通心络胶囊治疗冠心病稳定型心绞痛气虚血瘀络阻证临床疗效及对左心室功能的影响

Clinical efficacy of Tongxinluo capsule on stable angina pectoris of coronary heart diseasewith Qi deficiency and blood stasis syndrome and the improvement of left ventricular function

目的观察通心络胶囊治疗冠心病稳定型心绞痛气虚血瘀络阻证的临床疗效及对患者左心室功能的影响。方法将135例冠心病稳定型心绞痛气虚血瘀络阻证患者随机分为2组,对照组70例(脱落5例)采取西医常规治疗,治疗组65例(脱落2例)在对照组治疗基础上加用通心络胶囊。2组均治疗3个月。比较2组临床疗效、心电图疗效,治疗前后中医症状评分、血清同型半胱氨酸(Hcy)水平、左心室功能指标变化,以及治疗期间主要心血管事件发生情况及不良反应发生情况。结果治疗组临床总有效率92.06%(58/63),心电图总有效率80.95%(51/63),对照组分别为83.08%(54/65)、64.62%(42/65),治疗组临床疗效及心电图疗效均优于对照组(P<0.05)。治疗后,2组中医症状各单项评分及总分、Hcy水平均较本组治疗前降低(P<0.05),且治疗组均低于对照组(P<0.05)。治疗后,2组左室射血分数均较本组治疗前升高(P<0.05),左室舒张末期容积、左室收缩末期容积均较本组治疗前降低(P<0.05),且治疗后治疗组左室射血分数高于对照组(P<0.05),左室舒张末期容积、左室收缩末期容积均低于对照组(P<0.05)。治疗组主要心血管事件总发生率7.94%(5/63),对照组为15.38%(10/65),治疗组主要心血管事件总发生率低于对照组(P<0.05)。2组治疗前后血常规、尿常规、肝功能、肾功能无异常变化,未发生明显不良反应。结论通心络胶囊治疗冠心病稳定型心绞痛气虚血瘀络阻证,能提高临床疗效、心电图疗效,降低Hcy水平,改善左心室功能。

Objective To observe the clinical efficacy of Tongxinluo capsule in the treatment of stable angina pectoris of coronary heart disease(CHD)with Qi deficiency and blood stasis syndrome and the improvement of left ventricular function(LVF).Methods Totally 135 patients with stable angina pectoris of CHD(Qi deficiency and blood stasis syndrome)were randomized to receive conventional Western medicine(control group,n=70,5 cases of shedding)or Tongxinluo capsule+conventional Western medicine(treatment group,n=65,2 cases of shedding).Treated for 3 months,the aim was to compare clinical efficacy,electrocardiogram(ECG)efficacy,traditional Chinese medicine(TCM)syndrome scores before and after treatment,serum homocysteine(Hcy)levels,LVF indexes,the treatment-emergent adverse events including major cardiovascular events(MCE)and adverse reactions between groups before and after treatment.Results The total effective rate(92.06%[58/63]vs 83.08%[54/65])and ECG efficacy(80.95%[51/63]vs 64.62%[42/65])in the treatment group were better than those in the control group(P<0.05).There were significant differences in the single score and total score of TCM symptoms,and Hcy levels between groups before and after treatment(P<0.05),which were more pronouncedin the treatment group than in the control group(P<0.05).After treatment,the left ventricular ejection fraction(LVEF)in both groups was significantly higher than that before treatment(P<0.05),and the left ventricular end-diastolic volume(LVEDV)and end-systolic volume(LVESV)were significantly decreased(P<0.05).There were significant differences in LVEF,LVEDV,LVESV between groups(all P<0.05).The total incidence of MCI in the treatment group was significantly lower than that in the control group(7.94%[5/63]vs 15.38%[10/65],P<0.05).There were no obvious adverse reactions in blood routine,urine routine,liver and renal function before and after treatment between groups.Conclusion For stable angina pectoris of CHD(Qi deficiency and blood stasis syndrome),Tongxinluo capsule can improve the clinical efficacy and ECG efficacy,reduce Hcy level,and improve LVF.