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两种现代单相口服避孕药制剂可接受性的比较研究:30微克炔雌醇与150微克去氧孕烯或75微克孕二烯酮联合使用。

Comparative study on the acceptability of two modern monophasic oral contraceptive preparations: 30 microgram ethinyl estradiol combined with 150 microgram desogestrel or 75 microgram gestodene.

作者信息

Zichella L, Sbrignadello C, Tomassini A, Di Lieto A, Montoneri C, Zarbo G, Mancone M, Pietrobattista P, Bertoli G, Perrone G

机构信息

Clinica Ostetrica e Ginecologia, Universita degli Studi, La Sapienza, Roma, Italy.

出版信息

Adv Contracept. 1999;15(3):191-200. doi: 10.1023/a:1006745315344.

DOI:10.1023/a:1006745315344
PMID:11019950
Abstract

Cycle control and tolerability of two monophasic oral contraceptive pills containing 30 microg ethinyl estradiol (EE) with either 150 microg desogestrel (DSG) or 75 microg gestodene (GSD) were compared in women starting oral contraception. A minimum of 200 healthy women at risk for pregnancy were to be treated for a total of 6 cycles per patient in a prospective, randomized open parallel-group multicenter trial. Two hundred and forty-one subjects were randomized, 115 to DSG/EE and 126 to GSD/EE. Compliance to the study preparation was high (around 95%) in both groups and no pregnancies occurred during the study. Cycle control was excellent; there were no differences between the two groups with regard to incidence of spotting and breakthrough bleeding or duration and intensity of withdrawal bleeding. Side-effects were mild and in general comparable in the two groups. Both at baseline and during treatment, a higher proportion of women taking GSD/EE complained about breast tenderness. This resulted in more early withdrawals because of breast tenderness in the GSD/EE group. It was concluded that monophasic DSG/EE and GSD/EE are equally effective, have similar cycle control and both are generally well tolerated.

摘要

在开始口服避孕药的女性中,比较了两种含30微克炔雌醇(EE)与150微克去氧孕烯(DSG)或75微克孕二烯酮(GSD)的单相口服避孕药的周期控制和耐受性。在一项前瞻性、随机开放平行组多中心试验中,至少200名有怀孕风险的健康女性将接受治疗,每位患者总共治疗6个周期。241名受试者被随机分组,115名接受DSG/EE治疗,126名接受GSD/EE治疗。两组对研究制剂的依从性都很高(约95%),研究期间未发生妊娠。周期控制良好;两组在点滴出血和突破性出血的发生率、撤退性出血的持续时间和强度方面没有差异。副作用轻微,两组总体相当。在基线期和治疗期间,服用GSD/EE的女性中抱怨乳房压痛的比例更高。这导致GSD/EE组因乳房压痛而提前退出的人数更多。得出的结论是,单相DSG/EE和GSD/EE同样有效,具有相似的周期控制,并且总体耐受性良好。

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