感染性疾病中的成药治疗上市后研究初探与思考.pdf

Practice and Communication Chin J Evid-based Med 2015, 15(4): 488-492 感感染性疾病中成药治疗上市后研究初探与思考染性疾病中成药治疗上市后研究初探与思考 谭婧1,2，占美3，李幼平1*，徐珽3，周旭1，李向莲1 1. 四川大学华西医院中国循证医学中心（成都 610041）；2. 成都中医药大学公共卫生学院（成都 610041）； 3. 四川大学华西医院药学部（成都 610041） 摘要 感染性疾病治疗全球以西药为主，中国中西药并用。近年来，中成药在感染性疾病治疗中的使用比例 明显上升，但目前研究难以对其分类和与同类西药对接。对感染性疾病治疗相关的 46 种中成药说明书的研究发 现，说明书科学性和规范性欠缺。另以“清开灵”和“感染”为主题词检索发现，上市后临床研究质量较低，清开灵 联合用药超过 5 成，近 7 成与西药合用。未来研究需要寻找治疗感染性疾病的优势中成药品种，并提高临床研究 方法学质量和论文报告质量，从而规范和指导中成药在感染性疾病中的合理使用。 关键词 感染性疾病；中成药；上市后研究 A Preliminary Research and Th inking on Post-marketing Studies of Proprietary Chinese Medicine for Infectious Diseases TAN Jing1,2, ZHAN Mei1, LI You-ping1*, XU Ting1, ZHOU Xu1, LI Xiang-lian1 1. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China; 2. School of Public Heath, Chengdu University of Traditional Chinese Medicine, Chengdu 610041, China; 3. Department of Pharmacy, West China Hospital, Sichuan University, Chengdu 610041, China Abstract The western medicine are main drugs in treatment of infectious diseases, but the combination of Traditional Chinese and western medicine are used in China. In recent years, proportion of proprietary Chinese medicine increased significantly in this field. However, the classification of proprietary Chinese medicine and matching with the counterparts of western medicine were difficult, and the package inserts were less scientific and normative. By searching the terms of “Qing kai ling” and “Infection”, the paper found the quality of post-marketing clinical researches was low. The use proportion of Qing kai ling combined with other drugs was more than 50%, 70% of which was western medicine. The further studies are needed to explore some proprietary Chinese medicine with obvious competitive advantage and improve the quality of methodology and reporting, in order