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枣仁安神胶囊治疗失眠的有效性和安全性：随机对照试验的Meta分析

Efficacy and safety of Zaoren Anshen capsules in the treatment of insomnia: A meta-analysis of randomized controlled trials.

作者信息

Chen Bo-Wei, Yi Jian, Sun Bei, Jia Ping, Zhang Wen-Jiang, Liu Bai-Yan

机构信息

The First Affiliated Hospital, Hunan University of Chinese Medicine, Changsha, Hunan, P.R. China.

Yiyang Medicine College, Yiyang, Hunan, P.R. China.

出版信息

Medicine (Baltimore). 2020 Feb;99(6):e19033. doi: 10.1097/MD.0000000000019033.

DOI:10.1097/MD.0000000000019033
PMID:32028417
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7015645/
Abstract

BACKGROUND

Zaoren Anshen capsules (ZRAS) have been widely used to treat patients with insomnia. However, the efficacy and safety of ZRAS for insomnia treatment is not entirely clear. Therefore, it is necessary to clarify the effect of ZRAS for the treatment of insomnia by a systematic meta-analysis.

METHODS

We searched PubMed, EMBASE, Web of Science, Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), and WanFang databases and performed a manual search to retrieve relevant articles (available through January 2019) describing randomized controlled trials (RCTs) of ZRAS for the treatment of insomnia. The quality of the selected articles was assessed with the Cochrane risk-of-bias tool. A meta-analysis of the selected articles was performed with RevMan 5.3 software.

RESULTS

A total of 13 articles including 1175 patients were included in the study. Overall, our results showed that ZRAS was slightly higher than that of the conventional Western medicine for insomnia in terms of clinical efficacy rate; but there was no statistical difference between the 2 groups (relative risk [RR] = 1.03, 95% confidence interval [CI] = [0.97, 1.09], P = .34). However, it should be noted that ZRAS treatment causes far fewer adverse reaction than treatment with conventional Western medicine (RR = 0.20, 95% CI = [0.14, 0.28], P < .00001).

CONCLUSION

Our results suggested that ZRAS is an effective and safe treatment for insomnia, especially in adverse reaction. However, multi-regional and well-designed RCTs studies are needed in the future to validate the results.

摘要

背景

枣仁安神胶囊（ZRAS）已被广泛用于治疗失眠患者。然而，ZRAS治疗失眠的疗效和安全性尚不完全清楚。因此，有必要通过系统的荟萃分析来阐明ZRAS治疗失眠的效果。

方法

我们检索了PubMed、EMBASE、科学网、考克兰图书馆、中国知网（CNKI）和万方数据库，并进行了手工检索，以获取描述ZRAS治疗失眠的随机对照试验（RCT）的相关文章（截至2019年1月可用）。使用考克兰偏倚风险工具评估所选文章的质量。使用RevMan 5.3软件对所选文章进行荟萃分析。

结果

本研究共纳入13篇文章，涉及1175例患者。总体而言，我们的结果表明，ZRAS在临床有效率方面略高于治疗失眠的传统西药；但两组之间无统计学差异（相对风险[RR]=1.03，95%置信区间[CI]=[0.97，1.09]，P=0.34）。然而，应该注意的是，ZRAS治疗引起的不良反应远少于传统西药治疗（RR=0.20，95%CI=[0.14，0.28]，P<0.00001）。

结论

我们的结果表明，ZRAS是一种治疗失眠的有效且安全的方法，尤其是在不良反应方面。然而，未来需要多地区、设计良好的RCT研究来验证这些结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/bc9c4509113f/medi-99-e19033-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/39f737b52aab/medi-99-e19033-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/e09219cbd3ca/medi-99-e19033-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/8c2ec730fb99/medi-99-e19033-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/a8f01bdfcd34/medi-99-e19033-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/01a1bce39d9a/medi-99-e19033-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/ecc5d8378202/medi-99-e19033-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/bc9c4509113f/medi-99-e19033-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/39f737b52aab/medi-99-e19033-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/e09219cbd3ca/medi-99-e19033-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/8c2ec730fb99/medi-99-e19033-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/a8f01bdfcd34/medi-99-e19033-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/01a1bce39d9a/medi-99-e19033-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/ecc5d8378202/medi-99-e19033-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6631/7015645/bc9c4509113f/medi-99-e19033-g008.jpg

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