通心络胶囊在急性心肌梗死血运重建后的有效性和安全性研究

Efficacy and safety of Tongxinluo capsule in patients with acute myocardial infarction after reperfusion

目的观察通心络胶囊改善急性心肌梗死(AMI)后接受经皮冠状动脉介入术(PCI)或溶栓治疗患者缺血心肌功能的有效性和安全性。方法对我院收治的首次心电图ST段抬高并成功实施PCI或溶栓治疗的AMI患者112例,随机分为常规药物治疗组(对照组)52例和同时服用通心络胶囊治疗组(通心络组)60例,连续观察超声心动图改变,于发病的第1天和30天行血常规和生化检查并进行对照分析。结果(1)通心络组患者冠状动脉血运重建1周、2周、1月、6月后异常室壁运动节段恢复率分别为11.86％、18.12％、18.79％、70.03％,明显高于对照组的4.13％、8.27％、11.11％和51.68％(P<0.05或0.001);(2)通心络组LVEDV于发病后2周、1月、3月、6月时增加比率与对照组比较有显著性差异(P<0.05或0.01)。(3)2组血运重建前、用药1个月后,虽均有WBC、PT、PTA和Fib的降低,但仍在正常范围之内,且无显著性差异;(4)治疗1个月后,2组ALT、AST、BUN和Cr均有降低,但2组间无统计学差异;(5)在左室射血指数(LVEF)<45％的患者中,治疗前及治疗1个月后,2组的LVEDV、LVESV和LVEF均无统计学差异。结论通心络可以使部分存活心肌功能提前恢复,可以改善AMI后的心肌重构,对AMI血运重建后未增加出血及导致肝、肾和心功能恶化,临床应用是相对安全的。

Objective To observe safety and efficacy of Tongxinluo capsule in treating acute myocardial infarction (AMI) patients after reperfusion. Methods 112 AMI patients who underwent PCI or thrombolysis therapy successfully were randomly divided into Tongxinluo group ( n = 60) and control group( n - 52) . In Tongxinluo group patients received routine anti-AMI treatment and Tongxinluo,however, the patients in control group were only treated by routine anti-AMI treament. All the patients took the 2DE examination continously and the blood routine test and the blood biochemical examination on the first day and 30th day after PCI. The results of 2DE and blood tests were compared between the two groups. Results (1) The number of rehabilitated segments of left ventricular wall in Tongxinluo group after revascularization of coronary artery at 7d, 14d ,30d and 6 months were 11.86% , 18.12% , 18.79% and 70.03% respectively, which were significantly higher than those 4. 13%,8.27% ,11.11% and 51.68% respectively in control group ( P < 0.05 or P < 0.001) . (2) LVEDV was increased in Tongxinluo group on the second week, first month, third month and sixth month, there were significant differences between two groups ( P < 0.05 or P < 0.01) . (3)There were no significant differences in WBC,PLT,PT,PTA and Fib between two groups before revascularization one month after therapy.(4)There were no significant differences in ALT, AST, BUN and Cr between two groups after one-month therapy before revascularization.(5) There were no significant differences in LVEDV, LVESV and LVEF between two groups in those patients whose LVEF less than 45% before and after one-month therapy. Conclusion Tongxinluo capsule can make the early recovery of cardiac function in part viable myocardium and can improve myocardial remodeling after AMI and its clinical application is comparatively safe.