| 王育苗,李睿.伊伐布雷定的不良反应信号挖掘与评价[J].安徽医药,2021,25(8):1693-1696. |
| 伊伐布雷定的不良反应信号挖掘与评价 |
| Signal detection and evaluation of adverse reactions induced by ivabradine |
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| DOI：10.3969/j.issn.1009-6469.2021.08.051 |
| 中文关键词: 药物相关性副作用和不良反应 药物副反应报告系统 伊伐布雷定 信号挖掘 |
| 英文关键词: Drug-related side effects and adverse reactions Adverse drug reaction reporting systems Ivabradine Signal mining |
| 基金项目: |
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| 中文摘要: |
| 目的利用美国食品药品管理局公共数据开放项目( openFDA)检索伊伐布雷定的不良反应信号并进行评价，为临床用药提供参考。方法采用比例失衡法中的报告比值比法( ROR)与比例报告比值法( PRR)对美国 FDA不良事件报告系统(FAERS)中自 2015年 4月 15日至 2020年 11月 17日的报告进行关于伊伐布雷定的数据挖掘。结果使用 ROR法和 PRR法共得到 63个信号，其中 35个信号的不良反应未在伊伐布雷定的说明书中出现。结论挖掘和评价基于 FAERS数据库获得的伊伐布雷定不良反应相关信号，可为其临床的合理应用提供依据。 |
| 英文摘要: |
| Objective To detect and evaluate the signal of adverse drug reactions of ivabradine from the FDA public date program(openFDA), so as to provide references for the rational use of this drug in clinical practices.Methods Disproportionality analysis withreporting odds ratio (ROR) and proportional reporting ratio (PRR) was used to detect ADR signals of lenvatinib reports in the FDA Adverse Event Reporting System (FAERS) from April 15,2015 to November 17, 2020.Results Totally 63 ADR signals were obtained byboth ROR and PRR method, 35 of which not shown in the specification and label instruction of ivabradine.Conclusion The analysis of data inFAERS may provide ADR signals of ivabradine, and guidance for rational clinical use. |
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