Evidence-Based Medicine and Reassessment of Post-Marketed Chinese Herbs_Chinese Journal of Evidence-Based Medicine

Authors：

LI Tingqian , WANG Gang , WANG Lei

National Center for Drug Clinical Trial （TCM）; West China Hopital; Sichuan University; Chengdu 610041; China;

Corresponding author：

Keywords：

Evidence-based drug evaluation; Chinese herbs; Post-marketed reassessment

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Assessment on adverse drug reactions (ADR) that directly affects the quality of life and mortality and an important part of the post-marketed reassessment are developing gradually in China. Many problems have been identified in clinical validity and safety for the authorized Chinese herbs. An effective and standardized system is needed in the post-marketed drug reassessment. Evidence-based drug evaluation, which mainly includes clinical epidemiology, systematic review and health technology, will be used to assess the clinical validity, safety and cost of post-marketed drug and play an important role in the process of modernization and internationalization of Chinese herbs.

Citation： LI Tingqian,WANG Gang,WANG Lei. Evidence-Based Medicine and Reassessment of Post-Marketed Chinese Herbs. Chinese Journal of Evidence-Based Medicine, 2004, 04(4): 217-221. doi: Copy

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10.	李廷谦,毛兵,常静,杨晓楠,王蕾.中西医结合、中西医核心杂志临床研究论文有关临床试验的评价[J].华西医学,2000;15(3):266.
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14.	［8］Yuan Q, Liu M. Comprehensive assessment of clinical evidence for Ramipril: an exploration of evidence-based drug assessment[J]. Chinese Journal of Evidence-Based Medicine,2001 ;1(6): 285-291.
15.	袁强,刘鸣.雷米普利临床研究证据的综合评价[J].中国循证医学杂志,2001;1(6):285-291.
16.	［9］Zhao SJ,Yuan J. Recognizing the importance of ADR monitoring of drugs available on the market from PPA event[J]. China Pharmucy, 2001; 12(9): 551-552.
17.	赵树进,袁进.从PPA事件认识上市药品不良反应监测的重要性[J]中国药房,2001;12(9):551-552.
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19.	［11］Li TQ. Evidence-based medicine and the modernization of Traditional Chinese Medicine [ J ]. Chinese Journal of Information on Traditional Chinese Medicine, 2001 ;( 2 ): 91-92.
20.	李廷谦循证医学与中医药现代化[J].中国中医药信息杂志,2001;(2):91-92.

1. ［1］Song MX. Registration and technology assessment of Chinese herb[ C]. Forum of Drug Evaluation, 2003 ;3:87-90.
2. 宋民宪.中药注册与技术审评[C].第二届药品技术审评研讨会论文集(上集),2003;3:87-90.
3. ［2］Li J, Li YP, Liu M. Health Technology Assessment and Evidence-Based Medicine [J ]. West China Medical Journal,2000;15(1 ) :6-9.
4. 李静,李幼平,刘鸣.卫生技术评估与循证医学[J]华西医学,2000;15(1):6-9.
5. ［3］Li YP, Sun X. Evidence-Based Drug Evaluation[J ]. Chinese Hospital, 2002 ;6 ( 11 ) :60-62.
6. 李幼平,孙鑫.循证药物评价[J]中国医院,2002;6(11):60-62.
7. ［4］Wei WS, Chen ZJ, Du WX. Clinical treatment evaluation of pham1acy and survival quality assessment [ J ]. Strait Pharmaceutical Journal, 2002; 14 ( 5 ): 119-121.
8. 魏文树,陈志军,杜文霞临床药物治疗评价与生存质量测定[J]海峡药学,2002;14(5):119-121.
9. ［5］Li TQ, Mao B, Chang J, Yang XL, Wang L. An Evaluation of clinical research Literatures in core Journals of Traditional Chinese Medicine Integrated with Western Medicine or Traditional Chinese Medicine [ J ]. West China Medical Journal, 2000; 15 ( 3 ) :266.
10. 李廷谦,毛兵,常静,杨晓楠,王蕾.中西医结合、中西医核心杂志临床研究论文有关临床试验的评价[J].华西医学,2000;15(3):266.
11. ［6］Weinstein MC, Stason WB. Foundations of cost-effectiveness analysis for health and medical practices[J]. N Engl J Med,1977 ;296:716-721.
12. ［7］Zhang CX. The general situation of evaluating to marketed drugs [J ]. Chinese Pharmaceutical Information, 2002; 8 ( 3 ):17-19.
13. 张承绪药品上市后再评价概览[J]中国医药情报,2002;8(3):17-19.
14. ［8］Yuan Q, Liu M. Comprehensive assessment of clinical evidence for Ramipril: an exploration of evidence-based drug assessment[J]. Chinese Journal of Evidence-Based Medicine,2001 ;1(6): 285-291.
15. 袁强,刘鸣.雷米普利临床研究证据的综合评价[J].中国循证医学杂志,2001;1(6):285-291.
16. ［9］Zhao SJ,Yuan J. Recognizing the importance of ADR monitoring of drugs available on the market from PPA event[J]. China Pharmucy, 2001; 12(9): 551-552.
17. 赵树进,袁进.从PPA事件认识上市药品不良反应监测的重要性[J]中国药房,2001;12(9):551-552.
18. ［10］Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies [ J ].JAMA, 1998; 279 ( 15 ): 1 200-1 205.
19. ［11］Li TQ. Evidence-based medicine and the modernization of Traditional Chinese Medicine [ J ]. Chinese Journal of Information on Traditional Chinese Medicine, 2001 ;( 2 ): 91-92.
20. 李廷谦循证医学与中医药现代化[J].中国中医药信息杂志,2001;(2):91-92.

Chinese Journal of Evidence-Based Medicine

Evidence-Based Medicine and Reassessment of Post-Marketed Chinese Herbs

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