Veroux Pierfrancesco, Veroux Massimiliano, Macarone Maurizio, Bonanno Maria Giovanna, Tumminelli Maria Giuseppina
Department of Surgery, Transplantation and Advanced Technologies, University Hospital of Catania, Catania, Italy.
Curr Ther Res Clin Exp. 2004 May;65(3):255-65. doi: 10.1016/S0011-393X(04)80067-5.
Patients with advanced peripheral atherosclerotic occlusive disease who are no longer candidates for either surgical or intravascular treatment or who have undergone unsuccessful surgical revascularization may be treated with IV prostanoids.
The aim of this study was to assess the efficacy, tolerability, compliance, and cost of a new system of prostanoid administration that provides a constant plasma concentration of iloprost and maintains the efficacy of the drug while reducing the risk for adverse effects (AEs) and the overall cost of treatment compared with the actually adopted infusion system.
This open-label, nonrandomized study was conducted at the University Hospital of Catania (Catania, Italy). Patients with chronic critical ischemia who were not candidates for surgical revascularization were observed. The study population was divided into 2 groups: patients in group A were treated with a continuous 6-hour IV infusion of iloprost 0.5 to 2.0 ng/kg.min once daily for at least 14 consecutive days, and patients in group B were treated with a 20-day iloprost continuous IV infusion at a mean dosage of 25 μg/d by means of a portable elastomeric infusion system. Every 5 days the patient was admitted to the day-hospital setting to replenish the drug. Primary end points were rates of major and minor amputations and death; secondary end points were complete relief or a marked reduction of pain at rest, as reflected by discontinuation of analgesic therapy and by a decrease in the patients' complaints of pain, as well as by the satisfactory healing of ulcerations. Tolerability, compliance, and cost also were assessed.
Fifty-six patients (34 men, 22 women; mean [SD] age, 67 [11] years) entered the study. Group A comprised 25 patients; group B, 31 patients. The rate of major amputation in patients at Fontaine stage IV was higher in group A (33.3%) compared with group B (20.0%). The death rate was higher in group A (4.0%) than in group B (3.2%). Pain at rest completely subsided in 37.5% of patients in group A and 68.8% of patients in group B. Trophic lesions healed in 44.4% and 73.3% of patients in groups A and B, respectively. In group A, 40.0% of patients experienced AEs (ie, hyperemia, headache, flushing) that required a reduction in dose. In group B, 6.5% of patients had hyperemia at the injection site that required a reduction in dose. Total cost wasin group B wasd €1995.60, with a mean hospital stay of 6 days. Overall, patients' quality of life, assessed as the ability to resume their normal social activities, improved.
In this study of patients with chronic lower-limb critical ischemia, due to the consistent blood level achieved with iloprost, 20-day iloprost continuous IV infusion at a mean dosage of 25 μg/d administered by means of a portable elastomeric infusion system was shown to be similarly or more effective than the Methods used by the most important European trials (ie, iloprost 0.5-2.0 ng/kg·min once daily for at least 14 consecutive days). Furthermore, the patients were more compliant and the cost of treatment and the length of hospitalization were reduced compared with iloprost 0.5 to 2.0 ng/kg·min once daily for at least 14 consecutive days.
晚期外周动脉粥样硬化闭塞性疾病患者若不再适合手术或血管内治疗，或手术血运重建失败，可采用静脉注射前列腺素类药物治疗。
本研究旨在评估一种新的前列腺素给药系统的疗效、耐受性、依从性和成本，该系统可使伊洛前列素的血浆浓度恒定，维持药物疗效，同时降低不良反应（AE）风险和总体治疗成本，并与实际采用的输注系统进行比较。
这项开放标签、非随机研究在意大利卡塔尼亚大学医院进行。观察慢性严重缺血且不适合手术血运重建的患者。研究人群分为2组：A组患者每天接受一次伊洛前列素0.5至2.0 ng/kg·min持续6小时静脉输注，至少连续14天；B组患者通过便携式弹性体输注系统以平均剂量25μg/d进行20天的伊洛前列素持续静脉输注。每5天患者到日间医院补充药物。主要终点是大截肢和小截肢率以及死亡率；次要终点是静息痛完全缓解或显著减轻，表现为停止镇痛治疗、患者疼痛主诉减少以及溃疡愈合良好。还评估了耐受性、依从性和成本。
56例患者（34例男性，22例女性；平均[标准差]年龄67[11]岁）进入研究。A组25例患者；B组31例患者。A组中处于Fontaine IV期患者的大截肢率（33.3%）高于B组（20.0%）。A组死亡率（4.0%）高于B组（3.2%）。A组37.5%的患者静息痛完全缓解，B组为68.8%。A组和B组分别有44.4%和73.3%的患者营养性病变愈合。A组40.0%的患者出现需要减少剂量的AE（即充血、头痛、潮红）。B组6.5%的患者注射部位出现充血，需要减少剂量。B组总费用为1995.60欧元，平均住院天数为6天。总体而言，患者恢复正常社交活动能力所评估的生活质量有所改善。
在这项针对慢性下肢严重缺血患者的研究中，由于伊洛前列素可实现稳定的血药浓度，通过便携式弹性体输注系统以平均剂量25μg/d进行20天的伊洛前列素持续静脉输注显示出与欧洲最重要试验所采用方法（即每天一次伊洛前列素0.5 - 2.0 ng/kg·min，至少连续14天）相似或更有效的效果。此外，与每天一次伊洛前列素0.5至2.0 ng/kg·min至少连续14天相比，患者依从性更高，治疗成本和住院时间降低。
