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紧急避孕中的优思明(UPA)和左炔诺孕酮(LNG):欧洲药品管理局(EMA)提供的信息及科学证据表明其主要作用为抗着床。

UPA and LNG in emergency contraception: the information by EMA and the scientific evidences indicate a prevalent anti-implantation effect.

作者信息

Mozzanega Bruno, Nardelli Giovanni Battista

机构信息

a Department SDB Woman's and Child's Health , University of Padua , Padova , Italy.

出版信息

Eur J Contracept Reprod Health Care. 2019 Feb;24(1):4-10. doi: 10.1080/13625187.2018.1555662. Epub 2019 Jan 18.

Abstract

RATIONALE AND OBJECTIVES

Emergency contraceptives pills (ECPs) are described as drugs that work by either inhibiting or delaying ovulation without affecting implantation. In our opinion, as we aim at demonstrating, both EMA documents and the experimental papers indicate that they prevalently inhibit embryo-implantation. LNG-ECPs: literature: LNG-ECPs never prevent ovulation when are taken in the most fertile days (EMA-EPAR on ellaOne p. 9, first table). Conversely, they prevent the formation of an adequate corpus luteum. When they are taken pre-ovulatory ovulations occur regularly, but pregnancies do not appear. Taken after ovulation, they seem ineffective in preventing pregnancies. UPA-ECPs: literature: EllaOne prevents ovulation only when is taken in the first fertile day. Thereafter, its anti-ovulatory effect drops sharply and becomes insignificant (8%) 36 h before ovulation, in the most fertile days (Brache); its decreasing anti-ovulatory effect cannot explain a consistently high effectiveness in preventing pregnancies (≥80%) that does not decrease depending on which of the 5 d it is taken after unprotected intercourse. Besides, ovulation occurs regularly in 91.7% of women taking ellaOne weekly, for eight consecutive weeks (EMA-CHMP-Assessment Report 'EMA/73099/2015': study HRA2914-554, p. 7). Lastly, Lira-Albarrán administered ellaOne to women in the most fertile pre-ovulatory days: they had normal ovulation, but their endometrium, evaluated through samples obtained in the implantation window, became inhospitable: the expression of 1183 genes was exactly the opposite of that observed in the receptive pro-gestational endometrium. This agrees with information by EMA-CHMP-Assessment Report 'EMEA/261787/2009' (p. 8): after UPA administration 'the proteins necessary to begin and maintain pregnancy are not synthesized'.

CONCLUSIONS

Emergency Contraceptives work prevalently by preventing embryo-implantation. People shall receive correct information.

摘要

原理与目的

紧急避孕药(ECPs)被描述为通过抑制或延迟排卵而不影响着床来发挥作用的药物。在我们看来,正如我们旨在证明的那样,欧洲药品管理局(EMA)的文件和实验论文均表明它们主要抑制胚胎着床。左炔诺孕酮紧急避孕药(LNG - ECPs):文献:当在最易受孕的日子服用时,LNG - ECPs从不阻止排卵(关于ellaOne的EMA - EPAR,第9页,第一个表格)。相反,它们会阻止形成足够的黄体。在排卵前服用时,排卵会正常发生,但不会怀孕。在排卵后服用,它们似乎无法有效预防怀孕。炔诺酮肟紧急避孕药(UPA - ECPs):文献:EllaOne仅在第一个易受孕日服用时才会阻止排卵。此后,其抗排卵作用急剧下降,在排卵前36小时、最易受孕的日子里变得微不足道(8%)(布拉谢);其抗排卵作用的降低无法解释其在预防怀孕方面始终保持高有效性(≥80%),且这种有效性不会因在无保护性交后哪5天服用而降低。此外,连续八周每周服用EllaOne的女性中,91.7%会正常排卵(EMA - CHMP评估报告“EMA/73099/2015”:研究HRA2914 - 554,第7页)。最后,利拉 - 阿尔巴兰在排卵前最易受孕的日子给女性服用EllaOne:她们排卵正常,但通过在着床窗口获取的样本评估其子宫内膜变得不利于着床:1183个基因的表达与在接受性孕激素子宫内膜中观察到的情况完全相反。这与EMA - CHMP评估报告“EMEA/261787/2009”(第8页)中的信息一致:服用UPA后“开始和维持妊娠所需的蛋白质无法合成”。

结论

紧急避孕药主要通过阻止胚胎着床发挥作用。人们应该获得正确的信息。

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