35种常用口服中成药治疗脑出血的临床研究证据图分析  

Evidence mapping of clinical research on 35 commonly used oral Chinese patent medicines in treatment of intracerebral hemorrhage

作　　者：张雯[1] 姜俊杰[2] 马永庆 李巧凤 廖星[2] 吴承玉[1] 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)

机构地区：[1]南京中医药大学中医学院,江苏南京210023 [2]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2025年第2期555-568,共14页China Journal of Chinese Materia Medica

基　　金：中国中医科学院科技创新工程项目(CI2021A05305,CI2021B003);中国中医科学院科技创新工程中医临床基础学科创新团队项目(CI2021B003);山西省中医药管理局项目(2023ZYYB078,2023ZYYC077);全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]75号)。

摘　　要：运用证据图系统检索与梳理口服中成药治疗脑出血(intracerebral hemorrhage,ICH)的临床研究证据,了解该领域现有证据分布及质量。通过检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Web of Science、EMbase、Cochrane Library数据库,建库至2024年7月5日发表的相关文献,采用图、表结合文字形式展示数据分布特征。共检索到35种中成药,纳入261篇文献,将中成药的基本信息、发文趋势、中医证型、干预措施、结局指标等进行对比和分析,并对文献方法学质量进行评价。结果显示,治疗ICH的中成药临床定位宽泛;未充分体现中医优势与特色;安全性信息尚不完善;结局指标评价方面评价标准不统一,对认知功能、心理学方面关注略显不足;文献方法学质量较低。建议在今后的临床研究中,规范试验设计,突出中医特色;将中医证候评价作为重要结局指标,并统一评价标准,多关注患者认知功能与心理学情况;建议治疗ICH中成药的上市许可持有人按照国家药品监督管理局相关要求,规范临床定位,修订完善说明书中安全性信息;提高医保目录中甲类中成药占比,合理配置有限的医疗资源。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.

关 键 词：中成药 脑出血 临床研究 证据图 

分 类 号：R277.7[医药卫生—中医学] G353.1[文化科学—情报学]