Tsai Y S, Lin J S, Lin Y M
Department of Urology, National Cheng Kung University Medical College and Hospital, Tainan, Taiwan.
Eur Urol. 2000 Aug;38(2):177-83. doi: 10.1159/000020277.
To evaluate the long-term efficacy and safety of intracavernosal alprostadil (CAVERJECT((R))) in diabetic patients with erectile dysfunction (ED).
This study included 31 diabetic men (aged 44-75 years) with ED of >/=4 months duration. All patients were initially instructed in the self-injection technique at the investigator's clinic. The optimal dose was determined for each patient and set at one of the following: 5, 10, 20, 30, 40, 50, or 60 microg. After the optimal dose was determined and the patient was well trained, the self-injection home phase was followed for 6 months. The efficacy and adverse events were documented.
An optimal dose was determined for 29 men (93.5%) and in 16 men (55%) it was >/=20 microg. During the home phase, 76.5% of injections assessed by the patients resulted in satisfactory sexual activity and 72.5% of injections assessed by partners resulted in satisfactory intercourse. A total of 16 patients dropped out during the titration phase (n = 2) and the home phase (n = 14). The most common reasons included lack of efficacy (n = 3, all in the home phase), intolerable penile pain (1 in the titration phase, 2 in the home phase) and dissatisfaction with the higher dosage (n = 2). Penile pain occurred in 19 (61%) of 31 patients. Most were tolerable, and the incidence decreased with time. Prolonged erection occurred in 2 men (6.5%), and no priapism was noted. Penile fibrosis occurred in 1 patient (3. 2%). None of the systemic medical events were related to the study mediction. However, 1 patient suffered from right putaminal hemorrhage in the last month, and this was considered to be caused by underlying hypertension and not drug-related.
Despite the high incidence of penile pain, most of the occurrences were tolerable. Despite a higher withdrawal rate in this study, intracavernosal alprostadil is still considered as a relatively effective and safe treatment in some diabetic patients with ED if the individual dose is established by titration and patients are trained in the self-injection technique with period supervision.
评估海绵体内注射前列地尔（凯威捷（R））治疗糖尿病性勃起功能障碍（ED）患者的长期疗效和安全性。
本研究纳入31例患有ED且病程≥4个月的糖尿病男性患者（年龄44 - 75岁）。所有患者最初在研究者的诊所接受自我注射技术指导。为每位患者确定最佳剂量，并设定为以下剂量之一：5、10、20、30、40、50或60微克。在确定最佳剂量且患者接受充分培训后，进行为期6个月的家庭自我注射阶段。记录疗效和不良事件。
为29名男性（93.5%）确定了最佳剂量，其中16名男性（55%）的最佳剂量≥20微克。在家庭自我注射阶段，患者评估的注射中有76.5%导致满意的性活动，伴侣评估的注射中有72.5%导致满意的性交。共有16名患者在滴定阶段（2例）和家庭自我注射阶段（14例）退出研究。最常见的原因包括疗效不佳（3例，均在家庭自我注射阶段）、难以忍受的阴茎疼痛（滴定阶段1例，家庭自我注射阶段2例）以及对较高剂量不满意（2例）。31例患者中有19例（61%）出现阴茎疼痛。大多数疼痛可耐受，且发生率随时间下降。2名男性（6.5%）出现阴茎异常勃起延长，未观察到阴茎持续勃起。1例患者（3.2%）出现阴茎纤维化。无全身性医疗事件与研究药物相关。然而，1例患者在最后一个月发生右侧壳核出血，这被认为是由潜在的高血压引起而非药物相关。
尽管阴茎疼痛发生率高，但大多数情况可耐受。尽管本研究中有较高的退出率，但如果通过滴定确定个体剂量并在定期监督下对患者进行自我注射技术培训，海绵体内注射前列地尔在一些糖尿病性ED患者中仍被认为是一种相对有效且安全的治疗方法。
