Guay A T, Perez J B, Velásquez E, Newton R A, Jacobson J P
Center For Sexual Function, Lahey Clinic Northshore, Peabody, MA 01960, USA.
Eur Urol. 2000 Dec;38(6):671-6. doi: 10.1159/000020360.
The Food and Drug Administration (USA) approved the transurethral administration of prostaglandin (alprostadil in January 1997), which had an efficacy of approximately 50% in clinical trials. We studied its effectiveness in clinical practice.
Patient and partner education was followed by an initial office trial of a medicated urethral system for erection (MUSE) after other medical risk factors were corrected during a 2- to 4-month period. The initial titration dose of alprostadil was usually 125 or 250 microg. Further titration, if needed, was instituted by the patient at home. Success was determined as the satisfactory completion of sexual intercourse in more than 66% of attempts, with a minimum of two being required.
Two hundred and seventy patients entered the trials, and follow-up information was available in 229 (85%). The overall success rate was 56%. The dose required was 500 microg in 49.2% and 1,000 microg in 42.2%. Of the 44% in whom treatment failed, 61.4% did so because of lack of efficacy and 38.6% because of side effects (genital pain or urethral bleeding). Minor urogenital symptoms, which did not interfere with treatment, occurred in an additional 40% of patients.
The efficacy of transurethral administration of alprostadil (56%) is higher than the initial published clinical trial data and higher than recent reported clinical experiences, although higher doses were required in our study. Men over 50 years of age, having an organic cause for erectile dysfunction, had better responses. Patient and partner education is important for successful treatment, and the in-office initial titration is an integral part of this success. Prior correction of medical risk factors may enhance the success rate.
美国食品药品监督管理局于1997年1月批准经尿道给予前列腺素（前列地尔），其在临床试验中的有效率约为50%。我们研究了其在临床实践中的有效性。
在2至4个月期间纠正其他医学风险因素后，先对患者及其伴侣进行教育，然后进行初次门诊试用阴茎海绵体注射前列地尔。前列地尔的初始滴定剂量通常为125或250微克。如有需要，患者可在家中进行进一步滴定。成功的判定标准为超过66%的性交尝试能够满意完成，且至少需要两次尝试。
270名患者进入试验，229名（85%）有随访信息。总体成功率为56%。所需剂量为500微克的占49.2%，1000微克的占42.2%。在治疗失败的44%患者中，61.4%是因为缺乏疗效，38.6%是因为副作用（生殖器疼痛或尿道出血）。另外40%的患者出现了不影响治疗的轻微泌尿生殖系统症状。
经尿道给予前列地尔的有效率（56%）高于最初发表的临床试验数据，也高于近期报道的临床经验，尽管在我们的研究中需要更高的剂量。50岁以上、有器质性勃起功能障碍病因的男性反应更好。患者及其伴侣的教育对成功治疗很重要，门诊初次滴定是成功的一个组成部分。预先纠正医学风险因素可能会提高成功率。
