摘要
目的:基于FDA自发呈报系统/不良反应报告系统数据库评价阿司匹林与氯吡格雷关联使用同华法林治疗发生出血不良反应的差异。方法:去掉重复报告后,依据用药情况,把不良反应报告分为阿司匹林/氯吡格雷组,华法林治疗组和对照组,依据《国际医学用语辞典》定义出血有关的不良反应。采用描述性统计、Logistic回归模型和不良反应风险比分析阿司匹林/氯吡格雷用药与华法林用药情况下患者发生出血情况之间的差异。结果:阿司匹林与氯吡格雷关联使用的出血率为20.80%,发生率最高的为胃肠系统出血(8.23%),华法林治疗的出血率为22.30%,发生率最高的为胃肠系统出血(7.81%)。两种治疗发生的神经系统出血差异无统计学意义(P>0.05)。两种用药情况下患者出血率随着年龄段的升高而升高。结论:依据FDA不良反应数据库分析得出,华法林治疗导致的出血率(22.30%)高于阿司匹林与氯吡格雷关联使用(20.80%)(P<0.05),且两种用药情况下,患者发生的出血类型存在一定差异。
AIM： To compare the risk of bleeding complication due to the associated use of aspirin with clopidogrel compared to those warfarin used alone based on FDA Spontaneous Reporting System and Adverse Events Reporting System （SRS/AERS） database. METHODS： After excluding duplicated records, reports were divided into three index groups i. e. associated use of aspirin with clopidogrel group, warfarin group and reference group, and define haemor rhagesrelated adverse events （HRAEs） accord ing to Medical Dictionary for Regulatory Activi ties. Descriptive statistics, logistic regression and odds ratios were used to estimate the risk and difference of bleeding complications for these three scenarios. RESULTS： frequency of HRAE connected with the associated aspirin/clopidogrel use was 20.80%, and gastrointestinal system HRAEs were the most frequently reportedbleeding event （8.23%）. The frequency of HRAE connected with the warfarin used alone was 22.30%, and gastrointestinal system HRAEs were the most frequently reported bleeding event （7.81X）. The frequency of nerv ous system HRAEs for different groups has no significant difference （P〉0.05）. The frequency of HRAEs increased as age increases for both groups. CONCLUSION： The risk of HRAEs with warfarin used alone （20. 80%） is higher than the associated aspirin/clopidogrel use （22.30%） in the clinical use based on FDA SRS/AERS （P〈0.05）. The types of bleeding complications are not similar for both situation.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2013年第11期1251-1259,共9页
Chinese Journal of Clinical Pharmacology and Therapeutics
