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在欧洲,91 天延长型左炔诺孕酮复合口服避孕药的真实世界应用:一项多国数据库研究。

Real world utilization of 91 day extended levonorgestrel-containing combined oral contraceptives in Europe: a multinational database study.

机构信息

Teva Pharmaceutical Industries Ltd., Netanya, Israel.

IQVIA, La Défense, France.

出版信息

Curr Med Res Opin. 2021 Mar;37(3):515-522. doi: 10.1080/03007995.2021.1876008. Epub 2021 Feb 10.

Abstract

OBJECTIVE

As part of the risk management plan in Europe, this study was conducted to characterize drug utilization patterns of Seasonique, a 91 day extended levonorgestrel-containing combined oral contraceptive (COC).

METHODS

A retrospective observational study was conducted in France, Italy and Belgium using electronic medical record databases obtained from general practitioners (GPs) in all participating countries and gynecologists in France from 2015 to 2018. The study population included women receiving ≥1 prescription of 91 day COC during the study period. Prescribing patterns of 91 day COC were examined including: (1) treatment duration; (2) indication; (3) use of combined oral contraceptive (COC) before 91 day COC initiation; and (4) switch from and to combined hormonal contraceptives (CHCs) or other contraceptives.

RESULTS

Totals of 235, 220, 207 and 659 women using 91 day COC were identified in French, Italian and Belgian GP, and French gynecologist databases, respectively. Across databases, 46-76% of women were prescribed a single 91 day COC prescription and median treatment duration ranged from 3 to 6 months. The most common indication was contraception (42-81%), followed by menstrual migraines (2-14%). Use of COC during the 6 months prior to 91 day COC initiation was 14% across GP databases, but was lower (8%) in the French gynecologist database. The frequency of switching from 91 day COC to CHCs or other contraceptives was generally low (5-12%), with the highest proportion being among patients of French gynecologists.

CONCLUSIONS

Findings indicate that 91 day COC was prescribed for relatively short durations and predominantly as indicated for contraception. Most results were comparable across all participating countries. KEY POINTSFindings from this drug utilization study in European databases across general practitioners and French gynecologists confirmed that 91 day extended levonorgestrel-containing combined oral contraceptive (COC) was prescribed for relatively short durations (median 3-6 months); predominantly for the intended indication of contraception.Combined oral contraceptive use during the 6 months prior to 91 day COC initiation, and switching from 91 day COC to combined hormonal contraceptives or other contraceptives, were generally low (14% or less).These findings were mostly consistent across participating countries.

摘要

目的

作为欧洲风险管理计划的一部分,本研究旨在描述 91 天左炔诺孕酮避孕药(COC)的药物利用模式,这种避孕药是一种延长周期的含左炔诺孕酮的复方口服避孕药。

方法

这是一项在法国、意大利和比利时进行的回顾性观察性研究,使用了来自所有参与国家的全科医生(GP)和法国妇科医生的电子病历数据库,时间范围为 2015 年至 2018 年。研究人群包括在研究期间接受至少 1 次 91 天 COC 处方的女性。检查了 91 天 COC 的处方模式,包括:(1)治疗持续时间;(2)适应证;(3)在开始 91 天 COC 之前使用复方口服避孕药(COC);以及(4)从联合激素避孕药(CHC)或其他避孕药转换。

结果

在法国、意大利和比利时的 GP 数据库以及法国妇科医生数据库中,分别确定了 235、220、207 和 659 名使用 91 天 COC 的女性。在所有数据库中,46-76%的女性被开具了单次 91 天 COC 处方,治疗持续时间中位数为 3-6 个月。最常见的适应证是避孕(42-81%),其次是月经性偏头痛(2-14%)。在开始 91 天 COC 之前的 6 个月内使用 COC 的比例在 GP 数据库中为 14%,但在法国妇科医生数据库中较低(8%)。从 91 天 COC 转换为 CHC 或其他避孕药的频率通常较低(5-12%),其中法国妇科医生的患者比例最高。

结论

研究结果表明,91 天 COC 的处方持续时间相对较短,主要用于避孕。大多数结果在所有参与国家都具有可比性。关键点:这项在欧洲全科医生和法国妇科医生数据库中进行的药物利用研究结果证实,91 天延长型左炔诺孕酮复方口服避孕药(COC)的处方持续时间相对较短(中位数为 3-6 个月);主要用于避孕这一预期适应证。在开始 91 天 COC 之前的 6 个月内使用 COC,以及从 91 天 COC 转换为联合激素避孕药或其他避孕药的情况通常较低(14%或更低)。这些发现在大多数情况下在参与国家中是一致的。

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