益气活血方辅助治疗慢性肺源性心脏病心力衰竭气虚血瘀型患者58例随机对照临床研究

The Effect of Yiqi Huoxue Formula(益气活血方)in the Treatment of Chronic Pulmonary Heart Disease and Heart Failure with Qi Deficiency and Blood Stasis Pattern of 58 Cases:A Randomized Controlled Trial

目的探讨益气活血方辅助治疗慢性肺源性心脏病心力衰竭气虚血瘀型患者的临床疗效和安全性。方法将120例慢性肺源性心脏病心力衰竭气虚血瘀型患者随机分为治疗组和对照组各60例,对照组给予常规西医基础治疗,治疗组在对照组基础上加用益气活血方配方颗粒口服,每日1剂。两组疗程均为8周。比较两组患者治疗前后中医症状积分、明尼苏达生活质量量表(MLHF-Q)评分、超声心动图指标[包括右室舒张末期内径(RVEDD)、左室舒张末期内径(LVEDD)、左房舒张末期内径(LAEDD)、肺动脉平均压(PAMP)]、六分钟步行距离(6MWD)、血浆N-末端B型利钠肽原(NT-ProBNP)水平。治疗后比较两组患者心功能疗效及中医证候疗效,并观察不良事件发生情况。结果治疗组和对照组各脱落2例,两组各58例纳入分析。治疗组心功能疗效及中医证候疗效总有效率分别为91.38%(53/58)及96.55%(56/58),均高于对照组的70.69%(41/58)、48.27%(28/58)(P<0.05)。与本组治疗前比较,治疗组患者治疗后中医症状积分、RVEDD水平明显降低,两组治疗后MLHF-Q评分、血浆NT-ProBNP水平、PAMP降低,6MWD升高(P<0.01)。治疗后组间比较,治疗组中医症状积分、MLHF-Q评分、血浆NT-ProBNP水平、PAMP水平低于对照组,6MWD高于对照组(P<0.01)。两组患者治疗后血、尿、便常规及肝肾功能指标均未出现明显异常,治疗过程两组各发生不良反应1例,发生率比较差异无统计学意义(P>0.05)。结论在西医常规治疗基础上口服益气活血方可以显著提高慢性肺源性心脏病心力衰竭气虚血瘀型患者临床疗效,改善临床症状和心功能,提升患者生活质量和运动耐量,且安全性较好。

Objective To explore the effectiveness and safety of Yiqi Huoxue Formula(益气活血方,YHF)in the adjuvant treatment of chronic pulmonary heart disease(CPHD)and heart failure(HF)with qi deficiency and blood stasis pattern.Methods One hundred and twenty patients with CPHD and HF with qi deficiency and blood stasis pattern were allocated randomly into treatment group and control group,with 60 case in each group.The control group was given conventional basic western medicine,while the treatment group was given oral administration of YHF granules in addition,one dose per day.The treatment course for both groups was 8 weeks.The TCM symptom scores,Minnesota Life Quality Scale(MLHF-Q)scores,echocardiographic indicators including right ventricular end-diastolic diameter(RVEDD),left ventricular end-diastolic diameter(LVEDD),left atrial end-diastolic diameter(LAEDD)and pulmonary artery mean pressure(PAMP),six-minute walking distance(6MWD),and plasma N-terminal pro-Btype natriuretic peptide(NT-ProBNP)level were compared between the groups.The effectiveness regarding cardiac function and TCM syndromes were compared between the two groups after treatment,and the occurrence of adverse events was observed.Results With two drop-outs both in the treatment group and control group,and 58 cases in each group were included in the outcome analysis.The total effective rate regarding cardiac function and TCM syndromes in the treatment group were 91.38%(53/58)and 96.55%(56/58),respectively,significantly higher than the corresponding 70.69%(41/58)and 48.27%(28/58)in the control group(P<0.05).After treatment,the TCM symptom scores and RVEDD level were significantly reduced in the treatment group,and MLHF-Q score,plasma NT-ProBNP level and PAMP level decreased significantly,while 6MWD increased in both groups(P<0.01).Compared to those in the control group,the TCM symptom scores,MLHF-Q score,plasma NT-ProBNP level and PAMP level significantly decreased,while 6MWD increased in the treatment group(P<0.01).There were no obvious abnormalities in the blood,urine,stool routine and liver and kidney function indicators in both groups.One adverse reaction each occurred in both groups,and there was no statistically significant difference in the incidence rates(P>0.05).Conclusion YHF combined with conventional western medicine can significantly improve the clinical efficacy,improve the clinical symptoms and cardiac function,increase the quality of life and exercise tolerance,and is relatively safe.