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.

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 treatment, 93.3% subjects achieved ≥ 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. CONCLUSION: 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.

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

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.

Lamotrigine monotherapy for paroxysmal kinesigenic dyskinesia in children.

PURPOSE: To evaluate the efficacy and tolerability of lamotrigine monotherapy in children with paroxysmal kinesigenic dyskinesia. METHOD: A sample of eighteen children aged between 2 years old and 13 years old who fulfilled the diagnostic criteria from January 2008 to December 2014 was enrolled, they received video electroencephalography, brain image scans and proline-rich transmembrane protein 2 genetic tests. Children with known or suspected diseases which would cause secondary paroxysmal kinesigenic dyskinesia were excluded. The initial dosage of lamotrigine was 6.25 mg, and it was gradually increased every week until attacks were controlled. Patients entered the maintenance dose phase upon reaching the effective dosage, and by being attack free at two consecutive outpatient visits. They were followed up for a couple of years until December 2014. RESULTS: By the end of the 4th week, the attack-free rate reached 100% among all the patients. During the maintenance dose phase, 16 patients remained attack free, 2 patients received additional drug due to attack relapses when they entered puberty. Three patients had relapses because of non-compliance to the therapy, but they became attack free as soon as they re-started the medicine. The mean daily dosage was 26.4 mg (range 6.25-50). Definite adverse effect related to the drug was not reported in follow up. CONCLUSION: LTG monotherapy is effective and well tolerated for PKD in children.

Endoplasmic reticulum stress plays critical role in brain damage after chronic intermittent hypoxia in growing rats.

Obstructive sleep apnea hypopnea syndrome (OSAHS) in children is associated with multiple system morbidities. Cognitive dysfunction as a result of central nervous system complication has been reported in children with OSAHS. However, the underlying mechanisms are poorly understood. Endoplasmic reticulum stress (ERS)-related apoptosis plays an important role in various diseases of the central nervous system, but very little is known about the role of ERS in mediating pathophysiological reactions to cognitive dysfunction in OSAHS. Chronic intermittent hypoxia (CIH) exposures, modeling OSAHS, across 2 and 4weeks in growing rats made more reference memory errors, working memory errors and total memory errors in the 8-Arm radial maze task, increased significantly TUNEL positive cells, upregulated the unfolded protein response in the hippocampus and prefrontal cortex as evidenced by increased phosphorylation of PKR-like endoplasmic reticulum kinase, inositol-requiring enzyme l and some downstream products. A selective inhibitor of eukaryotic initiation factor-2a dephosphorylation, salubrinal, prevented C/EBP-homologous protein activation in the hippocampus and prefrontal cortex throughout hypoxia/reoxygenation exposure. Our findings suggest that ERS mediated cell apoptosis may be one of the underlying mechanisms of cognitive dysfunction in OSAHS children. Further, a specific ERS inhibitor Salubrinal should be tested for neuroprotection against CIH-induced injury.

[An epidemiological survey of febrile convulsions among pupils in the Wenzhou region].

OBJECTIVE: To study the prevalence and clinical features of febrile convulsion (FC) among pupils in the Wenzhou region, Zhejiang Province, China. METHODS: Using a random stratified cluster sampling method, 6406 children under 12 years from two primary schools of urban areas and two primary schools of rural areas were surveyed. RESULTS: The prevalence of FC was 3.67% (235/6406). Most children (75.7%) experienced their first onset of FC at 6 months to 3 years of age (median: 16 months). The seizures were generalized (95.3%, 224/235), with a duration of less than 10 minutes (86.4%, 203/235). FC was developed into epilepsy in 13 children (5.5%) who all suffered from complex FC. Relapses were noted in 88 cases (37.4%), among whom 38 patients had only 1 recurrence and 50 patients had 2 or more relapses. EEG was performed in 200 cases, among whom 12(6.0%) showed abnormalities. CONCLUSIONS: The prevalence of FC is 3.67% among pupils in the Wenzhou region. The seizures are generalized, with a short duration. A part of complex FC can be developed into subsequent epilepsy.

[Unilateral spatial neglect in children with attention deficit hyperactivity disorder].

OBJECTIVE: To detect unilateral spatial neglect phenomenon in children with attention deficit hyperactivity disorder (ADHD) and to test the hypothesis that the phenomenon is associated with ADHD. METHODS: Thirty two boys met with ADHD diagnostic criteria of DSM-IV(TM) (ADHD group) and the 32 healthy boys without ADHD as control group participated in this study. All the participants received the flowing managements. The spatially sensitive tools of the Line Bisection test and the Star Cancellation test and some general measures (non-spatial) were used to evaluate spatial attention. RESULTS: (1) The score of Line Bisection test of boys with ADHD was (-9.37 +/- 6.57), and that of the control group was (-5.46 +/- 4.69), the difference between two groups was significant (t = -2.735, P < 0.01); the difference in left side score of the Star Cancellation test was statistically significant (t = -3.78, P < 0.01) in the ADHD group versus the control group (11.44 +/- 5.55 vs. 16.34 +/- 4.82), and the left side score was also lower than the right side one (17.13 +/- 6.36), the difference was significant (t = -3.09, P < 0.01). (2) Both groups' scores of the Line Bisection test were biased to the right side of "0" value respectively (ADHD group: t = -8.064, P < 0.01; control group: t = -6.585, P < 0.01), each side of which was lower versus "expected value" "27/27" on right side (ADHD group: t = -8.78, P < 0.01; control group: t = -7.39, P < 0.01) and left side (ADHD group: t = 15.85, P < 0.01; control group: t = -12.52, P < 0.01). CONCLUSIONS: The results suggest that left spatial neglect may be a common general phenomenon of school age boys. Compared with normal children, children with ADHD may have obvious left spatial neglect, which suggest that there be a common neurophysiologic mechanism between left spatial bias and ADHD.