Eur J Vasc Endovasc Surg. 1998 Apr;15(4):300-7. doi: 10.1016/s1078-5884(98)80032-4.
To assess efficacy and tolerability of two dosages of the oral prostacyclin analogue iloprost versus placebo in thromboangiitis obliterans (TAO).
Placebo-controlled, double-blind, study; TAO patients randomised to iloprost 100, 200 micrograms, or placebo bid for 8 weeks, with 6 months' follow-up.
Three-hundred and nineteen TAO patients with rest pain, trophic lesions (or both) from 23 clinics in six European countries. Primary endpoint: total healing of most important lesion. Secondary endpoint: relief of rest pain without need of analgesics. Combined endpoint: alive without major amputation, no lesions, no rest pain, no use of analgesics.
Total healing of lesions was not significantly different between treatment groups at any time point. For relief of rest pain without need of analgesics, low dose (LD) iloprost was significantly more effective than placebo at end of follow-up (placebo 49%; LD iloprost 63%; p = 0.020). This also applied to the combined endpoint (placebo 35%; LD iloprost 50%; p = 0.016). High dose iloprost (HD) failed to show significant treatment effects over placebo.
Iloprost LD was significantly more effective than placebo for relief of rest pain without need of analgesics and for a combined endpoint at 6 months of follow-up, whilst both iloprost doses showed no significant effects vs. placebo on total healing of lesions.
评估两种剂量的口服前列环素类似物伊洛前列素与安慰剂相比治疗血栓闭塞性脉管炎（TAO）的疗效和耐受性。
安慰剂对照、双盲研究；TAO患者随机分为伊洛前列素100微克、200微克组或安慰剂组，每日两次，治疗8周，并随访6个月。
来自欧洲六个国家23家诊所的319例有静息痛、营养性病变（或两者皆有）的TAO患者。主要终点：最重要病变完全愈合。次要终点：无需使用镇痛药即可缓解静息痛。联合终点：存活且未进行大截肢、无病变、无静息痛、未使用镇痛药。
在任何时间点，各治疗组之间病变的完全愈合情况均无显著差异。对于无需使用镇痛药即可缓解静息痛，低剂量（LD）伊洛前列素在随访结束时比安慰剂显著更有效（安慰剂组49%；LD伊洛前列素组63%；p = 0.020）。这也适用于联合终点（安慰剂组35%；LD伊洛前列素组50%；p = 0.016）。高剂量伊洛前列素（HD）未显示出比安慰剂更显著的治疗效果。
在随访6个月时，低剂量伊洛前列素在无需使用镇痛药即可缓解静息痛以及联合终点方面比安慰剂显著更有效，而两种剂量的伊洛前列素在病变完全愈合方面与安慰剂相比均未显示出显著效果。
