Esmya与PEARL研究：综述
Esmya and the PEARL studies: A review.
作者信息
Powell Martin, Dutta Deborata
机构信息
1 CircleNottingham, Nottingham NHS Treatment Centre, Nottingham, UK.
2 Nottingham University Hospitals, Nottingham, UK.
出版信息
Womens Health (Lond). 2016 Nov;12(6):544-548. doi: 10.1177/1745505717692591. Epub 2017 Feb 13.
Abstract
Ulipristal acetate was investigated in four phase 3 trials. In PEARL I, ulipristal produced significant normalisation of blood loss within 1 week and decreased fibroid volume. In PEARL II, ulipristal produced faster and more consistent control of bleeding than leuprorelin acetate and had a more favourable side-effect profile. Ulipristal-induced decreases in fibroid volume persisted for 6 months, whereas fibroids regrew after leuprorelin was stopped. PEARL III showed that ulipristal was effective during long-term treatment, with norethisterone further reducing the magnitude of bleeding in the off-treatment period. PEARL IV investigated ulipristal over four cycles, finding little difference between 5 and 10 mg ulipristal, further changes in menstruation and fibroid volume with repeat courses, and no increase in side effects.
摘要
醋酸乌利司他在四项3期试验中接受了研究。在PEARL I试验中，醋酸乌利司他在1周内使失血显著正常化，并减小了肌瘤体积。在PEARL II试验中，醋酸乌利司他比醋酸亮丙瑞林能更快、更持续地控制出血，且副作用更小。醋酸乌利司他引起的肌瘤体积减小持续了6个月，而醋酸亮丙瑞林停药后肌瘤又重新生长。PEARL III试验表明，醋酸乌利司他在长期治疗中有效，炔诺酮在停药期进一步减少了出血程度。PEARL IV试验对醋酸乌利司他进行了四个周期的研究，发现5毫克和10毫克醋酸乌利司他之间差异不大，重复疗程后月经和肌瘤体积有进一步变化，且副作用没有增加。
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