Servicio de Neumología, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.
Servicio de Neumología, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Am J Respir Crit Care Med. 2023 Mar 15;207(6):757-767. doi: 10.1164/rccm.202206-1091OC.
Obstructive sleep apnea (OSA) is associated with impaired glycemic control and a higher risk of vascular complications, such as diabetic kidney disease (DKD). However, the effect of apnea-hypopnea suppression on DKD progression is unclear. To assess the effect of continuous positive airway pressure (CPAP) on the urinary albumin-to-creatinine ratio (UACR) in patients with DKD and OSA. In a 52-week, multicentric, open-label, parallel, and randomized clinical trial, 185 patients with OSA and DKD were randomized to CPAP and usual care ( = 93) or usual care alone ( = 92). UACR, estimated glomerular filtration rate, serum concentrations of creatinine and glycated hemoglobin, insulin resistance, lipid concentrations, sleepiness, and quality of life. A 52-week change in UACR from baseline did not differ significantly between the CPAP group and the usual-care group. However, in per-protocol analyses that included 125 participants who met prespecified criteria for adherence, CPAP treatment was associated with a great reduction in UACR (mean difference, -10.56% [95% confidence interval, -19.06 to -2.06]; = 0.015). CPAP effect on UACR was higher in nonsleepy patients with more severe OSA, worse renal function, and a more recent diagnosis of DKD. CPAP treatment also improved glycemic control and insulin resistance, as well as sleepiness and health-related quality of life. In patients with OSA and DKD, the prescription of CPAP did not result in a statistically significant reduction in albuminuria. However, good adherence to CPAP treatment in addition to usual care may result in long-term albuminuria reduction compared with usual care alone. Clinical trial registered with www.clinicaltrials.gov (NCT02816762).
阻塞性睡眠呼吸暂停(OSA)与血糖控制受损和血管并发症风险增加相关,如糖尿病肾病(DKD)。然而,关于呼吸暂停低通气综合征抑制对 DKD 进展的影响尚不清楚。评估持续气道正压通气(CPAP)对伴有 OSA 和 DKD 的患者尿白蛋白与肌酐比值(UACR)的影响。在一项为期 52 周、多中心、开放标签、平行、随机临床试验中,185 例 OSA 和 DKD 患者被随机分配至 CPAP 和常规护理( = 93)或单独常规护理( = 92)。UACR、估计肾小球滤过率、血清肌酐和糖化血红蛋白浓度、胰岛素抵抗、脂质浓度、嗜睡和生活质量。CPAP 组和常规护理组之间 UACR 从基线的 52 周变化无显著差异。然而,在符合预先指定的依从性标准的 125 名参与者的意向治疗分析中,CPAP 治疗与 UACR 的显著降低相关(平均差异,-10.56%[95%置信区间,-19.06 至-2.06]; = 0.015)。CPAP 对 UACR 的影响在睡眠不佳的患者中更高,这些患者的 OSA 更严重、肾功能更差、且 DKD 的诊断更新。CPAP 治疗还改善了血糖控制和胰岛素抵抗,以及嗜睡和健康相关的生活质量。在伴有 OSA 和 DKD 的患者中,CPAP 的处方并未导致蛋白尿的统计学显著减少。然而,与单独常规护理相比,在常规护理的基础上坚持良好的 CPAP 治疗可能会导致长期蛋白尿减少。该临床试验已在 www.clinicaltrials.gov (NCT02816762)上注册。