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首页> 外文期刊>Prescrire international >Nimesulide: patients still exposed to a risk of severe hepatitis.
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Nimesulide: patients still exposed to a risk of severe hepatitis.

机译：尼美舒利：仍暴露于严重肝炎的患者。

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Nimesulide, a nonsteroidal antiinflammatory drug (NSAID) that has been marketed in France since 1998, is neither more effective nor better tolerated than other NSAIDs. Many reports and reviews published by drug regulatory agencies in Spain, Ireland and Italy have warned of the hepatic adverse effects of nimesulide. In early 2008, 17 cases of nimesulide-induced liver damage requiring transplantation had been reported in Ireland, Italy, Spain, Finland and France. An Italian retrospective study conducted between 1997 and 2001, including about 400 000 patients exposed to NSAIDs, showed that the risk of severe liver damage was twice as high with nimesulide as with other NSAIDs. The European pharmacovigilance database shows that nimesulide is associated with more cases of severe liver damage than other NSAIDs, as well as more cases of liver damage than with cox-2 inhibitors. Young women are particularly at risk. In the vast majority of cases of liver damage, the dose of nimesulide used was that recommended in the summary of product characteristics (SPC). Liver damage occurred within 15 days after taking the first dose of nimesulide in one-third of cases. It is unacceptable that nimesulide still remains on the market in France and other countries: reports of severe liver damage continue to accumulate, and many other therapeutic options are available.
机译：尼美舒利是一种非甾体类抗炎药（NSAID），自1998年以来在法国开始销售，其抗药性和耐受性均优于其他NSAID。西班牙，爱尔兰和意大利的药品监管机构发布的许多报告和评论都警告了尼美舒利对肝脏的不良影响。在2008年初，爱尔兰，意大利，西班牙，芬兰和法国报告了17例尼美舒利引起的肝损害需要移植。在1997年至2001年之间进行的一项意大利回顾性研究中，包括约40万暴露于NSAID的患者，发现尼美舒利对严重肝损害的风险是其他NSAID的两倍。欧洲药物警戒数据库显示，与其他NSAID相比，尼美舒利与更多的严重肝损伤病例相关，并且与cox-2抑制剂相比，与肝损伤相关的病例更多。年轻妇女尤其危险。在绝大多数肝损害病例中，使用尼美舒利的剂量是产品特征摘要（SPC）中建议的剂量。三分之一的病例在服用第一剂尼美舒利后15天内发生肝损害。在法国和其他国家，尼美舒利仍然保留在市场上是不可接受的：关于严重肝损害的报道不断积累，还有许多其他治疗选择。

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