小児の部分発作に対するzonisamide単剤1日1回投与法の効果と血中濃度 [in Japanese] Clinical Effect and Plasma Levels of Zonisamide in Epileptic Children with Partial Seizures Treated with Once-daily Dose of Zonisamide Monotherapy [in Japanese]
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過去に2回以上の部分発作を示す, それまで未治療の潜因性局在関連性てんかん患児45例を対象に, zonisamide (ZNS) を単剤で1日1回の投与を行い, 血中濃度の日内変動 (最高/最低血中濃度比) と年齢的変化を検討した。ZNSの初回維持量は8mg/kg/dayを基準としたが, 最高/最低血中濃度比は1.25±0.13で, 日内の血中濃度は比較的一定に保たれた。<BR>さらに, 前述の対象のうち, 調査時まで12カ月以上にわたり経過を観察しえた25例について, ZNS単剤1日1回投与法の臨床効果を血中濃度面から検討した。初回維持量で, 25例中5例で発作が再発し, 3例で眠気が出現したが, 再発例は最低血中濃度が15μg/m<I>l</I>l前後の者に多く, 眠気は最高血中濃度が40μg/m<I>l</I>以上の者に出現した。<BR>また, ZNS単剤治療を継続した22例中8例では, 治療開始後12カ月の時点で, 脳波上のてんかん発射が消失していた。
The clinical effects and plasma levels of zonisamide (ZNS) were investigated in children with cryptogenic localization-related epilepsies, who were administered ZNS once a day as a single drug. ZNS is absorbed slowly from the gastrointestinal tract, and its biological half-life is long compared with the other prevalent antiepileptic drugs.<BR>The patients comprised 45 previously untreated children aged 3 months to 14 years (mean, 8 years and 6 months) with any of simple, complex or secondarily generalized partial seizures. A daily dose of 2mg/kg of ZNS was introduced and the dosage was increased gradually to the initial maintenance daily dose of 8mg/kg. ZNS was prescribed once a day in the morning. Blood samples for determination of the plasma levels were taken before and 4 hours after the morning dose, each of which represents the trough and peak levels in a day.<BR>The initial maintenance daily dosage of ZNS (8.01±0.54mg/kg) gave the trough and peak plasma levels of 27.1±8.2 and 33.4±9.1μg/m<I>l</I>, respectively. The peak totrough plasma level ratios were as small as 1.25±0.13. The plasma level (μg/m<I>l</I>) to dose (mg/kg/day) ratios estimated by the trough and peak plasma levels increased both with the advance in age, but the peak to trough plasma level ratios were maintained almost uniformly throughout the pediatric age period.<BR>Of the total 25 patients who were followed up clinically for more than 12 months, seizures were not controlled in 5 with the initial maintenance dosage. Three of the 5 patients who had seizure recurrences showed the trough plasma ZNS levels around 15μg/m<I>l</I>. In 3 patients whose peak levels were above 40μg/m<I>l</I>, the dosage was decreased to tolerable levels because of the continuous complaint of drowsiness.However, for the period of treatment, ranging from 12 to 34 months (mean, 15.7months) from starting ZNS therapy, complete seizure control was obtained in 17 out of the 25 patients on the initial maintenance dosage.<BR>Once-daily dose of ZNS monotherapy assisted by blood level monitoring may be effective for the control of partial seizures in children.
- Journal of the Japan Epilepsy Society
Journal of the Japan Epilepsy Society 13(3), 220-226, 1995-10-31
JAPAN EPILEPSY SOCIETY