Margins

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Margins

机译：保证金

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Far too many marketing authorisations are based on non-inferiority trials. Two concrete examples are featured in this issue: the oral anticoagulant rivaroxaban in patients with atrial fibrillation (see page 257) and the antiretroviral rilpivirine as first-line therapy for HIV infection (see page 262).To conclude that a new drug is "non-inferior" for the primary endpoint, the trial protocol must prespecify the maximum acceptable loss of efficacy with the new drug compared to the standard treatment.But the selection of the non-inferiority margin varies widely between trials: 46% and 12%, respectively, in the examples reported in this issue.

机译：太多的营销授权是基于非自卑性试验的。本期有两个具体的例子：房颤患者口服抗凝剂利伐沙班（参见第257页）和抗逆转录病毒利必韦林作为HIV感染的一线疗法（参见第262页）。 -“次等”作为主要终点，试验方案必须预先规定与标准治疗相比新药的最大可接受的疗效损失。但是，试验之间非劣效性的选择差异很大：分别为46％和12％，在本期报道的示例中。

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《Prescrire international》 |2012年第132期|共1页
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