某三甲儿童医院住院患者静脉用药不良反应的分析

doi:10.19803/j.1672-8629.2022.07.14

摘要/Abstract

摘要： 目的调查真实世界儿童住院患者静脉用药相关药品不良反应（ADR）发生的特点及规律,为儿科临床药物的合理使用和用药安全评价提供参考。方法采用回顾性分析方法,收集2018年1月1日至2019年12月31日某儿童专科医院接受过静脉治疗的住院患儿信息,并对因静脉用药导致的ADR报告予以评价分析,就患儿的年龄特点、可疑药物、发生时间、累及系统-器官等进行统计分析。结果接受过静脉治疗的50 194人次住院患儿中,共收到有效ADR报告423例,ADR发生率为8.43‰。7~12岁静脉用药患儿的ADR发生率最高（10.24‰）,其次为4~6岁年龄段患儿（8.93‰）,新生儿期静脉用药患儿ADR发生率最低（3.40‰）。儿童静脉用药ADR涉及药物共19类61个品种,其中占比最高的前3位药物分别为抗菌药物（259例,61.23%）、电解质/酸碱平衡及营养药物（35例,8.27%）和中药注射剂（24例,5.67%）。儿童静脉用药ADR主要发生在给药1 h之内（67.38%）,其中30 min内发生ADR占比为51.88%。423例ADR中最常见的累及系统-器官为皮肤及其附件（62.27%）,其次为胃肠道反应（20.61%）以及全身性损害（5.56%）。结论应对不同年龄段儿童静脉用药的ADR发生特点予以重视,并采取积极措施对儿童静脉用药潜在的ADR风险加以防范,保障儿童药物治疗的安全有效。

关键词: 药品不良反应, 儿童, 静脉用药, 住院

Abstract: Objective To study the patterns and characteristics of adverse drug reactions(ADR) among the real-world pediatric inpatients in order to provide reference for clinical rational drug use and for safety evaluation of drugs in pediatric populations. Methods In this retrospective study, the data on pediatric inpatients treated with intravenous administration and reports about adverse drug reactions in a tertiary children's hospital collected between 2018 to 2019 were analyzed in terms of patients' age, medications, time of occurrence, and organs/systems involved. Results Among the 50 194 pediatric inpatients who had received intravenous administration, a total of 423 ADR reports in our hospital were collected. The incidence of adverse reactions of intravenous medicines averaged 8.43%. The incidence of ADR was the highest among patients ages 7 to 12 (10.24‰) and 4 to 6 (8.93‰), but was the lowest in newborns (3.40‰). The 423 ADR reports involved 61 types of drugs. 259 of these ADR involved anti-infectious drugs, accounting for 61.23%, 35 involved drugs for regulation of electrolytes and acid-base balance and nutritional drugs, accounting for 8.27%, and 24 were related to traditional Chinese medicine injections, accounting for 5.67%. Intravenous ADR mainly occurred within one hour of medication (67.38%), and 51.88% of the ADR occurred within 30 minutes of injection. ADR involving organs/systems were mostly the damage to the skin and its accessories (62.27%), followed by gastrointestinal side effects (20.61%) and systemic damage (5.56%). Conclusion More attention should be paid to the regularity and characteristics of adverse reactions during intravenous administration in children. Preventive measures should be taken to ensure the safety and effectiveness of pediatric drugs.

Key words: adverse drug reaction, children, intravenous medicine, hospitalization

中图分类号:

R994.11

刘畅, 林慧君, 申红霞, 闫美兴. 某三甲儿童医院住院患者静脉用药不良反应的分析[J]. 中国药物警戒, 2022, 19(7): 762-766.

LIU Chang, LIN Huijun, SHEN Hongxia, YAN Meixing. Analysis of Adverse drug reactions of intravenous medication in pediatric inpatients in a tertiary children's hospital[J]. Chinese Journal of Pharmacovigilance, 2022, 19(7): 762-766.

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