Vanderschueren D, Heyrman R M, Keogh E J, Casey R W, Weiske W H, Ogrinc F G, de Koning Gans H J
Department of Endocrinology, Catholic University of Leuven, Belgium.
J Urol. 1995 Nov;154(5):1744-7.
Prostaglandin E1 sterile powder and sterile solution are 2 new formulations of exogenous prostaglandin E1 that are more convenient for auto-injection therapy for erectile dysfunction than the presently used pediatric sterile solution. Therefore, the pharmacodynamic profiles of intracavernous prostaglandin E1 sterile powder and nonalcohol sterile solution were compared with the pediatric sterile solution in men with erectile dysfunction who were known to be stable responders to intracavernous prostaglandin E1.
Based on the dose used at home, patients were randomized to 1 of 5 dose groups: 0 microgram. (placebo), 2.5 micrograms., 5 micrograms., 10 micrograms. or 20 micrograms. Each patient received a single injection of the same dose of each of the 3 formulations. The primary pharmacodynamic end points were clinical evaluation of erectile response, RigiScan real-time evaluation of erectile response and patient evaluation of erectile response.
No significant differences were identified among the formulations for any of these end points, either by comparison among all active doses or by comparison at each prostaglandin E1 dose level. There was also little or no intra-patient variation in dose response and the inter-dose variation in response between patients was not significant. Pharmacodynamic end points were well intercorrelated, although assessment of erectile response by the patients tended to be more positive than that by RigiScan or clinical evaluation. There were no major side effects. Penile pain on injection and/or during erection occurred in 9 to 17% of the patients according to the formulations. However, penile pain was also reported by 11% of the placebo-treated patients. CONCLUSIONS;: The 3 formulations of prostaglandin E1 showed equivalence and were safe for the treatment of erectile dysfunction with respect to side effects.
前列腺素E1无菌粉末和无菌溶液是两种新型外源性前列腺素E1制剂，与目前使用的儿科无菌溶液相比，在勃起功能障碍的自动注射治疗中更为方便。因此，在已知对海绵体内前列腺素E1反应稳定的勃起功能障碍男性中，比较了海绵体内前列腺素E1无菌粉末和无醇无菌溶液与儿科无菌溶液的药效学特征。
根据患者在家中使用的剂量，将患者随机分为5个剂量组之一：0微克（安慰剂）、2.5微克、5微克、10微克或20微克。每位患者接受一次注射，三种制剂的剂量相同。主要药效学终点是勃起反应的临床评估、勃起反应的RigiScan实时评估和患者对勃起反应的评估。
在所有活性剂量之间进行比较，或在每个前列腺素E1剂量水平进行比较时，这些终点在任何一种制剂之间均未发现显著差异。患者内剂量反应的变化也很小或没有，患者之间剂量反应的变化也不显著。药效学终点之间相关性良好，尽管患者对勃起反应的评估往往比RigiScan或临床评估更为积极。没有重大副作用。根据制剂不同，9%至17%的患者在注射时和/或勃起期间出现阴茎疼痛。然而，11%接受安慰剂治疗的患者也报告有阴茎疼痛。结论：前列腺素E1的三种制剂在治疗勃起功能障碍方面显示出等效性，且副作用方面是安全的。
