注射用红花黄色素用于急性缺血性脑卒中有效性和安全性的Meta分析  

Efficacy and Safety of Safflower Yellow for Injection in Acute Ischemic Stroke:A Meta-Analysis

作　　者：陈政国 陈峦峦 叶秋绵 宣建伟 司徒冰[1] CHEN Zhengguo;CHEN Luanluan;YE Qiumian;XUAN Jianwei;SITU Bing(Department of Clinical Research Management Office,The Third Affiliated Hospital of Guangzhou Medical University,Guangdong Provincial Key Laboratory of Major Obstetric Diseases,Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology,Guangzhou 510150,China;Health Economic Research Institute,School of Pharmacy,Sun Yat-Sen University,Guangzhou 510000,China)

机构地区：[1]广州医科大学附属第三医院临床研究管理办公室,广东省产科重大疾病重点实验室,广东省妇产疾病临床医学研究中心,广州510150 [2]中山大学药学院医药经济研究所,广州510000

出　　处：《中国药学杂志》2024年第20期1967-1977,共11页Chinese Pharmaceutical Journal

摘　　要：目的系统评价注射用红花黄色素(SYI)用于急性缺血性脑卒中(AIS)的有效性和安全性。方法计算机检索中国知网、万方数据库、维普网、中国生物医学文献数据库、PubMed、Embase、Web of Science和Cochrane Library,收集SYI联合常规治疗作为实验组(EG)和常规治疗作为对照组(CG)的随机对照试验(RCT)研究。采用Cochrane偏倚风险评估工具评价纳入研究的方法学质量。使用R4.3.1软件进行统计分析。结果共纳入29项RCT。Meta分析结果显示:有效性方面:与CG组相比,EG组临床治疗的总有效率更高(P<0.0001);改善患者NIHSS、Barthel、IL-8、IL-6、血浆黏度、红细胞比积指标的效果更优(P<0.05);而在血清一氧化氮(NO)和纤维蛋白原(FIB)指标上,2组差异无统计学意义(P>0.05)。安全性方面:药物不良反应总发生率EG组低于CG组(P=0.0018)。敏感性分析和发表偏倚分析结果显示,除不良反应发生率翻转为两组差异无统计学意义外(P=0.1734),所得结果基本稳定,且存在发表偏倚的可能性较小。结论与常规治疗相比,SYI联合常规治疗有效性方面总体较优,且并未增加不良反应发生风险。OBJECTIVE To systematically evaluate the effectiveness and safety of safflower yellow for injection(SYI)in acute ischemic stroke(AIS).METHODS Computer searches were conducted on CNKI,Wanfang Database,VIP.com,Chinese Biomedical Literature Database,PubMed,Embase,Web of Science and Cochrane Library for randomized controlled trials(RCTs)of SYI combined with conventional Western medicine treatment as experimental group(EG)and conventional Western medicine treatment as control group(CG).The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of included studies.Statistical analysis was performed using R4.3.1 software.RESULTS A total of 29 RCTs were included.Meta-analysis results showed that compared with the CG group,the total effective rate of the EG group was higher(P<0.0001),the patients′NIHSS,Barthel,IL-8,IL-6,plasma viscosity,and hematocrit indexes were improved(P<0.05);while in terms of NO and FIB indexes,there was no statistically significant difference between the two groups(P>0.05).In terms of safety,the total incidence of adverse drug reactions in the EG group was lower than that in the CG group(P=0.0018).The results of sensitivity analysis and publication bias analysis showed that except for the fact that the incidence of adverse reactions reversed to a point had no statistically significant difference between the two groups(P=0.1734),the results obtained in the study were basically stable,and the possibility of publication bias was small.CONCLUSION Compared with conventional treatment,SYI combined with conventional treatment is generally more effective in terms of effectiveness and does not increase the risk of adverse reactions.

关 键 词：红花黄色素 急性缺血性脑卒中 有效性 安全性 META分析 

分 类 号：R972[医药卫生—药品]