华法林加阿司匹林长期联合应用对周围动脉硬化闭塞病患者心脑血管事件一级预防效应及其安全性:随机、盲法评估、两年随访的临床对照实验

Long-term effect and reliability of warfarin and aspirin for primary prevention of cardio-cerebral vessels events in patients with peripheral arteriosclerotic occlusive disease:a randomized,single-blind,controlled clinical trial with two-year foll-low-up

目的:评估华法林与阿司匹林联合长期治疗对周围动脉硬化闭塞病患者心脑血管事件的一级预防效果及其安全性,并与单用阿司匹林进行对比。方法:纳入的30例诊断明确的周围动脉硬化闭塞病患者为2002-10/12解放军总医院门诊部收治,所有患者年龄(72±6)岁,无心房纤颤,严重心力衰竭和心律失常。先进入2～4周的导入期,导入期间每例患者均口服华法林3mg/d,加阿司匹林80mg/d,当国际标准化比值(INR)达到2.0～3.0后,30例患者被随机(隐蔽分配)分为联合用药组和阿司匹林组各15例。联合用药组接受中等剂量华法林(INR2.4～3.0)联合阿司匹林(80mg/d)治疗,阿司匹林组单用阿司匹林(80mg/d)治疗。所有患者连续随访观察24个月,记录两组各发生心脑血管事件的例数及有无出血事件的发生。结果采用盲法评估。结果:按意向处理分析,30例患者均完成了治疗,随访率100%。至研究结束,联合用药组未出现终点事件,阿司匹林组1例患者接受下肢截肢,另1例患者出现脑梗死,经时序检验法,两组在预防心脑血管事件方面的差异无显著统计学意义,但联合用药组仍在数值上优于阿司匹林组。两组均未出现严重的出血事件。结论:较之单独使用阿司匹林,华法林(INR2.4～3.0)与阿司匹林联合长期治疗在降低周围动脉硬化闭塞病患者心脑血管事件的发生率上有一定优?

AIM:To evaluate the long-term effect of warfarin and aspirin combined therapy versus aspirin alone on primary prevention for cardio-cerebral vessels events in patients with peripheral arteriosclerotic occlusive disease(PAOD) and the reliability. METHODS:Totally 30 patients with PAOD,(72±6) years of age,were selected from the Outpatient Department,General Hospital of Chinese PLA from October to December 2002.All the patients had no atrial fibrillation, severity heart failure and arrhythmia.Patients took 3 mg per day warfarin and 80 mg per day aspirin during 2 to 4 weeks.The 30 patients with PAOD were divided randomly into warfarin(INR 2.4-3.0) and aspirin(80 mg per day) combined therapy group(n=15) and aspirin(80 mg per day) alone group(n=15) following the International Normalized Ratio (INR) reached to 2.0-3.0.The patients were followed up for 24 months to detect the incidence of cardio-cerebral vessels events and the ischemia.The results were evaluated with blind method. RESULTS:The treatment was completed in all 30 patients and the rate of follow-up was 100%.Until the end of study,no cardio-cerebral vessels occurred in combined therapy group,and in aspirin alone group,one patient received the limb amputation and another patient suffered cerebral infarction. There was no significant difference in occurrence of cardio-cerebral vessels events between the two groups.But the combined therapy group was still numerically superior to the aspirin alone group.No severe ischemia occurred in both groups. CONCLUSION:Long-term warfarin and aspirin combined therapy with good safety can decrease the incidence of cardio-cerebral vessels events in patients with PAOD as compared with aspirin alone.