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尽管奈西立肽从一开始就带有明显的安全问题,VMAC试验并没有显示出奈西立肽与硝酸甘油相比,在30天内对死亡和复发住院的任何优势;一项荟萃分析也显示使用奈西立肽会增加肾功能异常的发生……但这并不影响奈西立肽的销售,2005年奈西立肽的整个预计销售额为7亿美元,几乎为上一年的2倍。奈西立肽的故事反映了一些重复性的问题:在近来出现的另一些案例中也可以看到,大多数的药物安全问题在药物批准生产之后被指出。奈西立肽是基于一个简单的、以使用后3小时作为其替代终点的试验结果而被通过的。
Although nesiritide possessed significant safety issues from the outset, the VMAC trial did not show any advantage of nosinide in hospitalization for death and relapse within 30 days compared to nitroglycerin; a meta-analysis also showed The use of nesiritide increased renal dysfunction ... ... but this did not affect the sales of nisidipine, the entire estimated sales of nisinidil in 2005 was 700 million U.S. dollars, almost double the previous year . Nesiritide’s story reflects some of the repetitive issues: in other recent cases, we can see that most of the drug safety problems were pointed out after the drugs were approved for production. Nesiritide was passed on the basis of a simple test that used 3 hours after its use as an alternative endpoint.