变化方面均无显著差异,夜间血压下降情况也无差异。在符合方案分析中,CPAP对夜间收缩压的效果最佳,与对照组相比,收缩压进一步降低4.7 mmHg(95%置信区间,-11.3至+3.1 mmHg;P=0.24),夜间血压下降增加2.2%(95%置信区间,-1.6%至+5.8%;P=0.25)。总之,CPAP治疗对难治性高血压合并中度/重度阻塞性睡眠呼吸暂停患者的诊室血压和动态血压无显著影响,尽管对于动态血压未得到控制的患者,CPAP可能对夜间收缩压和夜间血压下降有有益作用。