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上市后药物经济学评价方法(Ⅰ)--建立经济学评价框架,评价经济学证据
引用本文:孙鑫,Ewa Orlewska,李幼平,杨焕,鄢琳.上市后药物经济学评价方法(Ⅰ)--建立经济学评价框架,评价经济学证据[J].中国循证医学杂志,2005,5(12):944-949.
作者姓名:孙鑫  Ewa Orlewska  李幼平  杨焕  鄢琳
作者单位:1. 四川大学华西医院循证医学与临床流行病学教研室中心,成都,610041
2. 波兰华沙药物经济学中心
3. 国家食品与药品监督管理局药物审评中心
4. 国家食品与药品监督管理局药品再评价中心,北京,100061
摘    要:药品是中国重要的卫生资源.尽管上市前药品研究已受到相当重视,但对上市后药品的实际问题关注较少.合理使用和分配上市后药品资源是中国的决策者面临的主要问题之一.经济学评价作为优化分配和使用药品的有效工具现已得到公认.本文介绍了上市后药物的经济学评价方法与原则.上市后药物的经济学评价根据证据的有效性和数量分为三种情况,并相应地采取不同的研究方法.但上市后药物经济学评价方法应采取标准路径.此外,本文还介绍了建立经济学评价框架和评价经济学证据的方法,特别是针对同类药物的评价方法.

关 键 词:经济学评价  成本-效果  药物评价  循证医学
文章编号:1672-2531(2005)12-0944-06
收稿时间:08 22 2005 12:00AM
修稿时间:2005年8月22日

An Introduction to Methods for Economic Evaluation of Marketed Medicines I: Setting up an Economic Framework and Reviewing Existing Evidence
SUN Xin,Ewa Orlewska,LI You-ping,YANG Huan,YAN Lin.An Introduction to Methods for Economic Evaluation of Marketed Medicines I: Setting up an Economic Framework and Reviewing Existing Evidence[J].Chinese Journal of Evidence-based Medicine,2005,5(12):944-949.
Authors:SUN Xin  Ewa Orlewska  LI You-ping  YANG Huan  YAN Lin
Institution:1. Chinese Ecidence-Based Medcine and Clinical Epedimiology Ceotre, West China Hospital, Sichuan University, Chengdu 610041 , China ; 2. Centre for Pharmacoeconomics, Warsaw, Poland ; 3. Center for Drug Evaluation State Food and Drug Administration, Beijing 100061 , China; 4. Center for Dntg Reevoluation , State Food and Drug Administration , Beijing 100061 , China
Abstract:Medichie is a very important health resource in Chins Although numerous efforts are paid to pre-marketed medicines, little is done to address practical problems in marketed medicines. The rational use and allocation of marketed medicines remain a major concern for decision-makers in China. It has been recognized that economic evaluation is an efficient tool for priotiting the choice, and optimizing the use of medicines. This paper has explored the methods and principles for conducting econonfic evaluathm of marketed medicines Different strategies will be adopted for economic evidence for marketed medicines in terms of adequacy and suficiency. However, a standard study pathway should be applied in economic evaluanon of marketed medicines. Besides, the aspects for developing economic framework and the methods for reviewing existing economic evidence are also introduced in this paper, particularly, for marketed medicines within the same therapeutic group.
Keywords:Economic evaluation  Cost-benefit  Drug evaluation  Evidence-based medicine
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