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一种含有天然雌激素17β-雌二醇的新型口服避孕药的临床试验。

Clinical trial of a new oral contraceptive pill containing the natural oestrogen 17 beta-oestradiol.

作者信息

Astedt B, Jeppsson S, Liedholm P, Rannevik G, Svanberg L

出版信息

Br J Obstet Gynaecol. 1979 Sep;86(9):732-6. doi: 10.1111/j.1471-0528.1979.tb11276.x.

Abstract

The natural oestrogen, 17 beta-oestradiol, has been shown not to depress fibrinolysis and apparently has less influence on liver function and lipid metabolism than ethinyl oestradiol, the synthetic oestrogen in conventional 'combined' oral contraceptive tablets. A triple-blind study was therefore made of 215 women during 2051 treatment cycles with oral contraceptives containing either (i) 4 mg of micronized 17 beta-oestradiol and 3 mg norethisterone (Netagen 403), (ii) 4 mg 17 beta-oestradiol plus 2 mg of oestriol and 3 mg norethisterone (Netagen 423) or (iii) 50 microgram ethinyl oestradiol and 3 mg norethisterone (Netasyn). There were no pregnancies or thrombotic incidents. The numbers discontinuing treatment were about the same in the three groups, the main reasons being intermenstrual spotting in those on Netagen 423, amenorrhoea and weight gain in those on Netagen 403 and nausea and weight gain in those on Netasyn. The natural oestrogen showed promise as a new and safe component of the 'combined' pill.

摘要

天然雌激素17β - 雌二醇已被证明不会抑制纤维蛋白溶解,而且与传统“复方”口服避孕药片中的合成雌激素炔雌醇相比,对肝功能和脂质代谢的影响明显较小。因此,对215名女性进行了一项三盲研究,研究在2051个治疗周期中使用了以下三种口服避孕药:(i)4毫克微粉化17β - 雌二醇和3毫克炔诺酮(内泰净403);(ii)4毫克17β - 雌二醇加2毫克雌三醇和3毫克炔诺酮(内泰净423);或(iii)50微克炔雌醇和3毫克炔诺酮(奈塔辛)。研究期间无妊娠或血栓形成事件发生。三组中停止治疗的人数大致相同,主要原因是服用内泰净423的女性出现经间期点滴出血,服用内泰净403的女性出现闭经和体重增加,服用奈塔辛的女性出现恶心和体重增加。天然雌激素有望成为“复方”避孕药中一种新的安全成分。

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