通心络胶囊联合阿司匹林预防非瓣膜病性心房颤动患者脑栓塞的对照研究

目的比较通心络胶囊联合阿司匹林、华法林和阿司匹林预防非瓣膜性心房颤动(NVAF)患者脑栓塞的疗效和不良反应。方法NVAF患者150例,其中通心络胶囊联合阿司匹林组50例,予通心络胶囊0.76g,3次/d,阿司匹林100mg/d;华法林组50例,予华法林1.25~5.0mg/d,维持国际标准化比值(INR)1.8~2.5;阿司匹林组50例,予阿司匹林100mg/d。所有患者均给予基础疾病治疗,随访2年,以脑栓塞发病率作为疗效判定依据。结果脑栓塞年发病率通心络胶囊联合阿司匹林组(6.0%)与华法林组(3.0%)比较差异无显著意义(P>0.05),阿司匹林组(15.0%)与通心络胶囊联合阿司匹林组比较差异有显著意义(P<0.05),华法林组与阿司匹林组比较差异有非常显著意义(P<0.01)。华法林组有1例出现脑出血,1例出现消化道出血;通心络胶囊联合阿司匹林组有6例出现上腹痛、恶心,2例出现牙龈肿痛;阿司匹林组有5例出现上腹痛、恶心。结论通心络胶囊联合阿司匹林预防NVAF患者脑栓塞的效果和华法林比较差异无显著意义,优于单用阿司匹林,无严重不良反应发生,且不需检测凝血酶原时间(PT)和INR。不愿意接受华法林治疗的NVAF患者可给予通心络胶囊联合阿司匹林预防脑栓塞并发症。

A control study of Tongxinluo capsule in combination with aspirin to prevent cerebral thromboembolism due to nonvalvular atrial fibrillation

Objective To compare the effect and safety of Tongxinluo capsule combined with aspirin,warfarin and aspirin to prevent cerebral thromboem bolism due to nonvalvular atrial fibrillation(NVAF).Methods One hundred and fifty patients with NVAF were randomly divided into three groups.The patients of Tongxinluo capsule in combination with aspirin group (n=50) took orally Tongxinluo capsule (0.76 g,3 times a day) and aspirin (0.1g/day);Patients of warfarin group (n=50) took orally warfarin,The range of dosage was 1.25～5.0 mg/day and kept the INR between 1.8 and 2.5;Patients of aspirin group (n=50) took orally aspirin (0.1 g/day).The primary diseases of all patients were treated.The incidence of cerebral thromboembolism and the side effects were followed up during 2 years.Results The incidence of cerebral thromboembolism in Tongxinluo capsule combined with aspirin group (6.0%/year) was significantly lower than that in aspirin group (15.0%/year,P<0.05),The incidence of cerebral thromboembolism in aspirin group was significantly higher than that in warfarin group (P<0.01),but there was no difference between Tongxinluo capsule combined with aspirin group and warfarin group (3.0%/year,P> 0.05 ).The incidence of hemorrage in warfarin group was 2.0%/year (n=2) and it was zero in the other two groups.Conclusion The effect of Tongxinluo capsule in combination with aspirin to prevent cerebral thromboembolism due to NVAF is same to that of warfarin and significantly better than that of aspirin. Tongxinluo capsule in combination with aspirin to prevent cerebral thromboembolism due to NVAF is safe,and it does not need detecting INR.