益活强心方治疗气虚血瘀证冠心病合并心力衰竭的临床研究

Effect of Yihuo Qiangxin Prescription on Qi Deficiency and Blood Stasis Type of Coronary Heart Disease Complicated Heart Failure

目的评价益活强心方治疗气虚血瘀证冠心病合并心力衰竭的临床疗效及安全性。方法采用随机对照设计方法,选取2012年6月—2019年6月在上海中医药大学附属曙光医院心内科门诊治疗的冠心病合并心力衰竭病人325例,其中治疗组159例,对照组166例,进入符合方案集(PPS)分析302例,其中治疗组153例,对照组149例。对照组给予西药标准治疗,治疗组在西药标准治疗基础上加用益活强心方(每次1包,每天1次),连续用药治疗180 d,随访365 d。观察两组治疗前、随访6个月、随访12个月临床复合终点事件、左室射血分数(LVEF)、血脑钠肽(BNP)、6 min步行距离(6MWD)、肝肾功能、电解质、心肌酶变化。结果两组随访6个月时、12个月时复合终点事件比较差异均无统计学意义(P>0.05)。对照组死亡3例(1.8%),治疗组死亡1例(0.6%),两组死亡率比较差异无统计学意义(P=0.336);对照组非致死性心肌梗死7例(4.2%),治疗组非致死性心肌梗死3例(1.9%),两组非致死性心肌梗死发生率比较差异无统计学意义(P=0.224);对照组非致死性脑卒中9例(5.4%),治疗组非致死性脑卒中3例(1.9%),两组非致死性脑卒中发生率比较差异无统计学意义(P=0.080);对照组再入院115例(69.3%),治疗组再入院73例(45.9%),两组再入院发生率比较差异有统计学意义(P=0.002)。随访6个月时,两组LVEF较治疗前明显增加,BNP较治疗前明显降低,差异均有统计学意义(P<0.05);随访12个月时,两组LVEF、6MWD较治疗前明显增加,BNP较治疗前明显降低,差异均有统计学意义(P<0.05)。治疗组随访6个月时BNP低于对照组,6MWD高于对照组,差异均有统计学意义(P<0.05);随访12个月时,治疗组LVEF、6MWD高于对照组,BNP低于对照组,差异均有统计学意义(P<0.05)。两组治疗前、随访6个月、随访12个月时肝肾功能、电解质、心肌酶组内及组间同时期比较差异均无统计学意义(P>0.05)。结论在西药标准治疗基础上加用益活强心方治疗冠心病合并心力衰竭,可明显提高病人LVEF和6MWD,降低再入院率,且安全性较好。

Objective To evaluate the clinical efficacy and safety of Yihuo Qiangxin prescription in the treatment of coronary heart disease complicated with heart failure.Methods Randomized,controlled,and multicenter design methods were used.Three hundred and twenty-five patients with coronary heart disease complicated heart failure were selected,with 159 patients in treatment group and 166 patients in control group.A total of 302 patients were enrolled in the PPS analysis,including 153 patients in treatment group and 149 patients in control group.The patients in control group were given standard western medicine treatment,and the patients in treatment group were given Yihuo Qiangxin prescription,one dose at a time,twice a day,based on standard western medicine treatment for half a year.Clinical composite end point events,left ventricular ejection fraction(LVEF),brain natriuretic peptide(BNP),6 minute walking distance(6MWD),liver and kidney function,electrolyte,and myocardial enzyme were observed before treatment,at 6 months and 12 months.Results There was no significant difference in the clinical composite end point events between two groups at 6 months and 12 months(P>0.05).Three patients died in control group(1.8%)and 1 patients died in treatment group(0.6%),and there was no significant difference in mortality between two groups(P=0.336).There were 7 cases with non-fatal myocardial infarction in control group(4.2%),and 3 cases of non-fatal myocardial infarction in treatment group(1.9%),there was no significant difference between two groups(P=0.224).There were 9 cases with non-fatal stroke in control group(5.4%),and 3 cases with non-fatal stroke in treatment group(1.9%),there was no significant difference between two groups(P=0.080).One hundred and fifteen cases were readmitted to the hospital in control group(69.3%),and 73 cases were readmitted to the hospital in treatment group(45.9%),and there was statistically significant difference in the incidence of readmission between the two groups(P=0.002).At 6 months of follow-up,LVEF significantly increased and BNP significantly decreased in both groups compared with that before treatment(P<0.05).At 12 months of follow-up,LVEF and 6MWD significantly increased and BNP significantly decreased in both groups compared with before treatment(P<0.05).At 6 months of follow-up,BNP and 6MWD in treatment group were lower than those in control group(P<0.05).At 12 months of follow-up,LVEF and 6MWD in treatment group were higher than those in control group(P<0.05).There were no significant differences in liver and kidney function,electrolyte,and myocardial enzyme between two groups before treatment,at 6 months and 12 months of follow-up(P>0.05).Conclusion Western medicine standard treatment combined with Yihuo Qiangxin prescription could improve LVEF and 6MWD,reduce the readmission rate.