Pharmacokinetics and Safety of WHO-Recommended Dosage and Higher Dosage of Levofloxacin for Tuberculosis Treatment in Children: a Pilot Study.

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases Pub Date : 2022-09-01 Epub Date: 2022-07-13 DOI:10.1016/j.ijid.2022.07.029

Watsamon Jantarabenjakul, Piyarat Suntarattiwong, Noppadol Wacharachaisurapol, Praon Supradish Na Ayudhya, Weeraya Phaisal, Monta Tawan, Juthamanee Moonwong, Tavitiya Sudjaritruk, Pajaree Chariyavilaskul, Thanyawee Puthanakit

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引用次数: 1

Abstract

Objectives: To evaluate the pharmacokinetic parameters of the 2020 World Health Organization (WHO)-recommended pediatric dosage of levofloxacin and the higher-than-WHO dosage.

Methods: Children aged 1-15 years with tuberculosis who received levofloxacin-based treatment for at least 7 days were enrolled. First, five children were enrolled to receive the WHO-recommended dosage (15-20 mg/kg/day), then an additional five children received a dosage higher than the WHO-recommended dosage (20-30 mg/kg/day). Blood samples were collected at predose and postdose 1, 2, 4, 6, 8, and 12 hours. A target of the ratio of the free area under the concentration-time curve to minimum inhibitory concentration (fAUC/MIC) was 100.

Results: The median (interquartile range) age was 9.6 (4.9-10.5) and 12.0 (10.1-12.3) years in the WHO dosage and higher-than-WHO dosage groups, respectively. The median (interquartile range) duration of antituberculosis treatment was 24 (8-24) weeks. The geometric mean (95% confidence interval) of fAUC/MIC was 60.4 (43.5-84.0) and 103.2 (70.1-151.8) in the WHO and higher-than-WHO dosage groups, respectively. There was no adverse event of QT prolongation or any other grade 3 or 4 adverse events.

Conclusion: Levofloxacin at a higher dose of 20-30 mg/kg/day could achieve the fAUC/MIC target in children.

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世卫组织推荐剂量和更高剂量左氧氟沙星治疗儿童结核病的药代动力学和安全性:一项初步研究。

目的:评价2020年世界卫生组织(WHO)推荐的儿童左氧氟沙星剂量和高于WHO推荐剂量的药代动力学参数。方法:1-15岁的儿童结核患者接受左氧氟沙星治疗至少7天。首先，5名儿童接受了世卫组织推荐剂量(15-20 mg/kg/天)，然后另外5名儿童接受了高于世卫组织推荐剂量(20-30 mg/kg/天)的剂量。在给药前和给药后1、2、4、6、8和12小时采集血样。浓度-时间曲线下自由面积与最低抑菌浓度(fac /MIC)之比的目标为100。结果:WHO剂量组和高于WHO剂量组的中位年龄(四分位数间距)分别为9.6(4.9-10.5)和12.0(10.1-12.3)岁。抗结核治疗的中位(四分位数范围)持续时间为24(8-24)周。WHO和高于WHO剂量组的fac /MIC几何平均值(95%置信区间)分别为60.4(43.5-84.0)和103.2(70.1-151.8)。没有QT延长的不良事件或任何其他3级或4级不良事件。结论:较高剂量的左氧氟沙星20 ~ 30 mg/kg/d可达到儿童fac /MIC指标。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases

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