Int Angiol. 1994 Mar;13(1):70-4.
GISAP, a multicentre open study, was aimed to confirm the feasibility and safety of iloprost treatment in normal clinical practice and to identify subgroups of patients with severe POAD more likely to benefit from iloprost treatment than others. One hundred forty six patients were treated at the maximum tolerated dose of iloprost up to 2 ng/kg/min, 6 hours infusion per day, for a minimum of 3 weeks and a maximum of 8 weeks. Clinical efficacy was assessed by rest pain reduction, analgesic consumption, healing of trophic lesions, walking ability. A significant improvement of the efficacy parameters was recorded during and at the end of treatment: no difference between diabetics and non diabetics, stage III and IV patients was observed. After one year follow-up 10% major amputation and 6.8% death were recorded, these events were balanced between the diabetic and non diabetic patients. Overall 80% of the patients at risk of amputation at entry to the trial were alive with a viable limb after one year. Tolerability resulted quite acceptable. Even with the limitation of an open trial, it has been confirmed the therapeutic potential of iloprost in the treatment of POAD patients.
GISAP是一项多中心开放性研究，旨在证实伊洛前列素在常规临床实践中的可行性和安全性，并确定重度外周动脉疾病（POAD）患者中比其他患者更可能从伊洛前列素治疗中获益的亚组。146例患者接受伊洛前列素治疗，最大耐受剂量为2 ng/kg/min，每天输注6小时，最少3周，最多8周。通过静息痛减轻、镇痛药使用、营养性病变愈合、行走能力来评估临床疗效。在治疗期间和结束时记录到疗效参数有显著改善：未观察到糖尿病患者与非糖尿病患者、III期和IV期患者之间存在差异。经过一年随访，记录到10%的患者进行了大截肢，6.8%的患者死亡，这些事件在糖尿病患者和非糖尿病患者之间是平衡的。总体而言，在试验开始时有截肢风险的患者中，80%在一年后存活且肢体存活。耐受性相当可接受。即使存在开放性试验的局限性，但已证实伊洛前列素在治疗POAD患者方面的治疗潜力。
