论文部分内容阅读
目的:探讨伊伐布雷定致心房颤动（房颤）的风险及影响因素。方法:检索美国FDA不良事件报告系统（FAERS）数据库，提取2015年第2季度至2019年第4季度药物相关不良事件（AE）报告。根据首要可疑药物，AE报告被分为伊伐布雷定组和其他药物组，并各自分为房颤事件与非房颤事件组。采用报告比值比（n ROR）法对伊伐布雷定相关房颤信号进行检测，房颤事件报告数≥3且n ROR的95%置信区间（n CI）下限>1为房颤信号阳性。通过亚组分析和敏感性分析评价检测结果的稳定性。使用logistic回归模型计算校正n ROR值以减少混杂因素的影响。比较伊伐布雷定相关房颤事件和非房颤事件组患者年龄、性别、用药剂量和适应证等临床特征的差异，将差异有统计学意义（n P<0.05）的临床特征纳入多因素logistic回归模型，分析伊伐布雷定致房颤的影响因素。n 结果:纳入分析的报告为6 019 954例，伊伐布雷定组1 799例（0.03%），其他药物组6 018 155例（99.97%）。伊伐布雷定组中房颤事件组51例（2.83%），其他药物组中房颤事件组24 266例（0.40%）。伊伐布雷定致房颤事件总体n ROR为7.21（95n %CI：5.45~9.52），总体校正n ROR为6.81（95n %CI：5.13~9.02）；亚组分析和敏感性分析结果与总体分析结果基本一致。多因素logistic回归分析结果显示，与<60岁组比较，70~79岁和≥80岁组患者应用伊伐布雷定后发生房颤的风险更高[比值比（n OR）=6.525，95n %CI：1.896~22.456，n P=0.003；n OR=4.948，95n %CI：1.050~23.315，n P=0.043）]。n 结论:伊伐布雷定有导致房颤的风险，高龄可能与伊伐布雷定相关房颤风险增加有关。“,”Objective:To explore the risk and influencing factors of atrial fibrillation (AF) due to ivabradine.Methods:The database of US FDA Adverse Event Reporting System (FAERS) was searched and the drug-related adverse event (AE) reports from the 2nd quarter of 2015 to the 4th quarter of 2019 were extracted. According to the first suspicious drug, the reports were divided into ivabradine group and other drugs group, which were further divided into AF event group and non AF event group, respectively. The signal intensity of AF events related to ivabradine was screened and statistically analyzed by reporting odds ratio (n ROR). If the number of AF events was more than 3 and the lower limit of 95% confidence interval (n CI) of n ROR was more than 1, the AF signal was positive. The stability of the results was evaluated by subgroup analysis and sensitivity analysis and the adjusted n ROR value was calculated using logistic regression model in order to reduce the influence of confounding factors. The differences of clinical characteristics such as age, gender, dose, and indications between patients in the AF event group and non AF event group were compared. The clinical characteristics with significant difference (n P<0.05) were enrolled in the multivariate logistic regression model to analyze the influencing factors of AF induced by ivabradine.n Results:A total of 6 019 954 reports were entered in the analysis, including 1 799 cases (0.03%) in the ivabradine group and 6 018 155 cases (99.97%) in the other drugs group. There were 51 cases (2.83%) of AF events in the ivabradine group and 24 266 cases (0.40%) of AF events in the other drugs group. The overall n ROR of AF events induced by ivabradine was 7.21 (95n %CI: 5.45-9.52) and the overall adjusted n ROR was 6.81 (95n %CI: 5.13-9.02). The results of subgroup analysis and sensitivity analysis were consistent with the results of overall analysis basically. Multivariate logistic regression analysis showed that the risks of AF after ivabradine administration in the 70-79 years old and ≥80 years old patients were higher than that in the <60 years old patients [odds ratio ( n OR)=6.525, 95n %CI: 1.896-22.456, n P=0.003; n OR=4.948, 95n %CI: 1.050- 23.315, n P=0.043].n Conclusions:Ivabradine has a risk of AF. Advanced age may be associated with increased risk of ivabradine related AF.