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国内外利巴韦林药品信息比较 被引量:12

A systematic review of drug information of ribavirin
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摘要 利巴韦林可导致溶血性贫血,存在明显的致畸和致突变作用,并可能存在一定的致癌作用。由于其潜在的巨大风险,有必要规范利巴韦林药品的应用。本研究对国内外利巴韦林药品信息进行详细的比较,发现国外利巴韦林剂型较少,适应证较窄,且有各种详尽不一的药品信息。而我国则作为广谱的抗病毒药物,制成各种剂型并广泛的应用,但药品信息较少,药品说明书简略。药品的毒性作用、禁忌证、不良反应、投药与剂量等方面也都存在显著的差异。建议管理部门及时完善修订药品说明书等,以保障公众用药安全有效。 The primary toxicity of ribavirin was hemolytic anemia.Although the current study were not adequate to fully characterize the carcinogenic potential of ribavirin,significant teratogenic and mutagenic effects had been demonstrated when exposed to ribavirin.Considering the great potential harm of using ribavirin,definite criterion must be taken to restrict its application.This study compared the related product information and specification of ribavirin between home and abroad.There were great differences on indication and usage,toxicity,contraindications,adverse effects,dosage,etc.It's suggested that relevant department emend drug specification in time to guarantee public's safety when using ribavirin.
出处 《中国药物应用与监测》 CAS 2006年第4期48-51,共4页 Chinese Journal of Drug Application and Monitoring
关键词 利巴韦林 药品信息 Ribavirin Drug information
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参考文献4

  • 1[1]Schering Corporation.Rebetol capsule product information[EB/OL].http://www.fda.gov/medwatch/SAFETY/2003/03Jul_PI/Rebetol_PI.pdf.2003-10-21.
  • 2[2]CHMP.Rebetol summary of product characteristics[EB/OL].http://www.emea.eu.int/humandocs/PDFs/EPAR/Rebetol/H -246 -PI -EN.pdf,2004-11-25.
  • 3[3]Roche Laboratories Inc.Copegus tablets product information[EB/OL],http://www.fdagov/medwatch/SAFETY/2005/Feb_PI/Copegus_PI.pdf,2005-4-25.
  • 4[4]CPMP.Cotronak capsule summary of product characteristics[EB/OL].http://www.emea.eu.int/humandocs/PDFs/EPAR/Cotronak/104699EN4.pdf,2001-04-23.

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