A Preliminary Research and Thinking on Post-marketing Studies of Proprietary Chinese Medicine for Infectious Diseases_Chinese Journal of Evidence-Based Medicine

Authors：

 TANJing ^1,2 , ZHANMei ³ ,  LIYou-ping ¹ , XUTing ³ , ZHOUXu ¹ , LIXiang-lian ¹

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;

Corresponding author：

LIYou-ping, Email: yzmylab@hotmail.com

Keywords：

Infectious diseases; Proprietary Chinese medicine; Post-marketing clinical researches

DOI：

10.7507/1672-2531.20150081

Video：

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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 to standardize and guide the rational use of proprietary Chinese medicine in infectious diseases.

Citation： TANJing, ZHANMei, LIYou-ping, XUTing, ZHOUXu, LIXiang-lian. A Preliminary Research and Thinking on Post-marketing Studies of Proprietary Chinese Medicine for Infectious Diseases. Chinese Journal of Evidence-Based Medicine, 2015, 15(4): 488-492. doi: 10.7507/1672-2531.20150081 Copy

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1. 王宇明, 主编. 感染病学. 第2版. 人民卫生出版社, 2010.
2. 王镓, 董竞成. 浅析中医药防治呼吸道病毒感染的概况. 中华中医药杂志, 2014, 29(1):17-21.
3. 姜林嵩, 刘青. 试论中药抗感染的优势. 甘肃科技纵横, 2008, 37(2):175.
4. 王秀莲. 中医药治疗感染病的优势与思路. 天津中医药大学学报, 2007, 26(3):116-117.
5. 国家食品药物监督管理总局网站. 关于加强零售药店抗菌药物销售监管促进合理用药的通知. Available at:http://www.sda.gov.cn/WS01/CL0055/10126.html.
6. 薛文翰. 临床正确使用中成药. 甘肃医药, 2010, 29(3):276.
7. 吕爱平, 王丽颖. 加强中成药合理使用的建议. 中国中药杂志, 2011, 36(20):2762-2763.
8. WHO. About the Global Burden of Disease (GBD) project. Available at:http://www.who.int/healthinfo/global_burden_disease/about/en.
9. IHME(Institute for Health Metrics and Evaluation)网站. GBD Compare. Available at:http://www.healthdata.org/data-visualization/gbd-compare.
10. 陈新谦, 金有豫, 汤光. 新编药物学. 第17版. 北京:人民卫生出版社, 2011.
11. WHO. WHO Model Lists of Essential Medicines. Available at:http://www.who.int/medicines/publications/essentialmedicines/en/.
12. 中华人民共和国国家卫生和计划生育委员会网站. 《国家基本药物目录》(2012年版)(卫生部令第93号. Available at:http://www.moh.gov.cn/mohywzc/s3580/201303/f01fcc9623284509953620abc2ab189e.shtml.
13. 张伯礼, 主编. 《循证用药手册——中成药分册》. 北京, 人民卫生出版社, In Press.
14. 张文宏, 翁心华. 中国感染性疾病防治进展10年回顾与展望. 中华内科杂志, 2013, 52(2):118-120.
15. 杜月英, 丛丽. 对中西医的抗感染概念的再认识-由中西医对感染性疾病的差异性比较引发. 成都中医药大学学报, 2006, 29(4):55-56.
16. 国家食品药品监督管理总局(SFDA)网站. 药品上市后为何还会修改药品说明书?Available at:http://www.sfda.gov.cn/WS01/CL0748/51357.html.
17. 魏戌, 谢雁鸣. 中药注射剂不良反应的影响因素与发生机制分析. 中国中药杂志, 2012, 37(18):2748-2750.
18. 林明宝. 中药引发过敏反应的危险因素及中成药致敏成分研究. 浙江大学博士学位论文, 2013.

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