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.
Mycoses. 2020 Jun;63(6):604-609. doi: 10.1111/myc.13084. Epub 2020 Apr 15.
To date, there are few studies that describe pharmacokinetics, safety and efficacy of posaconazole delayed-release tablet (DRT) formulation in the paediatric population.
We evaluated retrospectively posaconazole plasma concentrations and safety of posaconazole DRT in paediatric haematology-oncology patients.
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.
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.
Posaconazole DRT is feasible in paediatric patients capable to swallow tablets. Specific pharmacokinetic studies are needed.
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。
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。
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。
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。
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。
