雌四醇(E4)15 毫克/屈螺酮(DRSP)3 毫克联合循环疗法治疗原发性和继发性痛经的有效性和安全性:一项多中心、安慰剂对照、双盲、随机研究。

IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY
Yutaka Osuga, Takao Kobayashi, Akihiro Hirakawa, Toshiaki Takayanagi, Masayoshi Nogami, Kyaw Tayzar, Takayuki Mochiyama, Masashi Hirayama, Jean-Michel Foidart, Tasuku Harada
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引用次数: 0

摘要

目的评估雌烯醇(E4)15 毫克/屈螺酮(DRSP)3 毫克联合用药在原发性和继发性痛经的日本女性中的疗效和安全性:设计:一项为期 16 周的多中心、随机、双盲、安慰剂对照、平行组研究,随后是一项为期 36 周的开放标签扩展研究:162名患有原发性和继发性痛经的日本女性:参与者被随机分配到 E4/DRSP 组或安慰剂组。在E4/DRSP组,参与者每天口服一片含E4 15毫克和DRSP 3毫克的药片,连续服用24天,然后再服用一片安慰剂,连续服用4天,构成一个周期。安慰剂组每天服用一片安慰剂,共服用 28 天。16周后,安慰剂组的参与者转为接受E4/DRSP治疗36周:从基线到16周双盲期结束时最严重痛经总分的绝对变化:第16周时,E4/DRSP将最严重的痛经总分从基线降低了2.3分。组间差异显著(-1.4,双侧 95% 置信区间:-1.8 至-1.0),显示优于安慰剂(p结论:E4/DRSP 是一种有效的治疗痛经的药物:E4/DRSP是一种有效的痛经治疗方法,提供了一种安全的新治疗选择,并有可能降低血栓栓塞风险。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of estetrol (15 mg)/drospirenone (3 mg) combination in a cyclic regimen for the treatment of primary and secondary dysmenorrhea: a multicenter, placebo-controlled, double-blind, randomized study.

Objective: To evaluate the efficacy and safety of the estetrol (E4) (15 mg)/drospirenone (DRSP) (3 mg) combination in a cyclic regimen in Japanese women with primary and secondary dysmenorrhea.

Design: A 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, followed by a 36-week, open-label, extension study.

Setting: Double-blined study.

Patient(s): A total of 162 Japanese women with primary and secondary dysmenorrhea.

Intervention(s): Participants were randomly allocated to either the E4/DRSP group or the placebo group. In the E4/DRSP group, participants orally received one tablet containing E4 (15 mg) and DRSP (3 mg daily) for 24 days, followed by a placebo tablet for 4 days, constituting one cycle. The placebo group was given one placebo tablet daily for 28 days. After 16 weeks, participants in the placebo group were switched to receive E4/DRSP for 36 weeks.

Main outcome measure(s): Absolute change in the most severe total dysmenorrhea score from baseline to the end of the 16-week double-blinded period.

Result(s): Estetrol/drospirenone reduced the most severe total dysmenorrhea score by 2.3 points from baseline at week 16. The between-group difference was significant (-1.4, two-sided 95% confidence interval, -1.8 to -1.0), showing superiority to placebo. The responder rate, the proportion of participants who achieved a ≥2.0-point reduction in the most severe total dysmenorrhea score from baseline, was 64.3% in the E4/DRSP group, significantly higher than in the placebo group, 28.4%. In the E4/DRSP group, visual analogue scale scores for pelvic pain and dysmenorrhea symptoms during the menstrual bleeding periods were decreased by 44.2 and 42.3 mm, respectively, from baseline at week 16, significantly more than in the placebo group. Objective gynecological examinations suggested amelioration of pelvic tenderness, uterine mobility, and cul-de sac induration in the E4/DRSP group. Estetrol/drospirenone improved the quality of life-related questionnaires (interference with daily activities and sleeping) and global impression scores. Intermenstrual bleeding was the primary treatment-emergent adverse event in the E4/DRSP group, similar to combined oral contraceptives. There were no cases of venous thromboembolism and less impact on hemostasis parameters in the E4/DRSP group.

Conclusion(s): Estetrol/drospirenone is an effective treatment for dysmenorrhea, offering a safe, new treatment option with potentially reduced thromboembolic risk.

Clinical trial registration number: This study was registered in Clinical Trials Registry of jRCT with registration number jRCT2011210023 (https://jrct.niph.go.jp/latest-detail/jRCT2011210023; date of registration: July 28, 2021; date of enrollment of the first subject: August 2, 2021).

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来源期刊
Fertility and sterility
Fertility and sterility 医学-妇产科学
CiteScore
11.30
自引率
6.00%
发文量
1446
审稿时长
31 days
期刊介绍: Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.
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