• 首都醫(yī)科大學(xué)北京同仁醫(yī)院心血管中心,北京,100073;

本文通過回顧羅非昔布導(dǎo)致心腦血管疾病發(fā)生率增加而被召回這一事件,提出現(xiàn)有上市后藥物安全性監(jiān)測的問題和對策.

引用本文： 胡大一,楊進(jìn)剛. 應(yīng)重視上市后藥物安全性的循證醫(yī)學(xué)再評價(jià)--羅非昔布召回的意義. 中國循證醫(yī)學(xué)雜志, 2005, 05(2): 94-96. doi: 復(fù)制

版權(quán)信息： ?四川大學(xué)華西醫(yī)院華西期刊社《中國循證醫(yī)學(xué)雜志》版權(quán)所有，未經(jīng)授權(quán)不得轉(zhuǎn)載、改編

1. Hunt RH, Bowen B, Mortensen ER, Simon TJ, James C, Cagliola A, Quan H, Bolognese JA.A randomized trial measuring fecal blood loss after treatment with refecoxib, ibuprofen, or placebo in healthy subjects[J]. Am J Med, 2000;109(3): 201-206.
2. Department of Health and Ageing. Consumer level recall of arthritis drug[R]. Available from URL: http://www.tga.gov.au/media/2004/040930_vioxx.htm, 2004;10.
3. Mamdani M, Rochon PA, Juurlink DN, Kopp A, Anderson GM, Naglie G, Peter C Austin, Andreas Laupacis. Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs[J]. BMJ, 2002;325(7 365): 624.
4. Topol EJ. Failing the public health-Refecoxib, Merck, and the FDA[J]. New Eng J Med, 2004;1 466(351): 1 707-1 709.
5. Khan KN, Paulson SK, Verburg KM, Lefkowith JB, Maziasz TJ. Pharmacology of Cyclooxygenase-2 inhibition in the kidney[J]. Kidney Int, 2002;61(4): 1 210-1 219.
6. Layton D, Riley J, Wilton LV, Shakir SA. Safety profile of refecoxib as used in general practice in England: results of a prescription-event monitoring study[J]. Br J Clin Pharmacol, 2003;55(23): 166-174.
7. Fendrick AM, Garabedian-Ruffalo SM. A clinician’s guide to the selection of NSAID therapy[J]. P & T, 2002;53(27): 579- 582.
8. Cox ER, Frisse M, Behm A, Fairman KA. Over-the-counter pain reliever and aspirin use within a sample of long-term cyclooxygenase-2 users[J]. Arch Intern Med, 2004;456(164): 1 243- 1 246.
9. Chan FK, Hung LC, Suen BY. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis[J]. N Engl J Med, 2002;847(347): 2 104- 2 110.
10. Bjordal JM, Ljunggren AE, Klovning A, Slordal L. Non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomized placebo controlled trials[J]. BMJ, 2004;329(7 478): 1 317.
11. Dieppe P, Bartlett C ,Davey P, Doyal L, Ebrahim S. Balancing benefits and harms: the example of non-steroidal anti-inflammatory drugs[J]. BMJ, 2004;2 562(329): 31-34.
  1. 1. Hunt RH, Bowen B, Mortensen ER, Simon TJ, James C, Cagliola A, Quan H, Bolognese JA.A randomized trial measuring fecal blood loss after treatment with refecoxib, ibuprofen, or placebo in healthy subjects[J]. Am J Med, 2000;109(3): 201-206.
  2. 2. Department of Health and Ageing. Consumer level recall of arthritis drug[R]. Available from URL: http://www.tga.gov.au/media/2004/040930_vioxx.htm, 2004;10.
  3. 3. Mamdani M, Rochon PA, Juurlink DN, Kopp A, Anderson GM, Naglie G, Peter C Austin, Andreas Laupacis. Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs[J]. BMJ, 2002;325(7 365): 624.
  4. 4. Topol EJ. Failing the public health-Refecoxib, Merck, and the FDA[J]. New Eng J Med, 2004;1 466(351): 1 707-1 709.
  5. 5. Khan KN, Paulson SK, Verburg KM, Lefkowith JB, Maziasz TJ. Pharmacology of Cyclooxygenase-2 inhibition in the kidney[J]. Kidney Int, 2002;61(4): 1 210-1 219.
  6. 6. Layton D, Riley J, Wilton LV, Shakir SA. Safety profile of refecoxib as used in general practice in England: results of a prescription-event monitoring study[J]. Br J Clin Pharmacol, 2003;55(23): 166-174.
  7. 7. Fendrick AM, Garabedian-Ruffalo SM. A clinician’s guide to the selection of NSAID therapy[J]. P & T, 2002;53(27): 579- 582.
  8. 8. Cox ER, Frisse M, Behm A, Fairman KA. Over-the-counter pain reliever and aspirin use within a sample of long-term cyclooxygenase-2 users[J]. Arch Intern Med, 2004;456(164): 1 243- 1 246.
  9. 9. Chan FK, Hung LC, Suen BY. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis[J]. N Engl J Med, 2002;847(347): 2 104- 2 110.
  10. 10. Bjordal JM, Ljunggren AE, Klovning A, Slordal L. Non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomized placebo controlled trials[J]. BMJ, 2004;329(7 478): 1 317.
  11. 11. Dieppe P, Bartlett C ,Davey P, Doyal L, Ebrahim S. Balancing benefits and harms: the example of non-steroidal anti-inflammatory drugs[J]. BMJ, 2004;2 562(329): 31-34.