芪红胶囊治疗气虚血瘀型慢性心力衰竭随机对照临床研究

Qihong Capsule for Chronic Heart Failure Patients with Qi Deficiency and Blood Stasis Syndrome:A Randomized Controlled Trial

目的观察芪红胶囊治疗慢性心力衰竭(CHF)的临床疗效。方法采用随机、阳性药物平行对照的研究方法,将患者随机分为试验组(39例)、对照组(39例)。试验组给予西医CHF基础治疗加芪红胶囊口服,1天3次,1次6粒;对照组给予西医CHF基础治疗加芪苈强心胶囊1天3次,1次4粒,两组均治疗12周。以N-末端脑钠肽前体(NT-Pro BNP)、6分钟步行试验(6MWT)距离等级、美国纽约心脏病协会(NYHA)心功能分级、左室舒张末期内径(LVED)、左室射血分数(LVEF)、明尼苏达心衰生活质量调查表(MLHF)评分、中医症状评分、中医疗效判定为疗效指标,以血常规、肝肾功、电解质、凝血四项为安全性指标。结果共计62例患者纳入疗效统计分析,16例脱落(试验组8例、对照组8例)。与本组治疗前比较,两组治疗后NT-Pro BNP水平、NYHA心功能等级、MLHF评分、中医症状积分降低(P<0.05,P<0.01),6MWT距离等级提高(P<0.01)。两组治疗后各指标及两组有效率比较,差异均无统计学意义(P>0.05)。两组均未观察到不良事件。结论芪红胶囊用于治疗慢性心力衰竭(气虚血瘀证)疗效与芪苈强心胶囊相当,且安全性好。

Objective To observe the clinical efficacy of Qihong Capsule in the treatment of chronic heart failure(CHF).Methods By the method of random parallel controlled drugs,patients were randomly divided into trial group(39 cases)and control group(39 cases).Trial group was treated with the Western medicine to chronic heart failure(CHF)and Qihong Capsule foundation treatment,6 pills,3 times a day;control group was treated with Western medicine and Qiliqiangxin Capsules,4 pills,3 times a day,treatment for 12 weeks.Take N-terminal pro-brain natriuretic peptide(NT-Pro BNP),6-minute walk test(6MWT)distance grade,New York Heart Association(NYHA)heart function grade,left ventricular end-diastolic diameter(LVED),left ventricular ejection fraction(LVEF),Minnesota Heart Failure Quality of Life Questionnaire(MLHF)score,Chinese medicine(CM)symptom score and CM therapeutic effect as the index of curative efficacy evaluation.Blood routine,liver and kidney function,electrolytes and blood coagulation were used as safety indexes.Results Totally 62 patients were included in the statistical analysis of curative effect.There were 16 cases(8 cases in the test group and 8 cases in the control group)lost follow-up.Compared with before treatment,the levels of NT-Pro BNP,NYHA heart function grade,MLHF score and CM symptom score decreased(P<0.05,P<0.01),6MWT distance grade increased in the 2 groups(P<0.01).There was no significant difference in all indexes and effective rates between 2 groups after treatment(P>0.05).The adverse events were not observed in both groups.Conclusion The efficacy of Qihong Capsule for the treatment of CHF(Qi deficiency and blood stasis syndrome)is equal to Qiliqiangxin Capsule,and shows a good safety.