利伐沙班与华法林治疗非瓣膜性心房颤动患者有效性和安全性比较的Meta分析

Comparison of efficacy and safety of rivaroxaban and warfarin in the treatment of patients with nonvalvular atrial fibrillation:a Meta-analysis

目的 采用Meta分析方法,比较利伐沙班与华法林治疗非瓣膜性心房颤动(NVAF)的有效性和安全性。方法 计算机检索PubMed、中国知网、万方数据知识服务平台、维普网及中华医学期刊全文数据库中公开发表的利伐沙班与华法林治疗NVAF的随机对照试验(RCTs),检索时限均从建库至2023年5月。试验组采用利伐沙班治疗,对照组采用华法林治疗。采用Cochrane Handbook 5.1.0对RCTs进行质量评价,使用RevMan 5.4进行Meta分析。绘制漏斗图评价文献发表偏倚。结果 最终纳入11篇RCTs,共包含15 563例患者。Meta分析结果显示,试验组总血栓栓塞事件发生率[OR=0.69,95%CI(0.57,0.82),P<0.000 1]、缺血性脑卒中发生率[OR=0.46,95%CI(0.22,0.93),P=0.03]、总出血事件发生率[OR=0.46,95%CI(0.27,0.78),P=0.004]、严重出血事件发生率[OR=0.60,95%CI(0.47,0.78),P=0.000 1]低于对照组;2组不良反应发生率比较,差异无统计学意义[OR=0.63,95%CI(0.30,1.30),P=0.21]。漏斗图分析结果显示,报道总血栓栓塞事件发生率的文献呈不对称分布,提示可能存在发表偏倚;报道总出血事件发生率的文献散点分布基本对称,提示无明显发表偏倚。结论 基于当前证据表明,利伐沙班治疗NVAF的有效性和安全性优于华法林。

Objective To compare the efficacy and safety of rivaroxaban and warfarin in the treatment of nonvalvular atrial fibrillation by Meta-analysis.Methods Database-searching RCTs about efficacy and safety of rivaroxaban and warfarin in the treatment of patients with nonvalvular atrial fibrillation conducted in PubMed,CNKI,Wanfang Data,VIP and Chinese Medical Journal full-text databases through computers,and the search time limit was from the establishment of the database to May 2023.Patients in the experimental group were given rivaroxaban,and patients in the control group were given warfarin.Cochrane Handbook 5.1.0 was utilized for quality evaluation of RCTs,and RevMan 5.4 was utilized for Meta-analysis.Funnel diagram was drew to evaluate the literature publication bias.Results A total of 11 RCTs were included,with a total of 15563 patients.Meta-analysis results showed that,the experimental group of incidence of total thromboembolism events[OR=0.69,95%CI(0.57,0.82),P<0.0001],ischemic stroke[OR=0.46,95%CI(0.22,0.93),P=0.03],total bleeding events[OR=0.46,95%CI(0.27,0.78),P=0.004],severe bleeding events[OR=0.60,95%CI(0.47,0.78),P=0.0001]were lower than those in the control group.There was no significant difference of incidence of adverse reactions between the two group[OR=0.63,95%CI(0.30,1.30),P=0.21].Funnel diagram showed that,literature reported the incidence of total thromboembolism events were asymmetrically distributed,suggested that there may be publication bias;Scattered distribution of the literature reported the incidence of total bleeding events was basically symmetrical,suggested that there was no obvious publication bias.Conclusion Current evidence suggests that rivaroxaban renders increasingly more efficacy and safety than warfarin in the treatment of nonvalvular atrial fibrillation.