经导管主动脉瓣置换术后双联抗血小板用药时间对术后并发症疗效和安全性影响的Meta分析
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篇名: 经导管主动脉瓣置换术后双联抗血小板用药时间对术后并发症疗效和安全性影响的Meta分析
TITLE:
摘要: 目的:系统评价经导管主动脉瓣置换术(TAVI)后双联抗血小板用药时间对术后并发症疗效和安全性的影响,为TAVI术后抗血小板治疗方案的制订提供循证参考。方法:计算机检索Cochrane临床对照试验注册中心、PubMed、Embase、Web of Science、万方数据以及中国期刊全文数据库,检索时限均为建库起至2019年2月,收集双联抗血小板用药时间对TAVI术后并发症疗效(全因死亡率及脑卒中事件发生率)和安全性(大出血事件发生率)影响的随机对照试验(RCT)和观察性研究。对符合纳入标准的临床研究进行资料提取后,采用Cochrane偏倚风险评价工具5.1.0(RCT)或纽卡斯尔-渥太华量表(观察性研究)进行质量评价,采用Rev Man 5.3及Stata 14.0统计软件进行Meta分析,并针对各结局及不同用药时间进行Meta回归分析。结果:共纳入3项RCT、10项观察性研究,合计 2 868 例患者。Meta分析结果显示,用药后1个月和6个月的全因死亡率分别为0.05[95%CI(0.03,0.07),P<0.001]、0.07[95%CI(0.05,0.08),P<0.001];用药后1个月、3个月、6个月的大出血事件发生率分别为0.14[95%CI(0.08,0.19),P<0.001]、0.11[95%CI(0.03,0.19),P=0.007]、0.13 [95%CI(0.05,0.22),P=0.002];用药后1个月的脑卒中事件发生率为0.04[95%CI(0.03,0.05),P<0.001]。Meta回归分析结果显示,用药后6个月内的全因死亡率[回归系数=0.005 7,95% CI(-0.001 6, 0.013 0),P=0.116]、大出血事件发生率[回归系数=-0.000 5,95%CI(-0.022 4,0.021 4),P=0.959]、脑卒中事件发生率[回归系数=0.001 4,95%CI(-0.003 8,0.006 5),P=0.570]与双联抗血小板治疗方案的用药时间均无相关性。结论:延长双联抗血小板治疗方案的用药时间对增加TAVI术后并发症的治疗效果无明显影响,对安全性也无明显影响。
ABSTRACT: OBJECTIVE: To systematically evaluate the effects of dual-antiplatelet medication time on efficacy and safety of postoperative complications after transcatheter aortic valve implantation (TAVI), and to provide evidence-based reference for the formulation of antiplatelet therapy after TAVI. METHODS: Retrieved from Cochrane clinical controlled trial registration center, PubMed, Embase, Web of Science, Wanfang database and CJFD, during database establishment to Feb. 2019, RCTs and observational study about efficacy (all-cause mortality and incidence of stroke) and  safety (the incidence of major bleeding events) the effects of dual-antiplatelet therapy for postoperative complications after TAVI at different time points were collected. After data extraction of clinical studies met inclusion criteria, quality evaluation with Cochrane bias risk evaluation tool 5.1.0 (for RCT) or Newcastle- Ottawa Scale (for observational study), Meta-analysis was conducted by using Rev Man 5.3 and Stata 14.0 statistical software. Meta-regression analysis was also conducted for outcome and different treatment duration. RESULTS: A total of 3 RCTs and 10 observational studies were included, involving 2 868 patients. The results of Meta-analysis showed that the incidence of all-cause mortality one month and 6 months after medication were 0.05 [95%CI (0.03, 0.07), P<0.001] and 0.07 [95%CI (0.05, 0.08), P<0.001]. The incidence of major bleeding events 1, 3 and 6 months after medication were 0.14 [95%CI (0.08,0.19), P<0.001], 0.11 [95%CI (0.03, 0.19), P=0.007] and 0.13 [95%CI (0.05, 0.22), P=0.002]. The incidence of stroke after one month after medication was 0.04 [95%CI (0.03, 0.05), P<0.001]. Results of Meta-regression analysis showed that the all-caused mortality [regression coefficient=0.005 7, 95%CI (-0.001 6, 0.013 0), P=0.116], major bleeding [regression coefficient=-0.000 5,95%CI(-0.022 4,0.021 4), P=0.959] or the incidence of stroke [regression coefficient=0.001 4, 95%CI (-0.003 8, 0.006 5), P=0.570] were not related to medication duration of dual-antiplatelet therapy.  CONCLUSIONS: The prolongation of the medication time of the dual-antiplatelet therapy has no significant effect on the efficacy and safety of TAVI.
期刊: 2019年第30卷第13期
作者: 朱岳鑫,黄雨思,陈慧婷,张蕾,李旸,曾庆春,许顶立
AUTHORS: ZHU Yuexin,HUANG Yusi,CHEN Huiting,ZHANG Lei,LI Yang,ZENG Qingchun,XU Dingli
关键字: 经导管主动脉瓣置换术;双联抗血小板治疗;用药时间;术后并发症;疗效;安全性;Meta分析
KEYWORDS: Transcatheter aortic valve implantation; Dual-antiplatelet therapy; Medication time; Postoperative complication; Efficacy; Safety; Meta-analysis
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