参芪扶正注射液改善老年射血分数保留的心衰患者临床疗效机制初探

A preliminary study on the mechanism of clinical efficacy of Shenqi Fuzheng injection in the treatment of the elderly patients with HFpEF

目的评价参芪扶正注射液治疗老年射血分数保留的心衰(HFpEF)患者疗效,探索相关血流动力学机制。方法2016年9月—2017年8月,复旦大学附属华山医院静安分院心内科住院的老年HFpEF患者132例,通过随机化区组随机分为标准治疗+参芪扶正注射液治疗组(观察组)和标准治疗组(对照组),每组66例。评估治疗前后的血浆N末端脑钠肽前体(NT-proBNP)、经胸超声心动图参数、6 min步行距离(6MWD)、纽约心脏病协会(NYHA)心功能分级及明尼苏达心功能不全问卷生活质量评分(MLHFQ),监测不良反应的发生。结果治疗14 d后,观察组NYHA心功能分级显效20例、有效38例、无效8例,总有效率87.88%;对照组显效7例、有效39例、无效20例,总有效率69.70%,观察组NYHA心功能分级的改善优于对照组(87.88%vs 69.70%,P=0.004)。2组NT-proBNP均较入院时下降,2组治疗前后的NT-proBNP差值差异有统计学意义(P=0.002),且观察组血浆NT-proBNP下降>30%的比例高于对照组(48.48%vs 31.82%,P<0.001)。出院后90 d,观察组三尖瓣瓣环平面收缩位移较入院时提高(P=0.02),二尖瓣口E峰/整体心肌应变率增加(P=0.04)。治疗14 d后,2组6MWD均提高,MLHFQ评分均下降,观察组6MWD平均变化率大于对照组,差异有统计学意义(P=0.006),MLHFQ评分平均变化率观察组更大,差异有统计学意义(P=0.01)。2组住院期间均无严重不良事件发生。结论参芪扶正注射液短期治疗能改善老年HFpEF患者的右室收缩功能,安全性较高。

Objective To evaluate the efficacy of Shenqi Fuzheng injection in the treatment of elderly patients with heart failurewith preserved ejection fraction(HFpEF)and to explore the related hemodynamicmechanisms.Methods FromSeptember 2016 toAugust 2017,132 elderly patients with HFpEFwere randomly divided into standard treatment+Shenqi Fuzheng injection treatment group(observation group)and standard treatment group(control group),66 cases in each group.PlasmaN-terminal prohormone of brain natriuretic peptide(NT-proBNP),echocardiography parameters,6 minutes walking distance(6MWD),New York heart association(NYHA)cardiac function classification and Minnesota living with heart failure questionnaire(MLHFQ)were evaluated before and after treatment,and adverse reactions were monitored.Results After 14 days of the treatment,the NYHA cardiac function classification in the observation group was markedly effective in 20 cases,effective in 38 cases,and ineffective in 8 cases,with the total effective rate of 87.88%;in the control group,7 cases were markedly effective,39 cases were effective,and 20 cases were ineffective,with the total effective rate of 69.70%.The improvement of NYHA cardiac function classification in the observation group was better than that in the control group(87.88%vs 69.70%,P=0.004).NT-proBNP in both groups decreased compared with the admission,the difference in NT-proBNP before and after the treatment in both groupswas statistically significant(P=0.002),and the percentage of plasmaNT-proBNP decreased by>30%in the observation group was higher than that in the control group(48.48%vs 31.82%,P<0.001).90 days after discharge from the hospital,the plane contraction displacement of the tricuspid annulus in the observation group was higher than that at the time of admission(P=0.02),and the E peak of the mitral valve/global myocardial strain rate increased(P=0.04).After 14 days of treatment,the 6MWD of both groups increased,and the MLHFQ scores decreased.The average change rate of 6MWD in the observation group was greater than that in the control group(P=0.006),and the average change rate of MLHFQ score was larger in the observation group(P=0.01).No serious adverse events occurred during hospitalization in both groups.Conclusion Short-termtreatment of Shenqi Fuzheng injection can improve the right ventricular systolic function in patients with HFpEF,with high safety.