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The efficacy and safety of nimodipine in acute ischemic stroke patients with mild cognitive impairment: a double-blind, randomized,placebo-controlled trial

查看全文 作  者:Huaguang [1]Zheng;Yilong [1]Wang;Anxin [1]Wang;Hao [2]Li;David [3]Wang;Xingquan [1]Zhao;Penglian [1]Wang;Haipeng [4]Shen;Lijun [1]Zuo;Yuesong [1]Pan;Zixiao [1]Li;Xia [1]Meng;Xianwei [1]Wang;Weixiong [1]Shi;Yi [1]Ju;Liping [1]Liu;Kehui [1]Dong;Chunxue [1]Wang;Rubo [5]Sui;Rong [6]Xue;Xiaoping [7]Pan;Xiaoyua [8]Niu;Benyan [9]Luo;Yi [10]Sui;Huali [11]Wang;Tao [1]Feng;Yongjun [1]Wang 高影响力作者 机构地区:[1]Beijing Tiantan Hospital, Capital Medical University;[2]China National Clinical Research Center for Neurological Diseases;[3]OSF Saint Francis Medical Center Peoria;[4]Faculty of Business and Economics, University of Hong Kong;[5]The First Hospital, Liao Ning Medical College;[6]The General Hospital, Tianjin Medical University;[7]Guangzhou First People’s Hospital, School of Medicine, South China University of Technology;[8]The First Hospital of Shanxi Medical University;[9]The First Hospital, Zhejiang Medical University;[10]Shenyang First People’s Hospital, Shenyang Medical College;[11]Dementia Care & Research Center, Peking University Institute of Mental Health高影响力机构 出  处:《Science Bulletin》索引2019年第64卷第2期,共7页高影响力期刊 基  金:supported by the National 11th&12th Five Year S&T Major Projects(2011BAI08B01,2011BAI08B02);the National Key Technology Research and Development Program of the Ministry of Science and Technology of China(2013BAI09B03);the Ministry of Science and Technology of China(2012ZX09303-005-001);Beijing Biobank of Cerebral Vascular Disease(D131100005313003) 摘  要:Nimodipine might be effective in subcortical vascular dementia(VaD). Its benefit in preventing further cognitive decline in patients with acute ischemic stroke(AIS) and vascular mild cognitive impairment(VaMCI) remains to be established. In this multicenter, double-blind trial, we randomly assigned 654 eligible patients to nimodipine 30 mg three times a day or placebo. The primary outcome was any cognitive decline defined by the changes on the Mini-Mental State Examination(DMMSE à3) or vascular AD assessment scale cognitive subscale(DADAS-cog ! 4) at 6 months. Secondary outcomes included any distribution shift of DADAS-cog, DMMSE or cognitive improvement defined by DADAS-cog à2, or DMMSE ! 0. The primary outcome in the nimodipine group and placebo group were similar for DMMSE à3(4.18% and 7.22%, respectively, P = 0.15) and DADAS-cog ! 4(8.36% and 8.93% respectively,P = 0.88). The distribution shift of DADAS-cog and DMMSE differed significantly between the two groups(P = 0.03 and P = 0.05 respectively). Cognitive improvement occurred in 55.4% in the nimodipine group and 43.6% in the placebo group measured by DADAS-cog à2(Odds Ratio, 1.54; 95% confidence interval[CI] 1.10–2.14, P < 0.01) or 84.0% and 74.6% respectively by DMMSE ! 0(Odds Ratio, 1.79; 95% CI 1.18–2.70, P < 0.01). Nimodipine was associated with better cognitive function in the memory domain. The adverse events rate was similar in two groups. This study is registered with ClinicalTrials.gov,NCT01220622. Nimodipine did not show benefit to prevent cognitive decline in AIS patients with VaMCI, but improved cognition moderately, especially measured in the memory domain. 关 键 词:NIMODIPINE Acute ischemic stroke MILD COGNITIVE IMPAIRMENT COGNITIVE DECLINE Prevention
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