기질성 뇌증후군에서 Oxiracetam의 임상적 효과에 대한 이중맹검 대조연구

• 영문명: The Clinical Effect of Oxiracetam in Patients with Organic Brain Syndrome-Double Blind, Placebo-Controlled Study
• 발행기관: 대한약학회
• 저자명: 이병철(Byung Chul Lee) 권기한(Ki Han Kwon) 김상윤(Sang Yun Kim) 송홍기(Hong Ki Song) 김성민(Sung Min Kim) 유경호(Kyung Ho Yoo) 이현미(Hyun Mi Lee) 강경수(Kyung Soo Kang) 윤여훈(Yeo Hun Yoon)
• 간행물 정보: 『약학회지』제37권 제5호 (1993년), 442~452쪽, 전체 11쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 1993.10.30

영문 초록

Previous experimental and clinical investigations suggest a possible role of new nootropic drug, oxiracetam, in improving cognitive performances in patients affected by organic brain syndrome. In this study, that cognitive and behavioral effects of oxiracetam treatment in patients with clinical symptoms of organic brain syndrome were evaluated. Sixty-six patients were enrolled and assigned to either oxiracetam or placebo, according to a randomized, double-blind design between two patient-groups. Either oxiracetam or placebo was orally given bid for 8 weeks ; daily dose of oxiracetam was 1600mg. All the patients, enrolled in this study, were diagnosed as having mild to moderate cognitive dysfunction as defined by a baseline Mini Mental State Examination Korean version (MMSE-K) score between 14 and 25. The patients underwent, at baseline, 4 weeks and 8 weeks after, routine laboratory study (CBC, SMA12, U/A, EKG) and the following neuropsychological tests ; MMSE-K, modified Korean Wechsler Intelligence Scale(MKWIS), Nurses'' Observation Scale for Geriatric patients(NOSGER). Fifteen patients of whom were dropped out or excluded from the analysis because of poor compliance or violation of the protocol. Fiftyone patients (aged 54~78 years, male 25, female 26) were analyzed (vascular dementia, 30 ; senile dementia of Alzheimer type, 9 ; mixed type, 5 ; other cause, 7). Statistical analysis of the data demonstrated that the two groups were comparable at baseline. At the end of each study period the oxiracetam group scored significantly better on the majority of the tests evaluating cognitive function, psychometricity and the improvement rating scale of subjective symptoms than placebo group, in which worsening trends or no changes were seen on the whole. No side effects were noted during oxiracetam treatment. The present study, showing positive clinical findings after oxiracetam therapy, confirmed that this drug can be useful pharmacological treatment in organic brain syndrome.

키워드

Organicbrainsyndrome oxiracetam MMSE-K MKWIS NOSGER.