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冠心病抗血小板治疗加用口服Ⅹa因子抑制药有效性及安全性的Meta分析

Efficacy and Safety of Adding Oral Ⅹa Factor Inhibitor to Anti platelet Therapy in Coronary Artery Disease: A Meta analysis

DOI：

中文关键词: Ⅹa因子抑制药冠心病抗血小板治疗 Meta分析

英文关键词:Factor Ⅹa inhibitor Coronary artery disease Anti platelet therapy Meta analysis

基金项目:

作者	单位
艾力亚尔·图尼亚孜周福亮于云霞程昭李旭影贾大林	中国医科大学附属第一医院心血管内科沈阳110001

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中文摘要:

摘要目的：采用Meta分析方法评价冠心病抗血小板治疗基础上加用口服Ⅹa因子抑制药的有效性及安全性。方法：计算机检索PubMed、the Cochrane Library、Embase、Clinical Trials.gov、CNKI、WanFang Data数据库，搜集关于冠心病患者加用口服Ⅹa因子抑制药的随机对照试验（RCTs），检索时限均为建库至2018年2月，由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后，采用RevMan 5.0软件进行Meta分析。 结果：共纳入7项研究，共有50 044例患者。Meta分析结果显示：加用口服Ⅹa因子抑制药可减少缺血复合终点事件发生率[RR=0.84，95%CI（0.79，0.91），P<0.001]、全因死亡率[RR=0.88，95%CI（0.79，0.97），P=0.01]、心肌梗死发生率[RR=0.89，95%CI（0.80，0.98），P=0.02]及缺血性卒中发生率[RR=0.63，95%CI（0.51，0.78），P<0.001]；然而却明显增加TIMI大出血的风险[RR=3.22，95%CI（2.35，4.42），P<0.001]、TIMI小出血的风险[RR=2.40，95%CI（1.69，3.41），P<0.001]及颅内出血的风险[RR=1.83，95%CI（1.20，2.81），P=0.005]。加用Ⅹa因子抑制药对增加致命性出血风险的差异无统计学意义[RR=1.63，95%CI（0.96，2.78)，P=0.07]。结论：冠心病标准抗血小板治疗基础上加用口服Ⅹa因子抑制药是有效的，可以减少缺血复合终点事件、全因死亡、心肌梗死、缺血性卒中的发生风险，但安全性方面，口服Ⅹa因子抑制药会增加出血风险。

英文摘要:

ABSTRACT Objective: To systematically evaluate efficacy and safety of oral Ⅹa inhibitor in addition to anti platelet therapy in patients with coronary artery disease.Methods:PubMed, the Cochrane Library, Embase, Clinical Trials.gov and CNKI and WanFang Data were electronically searched to collect randomized controlled trials (RCTs) of addition of oral Ⅹa inhibitor to anti platelet therapy for coronary artery disease from database inception to February, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. RevMan 5.0 software was used for Meta analysis. Results:A total of 7 RCTs involving 50 044 patients were included. The results of Meta analysis showed that addition of oral Ⅹa inhibitor to anti platelet therapy in patients with coronary artery disease could significantly lower the risk of ischemic composite endpoints (RR=0.84, 95%CI 0.79 to 0.91, P<0.001). Besides, risk of all cause mortality (RR=0.88, 95%CI 0.79 to 0.97, P=0.01), myocardical infarction (RR=0.89, 95%CI 0.80 to 0.98, P=0.02), and ischemic stroke (RR=0.63, 95%CI 0.51 to 0.78, P<0.001) were also significantly reduced. However, risk of TIMI major bleeding (RR=3.22, 95%CI 2.35 to 4.42, P<0.001), TIMI minor bleeding (RR=2.40, 95%CI 1.69 to 3.41, P<0.001), and intracranial bleeding (RR=1.83, 95%CI 1.20 to 2.81, P=0.005) were significantly increased, respectively. Ⅹa inhibitor also intended to increase risk of fatal bleeding, but has no significant difference (RR=1.63, 95%CI 0.96 to 2.78, P=0.07). Conclusion:Addition of oral Ⅹa inhibitor to anti platelet therapy in patients with coronary artery disease was effective, which could reduce the risk of ischemic composite endpoints, all cause mortality, myocardial infarction, ischemic stroke. However it could significantly increase risk of bleeding in safety.

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