Werner-Schlenzka H, Kuhlmann R K
Schering AG, Strategische Geschäftseinheit Onkologie und Dermatologie.
Vasa. 1994;23(2):145-50.
The disturbed microcirculation is seen as a causative factor in provoking venous leg ulcers. The stable prostacyclin analogue iloprost has shown beneficial effects on the disturbed microcirculation after intravenous infusions. In this study the topical route was chosen in order to facilitate handling and to reduce the possibility of systemic adverse reactions. The aim of this study was to assess the efficacy and tolerability of two concentrations of iloprost solutions (0.0005% and 0.002%). The trial design was a randomized, double-blind, placebo controlled study in 11 centres in Germany with 49 patients allocated to treatment 1 (placebo solution); 49 patients to treatment 2 (0.0005% iloprost solution) and 50 patients to treatment 3 (0.002% iloprost solution). The study solutions were applied twice weekly for a period of eight weeks on the ulcer edge and ulcer surrounding. This study failed to show any statistically significant reduction in the ulcer size as a result of the iloprost treatment compared to the placebo treatment. Possible reasons for the findings are discussed.
微循环紊乱被视为引发下肢静脉溃疡的一个致病因素。稳定的前列环素类似物伊洛前列素在静脉输注后，已显示出对紊乱的微循环有有益作用。在本研究中，选择局部给药途径是为了便于操作并降低发生全身不良反应的可能性。本研究的目的是评估两种浓度的伊洛前列素溶液（0.0005%和0.002%）的疗效和耐受性。试验设计为一项在德国11个中心进行的随机、双盲、安慰剂对照研究，49例患者被分配到治疗1组（安慰剂溶液）；49例患者被分配到治疗2组（0.0005%伊洛前列素溶液），50例患者被分配到治疗3组（0.002%伊洛前列素溶液）。研究溶液每周两次应用于溃疡边缘和溃疡周围，持续八周。与安慰剂治疗相比，本研究未能显示伊洛前列素治疗导致溃疡大小有任何统计学上的显著减小。文中讨论了该研究结果的可能原因。
