新通冠颗粒(芪麦通冠协定方)对急性心肌梗死后心力衰竭患者心功能影响的随机双盲对照研究

Effects of New Tongguan Granule( Qimai Tongguan Formula) on Heart Failure after Acute Myocardial Infarction: A Randomized Controlled Trial

目的观察新通冠颗粒(芪麦通冠协定方)对急性心肌梗死后心力衰竭患者心功能影响。方法本研究为探索性前瞻随机双盲对照研究,将60例急性心肌梗死后心力衰竭患者随机分为治疗组和对照组,每组30例。两组均给予西医常规治疗,在此基础上治疗组给予新通冠颗粒(6 g/袋),每次1袋,水冲服,每日3次,对照组给予等量安慰剂治疗,连续服用3个月。观察两组患者治疗前后纽约心脏病协会心功能分级(Heart function classification of New York Heart Association,NYHA)、气虚血瘀证候量表评分、明尼苏达生活质量评分分数、6 min步行试验、6 min步行距离增值、步行距离占预计值百分数;心脏超声检查相关指标;观察B型尿钠肽(type B natriuretic peptide,BNP)水平、肝肾功能及主要心血管不良事件(major adverse cardiovas-cular events,MACE)。结果最终纳入52例患者进行评价分析,其中治疗组27例和对照组25例。与本组治疗前比较,两组NYHA心功能分级、气虚血瘀证候量表分值、明尼苏达生活质量评分均有改善(P <0. 05);BNP和AST水平均下降(P <0. 05); 6 min步行距离和步行距离占预计值百分数均增加(P <0. 05);对照组心脏超声左室舒张末内径、每搏心输出量值增加(P <0. 05)。治疗后与对照组比较,治疗组NYHA心功能分级、气虚血瘀症状量表分值、明尼苏达生活质量评分明显下降(P <0. 05),治疗组6 min步行距离增值优于对照组(P <0. 05)。治疗过程中两组BNP水平与肝肾功能差异无统计学意义(P> 0. 05),随访期间两组均无发生MACE事件。结论新通冠颗粒可改善急性心肌梗死后心力衰竭患者的心功能,改善中医证候评分,提高生活质量及运动耐力。

Objective To observe the effects of New Tongguan Granule( NTG,Qimai Tongguan Formula) in treatment of heart failure patients after acute myocardial infarction. Methods A prospective randomized double-blinded controlled trial was conducted. Totally 60 patients with heart failure after acute myocardial infarction were randomly assigned to treatment group( 30 cases) and control group( 30 cases). Patients in the treatment group received routine therapy and NTG[1 package each time( 6 g),3 times a day]. While patients in the control group received routine therapy and placebo granule [1 package each time( 6 g),3 times a day]. The treatment course for all was 3 months.Before and after treatment,the Heart function classification of New York Heart Association( NYHA),Scores for Qi-deficiency and Blood-stasis Syndrome( SQBS),Minnesota Living with Heart Failure Questionnaire( MLHFQ),walking distance and the percentages of 6-minute walking distance in predicted value in 6-minute walk test,Major Adverse Cardiovascular Events( MACE) were used to evaluate therapeutic effects. Echocardiography related indicators were observed for cardiac function evaluation. The type B natriuretic peptide( BNP),liver function and kidney function were detected in the two groups. Results Finally,52 patients completed the trial( 27 cases in the treatment group and 25 cases in the control group). Compared with before treatment in the same group,NYHA classification,SQBS,MLHFQ were improved(P < 0. 05),BNP and Glutamic-oxalacetic transaminase( AST) level were decreased(P < 0. 05);6-minute walk test distance and the percentages of 6-minute walking distance in predicted value were increased( P <0. 05) in the two groups after treatment. The values of left ventricular end heart size diastolic diameter( LVEDD),stroke volume( SV) in the control group were increased( P < 0. 05). After treatment,compared with the control group,the improvement of NYHA classification,SQBS,MLHFQ in the treatment group were better(P < 0. 05). The increment of 6-minute walking distance was superior in the treatment group than in the control group( P < 0. 05).There was no statistical difference in levels of BNP、liver and kidney function between the two groups(P > 0. 05). No MACE events occurred in either group during the treatment course. Conclusion The NTG could improve the heart function and the SQBS,evaluate the life quality and exercise tolerance of patients with heart failure after acute myocardial infarction.