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养血清脑颗粒治疗偏头痛的疗效与安全性:一项系统评价与Meta分析

Efficacy and safety of Yangxue Qingnao Granules in treatment of migraine: A systematic review and meta-analysis.

作者信息

Zhou Bo, Wang Gui-Shu, Yao Yu-Ning, Hao Tong, Li Huan-Qin, Cao Ke-Gang

机构信息

Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.

Department of Infectious Disease, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.

出版信息

World J Clin Cases. 2024 Jan 16;12(2):335-345. doi: 10.12998/wjcc.v12.i2.335.

DOI:10.12998/wjcc.v12.i2.335
PMID:38313632
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10835686/
Abstract

BACKGROUND

Yangxue Qingnao Granules (YXQN) is a Chinese patent medicine that has been commonly used in the clinical treatment of migraine.

AIM

To assess the efficacy and safety of YXQN alone for the treatment of migraine.

METHODS

We searched 10 databases to identify relevant randomized controlled trials (RCTs) published before September 2022. Two review authors independently searched and screened the literature, extracted the data, and assessed the methodological quality of the studies using criteria from ROB 2.0, and analyzed the data using Review Manager 5.4 software.

RESULTS

A total of 12 RCTs including 767 participants with migraine met the selection criteria. We divided these studies into comparisons of YXQN with placebo, routine treatment drugs, and other Chinese patent medicines. The meta-analysis showed the following: (1) Efficacy: The YXQN group outperformed the placebo group [relative risk (RR) = 0.29, 95% confidence interval (95%CI): 0.15-0.43, < 0.00001], routine treatment group (RR = 0.18, 95%CI: 0.09-0.27, < 0.0001), and Chinese patent medicine group (RR = 0.27, 95%CI: 0.13-0.41, < 0.001); (2) frequency of headache: There was a significant difference between YXQN placebo [mean difference (MD) = -1.25, 95%CI: -1.60 to -0.90, < 0.00001], routine treatment drugs (MD = -0.85, 95%CI: -1.15 to -0.56, < 0.00001), and Chinese patent medicine (MD = -0.91, 95%CI: -1.35 to -0.46, < 0.0001); (3) headache duration: We found great heterogeneity between studies, with no differences between YXQN and placebo (MD = -0.61, 95%CI: -1.53 to -0.31, = 0.19) and routine treatment drugs (MD = -0.22, 95%CI: -0.89 to 0.46, < 0.53). YXQN was more effective than other Chinese patent medicines in reducing headache duration (MD = -1.24, 95%CI: -1.70 to -0.77, < 0.00001); and (4) headache severity: There was no significant difference between YXQN placebo (MD = -1.67, 95%CI: -3.52 to 0.19, = 0.08), routine treatment drugs (MD = -0.53, 95%CI: -2.02 to 0.96, = 0.68), and other Chinese patent medicines (MD = -0.49, 95%CI: -2.83 to 1.85, = 0.68). Mild gastrointestinal adverse reactions were reported in three cases.

CONCLUSION

This study revealed that YXQN is effective and safe for treatment of migraine.

摘要

背景

养血清脑颗粒(YXQN)是一种常用于偏头痛临床治疗的中成药。

目的

评估单独使用YXQN治疗偏头痛的疗效和安全性。

方法

我们检索了10个数据库,以识别2022年9月之前发表的相关随机对照试验(RCT)。两位综述作者独立检索和筛选文献,提取数据,并使用ROB 2.0的标准评估研究的方法学质量,并用Review Manager 5.4软件分析数据。

结果

共有12项RCT(包括767名偏头痛患者)符合入选标准。我们将这些研究分为YXQN与安慰剂、常规治疗药物和其他中成药的比较。荟萃分析结果如下:(1)疗效:YXQN组优于安慰剂组[相对危险度(RR)=0.29,95%置信区间(95%CI):0.15 - 0.43,P<0.00001]、常规治疗组(RR = 0.18,95%CI:0.09 - 0.27,P<0.0001)和中成药组(RR = 0.27,95%CI:0.13 - 0.41,P<0.001);(2)头痛频率:YXQN与安慰剂[平均差(MD)=-1.25,95%CI:-1.60至-0.90,P<0.00001]、常规治疗药物(MD = -0.85,95%CI:-1.15至-0.56,P<0.00001)和中成药(MD = -0.91,95%CI:-1.35至-0.46,P<0.0001)之间存在显著差异;(3)头痛持续时间:我们发现各研究之间存在很大异质性,YXQN与安慰剂(MD = -0.61,95%CI:-1.53至-0.31,P = 0.19)和常规治疗药物(MD = -0.22,95%CI:-0.89至0.46,P = 0.53)之间无差异。YXQN在缩短头痛持续时间方面比其他中成药更有效(MD = -1.24,95%CI:-1.70至-0.77,P<0.00001);(4)头痛严重程度:YXQN与安慰剂(MD = -1.67,95%CI:-3.52至0.19,P = 0.08)、常规治疗药物(MD = -0.53,95%CI:-2.02至0.96,P = 0.68)和其他中成药(MD = -0.49,95%CI:-2.83至1.85,P = 0.68)之间无显著差异。有3例报告了轻度胃肠道不良反应。

结论

本研究表明,YXQN治疗偏头痛有效且安全。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd22/10835686/01b569d6fe3a/WJCC-12-335-g006.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd22/10835686/01b569d6fe3a/WJCC-12-335-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd22/10835686/f2a9e0fd4435/WJCC-12-335-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd22/10835686/6d3d28d83bdc/WJCC-12-335-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd22/10835686/81fedb428db1/WJCC-12-335-g003.jpg
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