• 四川大學(xué)華西醫(yī)院,國(guó)家藥品臨床研究基地,中藥,成都,610041;

目前,我國(guó)已逐漸開(kāi)展對(duì)上市后藥物的不良反應(yīng)監(jiān)測(cè),并開(kāi)始重視其對(duì)患者生存質(zhì)量、患者死亡率等指標(biāo)的影響.已獲上市批準(zhǔn)的中藥中,有很多在不良反應(yīng)的發(fā)現(xiàn)和管理上存在時(shí)滯現(xiàn)象,且在臨床有效性和安全性方面存在一定問(wèn)題.對(duì)中藥上市后的再評(píng)價(jià),需要有效、規(guī)范的評(píng)價(jià)體系.循證藥物評(píng)價(jià)運(yùn)用循證醫(yī)學(xué)的理念,結(jié)合臨床流行病學(xué)、系統(tǒng)評(píng)價(jià)、衛(wèi)生技術(shù)評(píng)估等手段,評(píng)價(jià)新藥和上市后藥物的臨床有效性、安全性、經(jīng)濟(jì)性和適用性,對(duì)我國(guó)中藥的現(xiàn)代化與國(guó)際化進(jìn)程具有重要作用.

引用本文： 李廷謙,王剛,王蕾. 循證醫(yī)學(xué)與中藥上市后的再評(píng)價(jià). 中國(guó)循證醫(yī)學(xué)雜志, 2004, 04(4): 217-221. doi: 復(fù)制

1. ［1］Song MX. Registration and technology assessment of Chinese herb[ C]. Forum of Drug Evaluation, 2003 ;3:87-90.
2. 宋民憲.中藥注冊(cè)與技術(shù)審評(píng)[C].第二屆藥品技術(shù)審評(píng)研討會(huì)論文集(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. 李靜,李幼平,劉鳴.衛(wèi)生技術(shù)評(píng)估與循證醫(yī)學(xué)[J]華西醫(yī)學(xué),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,孫鑫.循證藥物評(píng)價(jià)[J]中國(guó)醫(yī)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. 魏文樹(shù),陳志軍,杜文霞臨床藥物治療評(píng)價(jià)與生存質(zhì)量測(cè)定[J]海峽藥學(xué),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. 李廷謙,毛兵,常靜,楊曉楠,王蕾.中西醫(yī)結(jié)合、中西醫(yī)核心雜志臨床研究論文有關(guān)臨床試驗(yàn)的評(píng)價(jià)[J].華西醫(yī)學(xué),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. 張承緒藥品上市后再評(píng)價(jià)概覽[J]中國(guó)醫(yī)藥情報(bào),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. 袁強(qiáng),劉鳴.雷米普利臨床研究證據(jù)的綜合評(píng)價(jià)[J].中國(guó)循證醫(yī)學(xué)雜志,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. 趙樹(shù)進(jìn),袁進(jìn).從PPA事件認(rèn)識(shí)上市藥品不良反應(yīng)監(jiān)測(cè)的重要性[J]中國(guó)藥房,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. 李廷謙循證醫(yī)學(xué)與中醫(yī)藥現(xiàn)代化[J].中國(guó)中醫(yī)藥信息雜志,2001;(2):91-92.
  1. 1. ［1］Song MX. Registration and technology assessment of Chinese herb[ C]. Forum of Drug Evaluation, 2003 ;3:87-90.
  2. 2. 宋民憲.中藥注冊(cè)與技術(shù)審評(píng)[C].第二屆藥品技術(shù)審評(píng)研討會(huì)論文集(上集),2003;3:87-90.
  3. 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. 4. 李靜,李幼平,劉鳴.衛(wèi)生技術(shù)評(píng)估與循證醫(yī)學(xué)[J]華西醫(yī)學(xué),2000;15(1):6-9.
  5. 5. ［3］Li YP, Sun X. Evidence-Based Drug Evaluation[J ]. Chinese Hospital, 2002 ;6 ( 11 ) :60-62.
  6. 6. 李幼平,孫鑫.循證藥物評(píng)價(jià)[J]中國(guó)醫(yī)院,2002;6(11):60-62.
  7. 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. 8. 魏文樹(shù),陳志軍,杜文霞臨床藥物治療評(píng)價(jià)與生存質(zhì)量測(cè)定[J]海峽藥學(xué),2002;14(5):119-121.
  9. 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. 10. 李廷謙,毛兵,常靜,楊曉楠,王蕾.中西醫(yī)結(jié)合、中西醫(yī)核心雜志臨床研究論文有關(guān)臨床試驗(yàn)的評(píng)價(jià)[J].華西醫(yī)學(xué),2000;15(3):266.
  11. 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. 12. ［7］Zhang CX. The general situation of evaluating to marketed drugs [J ]. Chinese Pharmaceutical Information, 2002; 8 ( 3 ):17-19.
  13. 13. 張承緒藥品上市后再評(píng)價(jià)概覽[J]中國(guó)醫(yī)藥情報(bào),2002;8(3):17-19.
  14. 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. 15. 袁強(qiáng),劉鳴.雷米普利臨床研究證據(jù)的綜合評(píng)價(jià)[J].中國(guó)循證醫(yī)學(xué)雜志,2001;1(6):285-291.
  16. 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. 17. 趙樹(shù)進(jìn),袁進(jìn).從PPA事件認(rèn)識(shí)上市藥品不良反應(yīng)監(jiān)測(cè)的重要性[J]中國(guó)藥房,2001;12(9):551-552.
  18. 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. 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. 20. 李廷謙循證醫(yī)學(xué)與中醫(yī)藥現(xiàn)代化[J].中國(guó)中醫(yī)藥信息雜志,2001;(2):91-92.