关于建立稳定性冠心病综合疗效评价体系的研究与思考  

Comprehensive efficacy evaluation system for stable coronary angina disease

作　　者：许嘉芯 代欣玥 赵阳 于滨洋 高蕊 XU Jia-xin;DAI Xin-yue;ZHAO Yang;YU Bin-yang;GAO Rui(Graduate School of Beijing University of Traditional Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学研究生院,北京100029

出　　处：《中国新药杂志》2025年第3期231-235,共5页Chinese Journal of New Drugs

摘　　要：目的:从“三结合”注册审评证据视角出发,针对领域内瓶颈问题,为优化中药治疗稳定性冠心病疗效评价指标体系提供参考。方法:系统梳理古代典籍文献、现代随机对照研究,检索《中华医典》数据库、CNKI、WanFang Data、SinoMed(CBM)、维普、PubMed、Cochrane Library、Embase和Web of Science数据库提取中医药治疗稳定性冠心病的结局指标,构建初始指标条目池,采用德尔菲问卷调查方法逐层筛选指标寻求共识性结论。结果:共纳入古籍书目30本、现代文献研究190篇,指标合并整理后初始条目池共包含主客观疗效指标90个,结合2轮德尔菲问卷专家调研共识性意见,课题组参照临床疗效总评量表研究范式,综合架构“心绞痛发作次数与加拿大心血管学会分级标准”构建稳定性冠心病总体印象疗效评价量表。结论:建议在实施运动负荷试验有一定困难或以改善症状、生存质量为主的中医药临床研究中可采用本量表反映疾病核心症状的动态性变化,同时根据不同研究目的实际情况辅助选择对应的客观疗效指标。Objective:From the perspective of the evidence of the“three combinations”registration review,this study aims to address the bottleneck problems in the field and provides a reference for optimizing the evaluation index system of the efficacy of TCM in the treatment of stable coronary heart disease.Methods:The ancient classics and modern randomized controlled studies were systematically reviewed,and databases including Chinese Medical Classics,CNKI,WanFang Data,SinoMed(CBM),VIP,PubMed,Cochrane Library,Embase and Web of science databases were searched to extract the outcome indicators of TCM in the treatment of stable coronary heart disease.An initial pool of index items was constructed,and the Delphi questionnaire survey method was employed to screen these indicators layer by layer to seek a consensus conclusions.Results:A total of 30 ancient bibliographies and 190 modern literature studies were included in this analysis.The initial item pool included 90 subjective and objective efficacy indicators,which were subsequently combined and sorted.Conclusion:This scale is recommended for use in clinical research of traditional Chinese medicine to reflect the dynamic changes of the core symptoms of the disease,where it is difficult to implement the exercise stress test,improve the symptoms and quality of life,or assist in the selection of the corresponding objective efficacy indicators according to the actual situation of different research objectives.

关 键 词：稳定性冠心病 疗效评价 临床疗效总评量表 

分 类 号：R972.2[医药卫生—药品]