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目的:检测替格瑞洛上市后出血不良反应信号,并分析其影响因素,为临床合理用药提供参考。方法:采用报告比值比法(ROR)对美国食品药品监督管理局不良事件报告系统(AERS)数据库进行替格瑞洛不良反应信号检测,应用标准MedDRA分析查询(SMQ)检索其中的出血信号,并利用SPSS 17.0分析年龄、性别、用药时长对出血信号的影响。结果:总的药物不良反应报告6 806 330份,以替格瑞洛为首要怀疑药物的不良反应报告5 279份,经ROR法检测,共得到158个替格瑞洛不良反应信号,其中出血信号42个。统计学分析结果显示:维持剂量时,与其他ADR相比,出血ADR在年龄(P=0.003)、用药时长(P=0.026)分布中差异有统计学意义,在性别(P=0.417)分布中差异无统计学意义;负荷剂量时,与其他ADR相比,出血ADR在年龄(P=0.000)分布中差异有统计学意义,在性别(P=0.846)分布中差异无统计学意义。其中,年龄大于75岁负荷剂量时,维持剂量用药半年内,发生出血ADR风险更大。结论:检测到的替格瑞洛不良反应信号和影响因素,有必要进行进一步信号评价和验证,为临床安全用药提供依据。
OBJECTIVE: To detect the signal of adverse reactions of ticagrelor on the market and analyze its influencing factors, so as to provide a reference for clinical rational drug use. METHODS: Tiregregory adverse reaction signals were detected using the Report Ratios Method (ROR) against the U.S. Food and Drug Administration’s AERS database and the standard MedDRA analysis (SMQ) was used to search for bleeding signals SPSS 17.0 was used to analyze the influence of age, sex and medication duration on hemorrhagic signal. RESULTS: A total of 6 806 330 reports of adverse drug reactions were reported. A total of 5 279 reports of adverse reactions with ticagrelor as the most important drug were reported. A total of 158 ticagrelor adverse reactions were detected by the ROR method. Bleeding signals 42. Statistical analysis showed that there was a significant difference in age (P = 0.003) and duration of drug use (P = 0.026) when compared with other ADRs at maintenance dose. In the distribution of gender (P = 0.417) There was no significant difference between the two groups (P = 0.000). Compared with other ADRs, there was no significant difference in age (P = 0.000). Among them, the age greater than 75-year-old load dose, maintenance dose medication within six months, the risk of bleeding greater risk of ADR. Conclusion: The signal and the influencing factors of ticagrelor detected adverse reactions, it is necessary to further evaluate and verify the signal to provide the basis for clinical safety medication.