Jiménez Cruz J F, Vera Donoso C D, Iborra I, Solsona E, Forner E, Villavicencio H, Díaz C, González C, Rioja L, Pertusa C
Instituto Valenciano de Oncología, Hospital La Fe, Valencia.
Actas Urol Esp. 1994 Feb;18(2):90-3.
Seventy-two patients were admitted in a multicentre trial with the purpose of assessing the clinical efficacy and safety of the hormonal control and tolerance of leuprolide acetate in a once-a-month depot injection formulation for the treatment of disseminated prostate cancer. During a 1-year follow-up, there were ten withdrawals for different reasons. At baseline and at 6 months of treatment the following parameters were evaluated: clinical examination, routine blood analysis, PAP, PSA, LH and testosterone, as well as bone scan. LH and testosterone determinations were repeated at 2, 4, 8, 12, 16, 20 and 24 weeks. Testosterone reached castration levels within the second week and was maintained until the end of the study. In agreement with the NPCP criteria, 65 patients were assessed as: complete response 3%, partial response 40%, disease stabilization 36%, and progression 21%. In summary, a once-a-month injection of leuprolide acetate offers a safe and effective alternative to surgical castration.
在一项多中心试验中,72名患者入组,目的是评估醋酸亮丙瑞林每月一次长效注射制剂治疗播散性前列腺癌时激素控制情况及耐受性的临床疗效和安全性。在1年的随访期间,有10名患者因不同原因退出。在基线和治疗6个月时,评估了以下参数:临床检查、血常规分析、前列腺酸性磷酸酶(PAP)、前列腺特异性抗原(PSA)、促黄体生成素(LH)和睾酮,以及骨扫描。在第2、4、8、12、16、20和24周重复测定LH和睾酮。睾酮在第二周内达到去势水平,并维持到研究结束。根据NPCP标准,65名患者的评估结果为:完全缓解3%,部分缓解40%,病情稳定36%,进展21%。总之,每月一次注射醋酸亮丙瑞林为手术去势提供了一种安全有效的替代方法。