Wu Juan, Chen Changcheng, Luo Chengjuan, Ning Botao, Liu Yue, Li Zhuo, Zhang Shunguo, Li Zhiling
Department of Pharmacy, Shanghai Children's Medical Center, School of Medicine, Shanghai JiaoTong University, Shanghai, China.
Department of Hematology and Oncology, Shanghai Children's Medical Center, School of Medicine, Shanghai JiaoTong University, Shanghai, China.
Antimicrob Agents Chemother. 2024 Dec 5;68(12):e0111224. doi: 10.1128/aac.01112-24. Epub 2024 Nov 6.
This study aimed to investigate the dose and trough concentration () of posaconazole delayed-release tablets and injections, and their correlation with efficacy and safety in pediatric patients. Patients younger than 18 years old received posaconazole delayed-release tablets or injections for prophylaxis or treatment of invasive fungal disease (IFD). Blood samples were collected to determine the plasma s, and dose regimen adjustments were made if necessary. Clinical data were collected. A total of 210 s of 113 pediatric patients were detected. The median s were 1.0 and 1.3 mg/L for tablets and injections, respectively ( < 0.05). The median doses required to achieve the target were about 6.0 mg/kg of body weight/day, and no statistical difference was observed between different age groups, formulations, or indications ( > 0.05). Concomitant treatment of tacrolimus and diarrhea were found to affect s of tablets, while age, gender, and BMI were found to be correlated with s of injections. IFD breakthrough occurred in 9.2% of patients with a median s of 0.74 mg/L for prophylaxis, and infection progression occurred in 43.2% of patients with a median s of 0.97 mg/L for treatment, respectively. Transaminitis was the most common adverse event. Posaconazole delayed-release tablets and injections are safe for prophylaxis and treatment of IFD in pediatric patients. An empirical initial dose of 6.0 mg/kg of body weight/day is appropriate for prophylaxis, while a higher dose should be required for the treatment of IFD. It is necessary to adjust the dose regimen according to the results of therapeutic drug monitoring.This study is registered with chictr.gov.cn under identifier ChiCTR2300070008.
本研究旨在探讨泊沙康唑缓释片和注射剂的剂量及谷浓度（），以及它们与儿科患者疗效和安全性的相关性。18岁以下患者接受泊沙康唑缓释片或注射剂预防或治疗侵袭性真菌病（IFD）。采集血样以测定血浆，必要时进行剂量方案调整。收集临床数据。共检测了113例儿科患者的210份。片剂和注射剂的中位数分别为1.0和1.3mg/L（<0.05）。达到目标所需的中位数剂量约为6.0mg/（kg体重·天），不同年龄组、剂型或适应证之间未观察到统计学差异（>0.05）。发现同时使用他克莫司和腹泻会影响片剂的，而年龄、性别和BMI与注射剂的相关。9.2%的预防患者发生IFD突破，预防时中位数为0.74mg/L，43.2%治疗患者发生感染进展，治疗时中位数为0.97mg/L。转氨酶升高是最常见的不良事件。泊沙康唑缓释片和注射剂用于儿科患者预防和治疗IFD是安全的。预防的经验性初始剂量为6.0mg/（kg体重·天）是合适的，但治疗IFD需要更高的剂量。有必要根据治疗药物监测结果调整剂量方案。本研究在chictr.gov.cn注册，标识符为ChiCTR2300070008。
