Donnez Jacques, Donnez Olivier, Brethous Michel, Bestel Elke, Garner Elizabeth, Charpentier Sébastien, Humberstone Andrew, Loumaye Ernest
Université Catholique de Louvain, Louvain, Belgium; Société de Recherche pour l'infertilité (SRI), Brussels, Belgium.
Polyclinique Urbain V (ELSAN Group), Institut du Sein et de Chirurgie Gynécologique d'Avignon, Avignon, France.
Reprod Biomed Online. 2022 Jan;44(1):200-203. doi: 10.1016/j.rbmo.2021.09.019. Epub 2021 Oct 3.
Does a once-daily regimen of linzagolix, a new oral gonadotrophin-releasing hormone (GnRH) antagonist, given at a fully suppressive dose (200 mg) for 12 weeks, followed by a partially suppressive dose (100 mg) for a further 12 weeks, reduce adenomyotic uterine size and associated symptoms?
Eight women (aged 37-45 years) with adenomyosis confirmed by magnetic resonance imaging (MRI) were enrolled in a single-centre, open-label pilot study. The primary efficacy end-point was the change in uterine volume on MRI at 24 weeks. Secondary efficacy end-points included serum oestradiol, overall pelvic pain, dysmenorrhoea, non-menstrual pelvic pain, dyspareunia, dyschezia and quality of life (QoL). Bone mineral density (BMD) was assessed at baseline and 24 weeks.
At baseline, uterine volume (mean ± SD) was 333 ± 250 cm. After 24 weeks, it was 204 ± 126 cm, a reduction of 32% from baseline (P = 0.0057). After 12 weeks, it was 159 ± 95 cm, a reduction of 55% (P < 0.0001). Median serum oestradiol was suppressed below 20 pg/ml during the 12 weeks on 200 mg linzagolix, and maintained below 60 pg/ml on 100 mg linzagolix. Improvements in overall pelvic pain, dysmenorrhoea, non-menstrual pelvic pain, dyspareunia, dyschezia and QoL were observed. Mean percentage change in BMD loss at 24 weeks was -2.4%, -1.3% and -4.1% for the spine, femoral neck and total hip, respectively. The most common adverse events were hot flushes.
A once-daily regimen of 200 mg linzagolix for 12 weeks and then 100 mg for another 12 weeks decreased adenomyotic uterine volume and improved associated symptoms.
一种新型口服促性腺激素释放激素（GnRH）拮抗剂林扎戈利克，以完全抑制剂量（200毫克）每日一次给药12周，随后以部分抑制剂量（100毫克）再给药12周，是否能减小子宫腺肌病患者的子宫大小并缓解相关症状？
八名经磁共振成像（MRI）确诊为子宫腺肌病的女性（年龄37 - 45岁）参与了一项单中心、开放标签的试点研究。主要疗效终点是24周时MRI检查的子宫体积变化。次要疗效终点包括血清雌二醇、总体盆腔疼痛、痛经、非经期盆腔疼痛、性交困难、排便困难以及生活质量（QoL）。在基线和24周时评估骨密度（BMD）。
基线时，子宫体积（均值±标准差）为333±250立方厘米。24周后，为204±126立方厘米，较基线减少了32%（P = 0.0057）。12周后，为159±95立方厘米，减少了55%（P < 0.0001）。在服用200毫克林扎戈利克的12周内，血清雌二醇中位数被抑制至20皮克/毫升以下，在服用100毫克林扎戈利克时维持在60皮克/毫升以下。观察到总体盆腔疼痛、痛经、非经期盆腔疼痛、性交困难、排便困难和生活质量有所改善。24周时，脊柱、股骨颈和全髋关节的骨密度损失平均百分比变化分别为-2.4%、-1.3%和-4.1%。最常见的不良事件是潮热。
林扎戈利克每日一次，200毫克服用12周，然后100毫克再服用12周的方案可减小子宫腺肌病患者的子宫体积并改善相关症状。
