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持续气道正压通气对合并阻塞性睡眠呼吸暂停低通气综合征和糖尿病肾病患者蛋白尿进展的影响:一项随机临床试验。

Continuous Positive Airway Pressure Effect on Albuminuria Progression in Patients with Obstructive Sleep Apnea and Diabetic Kidney Disease: A Randomized Clinical Trial.

机构信息

Servicio de Neumología, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.

Servicio de Neumología, Hospital Universitario Ramón y Cajal, Madrid, Spain.

出版信息

Am J Respir Crit Care Med. 2023 Mar 15;207(6):757-767. doi: 10.1164/rccm.202206-1091OC.

DOI:10.1164/rccm.202206-1091OC
PMID:36342964
Abstract

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).

摘要

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。

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