Arcan J C, Blanchard J, Boissel J P, Destors J M, Panak E
ACT Research Group, Laboratoires Millot-Solac Sanofi, Paris, France.
Angiology. 1988 Sep;39(9):802-11. doi: 10.1177/000331978803900904.
In this multicenter trial 169 patients with chronic intermittent claudication due to obstructive peripheral vascular disease were randomized in a double-blind fashion into two parallel groups receiving either 250 mg ticlopidine or placebo, twice daily. At entry, the two groups (83 ticlopidine, 86 placebo) were well matched for the major clinical features apart from an excess of women in the ticlopidine group. At six months, 167 patients were alive, 2 having died of malignant disease (1 from each group). At this stage, 39 patients from the ticlopidine group and 29 from the placebo group (p = 0.04) had increased their walking distance by more than 50% of baseline values. For the groups as a whole pain-free and total walking distance were greater in the ticlopidine group than in the placebo group (194 vs 124 meters, p = 0.03 and 236 vs 170 meters, p = 0.04, respectively). Two patients from the ticlopidine group vs 9 patients from the placebo group (p = 0.03) developed significant cardiovascular events during the study. These results indicate that ticlopidine has a beneficial effect both in the treatment of the symptoms and the prevention of vascular complications in patients with intermittent claudication.
在这项多中心试验中，169例因阻塞性外周血管疾病导致慢性间歇性跛行的患者以双盲方式随机分为两个平行组，分别接受每日两次250毫克噻氯匹定或安慰剂治疗。入组时，除噻氯匹定组女性过多外，两组（83例噻氯匹定组，86例安慰剂组）的主要临床特征匹配良好。6个月时，167例患者存活，2例死于恶性疾病（每组各1例）。在此阶段，噻氯匹定组39例患者和安慰剂组29例患者（p = 0.04）步行距离增加超过基线值的50%。总体而言，噻氯匹定组无痛步行距离和总步行距离均大于安慰剂组（分别为194米对124米，p = 0.03；236米对170米，p = 0.04）。在研究期间，噻氯匹定组2例患者与安慰剂组9例患者（p = 0.03）发生了严重心血管事件。这些结果表明，噻氯匹定在治疗间歇性跛行患者的症状和预防血管并发症方面均有有益作用。
