Peetermans C, Roux E
Medical Department of SCHERING NV/SA, Diegem, Belgium.
Acta Urol Belg. 1994 Apr;62(1):77-82.
Androcur 50 was administered as monotherapy (n = 73) or as combined therapy with LH-RH agonists (n = 130) in 203 patients during a 6 month period. Eighty two patients had a local invasive disease, 119 had metastatic disease and 2 had a tumor confined to the prostate. Quality of life could be evaluated in 164 patients considered as valid cases for efficacy analysis. General well being improved in 41% of the patients, appetite was better in 34% of the patients and weight increased in 36%. Pain due to metastatic disease decreased or stabilised in 96% of the patients. Of the 203 patients, 8 patients had objective metastatic progression which led to death in one patient. The incidence of side effects observed in all 203 is as follows: 9% gynaecomastia, 6.5% gastro-intestinal disorders. Hot flushes were reported in 2% of the patients in the monotherapy and in 13% of the patients in the combined treatment. This open not controlled trial shows that the use of Androcur 50 in monotherapy or in combined treatment is an effective drug for prostatic carcinoma, improves quality of life and is generally well tolerated.
在6个月期间,对203例患者使用环丙孕酮50进行单一疗法治疗(n = 73)或与促黄体生成激素释放激素激动剂联合治疗(n = 130)。82例患者患有局部浸润性疾病,119例患有转移性疾病,2例肿瘤局限于前列腺。可对164例被视为有效疗效分析病例的患者进行生活质量评估。41%的患者总体健康状况有所改善,34%的患者食欲增强,36%的患者体重增加。96%的转移性疾病患者的疼痛减轻或稳定。在203例患者中,8例出现客观的转移进展,其中1例导致死亡。在所有203例患者中观察到的副作用发生率如下:乳腺增生9%,胃肠道疾病6.5%。单一疗法中2%的患者和联合治疗中13%的患者报告有潮热。这项开放的非对照试验表明,环丙孕酮50单一疗法或联合治疗是治疗前列腺癌的有效药物,可改善生活质量,且总体耐受性良好。