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Is there evidence to decrease the approved dose of 600 mg of mifepristone for medical abortion?

机译:有证据表明可以减少米非司酮用于医学流产的批准剂量600毫克吗?

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We read with interest the letter of Piaggio et al. [1] challenging the methodology used in our meta-analysis using a noninferiority approach to assess both the efficacy and safety aspects of the two-dose regimen of mifepristone for medical abortion [2]. We agree that since the introduction of mifepristone at a dosage of 600 mg (600 mg being the originally approved dosage, not 200 mg), no direct comparative studies, powered to demonstrate' the difference between dosages with regard to the end point of continuing pregnancy, have been performed. This is unfortunate because, for the women concerned and with respect to the safety of the procedure, this end point is critical. It is therefore of concern that treatment regimens may be changed without evidence that these changes will not result in more adverse outcomes. The meta-analysis was performed to use what information there is in order to assess the effect of a dose of mifepristone on the critical end point of continuing pregnancy.
机译:我们感兴趣地阅读了Piaggio等人的信。 [1]挑战我们在荟萃分析中使用的非劣效性方法来评估米非司酮用于药物流产的两剂方案的疗效和安全性[2]。我们同意,由于米非司酮的剂量为600 mg(最初批准的剂量为600 mg,而不是200 mg),因此没有直接的比较研究能够证明“剂量之间在持续妊娠终点方面的差异” ,已执行。这是不幸的,因为对于相关妇女以及手术安全而言,这一终点至关重要。因此,令人担忧的是,在没有证据表明这些改变不会导致更多不良后果的情况下,可能会改变治疗方案。进行荟萃分析以利用现有信息,以评估一定剂量的米非司酮对持续妊娠的关键终点的影响。

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