• Title/Summary/Keyword: Antiepileptic drug

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Bioequivalence Test of Gabapentin 400 mg Capsules (가바펜틴 400밀리그람 캡슐의 생물학적동등성시험)

  • Kim, Se-Mi;Kang, Hyun-Ah;Cho, Hea-Young;Shin, Sae-Byeok;Yoo, Hee-Doo;Yoon, Hwa;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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    • pp.195-200
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    • 2008
  • Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug Co. Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.

Glucose transport 1 deficiency presenting as infantile spasms with a mutation identified in exon 9 of SLC2A1

  • Lee, Hyun Hee;Hur, Yun Jung
    • Clinical and Experimental Pediatrics
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    • v.59 no.sup1
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    • pp.29-31
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    • 2016
  • Glucose transport 1 (GLUT-1) deficiency is a rare syndrome caused by mutations in the glucose transporter 1 gene (SLC2A1) and is characterized by early-onset intractable epilepsy, delayed development, and movement disorder. De novo mutations and several hot spots in N34, G91, R126, R153, and R333 of exons 2, 3, 4, and 8 of SLC2A1 are associated with this condition. Seizures, one of the main clinical features of GLUT-1 deficiency, usually develop during infancy. Most patients experience brief and subtle myoclonic jerk and focal seizures that evolve into a mixture of different types of seizures, such as generalized tonic-clonic, absence, myoclonic, and complex partial seizures. Here, we describe the case of a patient with GLUT-1 deficiency who developed infantile spasms and showed delayed development at 6 months of age. She had intractable epilepsy despite receiving aggressive antiepileptic drug therapy, and underwent a metabolic workup. Cerebrospinal fluid (CSF) examination showed CSF-glucose-to-blood-glucose ratio of 0.38, with a normal lactate level. Bidirectional sequencing of SLC2A1 identified a missense mutation (c.1198C>T) at codon 400 (p.Arg400Cys) of exon 9.

Unexpected Seizure Attack in a Patient with Spinal Metastasis Diagnosed as Posterior Reversible Encephalopathy Syndrome

  • Kim, Chang-Hyoun;Kim, Chi-Heon;Chung, Chun-Kee;Jahng, Tae-Ahn
    • Journal of Korean Neurosurgical Society
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    • v.50 no.1
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    • pp.60-63
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    • 2011
  • Seizure is a foreseeable risk in patients with brain lesion. However, seizure during treating non-brain lesion is not a familiar situation to neurosurgeon. Posterior reversible encephalopathy syndrome (PRES) is a relatively common situation after systemic chemotherapy. The aim of this study is to make neurosurgeons aware of this potential medical problem. A 52-year-old woman with advanced gastric cancer, presented with low back pain due to spinal metastasis at the 4th lumbar vertebra. Ten cycles of chemotherapy with FOLFOX (5-Fluoruracil/Oxaliplatin) had been completed 23 days ago. Two days before the planned operation, a generalized tonic clonic seizure occurred. She did not have a history of hypertension or seizure. The seizure was stopped with lorazepam 4mg. The brain magnetic resonance (MR) imaging showed high signal changes in both parieto-occipital lobes on the T2-weighted images, and these were partially enhanced, suggesting PRES. The surgery was preceded by treatment with an antiepileptic drug. The MR images, taken 1.5 months after the seizure, showed that the lesion was no longer present. At 3 month follow-up, no additional seizure attack occurred without any seizure medication. The possibility of a seizure attack should be considered if the patient has a history of chemotherapy.

Reflex seizures induced by micturition : A pediatric case and ictal EEG finding (배뇨 유발 반사 발작 : 소아에서 발작시 뇌파를 시행한 1예)

  • Rho, Young Il
    • Clinical and Experimental Pediatrics
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    • v.51 no.12
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    • pp.1346-1349
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    • 2008
  • Reflex seizures induced by micturition are rare, and there have been few reports on ictal electroencephalogram (EEG) findings. Here, we report a 7-year-old boy with secondarily generalized partial seizures induced by micturition. The seizures occurred every time he urinated. A few seconds after micturition begun, he toppled down with hand automatism followed by a secondarily generalized tonic posture and loss of consciousness. Ictal video-EEG recording during urination was performed. An ictal EEG demonstrated a polyspike wave discharge onset from the left frontotemporal region, with rapid spread to the right frontotemporal region. He was treated with the antiepileptic drug valproate sodium, which improved seizure control. He remained seizure-free until the last followup for a period of 2 years.

Effects of Ukgansan (Yokukansan in Japanese, Yigansan in chinese) on the Locomotor Velocity and Glutamate-Induce Paroxysm in Planarian (Planarian 모델을 이용한 억간산의 항발작 효과)

  • Park, Woong;Yoo, Du Man;So, June No
    • KSBB Journal
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    • v.29 no.1
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    • pp.67-71
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    • 2014
  • Planaria were recently reported to be a simple and sensitive model to investigate the mechanistic aspect of seizure and to screen potential anticonvulsants. Using planarian model, we analyzed the pharmacological effect of ukgansan (UGS), an oriental herbal medicine containing seven medicinal herbs, on the planarian locomotor velocity (pLMV) and glutamate-induced seizure-like activity (pSLA). To test whether D. japonica is suitable for studying anti-seizure agents, we investigated the effect of glutamate on pLMV and pSLA in D. japonica. In the present study we first confirmed that pSLA in D. japonica was induced by L-glutamate. Glutamate significantly produced pSLA in a dose dependent manner, but did not affect pLMV. These glutamate-induced paroxysms were decreased by antiepileptic drug, topiramate. A similar inhibitory effect on glutamate-induced pSLA was observed after the treatment of UGS. The present results suggest that UGS and its active constituents possess useful substance inhibiting seizure in planarian and that D. japonica provides a convenient model to search active herbs containing anti-seizure activity.

Herbal Medicine Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex : A Case Report

  • Son, Kwanghyun;Lee, Jinsoo;Kim, Moonju
    • The Journal of Korean Medicine
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    • v.36 no.2
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    • pp.50-55
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    • 2015
  • Infants with tuberous sclerosis complex (TSC) have a higher chance of experiencing seizures before the age of 1 year; in particular, they commonly accompany infantile spasms. In cases where infantile spasms resulting from TSC are drug-resistant, more severe neuro-developmental and cognitive impairments occur. This particular case dealt with an infant with TSC who continued to experience partial seizures and infantile spasms despite using two different kinds of antiepileptic drugs (AEDs). His spasms ceased on the seventh day of taking modified Yukmijihwang-tang (YMJ), at which point he stopped the use of all AEDs. He became seizure-free after a month of the treatment and modified hypsarrythmia was found to have been resolved in the electroencephalogram test. Until now, the infant has been taking YMJ for 16 months and is maintaining the seizure-free state without side effects. Moreover, his developmental status is continually improving, with a significant progress in language and cognitive-adaptive abilities. Such results suggest that YMJ can serve as an alternative treatment option for refractory epilepsy.

Controversies in Usefulness of EEG for Clinical Decision in Epilepsy: Pros. (간질 치료에서 뇌파의 임상적 유용성에 관한 논란: 긍정적 관점에서)

  • Shon, Young-Min;Kim, Yeong In
    • Annals of Clinical Neurophysiology
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    • v.9 no.2
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    • pp.63-68
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    • 2007
  • The EEG plays an important diagnostic role in epilepsy and provides supporting evidence of a seizure disorder as well as assisting with classification of seizures and epilepsy syndromes. There are a variety of electroclinical syndromes that are really defined by the EEG such as Lennox-Gastaut syndrome, benign rolandic epilepsy, childhood absence epilepsy, juvenile myoclonic epilepsy and also for localization purposes, it is vitally important especially for temporal lobe epilepsy. The sensitivity of first routine EEG in diagnosis of epilepsy has been known about 20-50%, but this proportion rises to 80-90% if sleep EEG and repetitive recording should be added. Convincing evidences suggest that the EEG may also provide useful prognostic information regarding seizure recurrence after a single unprovoked attack and following antiepileptic drug (AED) withdrawal. Moreover, patterns in the EEG make it possible to disclose an ictal feature of nonconvulsive status epilepticus, separate epileptic from other non-epileptic episodes and clarify the clues predictive of the cause of the encephalopathy (i.e., triphasic waves in metabolic encephalopathy). Therefore, regardless of its low sensitivity and other pitfalls, EEG should be considered not only in the situation of new onset episode such as a newly developed, unprovoked seizure or a condition manifesting decreased mentality from obscure origin, but also as a barometer of the long-term outcome following AED withdrawal.

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Controversies in Usefulness of EEG for Clinical Decision in Epilepsy: Cons. (간질 치료에서 뇌파의 임상적 유용성에 관한 논란: 부정적 관점에서)

  • Lee, Seo-Young;Lee, Sang-Kun;Kim, Nam Hee
    • Annals of Clinical Neurophysiology
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    • v.9 no.2
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    • pp.69-74
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    • 2007
  • Electroencephalogram (EEG) is a representative diagnostic tool in epilepsy. However, there are several points of debate on the role of EEG in diagnosis and management of epilepsy. We suggest that EEG has some limitations for differential diagnosis from nonepileptic episodic diseases, classification of epilepsy, prediction of recurrence, and evaluation of treatment response. Interictal EEG cannot diagnose or exclude epilepsy because interictal epileptic discharge (IED) is frequently absent in epilepsy and can appear in nonepileptic conditions. Although EEG is helpful in classification of epilepsy, focal spikes in generalized epilepsy and secondary bilateral synchrony in localization related epilepsy cause interrater disagreement. It is controversial whether EEG predicts recurrence after the first seizure in adults. The predictive value of EEG in antiepileptic drug (AED) withdrawal is not absolute. The prognosis after AED withdrawal depends on epilepsy syndrome. Many studies could not confirm the value of EEG in assessing the treatment response. After all, epilepsy is clinically diagnosed and assessed. Interictal EEG alone does not provide decisive information and routine follow-up of EEG is not recommended.

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Probable Nonconvulsive Status Epilepticus after Drainage of a Chronic Subdural Hematoma in a Patient with Moyamoya Disease

  • Lee, Chang-Sub;Huh, Ji-Soon;Sim, Ki-Bum;Choi, Jay-Chol
    • Journal of Korean Neurosurgical Society
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    • v.41 no.6
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    • pp.414-417
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    • 2007
  • A 52-year-old woman with hypertension and moyamoya disease presented with chronic subdural hematoma [CSDH]. The presumed cause of bleeding was ascribed to administrated antiplatelet agents. She responded slowy and clumsily to verbal commands and had right arm weakness. After surgery, her clinical condition improved. But two days after surgery, her symptoms became aggravated and a convulsive seizure was noted within 24 hours. Brain magnetic resonance imaging showed no organic lesion except a small amount of residual CSDH. In addition, there was no laboratory evidence of metabolic brain disease. Moreover, after the administration of an antiepileptic drug [phenytoin], her manifestations disappeared. Therefore, the authors presume that her symptoms were resulted from nonconvulsive status epilepticus [NCSE], despite a lack of ictal period electroencephalographic findings. The authors were unable to find a single case report on postoperative NCSE in Korea. Therefore, the authors report this case of nonconvulsive status epilepticus after drainage of a CSDH in a patient with moyamoya disease.

Thermographic Changes by Administering Gabapentin in Neuropathic Pain -A report of three cases- (신경병증성 통증 치료시 Gabapentin 투여에 따른 제통 효과와 체열상의 변화 -증례 보고-)

  • Lee, Jang-Won;Kim, Jung-Soon;Bae, Duck-Ku;Park, Wook
    • The Korean Journal of Pain
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    • v.14 no.1
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    • pp.98-103
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    • 2001
  • Neuropathic pain originating from multiple condition of nerve cell injury is common, but is difficult to treat. Even though many drugs such as anti-convulsants, anti-depressants, NSAIDs, opioids have been used, their clinical analgesic action were not satisfactory due to occur severe side effects. Gabapentin was introduced in 1994 as a novel antiepileptic drug and has been used to treat partial seizure. After 1995 gabapentin treatment for reflex sympathetic dystrophy (RSD) started, 45% of the reports about the analgesic efficacy of gabapentin were restricted to the treatments of non-epileptic pain syndrome. This drug is preferred to treat neuropathic pain because of a lower incidence of its side effects than those of other anti-convulsants and anti-depressants. For evaluating it's analgesic efficacy, the changes in the patients' subjective pain intensity was measured by the score on the visual analogue scale (VAS) and patient's objective pain intensity by measuring the skin temperature via infrared thermography were investigated respectively. Side effects of gabapentin were look into. We observed successful relief of neuropathic pain in the three patients which included post-herpetic neuraligia, complex regional pain syndrome (CRPS) and diabetic neuropathic pain, and the side effects of gabapentin were at acceptable levels.

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