甘草酸二铵致药源性低钾血症报告情况及影响因素分析

Reports and influencing factors of drug-induced hypokalemia induced by diammonium glycyrrhizinate

目的分析甘草酸二铵不良反应人群中药源性低钾血症报告情况及其影响因素。方法回顾性分析国家药品不良反应监测系统2004年1月1日至2020年6月30日收集的甘草酸二铵不良反应报告,共12816例甘草酸二铵不良反应/事件报告纳入分析,其中低钾血症报告数110例;按照年龄、性别、药品剂型、用药时间和原患疾病(糖尿病和高血压)分组统计低钾血症报告率,采用卡方检验比较不同分组低钾血症报告率差异,利用Logistic回归分析进一步探讨低钾血症的影响因素。结果甘草酸二铵不良反应人群中,口服制剂组低钾血症报告率为1.72%,注射制剂组为0.56%(差异有统计学意义),且随着年龄和用药时间增长,低钾血症报告率显著升高。Logistic回归分析结果显示:与注射制剂相比,口服制剂校正OR值为2.171;与青壮年组相比,中、老年组校正OR值为2.534和3.394;与用药1 d组相比,用药2~3、4~6、7~14、15~30、>30 d以上组校正OR值为6.761、28.253、28.762、48.071、134.501;与非糖尿病患者相比,糖尿病患者校正OR值为3.223。结论甘草酸二铵不良反应人群中,高龄、使用口服制剂、长时间用药以及患有糖尿病是出现药源性低钾血症的影响因素。

Objective To analyze reports and influencing factors of drug-induced hypokalemia in diammonium oxalate adverse reactions.Methods the ADR reports from January 1,2004 to June 30,2020 of diammonium glycyrrhizinate collected by the national adverse drug reaction monitoring system from January 1,2004 to June 30,2020 were retrospectively analyzed.A total of 12816 adverse reaction/event reports of diammonium glycyrrhizinate were included in the analysis,including 110 reports of hypokalemia.The reporting rate of hypokalemia was analyzed according to age,gender,dosage form,medication time and underlying diseases(diabetes and hypertension).The chi-square test was conducted to compare the difference in the reports rate of hypokalemia among different groups.Logistic regression analysis was conducted to further explore the influencing factors of hypokalemia.Results Among the adverse reactions of diammonium glycyrrhizinate,the reporting rate of hypokalemia was 1.72%in the oral preparation group,and 0.56%in the injection preparation group(the difference was statistically significant)and the reporting rate of hypokalemia increased significantly with age as well as duration of medication.Logistic regression analysis showed that the corrected OR value of the oral preparation was 2.171 compared with the injection preparation.The corrected OR values of middle-aged and elderly groups were 2.534 and 3.394 compared with the young group.The corrected OR values of 2~3,4~6,7~14,15~30 and>30 days were 6.761,28.253,28.762,48.071 and 134.501 compared with the 1 day group.The corrected OR value of diabetic patients was 3.223 compared with non-diabetic patients.Conclusion Elderly,oral preparations,long time medication and diabetes mellitus are risk factors for drug-induced hypokalemia among the adverse reaction of diammonium glycyrrhizinate.