Laurora G, Belcaro G, Cesarone M R, Incandela L, De Sanctis M T, Dugall M
Angiology and Vasc. Surgery, Clinical Trials Unit, Pierangeli Clinic, Pescara.
Minerva Cardioangiol. 1998 Oct;46(10 Suppl 1):65-8.
A group of patients with severe peripheral vascular disease has been treated with PGE1 alpha-ciclodestrina (as reported in the previous 9 articles) including 595 patients (mean age 64.52 +/- 12; 307 with intermittent claudication and 237 with critical limb ischemia, rest pain and gangrene). Also 51 diabetics were studied and treated (25% with claudication and the remaining group with critical ischemia and/or neuropathy). The mean dosage administered in most patients (83% were treated with the short-term protocol) had been 20 + 40 micrograms on the first day and 60 + 40 micrograms on the second day.
Subjects had been treated on average 2.6 times (cycles of short term treatment); 37% of patients had received at least 3 cycles of short term treatment. Clinically relevant side effects have been observed in 30 patients (5% of the 595 treated patients). Temporary suspension of treatment has reduced/abolished side effects in 18 out of 30 patients and only in 5 patients (0.8%) therapy had to be suspended. Clinical improvement was evaluated according to subjective improvement, objective improvement (as defined by the treating physician/surgeon) and one or more physiological parameters (flux, flow, treadmill test). Among patients with intermittent claudication (only considered endpoint was walking distance) 78% was significantly improved. In patients with critical ischemia (endpoints were pain control, decrease of ischemic areas and perfusion improvement, objectively measured) 66% of patients improved. In diabetics (including both claudicants and subjects with critical ischemia) 58% improved.
Global analysis of the previous 9 studies indicates that PGE1 alpha-ciclodestrina treatment is effective, there are few and controllable (in most patients) side effects and the treatment (particularly the short term protocol) is very cost effective.
一组患有严重外周血管疾病的患者接受了前列地尔α-环糊精治疗（如之前9篇文章所报道），包括595名患者（平均年龄64.52±12岁；307名间歇性跛行患者，237名严重肢体缺血、静息痛和坏疽患者）。还对51名糖尿病患者进行了研究和治疗（25%为间歇性跛行患者，其余为严重缺血和/或神经病变患者）。大多数患者（83%接受短期治疗方案）的平均给药剂量在第一天为20 + 40微克，第二天为60 + 40微克。
受试者平均接受了2.6次治疗（短期治疗周期）；37%的患者接受了至少3个短期治疗周期。在30名患者（595名接受治疗患者中的5%）中观察到了临床相关副作用。30名患者中有18名通过暂时中止治疗减轻/消除了副作用，只有5名患者（0.8%）不得不中止治疗。根据主观改善、客观改善（由治疗医生/外科医生定义）以及一个或多个生理参数（通量、流量、跑步机测试）对临床改善情况进行评估。在间歇性跛行患者中（仅将行走距离视为终点），78%有显著改善。在严重缺血患者中（终点为疼痛控制、缺血区域减小和灌注改善，通过客观测量），66%的患者有所改善。在糖尿病患者中（包括间歇性跛行患者和严重缺血患者），58%有所改善。
对之前9项研究的综合分析表明，前列地尔α-环糊精治疗有效，副作用少且（大多数患者）可控，并且该治疗（尤其是短期治疗方案）性价比非常高。
