Analysis of clinical characteristics and influential factors of drug-induced liver injury in children caused by intravenous azithromycin

LI Wanhui; LYU Xiaoqian; SU Dan; HUO Baofeng; CHEN Hejun; YAN Ping

doi:10.6039/j.issn.1001-0408.2025.20.14

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Analysis of clinical characteristics and influential factors of drug-induced liver injury in children caused by intravenous azithromycin

更新时间：2025-10-25

- Analysis of clinical characteristics and influential factors of drug-induced liver injury in children caused by intravenous azithromycin
- ZHONGGUO YAOFANG Vol. 36, Issue 20, Pages: 2566-2570(2025)
- 作者机构：
  
  1.衡水市人民医院小儿内科，河北衡水　053000
  2.衡水市人民医院药学部，河北衡水　053000
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.20.14
  CLC： R985;R978.1;R969.3
- Received：12 June 2025，
  
  Revised：2025-09-25，
  
  Accepted：25 September 2025，
  
  Published：30 October 2025
- 稿件说明：
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李婉慧,吕晓倩,苏丹,等.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 [J].中国药房,2025,36(20):2566-2570.

LI Wanhui,LYU Xiaoqian,SU Dan,et al.Analysis of clinical characteristics and influential factors of drug-induced liver injury in children caused by intravenous azithromycin[J].ZHONGGUO YAOFANG,2025,36(20):2566-2570.
李婉慧,吕晓倩,苏丹,等.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 [J].中国药房,2025,36(20):2566-2570. DOI： 10.6039/j.issn.1001-0408.2025.20.14.

LI Wanhui,LYU Xiaoqian,SU Dan,et al.Analysis of clinical characteristics and influential factors of drug-induced liver injury in children caused by intravenous azithromycin[J].ZHONGGUO YAOFANG,2025,36(20):2566-2570. 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），

＝0.021

]

和阿奇霉素日剂量＞10 mg/kg[OR＝2.237，95%CI（1.075，4.655），

＝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。

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），

＝0.021

]

， daily dose of azithromycin＞10 mg/kg [OR＝2.237， 95%CI （1.075， 4.655），

＝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-induced DILI in children.

关键词

Keywords

references

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