Eur J Vasc Endovasc Surg. 1996 Oct;12(3):363-71. doi: 10.1016/s1078-5884(96)80258-9.
To investigate the effect of a 3 day perioperative iloprost regimen on the patency of femorodistal bypass grafts.
Prospective, randomised, placebo-controlled study.
Twenty-one specialised vascular surgical centres in Northern Europe. SUBJECTS AND TREATMENTS: Preoperatively 528 patients undergoing femorodistal bypass surgery were randomised to receive either iloprost or placebo intravenously at the beginning of the operation and in three daily 6 h infusions postoperatively with an intragraft injection given on completion of the bypass procedure.
Patency, surgical interventions and clinical outcome were recorded in all cases for 12 months after bypass.
Five hundred and seventeen patients received a bypass as planned and were evaluable. The graft material was vein in 424 cases (82%) and prosthetic or partly prosthetic in 92 (18%). Overall primary patency rates at 12 months were 52.0% for vein grafts and 45.1% for prosthetic grafts (p = 0.25). The effect of iloprost on primary patency was not statistically significant at 12 months in either vein or prosthetic grafts, but an early effect of improved patency in prosthetic grafts was seen over the first 3 days. Other results at the end of follow-up were similar in both treatments groups: 105 patients (20.3%) had been amputated, a further 85 (16.4%) had died and 78 (15.1%) were still suffering from rest pain or trophic lesions. Two hundred and thirty-eight patients (46.0%) were alive with both legs and either no symptoms or only intermittent claudication after 12 months.
In the setting of this multicentre trial no long-term benefits from the use of a 3 day iloprost regimen were demonstrated. Surprisingly small differences were found between the outcomes of vein and prosthetic femorodistal bypass grafts.
探讨围手术期3天伊洛前列素治疗方案对股腘动脉搭桥移植物通畅率的影响。
前瞻性、随机、安慰剂对照研究。
北欧21个专业血管外科中心。
528例行股腘动脉搭桥手术的患者，术前随机分为两组，一组在手术开始时静脉给予伊洛前列素，术后每日6小时静脉输注，共3天，并在搭桥手术完成时进行移植物内注射；另一组给予安慰剂。
记录所有病例搭桥术后12个月的通畅率、手术干预情况及临床结局。
517例患者按计划接受了搭桥手术并可进行评估。移植物材料为静脉的有424例（82%），人工血管或部分人工血管的有92例（18%）。12个月时静脉移植物的总体原发性通畅率为52.0%，人工血管移植物为45.1%（p = 0.25）。伊洛前列素对12个月时静脉或人工血管移植物原发性通畅率的影响无统计学意义，但在人工血管移植物中，最初3天可见通畅率改善的早期效应。随访结束时，两个治疗组的其他结果相似：105例患者（20.3%）接受了截肢手术，另有85例（16.4%）死亡，78例（15.1%）仍有静息痛或营养性病变。12个月后，238例患者（46.0%）双腿存活，无症状或仅有间歇性跛行。
在这项多中心试验中，未证明使用3天伊洛前列素治疗方案有长期益处。股腘动脉搭桥静脉移植物和人工血管移植物的结果差异惊人地小。
