中国药物警戒 ›› 2025, Vol. 22 ›› Issue (11): 1282-1286.
DOI: 10.19803/j.1672-8629.20250288

• 安全与合理用药 • 上一篇    下一篇

213例儿童住院患者药品不良反应特点及用药分析

赵杰1, 徐娟2, 李杏花3*   

  1. 1山西省儿童医院药剂科,山西 太原 030013;
    2山西白求恩医院药学部,山西 太原 030032;
    3长治市人民医院药剂科,山西 长治 046000
  • 收稿日期:2025-05-07 出版日期:2025-11-15 发布日期:2025-11-14
  • 通讯作者: *李杏花,女,博士,主管药师,中药学及临床药学。E-mail: xinghualiabc@163.com
  • 作者简介:赵杰,女,硕士,主任药师,儿科临床药学。
  • 基金资助:
    山西省自然科学基金资助项目（202303021222376）; 山西省科技厅基础研究计划青年项目（202203021212109）

Adverse Drug Reactions and Medications among 213 Pediatric Inpatients

ZHAO Jie1, XU Juan2, LI Xinghua3*   

  1. 1Department of Pharmacy, Shanxi Provincial Children's Hospital, Taiyuan Shanxi 030013, China;
    2Department of Pharmacy, Shanxi Bethune Hospital, Taiyuan Shanxi 030032, China;
    3Department of Pharmacy, Changzhi People's Hospital, Changzhi Shanxi 046000, China
  • Received:2025-05-07 Online:2025-11-15 Published:2025-11-14

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摘要： 目的 对儿童住院患者药品不良反应（ADR）发生特点及用药情况进行分析,为临床安全用药提供参考。方法 回顾性分析 2024年4月1日至 2025 年3月31日某三级甲等儿童医院住院患者上报ADR情况,评价药物与ADR之间的关联性,采用《不良事件通用术语评价标准》（5.0版）对ADR的严重程度进行分级。结果 上报的213例ADR中,男性患儿110名,女性患儿103名。年龄分布情况：≤1岁者10例（4.70%）,1~3岁36例（16.90%）,4~6岁68例（31.92%）,7~12岁91例（42.72%）,12~17岁8例 (3.76%)。发生总例次排名首位为抗感染药物;给药途径排名首位为静脉注射（79.73%）;累及最多的系统-器官为皮肤及其附件（59.73%）,主要临床表现为皮疹。严重不良反应45例（21.13%）,涉及药品中排名前3位的分别为：注射用头孢噻肟钠5例、注射用乳糖酸红霉素4例、水合氯醛灌肠液3例。新的药品不良反应1例。结论 儿童患者ADR,以抗感染药物相关ADR为主,主要表现为皮肤损害;非抗感染类药物（如水合氯醛、莪术油）在儿童群体中引发严重过敏反应也应引起关注;家长自行用药行为是儿童ADR发生的重要危险因素;临床用药物时应特别关注12岁以下儿童的用药安全。

关键词: 儿童患者, 水合氯醛, 磷酸奥司他韦颗粒, 贝林妥欧单抗, 抗感染药物, 用药分析, 药品不良反应

Abstract: Objective To analyze the adverse drug reactions (ADR) among and medications for hospitalized pediatric patients so as to provide references for rational drug use. Methods A retrospective analysis was conducted of ADR reports involving inpatients treated at a tertiary children's hospital between April 1, 2024 and March 31, 2025. The association between medications and ADR was studied, and the severity of ADR was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results Among the 213 patients involved, 110 were male and 103 were female. There were 10 cases (4.70%) aged 1 or younger, 36 cases (16.90%) ages 1 to 3, 68 cases (31.92%) ages 4 to 6, 91 cases (42.72%) ages 7 to 12 and 8 cases (3.76%) aged 12 to 17. The most common type of drug involved was anti-infective drugs, the dominating route of administration was intravenous injection (79.73%), and the most vulnerable organ was the skin and its accessories (59.73%), with rash as the primary clinical manifestation. Severe adverse reactions occurred in 45 cases (21.13%), and the top three drugs involved were cefotaxime sodium for injection (5 cases), erythromycin lactobionate for injection (4 cases), and chloral hydrate enema solution (3 cases). One case of new drug adverse reactions was reported. Conclusion ADR among pediatric patients are mostly adverse reactions that are caused by anti-infective drugs and manifest as skin damage. Severe allergic reactions caused by non-anti-infective drugs (such as chloral hydrate and turmeric oil) in children deserve more attention. Self-medication by parents is an important risk factor for ADR in children. Clinicians should try to ensure safe medications among children under 12.

Key words: Pediatric Patients, Chloral Hydrate, Oseltamivir, Blinatumomab, Anti-Infective Drugs, Medication Analysis, Adverse Drug Reactions

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