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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.
Wang, Yi; Chen, Yin-Bo; Zhang, Yu-Qin; Luo, Rong; Wang, Hua; Lv, Jun-Lan; Wang, Dong; Zhu, Sui-Qiang; Lin, Zhong-Dong; Qin, Jiong.
Afiliación
  • Wang Y; Department of Neurology, Children's Hospital of Fudan University, Shanghai, China.
  • Chen YB; Department of Pediatric Neurology, The First Bethune Hospital of Jilin University, Changchun, China.
  • Zhang YQ; Department of Neurology, Tianjin Children's Hospital, Tianjin, China.
  • Luo R; Department of Pediatric Neurology, West China Second University Hospital of Sichuan University, Chengdu, China.
  • Wang H; Department of Pediatric Neurology, Shengjing Hospital of China Medical University, Shenyang, China.
  • Lv JL; Department of Neurology, Beijing Children's Hospital, Capital Medical University, Beijing, China.
  • Wang D; Department of Neurology, Xi'an Children's Hospital, Xi'an, China.
  • Zhu SQ; Department of Neurology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China.
  • Lin ZD; Department of Pediatric Neurology, The 2nd Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
  • Qin J; Department of Pediatrics, Peking University People's Hospital, No.11 Xizhimen South Str., Xicheng District, Beijing, 100044, China. jiongqinbeijing01@126.com.
World J Pediatr ; 13(6): 551-559, 2017 Dec.
Article en En | MEDLINE | ID: mdl-28646433
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carbamazepina / Epilepsia Generalizada / Epilepsia Tónico-Clónica / Anticonvulsivantes Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: World J Pediatr Asunto de la revista: PEDIATRIA Año: 2017 Tipo del documento: Article País de afiliación: China Pais de publicación: Suiza
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carbamazepina / Epilepsia Generalizada / Epilepsia Tónico-Clónica / Anticonvulsivantes Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Prognostic_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: World J Pediatr Asunto de la revista: PEDIATRIA Año: 2017 Tipo del documento: Article País de afiliación: China Pais de publicación: Suiza