Department of Neurology, School of Medicine, Keio University, Tokyo, Japan; the Department of Neurology, Iwate Medical University School of Medicine, Iwate, Japan; the Department of Neurology, Gunma University School of Medicine, Gunma, Japan; the Second Department of Internal Medicine, Nippon Medical School, Tokyo, Japan; the Department of Internal Medicine, Yokufukai Geriatric Hospital, Tokyo, Japan; the Department of Neurology, Tokai University School of Medicine, Kanagawa, Japan; the Department of Neurology, National Higashi-Nagoya Hospital, Aichi, Japan; the Third Department of Internal Medicine, Kanazawa University School of Medicine, Ishikawa, Japan; the Cerebrovascular Division, Department of Medicine, National Cardiovascular Center, Osaka, Japan; the First Department of Internal Medicine, Fukuoka University School of Medicine, Fukuoka, Japan; and the Department of Biostatistics, School of Health Sciences and Nursing, University of Tokyo, Tokyo, Japan.
J Stroke Cerebrovasc Dis. 2000 Jul-Aug;9(4):147-57. doi: 10.1053/jscd.2000.7216.
Cilostazol, an antiplatelet drug that increases the cyclic adenosine monophosphate (AMP) levels in platelets via inhibition of cyclic AMP phosphodiesterase, has been used in chronic arterial occlusive disease. The purpose of the present study was to examine the effects of cilostazol on the recurrence of cerebral infarction using a multicenter, randomized, placebo-controlled, double-blind clinical trial method. Patients who suffered from cerebral infarction at 1 to 6 months before the trial were enrolled between April 1992 and March 1996. Oral administration of cilostazol (100 mg twice daily) or placebo was randomly assigned to the patients and continued until February 1997. The primary endpoint was the recurrence of cerebral infarction. In total, 1,095 patients were enrolled. An analysis based on 1,052 eligible patients (526 given cilostazol and 526 given placebo) showed that the cilostazol treatment achieved a significant relative-risk reduction (41.7%; confidence interval [CI], 9.2% to 62.5%) in the recurrence of cerebral infarction as compared with the placebo treatment (P=.0150). Intention-to-treat analysis of 1,067 patients also showed a significant relative-risk reduction (42.3%; CI, 10.3% to 62.9%, P=.0127). No clinically significant adverse drug reactions of cilostazol were encountered. Long-term administration of cilostazol was effective and safe in the secondary prevention of cerebral infarction.
西洛他唑是一种抗血小板药物，通过抑制环磷酸腺苷磷酸二酯酶增加血小板中环磷酸腺苷（AMP）的水平，已用于慢性动脉闭塞性疾病。本研究旨在采用多中心、随机、安慰剂对照、双盲临床试验方法，观察西洛他唑对脑梗死复发的影响。试验前 1 至 6 个月患有脑梗死的患者于 1992 年 4 月至 1996 年 3 月期间入选。患者随机接受西洛他唑（每日 2 次，每次 100mg）或安慰剂口服治疗，并持续至 1997 年 2 月。主要终点是脑梗死的复发。共有 1095 例患者入选。对 1052 例合格患者（西洛他唑组 526 例，安慰剂组 526 例）的分析显示，与安慰剂组相比，西洛他唑治疗可显著降低脑梗死复发的相对风险（41.7%；置信区间[CI]，9.2%至 62.5%）（P=.0150）。对 1067 例患者的意向治疗分析也显示，相对风险显著降低（42.3%；CI，10.3%至 62.9%，P=.0127）。未发现西洛他唑有明显的药物不良反应。长期服用西洛他唑对脑梗死的二级预防有效且安全。
