阿司匹林联合活血化瘀类中成药治疗老年缺血性脑卒中效果与安全性的Meta分析

Effect and safety of aspirin combined with Huoxue Huayu proprietary Chinese medicine in ischemic cerebrovascular disease in elderly patients： a Meta-analysis

目的 评价阿司匹林联合活血化瘀类中成药治疗老年缺血性脑卒中患者的疗效与安全性.方法 收集首都医科大学宣武医院2012年1月1日至2012年6月30日门诊处方,调取条件为年龄≥60岁,诊断为脑梗、脑梗死、脑卒中、脑梗塞、脑缺血、缺血性脑梗死、缺血性脑卒中,服用阿司匹林.同时调取以上患者服用中成药的处方.按照使用人数由高到低排序,选出排名居前的银杏叶制剂、血塞通片、复方丹参滴丸、血栓心脉宁片、培元通脑胶囊、复方地龙胶囊、脑得生片、心元胶囊8种中成药,以阿司匹林分别加上述药物以及相应的英文词汇为关键词,检索中国期刊全文数据库（CNKI）、万方数据库、中文科技期刊数据库（CSTJ）、PubMed和荷兰医学文摘数据库（Embase）,筛选阿司匹林联合中成药组（观察组）与单用阿司匹林组（对照组）治疗老年缺血性脑卒中患者疗效与安全性比较的随机对照试验进行Meta分析.结果 共纳入14篇文献,包括银杏叶制剂5篇、血塞通注射液3篇、血塞通冻干粉1篇、复方丹参滴丸3篇、血栓心脉宁片2篇,涉及患者1 580例,其中观察组793例,对照组787例.Meta分析结果显示,观察组降低血浆纤维蛋白原浓度、改善神经功能缺损及日常生活活动能力效果均优于对照组,差异有统计学意义（均数差=-0.69,95％置信区间（CI）：-1.12--0.26,P=0.002;比值比=4.57,95％CI：3.19-6.54,P＜0.000 01）.2组不良反应发生率比较,差异无统计学意义（比值比=1.64,95％ CI：0.81-3.29,P=0.17）.结论 老年缺血性脑卒中患者在服用阿司匹林的同时服用活血化瘀类中成药可增强疗效、改善预后、提高患者生活质量,但仍需注意不良反应发生风险.

Objective To evaluate the effective and safety of aspirin combined with Huoxue Huayu proprietary Chinese medicine in ischemic cerebrovascular disease in elderly patients by using Meta-analysis.Methods The prescriptions of patients ≥60 years old who received aspirin due to cerebral infarction,stroke,cerebral ischemia and cerebral ischemic infarction from January 2012 to June 2012 were collected.Meanwhile,Chinese medicine prescriptions for above patients were collected.Eight frequently-used Chinese medicines were selected according to the patient number receiving the medicine,including Ginkgo biloba extract （Ginaton and Shuxuening）,Xuesaitong tablet a/injection,Fufang danshen dripping pills,Xueshuan xinmaining tablet,Peiyuan tongnao capsule,Fufang dilong capsule,Naodesheng tablet,and Xinyuan capsule.The randomized controlled trials （RCT） about the effect and safety of aspirin combined with proprietary Chinese medicine in treating ischemic cerebrovascular disease in the elderly patients were retrieved in China National Knowledge Infrastructure （CNKI）,Wanfang Database,China Science and Technology Journal Database （CSTJ）,PubMed and Excerpta medica database （Embase） taking ＆quot; aspirin ＆#177; above medicines （related English words） ＆quot; as the key words and the Meta-analysis was processed.Results A total of 14 literatures were enrolled,including 5 literatures about Ginkgo biloba extract,3 literatures about Xuesaitong inject,1 literature about Xuesaitong freeze-dried powder,3 literatures about Fufang danshen dripping pills and 2 literatures about Xueshuan xinmaining tablets.A total of 1 580 patients were entered,with 793 patients receiving combination therapy of aspirin and proprietary Chinese medicine （observation group） and 787 receiving aspirin （control group）.The Meta-analysis showed that compared with control group,observation group had better effects on reducing the blood fibrinogen concentration [mean difference （MD） =-0.69,95% confidence interval（CI）：-1.12,-0.26,P =0.002]and improving the nerve function defect [odds ratio （OR） =4.57,95% CI：3.19,6.54,P 〈 0.000 01],but with no higher incidence of the adverse drug reaction [OR =1.64,95% CI =0.81,3.29,P =0.17].Conclusions In the elderly patients with ischemic cerebrovascular disease,aspirin combined with Huoxue Huayu proprietary Chinese medicine can enhance the curative effect,improve the prognosis and raise the life quality,but still need to pay attention to the adverse reactions.