3期临床研究证实,促性腺激素释放激素(GnRH)受体拮抗剂Relugolix 显着减轻子宫内膜异位症女性的疼痛

2020-04-25 MedSci原创 MedSci原创

Myovant Sciences公司宣布,每日一次Relugolix联合疗法治疗子宫内膜异位症女性疼痛的三期研究达到主要疗效终点和六个次要终点,且耐受良好。

Myovant Sciences公司宣布,每日一次Relugolix联合疗法(Relugolix 40毫克联合雌二醇1.0毫克,醋酸炔诺酮0.5毫克)治疗子宫内膜异位症女性疼痛的三期研究SPIRIT 2达到主要疗效终点和六个次要终点。并且Relugolix联合疗法耐受良好。

Relugolix是一种每日一次的口服促性腺激素释放激素(GnRH)受体拮抗剂,可减少卵巢雌二醇的产生,该激素可刺激子宫肌瘤和子宫内膜异位症的生长。

在SPIRIT 2的结果分析中,接受Relugolix联合疗法的女性有75.2%实现了痛经的临床上有意义的改善,而安慰剂组为30.4%(p <0.0001)。对于非经期盆腔痛,Relugolix联合疗法有66.0%的女性实现了临床上有意义的改善,安慰剂组为42.6%(p <0.0001)。平均而言,根据11点(0至10)数字评分量表评测,接受Relugolix联合治疗的女性痛经从7.2(严重疼痛)降低到1.7(轻度疼痛),降低了75.1%。

Myovant还宣布,在另一项临床研究中,根据Hoogland-Skouby评估量表评估,在84天的治疗期内,relugolix联合疗法在67名健康女性中实现了100%的排卵抑制。此外,停药后100%的妇女恢复排卵或月经,平均排卵时间为23.5天。

子宫内膜异位症是一种雌激素依赖的炎症性疾病。子宫内膜异位症引起的疼痛,初始治疗选择包括激素避孕药和非处方止痛药。在更严重的情况下,GnRH激动剂可用于短期治疗。全球有近2亿女性受到该疾病影响。

原始出处:

https://www.firstwordpharma.com/node/1717500?tsid=4

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