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脑心通胶囊联用阿司匹林和他汀类药物治疗脑梗死临床疗效和安全性的Meta分析

Clinical Efficacy and Safety of Naoxintong Capsules Combined with Aspirin and Statins Capsule for Cerebral Infarction: a Meta analysis

DOI：

中文关键词: 脑心通胶囊联合用药脑梗死 Meta分析随机对照试验

英文关键词:Naoxintong capsule Drug combination Cerebral infarction Meta analysis Randomized controlled trial

基金项目:国家科技重大专项“重大新药创制”项目（编号：2015ZX09501004-001-007）

作者	单位
王盼盼1 李学林1,2 李春晓2 张明亮2 刘淑钰1 李冰1 李俊凯2	1.河南中医药大学郑州 450046；2.河南中医药大学第一附属医院中药临床评价技术河南省工程实验室

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中文摘要:

摘要目的：系统评价脑心通胶囊联用阿司匹林和他汀类药物治疗脑梗死的临床疗效和安全性，为临床治疗脑梗死提供参考依据。 方法：计算机检索CNKI、WanFang Data、VIP、PubMed、Embase、the Cochrane Library和Web of Science数据库，搜集脑心通胶囊治疗脑梗死的随机对照试验（RCTs），检索时限均从建库至2019年3月，由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后，采用RevMan 5.3软件进行Meta分析。 结果：纳入11项研究，共1 137例患者。Meta分析结果显示，与单独服用阿司匹林和他汀类等西医常规疗法对照组相比，脑心通胶囊联合联用阿司匹林和他汀类药物的治疗组能够提高脑梗死治疗的临床总有效率[RR=1.19，95%CI（1.05，1.34），P=0.007]，降低NIHSS评分[MD=-3.39，95%CI（-3.84，-2.94），P<0.000 01]，增加日常生活能力评分（BI评分）[MD=22.18，95%CI（11.00，33.35），P=0.000 1]，降低脑梗死复发率[RR=0.48，95%CI（0.31，0.72），P=0.000 5]和超敏反应蛋白（hs CRP，mg·L-1）水平[MD=-1.31，95%CI（-1.70，-0.92），P<0.000 01]，降低总胆固醇（TC，mmol·L-1）水平[MD=-0.23，95%CI（-0.42，-0.05），P=0.01]、三酰甘油（TG，mmol·L-1）水平[MD=-0.59，95%CI（-0.97，-0.20），P=0.003]和低密度脂蛋白胆固醇（LDL C，mmol·L-1）水平[MD=-0.26，95%CI（-0.46，-0.06），P=0.01]，升高高密度脂蛋白胆固醇（HDL C，mmol·L-1）水平[MD=0.11，95%CI（0.05，0.16），P=0.000 2]，纳入研究中两组均未发生药品不良反应。〖HTH〗结论：〖HTK〗脑心通胶囊联合联用阿司匹林和他汀类药物较单纯西医常规治疗可能会明显提高临床总有效率、改善脑梗死患者神经功能缺损状态和日常生活能力、降低脑梗死复发率和hs CRP水平，调节血脂水平，两组均未见不良反应。

英文摘要:

ABSTRACT Objective:To evaluate the clinical efficacy of Naoxintong Capsules combined with aspirin and statins in the treatment of cerebral infarction in order to provide a reference for clinical treatment of cerebral infarction. Methods:CNKI, WanFang Data, VIP, PubMed, Embase, the Cochrane Library and Web of Science were electronically searched to collect randomized controlled trials (RCTs) of Naoxintong Capsules on cerebral infarction from inception to March, 2019. Two researchers independently screened literature, extracted data and assessed the risk of bias of included studies, then, Meta analysis were performed by using the RevMan 5.3 software. Results:Eleven RCTs involving 1 137 patients were included. Naoxintong Capsule plus western medicine compared with the western medicine alone significantly improved the total clinical response rate of cerebral infarction treatment (RR=1.19, 95%CI 1.05 to 1.34, P=0.007), reduced the NIHSS (MD=-3.39, 95%CI -3.84 to -2.94, P<0.000 01), increased BI (MD=22.18, 95%CI 11.00 to 33.35, P=0.000 1), reduced the recurrence rate of cerebral infarction (RR=0.48, 95%CI 0.31 to 0.72, P=0.000 5) and the level of hs CRP (mg·L-1) (MD=-1.31, 95%CI -1.70 to -0.92, P<0.000 01), and reduced the level of TC (mmol·L-1) (MD=-0.23, 95%CI -0.42 to -0.05, P=0.01), TG (mmol·L-1) (MD=-0.59, 95%CI -0.97 to -0.20, P=0.003) and LDL C (mmol·L-1) (MD=-0.26, 95%CI -0.46 to -0.06, P=0.01), increased the level of HDL C (mmol·L-1) (MD=0.11, 95%CI 0.05 to 0.16, P=0.000 2). No adverse reactions were observed in either group. Conclusion:Naoxintong capsule combined with western medicine may significantly improve the clinical efficacy of cerebral infarction patients, improve the neurological function and the ability of daily life, reduce the recurrence rate of cerebral infarction and the level of hs CRP, and regulate lipid levels. The patients of two groups had not happened the adverse drug reaction.

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