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儿童患者地高辛血药浓度超出治疗窗上限的危险因素分析
胡美绘,张雯婷,栗金权,郑爱斌
0
(南通大学附属常州儿童医院,江苏常州 213018)
摘要:
目的:探讨儿童患者地高辛血药浓度(SDC)超出治疗窗上限的危险因素,为临床合理用药提供参考。方法:回顾性分析 2022 年7 月-2025 年6 月我院使用地高辛并监测SDC 的患儿病例资料,根据SDC 监测结果,分为达标组(0. 5~2. 0 ng/ mL)和超 标组(>2.0 ng/ mL);对两组患儿性别、年龄、日剂量、肝肾功能、联合用药等数据进行分析。结果:共纳入105 例患儿,其中男50 例,女55 例,年龄21 d~14 岁;单因素分析和多因素logistic 回归分析显示,地高辛日剂量(OR=2. 732, 95%CI 1. 649~6. 269,P =0. 002)和联 用阿奇霉素(OR=17. 050, 95%CI 1. 948~435. 700,P =0. 029)为SDC 超出治疗窗上限的独立危险因素。不同剂量组比较显示,地 高辛日剂量>10 μg/ kg 组SDC 超出治疗窗上限的比例最高(55. 17%),高于<5 μg/ kg 组(5. 56%),而5~10 μg/ kg 组SDC 均未超出 治疗窗上限;剂量组间SDC 超出治疗窗上限的比例比较差异有统计学意义(P<0. 05)。结论:地高辛日剂量和联用阿奇霉素为儿 童患者SDC 超出治疗窗上限的独立危险因素,地高辛日剂量>10 μg/ kg 时,可能会导致SDC 超出治疗窗上限的发生率明显升高。
关键词:  儿童  地高辛  治疗药物监测  危险因素  安全性
DOI:10.13407/j.cnki.jpp.1672-108X.2025.12.009
基金项目:常州市科技局应用基础研究专项课题,编号CJ20253122。
Risk Factors for Serum Digoxin Concentration Exceeding the Limit of Treatment Window in Children
Hu Meihui, Zhang Wenting, Li Jinquan, Zheng Aibin
(Affiliated Changzhou Children’ s Hospital of Nantong University, Jiangsu Changzhou 213018, China)
Abstract:
Objective: To explore the risk factors for serum digoxin concentration (SDC) exceeding the limit of treatment window in children, and to provide reference for rational clinical medication. Methods: Patients treated with digoxin and monitored for serum concentration in our hospital from Jul. 2022 to Jun. 2025 were retrospectively analyzed. All patients were divided into goal-attaining group (from 0. 5 to 2. 0 ng/ mL) and limit-exceeding group (>2. 0 ng/ mL) according to the levels of SDC. Gender, age, daily dosage, liver and kidney function, and drug combination of two groups were analyzed. Results: A total of 105 children were enrolled, including 50 males and 55 females, aged from 21 d to 14 years old. Univariate analysis and multivariate logistic regression analysis showed that the daily dose of digoxin (OR=2. 732, 95% CI 1. 649 to 6. 269, P =0. 002) and the combination of azithromycin (OR=17. 050, 95% CI 1. 948 to 435. 700, P = 0. 029) were independent risk factors for SDC exceeding the limit of treatment window. Comparative analysis across different dosage groups demonstrated that the proportion of SDC exceeding the limit of treatment window in the group with a daily dose of digoxin >10 μg/ kg was the highest (55. 17%), higher than that in the group with a daily dose <5 μg/ kg (5. 56%), while the SDC did not exceed the limit of treatment window in the 5 to 10 μg/ kg group; there was statistically significant difference in the proportion of SDC exceeding the limit of treatment window among different dose groups (P <0. 05). Conclusion: The daily dose of digoxin and combination of azithromycin were independent risk factors for SDC exceeding the limit of treatment window in children. When the daily dose of digoxin >10 μg/ kg, the incidence of SDC exceeding the limit of treatment window is significantly increased.
Key words:  children  digoxin  therapeutic drug monitoring  risk factors  safety

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