Department of Hepatology and Liver Transplantation, Institute of Liver and Biliary Sciences, New Delhi, India.
Department of Pulmonary Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
Clin Mol Hepatol. 2019 Jun;25(2):199-209. doi: 10.3350/cmh.2018.0084. Epub 2019 Mar 11.
BACKGROUND/AIMS: The aim of this study was to study the efficacy and safety of zolpidem for sleep disturbances in patients with cirrhosis.
Fifty-two Child-Turcotte-Pugh (CTP) class A or B cirrhotics with Pittsburgh Sleep Quality Index >5 were randomized to either zolpidem 5 mg daily (n=26) or placebo (n=26) for 4 weeks.
The therapy of 4 weeks was completed by 23 patients receiving zolpidem (3 stopped treatment due to excessive daytime drowsiness) and 24 receiving placebo (2 refused to continue the study). In the zolpidem group, after 4 weeks of therapy, there was significant increase in total sleep time (TST) and sleep efficiency compared to baseline and improvement in polysomnographic parameters of sleep initiation and maintenance (i.e., decrease in sleep latency time, decrease in wake time, and decreases in number of arousals and periodic limbs movements per hour of sleep), without any significant change in sleep architecture.
Four weeks of 5 mg daily zolpidem in CTP class A or B cirrhosis patients with insomnia led to significant increases in TST and sleep efficiency and improvement in polysomnographic parameters of sleep initiation and maintenance without any significant change in sleep architecture.
背景/目的：本研究旨在研究佐匹克隆治疗肝硬化患者睡眠障碍的疗效和安全性。
52 例匹兹堡睡眠质量指数（PSQI）>5 的 Child-Turcotte-Pugh（CTP）A级或 B 级肝硬化患者被随机分为佐匹克隆 5mg 组（n=26）或安慰剂组（n=26），治疗 4 周。
23 例接受佐匹克隆治疗（3 例因白天过度嗜睡停止治疗）和 24 例接受安慰剂治疗的患者完成了 4 周的治疗。在佐匹克隆组中，治疗 4 周后，总睡眠时间（TST）和睡眠效率与基线相比显著增加，睡眠起始和维持的多导睡眠图参数得到改善（即，睡眠时间潜伏期缩短，觉醒时间减少，以及每小时睡眠中的觉醒次数和周期性肢体运动减少），而睡眠结构无明显变化。
在 CTP 分级 A 或 B 的肝硬化合并失眠症患者中，每天服用 5mg 佐匹克隆治疗 4 周，可显著增加 TST 和睡眠效率，改善睡眠起始和维持的多导睡眠图参数，而睡眠结构无明显变化。
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