Wu C C, Xue Z Y, Apichat K, Huang S T, He Z, Garceau R J
ChangGung Memorial Hospital, Taoyoan, Taiwan, People's Republic of China.
Clin Ther. 1996 Mar-Apr;18(2):256-64. doi: 10.1016/s0149-2918(96)80006-3.
This study evaluated the individual optimal dose of alprostadil in the office setting that could be used as the basis for effective home self-injection therapy. The study included 150 Asian men with erectile dysfunction (ED). The mean age of study participants was 48.3 years (range, 21 to 74 years), and the mean duration of ED was 3.6 years. The most common cause of ED was venogenic (24%), psychogenic (21%), arteriogenic (13%), neurogenic (0.7%), or a combination of these (41%). An optimal response was seen in 72% of patients (n = 108) in the office and 96% of patients (n = 100) at home. The mean +/- SD office dose of alprostadil was 19.4 +/- 12.8 micrograms versus 18.0 +/- 12.2 micrograms at home. More than half of the patients (57% in an office setting and 53% at home) achieved an optimal response at a dose between 5 and 15 micrograms. By the 20-micrograms dose, 82% of patients had achieved an optimal dose at home compared with 70% of patients in the office. An optimal response was seen at the same dose in the office and home in 75% of patients; the dose at home decreased from the office dose for 16% of the patients and increased for 9%. There were 24 patients who experienced adverse events: penile pain after injection (18 patients), cold sweating (2 patients), pediculosis (1 patient), broken leg (1 patient), ankle pain (1 patient), and prolonged erection (1 patient). One patient discontinued the study because of penile pain. Alprostadil sterile powder offered safe and effective treatment of ED for home self-injection therapy. Once an optimal dose response had been established in the physician's office, further home adjustments were needed in 25% of patients. Penile pain, usually mild, was the most common, possibly related adverse effect reported.
本研究评估了在门诊环境中前列地尔的个体最佳剂量，该剂量可作为有效的家庭自我注射治疗的基础。该研究纳入了150名患有勃起功能障碍（ED）的亚洲男性。研究参与者的平均年龄为48.3岁（范围为21至74岁），ED的平均持续时间为3.6年。ED最常见的病因是静脉性（24%）、心理性（21%）、动脉性（13%）、神经性（0.7%）或这些因素的组合（41%）。72%的患者（n = 108）在门诊出现最佳反应，96%的患者（n = 100）在家中出现最佳反应。前列地尔在门诊的平均±标准差剂量为19.4±12.8微克，在家中为18.0±12.2微克。超过一半的患者（门诊为57%，在家中为53%）在5至15微克的剂量下达到最佳反应。到20微克剂量时，82%的患者在家中达到最佳剂量，而门诊为70%。75%的患者在门诊和家中相同剂量下出现最佳反应；16%的患者在家中的剂量低于门诊剂量，9%的患者高于门诊剂量。有24名患者经历了不良事件：注射后阴茎疼痛（18名患者）、冷汗（2名患者）、虱病（1名患者）、腿部骨折（1名患者）、踝关节疼痛（1名患者）和阴茎异常勃起（1名患者）。1名患者因阴茎疼痛而退出研究。前列地尔无菌粉末为家庭自我注射治疗ED提供了安全有效的治疗方法。一旦在医生办公室确定了最佳剂量反应，25%的患者还需要在家中进一步调整。阴茎疼痛通常较轻，是报告的最常见的可能相关的不良反应。
