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[依洛前列素,一种稳定的前列环素衍生物,用于治疗4期动脉闭塞性疾病。一项安慰剂对照的多中心研究]

[Iloprost, a stable prostacyclin derivative, in stage 4 arterial occlusive disease. A placebo-controlled multicenter study].

作者信息

Diehm C, Abri O, Baitsch G, Bechara G, Beck K, Breddin H K, Brock F E, Clevert H D, Corovic D, Marshall M

机构信息

Abteilung für Kardiologie und Angiologie der Universität Heidelberg.

出版信息

Dtsch Med Wochenschr. 1989 May 19;114(20):783-8. doi: 10.1055/s-2008-1066673.

Abstract

The effectiveness of iloprost, a prostacyclin derivative, was assessed in a placebo-controlled multicentre trial on 101 patients with chronic arterial disease, stage IV. All patients were on a basic local treatment, 53 randomly being assigned to the iloprost group, 48 to the placebo one. Both groups received identical saline infusions, one with the other without iloprost. Infusions were given on 28 consecutive days, iloprost being added at a dose of up to 2 ng/kg.min over six hours. At the end of the treatment period, 32 of 52 patients (61.5%) of the iloprost group and eight of the 47 in the placebo group (17%) had partial or complete healing of ulcers (P less than 0.05), the treatment effect persisting in both groups for a mean duration of at least one year. Iloprost was well tolerated, once individual dosages had been appropriately adjusted. Facial flushes, headache and nausea were the most common side effects. Heart rate and blood-pressure variations did not differ between the two groups.

摘要

在一项安慰剂对照的多中心试验中,对101例IV期慢性动脉疾病患者评估了前列环素衍生物伊洛前列素的有效性。所有患者均接受基本的局部治疗,53例被随机分配至伊洛前列素组,48例被分配至安慰剂组。两组均接受相同的生理盐水输注,一组加入伊洛前列素,另一组不加。连续28天进行输注,伊洛前列素以高达2 ng/kg·min的剂量在6小时内加入。在治疗期结束时,伊洛前列素组52例患者中的32例(61.5%)和安慰剂组47例中的8例(17%)出现溃疡部分或完全愈合(P<0.05),两组的治疗效果均持续至少一年。一旦个体剂量得到适当调整,伊洛前列素耐受性良好。面部潮红、头痛和恶心是最常见的副作用。两组之间心率和血压变化无差异。

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