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加味酸枣仁汤联合劳拉西泮治疗慢性失眠的疗效与安全性:一项平行组随机对照试验

Efficacy and Safety of Jiawei Suanzaoren Decoction Combined with Lorazepam for Chronic Insomnia: A Parallel-Group Randomized Controlled Trial.

作者信息

Song Ming-Fen, Chen Li-Qiong, Shao Qiong-Yan, Hu Lin-Lin, Liu Wen-Juan, Zhang Yong-Hua

机构信息

Molecular Biology Laboratory, Hangzhou Seventh People's Hospital, Hangzhou, Zhejiang, China.

Hangzhou Hospital of Traditional Chinese Medicine, Guang Xing Hospital Affiliated to Zhejiang Chinese Medical University, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.

出版信息

Evid Based Complement Alternat Med. 2020 Feb 8;2020:3450989. doi: 10.1155/2020/3450989. eCollection 2020.

DOI:10.1155/2020/3450989
PMID:32089719
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7031716/
Abstract

BACKGROUND

Chronic insomnia is a major public health problem, but there are limited effective therapies. Jiawei Suanzaoren Decoction (JW-SZRD) has been used as an alternative option for treating insomnia. This study aimed to investigate the long-term efficacy and safety of JW-SZRD in combination with lorazepam for chronic insomnia.

METHODS

A total of 207 participants were analyzed in this study. The treatment group (TG) received JW-SZRD and lorazepam orally, and the control group (CG) received lorazepam alone. The Insomnia Severity Index (ISI), the Self-Rating Depression Scale (SDS), the Self-Rating Anxiety Scale (SAS), and the Somatic Self-rating Scale (SSS) were evaluated at baseline, weeks 4, 8, and 12. The MOS 36-item Short Form Health Survey (SF-36) was assessed at baseline and week 12. Adverse effects (AEs) were evaluated by the Treatment Emergent Symptom Scale (TESS).

RESULTS

Both TG and CG showed obvious improvements in the sleep onset latency (SOL) (=0.001 and 0.005) and total sleep time (TST) (=0.001 and 0.005) and total sleep time (TST) (=0.001 and 0.005) and total sleep time (TST) (=0.001 and 0.005) and total sleep time (TST) (=0.001 and 0.005) and total sleep time (TST) (=0.001 and 0.005) and total sleep time (TST) ( = 1.28). The ISI reduction rate in TG was higher than that in CG at weeks 4, 8, and 12 (=0.001 and 0.005) and total sleep time (TST) (=0.001 and 0.005) and total sleep time (TST) (=0.001 and 0.005) and total sleep time (TST) (=0.001 and 0.005) and total sleep time (TST) (=0.001 and 0.005) and total sleep time (TST) (=0.001 and 0.005) and total sleep time (TST) (.

CONCLUSION

The combination of JW-SZRD with lorazepam can significantly improve sleep quality with fewer AEs. It is an effective treatment and superior to lorazepam alone for chronic insomnia.

摘要

背景

慢性失眠是一个主要的公共卫生问题,但有效的治疗方法有限。加味酸枣仁汤已被用作治疗失眠的替代选择。本研究旨在探讨加味酸枣仁汤联合劳拉西泮治疗慢性失眠的长期疗效和安全性。

方法

本研究共分析了207名参与者。治疗组(TG)口服加味酸枣仁汤和劳拉西泮,对照组(CG)仅口服劳拉西泮。在基线、第4周、第8周和第12周评估失眠严重程度指数(ISI)、自评抑郁量表(SDS)、自评焦虑量表(SAS)和躯体自评量表(SSS)。在基线和第12周评估MOS 36项简短健康调查(SF-36)。通过治疗中出现的症状量表(TESS)评估不良反应(AE)。

结果

TG组和CG组在入睡潜伏期(SOL)(=0.001和0.005)、总睡眠时间(TST)(=0.001和0.005)方面均有明显改善。在第4周、第8周和第12周,TG组的ISI降低率高于CG组(=0.001和0.005)以及总睡眠时间(TST)(=0.001和0.005)等(此处原文重复表述较多且混乱,译文尽量按原文呈现)。

结论

加味酸枣仁汤联合劳拉西泮可显著改善睡眠质量,且不良反应较少。对于慢性失眠,它是一种有效的治疗方法,优于单独使用劳拉西泮。

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