环氧化酶-2抑制剂：是一流药物还是仅仅被大力推广。
COX-2 inhibitors: a CLASS act or Just VIGORously promoted.
作者信息
Malhotra Samir, Shafiq N, Pandhi P
机构信息
Department of Pharmacology, Postgraduate Institute of Medical, Education & Research, Chandigarh, India.
出版信息
MedGenMed. 2004 Mar 23;6(1):6.
Abstract Selective cyclo-oxygenase (COX)-2 inhibitors were developed with the hope of producing lesser gastrointestinal (GI) side effects as compared with the conventional nonsteroidal anti-inflammatory drugs (NSAIDs). Soon after their introduction into the market, the sales of celecoxib and rofecoxib went up considerably. Most of this was attributed to the results of the Celecoxib Long-term Arthritis Safety Study (CLASS) and Vioxx Gastrointestinal Outcome Research (VIGOR) trials. However, several discrepancies were noted in the presentation of the actual trial results submitted to the US Food and Drug Administration (FDA) and those used for the purpose of publication in scientific journals. These issues were discussed subsequently by the way of scientific communications. Moreover, with increasing use of these agents, evidence of their adverse effects is coming to light. The present review aims at discussing the above issues, with emphasis on the results of the CLASS and VIGOR trials.
摘要 选择性环氧化酶（COX）-2抑制剂的研发旨在产生比传统非甾体抗炎药（NSAIDs）更少的胃肠道（GI）副作用。在它们上市后不久，塞来昔布和罗非昔布的销量大幅上升。这主要归因于塞来昔布长期关节炎安全性研究（CLASS）和万络胃肠道结果研究（VIGOR）试验的结果。然而，提交给美国食品药品监督管理局（FDA）的实际试验结果与用于在科学期刊上发表的结果之间存在一些差异。随后通过科学交流的方式对这些问题进行了讨论。此外，随着这些药物的使用增加，它们的不良反应证据也逐渐显现。本综述旨在讨论上述问题，重点是CLASS和VIGOR试验的结果。
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