中国药物警戒 ›› 2023, Vol. 20 ›› Issue (4): 433-440.
DOI: 10.19803/j.1672-8629.20211045

• 安全与合理用药 • 上一篇    下一篇

头痛宁胶囊治疗慢性头痛的有效性及安全性Meta分析

苏鑫鑫1, 吕健2, 谢雁鸣1,*   

  1. 1中国中医科学院中医临床基础医学研究所,北京 100700;
    2中国中医科学院西苑医院,北京 100091
  • 收稿日期:2021-12-06 出版日期:2023-04-15 发布日期:2023-04-20
  • 通讯作者: *谢雁鸣,女,首席研究员·博导,中医临床评价。E-mail: ktzu2018@163.com
  • 作者简介:苏鑫鑫,女,本科,中成药上市后评价。
  • 基金资助:
    国家重点研发计划（2018YFC1707400）; 国家自然科学基金资助项目（81973982）

Efficacy and safety of Toutongning capsules in the treatment of chronic headache: a Meta-analysis

SU Xinxin1, LYU Jian2, XIE Yanming1,*   

  1. 1Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China
  • Received:2021-12-06 Online:2023-04-15 Published:2023-04-20

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摘要： 目的 对头痛宁胶囊治疗慢性头痛的有效性和安全性进行系统评价。方法 系统检索中国知网、万方数据、维普网、SinoMed、Cochrane Library、PubMed、Embase、Web of Science、Clinical-Trials.gov数据库,筛选出发表时间为文献数据库自建库起至2021年4月30日的头痛宁胶囊治疗慢性头痛的随机对照试验（randomized controlled trial, RCT）全部文献,并根据Cochrane Handbook 5.1评价标准工具和RevMan 5.3软件对最终纳入的研究进行Meta分析。结果 全部纳入Meta分析9项研究,总样本量886例,试验组450例,对照组436例。Meta分析结果显示,去掉异质性较差的文献,有效性分析：头痛宁胶囊联合常规治疗（conventional treatment, CT）在慢性头痛的头痛程度评分方面优于单用常规治疗（MD=-0.91,95%CI[-1.19,-0.63],P<0.000 01）;头痛宁胶囊联合常规治疗在慢性头痛持续时间方面优于常规治疗（MD=-2.32,95%CI[-3.86,-0.79],P=0.003）;头痛宁胶囊联合常规治疗在慢性头痛的显效率方面优于单用常规治疗（RR=2.55,95%CI[1.96,3.30],P<0.000 01）;头痛宁胶囊治疗在慢性头痛的显效率方面优于单用常规治疗（RR=1.24,95%CI[1.02,1.50],P=0.03）;安全性方面,头痛宁胶囊的不良反应包括胸闷、头晕、胃肠反应、胃部不适、头昏及口干,试验组与对照组不良反应发生率无统计学差异。结论 基于现有数据和方法,头痛宁胶囊单用或联合常规治疗对慢性头痛的头痛评分、头痛发作次数、头痛持续时间、显效率方面均优于常规治疗,临床疗效明确。暂未发现头痛宁胶囊的严重不良反应,且未发现其增加不良反应发生率,可为临床实践提供循证医学证据,对进一步临床用药提供参考。

关键词: 头痛宁胶囊, 慢性头痛, 随机对照试验, 系统评价, Meta分析, 有效性, 安全性

Abstract: Objective To evaluate the efficacy and safety of Toutongning capsules in the treatment of chronic headache. Methods Literature related to randomized controlled trials of Toutongning capsules for chronic headache that was published between inception and April 30, 2021 was screened out by searching CNKI, Wanfang, VIP, SinoMed, Cochrane Library, PubMed, Embase and Web of Science. The evaluation criteria of Cochrane Handbook 5.1.0 and RevMan 5.3 software were used for Meta-analysis of the enrolled studies. Results A total of 9 studies were included in the meta-analysis, with a total sample size of 886 cases including 450 cases in the experimental group and 436 cases in the control group. The results of Meta-analysis showed that after the literature with poor heterogeneity was excluded, the headache severity score of Toutongning capsules combined with conventional treatments was better than that of conventional treatments alone (MD=-0.91, 95%CI[-1.19, -0.63], P＜0.000 01), so were the duration of therapeutic effect (MD=-2.32, 95%CI[-3.86, -0.79］, P=0.003) and efficacy(RR=2.55, 95%CI[1.96, 3.30］against chronic headache (P＜0.000 01). In terms of safety, the adverse reactions caused by Toutongning capsules included chest tightness, dizziness, gastrointestinal reaction, stomach discomfort, dizziness and dry mouth, but there was no significant difference in the incidence of adverse reactions between the experimental group and the control group. Conclusion Toutongning capsules alone or combined with conventional treatments are more effective than conventional treatments alone. No serious adverse reactions have been found, which can provide evidence-based data for clinical practice and clinical drug use.

Key words: Toutongning capsule, chronic headache, randomized controlled trial, systematic review, Meta-analysis, efficacy, safety

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