Arosio E, Pancera P, Zannoni M, Arcaro G, Priante F, Lechi A
Istituto di Clinica Medica dell'Università di Verona, Italy.
Int J Clin Pharmacol Ther Toxicol. 1989 Nov;27(11):526-9.
In a pilot study, defibrotide was administered to 22 patients with arterial occlusive disease of the lower limbs (mean age 59 years; range 48-71 years), of whom 12 were Fontaine 2nd stage and 10 Fontaine 3rd stage. In the first group, treatment enabled significant improvement in the walking distance (580 +/- 95 vs 220 +/- 65 m; M +/- SD; p less than 0.001), even 15 days after discontinuation of therapy (445 +/- 110 m; p less than 0.05). In 3rd stage patients, treatment caused reasonable reduction of pain, with elimination of resting pain in 4 patients. Both groups underwent no modification of Doppler velocimetry and Winsor index, while photoplethysmography in 8 patients at 2nd- and in 3 patients at 3rd-stage showed improvement at the end of treatment. There were no modifications of hepatic, renal, hemopoietic and hemocoagulative functions. Beta-thromboglobulin showed a statistically significant reduction (62 +/- 10 vs 116 +/- 18 ng/ml; M +/- SEM; p less than 0.001), from 2 weeks after the first dose until 15 days after discontinuation of therapy. Defibrotide proved particularly efficacious in Fontaine 2nd-stage patients, showing its suitability for treating the stages of occlusive atherosclerotic disease at which collateral circulation can still be activated.
在一项试点研究中，对22例下肢动脉闭塞性疾病患者（平均年龄59岁；范围48 - 71岁）给予去纤苷治疗，其中12例为Fontaine 2期，10例为Fontaine 3期。在第一组中，治疗使步行距离显著改善（580±95 vs 220±65米；均数±标准差；p＜0.001），甚至在治疗中断15天后仍有改善（445±110米；p＜0.05）。在3期患者中，治疗使疼痛合理减轻，4例患者静息痛消失。两组患者的多普勒测速和温莎指数均未改变，而2期的8例患者和3期的3例患者在治疗结束时光电容积描记法显示有所改善。肝、肾、造血和血液凝固功能均无改变。β - 血小板球蛋白从首次给药后2周直至治疗中断15天呈统计学显著降低（62±10 vs 116±18纳克/毫升；均数±标准误；p＜0.001）。去纤苷在Fontaine 2期患者中证明特别有效，表明其适用于治疗仍可激活侧支循环的闭塞性动脉粥样硬化疾病阶段。
