Janzon L, Bergqvist D, Boberg J, Boberg M, Eriksson I, Lindgärde F, Persson G, Almgren B, Fagher B, Kjellström T
Department of Surgery, Malmö General Hospital, Sweden.
J Intern Med. 1990 May;227(5):301-8. doi: 10.1111/j.1365-2796.1990.tb00164.x.
The Swedish Ticlopidine Multicentre Study (STIMS) was a double-blind placebo-controlled trial designed to determine whether ticlopidine, a platelet antiaggregatory agent, reduces the incidence of myocardial infarction, stroke and transitory ischaemic attacks in patients with intermittent claudication. A total of 687 patients was monitored for a minimum of 5 years or until an end-point was reached. The number of end points (99 vs. 89), analysed according to the intention-to-treat principle, was 11.4% lower in the ticlopidine group (P = 0.24). The mortality rate was 29.1% lower in the ticlopidine group (64 vs. 89, P = 0.015); this observation could be accounted for by a reduced mortality from ischaemic heart disease. On-treatment analysis showed there to be significantly fewer end points in the ticlopidine group (47 vs. 76, P = 0.017). Diarrhoea was the most common side-effect. Reversible leucopenia or thrombocytopenia was reported in seven patients on ticlopidine. It is concluded that the high morbidity and mortality from cardio- and cerebrovascular disease in patients with intermittent claudication can be reduced by long-term treatment with ticlopidine.
瑞典噻氯匹定多中心研究（STIMS）是一项双盲、安慰剂对照试验，旨在确定血小板抗聚集剂噻氯匹定是否能降低间歇性跛行患者心肌梗死、中风和短暂性脑缺血发作的发生率。共对687例患者进行了至少5年的监测，或直至达到终点。根据意向性分析原则，噻氯匹定组的终点事件数量（99例 vs. 89例）比安慰剂组低11.4%（P = 0.24）。噻氯匹定组的死亡率低29.1%（64例 vs. 89例，P = 0.015）；这一观察结果可归因于缺血性心脏病死亡率的降低。治疗中分析显示，噻氯匹定组的终点事件明显较少（47例 vs. 76例，P = 0.017）。腹泻是最常见的副作用。有7例服用噻氯匹定的患者报告出现可逆性白细胞减少或血小板减少。结论是，长期使用噻氯匹定治疗可降低间歇性跛行患者心血管和脑血管疾病的高发病率和死亡率。
