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目的综合评价CYP2C9和VKORC1基因检测指导华法林给药的有效性和安全性。方法采用Meta分析方法,制定原始文献的纳入标准、排除标准及检索策略,检索Pubmed、Embase、Cochrane图书馆、中国期刊全文数据库、维普数据库和万方数据库,采用Revman 5.2软件对满足纳入标准的RCTs研究进行Meta分析。主要观察指标为国际标准化比率(INR)治疗窗内时间、出血发生率,次要观察指标为INR大于4发生率和华法林剂量调整次数。结果共检索出973篇文献,符合纳入标准的8篇随机对照研究,共计2 347例患者。Meta分析结果显示CYP2C9和VKORC1基因导向的华法林给药模式可以显著降低出血事件发生率[RR=0.83,95%CI(0.70,0.98),P=0.03],减少华法林剂量调整次数[MD=-0.55,95%CI(-0.93,-0.16),P=0.005]。尽管在INR治疗窗内时间[MD=2.16,95%CI(-2.36,6.68),P=0.35]、INR大于4发生率[RR=0.90,95%CI(0.71,1.15),P=0.40]两个方面,CYP2C9和VKORC1基因导向的华法林给药模式与传统给药模式无显著差异,但是基因导向的华法林给药模式仍有增加INR治疗窗内时间,减少INR大于4发生率的趋势。结论 CYP2C9和VKORC1基因检测指导华法林给药可以提高华法林给药的安全性和有效性。
Objective To evaluate the effectiveness and safety of warfarin administration by CYP2C9 and VKORC1 gene tests. Methods The inclusion criteria, exclusion criteria and search strategies of the original documents were established using Meta analysis. The Pubmed, Embase, Cochrane Library, Chinese Journal Full-text Database, VIP database and Wanfang database were searched. The Revman 5.2 software was used to validate the inclusion criteria of RCTs Study Meta-analysis. MAIN OUTCOME MEASURES: Time to INR, incidence of bleeding in INR, secondary outcome measures of INR greater than 4 and warfarin dose adjustments. Results A total of 973 articles were retrieved and 8 RCTs were included in the inclusion criteria for a total of 2 347 patients. Meta-analysis showed that the warfarin-administered CYP2C9 and VKORC1 gene-driven warfarin administration patterns significantly reduced the incidence of bleeding events [RR = 0.83, 95% CI (0.70, 0.98), P = 0.03] MD = -0.55, 95% CI (-0.93, -0.16), P = 0.005]. INR was greater than 4 incidence [RR = 0.90, 95% CI (0.71, 1.15), P = 0.40] despite the time within the INR treatment window [MD = 2.16,95% CI (-2.36,6.68), P = 0.35] In both aspects, there was no significant difference between warfarin-administered and CYP2C9-targeted and warfarin-targeted warfarin administration patterns, but gene-directed warfarin administration still increased the time to INR in the treatment window and decreased the incidence of INR greater than 4 the trend of. Conclusion CYP2C9 and VKORC1 gene testing guide warfarin administration can improve the safety and efficacy of warfarin administration.