通心络胶囊治疗颈动脉粥样硬化临床随机对照试验的Meta分析

Meta-analysis of clinical randomized controlled trials of Tongxinluo capsule in the treatment of carotid atherosclerosis

目的:系统评价通心络胶囊治疗颈动脉粥样硬化(Carotid Atherosclerosis,CAS)的临床疗效和安全性,以期为中医药治疗CAS提供临床参考。方法:计算机检索中国知网、万方科技信息数据库、维普资讯网、中国生物医学文献数据库;英文期刊PubMed、EMbase、Cochrane Library电子数据库,搜索通心络胶囊治疗CAS的临床随机对照试验(Randomized Controlled Trials,RCT),根据Cochrane偏倚风险评估工具进行文章的质量评价,采用RevMan5.3软件对颈动脉中-内膜厚度(Intima-media Thickness,IMT)、颈动脉粥样硬化斑块Course积分、颈动脉斑块面积、不良反应等相关指标进行Meta分析。结果:共纳入11个RCT,总样本量1319例;Meta分析结果显示:联合通心络胶囊可以缩小颈动脉粥样硬化患者IMT厚度(MD=-0.34,95%CI[-0.51,-0.18],P<0.0001)、降低颈动脉斑块Crouse积分(MD=-1.14,95%CI[-1.31,-0.98],P<0.0001),且对CAS患者颈动脉斑块面积的改善优于常规西药治疗(MD=-2.24,95%CI[-4.06,-0.43],P=0.02);同时,通心络组和对照组在不良反应上差异无统计学意义(RR=1.95,95%CI[0.87,4.36],P=0.11)。结论:通心络胶囊联合常规西药治疗可改善CAS患者IMT、颈动脉斑块Crouse积分及颈动脉斑块面积,且安全性良好。

Objective:To systematically evaluate the clinical efficacy and safety of Tongxinluo capsule(通心络胶囊)on carotid atherosclerosis(CAS),with a prospect of providing clinical reference for the treatment of CAS by Chinese medicine.Methods:Computer retrieval of China Basic Knowledge Infrastructure Project,Wanfang Science and Technology Information Database,VIP Information Network,Chinese Biomedical Literature Database;English journals PubMed,EMbase,Cochrane Library electronic databases.The clinical randomized controlled trial(RCT)of Tongxinluo capsule in the treatment of CAS was searched.The quality of the articles was evaluated according to the Cochrane risk assessment tool of bias,and meta-analysis was conducted on the related indicators of carotid artery medial-intimal thickness(IMT),carotid atherosclerotic plaque Course score,carotid plaque area,and adverse reactions by using RevMan5.3 software.Results:11 RCTs were included,with a total sample size of 1319 cases.Meta-analysis results showed that the combination of Tongxinluo capsule could reduce the thickness of IMT in patients with carotid atherosclerosis(MD=-0.34,95%CI[-0.51,-0.18],P<0.0001)and reduce the carotid plaque Crouse score(MD=-1.14,95%CI[-1.31,-0.98],P<0.0001),and the improvement of carotid artery plaque area in CAS patients was better than conventional western medicine treatment(MD=-2.24,95%CI[-4.06,-0.43],P=0.02).At the same time,Tongxinluo group and the control group had no statistically significant difference adverse reactions(RR=1.95,95%CI[0.87,4.36],P=0.11).Conclusion:Tongxinluo capsule with conventional western medicine can improve IMT,carotid plaque Crouse score and carotid plaque area in CAS patients,and it is safe.