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醋酸炔诺酮50毫克加戊酸雌二醇5毫克作为每月注射用避孕药的多中心III期临床试验;最终三年报告。

Multicentred, phase III clinical trial of norethisterone enanthate 50 mg plus estradiol valerate 5 mg as a monthly injectable contraceptive; final three-year report.

作者信息

von Kesseru E, Aydinlik S, Etchepareborda J J

机构信息

First Gynecological Clinic, University of Buenos Aires, Argentina.

出版信息

Contraception. 1994 Oct;50(4):329-37. doi: 10.1016/0010-7824(94)90020-5.

DOI:10.1016/0010-7824(94)90020-5
PMID:7813221
Abstract

Norethisterone enanthate (NET-EN) 50 mg combined with estradiol valerate (EV) 5 mg was studied as a once-a-month injectable contraceptive with regard to effectiveness, cycle control, adverse events and acceptability. In eight Family Planning Centres from five Latin American countries, 931 fertile women were followed-up for a period of 36 months, providing a total of 15,787 woman-months of experience. Only one pregnancy occurred: in the first treated month a few days before the second injection (failure rate 0.08 per 100 woman-years). Under treatment, the first cycle was drastically shortened in most cases, but thereafter cycles tended to recover to pre-treatment patterns. There was a significant decrease of hypermenorrhoea and dysmenorrheic cycles. Intracyclic bleeding and spotting appeared in 1.8% and 2.2%, respectively, and amenorrhea in 2.8% of cycles. The incidence of other adverse events was very low with the exception of weight gain of more than 2 kg (36.8%). The continuation rate at 12 months was 64.7%, at 24 months 31.0% and at 36 months 20.4%. The cumulative discontinuation rate due to bleeding problems was 6.1% and 7.2% due to adverse events at 36 months. The treatment was shown to be a highly effective contraceptive method that offers fairly good cycle control, good tolerance and a continuation rate that makes it suitable for use in family planning programmes in the Latin American area.

摘要

研究了庚酸炔诺酮(NET-EN)50毫克与戊酸雌二醇(EV)5毫克联合使用作为每月一次的注射用避孕药的有效性、周期控制、不良事件和可接受性。在来自五个拉丁美洲国家的八个计划生育中心,对931名育龄妇女进行了为期36个月的随访,共积累了15787个妇女月的经验。仅发生了1例妊娠:在首次治疗的月份,第二次注射前几天(失败率为每100妇女年0.08)。治疗期间,大多数情况下第一个周期大幅缩短,但此后周期趋于恢复到治疗前的模式。月经过多和痛经周期显著减少。周期内出血和点滴出血的发生率分别为1.8%和2.2%,闭经发生率为2.8%。除体重增加超过2千克(36.8%)外,其他不良事件的发生率非常低。12个月时的持续使用率为64.7%,24个月时为31.0%,36个月时为20.4%。36个月时,因出血问题导致的累积停药率为6.1%,因不良事件导致的为7.2%。该治疗方法被证明是一种高效的避孕方法,能提供较好的周期控制、良好的耐受性和持续使用率,适用于拉丁美洲地区的计划生育项目。

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