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静脉滴注阿奇霉素致儿童药物性肝损伤的临床特征及影响因素

分析
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李婉慧 ，吕晓倩 ，苏 丹 ，霍保凤 ，陈赫军 ，闫 平（1. 衡水市人民医院小儿内科，河北 衡水 053000；
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2.衡水市人民医院药学部，河北 衡水 053000）
中图分类号 R985；R978.1；R969.3 文献标志码 A 文章编号 1001-0408（2025）20-2566-05
DOI 10.6039/j.issn.1001-0408.2025.20.14

摘 要 目的 分析静脉滴注阿奇霉素致儿童药物性肝损伤（DILI）的临床特征及影响因素。方法 收集衡水市药品不良反应监测
中心2015年1月－2025年1月报告的157例静脉滴注阿奇霉素致DILI的患儿的临床资料，作为观察组；按照1∶1的比例，回顾性
收集衡水市人民医院同期收治的静脉滴注阿奇霉素但未发生DILI的患儿的临床资料，作为对照组。分析观察组患儿DILI的临床
分型、严重程度及预后。通过单因素分析和多因素Logistic回归分析筛选静脉滴注阿奇霉素致儿童DILI的独立危险因素。结果
157例DILI患儿中，92例（58.60%）为肝细胞损伤型，51例（32.48%）为胆汁淤积型，14例（8.92%）为混合型；DILI严重程度1、2、3级
分别有117例（74.52%）、33例（21.02%）、7例（4.46%）；经停药及对症治疗后，患儿的肝功能均恢复正常。合并使用对乙酰氨基酚
[OR＝3.769，95%CI（1.615，8.235），P＝0.021]和阿奇霉素日剂量＞10 mg/kg[OR＝2.237，95%CI（1.075，4.655），P＝0.034]是静脉滴
注阿奇霉素致儿童DILI的独立危险因素。结论 阿奇霉素致儿童DILI以肝细胞损伤型和胆汁淤积型较为常见，多为轻度，且预后
较好。合并使用对乙酰氨基酚、阿奇霉素日剂量＞10 mg/kg是阿奇霉素致儿童DILI的独立危险因素。
关键词 阿奇霉素；药物性肝损伤；儿童；临床特征；影响因素

Analysis of clinical characteristics and influential factors of drug-induced liver injury in children caused by
intravenous azithromycin
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LI Wanhui ，LYU Xiaoqian ，SU Dan ，HUO Baofeng ，CHEN Hejun ，YAN Ping（1. Dept. of Pediatric Internal
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Medicine， Hengshui People’s Hospital， Hebei Hengshui 053000， China；2. Dept. of Pharmacy， Hengshui
People’s Hospital， Hebei Hengshui 053000， China）
ABSTRACT OBJECTIVE To analyze the clinical characteristics and influential factors of drug-induced liver injury （DILI） in
children caused by intravenous azithromycin. METHODS Clinical data of 157 DILI pediatric cases caused by intravenous
azithromycin， reported by the Hengshui Adverse Drug Reaction Monitoring Center from January 2015 to January 2025， were
collected as the observation group. Clinical data of pediatric patients who received intravenous azithromycin but did not develop
DILI during the same period at Hengshui People’s Hospital were collected in a 1∶1 ratio to serve as the control group. The clinical
classification， severity and prognosis of DILI in pediatric patients from the observation group were analyzed. Univariate and
multivariate Logistic regression analyses were used to screen the independent risk factors for DILI in children caused by intravenous
azithromycin. RESULTS Among 157 DILI cases， 92 cases （58.60%） had hepatocellular injury-type， 51 cases （32.48%） had
cholestatic-type， and 14 cases （8.92%） had mixed-type. DILI severity was grade 1 in 117 cases （74.52%）， grade 2 in 33 cases
（21.02%）， and grade 3 in 7 cases （4.46%）. Liver function had all recovered after stopping medication and symptomatic treatment.
Combined with acetaminophen [OR＝3.769， 95%CI （1.615， 8.235）， P＝0.021]， daily dose of azithromycin＞10 mg/kg [OR＝
2.237， 95%CI （1.075， 4.655）， P＝0.034] were independent risk factors for DILI in children caused by intravenous azithromycin.
CONCLUSIONS Hepatocellular injury-type and cholestatic-type are relatively common in children with DILI caused by intravenous
azithromycin， with mild severity being predominant and showing a favorable prognosis. Combination with acetaminophen and daily
dose＞10 mg/kg are independent risk factors for azithromycin-
Δ 基金项目 河北省医学科学研究课题计划项目（No.20220463）
＊第一作者 主管护师。研究方向：儿科临床合理用药。E-mail： induced DILI in children.
38477948@qq.com KEYWORDS azithromycin； drug-induced liver injury； children；
# 通信作者 副主任药师。研究方向：临床药学、药物不良反应监 clinical characteristics； influential factors
测。E-mail：blueair2022@163.com

· 2566 · China Pharmacy 2025 Vol. 36 No. 20 中国药房 2025年第36卷第20期