Xa因子抑制剂对急性冠脉综合征疗效及安全性的Meta分析

Analysis of the Efficacy and the Safety of Factor Xa Inhibitor in Patients with Acute Coronary Syndrome

目的:评价Xa因子(FXa)抑制剂对急性冠脉综合征(ACS)的疗效及安全性。方法:计算机检索Cochrane Central Register of Controlled Trials、MEDLINE、EMbase、万方数据、中国知网数据库、中国生物医学文献数据库及维普数据库从建库至今有关FXa抑制剂对ACS患者疗效及安全性的临床随机对照试验(RCT)。由3名研究者进行文献提取和质量评价,对符合纳入标准的研究采用Review 5.1软件进行偏倚定性和Meta分析。结果:共纳入6篇RCT,均采用随机、双盲、安慰剂对照组,且数据完整,非选择性结果报道为低偏倚风险。Meta分析结果显示,低、中、高剂量FXa抑制剂均不能降低ACS患者全因死亡风险[RR=0.92,95%CI(0.80,1.07);RR=0.95,95%CI(0.48,1.87);RR=0.97,95%CI(0.38,2.52)];仅低剂量FXa抑制剂可以降低ACS患者再发心肌梗死风险[RR=0.87,95%CI(0.77,0.98)];FXa抑制剂不能明显降低ACS患者缺血性卒中风险[RR=0.98,95%CI(0.74,1.31)];低、中、高剂量FXa抑制剂均可增加ACS患者主要出血事件风险[RR=2.31,95%CI(1.66,3.21);RR=6.69,95%CI(2.73,16.43);RR=6.23,95%CI(2.75,14.14)]。结论:低剂量FXa抑制剂治疗ACS患者可以降低再发心肌梗死风险;FXa联合抗血小板药物治疗ACS对降低患者全因死亡、缺血性卒中和主要出血事件风险与既往抗血小板治疗比较并无明显优势。

Objective：To evaluate the efficacy and the safety of factor Xa inhibitor in patients with acute cort-nary syndrome（ACS）.Method：Cochrane Central Register of Controlled Trials,Medline,Embase,CNKI,Wanfang and VIP Data were searched for the RCTs of factor Xa inhibitor in patients with ACS from the date of 1 997 to 201 5. The included studies were evaluated and extracted by two researchers independently.The statistical analyses were performed by Review5.1.Results：A total of 6 articles,taking random and double-blind way,having placebo control group and complete statistic,were identified.The non-selected analysis found then were low bias risk.Meta analy-sis showed that the Xa inhibitor from low-dose to high-dose can＆#39;t decrease the all-cause mortally risk in ACS patients [RR=0.92,95%CI（0.80,1.07）],[RR=0.95,95%CI（0.48,1.87）],[RR=0.97,95%CI（0.38,2.52）].Meta analysis showed that low-dose Xa inhibitor decrease the risk of myocardial infarction （MI）with ACS[RR=0.87, 95%CI（0.77,0.98）]and Xa inhibitor can＆#39;t significantly decrease the risk of ischemic stroke in ACS patients[RR=0.98,95%CI （0.74,1.31）].Xa inhibitor from low-dose to high-dose increase the risk of major bleeding in ACS pa-tients [RR=2.31,95% CI（1.66,3.21 ）],[RR = 6.69,95% CI （2.73,1 6.43 ）],[RR = 6.23,95% CI （2.75, 14.14）].Conclusion：Low-dose Xa inhibitor could prevent incidence of MI in ACS patients.Compared to the tradi-tional antiplatelet therapy,the combined therapy of Xa inhibitor and anti-platelet agent can not have an advantage in＆amp;nbsp;decreasing the risk of all-cause mortally,ischemic stroke and major bleeding.