Bradley T Douglas, Logan Alexander G, Kimoff R John, Sériès Frédéric, Morrison Debra, Ferguson Kathleen, Belenkie Israel, Pfeifer Michael, Fleetham John, Hanly Patrick, Smilovitch Mark, Tomlinson George, Floras John S
Department of Medicine, University of Toronto, Toronto.
N Engl J Med. 2005 Nov 10;353(19):2025-33. doi: 10.1056/NEJMoa051001.
The Canadian Continuous Positive Airway Pressure for Patients with Central Sleep Apnea and Heart Failure trial tested the hypothesis that continuous positive airway pressure (CPAP) would improve the survival rate without heart transplantation of patients who have central sleep apnea and heart failure.
After medical therapy was optimized, 258 patients who had heart failure (mean age [+/-SD], 63+/-10 years; ejection fraction, 24.5+/-7.7 percent) and central sleep apnea (number of episodes of apnea and hypopnea per hour of sleep, 40+/-16) were randomly assigned to receive CPAP (128 patients) or no CPAP (130 patients) and were followed for a mean of two years. During follow-up, sleep studies were conducted and measurements of the ejection fraction, exercise capacity, quality of life, and neurohormones were obtained.
Three months after undergoing randomization, the CPAP group, as compared with the control group, had greater reductions in the frequency of episodes of apnea and hypopnea (-21+/-16 vs. -2+/-18 per hour, P<0.001) and in norepinephrine levels (-1.03+/-1.84 vs. 0.02+/-0.99 nmol per liter, P=0.009), and greater increases in the mean nocturnal oxygen saturation (1.6+/-2.8 percent vs. 0.4+/-2.5 percent, P<0.001), ejection fraction (2.2+/-5.4 percent vs. 0.4+/-5.3 percent, P=0.02), and the distance walked in six minutes (20.0+/-55 vs. -0.8+/-64.8 m, P=0.016). There were no differences between the control group and the CPAP group in the number of hospitalizations, quality of life, or atrial natriuretic peptide levels. An early divergence in survival rates without heart transplantation favored the control group, but after 18 months the divergence favored the CPAP group, yet the overall event rates (death and heart transplantation) did not differ (32 vs. 32 events, respectively; P=0.54).
Although CPAP attenuated central sleep apnea, improved nocturnal oxygenation, increased the ejection fraction, lowered norepinephrine levels, and increased the distance walked in six minutes, it did not affect survival. Our data do not support the use of CPAP to extend life in patients who have central sleep apnea and heart failure.
加拿大针对中枢性睡眠呼吸暂停合并心力衰竭患者的持续气道正压通气试验检验了以下假设:持续气道正压通气(CPAP)可提高中枢性睡眠呼吸暂停合并心力衰竭患者在不进行心脏移植情况下的生存率。
在优化药物治疗后,258例心力衰竭患者(平均年龄[±标准差],63±10岁;射血分数,24.5±7.7%)和中枢性睡眠呼吸暂停患者(每小时睡眠中呼吸暂停和低通气发作次数,40±16)被随机分配接受CPAP治疗(128例患者)或不接受CPAP治疗(130例患者),并平均随访两年。在随访期间,进行了睡眠研究,并获取了射血分数、运动能力、生活质量和神经激素的测量值。
随机分组三个月后,与对照组相比,CPAP组的呼吸暂停和低通气发作频率降低幅度更大(每小时-21±16次 vs. -2±18次,P<0.001),去甲肾上腺素水平降低幅度更大(-1.03±1.84 nmol/L vs. 0.02±0.99 nmol/L,P=0.009),夜间平均血氧饱和度升高幅度更大(1.6±2.8% vs. 0.4±2.5%,P<0.001),射血分数升高幅度更大(2.2±5.4% vs. 0.4±5.3%,P=0.02),六分钟步行距离增加幅度更大(20.0±55 m vs. -0.8±64.8 m,P=0.016)。对照组和CPAP组在住院次数、生活质量或心房利钠肽水平方面没有差异。不进行心脏移植的生存率早期差异有利于对照组,但18个月后差异有利于CPAP组,然而总体事件发生率(死亡和心脏移植)没有差异(分别为32次事件 vs. 32次事件;P=0.54)。
尽管CPAP减轻了中枢性睡眠呼吸暂停,改善了夜间氧合,增加了射血分数,降低了去甲肾上腺素水平,并增加了六分钟步行距离,但它并未影响生存率。我们的数据不支持使用CPAP来延长中枢性睡眠呼吸暂停合并心力衰竭患者的生命。