Paradiso-Hardy Fran L, Papastergiou John, Lanctôt Krista L, Cohen Eric A
Schulich Heart Program, Department of Pharmacy and HOPE Research Centre, Sunnybrook Women's College Health Sciences Centre, Toronto, Ontario.
Can J Cardiol. 2002 Jul;18(7):771-3.
Eleven cases of thrombotic thrombocytopenic purpura (TTP) associated with clopidogrel therapy have been published.
To perform a comprehensive causality assessment of the 11 published cases of TTP to assess quantitatively the extent to which clopidogrel was the causative factor.
The 11 reports of TTP were analyzed using the Bayesian Adverse Reaction Diagnostic Instrument to calculate the posterior probability (PsP) that clopidogrel caused the TTP based on epidemiological and clinical trials data (expressed as prior odds) and the clinical characteristics of each case (expressed as likelihood ratios).
Clopidogrel was implicated as the causative factor of the TTP (PsP>0.75) in only five of the 11 cases. The PsP for clopidogrel was lowered by concomitant use of a statin, a history of cancer and the occurrence of relapsing TTP (in the absence of clopidogrel) in the remaining six cases.
This systematic analysis provides strong evidence, based on the case information reported, that clopidogrel was the causative factor in at least some cases of TTP.
已有11例与氯吡格雷治疗相关的血栓性血小板减少性紫癜(TTP)病例发表。
对已发表的11例TTP病例进行全面的因果关系评估,以定量评估氯吡格雷作为致病因素的程度。
使用贝叶斯不良反应诊断工具分析11例TTP报告,根据流行病学和临床试验数据(表示为先验概率)以及每个病例的临床特征(表示为似然比)计算氯吡格雷导致TTP的后验概率(PsP)。
在11例病例中,只有5例氯吡格雷被认为是TTP的致病因素(PsP>0.75)。在其余6例病例中,同时使用他汀类药物、有癌症病史以及复发性TTP(在未使用氯吡格雷的情况下)的发生降低了氯吡格雷的PsP。
基于所报告的病例信息,该系统分析提供了有力证据,表明氯吡格雷在至少一些TTP病例中是致病因素。