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目的:了解和评价特非那丁不良反应的药物流行病学研究情况,探讨其在我国的应用前景.方法;统计北京地区十家医院1995~1998年特非那丁的销售情况,并通过MEDLINE和CBMEISC对国际国内1983一1997年特非那丁的药物流行病学情况进行了调查和文献分析.结果:美国 FDA之所以于 1997年1月14日做出建议特非那丁从市场上撤消的决定,是因为出现了替代产品非索那丁,如果按说明书应用,特非那丁严重不良反应的发生率并不高于其它抗组胺药.结论:如果修改说明书,现阶段特非那丁在我国使用的益处将超出其危害.
OBJECTIVE: To understand and evaluate the drug epidemiological study of adverse reactions of terfenadine and to explore its application prospects in our country.METHODS: The statistics of the sales of terfenadine in 10 hospitals in Beijing from 1995 to 1998 were analyzed and compared by MEDLINE And CBMEISC conducted surveys and literature analyzes of the pharmacoepidemiology of terfenadine in the international and domestic markets 1983-1997.RESULTS: The US FDA reasoned on January 14, 1997 that terfenadine was withdrawn from the market Of the decision is due to the emergence of a replacement product fexofenadine, if the application according to the instructions, the incidence of terfenadine serious adverse reactions is not higher than other antihistamines.Conclusion: If you modify the instructions, at this stage Tefina The benefits of using D in our country will outweigh its harmful effects.