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Efficacy and safety of the compound Chinese medicine SaiLuoTong in vascular dementia: A randomized clinical trial

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机构: [a]Innovation Center for Neurological Disorders, Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China [b]Beijing Key Laboratory of Geriatric Cognitive Disorders, Beijing, China [c]Center of Alzheimer’s Disease, Beijing Institute for Brain Disorders, Beijing, China [d]Key Laboratory of Neurodegenerative Diseases, Ministry of Education, Beijing, China [e]National Clinical Research Center for Geriatric Disorders, Beijing, China [f]Department of Gerontology, Fuxing Hospital, Capital Medical University, Beijing, China [g]Department of Health Statistics, Second Military Medical University, Shanghai, China [h]Department of Neurology, Daqing Oilfield General Hospital, China [i]Department of Neurology, Henry Ford Hospital, Detroit, MI, USA [j]Centre for Studies in Aging, McGill University, Montreal, QC, Canada
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关键词: Clinical trial Compound Chinese medicine SaiLuoTong/SLT Vascular dementia

摘要:
Introduction: No licensed medications are available to treat vascular dementia (VaD). Methods: Patients were randomly assigned to experimental groups (SaiLuoTong [SLT] 360 or 240 mg for groups A and B for 52 weeks, respectively) or placebo group (SLT 360 mg and 240 mg for group C only from weeks 27 to 52, respectively). Results: Three hundred twenty-five patients were included in final analysis. At week 26, the difference in VaD Assessment Scale–cognitive subscale scores was 2.67 (95% confidence interval, 1.54 to 3.81) for groups A versus C, and 2.48 (1.34 to 3.62) for groups B versus C (both P <.0001). However, at week 52, no difference was observed among the groups on the VaD Assessment Scale–cognitive subscale (P =.062) because of the emerging efficacy of SLT in placebo beginning at week 27. Discussion: This study suggests that SLT is effective for treatment of VaD, and this compound Chinese medicine may represent a better choice to treat VaD. © 2018 The Authors

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第一作者机构: [a]Innovation Center for Neurological Disorders, Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China [b]Beijing Key Laboratory of Geriatric Cognitive Disorders, Beijing, China [c]Center of Alzheimer’s Disease, Beijing Institute for Brain Disorders, Beijing, China [d]Key Laboratory of Neurodegenerative Diseases, Ministry of Education, Beijing, China [e]National Clinical Research Center for Geriatric Disorders, Beijing, China
通讯作者:
通讯机构: [a]Innovation Center for Neurological Disorders, Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China [b]Beijing Key Laboratory of Geriatric Cognitive Disorders, Beijing, China [c]Center of Alzheimer’s Disease, Beijing Institute for Brain Disorders, Beijing, China [d]Key Laboratory of Neurodegenerative Diseases, Ministry of Education, Beijing, China [e]National Clinical Research Center for Geriatric Disorders, Beijing, China
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