[關(guān)鍵詞]
[摘要]
目的 系統(tǒng)評(píng)價(jià)銀杏葉相關(guān)制劑對(duì)阿爾茨海默病的療效及安全性。方法 檢索PubMed、Web of Science、Embase、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)(CBM)、中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)(CNKI)、維普中文期刊全文數(shù)據(jù)庫(kù)(VIP)和萬(wàn)方數(shù)據(jù)庫(kù)關(guān)于銀杏葉制劑治療阿爾茨海默病的臨床隨機(jī)對(duì)照試驗(yàn)(RCT)。檢索時(shí)限為建庫(kù)-2019年10月29日,兩名評(píng)估人員獨(dú)立篩選文獻(xiàn),進(jìn)行質(zhì)量評(píng)價(jià),統(tǒng)計(jì)學(xué)分析采用RevMan 5.3.5軟件。結(jié)果 共納入21篇RCTs,涉及1 643例患者。Meta-分析結(jié)果顯示:(1)銀杏葉制劑較胞二磷膽堿可更有效改善簡(jiǎn)易精神狀態(tài)量表(MMSE)[MD=3.80,95% CI(2.05,5.55),P<0.000 1]、日常生活功能量表(ADL)評(píng)分[MD=-3.30,95% CI(-4.75,-1.85),P<0.000 01]及總有效率[OR=3.69,95% CI(1.87,7.27),P=0.000 2];(2)基礎(chǔ)治療或其他藥物聯(lián)用銀杏葉制劑較僅基礎(chǔ)治療或單用其他藥物可更有效改善MMSE[MD=2.68,95% CI(2.35,3.02),P<0.000 01]、ADL評(píng)分[MD=-3.48,95% CI(-4.36,-2.60),P<0.000 01]及總有效率[OR=3.50,95% CI(1.09,11.22),P=0.03];(3)與安慰劑或無(wú)干預(yù)措施相比,銀杏葉制劑可有效改善MMSE[MD=1.82,95% CI(0.33,3.32),P=0.02]、ADL評(píng)分[MD=-7.00,95% CI(-10.93,-3.07),P=0.000 5];(4)多奈哌齊聯(lián)用銀杏葉制劑較其單藥治療可顯著改善MMSE[MD=1.82,95% CI(0.33,3.32),P=0.02]、ADL評(píng)分[MD=-4.29,95% CI(-5.58,-2.99),P<0.000 01]及總有效率[OR=2.95,95% CI(1.42,6.13),P=0.004];(5)單用銀杏葉制劑改善MMSE[MD=-1.79,95% CI(-2.39,-1.20),P<0.000 01]及總有效率[OR=0.15,95% CI(0.08,0.30),P<0.000 01]作用顯著低于單用多奈哌齊。結(jié)論 銀杏葉制劑輔助治療阿爾茨海默病療效確切,且不良反應(yīng)發(fā)生無(wú)明顯差異。
[Key word]
[Abstract]
Objective To systematically evaluate the efficacy and safety of extract of Ginkgo biloba preparations (EGb) for Alzheimer's disease. Methods A randomized controlled trial (RCT) of EGb for Alzheimer's disease was conducted on PubMed, Web of Science, Embase, CBM, CNKI, VIP and Wanfang databases from inception to October 29, 2019. Two evaluators independently screened the literature for quality evaluation, and RevMan 5.3.5 software was used for statistical analysis. Results A total of 21 RCTs were included, including 1 643 patients. Meta-analysis results showed:(1) Compared with citicoline, EGb can improve MMSE[MD=3.80, 95%CI(2.05, 5.55), P<0.000 1], ADL scores[MD=-3.30, 95%CI(-4.75, -1.85), P<0.000 01] and total effective rate[OR=3.69, 95%CI(1.87, 7.27), P=0.000 2] more effectively; (2) Compared with the use of only basic treatment or other drugs alone, the combination of EGb can improve MMSE[MD=2.68, 95%CI(2.35, 3.02), P<0.000 01], ADL score[MD=-3.48, 95%CI(-4.36, -2.60), P<0.000 01] and total effective rate[OR=3.50, 95%CI(1.09, 11.22), P=0.03] more effectively; (3) Compared with placebo or no intervention, EGb can effectively improve MMSE[MD=1.82, 95%CI(0.33, 3.32), P=0.02] and ADL scores[MD=-7.00, 95%CI(-10.93, -3.07), P=0.0005]; (4) Compared with donepezil monotherapy, the combination of donepezil and EGb can improve MMSE[MD=1.82, 95%CI(0.33, 3.32), P=0.02], ADL scores[MD=-4.29, 95%CI(-5.58, -2.99), P<0.000 01] and total effective rate[OR=2.95, 95%CI(1.42, 6.13), P=0.004] more effectively; (5) EGb has a significantly lower effect on the MMSE score[MD=-1.79, 95%CI(-2.39, -1.20), P<0.000 01] and total effective rate[OR=0.15, 95%CI(0.08, 0.30), P<0.000 01] than donepezil. Conclusions EGb are effective in the treatment of Alzheimer's disease, and there is no significant difference in adverse reactions.
[中圖分類號(hào)]
R971
[基金項(xiàng)目]
國(guó)家自然科學(xué)基金青年科學(xué)基金項(xiàng)目(81302841);遼寧省高等學(xué)校優(yōu)秀人才支持計(jì)劃(LJQ2014086)