基于中国医院药物警戒系统评价儿童应用头孢唑肟的安全性

目的:借助中国医院药物警戒系统(CHPS)的真实世界数据，评价某院儿童使用头孢唑肟的安全性，并分析头孢唑肟相关药物不良反应(ADR)发生情况及影响因素。方法:基于CHPS平台，对我院2018年2月至2020年4月使用头孢唑肟的住院患儿进行单中心回顾性主动监测，药师对系统监测病例进行评定，获得头孢唑肟ADR发生率，并对ADR影响因素进行分析。结果:系统共回顾性监测了2 948例使用头孢唑肟的患儿，31例出现ADR,ADR发生率为1.09%。多因素logistic回归分析显示，头孢唑肟联合氟氯西林、单次用药剂量是儿童使用头孢唑肟发生ADR的独立影响因素。结论:头孢唑肟在儿童用药中发生ADR并不少见。减少与氟氯西林联合用药、根据说明书推荐剂量用药有助于降低临床用药风险，CHPS系统的应用对今后进行大样本量真实世界用药评价具有重要意义。

Study on the Safety Evaluation of Ceftizoxime in Children Based on China Hospital Pharmacovigilance System

Objective: Drawing on the real-world data from the China Hospital Pharmacovigilance System (CHPS), to evaluate the safety of ceftizoxime used in children of a hospital, and analyze the occurrence of ceftizoxime-related adverse drug reaction (ADR) and its influencing factors. Methods: Based on the CHPS platform, single-center retrospective active monitoring was carried out on the hospitalized children who had ceftizoxime for injection from February 2018 to April 2020. The system monitoring cases were evaluated by double pharmacists, the incidence of ceftizoxime ADR was obtained, and its influencing factors were analyzed. Results: Totally 2,948 children who used ceftizoxime were monitored retrospectively, and 31 cases of ADR occurred, with an incidence of 1. 09%. Multivariate logistic regression analysis showed that the combination of ceftizoxime and flucloxacillin and a single dose were independent influencing factors of ADR in children using ceftizoxime. Conclusion: The incidence of ADR in children with ceftizoxime is not a rare range. Reducing the combined use of flucloxacillin and adjusting the single dose according to the weight of the child will help reduce the clinical risk of medication. The application of the CHPS platform is of great significance for future large-sample real-world medication evaluation.