小剂量前列腺素E1乳膏治疗勃起功能障碍的疗效观察

目的 :探讨小剂量前列腺素E1(PGE1)乳膏尿道口给药治疗勃起功能障碍 (ED)的疗效。　方法 :按入选标准及国际勃起功能问卷 (IIEF) 5评分录取 4 3例ED病人 ,经签知情同意书后 ,进入为期 4周的开放性临床研究。采用尿道口内挤入乳膏的方法 ,以手持阴茎保持向上位以手指关闭尿道口 30s ,每次尿道口给药量为 30 0mcgPGE1(75mg乳膏 ) ,每例最少用药 2次以上。　结果 :对主要疗效指标 (IIEFQ3+Q4 )的分析结果显示 ,受试者在使用本研究药物后进行性活动时 ,其阴茎勃起程度达到显效和有效者占 70 .73%。若按性交次数计算 ,性交成功率达 86 .4 1%。总体疗效评估的分析结果为 73.17%。同时 ,所有次要疗效评估 (IIEFQ1、Q2、Q5～Q15 )的分析结果 ,均一致支持主要疗效评估的分析结果。因各种原因中止试验的有 2例 ,发生尿道疼痛或阴茎红肿共 6例 ,占14 .6 3% ,多数为轻度、一过性的。　结论 :可将乳膏的PGE1给药剂量降至 30 0mcg时 ,采用尿道口挤入方法给药 ,仍可取得良好的疗效

The Therapeutic Efficacy for ED Patients Treated with Low Dosage of PGE1

Objectives: To evaluate the efficacy of intrameatal application of low dosage alprostadil (PGE1) cream (300 mcg) for the treatment of erectile dysfunction (ED). Methods: A total of 43 ED patients were selected in the study based on the inclusion criteria. All of the patients signed informed consent forms and entered a 4 week open label clinical study. A dosage of 300 mg PGE1 in 75 mg cream was applied intrameatally. Results: The results showed that the primary efficacy (IIEF Q3+Q4) reached 70.73% after application of the cream.The successful intercourse rate was 86.41%. Based on the GAQ (global assessment Question), 73.17% of the patients were satisfied with their sexual life. At the same time, all of the secondary criteria supported the primary efficacy results. Two patients withdrew during the study period. Six patients (14.63%) had urethral pain or penile redness, which were mostly mild and transient. Conclusions: With intrameatal low dosage (300 mcg PGE1) of the PGE1 cream can achieve an equivalent efficacy as that with the full dosage. Natl J Androl,2003,9(1):48 50