目的 对药品效果评审计划进行介绍,结合我国实际情况提出建设完善我国药物综合评价体系的思路。方法 以近年来国内外文章及药品效果评审计划官方资料为依据进行分析、整理和归纳。结果 对美国药品效果评审计划的组织结构、评价流程、影响力及特点进行了介绍,提出我国完善药物综合评价体系过程中的注意事项。结论 我国药品综合评价体系可在鼓励发展第三方评价机构、合理制定药品评价顺序以及保障评价证据质量等方面做出改进。
Abstract
OBJECTIVE To introduce Drug Effectiveness Review Project, discuss how to improve Chinese Comprehensive Evaluation of Medicine. METHODS Analysis based on official information and research articles about the Drug Effectiveness Review Project. RESULTS The paper introduces the organization, evaluation, impact and characteristic of Drug Effectiveness Review Project, presented the considerations to improve Chinese Comprehensive Evaluation of Medicine.CONCLUSION Chinese Comprehensive Evaluation of Medicine should be improved in encouraging third-party evaluation agency, developing reasonable order for drug evaluation and ensuring the quality of evidence.
关键词
药品效果评审计划 /
药品综合评价 /
药品目录决策 /
循证决策
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Key words
:drug effectiveness review project /
drugs comprehensive evaluation /
drug list decisions /
evidence-based decision-making
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中图分类号：
R951
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参考文献
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[2] Orgeon Health & Science University. Methods of DERP Systematic Reviews . .http://www.ohsu.edu/xd/research/centers-institutes/evidence-based-policy-center/derp/documents/methods.cfm.
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[7] MCDONAGH M S, JONAS D E, GARTLEHNER G, et al. Methods for the drug effectiveness review project . BMC Med Res Methodol, 2012, 12:140.
[8] VANLARE J M, WONG H H, GIBBS J, et al. Comparative effectiveness research in practice: The drug effectiveness review project experience. J Comp Eff Res, 2013, 2(6):541-550.
[9] NEUMANN P J. Emerging lessons from the Drug Effectiveness Review Project. Health Aff, 2006, 25(4):262-271.
STEINBERG E P, LUCE B R. Evidence-based Caveat emptor. Health Aff, 2005, 24(1):80-92.
Chinese Drug Evaluation Guide Project Group.Guideline for comprehensive evaluation of medicine in China. Drug Evaluation(药品评价),2011, 8(18):6-27.
TAN Z X, XU P. Establishment of comprehensive drug evaluation system in China needs to be completed and further improvement . Drug Evaluation(药品评价),2011, 8(18):4-5.
ZHU H Y. Methodology research of drug clinical ecaluation. Chin Pharm J(中国药学杂志), 2001,36(7):493-495.
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脚注
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基金
“十二五”国家科技支撑计划资助项目(2013BAI06B04Y021)
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