Pharmacokinetics of Diazepam in Children with Status Epilepticus

Analysis of diazepam data and pharmacokinetic (PK) samples obtained from the NICHD-2003-10-2 (BPCA Status 2) study, a double-blinded, randomized, controlled trial comparing efficacy and short-term safety of lorazepam versus diazepam in pediatric status epilepticus (SE). The primary objective of the NICHD-2015-DZP01 (BPCA DZP01) study was to determine the PK of diazepam for pediatric SE using sparse sampling. The secondary objective was to determine the safety and efficacy of diazepam for pediatric SE. The Status 2 and DZP01 studies were both conducted under the Best Pharmaceuticals for Children Act (BPCA).

本数据集分析所用的地西泮相关数据及药代动力学（pharmacokinetics，PK）样本，来源于NICHD-2003-10-2（BPCA Status 2）研究。该研究为一项双盲随机对照试验，旨在比较劳拉西泮与地西泮治疗儿童癫痫持续状态（status epilepticus，SE）的疗效与短期安全性。另一项相关研究为NICHD-2015-DZP01（BPCA DZP01），其主要研究目标为采用稀疏采样法，评估儿童癫痫持续状态患者使用地西泮后的药代动力学特征；次要研究目标为明确地西泮用于儿童癫痫持续状态的安全性与疗效。上述两项研究均依据《儿童最佳药品法案》（Best Pharmaceuticals for Children Act，BPCA）开展。