| Project/Area Number |
09670832
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Pediatrics
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| Research Institution | KITASATO UNIVERSITY |
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Principal Investigator |
MIURA Hisao Kitasato University School of Medicine, Professor, 医学部, 教授 (60050465)
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| Co-Investigator(Kenkyū-buntansha) |
TAKEI Kenji Kitsato Univ.Sch.of Medicine, Research Associate, 医学部, 助手 (50236410)
SUNAOSHI Wataru Kitsato Univ.Sch.of Medicine, Assistant Professor, 医学部, 講師 (20171283)
SHIRAI Hiroyuki Kitsato Univ.Sch.of Medicine, Assistant Professor, 医学部, 講師 (10154353)
SHIMANUKI Kaoru Kitsato Univ.Sch.of Medicine, Research Associate, 医学部, 助手 (10265697)
IWASAKI Toshiyuki Kitsato Univ.Sch.of Medicine, Research Associate, 医学部, 助手 (70265627)
細田 のぞみ 北里大学, 医学部, 助手
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| Project Period (FY) |
1997 – 1999
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| Project Status |
Completed (Fiscal Year 1999)
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| Budget Amount *help |
¥2,600,000 (Direct Cost: ¥2,600,000)
Fiscal Year 1999: ¥800,000 (Direct Cost: ¥800,000)
Fiscal Year 1998: ¥800,000 (Direct Cost: ¥800,000)
Fiscal Year 1997: ¥1,000,000 (Direct Cost: ¥1,000,000)
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| Keywords | Epilepsy / Antiepileptic drug / Pharmacokinetics / Developmental pharmacology / Therapeutic drug monitoring / Valproic acid / カルバマゼーピン / バルプロ酸 / てんかん / 薬物体内動態 / 薬物総血中濃度 / 薬物遊離型血中濃度 / 蛋白結合比率 / カルバマゼピン / カルバマゼピン-10,11-エポキサイド / 薬物血中濃度 / ゾニサ・ミド / クロナゼパム |
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| Research Abstract |
We investigated the long-term outcome of epilepsy with grand mal seizures on awakening in a prospective randomized study in children who were treated with sodium valproate (VPA) monotherapy.
The patients comprised 194 previously untreated children aged 8 months to 15 years (mean, 8 years 1 month), who had been newly referred to our pediatric seizure clinic. A daily dose of 25-30 mg/kg of VPA was introduced, and the initial maintenance daily dosage of VPA (27.0±3.6mg/kg) gave the plasma levels of 103.1±1 8.2μg/ml.
Of the total 194 patients, seizures were not controlled in 16 by VPA monotherapy, and 58 patients were lost from follow-up during the course of treatment. In 108 out of the remaining 120 patients, VPA monotherapy was continued for a mean of 5 years and 8 months, and then the drug therapy was discontinued. The drug therapy was successfully discontinued in 87, in whom no seizure recurrences were ocurred during the follow-up period 6 months to 15 years (mean, 7 years 4 months) after stopping the therapy. However, in the other 21 patients seizures recurred 2 weeks to 4 years (mean, 7 months) after stopping the therapy. There were no differences in the course of treatment between the cases with seizure recurrences and those without recurrences after discontinuance of the therapy, but the recurrence rate was significantly higher in the patients who were taken ill after the age of 9 (17/43=39.5%). During the course of treatment from childhood to adolescence on the same maintence daily dosage, the plasma concentrations of VPA showed a decrease of about 20%.
The long-term outcome of epileptic children with grand mal seizures on awakening treated with VPA monotherpy is excellent, but the attention should be paid for the recurrence of seizures after stopping therapy in the cases of older patient.
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