Marrapodi E, Leanza D, Giordano S, Nazzari M, Corsi C
Cardioangiology Unit, S. Chiara Hospital, Firenze, Italy.
Clin Trials Metaanal. 1994 Apr;29(1):21-30.
In a random double-blind study versus placebo, 60 ambulatory patients with peripheral occlusive disease of the lower limbs and claudicatio intermittens (Leriche's stage 2), were treated for 60 days with defibrotide (400 mg b.i.d., oral, n = 30) or placebo (n = 30). Patients in the defibrotide group received additional treatment with the same drug at the reduced rate of 400 mg once daily for another 120 days for maintenance (total treatment duration 180 days). All patients were assessed at intake and 60 days for relative and absolute walking distance (RWD and AWD) in a standard treadmill test and for the Winsor Index (WI) at rest and after exercise; patients of the defibrotide treatment group were retested in the same way at 90-180 days. In a subgroup of patients (defibrotide = 11, placebo = 12), blood samples were obtained for the assessment of whole blood and plasma viscosity at intake and after 60 days of treatment. These samples could not be collected properly in the remaining cases, for technical reasons. At day 60, we compared the effects of the two treatments on physical performance: mean (SE) values of RWD were for defibrotide 148 (9.7) and 179 (12.4) m in basal and post-treatment conditions, respectively, and 209 (16.2) and 212 (17.1) m for placebo. Similar changes were observed for AWD: for defibrotide 206 (13.4) and 241 (15.2) m and for placebo 270 (22.9) and 272 (23.1) m. The mean changes were significantly larger with defibrotide: for RWD + 33 (7.1) vs. + 0.3 (3.8) m (p < 0.01) and for AWD + 34 (9.2) and -2 (6.6) m (p < 0.01). The overall gain of walking distance after maintenance therapy with the reduced defibrotide dosage amounted to approximately + 50% over basal (after 180 days). Blood and plasma viscosity improved in patients on defibrotide but the change fell short of statistical significance versus placebo. All findings confirm the potential usefulness of defibrotide in the treatment of peripheral arterial disease, at the same time encouraging further studies of the involved mechanisms of action.
在一项与安慰剂对照的随机双盲研究中，60例患有下肢外周血管闭塞性疾病和间歇性跛行（勒里什2期）的门诊患者，接受去纤苷（400毫克，每日两次，口服，n = 30）或安慰剂（n = 30）治疗60天。去纤苷组患者在随后的120天内以400毫克每日一次的减量继续接受相同药物的维持治疗（总治疗时长180天）。所有患者在入组时以及治疗60天时，通过标准跑步机测试评估相对和绝对步行距离（RWD和AWD），并在静息和运动后评估温莎指数（WI）；去纤苷治疗组患者在90 - 180天时以相同方式再次接受测试。在一组亚组患者中（去纤苷组 = 11例，安慰剂组 = 12例），在入组时和治疗60天后采集血样，以评估全血和血浆粘度。由于技术原因，其余病例未能妥善采集这些样本。在第60天时，我们比较了两种治疗对身体机能的影响：去纤苷组RWD的均值（SE）在基础状态和治疗后分别为148（9.7）米和179（12.4）米，安慰剂组分别为209（16.2）米和212（17.1）米。AWD也观察到类似变化：去纤苷组为206（13.4）米和241（15.2）米，安慰剂组为270（
