都梁软胶囊治疗偏头痛风寒瘀阻证的药品临床综合评价  

Comprehensive Clinical Evaluation of Duliang Soft Capsules in Treatment of Migraine withWind-cold Blood Stasis Syndrome

作　　者：赵晓晓 张旭明 席俊羽 路振凯 刘福梅[1] 王连心[1] 黎元元[1] 谢雁鸣[1] ZHAO Xiaoxiao;ZHANG Xuming;XI Junyu;LU Zhenkai;LIU Fumei;WANG Lianxin;LI Yuanyuan;XIE Yanming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Graduate School,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)

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]天津中医药大学研究生院,天津301617

出　　处：《中国实验方剂学杂志》2024年第8期223-232,共10页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家重点研发计划项目(2018YFC1707400);中国中医科学院科技创新工程项目(CI2021A00702-1);中央级公益性科研院所基本科研业务费专项(Z0737)。

摘　　要：目的:对都梁软胶囊治疗偏头痛风寒瘀阻证的临床综合价值进行评估,为国家医疗决策、药品临床推广、药事服务等提供参考。方法:依据《药品临床综合评价管理指南(2021年版试行)》,采用定性与定量相结合的方法,基于CSC v2.0软件,对都梁软胶囊上市前后的“安全性”,治疗偏头痛的临床实际用药效果即“有效性”,药品的成本-效果即“经济性”,药品的“创新性”,药品技术和临床用药的“适宜性”“可及性”及其“中医药特色”等“6+1”维度进行临床综合价值评估。结果:安全性:综合已知的不良反应[自发报告系统(SRS)数据、文献数据等],上市前毒理研究,上市后药物警戒工作开展情况等证据,综合评价都梁软胶囊安全性较好,证据比较充分,结果明确。有效性:Meta分析显示都梁软胶囊联合西药治疗偏头痛患者有效性优于单用西药,综合其证据质量及证据价值,评价该品有效性好,证据充足,结果确定。经济性:都梁软胶囊价格中等,为医保乙类产品,经济学研究表明其联合西药较单用西药经济性较好。综合证据价值及证据质量评价该品经济性较好。创新性:都梁软胶囊主要成分为白芷、川芎,有发明专利一项,获中国专利优秀奖一项。制药企业进行了都梁软胶囊有效成份提取工艺创新(CO_(2)超临界萃取技术)和制剂工艺创新(软胶囊制剂)。综合评价该品创新性较好,证据比较充分,结果明确。适宜性:都梁软胶囊问卷调查显示对患者和医护人员的适宜性好,“中成药信息服务评价”齐全,综合评价其适宜性好,证据充足,结果确定。可及性:都梁软胶囊药品价格水平中等、药品可负担性好、药品可获得性好,综合三方面证据,评价其可及性好,证据充足,结果确定。中医药特色:都梁软胶囊组方源自宋王璆《是斋百一选方》,载录于明代张介宾《景岳全书》“都梁丸”,上市后�Objective:To comprehensively assess the clinical value of Duliang soft capsules in the treatment of migraine with wind-cold blood stasis syndrome,and to provide guidance for national medical decision-making,clinical drug promotion,and pharmaceutical services.Method:The evaluation of Duliang soft capsules'clinical value was conducted in accordance with the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(Trial Version,2021)using a combination of qualitative and quantitative methods.Utilizing the CSC v2.0 software,this study conducted a comprehensive clinical evaluation of Duliang soft capsules across the"6+1"dimensions,including safety pre-and post-market launch,effectiveness in treating migraine,economy(cost-effectiveness),and innovation,suitability,accessibility,and traditional Chinese medicine(TCM)characteristics in both its technology and clinical applications.Result:Safety:Duliang soft capsules were found to have good safety based on evidence from known adverse reactions(spontaneous reporting system(SRS)data,literature data,etc.),pre-marketing toxicological research,and post-marketing drug monitoring.Effectiveness:A meta-analysis indicated that the combination of Duliang soft capsules and western medicine was more effective than Western medicine alone in the treatment of migraine.The product's effectiveness was rated as"Best"based on the quality and value of the evidence.Economy:Duliang soft capsules are moderately priced and categorized as a Type B medical insurance product.Economic research indicated that the combination of Western medicine and Duliang soft capsules was more cost-effective than Western medicine alone.The product's economy was rated as"Better".Innovation:Duliang soft capsules,with Angelicae Dahuricae Radix and Chuanxiong Rhizoma as the main components,hold one invention patent and have been awarded the China Patent Excellence Award.The pharmaceutical company has introduced innovative extraction(CO_(2) supercritical extraction technology)and formulation(soft capsule

关 键 词：都梁软胶囊 药品临床综合评价 偏头痛 有效性 安全性 经济性 

分 类 号：R284[医药卫生—中药学] R285[医药卫生—中医学] R289R287R22R2-031R33R24