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
机构:[1]Department of Pediatrics, Peking University People’s Hospital, No. 11 Xi Zhi Men Nan Da Jie, Xicheng District, Beijing 100044, China[2]Department of Pediatrics, Peking University First Hospital, Beijing, China[3]Department of Neurology, Children’s Hospital, Fudan University, Shanghai, China[4]Department of Pediatrics, Quanzhou Women’s and Children’s Hospital, Quanzhou, China[5]Department of Neurology, Tianjin Children’s Hospital, Tianjin, China[6]Department of Neurology, Beijing Children’s Hospital, Beijing, China临床科室泌尿外科小儿神经科首都医科大学附属北京儿童医院[7]Department of Pediatric Neurology, The First Bethune Hospital, Jilin University, Changchun, China[8]Department of Pediatric Neurology, The 2nd Affiliated Hospital, Wenzhou Medical University, Wenzhou, China[9]Department of Neurology, Xijing Hospital, Xi’an, China[10]Department of Pediatrics, Xiangya Hospital, Central South University, Changsha, China[11]Department of Neurology, Children’s Hospital, Chongqing Medical University, Chongqing, China[12]The third Department of Neurology, Guangdong 999 Brain Hospital, Guangzhou, China
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. 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 ae<yen> 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. Six hundred and six pediatric patients were enrolled and 531 (87.6%) completed the study. After 26 weeks of treatment, 93.3% subjects achieved ae<yen> 50% seizure frequency reduction, and 81.8% achieved 100% seizure frequency reduction compared to baseline. Among different seizure types, OXC was effective 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 experienced SAE. Rash (n = 18, 2.97%) was the most common AE. Only 17 subjects discontinued due to AEs. This study, reporting the real-world data, further confirms the efficacy and good safety profile of OXC oral suspension in Chinese pediatric patients aged 2-5 years with PS and/or GTCS.
基金:
This study was funded by Beijing Novartis Pharma Co., Ltd.
第一作者机构:[1]Department of Pediatrics, Peking University People’s Hospital, No. 11 Xi Zhi Men Nan Da Jie, Xicheng District, Beijing 100044, China[2]Department of Pediatrics, Peking University First Hospital, Beijing, China
通讯作者:
通讯机构:[1]Department of Pediatrics, Peking University People’s Hospital, No. 11 Xi Zhi Men Nan Da Jie, Xicheng District, Beijing 100044, China[2]Department of Pediatrics, Peking University First Hospital, Beijing, China
推荐引用方式(GB/T 7714):
Jiong Qin,Yi Wang,Xin-Fang Huang,et al.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[J].WORLD JOURNAL OF PEDIATRICS.2018,14(3):280-289.doi:10.1007/s12519-017-0114-6.
APA:
Jiong Qin,Yi Wang,Xin-Fang Huang,Yu-Qin Zhang,Fang Fang...&Xiang-Shu Hu.(2018).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.WORLD JOURNAL OF PEDIATRICS,14,(3)
MLA:
Jiong Qin,et al."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".WORLD JOURNAL OF PEDIATRICS 14..3(2018):280-289