白芍总苷胶囊治疗类风湿关节炎的临床综合评价  

Comprehensive Clinical Evaluation of Total Glucosides of White Paeony Capsules in the Treatment of Rheumatoid Arthritis

作　　者：黄正明 栗占国[2] 赵岩[3] 伍沪生[4] 刘燕鹰 杨新波 洪舟 HUANG Zhengming;LI Zhanguo;ZHAO Yan;WU Husheng;LIU Yanying;YANG Xinbo;HONG Zhou(Chinese Medical Education Association,CMEA,Beijing 100071,China;Peking University People′s Hospital,Beijing 100044,China;Peking Union Medical College Hospital,Beijing 100730,China;Beijing Jishuitan Hospital,Beijing 102208,China;Beijing Friendship Hospital,Beijing 100050,China;Ningbo Natural Plant Extract Association,Zhejiang Ningbo 315101,China)

机构地区：[1]中国医药教育协会,北京100071 [2]北京大学人民医院,北京100044 [3]北京协和医院,北京100730 [4]北京积水潭医院,北京102208 [5]北京友谊医院,北京100050 [6]宁波天然植物提取协会,浙江宁波315101

出　　处：《中国药物评价》2025年第1期6-10,共5页Chinese Journal of Drug Evaluation

摘　　要：目的:评价白芍总苷胶囊治疗类风湿关节炎的临床综合价值,从而为临床用药给予更优的选择。方法:按照《关于开展药品使用监测和临床综合评价工作的通知》,对白芍总苷胶囊安全性、有效性、经济性、创新性、适宜性以及可及性进行临床综合评价。结果:安全性评价:白芍总苷胶囊临床使用中不良反应轻微,安全性良好;有效性评价:白芍总苷胶囊治疗类风湿关节炎的疗效显著,临床有效率与羟氯喹比较具有优势;经济学研究显示,白芍总苷胶囊与羟氯喹相比成本更低,可作为优势方案;白芍总苷胶囊在知识产权创新和临床创新等方面证据充足,且作为医保目录品种,临床可及性和可获得性优势明显。结论:白芍总苷胶囊在治疗类风湿关节炎疾病方面展现出良好的临床应用价值。Objective:To evaluate the clinical comprehensive value of Total Glucosides of White Paeony Capsules in the treatment of rheumatoid arthritis,thus providing more optimal guidance for clinical drug use.Methods:According to the“Notice on Launching the Work of Drug Use Monitoring and Clinical Comprehensive Evaluation”,the safety,effectiveness,economy,innovation,suitability,and accessibility of Total Glucosides of White Paeony Capsules were evaluated clinically comprehensively.Results:The safety evaluation showed that the adverse reactions of Total Glucosides of White Paeony Capsules were mild in clinical use,and the safety was good.The pharmacodynamic study showed that the efficacy of Total Glucosides of White Paeony Capsules in the treatment of rheumatoid arthritis was significant,and the clinical effective rate was superior to that of hydroxychloroquine.The economic study showed that Total Glucosides of White Paeony Capsules was cheaper than hydroxychloroquine,and could be considered as an advantageous scheme.There was sufficient evidence of intellectual property innovation and clinical innovation in Total Glucosides of White Paeony Capsules,and it was a drug covered by the national basic medical insurance system,with obvious advantages in clinical accessibility and availability.Conclusion:Total Glucosides of White Paeony Capsules has shown good clinical application value in the treatment of rheumatoid arthritis.

关 键 词：白芍总苷胶囊 类风湿关节炎 安全性 有效性 临床综合评价 

分 类 号：R976[医药卫生—药品] R593.2[医药卫生—药学]