花青素治疗阿尔茨海默病的多中心随机对照研究

A multicenter randomized controlled study of Anthocyanins for the treatment of Alzheimer's disease

目的探讨花青素治疗阿尔茨海默病的安全性及效果。方法2018年11月至2020年12月6家医院采用多中心、双盲、随机对照的临床研究。两组的基础用药为美金刚,试验组为花青素复合物制剂,对照组为安慰剂。入组前进行简易智能状态量表(MMSE)、蒙特利尔认知评估量表(MoCA)、阿尔茨海默病评价量表-认知分量表(ADAS-cog)、日常生活能力量表(ADCS-ADL)及哈密尔顿抑郁量表(HAMD)评估,治疗16周后进行MMSE、MoCA、ADAS-cog、ADCS-ADL及基于临床医生面试和照料补充的总体印象变化量表(CIBIC-plus)等评估,记录不良反应事件。结果共入组66例患者,对照组和试验组各33例。入组前两组之间各认知功能评分无显著差异。两组治疗前后MMSE评分差值、MoCA评分差值和ADAS-cog评分差值分别为(1.9±2.4)分和(3.4±2.0)分(t=2.62,P=0.011)、(1.8±1.9)分和(2.9±1.4)分(t=2.45,P=0.018)、(3.0±2.3)分和(5.3±4.6)分(t=2.45,P=0.019),差异均有统计学意义。对照组治疗前后工具性日常生活能力(IADL)评分分别为(21.6±5.7)分和(22.6±6.2)分(t=2.09,P=0.046),试验组分别为(22.7±5.4)分和(23.4±5.4)分(t=2.45,P=0.021),两组治疗前后的差异有统计学意义。结论花青素治疗能够延缓阿尔茨海默病患者认知功能及日常生活能力下降,是未来治疗阿尔茨海默病具有前景的药物。

Objective To assess the safety and efficacy of Anthocyanins for the treatment of Alzheimer's disease.Methods From November 2018 to December 2020,a multicenter,double-blind,randomized controlled clinical study was conducted in 6 hospitals.The regular medication for the two groups was memantine,with the addition of a combination preparation containing Anthocyanins for the experimental group and a placebo for the control group.The Mini-Mental State Scale(MMSE),Montreal Cognitive Assessment Scale(MoCA),Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-cog),Activities of Daily Living Scale(ADCS-ADL)and Hamilton Depression Scale(HAMD)were used for assessment at the beginning.After 16 weeks of treatment,MMSE,MoCA,ADCS-ADL,ADAS-cog and the Clinician's Interview-Based Impression of Change Plus Caregiver Input(CIBIC-Plus)Scale were conducted and adverse events were recorded.Results A total of 66 patients were enrolled,with 33 in the control group and 33 in the experimental group.There were no significant differences in cognitive function scores between the two groups before enrollment.Differences in MMSE scores,MOCA scores and ADAS-cog scores before and after treatment between the control group and the experimental group were 1.9±2.4 vs.3.4±2.0(t=2.62,P=0.011),1.8±1.9 vs.2.9±1.4(t=2.45,P=0.018)and 3.0±2.3 vs.5.3±4.6(t=2.45,P=0.019),respectively.The differences were statistically significant.Instrumental activities of daily living(IADL)scores before and after treatment in the control group were 21.6±5.7 vs.22.6±6.2(t=2.09,P=0.046),and those in the experimental group were 22.7±5.4 vs.23.4±5.4(t=2.45,P=0.021).The differences between the two groups before and after treatment were statistically significant.Conclusions Treatment with Anthocyanins can delay the decline of cognitive function and activities of daily living ability in patients with Alzheimer's disease.Anthocyanins may be a promising therapeutic drug for Alzheimer's disease in the future.