脑髓康治疗血管性认知障碍脾肾亏虚、痰瘀互结证多中心随机对照研究  

Efficacy of Naosuikang on Vascular Cognitive Disorder with Pi-Shen Deficiency and PhlegmStasis:A Multicenter Randomized Controlled Trial

作　　者：郑浩涛 王建军[2] 孔繁鑫 秦秀德[2] 林松俊[2] 蔡浩斌[2] 黄汝成 孙景波 吴永雄[5] 王玉祥 关天翔 刘立瑾 华骏 虢周科 ZHENG Hao-tao;WANG Jian-jun;KONG Fan-xin;QIN Xiu-de;LIN Song-Jun;CAI Hao-bin;HUANG Ru-cheng;SUN Jing-bo;WU Yong-xiong;WANG Yu-xiang;GUAN Tian-xiang;LIU Li-jin;HUA Jun;and GUO Zhou-ke(Graduate School Guangzhou University of Chinese Medicine,Guangzhou,510006;Department of Neurology,Shenzhen Traditional Chinese Medicine Hospital,Guangdong,518033;Department of Neurology,Shenzhen Baoan Hospital of Traditional Chinese Medicine,Guangdong,518133;Department of Neurology,Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou,510120;Department of Neurology,Beijing University of Traditional Chinese Medicine Shenzhen Hospital,Guangdong,518172;Department of Neurology,Guangzhou University of Traditional Chinese Medicine Shenzhen Hospital,Guangdong,518034)

机构地区：[1]广州中医药大学研究生院,广州510006 [2]深圳市中医院脑病与心理病科,广东518033 [3]深圳市宝安中医院(集团)脑病科,广东518133 [4]广东省中医院脑病科,广州510120 [5]北京中医药大学深圳医院脑病科,广东518172 [6]广州中医药大学深圳医院脑病科,广东518034

出　　处：《中国中西医结合杂志》2022年第2期160-166,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：深圳市科创委2016学科布局课题(No.基JCYJ20160428174825490);广东省医学科学基金(No.A2020370);深圳市优秀科技创新人才培养项目(No.RCBS20200714114959156);深圳市科技计划项目(No.JCYJ20190812161807600);国家自然科学基金资助项目(No.82004350)。

摘　　要：目的评价脑髓康方治疗血管性认知障碍(VCI)患者的临床疗效。方法采取多中心随机研究设计,选取五家三级甲等中医院,筛选受试者454例,纳入符合标准362例,采用随机数字表法分为中药组和西药组,中药组口服脑髓康胶囊(每次3粒,每日3次),西药组口服尼莫地平片(每次20 mg,每日3次),连续服药6月。主要结局指标:蒙特利尔认知评估量表(Mo CA)评分,次要结局指标:血管性痴呆中医辨证量表(SDSVD)评分、汉密尔顿抑郁量表17项(HAMD-17)评分。结果与本组治疗前比较,两组治疗6月后Mo CA、SDSVD、HAMD-17评分降低(P<0.01);中药组Mo CA、SDSVD、HAMD-17评分优于西药组(P<0.01,P<0.05);Mo CA、SDSVD、HAMD-17评分差值高于西药组(P<0.05,P<0.01);析因分析提示两组干预因素与病情严重程度差异无统计学意义(P>0.05)。两组不良事件发生率差异无统计学意义(中药组为4.44%,西药组为4.95%,P>0.05)。结论脑髓康能有效地改善VCI患者的认知评分、中医证候、血管性认知障碍相关的抑郁症状,临床疗效优于尼莫地平,不受疾病严重程度的影响,且安全性较好。Objective To evaluate the clinical efficacy of Naosuikang in the treatment of patients with vascular cognitive impairment(VCI).Methods A multicenter randomized study design was adopted.Totally 454 subjects were screened from five tertiary care Chinese hospitals,362 subjects meeting the criteria were included,and were divided into Chinese medicine group and Western medicine group using random number table method,the Chinese medicine group was given Naosuikang Capsule(3 capsules each time,three times a day),and the Western medicine group was given oral Nimodipine Tablets(20 mg each time,three times a day),and the medication was taken continuously for 6 months.The following indicators were observed before and after treatment,primary outcome indicator:Montreal Cognitive Assessment Scale(MoCA)score,secondary outcome indicators:the Syndrome Differentiation Scale of Vascular Dementia(SDSVD),Hamilton Depression Scale 17-item(HAMD-17)score.Results Compared with the baseline,the MoCA,SDSVD,and HAMD-17 scores decreased in both groups at 6 months of treatment(P<0.01);MoCA,SDSVD,and HAMD-17 scores in the Chinese medicine group were lower than those in the Western medicine group(P<0.01,P<0.05);MoCA,SDSVD,and HAMD-17 score differences were higher than those of the Western medicine group(P<0.01,P<0.05);analysis of the causes suggested that the intervention factors and severity of the disease in the two groups were not statistically significant(P>0.05).The difference in the incidence of adverse events between the two groups was not statistically significant(4.44%in the Chinese medicine group and 4.95%in the Western medicine group,P>0.05).Conclusion Naosuikang can effectively improve cognitive scores,TCM evidence,and depressive symptoms associated with vascular cognitive impairment in patients with VCI,with better clinical efficacy than nimodipine,independent of disease severity,and with a better safety profile.

关 键 词：血管性认知障碍 脑髓康 尼莫地平 蒙特利尔认知评估量表 血管性痴呆中医辨证量表 汉密尔顿抑郁量表 随机对照试验 

分 类 号：R749.13[医药卫生—神经病学与精神病学]