Guan Yue-Yue, Yu Xin-Yuan, Li Chen-Yu, Shu Jian-Zhong, Tao Wen-Qiang, Mi Xiu-Juan, Luo Xiao-Qiong, Lian Zhi-Yun, Zhao Yu-Hua, Tang Jun, Liao Xing
Chongqing Traditional Chinese Medicine Hospital Chongqing 400021,China.
Center for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2021 Dec;46(24):6558-6567. doi: 10.19540/j.cnki.cjcmm.20210924.501.
In this study, the evidence mapping methodology was used to systematically retrieve and sort out the clinical research evidence of Chinese patent medicines in the treatment of tension-type headache(TTH), and to understand the distribution of evidence in this field and the basis and quality of evidence. Chinese and English articles on the 28 Chinese patent medicines for TTH, which were recorded in National Essential Medicines List(2018), Medicine Catalogue for National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance(2020), and Chinese Pharmacopoeia(2020), were retrieved from China National Knowledge Infrastructure(CNKI), Wanfang, VIP, China Biology Medicine disc(CBMdisc), PubMed, EMbase, and Cochrane Library from the establishment to June 2021, followed by descriptive analysis. Then, tables and bubble charts were plotted to analyze the distribution characteristics of evidence. A total of 129 eligible articles were yielded: 126 randomized/non-randomized controlled trials, and 3 systematic reviews. The functions, indications, and composition of the 28 medicines, as well as the proportion of related articles, publication trends, intervention measures, and outcome indicators were compared and analyzed. The results showed that the 28 Chinese patent medicines, composed of 128 Chinese medicinals, can be classified into six categories in terms of function: reinforcing healthy Qi, tranquilizing mind, dispelling stasis, regulating Qi, treating wind, and resuscitating. There are ongoing efforts to study the treatment of TTH with Chinese patent medicine in China, despite of little evidence. The clinical positioning of Chinese patent medicine for TTH is not clear, and clinical research fails to highlight the advantages of Chinese medicine. In addition, the outcome indicators have not been standardized and unified, and there is a lack of evidence on the long-term efficacy of Chinese patent medicine for TTH. This study is the first exploratory application of evidence maps to compare the characteristics and clinical research progress of 28 Chinese patent medicines for TTH, which can provide a reference for research on the optimization of Chinese medicine strategies for TTH.
在本研究中，采用证据图谱方法系统检索和梳理中成药治疗紧张型头痛（TTH）的临床研究证据，了解该领域证据分布情况以及证据的依据和质量。从中国知网（CNKI）、万方、维普、中国生物医学文献数据库（CBMdisc）、PubMed、EMbase和Cochrane图书馆中检索2018年《国家基本药物目录》、2020年《国家基本医疗保险、工伤保险和生育保险药品目录》以及2020年《中国药典》中收录的28种治疗TTH的中成药从建库至2021年6月的中英文文章，随后进行描述性分析。然后绘制表格和气泡图来分析证据的分布特征。共获得129篇合格文章：126篇随机/非随机对照试验和3篇系统评价。对这28种药物的功能、适应证、组成以及相关文章的比例、发表趋势、干预措施和结局指标进行了比较和分析。结果表明，这28种由128味中药组成的中成药在功能上可分为六类：补气、安神、化瘀、理气、治风、开窍。尽管证据较少，但国内仍在进行中成药治疗TTH的研究。中成药治疗TTH的临床定位不明确，临床研究未能突出中医药的优势。此外，结局指标尚未标准化和统一，缺乏中成药治疗TTH长期疗效的证据。本研究首次探索性应用证据图谱比较28种治疗TTH中成药的特点和临床研究进展，可为优化TTH中医治疗策略的研究提供参考。
