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目的通过随机、对照研究试验探讨华法林在窦性心律左心功能不全扩张型心肌病患者抗凝治疗中的有效性及安全性,旨在为中国扩张型心肌病患者抗凝治疗提供更为全面的理论依据。方法根据入组标准选取2013年10月—2015年5月在该院住院及门诊确诊的96例正常窦性心律左心室功能不全的扩张型心肌病患者随机分为两组:对照组48例(安慰剂组)及华法林组48例(初始剂量2.5 mg/d),逐渐调整剂量至目标国际标准化比值(INR)在2.0~3.0,定期门诊随访,并记录两组患者血栓栓塞事件及不良反应发生情况。结果共82例进入分析,对照组42例,华法林组40例,随访时间21个月。与对照组比较,华法林组在总血栓栓塞事件发生率(2.50%)较对照组(16.67%)明显下降,差异有统计学意义(P=0.031);华法林组轻微出血及严重出血发生率均高于对照组,差异有统计学意义(P=0.041,0.036)。结论抗凝治疗在窦性心律左心功能不全扩张型心肌病患者中是必要的,华法林组出血风险高于对照组,但严重出血风险多发生于INR>3.0时,故严密监测INR在2.0~3.0下使用华法林抗凝安全且有效。
Objective To investigate the effectiveness and safety of warfarin in the anticoagulant therapy of patients with sinus rhythm of left ventricular dysfunction in patients with dilated cardiomyopathy by randomized controlled trials to provide more anticoagulant therapy for patients with dilated cardiomyopathy in China Comprehensive theoretical basis. Methods Ninety-six patients with dilated cardiomyopathy of normal sinus rhythm and left ventricular dysfunction who were hospitalized and outpatient from October 2013 to May 2015 were randomly divided into two groups: control group (n = 48) Placebo group) and warfarin group (initial dose 2.5 mg / d), gradually adjusting the dose to the target international normalized ratio (INR) 2.0 to 3.0, regular out-patient follow-up, and recorded two groups of patients with thromboembolic events and adverse events Reaction occurred. Results A total of 82 cases were included in the analysis. Among the 42 cases in the control group and 40 cases in the warfarin group, the follow-up time was 21 months. Compared with the control group, the incidence of total thromboembolism (2.50%) in warfarin group was significantly lower than that in control group (16.67%), with significant difference (P = 0.031); minor bleeding and severe bleeding in warfarin group The incidence was higher than the control group, the difference was statistically significant (P = 0.041,0.036). Conclusion Anticoagulant therapy is necessary in patients with sinus rhythm of left ventricular dysfunction and dilated cardiomyopathy. The risk of bleeding in warfarin group is higher than that in control group. However, the risk of severe bleeding mostly occurs when INR> 3.0, so INR Warfarin is safe and effective at 2.0 to 3.0.