基于心肺运动试验评价达格列净对HFpEF患者的临床治疗效果

Evaluation of clinical treatment effect of dapagliflozin in HFpEF patients based on cardiopulmonary exercise test

目的探讨达格列净对射血分数保留的心力衰竭(HFpEF)患者心肺运动试验指标及预后的影响。方法选取2020年11月至2021年8月在青岛大学附属威海市中心医院心血管内科住院的120例HFpEF患者,采用随机数字表法分为常规治疗组(心衰指南规范药物治疗)和达格列净组(在常规治疗组基础上加用达格列净10 mg口服,1次/d),治疗6个月后,观察比较两组治疗前后心肺运动指标、6分钟步行距离、B型利钠肽(BNP)、明尼苏达心功能不全生活质量量表(MLHFQ)评分等。研究结束后所有患者继续服用药物,随访1年,记录两组患者发生心衰再住院、全因死亡、主要心血管不良事件(MACE)情况。结果最终入选患者110例,其中常规治疗组54例,达格列净组56例,治疗6个月后,达格列净组峰值摄氧量(VO _(2)peak)高于常规治疗组(P=0.026),无氧阈值(AT)高于常规治疗组(P=0.002),二氧化碳通气当量斜率(VE/VCO _(2)slope)低于常规治疗组(P=0.007),BNP、MLHFQ评分低于常规治疗组(P<0.05),6分钟步行距离优于常规治疗组(P=0.002)。两组不良反应发生率比较差异无统计学意义(P>0.05)。达格列净组心衰再住院率、全因死亡率、MACE发生率低于常规治疗组(P<0.05)。以全因死亡率为终点事件绘制的Kaplan-Meier生存曲线提示达格列净组总体生存率优于常规治疗组。多因素Cox比例风险回归分析显示,BNP(OR=0.993,95%CI:0.987~0.999,P=0.019)、VO _(2)peak(OR=0.198,95%CI:0.062~0.637,P=0.007)、VE/VCO _(2)slope(OR=1.374,95%CI:1.070~1.763,P=0.013)是HFpEF患者1年内全因死亡的风险因素。结论达格列净可以改善HFpEF患者心肺运动试验指标及预后。

Objective To investigate the effect of dapagliflozin on indexes of cardiopulmonary exercise test and prognosis in HFpEF patients.Methods A total of 120 HFpEF patients hospitalized in the cardiovascular department of Weihai Central Hospital Affiliated to Qingdao University from November 2020 to August 2021 were randomly divided into the conventional treatment group(standardized drug treatment according to the guidelines for heart failure)and the dapagliflozin group(10 mg of dapagliflozin was taken orally once a day in addition to the treatment for the conventional treatment group).After 6 months of treatment,observe and compare the cardiopulmonary exercise index,6-min walking distance,type B natriuretic peptide(BNP)and Minnesota Cardiac Insufficiency Quality of Life Scale(MLHFQ)score of the two groups.After the study,all patients continued to take the current drugs and were followed up for 1 year,and the re-admission of patients for heart failure,all-cause death,and major cardiovascular adverse events(MACE)were recorded in the two groups.Results Finally,110 patients were enrolled,including 54 patients in the conventional treatment group and 56 patients in the dapagliflozin group.After 6 months of treatment,the peak oxygen uptake(VO _(2)peak)of the dapagliflozin group was higher than that of the conventional treatment group(P=0.026),the anaerobic threshold(AT)was higher than that of the conventional treatment group(P=0.002),the slope of carbon dioxide ventilation equivalent(VE/VCO _(2)slope)was lower than that of the conventional treatment group(P=0.007),the BNP and MLHFQ scores were lower than those of the conventional treatment group(P<0.05),and the 6-minute walking distance was better than that in the conventional treatment group(P=0.002).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).The re-admission rate for heart failure,all-cause mortality,and the incidence of MACE in the dapagliflozin group were lower than those in the conventional treatment group(P<0.05).Kaplan Meier survival curve with all-cause mortality as the end point time indicated that the overall survival rate of the dapagliflozin group was better than that of the conventional treatment group.Multivariate Cox proportional hazard regression analysis showed that BNP(OR=0.993,95%CI:0.987~0.999,P=0.019),VO _(2)peak(OR=0.198,95%CI:0.062~0.637,P=0.007),VE/VCO_( 2)slope(OR=1.374,95%CI:1.070~1.763,P=0.013)were risk factors for all-cause death of HFpEF patients within one year.Conclusion Dapagliflozin can improve cardiopulmonary exercise test indexes and prognosis in HFpEF patients.