灯盏生脉胶囊联合常规西药治疗冠心病稳定性心绞痛临床研究

Clinical Study on Dengzhan Shengmai Capsules Combined with Routine Western Medicine for Stable Angina Pectoris of Coronary Heart Disease

目的:观察灯盏生脉胶囊联合常规西药治疗冠心病(CHD)稳定性心绞痛的临床效果。方法:将104例气阴两虚型CHD稳定性心绞痛患者按随机数字表法分为治疗组54例与对照组50例,2组均以常规西药对症治疗,治疗组加予灯盏生脉胶囊治疗,2组均治疗3个月。治疗前后评定中医证候评分,检测心功能指标[心输出量(CO)、左心室射血分数(LVEF)、左心室收缩末期内径(LVESD)]、炎症指标[血清超敏C-反应蛋白(hs-CRP)、白细胞介素-6(IL-6)]、收缩压(SBP)、心率(HR)、空腹血糖(FBG)、血脂指标[低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)、甘油三酯(TG)、总胆固醇(TC)]及肝肾功能指标[谷丙转氨酶(ALT)、谷草转氨酶(AST)、尿素(UREA)、肌酐(Cr)],评估2组的临床疗效,统计心血管不良事件及不良反应的发生率。结果:治疗后,治疗组临床疗效总有效率94.44%,高于对照组82.00%,差异有统计学意义(P<0.05)。2组中医证候积分均较治疗前降低(P<0.05),治疗组中医证候积分低于对照组(P<0.05)。2组CO、LVEF值均高于治疗前,LVESD值均低于治疗前,差异均有统计学意义(P<0.05);治疗组CO、LVEF值均高于对照组,LVESD值低于对照组,差异均有统计学意义(P<0.05)。2组HR、SBP水平均低于治疗前(P<0.05),治疗组FBG水平较治疗前下降并低于对照组(P<0.05)。2组hs-CRP、IL-6、TG、TC、LDL-C水平均低于治疗前(P<0.05),治疗组以上指标值均低于对照组(P<0.05)。2组HDL-C水平均高于治疗前(P<0.05),治疗组HDL-C水平高于对照组(P<0.05)。2组治疗前后AST、ALT、Cr、UREA水平比较,差异均无统计学意义(P>0.05)。治疗期间,2组心血管不良事件、不良反应发生率比较,差异均无统计学意义(P>0.05)。结论:采用灯盏生脉胶囊联合常规西药治疗气阴两虚型CHD稳定性心绞痛患者,能提高临床治疗效果,有效缓解临床症状,改善心功能,减轻机体炎症反应,调节心率、血压、血糖及血脂水平,从而有效控制病情,且对肝肾功能无明显影响,心血管不良事件及不良反应少,药物安全性高。

Objective:To observe the clinical effect of Dengzhan Shengmai Capsules combined with routine western medicine for stable angina pectoris of coronary heart disease(CHD).Methods:A total of104 cases of CHD patients with stable angina pectoris of qi and yin co-deficiency type were divided into the treatment group and the control group according to the random number table method,with 54 and50 cases in each group respectively.Both groups were treated with routine symptomatic treatment of western medicine,and the treatment group was additionally treated with Dengzhan Shengmai Capsules;both groups were treated for 3 months.Before and after treatment,the traditional Chinese medicine(TCM)syndrome scores were evaluated,and the heart function indexes including cardiac output(CO),left ventricular ejection fraction(LVEF)and left ventricular end systolic diameter(LVESD),inflammatory indexes including serum high-sensitivity C-reactive protein(hs-CRP)and interleukin-6(IL-6),systolic blood pressure(SBP),heart rate(HR),fasting blood glucose(FBG),blood lipid indexes including low-density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C),triglycerides(TG)and total cholesterol(TC),and liver and kidney function indexes including alanine aminotransferase(ALT),aspartate transaminase(AST),urea,and creatinine(Cr)were measured.Clinical effects were evaluated in the two groups.The incidence of cardiovascular adverse events and adverse reactions were calculated.Results:After treatment,the total effective rate of clinical effect was 94.44% in the treatment group,higher than that of 82.00% in the control group,the difference being significant(P<0.05).TCM syndrome scores in the two groups were decreased when compared with those before treatment(P<0.05),and TCM syndrome scores in the treatment group were lower than those in the control group(P<0.05).The values of CO and LVEF in the two groups were higher than those before treatment,and LVESD values were lower than those before treatment,differences being significant(P<0.05);the values of CO and LVEF in the treatment group were higher than those in the control group,and LVESD value in the treatment group was lower than that in the control group,differences being significant(P<0.05).The levels of HR and SBP in the two groups were lower than those before treatment(P<0.05),and FBG level in the treatment group was lower than that before treatment and that in the control group after treatment(P<0.05).The levels of hs-CRP,IL-6,TG,TC,and LDL-C in the two groups were lower than those before treatment(P<0.05),and the above indexes in the treatment group were lower than those in the control group in average(P<0.05).The levels of HDL-C in the two groups were higher than those before treatment(P<0.05),and the level of HDL-C in the treatment group was high than that in the control group(P<0.05).There was no significant difference being found in the comparison of levels of AST,ALT,Cr,and UREA in the two groups before and after treatment(P>0.05).During treatment,there was no significant difference being found in the comparison of the incidence of cardiovascular adverse events and adverse drug reactions between the two groups(P>0.05).Conclusion:For CHD patients with stable angina pectoris,Dengzhan Shengmai Capsules combined with routine symptomatic treatment of western medicine is better than the simple use of routine western medicine treatment in the effective improvement of clinical effects,the remission of clinical symptoms,the improvement of the heart function,the reduction of inflammatory responses of the body,and the regulation of levels of heart rate,blood pressure,blood glucose,and blood lipid,so as to effectively control the disease,with no significant impact on liver and kidney function,few cardiovascular adverse events and adverse reactions,and high medication safety.