Zhang Wen, Jiang Jun-Jie, Ma Yong-Qing, Li Qiao-Feng, Liao Xing, Wu Cheng-Yu
School of Chinese Medicine, Nanjing University of Chinese Medicine Nanjing 210023, China.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2025 Jan;50(2):555-568. doi: 10.19540/j.cnki.cjcmm.20241009.501.
Evidence mapping was used to systematically analyze the clinical research evidence of oral Chinese patent medicines in the treatment of intracerebral hemorrhage(ICH), thus revealing the distribution and quality of evidence in this field. The relevant articles were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science from inception to July 5, 2024. The distribution characteristics of evidence were presented numerically and graphically. A total of 35 Chinese patent medicines were identified, involving 261 articles. The basic information of the 35 Chinese patent medicines, publication trend, traditional Chinese medicine(TCM) syndromes, interventions, and outcome indicators were compared and analyzed, and the methodological quality of the articles was evaluated. The results indicated that the clinical scope of Chinese patent medicines in the treatment of ICH was broad. However, the available studies inadequately emphasized the advantages and characteristics of TCM, lacked the safety information and the standards for evaluating outcome indicators, and paid insufficient attention to cognitive ability and neuropsychology. In addition, these articles demonstrated low quality. It is recommended that follow-up clinical research should be standardized and highlight the characteristics of TCM. In the analysis of outcome indicators, TCM syndrome evaluation should be taken as an important outcome indicator, and the evaluation criteria should be unified. Moreover, more attention should be paid to patients' cognitive ability and neuropsychology. The holder of marketing license of Chinese patent medicines should standardize the clinical position and improve the safety information in the medicine instructions according to the relevant requirements of the National Medical Products Administration. Additionally, the proportion of Chinese patent medicines in the category A list of medical insurance should be increased, and the limited medical resources should be rationally allocated.
采用证据图谱法系统分析口服中成药治疗脑出血（ICH）的临床研究证据，从而揭示该领域证据的分布及质量。从创刊至2024年7月5日，在知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、Cochrane图书馆及Web of Science中检索相关文章。以数字和图表形式呈现证据的分布特征。共纳入35种中成药，涉及261篇文章。对35种中成药的基本信息、发表趋势、中医证候、干预措施及结局指标进行比较分析，并评估文章的方法学质量。结果表明，中成药治疗ICH的临床范围较广。然而，现有研究对中医优势和特色的强调不足，缺乏安全性信息及结局指标评价标准，对认知能力和神经心理学关注不够。此外，这些文章质量较低。建议后续临床研究应规范开展，突出中医特色。在结局指标分析中，应将中医证候评价作为重要结局指标，并统一评价标准。此外，应更多关注患者的认知能力和神经心理学。中成药上市许可持有人应按照国家药品监督管理局的相关要求规范临床定位，完善药品说明书中的安全性信息。此外，应提高中成药在医保甲类目录中的占比，合理分配有限的医疗资源。
