{"title":"[Evidence mapping of clinical research on 35 commonly used oral Chinese patent medicines in treatment of intracerebral hemorrhage].","authors":"Wen Zhang, Jun-Jie Jiang, Yong-Qing Ma, Qiao-Feng Li, Xing Liao, Cheng-Yu Wu","doi":"10.19540/j.cnki.cjcmm.20241009.501","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"50 2","pages":"555-568"},"PeriodicalIF":0.0000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Zhongguo Zhongyao Zazhi","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.19540/j.cnki.cjcmm.20241009.501","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
引用次数: 0
Abstract
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.
采用证据图谱的方法,系统分析口服中成药治疗脑出血的临床研究证据,揭示该领域证据的分布和质量。相关文章检索自CNKI、万方、维普、中国医学信息网、PubMed、EMbase、Cochrane Library和Web of Science,检索时间为创刊至2024年7月5日。证据的分布特征用数字和图形表示。共鉴定出35种中成药,涉及261篇。比较分析35种中成药的基本信息、发表趋势、中医证候、干预措施、结局指标,并评价文献的方法学质量。结果表明,中成药治疗脑出血的临床应用范围广泛。然而,现有的研究对中药的优势和特点强调不够,缺乏安全性信息和疗效指标评价标准,对认知能力和神经心理学的关注不够。此外,这些文章的质量也很低。建议后续临床研究规范化,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的结局指标,并统一评价标准。此外,应更多地关注患者的认知能力和神经心理。中成药上市许可持有人应当按照国家药品监督管理局的有关要求,规范临床位置,完善药品说明书中的安全信息。提高中成药在医保A类目录中的比例,合理配置有限的医疗资源。