中国药物警戒 ›› 2025, Vol. 22 ›› Issue (6): 674-679.
DOI: 10.19803/j.1672-8629.20240297

• 安全与合理用药 • 上一篇    下一篇

治疗头痛中成药的功效语义挖掘及安全性分析

刘逸宇1,2, 李彦文3, 王娇1, 周文静1, 彭雨蒙4, 贺文彬1,2#, 李志勇5*   

  1. 1山西中医药大学基础医学院,山西 晋中030619;
    2山西中医药大学中医脑病学山西省重点实验室,山西 晋中 030619;
    3中国中医科学院中医药信息研究所,北京 100700;
    4中央民族大学药学院,北京 100081;
    5中国中医科学院中药研究所,北京 100700
  • 收稿日期:2024-05-08 发布日期:2025-06-18
  • 通讯作者: *李志勇,男,博士,研究员,名优中成药二次开发。E-mail: lizhiyong7899@sina.com;#为共同通信作者。
  • 作者简介:刘逸宇,女,在读硕士,中药药理与方剂配伍作用研究。
  • 基金资助:
    国家自然科学基金资助项目（82374146）; 中医脑病学山西省重点实验室开放课题（CME-OP-202106）; 中国中医科学院中药研究所中央级公益性科研院所基本科研业务费（ZXKT23009）; 浙江省医学电子与数字健康重点实验室开放课题（MEDC202307）

Efficacy Semantic Mining and Safety Analysis of Chinese Patent Medicines for Headache

LIU Yiyu1,2, LI Yanwen3, WANG Jiao1, ZHOU Wenjing1, PENG Yumeng4, HE Wenbin1,2#, LI Zhiyong5*   

  1. 1School of Basic Medicine, Shanxi University of Chinese Medicine, Jinzhong Shanxi 030619, China;
    2Shanxi Key Laboratory of TCM Encephalopathy, Shanxi University of Chinese Medicine, Jinzhong Shanxi 030619, China;
    3Institute of Information on Traditional Chinese Medicine of China Academy of Chinese Medical Sciences, Beijing 100700, China;
    4School of Pharmacy, Minzu University of China, Beijing 100081, China;
    5Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • Received:2024-05-08 Published:2025-06-18

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摘要： 目的 系统性评价已上市治疗头痛中成药的安全性,对功效语义进行挖掘与分析,为临床用药提供参考。方法 以上述中成药组成药材的功效语义为基准构建治疗头痛相关的中药功效语义网络,采用Meta分析系统评价上述中成药在临床应用中发生的不良反应。结果 治疗头痛中成药的功效语义特征主要集中于清热、解毒、解表、止痛、祛风、疏风等方面; 纳入23项RCT研究的Meta分析结果显示,中成药单用或联合常规西药可以降低不良反应发生率[RR=0.46,95%CI（0.35,0.60）,P<0.05],服用天麻钩藤颗粒[RR=0.52,95%CI（0.31,0.88）,P<0.05]、枣仁安神颗粒[RR=0.27,95%CI（0.14,0.49）,P<0.05]的患者间的不良反应发生率,差异具有统计学意义。结论 治疗头痛中成药针对外感和内伤头痛呈现为不同类型的功效聚集特征,且具有较高的安全性。

关键词: 头痛, 中成药, 天麻钩藤颗粒, 枣仁安神颗粒, 功效语义网络, 安全性, Meta分析

Abstract: Objective To explore the efficacy semantics of Chinese patent medicines for headache currently on the market and to conduct a meta-analysis of safety of these medicines. Methods Based on the efficacy semantics of the above-mentioned Chinese patent medicines, an efficacy semantic network of Chinese patent medicines used for headache treatment was constructed. Meta-analysis was conducted to assess the adverse reactions of the above-mentioned Chinese patent medicines in clinic. Results The functional semantic features of Chinese patent medicines for headache focused on clearing heat, detoxification, relieving exterior syndrome, managing pain and dispelling wind. A total of 23 RCT studies were included. The results of Meta-analysis showed that Chinese patent medicines alone or combined with conventional Western medicine could reduce the incidence of adverse reactions [RR=0.46, 95 %CI (0.35,0.60), P<0.05].The incidence of adverse reactions was significantly different between patients taking Tianma Gouteng granules [RR=0.52, 95%CI (0.31,0.88), P<0.05] and those using Zaoren Anshen granules [RR=0.27, 95%CI (0.14,0.49), P<0.05]. Conclusion Chinese patent medicines for headache are different in efficacy aggregation when used to treat exogenous and internal headache, and are highly safe.

Key words: Headache, Chinese Patent Medicine, Tianma Gouteng Granules, Zaoren Anshen Granules, Efficacy Semantic Network, Safety, Meta-Analysis

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