Linzagolix子宫腺肌病治疗,口服促性腺激素释放激素受体拮抗剂:一个试点研究新的的重创,然后维护方案管理。

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Donnez J, Donnez O, Tourniaire J, Brethous M, Bestel E,加纳E,贝纳年代,Humberstone, Loumaye E

Linzagolix子宫腺肌病治疗,口服促性腺激素释放激素受体拮抗剂:一个试点研究新的的重创,然后维护方案管理。

中国医学。2021年12月10;10 (24)。pii: jcm10245794。doi: 10.3390 / jcm10245794。

PubMed ID

34945090 (在PubMed

]

文摘

(1)背景:本试验研究的目的是研究一个新的口服促性腺激素释放激素拮抗剂对子宫内膜异位的影响。(2)方法:八绝经前女性,年龄在37岁至45年,呈现与沉重的月经出血,盆腔疼痛、痛经由于扩散和传播子宫腺肌病,证实了磁共振成像(MRI),收到200毫克linzagolix一旦每日一段12周,之后,他们转向100毫克linzagolix每天一次12周。主要疗效终点是adenomyotic子宫的体积变化从基线到24周,通过MRI评估。次要疗效端点包括子宫体积的变化从基线到12至36周通过核磁共振,还有12周,24岁,和36评估经阴道超声(电大)。其他端点整体盆腔痛,痛经,non-menstrual盆腔疼痛、性交困难,闭经,生活质量的措施,骨矿物质密度(BMD),交界区厚度、和血清雌二醇值。(3)结果:平均血清雌二醇抑制低于20 pg / mL在12周linzagolix 200毫克,并保持低于60 pg / mL第二次12周期间linzagolix 100毫克。在基线,意思是+ / - SD子宫体积是333 + / - 250厘米(3)。治疗24周后,(3)204 + / - 126厘米,减少32% (p = 0.0057)。12周后,子宫体积是159 + / - 95厘米(3),从基线减少55% (p = 0.0001)。类似的模式时观察子宫体积被电大的评估。 Improvements in overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain, dyspareunia, and dyschezia, as well as quality of life measured using the EHP-30 were also observed. Mean percentage BMD loss at 24 weeks was, respectively, -2.4%, -1.3%, and -4.1% for the spine, femoral neck, and total hip. The most common adverse events were hot flushes, which occurred in 6/8 women during the first 12 weeks, and 1/8 women between 12 and 24 weeks. (4) Conclusions: Linzagolix at a dose of 200 mg/day reduced uterine volume, and improved clinically relevant symptoms. Treatment with 100 mg thereafter retains the therapeutic benefits of the starting dose while minimizing side effects. This 'hit hard first and then maintain' approach may be the optimal way to treat women with symptomatic adenomyosis.

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药物

Linzagolix