冠心静胶囊治疗气虚血瘀型冠心病心绞痛的“6+1”维度临床综合评价  

Clinical Comprehensive Evaluation of Guanxinjing Capsules in Treating Angina Pectoris of Coronary Heart Disease with Syndrome of Qi Deficiency and Blood Stasis in"6+1"Dimensions

作　　者：王萌萌 崔鑫 吕健 谢雁鸣[1] 王连心[1] WANG Mengmeng;CUI Xin;LYU Jian;XIE Yanming;WANG Lianxin(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院西苑医院,北京100091

出　　处：《中国实验方剂学杂志》2025年第2期120-128,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家重点研发计划“中医药现代化研究”项目(2022YFC3502004);第七批全国老中医药专家学术经验继承项目(国中医药人教函[2022]76号);谢雁鸣全国名老中医专家传承工作室建设项目(国家中医药人教函[2022]75);2024年度中药监管科学研究项目(ZYJGKX202407)。

摘　　要：目的:系统梳理冠心静胶囊治疗冠心病心绞痛(气虚血瘀证)现有研究,进行涵盖6+1维度及9个方面的临床证据和综合价值评估,明确冠心静胶囊临床定位及优势特点。方法:采用定性与定量相结合的评价方式,应用临床医学、流行病学、循证医学、药物经济学等方法学,通过公开资料、问卷调查、真实世界数据和文献综合评价,构建了对冠心静胶囊的6+1维度等9个方面的评价体系。通过专家为准则层和指标层赋予权重,并利用多准则层决策分析模型(MCDA)和CSC(V2.0)软件对各维度进行了度量,揭示了冠心静胶囊的临床价值。结果:①评估结果显示冠心静胶囊的安全性较高,根据说明书不良反应、临床安全性系统评价和Meta分析、国家药品不良反应监测中心收集等数据显示冠心静胶囊不良反应主要包括胸闷、呼吸困难、头晕和消化系统相关症状,标准化分数为0.75分,安全性良好。②从Meta分析结果中可以看出,在疗效标准一致的情况下,单用冠心静胶囊和冠心静胶囊联合西医常规或中成药来治疗冠心病时的有效性高于单纯西医常规或中成药参芍胶囊治疗,有效性标准化分数为0.57分,仍需一定的证据支持。③以2020年的个人可支配收入作为患者的预期付款假设阈值,与单用常规治疗相比,在一定条件转化下(高于106.91元),冠心病心绞痛患者通过联合冠心静胶囊与常规治疗会有成本效益,经济性较好。④目前已有3个关于冠心静胶囊的发明的专利获得批准,涵盖了临床创新、服务系统革新及产业发展等多个领域,创新性较好。⑤此外,针对医护人员所做的调查问卷涉及5个不同的维度,其统计分数和评价均表现出良好的适应性,适宜性良好。⑥居民报销比例较高,抽样调查发现冠心静胶囊在全国医院内配比较全,可及性良好。⑦源自清朝著名医学家王清任的活血化瘀理论,冠心静胶囊融�Objective:To systematically review the available studies about Guanxinjing capsules in treating angina pectoris of coronary heart disease(syndrome of Qi deficiency and blood stasis),evaluate the evidence quality and comprehensive value of Guanxinjing capsules in 6+1 dimensions involving 9 aspects,and clarify the clinical positioning and advantages of this medicine.Methods:A qualitative combined with quantitative evaluation method was adopted,involving clinical medicine,epidemiology,evidence-based medicine,and pharmacoeconomics.Through public data collection,questionnaire surveys,realworld data collection,and literature comprehensive evaluation,an evaluation system involving 9 aspects in 6+1 dimensions was constructed for Guanxinjing capsules.Experts assigned weights to the criterion layer and indicator layer,and the multi-criteria decision analysis(MCDA)model and CSC(V2.0)were employed to measure each dimension and reveal the clinical value of Guanxinjing capsules.Results:①The evaluation results showed that Guanxinjing capsules are safe.According to the adverse reactions in the instructions,the systematic evaluation and meta-analysis of clinical safety,and the data collected by the National Center for Adverse Drug Reaction Monitoring,the adverse reactions of Guanxinjing capsules mainly include chest tightness,dyspnea,dizziness,and digestive system-related symptoms,with a standardized score of 0.75 points,which suggests good safety.②The meta-analysis results suggest that according to the same efficacy standards,the effectiveness of Guanxinjing capsules alone and Guanxinjing capsules combined with conventional Western medicine or Chinese patent medicines is higher than that of conventional Western medicine or the Chinese patent medicine Shenshao capsules alone in treating coronary heart disease.The standardized score of effectiveness is 0.57,which indicates that the effectiveness still requires evidence support.③With the individual disposable income in 2020 as the expected payment assumption threshold,compare

关 键 词：冠心静胶囊 冠心病心绞痛 气虚血瘀 临床综合评价 多准则决策分析 

分 类 号：R259[医药卫生—中西医结合] R714.252[医药卫生—中医内科学] R256.2[医药卫生—中医学]