溶栓与抗凝治疗中高危肺血栓栓塞症有效性与安全性比较Meta分析

Comparison of Efficacy and Safety Between Thrombolysis and Anticoagulation for the Treatment of Intermediate-High-Risk Pulmonary Thromboembolism:A Meta-Analysis

目的评价中高危肺血栓栓塞症(PTE)溶栓与抗凝治疗的有效性与安全性。方法采用计算机检索PubMed,The Cochrane Library及中国知网(CNKI)、万方(WanFang)、维普(VIP)等数据库,检索时限为2000年1月1日至2023年1月1日,收集中高危PTE患者溶栓与抗凝治疗疗效比较的随机对照试验(RCT)或回顾性队列研究(RCS),提取数据,采用Cochrane推荐的偏倚风险评价工具RoB2(2019修订版)评价RCT的质量,采用纽卡斯尔-渥太华(NOS)评价表评价RCS的质量,采用RevMan 5.3软件进行Meta分析。结果共纳入15篇文献,涉及2065例患者,其中溶栓组972例,抗凝组1093例。Meta分析结果显示,溶栓组的有效率[OR=4.97,95%CI(2.98,8.31),P<0.00001]和PTE复发率[OR=0.18,95%CI(0.05,0.70),P=0.01]显著优于抗凝组,但出血率[OR=2.54,95%CI(1.37,4.70),P=0.003]显著高于抗凝组。两组患者的死亡率和慢性血栓栓塞肺动脉压(CTEPH)均无显著差异(P>0.05)。结论中高危PTE患者进行溶栓治疗的疗效优于抗凝治疗,且PTE复发率低,但出血风险较高。

Objective To evaluate the efficacy and safety of thrombolysis and anticoagulation in the treatment of patients with intermediate-high-risk pulmonary thromboembolism(PTE).Methods Randomized controlled trials(RCTs)or retrospective cohort studies(RCS)for comparing the efficacy of thrombolysis and anticoagulation therapy in patients with intermediate-high-risk PTE in the PubMed,The Cochrane Library,CNKI,WanFang and VIP databases were searched from January 1,2000 to January 1,2023,and data were extracted.The bias risk assessment tool RoB2(2019 Revision)recommended by the Cochrane Collaboration Network was used to evaluate the quality of RCTs,the Newcastle-Ottawa Scale(NOS)was used to evaluate the quality of RCS,and the Rev Man 5.3 software was used for the Meta-analysis.Results A total of 15 studies were included,involving 2065 patients,with 972 cases in the thrombolysis group and 1093 cases in the anticoagulation group.Meta-analysis results showed that the effective rate[OR=4.97,95%CI(2.98,8.31),P<0.00001],and the recurrence rate of PTE[OR=0.18,95%CI(0.05,0.70),P=0.01]in the thrombolysis group was significantly better than those in the anticoagulation group,but the bleeding rate[OR=2.54,95%CI(1.37,4.70),P=0.003]in the thrombolysis group was significantly higher than that in the anticoagulation group.There was no significant difference in mortality rate or chronic thromboembolic pulmonary hypertension(CTEPH)between the two groups(P>0.05).Conclusion Compared with anticoagulant therapy,thrombolysis therapy in the treatment of patients with intermediate-high-risk PTE is more effective with a lower recurrence rate of PTE,but it has a higher bleeding rate.