Oxcarbazepine oral suspension in young pediatric patients with partial seizures and/or generalized tonic-clonic seizures in routine clinical practice in China: a prospective observational study

作     者：Jiong Qin Yi Wang Xin-Fang Huang Yu-Qin Zhang Fang Fang Yin-Bo Chen Zhong-Dong Lin Yan-Chun Deng Fei Yin Li Jiang Ye Wu Xiang-Shu Hu 

作者机构：Department of PediatricsPeking University People’s HospitalNo.11 Xi Zhi Men Nan Da JieXicheng DistrictBeijing 100044China Department ofP ediatricsPeking University First HospitalBeijingChina Department ofN eurologyChildren’s HospitalFudan UniversityShanghaiChina Department ofP ediatricsQuanzhou Women’s andChildren’s HospitalQuanzhouChina Department of N eurologyTianjin Children’s HospitalTianjinChina Department of N eurologyBeijing Children’s HospitalBeijingChina Department of Pediatric NeurologyThe First Bethune HospitalJilin UniversityChangchunChina Department of Pediatric NeurologyThe 2nd Affi liated HospitalWenzhou Medical UniversityWenzhouChina Department of N eurologyXijing HospitalXi’anChina Department of P ediatricsXiangya HospitalCentral South UniversityChangshaChina Department of N eurologyChildren’s HospitalChongqing Medical UniversityChongqingChina The third Department ofN eurologyGuangdong 999 Brain HospitalGuangzhouChina 

出 版 物：《World Journal of Pediatrics》 (世界儿科杂志（英文版）)

年 卷 期：2018年第14卷第3期

页      面：280-289页

核心收录：

学科分类：1004[医学-公共卫生与预防医学(可授医学、理学学位)] 1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：funded by Beijing Novartis Pharma Co.  Ltd 

主　　题：Antiepileptic drugs Generalized tonic-clonic seizures Oxcarbazepine oral suspension Partial seizures Pediatric patients 

摘      要：Background This study aimed to assess efficacy and safety of oxcarbazepine (OXC) oral suspension in pediatric patients aged 2-5 years with partial seizures (PS) and/or generalized tonic-clonic seizures (GTCS) in real-world clinical practice in China. Methods This 26-week, prospective, single-arm, multicenter, observational study recruited pediatric patients aged 2-5 years with PS or GTCS suitable for OXC oral suspension treatment based on physicians judgments from 11 medical centers in China. Enrolled subjects started OXC oral suspension treatment as monotherapy or in combination with other antiepileptic drugs. Primary efficacy outcome was the percentage of pediatric subjects achieving ≥ 50% seizure frequency reduction at the end of the 26-week treatment. Secondary efficacy-related parameters and safety parameters such as adverse events (AEs) and serious AEs (SAEs) were also monitored during the 26-week treatment period. Results Six hundred and six pediatric patients were enrolled and 531 (87.6%) completed the study. After 26 weeks of treat-ment, 93.3% subjects achieved ≥ 50% seizure frequency reduction, and 81.8% achieved 100% seizure frequency reduction compared to baseline. Among diff erent seizure types, OXC was eff ective in all subjects with simple PS and in 90% of subject with other type of seizure present in the study. AEs were observed in 49 (8.1%) subjects. Only three subjects expe-rienced SAE. Rash (n = 18, 2.97%) was the most common AE. Only 17 subjects discontinued due to AEs. Conclusion This study, reporting the real-world data, further confi rms the efficacy and good safety profi le of OXC oral suspension in Chinese pediatric patients aged 2-5 years with PS and/or GTCS.