Objective

To compare the effectiveness of two different treatment regimens of dydrogesterone in the management of endometriosis-related chronic pelvic pain.

Design

Observational, prospective cohort study over six months.

Setting

Twenty gynecology clinics in the Russian Federation.

Patient(s)

Three hundred fifty women from 18 to 45 years of age with endometriosis and chronic pelvic pain with or without dysmenorrhea.

Intervention(s)

Dydrogesterone 10 mg 2 or 3 times daily, either between the 5th and 25th days of the menstrual cycle (prolonged cyclical treatment regimen) or continuously (continuous treatment regimen). For all patients, the data cutoff was at six months of treatment.

Main Outcome Measure(s)

Intensity of chronic pelvic pain on the 11-point numerical rating scale (after 6 months).

Result(s)

A marked reduction in chronic pelvic pain was observed with both the prolonged cyclical and continuous treatment regimens (mean ± standard deviation change from baseline –3.3 ± 2.2 and –3.0 ± 2.2, respectively), with no significant difference between the two groups. With both regimens, patients experienced significant improvements in the intensity of chronic pelvic pain, number of days in which analgesics were required, severity of dysmenorrhea, sexual well-being, and health-related quality-of-life parameters. A favorable safety profile of dydrogesterone was confirmed, and no serious adverse drug reactions were reported during the study.

Conclusion(s)

Prolonged cyclical and continuous treatment regimens of dydrogesterone therapy both demonstrated a pronounced and similar reduction in the severity of chronic pelvic pain and dysmenorrhea and led to marked improvements in all study parameters related to quality of life and sexual well-being.

Registration Number

NCT03690765.

中文翻译：

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地屈孕酮的长期周期性和连续方案可有效减轻子宫内膜异位症女性的慢性盆腔疼痛：ORCHIDEA 研究的结果

客观的

比较两种不同的地屈孕酮治疗方案在治疗子宫内膜异位症相关慢性盆腔疼痛中的有效性。

设计

为期六个月的观察性、前瞻性队列研究。

环境

俄罗斯联邦的 20 家妇科诊所。

耐心）

350 名 18 至 45 岁患有子宫内膜异位症和慢性盆腔痛并伴有或不伴有痛经的女性。

干预措施

地屈孕酮 10 毫克，每天 2 或 3 次，在月经周期的第 5 天和第 25 天之间（延长的周期治疗方案）或连续（连续治疗方案）。对于所有患者，数据截止时间为治疗六个月。

主要观察指标）

慢性盆腔疼痛的强度在 11 点数值评定量表上（6 个月后）。

结果）

长期周期性和连续治疗方案均观察到慢性盆腔疼痛显着减轻（平均±标准偏差与基线的变化分别为–3.3 ± 2.2 和–3.0 ± 2.2），两组之间没有显着差异。使用这两种方案，患者在慢性盆腔疼痛的强度、需要镇痛药的天数、痛经的严重程度、性健康和与健康相关的生活质量参数方面都有显着改善。地屈孕酮的安全性良好，研究期间未报告严重的药物不良反应。

结论

地屈孕酮治疗的长期周期性和连续治疗方案均显示出慢性盆腔疼痛和痛经的严重程度显着和类似的降低，并导致与生活质量和性福祉相关的所有研究参数的显着改善。

注册号码

NCT03690765。