Emtage L A, Perren T J, Stuart N S, Arkell D G, Wallace D M, Hughes M A, Cottam J, Farrar D, Young C H, Blackledge G R
West Midlands Cancer Research Campaign Clinical Trials Unit, Department of Medicine, Queen Elizabeth Hospital, Birmingham.
Br J Urol. 1987 Nov;60(5):436-42. doi: 10.1111/j.1464-410x.1987.tb05010.x.
Zoladex is a potent decapeptide analogue of luteinising hormone releasing hormone (LHRH). The drug is formulated as a 3.6 mg depot dispersed in a matrix of d,l-lactide-glycolide copolymer, which is totally biodegradable. This formula releases drug continuously for at least 28 days and reliably suppresses serum testosterone into the castrate range. The effect of the depot was studied in 29 patients with locally advanced or metastatic carcinoma of the prostate. Average age at entry was 71 years (range 52-87) and follow-up was from 13.5 to 34.5 months (median 23). Endocrine studies showed that medical castration was maintained in all cases. Three patients experienced bone pain in the first month of treatment and two others had temporary nephrostomies for worsening ureteric obstruction. Subjective improvement was seen in 23/28 cases (82%). There were no complete responses, but partial response was seen in 24/28 (85.7%) using our own criteria, 24/28 (85.7%) using the criteria recommended by the British Prostate Group (BPG) and 15/28 (53.6%) using NPCP criteria. Stable disease was seen in 3/28 patients (10.7%) by our own or BPG criteria, and in 12/28 patients (42.9%) according to NPCP criteria. Progression of disease was measurable in 21 patients (72.4%) whatever criteria were applied; 11/29 (37.9%) have died, giving a median survival of 10 months (range 2.4-26). Following these encouraging results, a multicentre randomised comparative study with stilboestrol 3 mg daily is being undertaken.
诺雷德是一种促黄体生成素释放激素（LHRH）的强效十肽类似物。该药物被制成3.6毫克的长效注射剂，分散于d，l-丙交酯-乙交酯共聚物基质中，这种基质完全可生物降解。该剂型可持续释放药物至少28天，并能可靠地将血清睾酮抑制到去势水平。对29例局部晚期或转移性前列腺癌患者研究了这种长效注射剂的效果。入组时的平均年龄为71岁（范围52 - 87岁），随访时间为13.5至34.5个月（中位数23个月）。内分泌研究表明所有病例均维持了药物去势状态。3例患者在治疗的第一个月出现骨痛，另外2例因输尿管梗阻加重而进行了临时肾造瘘术。28例中有23例（82%）出现主观改善。没有完全缓解的病例，但按照我们自己的标准，28例中有24例（85.7%）出现部分缓解；按照英国前列腺研究组（BPG）推荐的标准为24/28（85.7%）；按照NPCP标准为15/28（53.6%）。按照我们自己或BPG标准，28例中有3例（10.7%）病情稳定；按照NPCP标准为12/28例（42.9%）。无论采用何种标准，21例患者（72.4%）疾病出现进展；11/29（37.9%）已经死亡，中位生存期为10个月（范围2.4 - 26个月）。基于这些令人鼓舞的结果，正在进行一项与每日服用3毫克己烯雌酚的多中心随机对照研究。
