柴胡加龙骨牡蛎汤联合艾司唑仑治疗失眠的疗效及安全性：一项Meta分析

Efficacy and safety of Chaihu plus Longgu Muli decoction combined with Estazolam in the treatment of insomnia: a meta-analysis.

作者信息

Li Mengfan, Cai Zhaolian, Zhong Xiaoyong, Chen Bin, Zheng Haiyan, Chen Shangzhong, Lin Li, Liang Hui, Liu Zhizhen, Luo Jing

机构信息

Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, 350122, China.

Clinical Research Center, People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, 350004, China.

出版信息

Sleep Breath. 2025 Jun 28;29(4):229. doi: 10.1007/s11325-025-03404-1.

DOI:10.1007/s11325-025-03404-1

PMID:40581702

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12206178/

Abstract

BACKGROUND

Insomnia is a major sleeping disorder that affects the quality of life and overall health in a tremendous way. Those pharmacological therapies of insomnia, which are typically applied, i.e., benzodiazepines, may result in side effects that are rather dangerous, i.e., dependency and the decline of the cognitive status. Chaihu plus Longgu Muli decoction is a traditional Chinese herbal formula (TCM) which has been used in the treatment of insomnia and can be used as a safer alternative or complementary approach in the treatment of this ailment.

METHOS

PubMed, Embase, Cochrane library, CNKI, Wanfang, CQVIP and CBM databases have been searched in our meta-analysis since the establishment of the databases to July 2024. The studies containing the combination of Chaihu Longgu Muli decoction and Estazolam in treating insomnia were to be included in the proposed study without taking into consideration the published literatures, unpublished literatures, those which contain in-complete or inadequate information, animal experiments, literature synthesis and the systematic study. Data analysis was done on the STATA 15.1.

RESULTS

The meta-analysis revealed that the blend of Chaihu plus Longgu Muli decoction and Estazolam used to be extra potent than Estazolam treatment in enhancing the quality of sleep, as indicated by higher effective rates (RR = 1.29, 95% CI: 1.20-1.38, P = 0.000) and lower Pittsburgh Sleep Quality Index (PSQI) scores (WMD=-2.98, 95% CI: -4.06 to -1.90, P = 0.000). Also, lesser Traditional Chinese Medicine (TCM) syndrome scores followed the mixture therapy (WMD=-4.04, 95% CI: -4.38 to -3.70, P = 0.000) and reduced incidence of adverse events (RR = 0.35, 95% CI: 0.16-0.76, P = 0.000).

CONCLUSION

The combination of Chaihu plus Longgu Muli decoction and Estazolam is more effective and safer than Estazolam alone in treating insomnia. This integrative approach could offer a promising alternative for patients seeking effective and safer treatment options for insomnia.

摘要

背景

失眠是一种主要的睡眠障碍，极大地影响生活质量和整体健康。那些常用的失眠药物治疗方法，如苯二氮䓬类药物，可能会导致相当危险的副作用，如药物依赖和认知状态下降。柴胡加龙骨牡蛎汤是一种传统中药配方，已用于治疗失眠，可作为治疗这种疾病更安全的替代或辅助方法。

方法

在我们的荟萃分析中，自数据库建立至2024年7月，检索了PubMed、Embase、Cochrane图书馆、中国知网、万方、维普和中国生物医学文献数据库。纳入拟研究的是包含柴胡龙骨牡蛎汤与艾司唑仑联合治疗失眠的研究，不考虑已发表文献、未发表文献、信息不完整或不足的文献、动物实验、文献综述和系统评价。在STATA 15.1上进行数据分析。

结果

荟萃分析显示，柴胡加龙骨牡蛎汤与艾司唑仑联合使用在改善睡眠质量方面比单独使用艾司唑仑更有效，有效率更高（RR = 1.29，95%CI：1.20 - 1.38，P = 0.000），匹兹堡睡眠质量指数（PSQI）得分更低（WMD = -2.98，95%CI：-4.06至-1.90，P = 0.000）。此外，联合治疗后的中医证候评分更低（WMD = -4.04，95%CI：-4.38至-3.70，P = 0.000），不良事件发生率降低（RR = 0.35，95%CI：0.16 - 0.76，P = 0.000）。