Mouren X, Caillard P, Schwartz F
Department of Vascular Exploration, Hôpital Tenon, Paris, France.
Angiology. 1994 Jun;45(6):413-7. doi: 10.1177/000331979404500601.
In a randomized, placebo-controlled, double-blind, parallel study of 20 patients, the antiischemic effect of EGb 761 (Ginkgo biloba Extract) was studied by measuring the transcutaneous partial pressure of oxygen (TcPo2) during exercise. Transcutaneous oximetry during exercise provides a good, noninvasive estimation of local arterial perfusion and constitutes a real index of local and regional capillary perfusion. Twenty patients between the ages of forty-four and seventy-three years suffering from claudicating atherosclerotic arterial occlusive disease in stage II according to the Leriche and Fontaine classification, diagnosed for more than a year and stable for three months, were included. The eligible patients received placebo for fifteen days under single-blind conditions. At the end of this preinclusion period, the eligibility criteria were checked and the patients were randomized to two treatment groups. The first group received 320 mg per day of EGb 761 for four weeks and the second group received placebo. The treadmill walking test was performed under standardized conditions at the same time of day and by the same investigator. In a comparison of the differences before and after treatment, the areas of ischemia decreased by 38% in the EGb 761 group but remained essentially stable (+5%) in the placebo group. This difference between groups is significant (F [1.18] = 4.91; P = 0.04) and the 95% confidence interval for the difference ranges from 0.89 to 3.87. This study confirmed significantly the rapid antiischemic action of EGb 761 and its value in the management of peripheral arterial occlusive disease at the stage of intermittent claudication.
在一项针对20名患者的随机、安慰剂对照、双盲、平行研究中,通过测量运动期间的经皮氧分压(TcPo2)来研究银杏叶提取物761(EGb 761)的抗缺血作用。运动期间的经皮血氧测定法可对局部动脉灌注进行良好的无创评估,并构成局部和区域毛细血管灌注的真实指标。纳入了20名年龄在44岁至73岁之间、根据勒里什和方丹分类处于II期间歇性跛行的动脉粥样硬化性动脉闭塞疾病患者,诊断时间超过一年且病情稳定三个月。符合条件的患者在单盲条件下接受15天的安慰剂治疗。在这个入选前阶段结束时,检查入选标准并将患者随机分为两个治疗组。第一组每天服用320毫克EGb 761,持续四周,第二组服用安慰剂。在一天中的同一时间由同一名研究人员在标准化条件下进行跑步机行走测试。在比较治疗前后的差异时,EGb 761组的缺血面积减少了38%,而安慰剂组基本保持稳定(增加5%)。两组之间的这种差异具有统计学意义(F[1.18]=4.91;P=0.04),差异的95%置信区间为0.89至3.87。这项研究显著证实了EGb 761的快速抗缺血作用及其在间歇性跛行阶段外周动脉闭塞疾病管理中的价值。