Haynes R B, Sandler R S, Larson E B, Pater J L, Yatsu F M
Department of Clinical Epidemiology, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.
Arch Intern Med. 1992 Jul;152(7):1376-80.
Recommendations are broadening for the prophylaxis of atherosclerotic disorders, but aspirin is the only widely used agent. Ticlopidine hydrochloride, a new antiplatelet medication, has recently been approved for prescription in North America. We reviewed the major clinical trials of ticlopidine and derived guidelines for its use.
Studies of ticlopidine were sought through MEDLINE for 1980 to 1990 and through bibliographies of retrieved articles. All published, randomized trials of ticlopidine were appraised if they reported major morbidity and mortality as primary end points. All eligible studies were formally reviewed by an expert panel according to published principles for critical appraisal of the medical literature. Both benefits and risks were quantified.
Four randomized trials reported major clinical end points. In these, ticlopidine was more effective than placebo for preventing recurrences after completed stroke; was more effective than aspirin for patients with transient ischemic attacks and partial strokes; and reduced vascular death and nonfatal myocardial infarction in an open trial among patients with unstable angina. For patients with intermittent claudication ticlopidine, was not significantly better than placebo for preventing myocardial infarction or stroke. Side effects were more common with ticlopidine than with aspirin or placebo.
Ticlopidine should be prescribed in place of aspirin for stroke prophylaxis or unstable angina if the patient is unable to tolerate aspirin. Ticlopidine may also benefit patients who experience new ischemic events while taking aspirin or, probably, patients with peripheral vascular disease. A complete blood cell count should be performed every 2 weeks during the first 3 months of therapy to check for leukopenia.
预防动脉粥样硬化疾病的建议正在不断扩展，但阿司匹林是唯一广泛使用的药物。盐酸噻氯匹定是一种新型抗血小板药物，最近已在北美获批用于处方。我们回顾了噻氯匹定的主要临床试验并得出了其使用指南。
通过MEDLINE检索1980年至1990年关于噻氯匹定的研究，并通过检索文章的参考文献进行查找。所有已发表的噻氯匹定随机试验，若将主要发病率和死亡率作为主要终点进行报告，则予以评估。所有符合条件的研究均由一个专家小组根据已发表的医学文献批判性评价原则进行正式审查。对益处和风险都进行了量化。
四项随机试验报告了主要临床终点。在这些试验中，噻氯匹定在预防卒中后复发方面比安慰剂更有效；对于短暂性脑缺血发作和部分性卒中患者，比阿司匹林更有效；在一项不稳定型心绞痛患者的开放试验中，降低了血管性死亡和非致命性心肌梗死的发生率。对于间歇性跛行患者，噻氯匹定在预防心肌梗死或卒中方面并不比安慰剂显著更好。噻氯匹定的副作用比阿司匹林或安慰剂更常见。
如果患者不能耐受阿司匹林，应开具噻氯匹定以替代阿司匹林用于预防卒中或治疗不稳定型心绞痛。噻氯匹定可能也有益于在服用阿司匹林时发生新的缺血性事件的患者，或者可能有益于外周血管疾病患者。在治疗的前3个月，应每2周进行一次全血细胞计数检查白细胞减少情况。
