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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Safety evaluation of substituting clopidogrel for ticlopidine in Japanese patients with ischemic stroke - Hiroshima ticlopidine, clopidogrel safe exchange trial
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Safety evaluation of substituting clopidogrel for ticlopidine in Japanese patients with ischemic stroke - Hiroshima ticlopidine, clopidogrel safe exchange trial

机译：日本缺血性卒中患者用氯吡格雷替代噻氯匹定的安全性评估-广岛替氯匹定，氯吡格雷安全互换试验

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Background Clopidogrel is sometimes substituted for ticlopidine when cerebrovascular or cardiovascular patients develop hematologic abnormalities after ticlopidine treatment. However, the adverse event rate after the substitution to clopidogrel remains undetermined. Therefore, in this study, we aimed to define the risk of adverse events after substituting clopidogrel for ticlopidine without a washout period. Methods We prospectively enrolled patients older than 20 years who had a history of noncardioembolic strokes, including transient ischemic attacks, were treated with ticlopidine for at least 6 months. This study was conducted from August 26, 2008, when the first patient was enrolled, to January 16, 2012, the date of the last patient examination, at 8 active stroke centers in Hiroshima, Japan. We excluded patients who had severe disabilities, evidence of cardioembolic stroke, or history of a bleeding event. Each patient received clopidogrel (either 50 mg or 75 mg) once a day in place of ticlopidine without a washout period. Follow-up exams were scheduled within 12 months after the medication substitution. The primary end point of this study was adverse events of interest, including clinically significant reduced blood cell counts, hepatic dysfunction, bleeding, and other serious side effects. Results In this study, 110 patients were enrolled and analyzed in an intent-to-treat manner (modified intent to treat). Within the scheduled follow-up periods, 9 primary end point events were observed in separate patients. The primary end point events were observed at a rate of 8.4% per year (Kaplan-Meier method). At the time of enrolment, 16 patients met the exclusion criteria, of which 8 recovered from their abnormal hematologic results to the institutional normal limit after the substitution of ticlopidine for clopidogrel (57.4% per year). Conclusions The adverse event rates after the substitution of ticlopidine for clopidogrel is similar to the adverse event rates of patients who were initially treated with clopidogrel. The substitution of clopidogrel for ticlopidine should be considered for patients who develop hematologic abnormalities from ticlopidine treatment.
机译：背景技术当脑血管或心血管患者在噻氯匹定治疗后出现血液学异常时，氯吡格雷有时会代替噻氯匹定。但是，氯吡格雷替代后的不良事件发生率仍未确定。因此，在这项研究中，我们旨在确定在没有洗脱期的情况下用氯吡格雷替代噻氯匹定后发生不良事件的风险。方法我们前瞻性招募了20岁以上有非心脏栓塞性卒中病史（包括短暂性脑缺血发作）的患者，使用噻氯匹定治疗至少6个月。这项研究从2008年8月26日（在日本广岛市的8个活跃的卒中中心）招募第一位患者起至2012年1月16日（最后一次接受检查的日期）进行。我们排除了严重残疾，心脏栓塞性中风证据或出血事件史的患者。每位患者每天接受一次氯吡格雷（50毫克或75毫克）代替噻氯匹定，无冲洗期。计划在替代药物后的12个月内进行随访检查。这项研究的主要终点是所关注的不良事件，包括临床上明显减少的血细胞计数，肝功能障碍，出血和其他严重的副作用。结果在本研究中，以意向性治疗方式（修改后的意向性治疗）招募并分析了110例患者。在计划的随访期内，分别观察到9个主要终点事件。主要终点事件的发生率每年为8.4％（Kaplan-Meier方法）。在入组时，有16名患者符合排除标准，其中8名在用噻氯匹定替代氯吡格雷后从其异常血液学结果恢复至机构正常水平（每年57.4％）。结论噻氯匹定替代氯吡格雷后的不良事件发生率与最初接受氯吡格雷治疗的患者的不良事件发生率相似。因噻氯匹定治疗而出现血液学异常的患者应考虑用氯吡格雷替代噻氯匹定。

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