低剂量利伐沙班在非瓣膜性房颤患者中有效性和安全性的Meta分析  

Meta-analysis of Efficacy and Safety of Low-dose Rivaroxaban in Patients with Non-valvular Atrial Fibrillation

作　　者：孙洁[1] 陈国梅[1] 黄吉 SUN Jie;CHEN Guomei;HUANG Ji(Department of Pharmacy,the First People’s Hospital of Taicang,(The Affiliated Taicang Hospital of Suzhou University),Taicang,Jiangsu 215400,China)

机构地区：[1]太仓市第一人民医院(苏州大学附属太仓医院)药剂科,太仓215400

出　　处：《药学与临床研究》2021年第5期384-388,共5页Pharmaceutical and Clinical Research

基　　金：苏州市科技发展计划(民生科技-医疗卫生应用基础研究)项目(SYSD2018224)。

摘　　要：目的:评价低剂量利伐沙班在非瓣膜性房颤患者中的有效性和安全性。方法:计算机检索PubMed、Cochrane Library、Web of Science、GeenMedical、中国知网(CNKI)、维普数据库、万方数据库,查找所有比较低剂量利伐沙班(10~15 mg)和华法林治疗非瓣膜性房颤的有效性和安全性的随机对照试验和队列研究,检索时间为建库至2020年7月31日。对检索的文献进行筛选,采用Cochrane协作网出品的RevMan 5.3、Stata12软件进行统计学分析。结果:共纳入合格文献6篇,患者总数为66334例。Meta分析显示,与华法林相比,低剂量利伐沙班可降低总体房颤患者的脑卒中发生率[RR=0.80,95%CI(0.74,0.86),P<0.00001]和颅内出血发生率[RR=0.55,95%CI(0.48,0.64),P<0.00001],差异有统计学意义;在全因死亡率[RR=0.75,95%CI(0.50,1.12),P=0.16]、心肌梗死发生率[RR=0.77,95%CI(0.53,1.11),P=0.16]、消化道出血发生率[RR=0.80,95%CI(0.56,1.16),P=0.24]及轻微出血发生率[RR=0.85,95%CI(0.53,1.39),P=0.52]差异均无统计学意义。结论:与华法林治疗相比,低剂量利伐沙班可降低房颤患者脑卒中的风险,且与很少发生颅内出血并发症有关,在队列研究亚组中,这种差异体现的更明显。本研究在全因死亡、心梗发生率及轻微出血的发生率中虽未看到低剂量利伐沙班有更多的优势,但并不增加这些的发生率,与华法林相比,有效性及安全性并没有下降。另外,低剂量利伐沙班不增加消化道出血风险,且有减少此种风险的倾向。Objective:To evaluate the efficacy and safety of low-dose rivaroxaban in patients with non-valvular atrial fibrillation(NVAF).Methods:All randomized controlled trials and cohort studies about the comparison of the efficacy and safety between low-dose rivaroxaban(10 mg/15 mg)and warfarin in the treatment of NVAF were searched by computer in databases PubMed,Cochrane Library,Web of Science,GeenMedical,CNKI,VIP and Wanfang from the dates of their foundation to July 31,2020.The retrieved literatures were screened and statistically analyzed using the RevMan 5.3 and Stata12 software produced by the Cochrane Collaboration.Results:Totally 6 literatures involving 66334 patients were included.Meta analysis showed that low-dose rivaroxaban,compared with warfarin,significantly reduced the incidence of stroke[RR=0.80,95%CI(0.74,0.86),P<0.00001]and intracranial hemorrhage rate[RR=0.55,95%CI(0.48,0.64),P<0.00001],while did not significantly change the all-cause mortality[RR=0.75,95%CI(0.50,1.12),P=0.16],the incidence of myocardial infarction[RR=0.77,95%CI(0.53,1.11),P=0.16],the incidence of gastrointestinal bleeding[RR=0.80,95%CI(0.56,1.16),P=0.24]and the incidence of minor bleeding[RR=0.85,95%CI(0.53,1.39),P=0.52].Conclusion:Compared with the warfarin treatment,low-dose rivaroxaban was associated with a reduced risk of stroke and fewer complications of intracranial hemorrhage in patients with atrial fibrillation,which was even more pronounced in the cohort study subgroup.Although this study did not see more advantages of low-dose rivaroxaban in the incidences of all-cause death,myocardial infarction and minor bleeding,it did not increase their incidences,and there was no decrease in efficacy and safety compared with warfarin.In addition,low-dose rivaroxaban did not increase the risk of gastrointestinal bleeding,and had a strong tendency to reduce the risk.

关 键 词：低剂量利伐沙班 非瓣膜性房颤 有效性 安全性 META分析 华法林 

分 类 号：R969.3[医药卫生—药理学]