[關(guān)鍵詞]
[摘要]
目的 通過系統(tǒng)評(píng)價(jià)和試驗(yàn)序貫分析(TSA)綜合評(píng)價(jià)石杉?jí)A甲治療阿爾茨海默病(AD)的有效性和安全性。方法 計(jì)算機(jī)檢索PubMed、Embase、Cochrane Library、Web of Science、中國(guó)期刊全文數(shù)據(jù)庫(kù)(CNKI)、萬方數(shù)據(jù)庫(kù)(Wanfang data)、維普數(shù)據(jù)庫(kù)(VIP)、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)(CBM),納入比較石杉?jí)A甲治療AD的隨機(jī)對(duì)照試驗(yàn)和隊(duì)列研究,檢索時(shí)限均從建庫(kù)至2024年4月1日。由2位評(píng)價(jià)員獨(dú)立篩選和評(píng)價(jià),應(yīng)用RevMan 5.4和Stata 17.0軟件進(jìn)行系統(tǒng)評(píng)價(jià),TSA 0.9.5.10 beta軟件進(jìn)行TSA。結(jié)果 共納入25項(xiàng)研究,包括1 813例患者。Meta分析結(jié)果顯示:(1)與對(duì)照組相比,試驗(yàn)組有效率更高[RR=1.46,95% CI(1.29,1.65),P<0.000 01],不同藥物、劑量、療程、癡呆程度、研究類型的亞組分析結(jié)果一致;(2)試驗(yàn)組MMSE量表評(píng)分、MQ量表評(píng)分、HDS-R量表評(píng)分更高[MD=3.99,95% CI(2.32,5.67),P<0.000 01]、[MD=5.09,95% CI(2.71,7.47),P<0.000 1]、[MD=2.59,95% CI(1.62,3.55),P<0.000 01];(3)試驗(yàn)組不良反應(yīng)高于對(duì)照組,差異有統(tǒng)計(jì)學(xué)意義[RR=1.62,95% CI(1.21,2.19),P=0.001];(4)敏感性分析提示結(jié)果較為穩(wěn)??;(5)有效率和不良反應(yīng)的Egger’s檢驗(yàn)提示存在發(fā)表偏倚;(6)TSA進(jìn)一步表明石杉?jí)A甲治療AD有效率和不良反應(yīng)結(jié)論的可靠性。結(jié)論 石杉?jí)A甲能改善AD患者的認(rèn)知功能,存在的不良反應(yīng)多為輕度不良反應(yīng),臨床可根據(jù)患者總體情況綜合考慮。
[Key word]
[Abstract]
Objective To analyze the efficacy and safety of huperzine A for the treatment of Alzheimer's disease (AD) by systematic evaluation and trial sequencing.Methods Computerized searches of PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and Chinese Biomedical Literature Database (CBM) were performed to include randomized controlled comparing huperzine A treatment of AD trials and cohort studies, and the search timeframe was from the establishment of the database to April 1st, 2024 for all of them. Two evaluators independently screened and evaluated the studies, applying RevMan 5.4 and Stata 17.0 software for systematic evaluation, and TSA 0.9.5.10 beta software for TSA. Results A total of 25 papers were included, including 1 813 patients. The results of the Meta-analysis showed that:(1) compared with the control group, the effectiveness rate of the huperzine A group was higher [RR=1.46 with a 95% CI (1.29, 1.65), P < 0.000 01], with consistent results for subgroup analyses of different drugs, dosages, duration of treatment, degree of dementia, and type of study; (2) The MMSE scale scores, MQ scale scores, and HDS-R scale scores were higher in the sarcosine A group [MD = 3.99, 95% CI (2.32, 5.67), P < 0.000 01], [MD = 5.09, 95%CI (2.71, 7.47), P < 0.000 01], [MD = 2.59, 95%CI (1.62, 3.55), P < 0.000 01]; (3) The adverse reactions in the huperzine A group were higher than those in the control group; (4) Sensitivity analysis suggested that the results were more robust; (5) Egger's test for the effective rate and adverse reactions suggested that there was publication bias; And (6) TSA further affirmed the reliability of the conclusions on the effective rate and adverse reactions in the treatment of AD with huperzine A. Conclusion Huperzine A can improve cognitive function in patients with AD, and the common adverse reactions are mostly mild. The clinical selection may vary based on the overall condition of the patients.
[中圖分類號(hào)]
R971
[基金項(xiàng)目]
國(guó)家自然科學(xué)基金資助項(xiàng)目(82160933);廣西壯族自治區(qū)自然科學(xué)基金項(xiàng)目(2022GXNSFAA035577);廣西壯族自治區(qū)中醫(yī)藥管理局科技項(xiàng)目(GXZYZ20210072);廣西中醫(yī)藥適宜技術(shù)與開發(fā)與推廣項(xiàng)目(GZSY22-20)