摘要: 目的：分析阿司匹林、
氯吡格雷在抗血小板聚集治疗中的ADR及影响ADR结果的危险因素，为临床用药提供参考。方法：以2009-2012年上海ADR中心数据库阿司匹林和氯吡格雷病例为基数，通过年龄或单抗和双抗治疗随机分组进行回顾性分析，以报告类型、严重程度、原患疾病、用药原因、ADR致器官损害、ADR起始发病日、ADR结果作为观察指标，使用SPSS软件进行分析。结果：单抗和双抗两组基线特征比较差异无统计学意义(p > 0.05)。两组观察指标相关性检查及单因素独立危险因素比较，严重程度、出血、ADR结果和ADR最初阶段发病p < 0.05；多因素Logistic回归分析，ADR未好转OR = 3.404、95% CI 1.518~7.634；ADR周内发病OR = 3.329、95% CI 0.86~12.884。结论：双抗组的缺血、出血事件几率高于单抗组，单抗组未好转几率是双抗组的2.44倍，可能与抗血小板药物抵抗、合并用药的相互作用及剂量不足有关。长期抗血小板治疗应综合评估患者缺血、出血风险，制定个体化的预防措施和给药方法，在抗血小板效果与降低出血风险之间以取得平衡和最大获益。
Abstract:
Objective:
To analyze the adverse drug reaction and their risk factors of Aspirin and Clopidogrel
during the treatment for platelet aggregation, providing reference for clinical
medication. Methods: Based on 2009-2012 database of Shanghai ADRs center, ADR
cases about Aspirin and Clopidogrel were analyzed retrospectively through age
groups or randomized by combination and independence for retrospective
analysis. Also the types of reports, severity of diseases, the original
disease, the reason of medication, organ damage by ADR, as well as the initial
period and results of ADRs were applied as the observation indexes and were
analyzed by using the SPSS software. Results: In the groups of combination and
independence, their p value of baseline characteristics was above 0.05 (p > 0.05), which indicated no
statistical significance. In contrast, p values of observation index
correlation test, report types, severity, bleeding part, ADR results and the
initial period of ADR were below the level of 0.05 (p < 0.05). Comparing the independent risk factors between these
two groups, the result of p values of severity reports, death or life threat,
bleeding, ADR results, and ADR onset of three months was the same (p < 0.05). The result of
multivariable Logistic regression analysis was received forward step by step,
ADR didn’t recover, OR was 3.404, 95% CI was 1.518 - 7.634; For weeks of the
ADR onset, OR was 3.329, 95% CI was 0.86 - 12.884. Conclusion: The percentage
of ischemia and bleeding in the combined group was higher than that of
independent group, and the unrecovered ratio in the independent group was 2.44
times than that in the combined group, which might be related to antiplatelet
resistance, combined interaction and low dosage. In the long-term antiplatelet
therapy, ischemia, risk of bleeding should be involved in the comprehensive
evaluation, and it should develop an individual preventive measure and medication
for keeping balance and getting maximum benefits between antiplatelet effects
and reducing the risk of bleeding.