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天麻素治疗紧张型头痛的疗效与安全性的系统评价和Meta分析

[Systematic review and Meta-analysis of efficacy and safety of gastrodin in treatment of tension-type headache].

作者信息

Yan Yu, Zhang Yun-Ling, Jin Xiang-Lan, Liao Xing, Gong Xiao, Chen Wen-Jie, Wei Jing-Jing, Fan Xue-Ming, Piao Jing-Ze, Fu Guo-Jing, Guo Chun-Li

机构信息

Graduate School,Beijing University of Chinese Medicine Beijing 100029,China Center for Evidence-based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences Beijing 100700,China Dongfang Hospital,Beijing University of Chinese Medicine Beijing 100078,China.

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

出版信息

Zhongguo Zhong Yao Za Zhi. 2021 Sep;46(18):4615-4622. doi: 10.19540/j.cnki.cjcmm.20210615.501.

Abstract

The efficacy of gastrodin as a Chinese herbal medicine extract in the treatment of tension-type headache has been confirmed. This paper systematically reviewed the efficacy and safety of gastrodin in the treatment of tension-type headache, aiming to provide a new choice for the treatment of this disease. In this study, four Chinese databases, four English databases and two trial registries were searched from the date of establishment to September 2020. The related randomized controlled trials(RCTs) were screened out according to the predetermined criteria. The bias risk assessment tool developed by Cochrane collaboration was used to evaluate the quality of the reports. RevMan 5.4.1 was used for Meta-analysis, and GRADE system for the evidence-based evaluation on the quality of outcome indicators. A total of 177 articles were retrieved and 8 articles were finally included for analysis, with a total sample size of 1 091 cases, which included 565 cases in the treatment group and 526 cases in the control group. The overall quality of included stu-dies was not high. The results of Meta-analysis are as follows:(1)In terms of headache frequency, gastrodin group was better than wes-tern medicine group(MD=-2.90, 95%CI[-3.76,-2.03], P<0.000 01).(2)In terms of number of abnormal blood vessels in TCD, gastrodin group was better than western medicine group(MD=-88.96, 95%CI[-102.36,-75.55], P<0.000 01).(3)In terms of effective rate, gastrodin group was better than western medicine group(RR=1.47, 95%CI[1.29, 1.68], P<0.000 01). The results of subgroup analysis are as follows:(1)Effective rate based on age, for the patients upper age limit 40-46 years old, gastro-din group was better than western medicine group(RR=1.69, 95%CI[1.50, 1.90], P<0.000 01); for the patients upper age limit 55-60 years old, gastrodin group was better than western medicine group(RR=1.27, 95%CI[1.16, 1.38], P<0.000 01).(2)Effective rate based on dosage form, both the gastrodin capsules and injection groups were better than western medicine group(RR_(capsules)=1.42, 95%CI[1.08, 1.88], P=0.01; RR_(injection)=1.50, 95%CI[1.26, 1.77], P<0.000 01). GRADE evaluation showed that the above outcomes had low quality of evidence. Only one article detailed the occurrence of adverse reactions and thus the present study cannot make a positive conclusion on the safety of gastrodin in the treatment of tension-type headache. The small number and low quality of the included reports affected the reliability of the results. In the future, more high-quality randomized controlled trails are needed to improve the evaluation on the efficacy and safety of gastrodin in the treatment of tension-type headache.

摘要

天麻素作为一种中草药提取物治疗紧张型头痛的疗效已得到证实。本文系统评价了天麻素治疗紧张型头痛的疗效和安全性,旨在为该病的治疗提供新的选择。本研究检索了4个中文数据库、4个英文数据库和2个试验注册库,检索时间从建库至2020年9月。根据预先设定的标准筛选出相关的随机对照试验(RCT)。采用Cochrane协作网开发的偏倚风险评估工具对报告质量进行评价。使用RevMan 5.4.1进行Meta分析,使用GRADE系统对结局指标质量进行循证评价。共检索到177篇文章,最终纳入8篇进行分析,总样本量为1091例,其中治疗组565例,对照组526例。纳入研究的总体质量不高。Meta分析结果如下:(1)在头痛发作频率方面,天麻素组优于西药组(MD=-2.90,95%CI[-3.76,-2.03],P<0.000 01)。(2)在经颅多普勒(TCD)异常血管数量方面,天麻素组优于西药组(MD=-88.96,95%CI[-102.36,-75.55],P<0.000 01)。(3)在有效率方面,天麻素组优于西药组(RR=1.47,95%CI[1.29,1.68],P<0.000 01)。亚组分析结果如下:(1)基于年龄的有效率,年龄上限为40 - 46岁的患者,天麻素组优于西药组(RR=1.69,95%CI[1.50,1.90],P<0.000 01);年龄上限为55 - 60岁的患者,天麻素组优于西药组(RR=1.27,95%CI[1.16,1.38],P<0.000 01)。(2)基于剂型的有效率,天麻素胶囊组和注射剂组均优于西药组(RR_(胶囊)=1.42,95%CI[1.08,1.88],P=0.01;RR_(注射剂)=1.50,95%CI[1.26,1.77],P<0.000 01)。GRADE评价显示上述结局证据质量低。仅1篇文章详细描述了不良反应的发生情况,因此本研究无法对天麻素治疗紧张型头痛的安全性得出肯定结论。纳入报告数量少且质量低影响了结果的可靠性。未来需要更多高质量的随机对照试验来完善对天麻素治疗紧张型头痛疗效和安全性的评价。

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