改良酸枣仁汤治疗原发性失眠随机安慰剂对照试验

发布时间：2018-06-03 23:23

本文选题：失眠 + 酸枣仁汤　；参考：《中国心理卫生杂志》2017年08期

【摘要】：目的:酸枣仁汤作为传统古方已广泛用于失眠症,但对其疗效进行设计严格的研究却不多。本研究的目的是用主观和客观睡眠质量评价方法,对改良酸枣仁汤治疗原发性失眠的安全性和疗效进行为期4周的临床研究。方法:随机、双盲、安慰剂对照临床试验(临床研究注册号CUHK-CCT0087)。162位原发性失眠患者(年龄21~64岁,平均47岁;女性占68.5%),在香港中文大学两所附属医院的睡眠中心接受治疗和评估,其中139人(86%)按计划完成全部治疗和评估。受试者随机分为两组,分别接受改良酸枣仁汤(每日2包,每包5g)或安慰剂治疗。采用主观睡眠质量(subjective measures)及客观睡眠(objective measures)评价各睡眠阶段指标的变化。结果:4周后,治疗组VAS(visual analogue scales)测试比安慰剂组明显改善[睡眠深度,95%CI=-16.0(-22.1~-9.9)vs.-7.1(-13.3~-1.0),P0.05;恢复性睡眠,95%CI=-12.0(-18.2~-5.8)vs.-2.2(-8.9~4.5),P0.05]。两组客观指标、失眠严重程度评分及不良反应发生率差异均无统计学意义(均P0.05)。结论:短期服用改良酸枣仁汤可改善主观睡眠质量,但客观睡眠指标改善不明显。研究显示改良酸枣仁汤具有良好的安全性和耐受性。
[Abstract]:Objective: as a traditional prescription, Suanzaoren decoction has been widely used in insomnia. The purpose of this study was to evaluate the safety and efficacy of modified Suanzaoren decoction in the treatment of primary insomnia with subjective and objective sleep quality evaluation methods for 4 weeks. Methods: a randomized, double-blind, placebo-controlled clinical trial (clinical study registration number CUHK-CCT0087).162 patient with primary insomnia (age 21 to 64 years, mean 47 years old; female: 68.5%) was treated and evaluated at sleep centers in two affiliated hospitals of the Chinese University of Hong Kong. Of these, 139 were scheduled to complete the treatment and evaluation. The subjects were randomly divided into two groups, treated with modified Suanzaoren decoction (2 packets per day, 5 g per pack) or placebo. Subjective sleep quality measurement and objective sleep measurement were used to evaluate the changes of sleep stages. Results after 4 weeks, the VAS(visual analogue scales test in the treatment group was significantly improved than that in the placebo group. [sleep depth 95 was better than that in the placebo group (P 0.05). There was no significant difference between the two groups in objective indexes, score of insomnia severity and incidence of adverse reactions (P 0.05). Conclusion: short-term use of modified Suanzaoren decoction can improve subjective sleep quality, but the objective sleep index is not improved significantly. The study showed that the modified Suanzaoren decoction had good safety and tolerance.
【作者单位】：香港中文大学医学院精神科学系;香港大学李嘉诚医学院精神科学系;香港中文大学中医中药研究所;植物化学与西部植物资源持续利用国家重点实验室(香港中文大学);
【基金】：香港创新科技署资助(GHP/037/05)
【分类号】：R256.23

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