沙库巴曲缬沙坦治疗射血分数降低心力衰竭患者的回顾性研究

A retrospective analysis of Sacubitril/Valsartan in the treatment of heart failure with reduced ejection fraction

目的:探究常规抗心衰药物基础上换用沙库巴曲缬沙坦(Sacubitril/Valsartan,LCZ696)治疗射血分数降低型心力衰竭(HFrEF)患者的临床疗效并分析影响疗效的相关临床因素。方法:回顾性研究2017年12月—2018年12月在南京医科大学第一附属医院心内科住院治疗的HFrEF患者104例,患者在常规抗心衰药物基础上换用LCZ696治疗,平均观察时间为(3.9±2.2)个月,中途停药或死亡患者共计6例。统计入选患者人群基线特征、基础心脏病及既往病史种类。观察起始及终点时LCZ696剂量。比较患者治疗前后纽约心功能分级(NYHA),一般生命体征指标及相关实验室指标,观察治疗期间不良反应,并采用单因素及多因素Logistic回归分析影响LCZ696疗效的相关临床因素。结果:①LCZ696治疗后NYHA分级改善,较治疗前差异有统计学意义(P<0.05)。②LCZ696治疗后静息心率及收缩压较治疗前显著降低(P<0.05)。③LCZ696治疗后NTproBNP降低,较治疗前差异有统计学意义(P<0.05)。④LCZ696治疗后,患者左心室射血分数(LVEF)增高(P<0.05)、左心室舒张末期内径(LVDd)减小(P<0.05),左心室收缩末期内径(LVDs)治疗前后无改变(P>0.05)。⑤LCZ696治疗期间因出现严重咳嗽症状停药3例,因出现肌酐升高停药1例;因严重基础心脏瓣膜病导致死亡1例,因发现霍奇金淋巴瘤转至血液科治疗,后随访患者死亡1例。其余患者无症状性低血压、水肿或高钾血症等严重不良反应。⑥患者病史时间及起始LVDd水平是影响LCZ696疗效的临床因素,OR值分别为4.952、1.124。结论:在常规抗心衰药物基础上,HFrEF患者换用LCZ696后能提高NYHA分级及LVEF,降低NT-proBNP、静息心率、收缩压、LVDd,不良反应较低。并且患者病史时间和LVDd是LCZ696疗效的影响因素,符合适应证者因尽早开始LCZ696的治疗。

Objective:This study aims to investigate the clinical effect of sacubitri/valsartan in treating heart failure patients with reduced ejection fraction and to explore the clinical factors of poor treatment of Sacubitri/Valsartan.Methods:A retrospective study of104 heart failure patients with reduced ejection fraction in the Department of Cardiology,the First Affiliated Hospital of Nanjing Medical University was conducted from December 2017 to December 2018.All patients were treated with sacubitri/valsartan basing on their conventional anti-heart failure drugs for(3.9±2.2)months,6 patients were excluded for withdrawal or death.Baseline population characteristics including sex,age,primary diseases and other basic diseases were described,we also observed the catagories of conventional anti-heart failure drugs and doses of Sacubitri/Valsartan before and after the treatment.NYHA classification,the index of normal vatal signs(HR,SBP),laboratory examinaiton(NT-proBNP),cardiac structure(LVEF,LVDd,LVDs)were compared before and after treatment.The incidence of drug related adverse reactions was recorded.Univarite and multivariate Logistic regression model were applied to analyze the revelant clinical factors influencing the treatment of Sacubitril/Valsartan.Results:①There were statisitcally significant differences in NYHA classification before and after the treatment(P<0.05).②HR and SBP after treatment were statisitcally significant lower than those before the treatment(P<0.05);③After treatment,NT-proBNP was significanly less than before(P<0.05).④There were statisitcally significant differences in LVEF,LVDd before and after treatment(P<0.05),while LVDs did not show the difference(P>0.05).⑤During the treatment of sacubitri/valsartan,three patients withdrew because of severe cough,as well one patient with the increase of serum creatinine;One patient died because of severe valvular heart disease during the treatment,another patient was diagnosed Hodgkins lymphoma and then dead during the follow-up.No one left experienced any obvious hypotension,angioedema or hyperpotassemia.⑥Univariate and mutivariate Logistic regression analysis showed that the length of medical history(OR=4.952)and baseline LVDd(OR=1.124)were related with the poor treatment of sacubitri/valsartan.Conclusion:Sacubitri/valsartan can validly improve NYHA classification,LVEF and decrease NT-proBNP,HR,SBP,LVDd in patients with reduced ejection fraction basing on their conventional anti-heart failure therapy.Clinical factors including the length of medical history and LVDd can influence the treatment of sacubitri/valsartan.With advanced clinical effect and mild adverse reactions,sacubitri/valsartan is recommended for heart failure patients with reduced ejection fraction as early as possible.