新型口服抗凝药对比华法林用于左心室血栓有效性和安全性的Meta分析
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篇名: 新型口服抗凝药对比华法林用于左心室血栓有效性和安全性的Meta分析
TITLE: Efficacy and safety of new oral anticoagulants versus warfarin for left ventricular thrombus:a meta-analysis
摘要: 目的 比较新型口服抗凝药(NOACs)与华法林用于左心室血栓的有效性和安全性,为临床合理用药提供循证参考。方法计算机检索PubMed、CochraneLibrary、Embase、OvidMedline、中国知网、万方数据和维普网,检索时限为各数据库建库起至2022年3月。筛选文献、提取资料后,采用Cochrane系统评价员手册推荐的5.3.0偏倚风险评估工具评价随机对照研究(RCT)的质量,采用纽卡斯尔-渥太华量表评价队列研究的质量;采用RevMan5.3软件进行Meta分析及发表偏倚分析。结果共纳入13项研究,包括2项RCT、11项队列研究,合计2261例患者。Meta分析结果显示,两组患者的血栓完全溶解率[OR=1.05,95%CI(0.81,1.37),P=0.71]、脑卒中/系统性栓塞发生率[OR=0.89,95%CI(0.67,1.18),P=0.42]、大出血发生率[OR=0.61,95%CI(0.19,1.97),P=0.41]、再住院发生率[OR=0.84,95%CI(0.49,1.46),P=0.54]、全因死亡率[OR=0.93,95%CI(0.56,1.56),P=0.79]比较,差异均无统计学意义;试验组患者的任何出血事件发生率显著低于对照组[OR=0.65,95%CI(0.45,0.93),P=0.02]。亚组分析结果显示,试验组患者中随访时间≤6个月的血栓完全溶解率显著高于对照组,随访时间>6个月和欧洲地区患者的任何出血事件发生率显著低于对照组(P<0.05);随访时间>6个月的血栓完全溶解率、亚洲和美洲地区患者的任何出血事件发生率、RCT和队列研究中两组患者的任何出血事件发生率比较,差异均无统计学意义(P>0.05)。发表偏倚分析结果显示,血栓完全溶解率方面存在发表偏倚的可能性较小,而任何出血事件发生率方面存在发表偏倚可能性较大。结论NOACs早期能更快地消退血栓,但随着抗凝时间的延长,NOACs与华法林的疗效相当,且NOACs在任何出血事件方面的安全性优于华法林。
ABSTRACT: OBJECTIVE To compare the efficacy and safety of new oral anticoagulants (NOACs) and warfarin in the treatment of left ventricular thrombus (LVT), and to provide evidenced-based reference for rational drug use in clinic. METHODS Retrieved from PubMed, Cochrane Library, Embase, Ovid Medline, CNKI, Wanfang and VIP during the inceptions to March 2022, after screening the literature and extracting data, the quality of randomized controlled trials (RCTs) was evaluated by using bias risk evaluation tool recommended by Cochrane systematic evaluator manual. Newcastle Ottawa Scale was used to evaluate the quality of cohort studies, and RevMan 5.3 software was used for meta-analysis and bias risk analysis. RESULTS A total of 13 studies were included in the analysis, including 2 RCTs, 11 cohort studies and 2 261 patients; results of meta-analysis showed that there was no statistical significance in the incidence of complete LVT resolution [OR=1.05, 95%CI(0.81,1.37), P=0.71], the incidence of stroke/systemic embolism [OR=0.89, 95%CI(0.67,1.18), P=0.42], the incidence of massive haemorrhage [OR= 0.61, 95%CI(0.19,1.97), P=0.41], the incidence of rehospitalization [OR=0.84, 95%CI(0.49,1.46), P=0.54] or all-cause mortality [OR=0.93, 95%CI(0.56,1.56), P=0.79] between 2 groups. The incidence of any bleeding event in trial group was significantly lower than that control group[OR= 025-80863493。0.65, 95%CI(0.45,0.93), P=0.02]. Subgroup analysis showed that complete LVT resolution of patients with follow-up ≤6 months in trial group was significantly higher than control group, and the incidence of any bleeding event was significantly lower in patients with follow-up >6 months and in the European region than control group (P<0.05). There was no statistically significant difference in the rate of complete LVT resolution in patients with follow-up>6 months, the incidence of any bleeding event in patients from Asia and America, or the incidence of any bleeding event in the two groups included in the RCT or the cohort study (P>0.05). The publication bias analysis showed that publication bias was less likely in the rate of complete LVT resolution but more likely in the incidence of any bleeding event. CONCLUSIONS NOACs can eliminate thrombus faster in the early stage, but with the prolongation of anticoagulation time, the efficacy of NOACs is comparable to warfarin, and the safety of NOACs in any bleeding event is better than warfarin.
期刊: 2022年第33卷第24期
作者: 周强,臧月月,陶瑛瑛,黄晓晖,吴燕子,杨元素,魏萌
AUTHORS: ZHOU Qiang,ZANG Yueyue,TAO Yingying,HUANG Xiaohui,WU Yanzi,YANG Yuansu,WEI Meng
关键字: 左心室血栓;华法林;新型口服抗凝药;有效性;安全性
KEYWORDS: left ventricular thrombus; warfarin; new oral anticoagulants; efficacy; safety
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