뇌졸증 후유증에 대한 Idebenon(IBN-91)의 효과: 위약을 사용한 이중맹검 연구

Abstract

Background : Although the clinical efficacy of nootropics for patients suffering from neurological deficits caused by cerebrovascular diseases (CVA) is still controversial, idebenon has been claimed to be quite useful for those patients in Japan and also recently in Korea. Methods : We conducted a double blind placebo controlled study to evaluate the clinical efficacy of idebenon in patients suffering from CVA. The protocol consisted of baseline, 6th week and 12th week evaluation. Minimental state examination (MMESK), modified Graded Neurological Scale (GNS), Barthel index, subjective symptoms, and the physician's global evaluation. In addition, formal neuropsychological tests battery and subjective symptom checklist-90-reversion (SCL-90-R) were conducted before and after the drug treatment. Results : A total of 60 patients (30 patients each for idebenon and placebo groups) finished the study. There were no significant differences between idenbenon and placebo groups in MMSE-K and subjective symptom reports. However, idebenon group showed significant improvement in modified GNS (P=0.01) and Barthel index (P=0.01). For the physician's global evaluation, idebenon group showed more improvement (I : 73%, P : 53%) but was not statistically significant (P=0.11). Formal neuropsychological tests batter revealed significant improvement in long term memory (P=0.03) and reduced the perseveration ratio (P=0.037). SCL-90-R showed significan improvement only in obscessive compulsion (P=0.02) among 9 items. The incidence of adverse events and abnormalities of laboratory tests did not show any singnificant differences between idebenon and placebo groups. Conclusion : Administration of idebenon for 12 weeks showed significant improvement in some aspects of neurological function without any significant side effects.