Oefelein M G
74th Medical Group/SGOSU, Wright-Patterson Air Force Base, Ohio, USA.
J Urol. 1998 Nov;160(5):1685-8.
A time course to serum testosterone normalization after administration of a single 3-month luteinizing hormone-releasing hormone (LH-RH) agonist in the neoadjuvant setting was developed.
A total of 13 men with clinically localized prostate cancer were prospectively assessed for baseline libido, erectile function and mid morning serum testosterone. A single 3-month formulation LH-RH agonist was administered in the neoadjuvant setting before definitive treatment with radical perineal prostatectomy in 7 men or external beam radiotherapy in 6. Baseline and serial testosterone levels were measured 3, 4, 6, 7, 9, 12, 15 and 18 months after injection. Symptoms related to acute testosterone depletion, namely hot flashes and sweats, were recorded on the same schedule.
After a single 3-month LH-RH agonist injection median duration of castrate level testosterone (0.2 ng./ml. or less) was 6 months. Median duration of hypogonadal symptoms (hot flashes and sweats) was 13.6 months and resolution paralleled the gradual return of serum testosterone to baseline values.
The 3-month formulation of LH-RH agonist administered in the neoadjuvant setting provides castrate level testosterone for a longer duration than the product labeling suggests. If confirmed, these preliminary observations have important implications for dosing schedule and neoadjuvant study consideration.
制定新辅助治疗中单次注射3个月促黄体生成素释放激素（LH-RH）激动剂后血清睾酮恢复正常的时间进程。
前瞻性评估了13例临床局限性前列腺癌男性患者的基线性欲、勃起功能及清晨血清睾酮水平。在7例患者接受根治性会阴前列腺切除术或6例患者接受体外放疗进行确定性治疗之前，于新辅助治疗中给予单次3个月剂型的LH-RH激动剂。在注射后3、4、6、7、9、12、15和18个月测量基线及系列睾酮水平。按照相同时间安排记录与急性睾酮缺乏相关的症状，即潮热和盗汗。
单次注射3个月LH-RH激动剂后，去势水平睾酮（0.2 ng/ml或更低）的中位持续时间为6个月。性腺功能减退症状（潮热和盗汗）的中位持续时间为13.6个月，症状缓解与血清睾酮逐渐恢复至基线值同步。
在新辅助治疗中给予的3个月剂型LH-RH激动剂提供去势水平睾酮的持续时间比产品标签所示更长。如果得到证实，这些初步观察结果对给药方案和新辅助研究考量具有重要意义。
