Clinical Study of Controlled Release Form (Orfil Retard) of Sodium Valproate

J Korean Neurol Assoc > Volume 9(4); 1991 > Article

Journal of the Korean Neurological Association 1991;9(4): 456-464.

Sodium Valproate의 Controlled Release Form (Orfil Retard)에 대한 임상 연구

박수철, 이성수,허균,이병인,김진수,김정호,권오헌

연세대학교 신경과, 임상병리학.

Clinical Study of Controlled Release Form (Orfil Retard) of Sodium Valproate

Soo Chul Park, M.D., Sung Soo Lee, M.D., Kyoon Huh, M.D., Byung In Lee, M.D., Jin Soo Kim, M.D., Jeong Ho Kim, M.D.*, Oh Hun Kwon, M.D.*

Dep. Of Neurology & Clinical Pathology*, Yonsei University

Abstract

A cross-over study was conducted to compare the pharmacokinetic properties of controled release form of Sodium Valproate (Orfil Retard) with that of conventional forrnulation (Orfil in healthy adult volunteers. The clinical efficacy of Orfil Retard was also investigated in 15 epileptic patients under Orfil monotherapy by replacing an equivalent bid dosage of Orfil Retard for 2 months. Orfil Retard achieved more stable blood level than Orfil, which was statistically significant(P;0.0051). Orfil Retard was associated with less side effect. Especially of gastrointestinal system. None of epileptic patients showed worsening of seizure control after switch to the equivalent b.I.d. dosage of Orfil Retard. Our results indicate that Orfil Retard offers more advantage than Orfil in terms of more stable blood level and less side effect. Clinically. Orfil Retard in equivalent b I d dose is as effective as Orfil in b.I.d. or t.I.d. dosing schedule.