升解通瘀汤联合常规西药治疗缺血性心肌病致慢性心力衰竭气虚血瘀证的随机对照研究

Shengjie Tongyu Decoction(升解通瘀汤)Combined with Western Medicine for the Treatment of Qi Deficiency and Blood Stasis of Chronic Heart Failure caused by Ischemic cardiomyopathy:A Randomized Controlled Trial

目的 评价升解通瘀汤联合西药治疗缺血性心肌病致慢性心力衰竭气虚血瘀证的疗效及安全性。方法60例缺血性心肌病致慢性心力衰竭气虚血瘀证患者随机分为治疗组和对照组各30例。对照组予常规西药治疗,治疗组在对照组基础上联合升解通瘀汤口服,每日1剂,两组疗程均为8周。分别于治疗前后检测两组患者的堪萨斯城心肌病问卷(KCCQ)积分、纽约心脏协会(NYHA)心功能分级、左室射血分数(LVEF)、6分钟步行试验(6MWT)、血清N端脑钠肽前体(NTpro-BNP)水平及中医证候积分,治疗后判定中医证候疗效并进行安全性评价。结果 治疗组中医证候疗效总有效率为96.67%(29例/30例),对照组为50%(15例/30例),治疗组疗效优于对照组(P<0.05)。与本组治疗前比较,治疗后两组患者KCCQ积分、NYHA心功能分级、中医证候积分、6MWT均明显改善,治疗组LVEF、血清NTpro-BNP水平亦明显改善(P<0.05);与对照组治疗后比较,治疗组KCCQ积分、NYHA心功能分级、LVEF、6MWT、中医证候积分差异均有统计学意义(P<0.05),治疗组改善程度更佳。试验过程中对照组有6例患者、治疗组有1例患者因心力衰竭加重而入院,对照组发生不良事件8例,治疗组发生不良事件4例,经判断均与试验药物无关。结论在常规西药基础上联合升解通瘀汤治疗可改善缺血性心肌病致慢性心力衰竭气虚血瘀证患者的心功能、中医证候,提高运动耐量及生活质量,且安全性良好。

Objective To evaluate the effectiveness and safety of Shengjie Tongyu Decoction(升解通瘀汤,STD)in the treatment of chronic heart failure with qi deficiency and blood stasis caused by ischemic cardiomyopathy.Methods A total of 60 patients with chronic heart failure with qi deficiency and blood stasis caused by ischemic cardiomyopathy were randomly divided into the treatment and control groups with each group of 30 cases.The control group was treated with conventional western medicine,and the treatment group was treated with STD based on conventional western medicine with one dose daily in two divided doses.The duration of treatment for both groups was 8 weeks.The changes of Kansas City Cardiomyopathy Questionnaire score(KCCQ),New York Heart Association(NYHA)cardiac function class,left ventricular ejection fraction(LVEF),6-minute walk test distance(6MWTD),N-terminal brain natriuretic peptide precursor(NTpro-BNP)levels and Traditional Chinese Medicine(TCM)pattern score were detected before and after the treatment in the two groups,and the safety was evaluated.Results The total effectiveness of the treatment of the TCM pattern score of the treatment group was 96.67%(29/30 cases),and the control group was 50%(15/30 cases).The treatment group was better than the control group(P<0.05).Compared with those before treatment,the total KCCQ score,NYHA cardiac function classification,6MWTD,and TCM pattern score improved in both groups after treatment(P<0.05);and the improvement in the treatment group was better than that in the control group(P<0.05).During the trial,six patients in the control group and one in the treatment group were admitted for heart failure exacerbation,and eight adverse events occurred in the control group and four in the treatment group,which were judged to be unrelated to the adverse effects of the experimental drug.Conclusion STD combined with conventional western medicine therapy can improve cardiac function,TCM pattern,exercise tolerance,and quality of life in patients with chronic heart failure due to qi deficiency and blood stasis caused by ischemic cardiomyopathy with good safety.