基于中国医院药物警戒系统的哌拉西林钠-他唑巴坦钠致低钾血症的临床特征和危险因素分析

Clinical characteristics and risk factors of hypokalemia due to piperacillin sodium and tazobactam sodium based on the data of China Hospital Pharmacovigilance System

目的基于中国医院药物警戒系统(CHPS)探讨哌拉西林钠-他唑巴坦钠致低钾血症的临床特征和危险因素,为临床安全使用提供参考。方法利用CHPS 2.0版药品评价系统构建评价方案,选取2020年1月1日—2021年6月30日在许昌市中心医院使用哌拉西林钠-他唑巴坦钠治疗的住院患者。根据使用该药后是否出现低钾血症,将患者分为低钾血症组(血清钾<3.5 mmol/L)和非低钾血症组(血清钾≥3.5 mmol/L),比较两组患者的临床资料,分析哌拉西林钠-他唑巴坦钠致低钾血症的危险因素。结果共有402例患者纳入分析。其中,发生低钾血症者121例,发生率为30.1%。多因素logistic回归分析结果显示,女性(OR=2.026,95%CI:1.257~3.264,P=0.004)、较高的年龄(OR=1.031,95%CI:1.016~1.046,P<0.001,截断值:61.5岁)、哌拉西林钠-他唑巴坦钠使用前最后1次较低的血清钾检测值(OR=0.404,95%CI:0.224~0.729,P=0.003,截断值:3.685 mmol/L)是哌拉西林钠-他唑巴坦钠致低钾血症的独立危险因素。结论哌拉西林钠-他唑巴坦钠可引起低钾血症的发生,尤其是女性、高龄和该药使用前血清钾水平较低的患者,故临床在使用时应关注这些重点人群,监测其血清钾基线水平,以评估发生低钾血症风险。

Objective Clinical characteristics and risk factors of hypokalemia due to piperacillin sodium and tazobactam sodium were explored using the data of China Hospital Pharmacovigilance System(CHPS)for safe use of piperacillin sodium and tazobactam sodium in clinical practice.Methods An evaluation plan was constructed using CHPS v2.0 drug evaluation system to select the inpatients treated with piperacillin sodium and tazobactam sodium in Xuchang Central Hospital from January 1,2020to June 30,2021.The patients were assigned to hypokalemia group(serum potassium<3.5 mmol/L)or non-hypokalemia group(serum potassium≥3.5 mmol/L).Clinical characteristics were compared between the two groups of patients.Multivariate logistic regression model was used to analyze the risk factors of hypokalemia due to piperacillin sodium and tazobactam sodium.Results A total of 402 patients were enrolled into this study.Hypokalemia was identified in 121(30.1%)patients.Multivariate logistic regression analysis showed that female(OR=2.026,95%CI:1.257-3.264,P=0.004),old age(OR=1.031,95%CI:1.016-1.046,P<0.001,cutoff value:61.5 years)and lower serum potassium before use of piperacillin sodium and tazobactam sodium(OR=0.404,95%CI:0.224-0.729,P=0.003,cutoff value:3.685 mmol/L)were the independent risk factors of hypokalemia due to piperacillin sodium and tazobactam sodium.Conclusions Piperacillin sodium and tazobactam sodium can induce hypokalemia,especially in female patients,elderly patients,and patients with low baseline serum potassium level before use of piperacillin sodium and tazobactam sodium.Therefore,clinicians should be cautious when prescribing piperacillin sodium and tazobactam sodium for female and elderly patients,especially in case of prevalent lower serum potassium level.