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两种含炔雌醇与去氧孕烯或孕二烯酮的单相口服避孕药的疗效与可接受性。

Efficacy and acceptability of two monophasic oral contraceptives containing ethinylestradiol and either desogestrel or gestodene.

作者信息

Halbe H W, de Melo N R, Bahamondes L, Petracco A, Lemgruber M, de Andrade R P, da Cunha D C, Guazelli C A, Baracat E C

机构信息

Department of Gynecology and Obstetrics of São Paulo University, Hospital das Clínicas, Brazil.

出版信息

Eur J Contracept Reprod Health Care. 1998 Sep;3(3):113-20. doi: 10.3109/13625189809051413.

Abstract

OBJECTIVE

To assess the contraceptive efficacy, cycle control and acceptability of two monophasic oral contraceptives containing either 30 micrograms ethinylestradiol plus 150 micrograms desogestrel or 30 micrograms ethinylestradiol plus 75 micrograms gestodene.

METHODS

In a randomized, open-label, six-cycle, group-comparative, multicenter study performed in Brazil, pregnancies, cycle-control parameters, incidence of side-effects and the presence and severity of acne vulgaris were assessed, and blood pressure and body weight were measured at pretreatment and after one, three and six cycles of oral contraceptive use.

RESULTS

Of the 595 women enrolled, 274 (86.7%) in the desogestrel/ethinylestradiol group and 227 (81.4%) in the gestodene/ethinylestradiol group completed the six cycles, providing data for 1753 and 1487 treatment cycles, respectively. Two pregnancies occurred, one of which (in the desogestrel/ethinylestradiol group) was attributed to user failure, whilst the other (in the gestodene/ethinylestradiol group) was thought to result from method failure. Cycle control was observed to be excellent; the incidences of irregular bleeding and minor side-effects were low in both groups and decreased after an initial increase in the first cycle. Pre-existing acne improved in both groups, whereas blood pressure and body weight remained essentially unchanged.

CONCLUSIONS

Both desogestrel/ethinylestradiol and gestodene/ethinylestradiol provide effective oral contraception with comparable cycle control and acceptability.

摘要

目的

评估两种单相口服避孕药的避孕效果、月经周期控制情况及可接受性,这两种避孕药分别含有30微克炔雌醇加150微克去氧孕烯或30微克炔雌醇加75微克孕二烯酮。

方法

在巴西进行的一项随机、开放标签、为期六个周期的组间比较多中心研究中,评估了妊娠情况、月经周期控制参数、副作用发生率以及寻常痤疮的存在情况和严重程度,并在口服避孕药使用前及使用1个、3个和6个周期后测量了血压和体重。

结果

在纳入的595名女性中,去氧孕烯/炔雌醇组有274名(86.7%)、孕二烯酮/炔雌醇组有227名(81.4%)完成了六个周期,分别提供了1753个和1487个治疗周期的数据。发生了两例妊娠,其中一例(在去氧孕烯/炔雌醇组)归因于使用者未遵守规定,而另一例(在孕二烯酮/炔雌醇组)被认为是方法失败导致。观察到月经周期控制良好;两组不规则出血和轻微副作用的发生率均较低,且在第一个周期最初有所增加后有所下降。两组中既往存在的痤疮均有所改善,而血压和体重基本保持不变。

结论

去氧孕烯/炔雌醇和孕二烯酮/炔雌醇均能提供有效的口服避孕效果,在月经周期控制和可接受性方面相当。

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