鼠神经生长因子治疗阿尔茨海默病临床疗效和安全性的循证医学研究  

Evidence based medicine study on efficacy and safety of mouse nerve growth factor in treatment of Alzheimer’s disease

作　　者：潘冬梅 郭庆[1] 李静静 何伟[1] 脱鸣富 PAN Dongmei;GUO Qing;LI Jingjing;HE Wei;TUO Mingfu(Department of Geriatrics,Huangshi Central Hospital of Edong Healthcare Group,Huangshi 435000,China;Department of Pharmacy,Affiliated Hospital of Gansu Medical College,Pingliang 744000,China)

机构地区：[1]鄂东医疗集团黄石市中心医院老年病科,湖北黄石435000 [2]甘肃医学院附属医院药剂科,甘肃平凉744000

出　　处：《药物评价研究》2021年第1期170-178,共9页Drug Evaluation Research

基　　金：甘肃省高等学校创新能力提升项目(2019B-198)。

摘　　要：目的系统评价鼠神经生长因子(Mouse Nerve Growth Factor,mNGF)联合常规药物治疗阿尔茨海默病(Alzheimer′s disease,AD)的有效性和安全性。方法计算机检索PubMed、EMbase、The Cochrane Library、中国生物医学文献数据库(CBM)、中国学术期刊全文数据库(CNKI)、维普中文期刊全文数据库(VIP)和万方数据库,搜集关于mNGF联合常规药物治疗AD的随机对照试验(RCT),检索时限均从数据库建库至2020年5月31日。依据纳入和排除标准筛选文献、质量评价后采用Revman 5.3软件进行Meta分析。结果最终纳入13个RCTs,共1086例患者,其中mNGF组545例、对照组541例。与对照组比较,mNGF治疗组能更有效地改善简易智力状态检查量表评分(MD=2.29,95%CI=1.92~2.66,P<0.01)、临床痴呆评定量表评分(MD=-0.36,95%CI=-0.45~-0.26,P<0.01)、日常生活活动能力量表评分(MD=3.53,95%CI=2.48~4.59,P<0.01)和临床有效率(RR=1.29,95%CI=1.15~1.45,P<0.01);C-反应蛋白(MD=-0.84,95%CI=-0.99~-0.70,P<0.01)、白细胞介素-6(MD=-3.13,95%CI=-3.73~-2.54,P<0.01)和肿瘤坏死因子-α(MD=-3.52,95%CI=-4.43~-2.61,P<0.01)水平更低;两组不良反应发生率比较,差异无统计学意义(RR=1.09,95%CI=0.56~2.12,P=0.81)。结论常规治疗基础上联合mNGF可进一步改善AD患者的认知功能,降低痴呆程度,提高自主生活能力,提高临床有效性,且没有增加不良反应发生。Objectives To systematically review efficacy and safety of mouse nerve growth factor(mNGF)with routine treatment for Alzheimer’s disease(AD).Methods Databases including PubMed,EMbase,The Cochrane Library,CNKI,VIP,CBM and Wanfang Data were electronically searched from database up to 31 May 2020 to collect randomized controlled trials of mNGF with routine treatment for AD.The trial was screened based on inclusion and exclusion criteria,and the methodological quality of the included trial was assessed.Meta-analysis was performed by Revman 5.3 software.Results A total of 13 studies involving 1086 patients were included.The mNGF group included 545 patients and the control group included 541 patients.The result of Metaanalysis showed that,compared with the use of only routine treatment the combination of mNGF can improve score of mini-mental state examination(MD=2.29,95%CI=1.92 to 2.66,P<0.01),score of clinical dementia rating(MD=-0.36,95%CI=-0.45 to-0.26,P<0.01),score of activity of daily living(MD=3.53,95%CI=2.48 to 4.59,P<0.01)and clinical response rate(RR=1.29,95%CI=1.15 to 1.45,P<0.01);lower the value of C-reactive protein(MD=-0.84,95%CI=-0.99 to-0.70,P<0.01),IL-6(MD=-3.13,95%CI=-3.73 to-2.54,P<0.01)and TNF-α(MD=-3.52,95%CI=-4.43 to-2.61,P<0.01).There was no significant difference in number of adverse events between the mNGF group and the control group(RR=1.09,95%CI=0.56 to 2.12,P=0.81).Conclusion mNGF combined with routine therapy can improve the cognitive function of AD patients,reduce the degree of dementia,improve the ability of independent living,improve the clinical efficacy,and does not increase the incidence of adverse reactions.

关 键 词：鼠神经生长因子 阿尔茨海默病 META分析 循证医学研究 

分 类 号：R971[医药卫生—药品]