系统性硬化症患者的睡眠障碍：系统评价与荟萃分析

文献信息

中文摘要

背景： 系统性硬化症是一种罕见的自身免疫性疾病，与显著的发病率和生活质量下降相关。据报道，系统性硬化症患者中睡眠障碍的发生频率不一，但其患病率仍未得到充分描述。目的：本系统评价与荟萃分析旨在估计系统性硬化症患者睡眠障碍的合并患病率。方法：检索了六个数据库，截止日期为2026年2月15日，无语言限制。报告成人系统性硬化症患者睡眠结局的研究符合纳入条件。采用随机效应模型的对数转换及Hartung-Knapp校正对患病率估计值进行合并。使用I²统计量评估异质性。采用Egger检验和剪补法评估发表偏倚。本评价已在PROSPERO注册（CRD420251152354）。结果：所有分析共纳入23项研究，合计1,487例患者。11项研究（820例患者）纳入了使用匹兹堡睡眠质量指数评估睡眠质量差的主要荟萃分析。睡眠质量差的合并患病率为76.49%（95% CI 66.62至84.13%），异质性为中至显著（I² = 70.1%），95%预测区间为49.66%至91.47%，表明在不同SSc人群中真实患病率可能从约一半到几乎全部患者不等。5项研究（346例患者）纳入了阻塞性睡眠呼吸暂停的荟萃分析，合并患病率为40.30%（95% CI 25.56至57.04%，I² = 71.8%），95%预测区间为13.95%至73.75%。另有5项研究仅纳入定性综合，3项随机对照试验涉及睡眠干预。Egger检验发现可能存在漏斗图不对称。经剪补法校正后，插补了4项研究，校正估计值为69.62%（95% CI 57.33至79.63%），略低于主要估计值，提示主要估计值可能受到发表偏倚的轻度影响。根据GRADE，证据确定性被评为低。结论：现有证据提示，当使用PSQI评估时，睡眠障碍可能影响约四分之三的系统性硬化症患者；当使用客观工具评估时，阻塞性睡眠呼吸暂停可能影响超过三分之一。这些估计值具有低GRADE确定性且预测区间较宽，不应被解释为确定的患病率数据。需要更大规模的前瞻性研究和把握度充分的随机试验来确定更精确的估计值，并评估针对该人群的睡眠干预措施。

英文摘要

Background : Systemic sclerosis is a rare autoimmune disease associated with substantial morbidity and reduced quality of life. Sleep disturbance has been reported with variable frequency in patients with systemic sclerosis, though its prevalence remains incompletely characterised. Objective : This systematic review and meta-analysis aimed to estimate the pooled prevalence of sleep disorders in patients with systemic sclerosis. Methods : Six databases were searched up to 15 February 2026 without language restriction. Studies reporting sleep outcomes in adults with systemic sclerosis were eligible. Prevalence estimates were pooled using a logit transformation with a random-effects model and Hartung-Knapp correction. Heterogeneity was assessed using the I² statistic. Publication bias was evaluated with Egger's test and the trim-and-fill method. This review was registered in PROSPERO (CRD420251152354). Results : Twenty-three studies totalling 1,487 patients were included across all analyses. Eleven studies (820 patients) contributed to the primary meta-analysis of poor sleep quality assessed by the Pittsburgh Sleep Quality Index. The pooled prevalence of poor sleep quality was 76.49% (95% CI 66.62 to 84.13%), with moderate to substantial heterogeneity (I² = 70.1%) and a 95% prediction interval of 49.66% to 91.47%, indicating that the true prevalence may range from approximately half to nearly all patients across different SSc populations. Five studies (346 patients) contributed to the obstructive sleep apnea meta-analysis, yielding a pooled prevalence of 40.30% (95% CI 25.56 to 57.04%, I² = 71.8%) with a 95% prediction interval of 13.95% to 73.75%. Five additional studies were included in a qualitative synthesis only, and three randomised controlled trials addressed sleep interventions. Egger's test identified possible funnel plot asymmetry. After trim-and-fill adjustment, four studies were imputed and the corrected estimate was 69.62% (95% CI 57.33 to 79.63%), somewhat lower than the primary estimate, suggesting that the primary estimate may be modestly influenced by publication bias. The certainty of evidence was rated as low according to GRADE. Conclusion : Available evidence suggests that sleep disorders may affect approximately three quarters of patients with systemic sclerosis when assessed by the PSQI, and obstructive sleep apnea may affect more than one third when evaluated by objective tools. These estimates carry low GRADE certainty and wide prediction intervals, and should not be interpreted as definitive prevalence figures. Larger prospective studies and well-powered randomised trials are needed to establish more precise estimates and to evaluate targeted sleep interventions in this population.