丹蒌片在改善心肌梗死后左心室不良重塑的随机对照研究

Clinical Efficacy of Danlou Tablets in Improving Left Ventricular Adverse Remodeling after Myocardial Infarction:a Randomized Controlled Trial

目的探讨中药丹蒌片在改善心肌梗死后左心室不良重塑的临床疗效。方法选取2017年1月-2017年12月在我院接受治疗的120例痰瘀互结型急性心肌梗死病人,通过随机数字表法将病人分为试验组与对照组,每组60例。试验组给予丹蒌片1.5 g,每日3次;对照组予以同样剂量剂型的安慰剂治疗;治疗90 d。比较两组治疗前后中医证候评分、左心室舒张末期容积指数(LVEDVI)、左心室收缩末期容积指数(LVESVI)和左心室射血分数(LVEF),并比较治疗期间主要心血管不良事件(MACE)和药物不良反应发生情况。结果治疗后试验组中医证候积分明显低于对照组(P<0.05),LVEDVI、LVESVI明显低于对照组(P<0.05),LVEF明显高于对照组(P<0.05)。治疗及随访期间试验组MACE发生率明显低于对照组(P<0.05),其中心力衰竭发生率显著低于对照组(P<0.05)。两组药物不良反应发生率比较,差异无统计学意义(P>0.05)。结论丹蒌片能够显著改善急性心肌梗死后左心室不良重塑的发生,有助于改善心肌梗死病人的预后。

Objective To explore the clinical efficacy of Danlou tablets(DLT)in improving left ventricular adverse remodeling after acute myocardial infarction(AMI).Methods One hundred and twenty AMI patients with phlegm and blood stasis syndrome in our hospital from January 2017 to December 2017 were randomly divided into two groups:the experimental group(n=60)treated with DLT,and the control group(n=60)treated with placebo for 90 days.The traditional Chinese medicine(TCM)symptom scores,the left ventricular end-diastolic volume index(LVEDVI),the left ventricular end-systolic volume index(LVESVI),and the left ventricular ejection fraction(LVEF)before and after treatment were compared.Major cardiovascular adverse events(MACE)and adverse drug reactions were also recoreded.Results After treatment,the TCM syndrome scores,LVEDI,and LVESVI were significantly lower in the experimental group than those in the control group(P<0.05).LVEF in the experimental group was significantly more than that those in the control group(P<0.05).The incidence of MACE in experimental group was significantly lower than that in control group(P<0.05).The incidence of heart failure was significantly lower in experimental group than that control group(P<0.05).There was no significant difference in the incidence of adverse drug reactions between two groups(P>0.05).Conclusion DLT can significantly improve the left ventricular adverse remodeling after AMI,and improve the prognosis of patients with myocardial infarction.