泊沙康唑延迟释放片在儿科血液肿瘤患者中的应用。
Posaconazole delayed-release tablets in paediatric haematology-oncology patients.
机构信息
Pediatric Hematology Oncology, Department of Mother and Child, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.
Department of Pediatrics, Ospedale San Gerardo, University of Milano-Bicocca, Fondazione MBBM, Monza, Italy.
出版信息
Mycoses. 2020 Jun;63(6):604-609. doi: 10.1111/myc.13084. Epub 2020 Apr 15.
BACKGROUND
To date, there are few studies that describe pharmacokinetics, safety and efficacy of posaconazole delayed-release tablet (DRT) formulation in the paediatric population.
OBJECTIVES
We evaluated retrospectively posaconazole plasma concentrations and safety of posaconazole DRT in paediatric haematology-oncology patients.
PATIENTS AND METHODS
Posaconazole DRT was assessed in 28 haematological paediatric patients with a median age 15 of years (range 5-18) and a median body weight of 50 kg (range 22-83 kg). Twenty-one patients received posaconazole DRT as prophylaxis and 7 patients as therapy.
RESULTS
As prophylaxis, the median daily dose was 5.5 mg/kg/day (range 2.2-22.2) with posaconazole trough level ≥ 0.7 μg/mL in 80% by first week, 62.5% by second week and 87.5% by fourth week. As therapy, the median daily dose was 4 mg/kg/day (range 3.3-4.5) with trough level ≥ 1 μg/mL 100% by first week, 80% by second week and 33.4% by fourth week.
CONCLUSIONS
Posaconazole DRT is feasible in paediatric patients capable to swallow tablets. Specific pharmacokinetic studies are needed.
背景
迄今为止，仅有少数研究描述了泊沙康唑延迟释放片（DRT）制剂在儿科人群中的药代动力学、安全性和疗效。
目的
我们回顾性评估了泊沙康唑 DRT 在儿科血液肿瘤患者中的血药浓度和安全性。
患者和方法
评估了 28 例血液学儿科患者使用泊沙康唑 DRT 的情况，中位年龄为 15 岁（范围为 5-18 岁），中位体重为 50kg（范围为 22-83kg）。21 例患者使用泊沙康唑 DRT 进行预防治疗，7 例患者进行治疗。
结果
作为预防治疗，中位日剂量为 5.5mg/kg/天（范围为 2.2-22.2），第 1 周有 80%、第 2 周有 62.5%、第 4 周有 87.5%的患者泊沙康唑谷浓度≥0.7μg/mL。作为治疗，中位日剂量为 4mg/kg/天（范围为 3.3-4.5），第 1 周有 100%、第 2 周有 80%、第 4 周有 33.4%的患者泊沙康唑谷浓度≥1μg/mL。
结论
泊沙康唑 DRT 在能够吞服片剂的儿科患者中是可行的。需要进行特定的药代动力学研究。
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