左氧氟沙星在哺乳期非典型肺炎患者药动学的观察研究。

IF 1.8 3区医学 Q2 OBSTETRICS & GYNECOLOGY

Breastfeeding Medicine Pub Date : 2025-07-17 DOI:10.1177/15568253251361911

Jiahai Shang, Liangfang Pang, Jiaojiao Long, Yarui Liu, Yuanyuan Lu

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引用次数: 0

摘要

重要性：产后妇女的非典型肺炎可能通过细胞因子介导的血管通透性改变而改变药物药代动力学（PK），然而在这一人群中左氧氟沙星的母乳配置仍未确定。目的：本观察性研究旨在比较哺乳期非典型肺炎患者（n = 10）接受400 mg每日一次，连续3天的左氧氟沙星PK与历史健康对照，并评估婴儿暴露风险。方法：在最后一次给药后3天的预定时间点（0.5、1、2、4、6、8、10、12和24小时）采集受试者6-10的母乳样本。受试者1-5日间随机抽样。采用高效液相色谱紫外检测法测定母乳中左氧氟沙星浓度(相关系数：0.9997；检出限：0.15 μg/mL；复苏:91.36 - -102.28%;RSD结果：受试者1 ~ 5的Cmax为15.74±6.55 μg/mL，受试者6 ~ 10的Cmax为14.55±2.56 μg/mL；受试者1 ~ 5的消除半衰期（t1/2β）为7.46±3.39小时，受试者6 ~ 10的消除半衰期为4.57±1.14小时。受试者1 ~ 5 AUC0-24为84.31±22.60 mg·h/L，受试者6 ~ 10 AUC0-24为63.99±11.78 mg·h/L。结论：以150ml /kg/天的牛奶摄入量为基础，受试者1-5和受试者6-10的婴儿日暴露量分别为0.53±0.14和0.40±0.07 μg/kg/天，低于0-12月龄婴儿治疗剂量（10mg /kg每日一次）的10%。本研究首次采用一种经过验证的方法对非典型肺炎患者母乳中的左氧氟沙星进行定量分析。结果提示，在母体左氧氟沙星治疗期间，母乳喂养可谨慎继续。避免在药物浓度最高时母乳喂养，并监测婴儿的潜在反应。

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An Observational Study on the Pharmacokinetics of Levofloxacin in Lactating Atypical Pneumonia Patients.

Importance: Atypical pneumonia in postpartum women may alter drug pharmacokinetics (PK) through cytokine-mediated changes in vascular permeability, yet the breast milk disposition of levofloxacin in this population remains uncharacterized. Objective: This observational study aimed to compare levofloxacin PK in lactating atypical pneumonia patients (n = 10) receiving 400 mg once daily for 3 days with historical healthy controls and to assess infant exposure risks. Methods: Breast milk samples from subjects 6-10 were collected at predetermined time points (0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours) following the last dose of 3 days. Subjects 1-5 had random daytime sampling. The concentration of levofloxacin in breast milk was measured using a validated high-performance liquid chromatography method with ultraviolet detection (correlation coefficient: 0.9997; limit of detection: 0.15 μg/mL; recovery: 91.36-102.28%; RSD <5%). PK parameters were derived using noncompartmental analysis in Phoenix WinNonlin (version 8.35). Results: Key milk PK parameters included C_max of subjects 1-5 was 15.74 ± 6.55 μg/mL, and in subjects 6-10 was 14.55 ± 2.56 μg/mL. The elimination half-life (t_1/2β) in subjects 1-5 was 7.46 ± 3.39 hours and in subjects 6-10 was 4.57 ± 1.14 hours. The AUC_0-24 in subjects 1-5 was 84.31 ± 22.60 mg·h/L and in subjects 6-10 was 63.99 ± 11.78 mg·h/L. Conclusions: Based on a 150 mL/kg/day milk intake, the estimated infant daily exposure in subjects 1-5 and 6-10 was 0.53 ± 0.14 and 0.40 ± 0.07 μg/kg/day, respectively, which was below 10% of the therapeutic dose (10 mg/kg once daily) for infants aged 0-12 months. This study first quantified levofloxacin in atypical pneumonia patients' breast milk using a validated method. Results suggest that breastfeeding can continue cautiously during maternal levofloxacin therapy. Avoid breastfeeding at peak drug concentration and monitor the infant for potential reactions.

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来源期刊

Breastfeeding Medicine OBSTETRICS & GYNECOLOGY-PEDIATRICS

CiteScore

4.20

自引率

11.10%

发文量

130

审稿时长

6-12 weeks

期刊介绍： Breastfeeding Medicine provides unparalleled peer-reviewed research, protocols, and clinical applications to ensure optimal care for mother and infant. The Journal answers the growing demand for evidence-based research and explores the immediate and long-term outcomes of breastfeeding, including its epidemiologic, physiologic, and psychological benefits. It is the exclusive source of the Academy of Breastfeeding Medicine protocols. Breastfeeding Medicine coverage includes: Breastfeeding recommendations and protocols Health consequences of artificial feeding Physiology of lactation and biochemistry of breast milk Optimal nutrition for the breastfeeding mother Breastfeeding indications and contraindications Managing breastfeeding discomfort, pain, and other complications Breastfeeding the premature or sick infant Breastfeeding in the chronically ill mother Management of the breastfeeding mother on medication Infectious disease transmission through breast milk and breastfeeding The collection and storage of human milk and human milk banking Measuring the impact of being a “baby-friendly” hospital Cultural competence and cultural sensitivity International public health issues including social and economic issues.