通心络胶囊联合阿司匹林预防心房颤动患者脑栓塞的对照研究

A control study of tongxinluo capsule in combination with aspirin to prevent cerebra thromboembolism due to atrial fibrillation

目的比较通心络胶囊联合阿司匹林、阿司匹林和华法林预防心房颤动（AF）患者脑栓塞的疗效和不良反应。方法AF患者450例，随机分为通心络胶囊联合阿司匹林组（A组）150例，予通心络胶囊0．52g，3次／日，阿司匹林300mg／d；华法林组（B组）150例，予华法林1．25～5．0mg／d，维持国际标准化比值1．8～2．5；阿司匹林组（C组）15O例，予阿司匹林300mg／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A组8．0％，B组4．0％（两组比较x^2=4．5455，P=0．0330），C组14．0％（与A组比较x^2=6．2937，p=0．0121）。华法林组有2例出现脑出血，1例出现上消化道出血，其余两组无出血副作用。结论通心络胶囊联合阿司匹林预防AF患者脑栓塞的效果不如华法林，优于单用阿司匹林，无严重不良反应发生、安全，且不需检测INR。

Objective To comparison of the efficacy and safety of usage of Tongxinluo capsule combination with Aspirin, Warfarin and Aspirin to prevent Cerebral thromboembolism due to atrial fibrillation（AF）.Methods 450 patients with AF were divided into 3 groups randomly. Patients of Tongxinluo capsule combination with Aspirin grop（n = 150） were dispensed by Tongxinluo capsule（0. 52g/day） and Aspirin （0.3g/day）.Patients of Warfarin group （n=150） were dispensed by Warfarin, The range of dosage was 1.25-5mg/day and Keep the INR between 1.8 and 2.5. Patients of Aspirin group（n=150） were dispensed by Aspirin （0.3g/day）. The primary disease of all patients was intervention. Clinical prognosis of the three groups such as Cerebral tbromboembolism and side effect were followed up 2 years. Results The incidence rate of Cerebral thromboembolism in Tongxinluo capsule combination with Aspirin grop（8.0%/year） was difference than in Warfarin group（4.0%/year, x^2=4.5455, P=0.0330） and significantly lower than in aspirin grop（14.0%/year, x^2=6.2937,P=0.0121）.The incidence rate of hemorrage in Warfarin group was 1.0%/year （n=3）and it was zero in the other two grops（x^2=1.3468, P=0.2458）.Conelusion The effect of usage of Tongxinluo capsule combination with Aspirin to prevent Cerebral thromboembolism due to AF is no better than usage of Warfarin and significantly better than usage of Aspirin. lt is safe using Tongxinluo capsule combination with Aspirin to prevent Cerebral thromboembolism due to AF,and it does not need detect INR.