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Oxcarbazepine oral suspension in pediatric patients with partial seizures and/or generalized tonic-clonic seizures: a multi-center, single arm, observational study in China

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机构: [1]Fudan Univ, Dept Neurol, Childrens Hosp, Shanghai, Peoples R China; [2]Jilin Univ, Dept Pediat Neurol, Bethune Hosp 1, Changchun, Jilin, Peoples R China; [3]Tianjin Childrens Hosp, Dept Neurol, Tianjin, Peoples R China; [4]Sichuan Univ, Dept Pediat Neurol, West China Univ Hosp 2, Chengdu, Sichuan, Peoples R China; [5]China Med Univ, Dept Pediat Neurol, Shengjing Hosp, Shenyang, Liaoning, Peoples R China; [6]Capital Med Univ, Beijing Childrens Hosp, Dept Neurol, Beijing, Peoples R China; [7]Xian Childrens Hosp, Dept Neurol, Xian, Shaanxi, Peoples R China; [8]Huazhong Univ Sci & Technol, Dept Neurol, Tongji Med Coll, Tongji Hosp, Wuhan, Hubei, Peoples R China; [9]Wenzhou Med Univ, Dept Pediat Neurol, Affiliated Hosp 2, Wenzhou, Peoples R China; [10]Peking Univ, Dept Pediat, Peoples Hosp, 11 Xizhimen South Str, Beijing 100044, Peoples R China; [11]Peking Univ, Dept Pediat, Hosp 1, Beijing, Peoples R China
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关键词: children efficacy generalized tonic-clonic seizures oxcarbazepine oral suspension partial seizures

摘要:
To assess efficacy and safety of oxcarbazepine (OXC) oral suspension in pediatric patients aged 2-16 years with partial seizures (PS) and/or generalized tonic-clonic seizures (GTCS) in real-world clinical practice in China. This 26-week, single arm, multicenter and observational study recruited patients aged 2-16 years with PS or GTCS suitable for OXC oral suspension treatment. Enrolled patients received OXC oral suspension treatment for 26 weeks. Primary endpoints included mean seizure frequency at the end of the treatment and mean seizure frequency reduction at the end of the treatment vs. baseline. Secondary efficacy-related endpoints and safety parameters were also assessed. Nine hundred and eighty-seven pediatric patients were enrolled and 912 (92.4%) completed the study. The mean seizure frequencies at baseline and the end of week 26 were 13.40 +/- 64.92 and 1.62 +/- 19.47 times/ month, respectively. The mean seizure frequency reduction was 10.03 +/- 63.67 times/month and the mean seizure frequency reduction percentage was 90.02%+/- 5127.0% (P < 0.0001). After 26 weeks of treatment, 82.36%, 7.24% and 3.86% of the patients became controlled, significantly improved and improved, respectively. Adverse events (AEs) were reported in 74 (7.65%) patients. Rash was the most common AE. The efficacy of OXC was not affected by seizure types, age or gender. This study confirms the efficacy and good safety profile of OXC oral suspension in Chinese pediatric patients aged 2-16 years with PS and/or GTCS.

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出版当年[2016]版:
大类 | 4 区 医学
小类 | 4 区 儿科
最新[2023]版:
大类 | 2 区 医学
小类 | 3 区 儿科
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出版当年[2015]版:
Q3 PEDIATRICS
最新[2023]版:
Q1 PEDIATRICS

影响因子: 最新[2023版] 最新五年平均 出版当年[2015版] 出版当年五年平均 出版前一年[2014版] 出版后一年[2016版]

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第一作者机构: [1]Fudan Univ, Dept Neurol, Childrens Hosp, Shanghai, Peoples R China;
通讯作者:
通讯机构: [10]Peking Univ, Dept Pediat, Peoples Hosp, 11 Xizhimen South Str, Beijing 100044, Peoples R China; [11]Peking Univ, Dept Pediat, Hosp 1, Beijing, Peoples R China
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