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Drug-induced liver disease

机译:药物性肝病

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Although the year 2001 did not see any prescription drugs withdrawn because of drug-induced liver disease, the US Food and Drug Administration requested that dietary supplements containing comfrey be taken off the market because of the danger of hepatic injury. The'Food and Drug Administration remains very involved in the process by which drug-induced liver disease can be detected early in drug development and in the determination of how best to prevent hepatotoxicity after drug approval. A workshop on drug-induced liver disease cosponsored by the Food and Drug Administration, the Pharmaceutical Research and Manufacturers Association, and the American Association for the Study of Liver Diseases was held in Washington, DC, in February 2001, and the resulting white paper outlined several areas for research. A number of agents were newly described as causing various forms of liver injury, and several others had drug-induced liver disease confirmed by additional reports. Several investigators dealt with the difficulties inherent in establishing causality of drug-induced liver disease and the ?potential negative consequences of wrongly attributing hepatotoxicity to a particular agent. In one recent series, more than half the instances of alleged drug-induced liver disease were found to have other causes, often leading to a delay in the actual diagnosis and appropriate management. Case reportsln particular were often misleading. Although several drug assessment scales have been developed, none appears to be foolproof.
机译:尽管2001年没有发现由于药物引起的肝病而撤回任何处方药,但美国食品和药物管理局(FDA)要求将含有紫菜的膳食补充剂从市场上撤出,因为这有引起肝损伤的危险。美国食品和药物管理局仍然非常参与在药物开发过程中及早发现药物引起的肝病的过程中,以及在确定药物批准后如何最好地预防肝毒性的过程中。由食品和药物管理局,药物研究与制造商协会和美国肝病研究协会联合主办的关于药物性肝病的研讨会于2001年2月在华盛顿特区举行,会议概述了白皮书几个研究领域。新近描述了许多药物引起各种形式的肝损伤,另外一些报告证实了其他药物引起药物性肝病。一些研究人员处理了在确定药物性肝病的因果关系方面固有的困难,以及错误地将肝毒性归因于特定药物的潜在负面后果。在最近的一系列研究中,发现超过一半的所谓药物诱发的肝病是由其他原因引起的,通常导致实际诊断和适当治疗的延迟。特别是案例报告常常会产生误导。尽管已经开发了几种药物评估量表,但似乎没有万无一失。

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