| 引用本文:王威1，第五永长2，王登坤1，杨谦1，苟于瑞1，刘奇2，周源2.基于高质量研究系统评价中草药治疗轻度中度阿尔茨海默病患者的有效性与安全性[J].世界中医药,2023,(01):. |
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| 基于高质量研究系统评价中草药治疗轻度中度阿尔茨海默病患者的有效性与安全性 |
| Efficacy and Safety of Chinese Herbal Medicine in the Treatment of Mild to Moderate Alzheimer's Disease Based on High-quality Research：A Systematic Review |
| 投稿时间：2021-03-03 |
| DOI：10.3969/j.issn.1673-7202.2023.01.016 |
| 中文关键词: 中草药 中药 阿尔茨海默病 系统评价 Meta分析 |
| English Keywords:Chinese herbal medicine Chinese medicine Alzheimer's disease Systematic review Meta-analysis |
| 基金项目:国家自然科学基金项目（82074503）;陕西省“专项支持计划”技术创新领导工程项目（陕组通字2018-33号）；陕西省自然科学基础研究计划-重大项目（2017ZDJC-15）；陕西中医药大学学科创新团队项目（2019-QN05） |
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| 中文摘要: |
| 目的：系统评价中草药治疗轻度至中度阿尔茨海默病（AD）患者的有效性与安全性。方法：检索Cochrane图书馆、EMbase、PubMed、Medline、国家知识基础设施数据库（CNKI）等数据库，时间从建库至2020年1月18日。根据Cochrane工具评价文献的质量，排除没有提到随机与盲法的研究。采用RevMan5.3分析中草药治疗AD的疗效，通过计算Cochrane手册中的公式计算观察组与对照组的阿尔茨海默病评定量表（ADAS-Cog）、临床痴呆评定量表（CDR）和简易精神状态检查（MMSE）的效应值，对效应值进行Meta分析，分组描述其差异。结果：共纳入8项高质量的随机对照研究，国内外研究各4项，共582例患者，观察组与对照组每组291例。Meta分析结果显示2组异质性较高，通过亚组分析组间异质性降低，中草药治疗轻度中度AD可改善ADAS-cog评分，且优于安慰剂组（MD=-1.80,95%CI为-3.37~0.23,I2=0%,P=0.84）与多奈哌齐组（MD=-12.07,95%CI为-12.71~11.43,I2=53%,P=0.12,）；MMSE评分也优于多奈哌齐（MD=-0.73,95%CI为-0.12~1.58,I2=0%,P=0.57）；CDR评分也有改善，安慰剂组MD=-2.63,95%CI为-3.24~2.02,I2=42%,P=0.19；多奈哌齐组MD=-0.27,95%CI为-0.81~0.27,I2=75%,P=0.05。结论：中草药制剂与提取物都能够改善轻度至中度AD患者的认知能力ADAS-cog，MMSE与综合能力CDR,在改善认知能力方面优于多奈哌齐且不良反应发生率比多奈哌齐低，安全性较高，可供临床参考。 |
| English Summary: |
| To systematically review the efficacy and safety of Chinese herbal medicine in the treatment of patients with mild to moderate Alzheimer's disease(AD).Methods:Cochrane Library，EMbase，PubMed，Medline，CNKI，and other databases were searched from database inception to January 18，2020.According to the Cochrane risk of bias tool，the quality of the literature was evaluated，and studies that did not mention randomization and blinding were excluded.RevMan5.3 was used to analyze the efficacy of Chinese herbal medicine in the treatment of AD.The effect values of the Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog)，Clinical Dementia Rating(CDR)，and Mini-Mental State Examination(MMSE) of the treatment group and the control group were calculated according to the formulas in the Cochrane Handbook.The effect values underwent Meta-analysis and the differences were described by groups.Results:Eight high-quality randomized controlled trials(RCTs) were included，including four Chinese trials and four foreign ones，with 582 patients involved，including 291 in the treatment group and 291 in the control group.The Meta-analysis results showed that the heterogeneity of the two groups was high，and the heterogeneity between the groups was reduced by subgroup analysis.In the treatment of mild to moderate AD，Chinese herbal medicine could improve the ADAS-Cog score，which was superior to the placebo group(MD=-1.80，95%CI -3.37 to 0.23，I2=0%，P=0.84) and the donepezil group(MD=-12.07，95%CI -12.71 to 11.43，I2=53%，P=0.12).In terms of MMSE score improvement，Chinese herbal medicine was superior to donepezil(MD=-0.73，95%CI -0.12 to 1.58，I2=0%，P=0.57).In terms of CDR score improvement，Chinese herbal medicine was superior to placebo(MD=-2.63，95%CI -3.24 to 2.02，I2=42%，P=0.19) and donepezil(MD=-0.27，95%CI -0.81 to 0.27，I2=75%，P=0.05).Conclusion:Chinese herbal medicine preparations and extracts can improve the cognitive ability(ADAS-Cog and MMSE) and comprehensive ability(CDR) of patients with mild to moderate AD.They are superior to donepezil in improving cognitive ability with a lower incidence of adverse reactions than donepezil and higher safety，which can be used for clinical references. |
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