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炔雌醇/醋酸氯地孕酮

Ethinylestradiol/chlormadinone acetate.

作者信息

Curran Monique P, Wagstaff Antona J

机构信息

Adis International Limited, 41 Centorian Drive, PB 65901, Mairangi Bay, Auckland, New Zealand.

出版信息

Drugs. 2004;64(7):751-60; discussion 761-2. doi: 10.2165/00003495-200464070-00005.

DOI:10.2165/00003495-200464070-00005
PMID:15025547
Abstract

Ethinylestradiol/chlormadinone acetate 0.03/2mg (EE/CMA) is a combined monophasic contraceptive pill with antiandrogenic properties. In a large, noncomparative, multicentre trial (< or =24 cycles of treatment per woman) and two (6- and 12-cycle) postmarketing surveillance studies, EE/CMA was effective in preventing pregnancy. EE/CMA was significantly more effective than EE/levonorgestrel 0.03/0.15 mg/day in treating women with mild-to-moderate papulopustular acne of the face and related disorders in a randomised, single-blind, multicentre trial. EE/CMA was well tolerated in clinical trials and the postmarketing surveillance studies. Adverse events were those commonly reported with oral contraceptives. As expected, the most common menstrual disturbances were breakthrough bleeding, spotting and amenorrhoea.

摘要

炔雌醇/醋酸氯地孕酮0.03/2毫克(EE/CMA)是一种具有抗雄激素特性的复方单相避孕药。在一项大型、非对照、多中心试验(每位女性治疗≤24个周期)以及两项上市后监测研究(6周期和12周期)中,EE/CMA在预防妊娠方面有效。在一项随机、单盲、多中心试验中,EE/CMA在治疗面部轻至中度丘疹脓疱性痤疮及相关病症方面比炔雌醇/左炔诺孕酮0.03/0.15毫克/天显著更有效。EE/CMA在临床试验和上市后监测研究中耐受性良好。不良事件为口服避孕药常见的报告事件。正如预期的那样,最常见的月经紊乱为突破性出血、点滴出血和闭经。

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1
Ethinylestradiol/chlormadinone acetate.炔雌醇/醋酸氯地孕酮
Drugs. 2004;64(7):751-60; discussion 761-2. doi: 10.2165/00003495-200464070-00005.
2
Six-month evaluation of the benefits of the low-dose combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg in young women: results of the prospective, observational, non-interventional, multicentre TeeNIS study.年轻女性中低剂量复方口服避孕药屈螺酮 2 毫克/炔雌醇 0.03 毫克的 6 个月益处评估:前瞻性、观察性、非干预性、多中心 TeeNIS 研究结果。
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3
Ethinylestradiol/Chlormadinone acetate: dermatological benefits.炔雌醇/氯地孕酮:皮肤科获益。
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Safety data and beneficial effects of the combined oral contraceptive ethinylestradiol 0.03 mg/chlormadinone acetate 2 mg (Belara®): a 13-cycle, observational study in routine clinical practice.在常规临床实践中,进行了一项为期 13 个周期的、观察性的研究,评估了联合口服避孕药炔雌醇 0.03 毫克/醋酸氯地孕酮 2 毫克(Belara®)的安全性数据和有益效果。
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Long-term efficacy and safety of a monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen.24/4 天方案中应用含 0.02 毫克炔雌醇和 2 毫克氯地孕酮单相复方口服避孕药的长期疗效和安全性。
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Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial.含0.03毫克炔雌醇(EE)和2毫克醋酸氯地孕酮(CMA)的口服避孕药(贝拉乐)治疗中度痤疮的疗效:一项随机、双盲、安慰剂对照的III期试验。
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本文引用的文献

1
A 12-month evaluation of the CMA-containing oral contraceptive Belara: efficacy, tolerability and anti-androgenic properties.含醋酸环丙孕酮的口服避孕药Belara的12个月评估:疗效、耐受性和抗雄激素特性。
Contraception. 2003 Apr;67(4):305-12. doi: 10.1016/s0010-7824(02)00536-x.
2
Progestogens with antiandrogenic properties.具有抗雄激素特性的孕激素。
Drugs. 2003;63(5):463-92. doi: 10.2165/00003495-200363050-00003.
3
Acne resolution rates: results of a single-blind, randomized, controlled, parallel phase III trial with EE/CMA (Belara) and EE/LNG (Microgynon).
痤疮治愈率:一项针对炔雌醇/醋酸环丙孕酮(贝拉拉)和炔雌醇/左炔诺孕酮(妈富隆)的单盲、随机、对照、平行三期试验结果
Dermatology. 2001;203(1):38-44. doi: 10.1159/000051701.
4
A comparative study of the hemostatic effects of two monophasic oral contraceptives containing 30 mu(g) ethinylestradiol and either 2 mg chlormadinone acetate or 150 mu(g) desogestrel.一项关于两种单相口服避孕药止血效果的对比研究,这两种避孕药分别含有30微克炔雌醇和2毫克醋酸氯地孕酮或150微克去氧孕烯。
Eur J Contracept Reprod Health Care. 1999 Sep;4(3):145-54.
5
The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices.激素避孕法及宫内节育器的作用机制。
Am J Obstet Gynecol. 1999 Nov;181(5 Pt 1):1263-9. doi: 10.1016/s0002-9378(99)70120-1.
6
Efficacy and safety of the new antiandrogenic oral contraceptive Belara.新型抗雄激素口服避孕药Belara的疗效与安全性。
Contraception. 1998 Feb;57(2):103-9. doi: 10.1016/s0010-7824(98)00008-0.
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The antiandrogen cyproterone acetate: discovery, chemistry, basic pharmacology, clinical use and tool in basic research.抗雄激素醋酸环丙孕酮:发现、化学、基础药理学、临床应用及基础研究工具
Exp Clin Endocrinol. 1994;102(1):1-32. doi: 10.1055/s-0029-1211261.
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Hemostasis profile and lipid metabolism with long-interval use of a desogestrel-containing oral contraceptive.含去氧孕烯口服避孕药长期使用后的止血情况和脂质代谢
Contraception. 1994 Aug;50(2):153-65. doi: 10.1016/0010-7824(94)90051-5.
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Effects of steroids on the in vitro forward migration of human spermatozoa.类固醇对人精子体外向前运动的影响。
Contraception. 1981 Aug;24(2):183-94. doi: 10.1016/0010-7824(81)90091-3.
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Clinical pharmacokinetics of oral contraceptive steroids.口服避孕甾体激素的临床药代动力学。
Clin Pharmacokinet. 1983 Mar-Apr;8(2):95-136. doi: 10.2165/00003088-198308020-00001.