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将激素避孕药换用含醋酸氯地孕酮的口服避孕药。避孕转换研究。

Switching hormonal contraceptives to a chlormadinone acetate-containing oral contraceptive. The Contraceptive Switch Study.

作者信息

Schramm Georg, Heckes Birgit

机构信息

Grünenthal GmbH, Medical Department, 52099 Aachen, Germany.

出版信息

Contraception. 2007 Aug;76(2):84-90. doi: 10.1016/j.contraception.2007.03.014. Epub 2007 Jun 11.

DOI:10.1016/j.contraception.2007.03.014
PMID:17656175
Abstract

PURPOSE

This prospective observational noninterventional study aimed at collecting information on changes in cycle control, dysmenorrhea, androgen-related skin conditions and tolerability in a large cohort of women who switched their oral contraceptive (OC) to 2.0 mg chlormadinone acetate (CMA)/0.03 mg ethinylestradiol (EE) (Belara).

MATERIALS AND METHODS

In a total of 20,897 women who were enrolled in a four-cycle clinical evaluation at 1597 gynecological practices throughout Germany, there are 16,781 women who switched from another contraceptive.

RESULTS

The most frequently mentioned complaint for switching contraceptive was seborrhea/acne (6933/16,781 women; 41.3%). This was followed by cycle irregularities (18.8%), headache (15.9%), breast tension (15.1%), amenorrhea (14.9%), spotting (12.8%) and dysmenorrhea (11.7%). After switching to CMA/EE treatment, these symptoms decreased substantially or even disappeared in a large number of women. The vast majority of study participants scored both tolerability and well-being on CMA/EE intake as 'very good' or 'good'. The results revealed that 13,508 women (80.5%) stated being more satisfied or even much more satisfied on CMA/EE intake compared to their previously used contraceptive; most of them had taken progestins of the nortestosterone type. CMA/EE produced beneficial effects on skin conditions and well-being in OC switchers who experienced dissatisfaction with their previous contraceptive regimen.

CONCLUSION

The results of this observational study support that 2.0 mg CMA/0.03 mg EE is well tolerated, provides a reliable cycle stability and is very effective in diminishing dysmenorrhea and other cycle-related complaints. Women suffering from problems on hormonal contraception received benefit from switching to the progesterone derivative CMA-containing OC.

摘要

目的

这项前瞻性观察性非干预研究旨在收集大量将口服避孕药(OC)换成2.0毫克醋酸氯地孕酮(CMA)/0.03毫克炔雌醇(EE)(贝乐瑞)的女性在月经周期控制、痛经、雄激素相关皮肤问题和耐受性方面变化的信息。

材料与方法

在德国各地1597家妇科诊所参加为期四个周期临床评估的总共20897名女性中,有16781名女性从其他避孕药具转换而来。

结果

转换避孕药具时最常提到的抱怨是脂溢性皮炎/痤疮(6933/16781名女性;41.3%)。其次是月经周期不规律(18.8%)、头痛(15.9%)、乳房胀痛(15.1%)、闭经(14.9%)、点滴出血(12.8%)和痛经(11.7%)。换成CMA/EE治疗后,这些症状在大量女性中大幅减轻甚至消失。绝大多数研究参与者对服用CMA/EE的耐受性和舒适度评价为“非常好”或“好”。结果显示,13508名女性(80.5%)表示与之前使用的避孕药相比,对服用CMA/EE更满意甚至非常满意;其中大多数人之前服用的是诺睾酮类孕激素。CMA/EE对之前对避孕方案不满意的OC转换者的皮肤状况和舒适度产生了有益影响。

结论

这项观察性研究的结果支持2.0毫克CMA/0.03毫克EE耐受性良好,能提供可靠的月经周期稳定性,在减轻痛经和其他与月经周期相关的不适方面非常有效。患有激素避孕问题的女性从换成含孕激素衍生物CMA的OC中受益。

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