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目的:系统评价依度沙班对比华法林预防房颤患者卒中的疗效及出血风险,为临床提供循证参考。方法:计算机检索Cochrane 图书馆、Medline、EMBase、中国期刊全文数据库、万方数据库、中文科技期刊数据库,纳入依度沙班对比华法林预防房颤患者卒中疗效及出血风险的随机对照试验(RCT),按纳入与排除标准选择文献和提取资料,采用Rev Man 5.3统计软件对卒中发生率和大出血发生率进行Meta分析。结果:共纳入13项RCT,包括24 950例患者。Meta分析结果显示,依度沙班组患者卒中发生率[RR=0.97,95%CI(0.88,1.08),P=0.60]和大出血发生率[RR=0.84,95%CI(0.59,1.19),P=0.33]与华法林组比较,差异均无统计学意义。但亚组分析表明,当依度沙班日剂量>30 mg时,依度沙班组卒中发生率显著低于华法林组 [RR=0.84,95%CI(0.72,0.97),P=0.02];当依度沙班日剂量为30 mg时,依度沙班组大出血发生率显著低于华法林组[RR=0.46,95%CI (0.35,0.61),P<0.001],差异均有统计学意义。结论:相较于华法林,较高日剂量(>30 mg)的依度沙班可更有效地预防卒中的发生,而低日剂量(30 mg)的依度沙班可减少大出血风险。
OBJECTIVE: To systematically review the effect of stroke efficacy and bleeding risk of edoxaban versus warfarin in the prevention of patients with atrial fibrillation, and provide evidence-based reference for clinical treatment. METHODS: Retrieved from Cochrane Library, Medline, EMBase, CJFD, Wangfang Database and VIP Database, randomized controlled trials (RCT) about the stroke efficacy and bleeding risk of edoxaban versus warfarin in patients with atrial fibrillation were collected. Meta-analysis was performed for the incidences of stoke and excessive hemorrhage by using Rev Man 5.3 software after data extract. RESULTS: Totally 13 RCTs were included, involving 24 950 patients. Results of Meta-analysis showed, compared with warfarin group, there were no significant differences in the incidences of stoke [RR=0.97,95%CI(0.88,1.08),P=0.60] and excessive hemorrhage [RR=0.84,95%CI(0.59,1.19),P=0.33] in edoxaban group. But the subgroup analysis showed, when daily dose of edoxaban was more than 30 mg, the incidence of stroke in edoxaban group was significantly lower than warfarin group [RR=0.84, 95% CI(0.72, 0.97),P=0.02]; when it was 30 mg, the incidence of excessive bleeding in edoxaban group was significantly lower than warfarin group [RR=0.46, 95%CI(0.35,0.61),P<0.001], the difference was statistically significant. CONCLUSIONS: Compared with warfarin, higher doses(>30 mg/d)of edoxaban can more effectively prevent the occurrence of stroke and low doses(30 mg/d) can reduce the risk of excessive bleeding.
依度沙班房颤大出血卒中Meta分析
Edoxabanatrial fibrillationExcessive bleedingStrokeMeta-analysis
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