摘要
目的:对愈心痛胶囊治疗冠心病心绞痛开展临床综合评价,旨在明确其应用价值、保障用药安全、指导合理用药,为基药准入提供科学依据。方法:根据《药品临床综合评价管理指南(2021年版试行)》的有关要求,以企业提供的相关资料、文献资料和调查问卷为基础,针对愈心痛胶囊及其3种对比药物在治疗冠心病心绞痛方面的表现,从安全性、有效性、经济性、创新性、适宜性以及可及性6个方面开展临床综合评价。结果:安全性方面,未出现毒性反应,未出现严重不良反应;有效性方面,与单用常规西药治疗相比,加载愈心痛胶囊治疗可显著改善冠心病心绞痛病人临床疗效、心电图疗效,降低心绞痛发作次数、心绞痛发作持续时间并缓解西雅图心绞痛量表评分中的身体活动受限程度,药理作用机制明确;经济性方面,愈心痛胶囊相对具有成本-效果优势;创新性方面,愈心痛胶囊具有显著植物药优势,可提高稳定性冠心病病人运动耐量,获得了我国专利授权,并以一类创新药(原中药三类)上市,展现出巨大的创新潜力和极高的研究价值;适宜性方面,该药在药物技术特性及药品使用方面都具备良好的适宜性;可及性方面,药品供应货源充足,覆盖了各级医院,已纳入医保乙类目录,病人负担压力适中,原材料不涉及濒危动物药材,可及性良好。专家组推荐意见为A类(13/13),建议可直接转化为决策使用。结论:愈心痛胶囊治疗冠心病心绞痛在6个维度的综合评价中均有良好的表现,具有较好的临床价值。
Objective:A comprehensive clinical evaluation was conducted on the treatment of coronary heart disease with Yuxintong Capsules to clarify its application value,ensure medication safety,guide rational drug use,and provide a scientific basis for the inclusion of these drugs in the national essential medicine list.Methods:In accordance with the"Guidelines for Clinical Comprehensive Evaluation of Drugs(Trial Version 2021)",based on the relevant materials,literature,and questionnaires provided by the enterprise,a comprehensive clinical evaluation was conducted on the performance of Yuxintong Capsules and its three comparison drugs in the treatment of coronary heart disease and angina pectoris.The evaluation was carried out from six core aspects:safety,effectiveness,economy,innovation,suitability,and accessibility.Results:In terms of safety,no toxic reactions were observed,and no serious adverse reactions were noted.In terms of effectiveness,compared with conventional Western medicine alone,Yuxintong Capsules could significantly improve the clinical efficacy and electrocardiogram efficacy of patients with coronary heart disease and angina pectoris,reduce the frequency and duration of angina pectoris attacks,and alleviate the degree of physical activity limitation in the Seattle Angina Questionnaire score.Terms of economy,Yuxintong Capsules had more advantageous performance and effect.In terms of innovation,Yuxintong Capsules showed significant advantages over traditional pharmaceuticals.Yuxintong Capsules could enhance the exercise tolerance of patients with stable coronary heart disease.In terms of suitability,this drug showed excellent suitability in both its pharmaceutical technical characteristics and clinical application.In terms of accessibility,the supply of medicines was abundant.The raw materials did not involve endangered animal medicinal materials.and the accessibility was good.The expert group's recommendation was of category A(13/13),and it could be directly converted into a decision-making basis.Conclusion:The Yuchxintong Capsules have shown excellent performance in the treatment of coronary heart disease angina pectoris,possess significant clinical value.
作者
乔利杰
皮哲宇
赵瑞霞
郭红鑫
栗蕊
李易真
邢云飞
王永霞
李彬
QIAO Lijie;PI Zheyu;ZHAO Ruixia;GUO Hongxin;LI Rui;LI Yizhen;XING Yunfei;WANG Yongxia;LI Bin(Evidence-Based Medicine Center Office,The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450046,Henan,China;Heart Center,The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450046,Henan,China;Henan University of Chinese Medicine)
出处
《中西医结合心脑血管病杂志》
2025年第19期2889-2895,共7页
Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease
基金
中华中医药学会研究与评价专项课题(No.CACMRE2024-A-03)。
关键词
冠心病心绞痛
愈心痛胶囊
临床综合评价
coronary heart disease angina pectoris
Yuxintong Capsules
clinical comprehensive evaluation
