Werner-Schlenzka H, Lehnert W
Schering AG, Clinical Development Dermatology, Berlin, Germany.
Prostaglandins Leukot Essent Fatty Acids. 1994 Sep;51(3):203-6. doi: 10.1016/0952-3278(94)90135-x.
In a randomized, double-blind, placebo controlled study in patients with venous leg ulcers, the efficacy and tolerability of topical applications of a prostacylin hydrogel (iloprost) was investigated. 34 patients were allocated to the placebo treatment and 65 patients were allocated to the iloprost treatment. The iloprost treatment commenced with 10 micrograms/ml for the first 3 days and was increased to 40 micrograms/ml for the remaining treatment period if well tolerated. Maximally 3 ml of the hydrogel were applied daily on the ulcer base for a period of 8 weeks. The total area of the ulcers at the last individual assessment was chosen as the main criterion for evaluation of efficacy. Both concentrations of iloprost were well tolerated with almost the entire trial population on iloprost being treated with the 40 micrograms/ml iloprost hydrogel. With regards to efficacy, no significant difference was found in favour of the iloprost treatment.
在一项针对下肢静脉溃疡患者的随机、双盲、安慰剂对照研究中，对前列环素水凝胶（伊洛前列素）局部应用的疗效和耐受性进行了调查。34名患者被分配到安慰剂治疗组，65名患者被分配到伊洛前列素治疗组。伊洛前列素治疗开始时前3天使用10微克/毫升，若耐受性良好，则在剩余治疗期间增加至40微克/毫升。每天在溃疡底部最大涂抹3毫升水凝胶，持续8周。将最后一次个体评估时溃疡的总面积作为评估疗效的主要标准。两种浓度的伊洛前列素耐受性均良好，几乎整个伊洛前列素试验人群都接受了40微克/毫升伊洛前列素水凝胶治疗。在疗效方面，未发现伊洛前列素治疗有显著优势。
