摘要
目的系统评价通心络胶囊治疗阿司匹林抵抗的有效性和安全性。方法计算机检索中国知网(CNKI)、维普中文期刊(VIP)、万方数据知识服务平台(Wanfang)、中国生物医学文献数据库(CBM)、PubMed、Embase、the Cochrane Library 7个数据库中有关通心络胶囊治疗阿司匹林抵抗的随机对照试验(RCT),检索时间为建库起至2020年10月。2名研究者按照纳入、排除标准,对文献进行筛选、提取,并进行质量评价。采用Stata 14.1软件对结局指标进行Meta分析,并用GRADE profiler 3.2软件对结局指标进行证据质量分级。结果共纳入研究文献7篇,研究对象460例,其中试验组231例,对照组229例。Meta分析结果显示,试验组在降低二磷酸腺苷(ADP)诱导的血小板聚集率[SMD=-1.43,95%CI(-1.82,-1.04),P=0.000]、花生四烯酸(AA)诱导的血小板聚集率[SMD=-1.28,95%CI(-1.67,-0.89),P=0.000]、血栓素B2(TXB2)水平[SMD=-1.05,95%CI(-1.33,-0.76),P=0.000]和缺血事件发生率[RR=0.25,95%CI(0.13,0.49),P=0.000]等方面均优于对照组。2组出血事件发生率和普通不良反应事件发生率差异无统计学意义。亚组分析显示,ADP诱导的血小板聚集率和AA诱导的血小板聚集率分别与疗程和样本量有一定的关系。结局指标的GRADE分级为极低、低级。结论通心络胶囊可改善阿司匹林抵抗,且安全性较好。但限于原始研究数量和质量问题,所得结论需慎重对待,需要更多高质量的RCT进一步验证。
Objective To systematically evaluate the effectiveness and safety of Tongxinluo capsule in the treatment of aspirin resistance.Methods Seven databases including CNKI,VIP,Wanfang,CBM,PubMed,Embase,and the Cochrane Library,were retrieved from the establishment of the database to October 2020 for collecting the randomized controlled trials of Tongxinluo capsule in the treatment of aspirin resistance.Two investigators screened,extracted and evaluated the quality of the literature according to the inclusion and exclusion criteria,used Stata14.1 software to perform meta-analysis on the outcome indicators,and used GRADE profiler 3.2 software to classify the outcome indicators for the quality of evidence.Results A total of 7 studies were included,with a total sample of 460 cases,including 231 cases in the experimental group and 229 cases in the control group.Meta-analysis results showed that the experimental group achieved better results than the control group in decreasing adenosine diphosphate(ADP)-induced platelet aggregation rate[SMD=-1.43,95%CI(-1.82,-1.04),P=0.000],arachidonic acid(AA)-induced platelet aggregation rate[SMD=-1.28,95%CI(-1.67,-0.89),P=0.000],the level of thromboxane B2(TXB2)[SMD=-1.05,95%CI(-1.33,-0.76),P=0.000],and the incidence of ischemic events rate[RR=0.25,95%CI(0.13,0.49),P=0.000].There was no statistically significant difference in the incidence of bleeding events rate and common adverse events rate between the two groups.In addition,subgroup analysis showed that ADPinduced platelet aggregation rate and AA-induced platelet aggregation rate had a certain relationship with the course of treatment and sample size,respectively.The GRADE classification of the outcome indicators is very low and low.Conclusion Tongxinluo capsule can treat aspirin resistance and has good safety.However,the conclusions should be treated with caution due to the limits of the quantity and quality from original research,and more high-quality RCTs are needed for further verification.
作者
郭红鑫
郑超楠
马腾
于瑞
李彬
王永霞
朱明军
GUO Hongxin;ZHENG Chaonan;MA Teng;YU Rui;LI Bin;WANG Yongxia;ZHU Mingjun(Henan University of Traditional Chinese Medicine,Zhengzhou 450046 Henan,China;The First Affiliated Hospital of Henan College of Traditional Chinese Medicine,Zhengzhou 450099 Henan,China)
出处
《中药新药与临床药理》
CAS
CSCD
北大核心
2021年第4期585-591,共7页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
国家重点研发中医药现代化研究项目(2019YFC1710000,2019YFC1710003)
国家中医药管理局中医药循证能力建设项目(2019XZZX-XXG003)
河南省创新型科技团队项目(C20130050)。
