中国全科医学 ›› 2023, Vol. 26 ›› Issue (23): 2912-2917.DOI: 10.12114/j.issn.1007-9572.2023.0050

• 用药安全 • 上一篇    下一篇

沙库巴曲缬沙坦与达格列净治疗血压偏低的扩张型心肌病疗效及安全性比较研究

张勇, 蔡翔, 宁菲菲, 梁潇, 郭宁*()   

  1. 710061 陕西省西安市,西安交通大学第一附属医院心血管内科
  • 收稿日期:2023-02-01 修回日期:2023-02-20 出版日期:2023-08-15 发布日期:2023-02-27
  • 通讯作者: 郭宁

  • 作者贡献:张勇、梁潇负责研究的整体构思及稿件书写;蔡翔、宁菲菲负责研究数据收集管理及统计学分析;郭宁负责研究的管理、监督及稿件质量控制和审校。
  • 基金资助:
    国家自然科学基金资助项目(82100373)

Comparative Study of the Efficacy and Safety of Sacubitril/Valsartan and Dapagliflozin in the Treatment of Dilated Cardiomyopathy with Low Blood Pressure

ZHANG Yong, CAI Xiang, NING Feifei, LIANG Xiao, GUO Ning*()   

  1. Department of Cardiovascular Medicine, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China
  • Received:2023-02-01 Revised:2023-02-20 Published:2023-08-15 Online:2023-02-27
  • Contact: GUO Ning

摘要: 背景 扩张型心肌病预后极差,沙库巴曲缬沙坦与达格列净是改善预后的重要药物,但扩张型心肌病患者血压常偏低,两种药物可能无法同时使用,目前尚缺乏沙库巴曲缬沙坦与达格列净在血压偏低的扩张型心肌病中疗效及安全性比较的研究。 目的 探讨沙库巴曲缬沙坦与达格列净在血压偏低的扩张型心肌病中的疗效与安全性。 方法 选取2021年3月—2022年5月西安交通大学第一附属医院收治的扩张型心肌病患者124例为研究对象。患者均为首次诊断为扩张型心肌病,服药前收缩压(SBP)为95~110 mmHg,在出院前或出院时处方沙库巴曲缬沙坦(50 mg/次,2次/d)或达格列净片(10 mg/次,1次/d),按照临床药物使用情况分为沙库巴曲缬沙坦组(71例)和达格列净组(53例)。在出院后6个月进行门诊随访,随访截至2022年11月。通过医院电子病历系统收集两组患者的年龄、性别等一般资料,并记录患者基线及6个月随访SBP、舒张压(DBP)、BMI等。收集基线及6个月随访生化指标〔N末端B型利钠肽原(NT-proBNP)、糖化血红蛋白(HbA1c)、空腹血糖(FBG)、估算肾小球滤过率(eGFR)、血钾〕、心脏功能指标〔左心室射血分数(LVEF)、左心室舒张末期内径(LVEDD)、左心室收缩末期内径(LVESD)、左心房内径(LAD)〕、6 min步行试验(6MWT)及临床事件。比较两组患者治疗前后生化指标、心脏功能指标及临床事件发生率。 结果 与治疗前相比,治疗6个月后沙库巴曲缬沙坦组与达格列净组患者血钾、LVEF、6MWT水平均升高(P<0.05),且达格列净组患者6MWT升幅高于沙库巴曲缬沙坦组(t=2.444,P=0.016)。与治疗前相比,治疗6个月后沙库巴曲缬沙坦组与达格列净组患者SBP、DBP、BMI、NT-proBNP、HbA1c、FBG、LVEDD、LVESD、LAD水平均下降(P<0.05);且沙库巴曲缬沙坦组SBP(Z=5.217,P<0.001)、DBP(t=3.070,P=0.003)、eGFR(Z=2.495,P=0.013)降幅较高,而达格列净组BMI(Z=4.410,P<0.001)、HbA1c(Z=4.493,P<0.001)、FBG(t=4.832,P<0.001)、LAD(Z=2.830,P=0.005)降幅较高。两组患者随访6个月内均无死亡及低血糖停药事件发生,两组低血压停药、高钾血症停药、肾功能不全停药、泌尿系感染停药、心力衰竭再住院发生率比较,差异均无统计学意义(P>0.05)。 结论 在血压偏低的扩张型心肌病人群中使用沙库巴曲缬沙坦及达格列净均能有效改善患者心功能,两种药物安全性相当,使用沙库巴曲缬沙坦时更应注意低血压及肾功能不全的风险。

关键词: 心肌病, 扩张型, 沙库巴曲缬沙坦, 达格列净, 血压偏低, 疗效, 安全性, 对比研究

Abstract:

Background

Dilated cardiomyopathy has an extremely poor prognosis, sacubitril/valsartan and dapagliflozin are important drugs to improve the prognosis. However, patients with dilated cardiomyopathy tend to have low blood pressure, which would make it unable to use both drugs at the same time. There is no comparative study of the efficacy and safety of sacubitril/valsartan and dapagliflozin in the treatment of dilated cardiomyopathy with low blood pressure.

Objective

To investigate the efficacy and safety of sacubitril/valsartan and dapagliflozin in dilated cardiomyopathy patients with low blood pressure.

Methods

A total of 124 patients with dilated cardiomyopathy admitted to the First Affiliated Hospital of Xi'an Jiaotong University from March 2021 to May 2022 were selected as the study subjects. All patients were diagnosed with dilated cardiomyopathy for the first time, and the systolic blood pressure (SBP) was 95-110 mmHg before medication. Patients were prescribed with sacubitril/valsartan (50 mg/time, twice a day) or dapagliflozin tablets (10 mg/time, once a day) before or at discharge and divided into the sacubitril/valsartan group (71 cases) and dapagliflozin group (53 cases) according to clinical drug use. The outpatient follow-up was performed 6 months after discharge until November 2022. General information of the two groups such as age and gender were collected through the hospital electronic medical record system, baseline and 6-month follow-up SBP, diastolic blood pressure (DBP) , and BMI of the two groups were recorded. Baseline and 6-month biochemical indicators〔N-terminal pro-B-type natriuretic peptide (NT-proBNP) , glycated hemoglobin (HbA1c) , fasting blood glucose (FBG) , estimated glomerular filtration rate (eGFR) , blood potassium〕, cardiac function indicators〔left ventricular ejection fraction (LVEF) , left ventricular end-diastolic diameter (LVEDD) , left ventricular end-systolic diameter (LVESD) , left atrial diameter (LAD) 〕, 6 min walking test (6MWT) and clinical events were collected. The biochemical indicators, cardiac function indicators and incidence of clinical events before and after treatment were compared between the two groups.

Results

Compared with the pre-treatment period, the levels of blood potassium, LVEF and 6MWT were increased in the sacubitril/valsartan group and dapagliflozin group after 6 months of treatment (P<0.05) , and the elevations of 6MWT level in the dapagliflozin group was higher than that in the sacubitril/valsartan group (t=2.444, P=0.016) . Compared with the pre-treatment period, the levels of SBP, DBP, BMI, NT-proBNP, HbA1c, FBG, LVEDD, LVESD, LAD were decreased in the sacubitril/valsartan group and dapagliflozin group after 6 months of treatment (P<0.05) , the reductions of SBP (Z=5.217, P<0.001) , DBP (t=3.070, P=0.003) , eGFR (Z=2.495, P=0.013) levels in the sacubitril/valsartan group and BMI (Z=4.410, P<0.001) , HbA1c (Z=4.493, P<0.001) , FBG (t=4.832, P<0.001) , LAD (Z=2.830, P=0.005) levels in the dapagliflozin group were higher. There were no deaths or hypoglycemic discontinuation events in the two groups during 6 months of follow-up, and there were no statistical differences in the incidence of hypotension discontinuation, hyperkalemia discontinuation, renal insufficiency discontinuation, urinary system infection discontinuation and heart failure re-hospitalization between the two groups (P>0.05) .

Conclusion

Both sacubitril/valsartan and dapagliflozin were effective in improving cardiac function in dilated cardiomyopathy patients with low blood pressure. The safety of the two groups is similar. However, the use of sacubitril/valsartan should be noted for the risk of hypotension and renal insufficiency.

Key words: Cardiomyopathy, dilated, Sacubitril/valsartan, Dapagliflozin, Low blood pressure, Efficacy, Safety, Comparative study