芪附强心汤联合西药常规疗法治疗射血分数保留的心力衰竭心阳亏虚、血瘀水停证患者临床观察

Qifu Qiangxin Decoction combined with conventional therapy of western medicine treating heart failure with preserved ejection fraction of deficient heart-yang induced blood stasis and water retention pattern:A clinical observation

目的观察芪附强心汤联合西药常规治疗干预射血分数保留的心力衰竭(heart failure with preserved ejection fraction,HFpEF)心阳亏虚、血瘀水停证患者的临床疗效和安全性。方法选取2021年5月至2022年5月湖南中医药大学第一附属医院心血管科60例住院或门诊HFpEF患者,随机分成治疗组及对照组,各30例。对照组予西药常规治疗;治疗组在西药常规治疗的基础上联用芪附强心汤,每日1剂;疗程均为4周。观察比较两组治疗前后的中医证候积分、疗效、明尼苏达州心功能不全生命质量量表(Minnesota living with heart failure questionnaire,MLHFQ)积分、N末端脑钠肽前体(N-terminal pro-B natriuretic peptide,NT-proBNP)、无创血流动力学参数[心脏指数(cardiac index,CI)、心搏指数(stroke volume index,SI)、心率(heart rate,HR)]、超声心动图指标[左室射血分数(left ventricular ejection fraction,LVEF)、二尖瓣环舒张早期流速/二尖瓣环舒张晚期流速(mitral annulus early diastolic blood flow velocity/mitral annulus late diastolic blood flow velocity,E/A)、二尖瓣环舒张早期流速/二尖瓣环舒张早期运动速度(mitral annulus early diastolic blood flow velocity/mitral annulus early diastolic velocity,E/e')],治疗前后及治疗过程中进行安全性观察。结果治疗组临床总有效率(86.67%)优于对照组(73.33%)(P<0.05)。治疗后两组患者中医证候积分、MLHFQ积分及NT-proBNP、HR、E/e'水平均较治疗前下降(P<0.05),CI、SI水平均较治疗前上升(P<0.05)。治疗组在中医证候积分、MLHFQ积分及NT-proBNP、E/e'、CI、SI指标的改善程度上优于对照组(P<0.05)。两组患者治疗前后血常规、尿常规、肝功能、肾功能均未见明显异常。结论芪附强心汤联合西药常规治疗能改善HFpEF心阳亏虚、血瘀水停证患者的中医证候、NT-proBNP水平、无创血流动力学参数和心脏舒张功能,疗效优于西药常规治疗。

Objective To observe the clinical efficacy and safety of Qifu Qiangxin Decoction(QFQXD)combined with conventional therapy of western medicine in the treatment of heart failure with preserved ejection fraction(HFpEF)of deficient heart-yang induced blood stasis and water retention pattern.Methods A total of 60 inpatients or outpatients of the cardiovascular department in the First Hospital of Hunan University of Chinese Medicine from May 2021 to May 2022 were selected and randomly divided into treatment group(n=30)and control group(n=30).The control group was treated with conventional therapy of western medicine,while the treatment group was treated with QFQXD additionally,one dose a day.The treatment course of both groups was 4 weeks.The scores of TCM pattern,efficacy,Minnesota living with heart failure questionnaire(MLHFQ)scores,N-terminal pro-B natriuretic peptide(NT-proBNP)levels,non-invasive hemodynamic parameters including cardiac index(CI),stroke volume index(SI),and heart rate(HR),and echocardiographic indexes including left ventricular ejection fraction(LVEF),mitral annulus early diastolic blood flow velocity/mitral annulus late diastolic blood flow velocity(E/A),and mitral annulus early diastolic blood flow velocity/mitral annulus early diastolic velocity(E/e')of the two groups were measured and compared before and after treatment.The safety was also observed before,during,and after treatment.Results The total clinical effective rate of treatment group(86.67%)was superior to that of control group(73.33%)(P<0.05).After treatment,the TCM pattern scores,MLHFQ scores,levels of NT-proBNP,HR,and E/e'in both groups decreased(P<0.05),while CI and SI increased(P<0.05).The improvement of TCM pattern score,MLHFQ score,NT-proBNP level,E/e',CI,and SI in treatment group was better than that in control group(P<0.05).There were no obvious abnormalities in laboratory tests such as blood routine examination,routine urinalysis,liver and renal function tests in both groups.Conclusion QFQXD combined with conventional therapy of western medicine can improve the TCM pattern score,NT-proBNP level,non-invasive hemodynamic parameters and cardiac diastolic function of HFpEF patients with deficient heart-yang induced blood stasis and water retention pattern,and the curative efficacy is better than that of the conventional therapy of western medicine alone.