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银杏叶制剂治疗阿尔茨海默病的有效性和安全性:一项系统评价和荟萃分析。

Effectiveness and safety of ginkgo biloba preparations in the treatment of Alzheimer's disease: A systematic review and meta-analysis.

作者信息

Li Dawei, Ma Jinlong, Wei Baojian, Gao Shuang, Lang Yanmei, Wan Xueying

机构信息

School of Nursing, Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, Shandong, China.

School of Nursing, Yanbian University, Yanji, Jilin, China.

出版信息

Front Aging Neurosci. 2023 Mar 7;15:1124710. doi: 10.3389/fnagi.2023.1124710. eCollection 2023.

Abstract

OBJECTIVE

To conduct a meta-analysis of the effectiveness and safety of ginkgo biloba preparations combined with donepezil hydrochloride vs. donepezil for the treatment of Alzheimer's disease (AD).

METHODS

Three English databases (Cochrane Library, PubMed, EMBASE), and four Chinese databases [the China National Knowledge Infrastructure (CKNI), the Chinese Biomedical Literature database (CBM), the Chongqing VIP database, and WANFANG DATA)] were manually searched for literature published from the respective dates of inception of the databases to December 2022. The randomized controlled trials (RCTs) of ginkgo biloba preparations with donepezil hydrochloride vs. donepezil for the treatment of AD were included. Relevant literature was screened, and the data in the included studies were extracted for quality assessment according to the Risk of bias tool. The RevMan 5.3 software was used for meta-analysis.

RESULTS

A total of 1,642 participants were enrolled in the 18 RCTs. Of these, 842 were in the experimental group (ginkgo biloba preparations combined with donepezil hydrochloride) and 800 were in the control group (donepezil). The overall methodological quality of the included RCTs is poor due to the high risks of blindness and allocation concealment. The meta-analysis results showed statistically significant differences in several outcomes including Risk Ratio (RR) in change for clinical effectiveness rate (1.23, 95% CI 1.13, 1.34, < 0.00001), mean difference (MD) in change for Mini-Mental State Examination score (3.02, 95% CI 2.14, 3.89, < 0.00001), Activity of Daily Living Scale score (-4.56, 95% CI -5.09, -4.03, < 0.00001), Hasegawa Dementia Scale score (2.04, 95% CI 1.74, 2.34, < 0.00001), Montreal Cognitive Assessment score (2.38, 95% CI 0.72, 4.06, = 0.005), between the experimental and control groups. But there is no statistically significant difference in change for adverse reaction (0.91, 95% CI 0.58, 1.42, = 0.69).

CONCLUSION

Ginkgo biloba preparations plus donepezil can improve clinical effectiveness rate and vocabulary memory outcomes. However, more relevant high-quality RCTs are needed in the future to validate these results.

SYSTEMATIC REVIEW REGISTRATION

Identifier CRD42022378970.

摘要

目的

对银杏叶制剂联合盐酸多奈哌齐与盐酸多奈哌齐治疗阿尔茨海默病(AD)的有效性和安全性进行荟萃分析。

方法

手动检索三个英文数据库(Cochrane图书馆、PubMed、EMBASE)和四个中文数据库[中国知网(CKNI)、中国生物医学文献数据库(CBM)、重庆维普数据库和万方数据],检索从各数据库建库日期至2022年12月发表的文献。纳入银杏叶制剂联合盐酸多奈哌齐与盐酸多奈哌齐治疗AD的随机对照试验(RCT)。筛选相关文献,并根据偏倚风险工具提取纳入研究中的数据进行质量评估。使用RevMan 5.3软件进行荟萃分析。

结果

18项RCT共纳入1642名参与者。其中,842名在实验组(银杏叶制剂联合盐酸多奈哌齐),800名在对照组(盐酸多奈哌齐)。由于盲法和分配隐藏的高风险,纳入的RCT的总体方法学质量较差。荟萃分析结果显示,实验组和对照组在几个结局方面存在统计学显著差异,包括临床有效率变化的风险比(RR)(1.23,95%CI 1.13,1.34,P<0.00001)、简易精神状态检查表评分变化的平均差(MD)(3.02,95%CI 2.14,3.89,P<0.00001)、日常生活活动量表评分(-4.56,95%CI -5.09,-4.03,P<0.00001)、长谷川痴呆量表评分(2.04,95%CI 1.74,2.34,P<0.00001)、蒙特利尔认知评估评分(2.38,95%CI !0.72,4.06,P = 0.005)。但不良反应变化无统计学显著差异(0.91,95%CI 0.58,1.42,P = 0.69)。

结论

银杏叶制剂加盐酸多奈哌齐可提高临床有效率和词汇记忆结局。然而,未来需要更多相关的高质量RCT来验证这些结果。

系统评价注册

标识符CRD42022378970。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce72/10028084/7dcdd367b26a/fnagi-15-1124710-g0001.jpg

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