Joffre F, Meites G, Rousseau H, Staffin C, Allaert F A, Pelat P
Service de Radiologie, Hôpital de Rangueil, Toulouse.
Ann Radiol (Paris). 1994;37(3):239-44.
Randomized double-blind placebo controlled trial performed in two parallel groups of patients, aged 43 to 92, suffering from advanced arterial disease of the lower limbs to be treated with angioplasty. The aim was to compare the efficacy of infusions of buflomedil with placebo on peripheral tissue oxygenation following lower limb angioplasties. Treatments consisted of 3 hour infusion of buflomedil or isotonic saline combined with arterial disobstruction. The major outcome measures were transcutaneous oxygen tension (TCpO2) correlated to ankle systolic pressure index (SPI). An increase of TCpO2 values (p < 0.01) as well as the mean individual variations of TCpO2 (p < 0.05) before and after angioplasty were observed in the buflomedil-treated group, whereas SPI values varied similarly in both groups. No adverse event was shown. In conclusion, buflomedil infusions during angioplasties of the lower limbs may improve tissue oxygenation subsequent to arterial disobstruction and are well tolerated.
在两组年龄在43至92岁、患有下肢晚期动脉疾病且拟接受血管成形术治疗的患者中进行了随机双盲安慰剂对照试验。目的是比较丁咯地尔输注与安慰剂对下肢血管成形术后外周组织氧合的疗效。治疗包括3小时输注丁咯地尔或等渗盐水并联合动脉疏通术。主要结局指标是与踝部收缩压指数（SPI）相关的经皮氧分压（TCpO2）。在丁咯地尔治疗组中观察到血管成形术前和术后TCpO2值升高（p < 0.01）以及TCpO2的平均个体变化（p < 0.05），而两组的SPI值变化相似。未显示不良事件。总之，下肢血管成形术期间输注丁咯地尔可能改善动脉疏通术后的组织氧合，且耐受性良好。
