Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study
Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study
复制标题
DOI：
10.1016/j.fertnstert.2020.07.055
复制
发表时间：
2021-02-10
影响因子：
6.7
通讯作者：
Terakawa, Naoki
中科院分区：
文献类型：
--
作者：
Osuga, Yutaka;Seki, Yoshifumi;Terakawa, Naoki
目的：评价促性腺激素释放激素受体拮抗剂瑞洛格雷与安慰剂和亮丙瑞林3种剂量水平治疗子宫内膜异位症相关疼痛的疗效和安全性。设计：2期，多中心、随机、双盲、安慰剂对照研究。地点：医院和临床。患者(S)：成年绝经前子宫内膜异位症患者，有痛经和子宫内膜异位症相关性盆腔疼痛。干预(S)：在12周的治疗期间，患者服用瑞洛格利克斯10 mg(n=103)、20 mg(n=100)或40 mg(n=103)；主要结果(S)：主要终点是治疗结束前28天内盆腔疼痛视觉模拟评分与基线的变化。结果(S)：盆腔疼痛视觉模拟评分的平均变化：安慰剂组为-3.8 mm；瑞格列克斯10 mg组、20 mg组和40 mg组分别为-6.2、-8.1和-10.4 mm；亮丙瑞林组为-10.6 mm。瑞洛格雷的主要不良反应为潮热、子宫出血、月经不调、骨密度下降，且呈剂量反应关系，亮丙瑞林组的不良反应频率与瑞洛格雷40 mg组相当。结论：S口服瑞洛格雷可剂量反应地减轻子宫内膜异位症相关疼痛，且耐受性良好。瑞格列克斯40 mg的疗效和安全性与亮丙瑞林相当。((C)2020年，由美国生殖医学会提供。)
Objective: To evaluate the efficacy and safety of three dose levels of relugolix, a gonadotropin-releasing hormone receptor antagonist, compared with placebo and leuprorelin in women with endometriosis-associated pain.Design: Phase 2, multicenter, randomized, double-blind, placebo-controlled study.Setting: Hospitals and clinics.Patient(s): Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.Intervention(s): During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.Main Outcome Measure(s): Primary endpoint was the change from baseline in mean visual analog scale score for pelvic pain during 28 days before the end of treatment.Result(s): The mean changes in mean visual analog scale score for pelvic pain were -3.8mmin the placebo group; -6.2, -8.1, and -10.4 mm in the relugolix 10-mg, 20-mg, and 40-mg groups; respectively; and -10.6 mm in the leuprorelin group. The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose-response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group.Conclusion(s): Oral administration of relugolix alleviated endometriosis-associated pain in a dose-response manner and was generally well tolerated. Relugolix 40 mg demonstrated efficacy and safety comparable with those of leuprorelin. ((C) 2020 by American Society for Reproductive Medicine.)