Relugolix,口服促性腺激素释放激素受体拮抗剂,减少endometriosis-associated疼痛剂量反应的方式:一项随机,双盲,安慰剂对照研究。

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Osuga Y,塞其Y, Tanimoto M, Kusumoto T,工藤K, Terakawa N

Relugolix,口服促性腺激素释放激素受体拮抗剂,减少endometriosis-associated疼痛剂量反应的方式:一项随机,双盲,安慰剂对照研究。

Fertil杂志。2020年9月7日。pii: s0015 - 0282 (20) 30716 - 0。doi: 10.1016 / j.fertnstert.2020.07.055。

PubMed ID

32912633 (在PubMed

]

文摘

目的:评价疗效和安全性三个剂量水平的relugolix,促性腺激素释放激素受体拮抗剂,与安慰剂比较,leuprorelin女性endometriosis-associated疼痛。设计:第二阶段,多中心、随机、双盲、安慰剂对照研究。设置:医院和诊所。病人:成人绝经前女性子宫内膜异位症痛经,endometriosis-associated骨盆疼痛。干预:在12周的治疗期间,患者接受relugolix 10毫克(n = 103), 20毫克(n = 100),或40毫克(n = 103)作为每日口服剂量;安慰剂组(n = 97)作为每日口服剂量;或leuprorelin 3.75毫克(n = 80),每月一次皮下注射。主要结果测量:主要终点是基线的改变意味着骨盆疼痛视觉模拟量表评分在治疗结束前28天。结果(S):均值的变化意味着骨盆疼痛视觉模拟量表得分是-3.8毫米在安慰剂组;-6.2、-8.1和-10.4毫米的relugolix 10 mg, 20 mg,和40毫克组; 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. CLINICAL TRIAL REGISTRATION NUMBER: NCT01458301.

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药物

Relugolix