...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Clinical drug investigation >Safety data and beneficial effects of the combined oral contraceptive ethinylestradiol 0.03 mg/chlormadinone acetate 2 mg (Belara(R)): a 13-cycle, observational study in routine clinical practice.
【24h】

Safety data and beneficial effects of the combined oral contraceptive ethinylestradiol 0.03 mg/chlormadinone acetate 2 mg (Belara(R)): a 13-cycle, observational study in routine clinical practice.

机译：联合口服避孕药乙炔雌二醇0.03 mg /醋酸氯马酮2 mg（Belara®）的安全性数据和有益效果：在常规临床实践中为期13个周期的观察性研究。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

BACKGROUND: The monophasic hormonal combined oral contraceptive (COC) ethinylestradiol (EE) 0.03 mg/chlormadinone acetate (CMA) 2 mg (Belara(R)) has been shown to have good long-term efficacy and tolerability. OBJECTIVES: The aim of this study was to corroborate the long-term safety of EE 0.03 mg/CMA 2 mg by evaluating the incidence and severity of adverse drug reactions (ADRs) and cycle control over 13 treatment cycles. Additionally, the influence of EE 0.03 mg/CMA 2 mg on dysmenorrhoea, acne and the well-being of subjects was also investigated. Methods: This observational study was conducted in Spain, France and Italy from April 2006 to August 2008. Subjects of reproductive age, without contraindications mentioned in the current summary of product characteristics, were prescribed EE 0.03 mg/CMA 2 mg in routine clinical practice. RESULTS: 3771 subjects were analysed and at least one ADR was reported in 833 (22.1%) subjects, with the majority of ADRs (75.6%) being judged as mild or moderate. The most frequently reported ADRs were intermenstrual bleeding (7.7% of all analysed subjects), headache (5.1%) and breast pain (2.7%). Spotting and breakthrough bleeding (defined as slight and heavier intermenstrual bleeding) at baseline were reported by 677 (18.0%) and 268 (7.1%) subjects, but were less frequent in cycles 10-13 (9.6% and 1.7%, respectively). Before study start, 61.8% of subjects suffered from dysmenorrhea, with the intensity being moderate or severe in 66.9% of these subjects. In cycles 10-13, the corresponding values were noted in 15.0% and 25.6% of subjects. The proportion of subjects who suffered from acne decreased from 46.5% at study entry to 14.9% after 13 medication cycles. More than 50% of the subjects who had switched from another oral contraceptive (OC) pill stated that the tolerability of EE 0.03 mg/CMA 2 mg and their health-related well-being were much better or better after two cycles of EE 0.03 mg/CMA 2 mg than when they were taking their previous OC, and about 85% of the subjects assessed the tolerability of EE 0.03 mg/CMA 2 mg as very good or good during the study. CONCLUSION: These results re-affirmed the favourable ADR profile of the COC EE 0.03 mg/CMA 2 mg, as well as its good cycle control and beneficial effects on dysmenorrhoea, complaints typically occurring during the cycle, acne and well-being.
机译：背景：单相激素联合口服避孕药（COC）炔雌醇（EE）0.03 mg /醋酸氯马酮（CMA）2 mg（Belara®）已显示出良好的长期疗效和耐受性。目的：本研究的目的是通过评估药物不良反应（ADR）的发生率和严重程度以及对13个治疗周期的周期控制，来证实EE 0.03 mg / CMA 2 mg的长期安全性。此外，还研究了EE 0.03 mg / CMA 2 mg对痛经，痤疮和受试者健康的影响。方法：这项观察性研究于2006年4月至2008年8月在西班牙，法国和意大利进行。在常规临床实践中，对生育年龄的受试者（在当前产品特征摘要中未提及禁忌症）开具EE 0.03 mg / CMA 2 mg的处方。结果：分析了3771名受试者，在833名受试者中报告了至少一种ADR（22.1％），其中大多数ADR（75.6％）被判断为轻度或中度。报告最频繁的ADR是月经间出血（占所有分析对象的7.7％），头痛（5.1％）和乳房疼痛（2.7％）。 677（18.0％）和268（7.1％）个受试者报告了基线出现点滴血和突破性出血（定义为月经轻度和重度出血），但在10-13周期的发病率较低（分别为9.6％和1.7％）。在研究开始之前，有61.8％的受试者患有痛经，其中66.9％的受试者为中度或重度。在10-13周期中，在15.0％和25.6％的受试者中记录了相应的值。痤疮患者的比例从研究开始时的46.5％下降到13个用药周期后的14.9％。换用另一种口服避孕药（OC）的受试者中，超过50％的受试者表示，在接受0.03 mg EE的两个周期后，EE 0.03 mg / CMA 2 mg的耐受性及其与健康相关的福祉要好得多或更好/ CMA 2 mg比他们以前服用OC时要好，并且约有85％的受试者在研究期间将EE 0.03 mg / CMA 2 mg的耐受性评价为非常好。结论：这些结果再次证实了0.03 mg / CMA 2 mg COC EE的良好ADR曲线，以及良好的周期控制和对痛经的有益影响，周期痛通常在周期内出现，痤疮和健康。

著录项

相似文献

  • 外文文献
  • 中文文献
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号