Balzer K, Bechara G, Bisler H, Clevert H D, Diehm C, Heisig G, Held K, Mahfoud Y, Mörl H, Rücker G
Vascular Surgical Department Evangelishes Krankenhaus, Ruhr, Germany.
Int Angiol. 1991 Oct-Dec;10(4):229-32.
Severe pain at rest is a major symptom of advanced peripheral arterial occlusive disease (PAOD). Preliminary studies of treatment with iloprost, a prostacyclin analogue, showed encouraging results in patients with ischaemic rest pain. Therefore a randomized, placebo-controlled multicentre study was undertaken in 113 patients admitted to hospital with rest pain of at least 2 weeks duration caused by severe PAOD. The patients were randomly assigned to receive 2-week placebo or iloprost infusions for 6 hours per day at a dose of 0.5-0.2 ng/kg/min in addition to conventional care. Demographic data and arteriographic findings were similar in the two groups. Eleven patients withdrew from the study before completion and 102 patients could be included in the final analysis. Significantly more patients in the iloprost group (62.5% of 48) than in the placebo group (42.6% of 54) had complete relief of pain without analgesic therapy during at least five consecutive days at the end of the treatment period (p less than 0.05, chi 2-test). Facial flush, headache and nausea were the most common side effects during iloprost infusion. Serious adverse reactions did not occur. Thus, a 2-week iloprost infusion was shown to be safe and effective as a treatment for ischaemic rest pain caused by PAOD.
静息时的剧痛是晚期外周动脉闭塞性疾病（PAOD）的主要症状。对前列环素类似物伊洛前列素治疗的初步研究表明，对患有缺血性静息痛的患者有令人鼓舞的结果。因此，对113例因严重PAOD导致至少持续2周静息痛而入院的患者进行了一项随机、安慰剂对照的多中心研究。患者被随机分配接受为期2周的安慰剂或伊洛前列素输注，除常规治疗外，每天输注6小时，剂量为0.5 - 0.2 ng/kg/min。两组的人口统计学数据和血管造影结果相似。11例患者在研究完成前退出，102例患者可纳入最终分析。在治疗期结束时，伊洛前列素组（48例中的62.5%）比安慰剂组（54例中的42.6%）有显著更多的患者在至少连续五天内无需镇痛治疗即可完全缓解疼痛（p小于0.05，卡方检验）。面部潮红、头痛和恶心是伊洛前列素输注期间最常见的副作用。未发生严重不良反应。因此，为期2周的伊洛前列素输注被证明是治疗PAOD引起的缺血性静息痛的一种安全有效的方法。
