地诺孕素与复方口服避孕药治疗子宫内膜异位症相关疼痛的疗效：随机临床试验。
Efficacy of dienogest vs combined oral contraceptive on pain associated with endometriosis: Randomized clinical trial.
机构信息
Department of Obstetrics and Gynecology, American University of Beirut Medical Center, Beirut, Lebanon; Division of Reproductive Endocrinology and Infertility, American University of Beirut Medical Center, Beirut, Lebanon.
Department of Obstetrics and Gynecology, American University of Beirut Medical Center, Beirut, Lebanon; Division of Reproductive Endocrinology and Infertility, American University of Beirut Medical Center, Beirut, Lebanon.
出版信息
Eur J Obstet Gynecol Reprod Biol. 2021 Dec;267:205-212. doi: 10.1016/j.ejogrb.2021.10.029. Epub 2021 Oct 30.
OBJECTIVE
To compare the efficacy of dienogest with the combined oral contraceptive pill (COC) Yasmin for the control of endometriosis-associated pelvic pain.
STUDY DESIGN
Seventy women with endometriosis-associated chronic pelvic pain, dysmenorrhoea or both for >6 months were randomized to either dienogest (Visanne) 2 mg/day or monophasic COC (Yasmin, 0.03 mg ethinyl estradiol and 3 mg drospirenone) for 24 weeks. The primary efficacy variable was change in non-cyclic pelvic pain and dysmenorrhoea from baseline to end of treatment, assessed using a visual analogue scale (VAS). The secondary efficacy variable was change in the Biberoglu and Behrman (B&B) scale scores for chronic pelvic pain, dysmenorrhoea and dyspareunia. Health-related quality of life (HRQoL) was evaluated using the Endometriosis Health Profile-30 (EHP-30) questionnaire at baseline and 24 weeks. Safety variables included incidence of side-effects, bleeding pattern and treatment tolerability.
RESULTS
Both treatments improved the mean VAS score for endometriosis-associated pelvic pain significantly: mean difference 6.0 [95% confidence interval (CI) 4.9-7.1; p < 0.0001] in the dienogest group and 4.54 (95% CI 3.1-5.9; p < 0.0001) in the COC group; the difference between them was not significant (p = 0.111). Similarly, both dienogest and COC improved HRQoL in various core and modular segments of the EHP-30 questionnaire with comparable requirements for supplemental pain medication (p = 0.782 and 0.258 at 12 and 24 weeks, respectively), and redistribution of the B&B severity profile for chronic pelvic pain (p = 0.052 and 0.526 at 12 and 24 weeks, respectively), dysmenorrhoea (p = 0.521 and 1 at 12 and 24 weeks, respectively) and dyspareunia (p = 0.376 and 0.835, respectively). Nevertheless, dienogest was associated with fewer side-effects, and hence had a better safety and tolerability profile than COC.
CONCLUSIONS
Dienogest (2 mg/day) is comparable to the COC Yasmin for the relief of endometriosis-associated pelvic pain and improvement in HRQoL.
CLINICAL TRIAL REGISTRATION
Clinicaltrials.gov under number NCT04256200; date of registration 15/1/2020 (registered retrospectively).
目的
比较地诺孕素与复方口服避孕药（COC）优思明治疗子宫内膜异位症相关盆腔痛的疗效。
研究设计
70 例患有子宫内膜异位症相关慢性盆腔痛、痛经或两者兼有且持续>6 个月的女性患者被随机分为地诺孕素（Visanne）组 2mg/天或单相 COC（Yasmin，0.03mg 炔雌醇和 3mg 屈螺酮）组，治疗 24 周。主要疗效变量为治疗前后基线至结束时非周期性盆腔痛和痛经的变化，采用视觉模拟量表（VAS）评估。次要疗效变量为慢性盆腔痛、痛经和性交痛的 Biberoglu 和 Behrman（B&B）量表评分的变化。使用子宫内膜异位症健康状况问卷-30（EHP-30）问卷在基线和 24 周评估健康相关生活质量（HRQoL）。安全性变量包括不良反应发生率、出血模式和治疗耐受性。
结果
两种治疗方法均显著改善了子宫内膜异位症相关盆腔痛的平均 VAS 评分：地诺孕素组平均差值为 6.0[95%置信区间（CI）为 4.9-7.1；p<0.0001]，COC 组为 4.54（95%CI 为 3.1-5.9；p<0.0001）；两组之间无显著差异（p=0.111）。同样，地诺孕素和 COC 均改善了 EHP-30 问卷各核心和模块部分的 HRQoL，且对补充止痛药的需求相当（12 周和 24 周时分别为 p=0.782 和 0.258，p=0.052 和 0.526），慢性盆腔痛的 B&B 严重程度分布也发生了重新分配（12 周和 24 周时分别为 p=0.521 和 1，p=0.521 和 1），痛经（p=0.521 和 1，12 周和 24 周）和性交痛（p=0.376 和 0.835，分别为 12 周和 24 周）。然而，地诺孕素的不良反应发生率较低，因此与 COC 相比，具有更好的安全性和耐受性。
结论
地诺孕素（2mg/天）与 COC 优思明缓解子宫内膜异位症相关盆腔痛和改善 HRQoL 的疗效相当。
临床试验注册
Clinicaltrials.gov 编号为 NCT04256200；注册日期为 2020 年 1 月 15 日（回顾性注册）。
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