Department of Urology, Tama-hokubu Medical Center, 1-7-1 Aobacho, Higashimurayama, Tokyo, 189-8511, Japan.
Department of Urology, National Defense Medical College, Tokorozawa, Japan.
World J Urol. 2020 Jun;38(6):1465-1471. doi: 10.1007/s00345-019-02937-x. Epub 2019 Sep 3.
In a mouse model, degarelix generated the least metabolic consequences via low follicle-stimulating hormone (FSH) levels compared with orchiectomy and leuprolide after 4 months of androgen deprivation therapy (ADT). Here, we comparatively investigated the influence of ADT with degarelix or leuprolide on the development of metabolic syndrome in patients with prostate cancer (PCa).
Patients with hormone-naive PCa were recruited. Eligible patients were randomized (1:1) to monthly degarelix or monthly leuprolide for 6 months. Key trial variables were monitored monthly. The primary endpoint was changes in fasting blood sugar (FBS). Secondary endpoints were changes in body weight, abdominal circumference, lipid profiles, and hemoglobin A1c (HbA1c) and FSH levels. Computed tomography was performed to measure subcutaneous and visceral fat areas before and after 6 months of ADT. Data were analyzed using the χ test, Student's t test, and analysis of variance.
From the 100 patients registered, 85 completed the trial (degarelix: 40 patients; leuprolide: 45 patients). Mean increases in FBS did not differ between the two arms. Similarly, there were no differences between the arms in mean increases in body weight, abdominal circumference, lipid profiles, HbA1c, or subcutaneous and visceral fat areas. Follicle-stimulating hormone levels were significantly lower in the degarelix arm than in the leuprolide arm (p < 0.05).
Lipid and glucose metabolism did not differ significantly between the arms, while FSH levels were significantly lower in the degarelix arm.
在一项小鼠模型研究中，与去势和亮丙瑞林相比，在雄激素剥夺治疗（ADT） 4 个月后，低促卵泡激素（FSH）水平的达菲林导致的代谢后果最小。在此，我们比较研究了 ADT 中使用达菲林或亮丙瑞林对前列腺癌（PCa）患者代谢综合征发展的影响。
招募了激素初治 PCa 患者。符合条件的患者被随机（1:1）分为每月接受达菲林或亮丙瑞林治疗 6 个月。每月监测关键试验变量。主要终点是空腹血糖（FBS）的变化。次要终点是体重、腰围、血脂谱以及糖化血红蛋白（HbA1c）和 FSH 水平的变化。在 ADT 前和 6 个月后进行计算机断层扫描以测量皮下和内脏脂肪面积。使用 χ 检验、学生 t 检验和方差分析进行数据分析。
在登记的 100 名患者中，85 名完成了试验（达菲林组：40 名患者；亮丙瑞林组：45 名患者）。两组的 FBS 平均增加值无差异。同样，两组之间体重、腰围、血脂谱、HbA1c 或皮下和内脏脂肪面积的平均增加值也没有差异。达菲林组的 FSH 水平明显低于亮丙瑞林组（p < 0.05）。
两组之间的脂质和葡萄糖代谢没有显著差异，而达菲林组的 FSH 水平明显更低。
