Wechsel H W, Zerbib M, Pagano F, Coptcoat M J
Urological Clinic, University of Tübingen, Germany.
Eur Urol. 1996;30 Suppl 1:7-14; discussion 19-21. doi: 10.1159/000474238.
In a European, prospective, 1:2 randomized phase II multicentre study, 237 patients with advanced or metastatic prostate cancer were treated with either the 1M- (80 patients) or 3M-depot formulation (157 patients) of leuprorelin acetate for 9 months to compare efficacy and safety.
Standard clinical investigations and methods were employed in the study. Leuprorelin levels were determined using a specially modified RIA.
The two formulations produced virtually identical effects with a pronounced fall in testosterone and gonadotropin serum levels and a marked reduction in PSA levels. After 9 months' treatment, PSA was normalized (< or = 4 ng/ml) in 65.2 and 66.1% of the 1M and 3M depot patients, respectively. The best response to 1M vs. 3M depot during the study was as follows: complete remission in 5 vs. 5.7%, partial remission in 36.3 vs. 33.8% and stabilization in 40.0 vs. 40.8%. The main side effects of both formulations were related to androgen deprivation.
Comparable results were recorded for the two formulations of leuprorelin acetate in terms of clinical response, endocrine effects and tolerability. The newly developed leuprorelin acetate 3M depot, as a refinement of the established 1M depot, offers an opportunity to improve patient compliance and provides individualized and optimized, patient-orientated treatment by reducing the number of injections to four per year.
在一项欧洲前瞻性、1:2随机II期多中心研究中，237例晚期或转移性前列腺癌患者接受醋酸亮丙瑞林1M剂型（80例患者）或3M长效剂型（157例患者）治疗9个月，以比较疗效和安全性。
研究采用标准临床调查和方法。使用经过特殊改良的放射免疫分析法测定亮丙瑞林水平。
两种剂型产生的效果几乎相同，睾酮和促性腺激素血清水平显著下降，前列腺特异性抗原（PSA）水平明显降低。治疗9个月后，1M长效剂型和3M长效剂型患者中PSA正常化（≤4 ng/ml）的比例分别为65.2%和66.1%。研究期间1M长效剂型与3M长效剂型的最佳反应如下：完全缓解率分别为5%和5.7%，部分缓解率分别为36.3%和33.8%，病情稳定率分别为40.0%和40.8%。两种剂型的主要副作用均与雄激素剥夺有关。
醋酸亮丙瑞林的两种剂型在临床反应、内分泌效应和耐受性方面取得了可比的结果。新开发的醋酸亮丙瑞林3M长效剂型是现有1M长效剂型的改进，通过将注射次数减少至每年4次，为提高患者依从性提供了契机，并提供了个体化、优化的以患者为导向的治疗。
