Department of Dermatology, University Hospital of Tübingen, Germany.
J Dtsch Dermatol Ges. 2009 Dec;7(12):1055-9. doi: 10.1111/j.1610-0387.2009.07101.x.
Prostaglandin E₁ ethyl ester (PGE₁-EE) is a prodrug of prostaglandin E₁ but with much improved transdermal penetration.
We performed a randomized, double-blind, controlled study in 34 patients to assess the safety and efficacy of transdermally applied PGE₁-EE for the treatment of erectile dysfunction. In a first single-blinded titration period the most appropriate PGE₁-EE dose (maximum 1000 μg) was determined. PGE₁-EE was applied to the shaft of the penis using an adhesive foil patch which contained the drug. For home use, the patients were provided with 4 patches with the appropriate dose and 2 patches with placebo containing a small dose of 5 μg PGE₁-EE to use randomly prior to sexual intercourse, waiting three days between each use.
The median rigidity score as the primary outcome variable was significantly higher after verum versus placebo applications. Also, concerning the secondary outcome variable satisfactory sexual activity, superiority was shown for verum versus placebo. Although penetrating intercourse could not be performed significantly more frequently, 50 % of patients considered the treatment successful. It was well-tolerated and local side effects were generally mild.
PGE₁-EE could be a promising drug formulation in local penile therapy of ED. In further studies higher doses should be investigated in order to potentially achieve a higher level of efficacy.
前列腺素 E₁ 乙酯（PGE₁-EE）是前列腺素 E₁ 的前体药物，但透皮渗透能力有了很大提高。
我们对 34 名患者进行了一项随机、双盲、对照研究，以评估经皮应用 PGE₁-EE 治疗勃起功能障碍的安全性和疗效。在首次单盲滴定期，确定了最合适的 PGE₁-EE 剂量（最大 1000μg）。使用含有药物的粘性箔片将 PGE₁-EE 贴在阴茎的轴上。对于家庭使用，为患者提供了 4 个带有适当剂量的贴片和 2 个含有小剂量 5μg PGE₁-EE 的安慰剂贴片，以便在性交前随机使用，每次使用之间等待三天。
主要结局变量即硬度评分在使用真药后显著高于安慰剂。此外，在次要结局变量即满意的性活动方面，真药也优于安慰剂。虽然不能显著增加插入性交的频率，但 50%的患者认为治疗成功。它耐受性良好，局部副作用通常较轻。
PGE₁-EE 可能是 ED 局部阴茎治疗的一种有前途的药物制剂。在进一步的研究中，应该研究更高的剂量，以潜在地实现更高的疗效。
