复方丹参滴丸对急性ST段抬高心肌梗死介入治疗的临床作用

摘要

目的 观察复方丹参滴丸(CDDP)在急性ST段抬高的心肌梗死(STEMI)直接经皮冠状动脉介入治疗(PCI)中的临床作用及对临床事件的影响.方法 多中心、随机、连续入选2007年10月至2009年10月首次发作并进行直接PCI的STEMI患者500例,将患者采用随机号密封信封法分为2组:CDDP组和对照组.CDDP组在决定行诊断性冠状动脉造影前,立即口服CDDP 20粒,随后每天口服CDDP 10粒,3次/天,30天.观察住院和30天随访期间的临床事件.结果 两组患者一般临床资料除CDDP组糖尿病患者比例高于对照组外,差异均无统计学意义.两组患者发病至PCI的时间、冠脉病变的类型以及PCI后的TIMI血流分级差异均无明显统计学意义.CDDP组PCI术后LVEF明显高于对照组,室壁瘤发生率低于对照组(x2=1.99,P＜0.05).CDDP组PCI术后胸痛发生率、PCI术后的心律失常和住院期间的心律失常的发生率明显低于对照组(x2值分别为4.44、4.52,P＜0.05).结论 CDDP作为现代中药复方制剂,在ACS的临床治疗和PCI围术期的应用,具有明显降低PCI术后的心肌缺血、改善心肌血流和微循环,降低PCI术后心律失常的作用.%Objective To investigate the effects of compound Danshen dripping pill (CDDP) on the clinical events in patients with primary percutaneous coronary interventions (PCI) due to acute ST elevation myocardial infarction. Methods Five hundred patients were enrolled from October of 2007 to October of 2009. Ten medical centers in Tianjin City took part in the multi-center study. All patients were randomly and single blindly divided into the CDDP treatment group ( n = 252 ) and the control group ( n = 248). Patients in the CDDP group took 20 pills of CDDP before PCI followed by 10 pills thrice daily for 30 days. The clinical events in hospitalization and follow-up of 30 days were observed. Results 1. There were no significant differences of the baseline data between the two groups except the ratio of diabetic patients (24.7％ vs 38.49％, P ＜ 0.01 ). 2. The coronary lesions and PCI procedures in CDDP group were comparable control group. 3. Compared with the control group, left ventricular ejection fraction was higher (51.9％ ± 9.9％ vs 57.1％ ± 8.7％, P ＜ 0.05 ) but the rate of ventricular aneurysm (3.63％ vs 0.08％,P ＜ 0.05) was lower in the CDDP group. 4. The rates of chest pain (78.30％ vs 89. 29％, P ＜ 0.01 ) and arrhythmias (31.86％ vs 17.86％, P ＜0.05) post PCI is lower in CDDP group compaired with the control group. Conclusion CDDP could improve myocardial blood flow, microcirculation and decrease the occurrence of arrhythmias in STEMI patients with primary PCI.