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沙库巴曲缬沙坦钠联合常规对症治疗射血分数保留心力衰竭患者的临床疗效及安全性研究

Clinical efficacy and safety of sacubactril valsartan sodium combined with conventional symptomatic treatment in patients with heart failure with preserved ejection fraction
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摘要 目的 观察沙库巴曲缬沙坦钠联合常规对症治疗射血分数保留心力衰竭(HFpEF)的临床疗效,并探讨其对患者心功能、心率变异、炎性因子、血管内皮功能和再住院率的影响。方法 选取2021年1月至2022年12月许昌医院收治的108例HFpEF患者作为研究对象,按随机数表法分为联合组和对照组各54例。对照组患者行常规的利尿药物、β受体阻滞剂、血管紧张素转换酶抑制剂等对症支持治疗,联合组患者则在对照组治疗的基础上联合沙库巴曲缬沙坦钠治疗。治疗8周后,比较两组患者的临床疗效,以及治疗前后的心功能指标[左心室射的血分数(LVEF)、左心室的收缩末期内径(LVESD)、左心室的舒张末期内径(LVEDD)]、心率变异性指标[24 h窦性心律R-R间期标准差(SDNN)、24 h相邻正常R-R间期差值>50 ms百分比(RNN50)]、炎性因子[血清白细胞介素(IL)-1β、IL-8]、血管内皮功能[一氧化氮(NO)、内皮素-1 (ET-1)]水平,同时比较两组患者治疗期间的不良反应发生率和治疗结束后随访3个月的再住院率。结果 治疗8周后,联合组患者的治疗总有效率为92.59%,明显高于对照组的70.37%,差异有统计学意义(P<0.05);治疗8周后,联合组患者的LVEF、RNN50、SDNN分别为(61.11±5.03)%、(12.01±2.24)%、(112.20±12.23) ms,明显高于对照组的(58.85±4.72)%、(10.31±1.89)%、(103.34±10.18) ms,而LVESD、LVEDD分别为(40.37±4.12) mm、(47.71±4.55) mm,明显低于对照组的(45.17±4.38) mm、(50.52±4.67) mm,差异均有统计学意义(P<0.05);治疗8周后,联合组患者的血清IL-1β、IL-8、ET-1水平分别为(9.94±1.25) ng/L、(53.53±5.04) ng/L、(82.26±7.05) ng/L,明显低于对照组的(15.76±2.21) ng/L、(76.67±7.11) ng/L、(88.18±8.24) ng/L,血清NO水平为(89.65±7.53)μmol/L,明显高于对照组的(70.52±6.61)μmol/L,差异均有统计学意义(P<0.05);治疗期间,联合组患者的并发症总发生率为12.96%,略高于对照组的9.26%,但差异无统计学意义(P>0.05);治疗结束后随访3个月,联合组患者因心衰再住院率为3.70%,明显低于对照组的16.67%,差异有统计学意义(P<0.05)。结论 沙库巴曲缬沙坦钠联合常规对症治疗HFpEF可进一步改善患者的心功能、心率变异及血管内皮功能,减轻炎性状态,降低再住院率,其临床疗效确切且具有较高的安全性。 Objective To observe the clinical efficacy of sacubatrol valsartan sodium combined with conven-tional symptomatic treatment in patients with heart failure with preserved ejection fraction(HFpEF),and to investigate its effects on cardiac function,heart rate variability,inflammatory factors,vascular endothelial function,and re-hospital-ization rate.Methods A total of 108 patients with HFpEF treated in Xuchang Hospital from January 2021 to December 2022 were selected as research objects.They were divided into a combination group and a control group by random num-ber table method,with 54 patients in each group.The patients in the control group received conventional diuretic drugs,β-blockers,angiotensin-converting enzyme inhibitors and other symptomatic supportive treatment.The patients in the combination group were treated with sacubatrol valsartan sodium on the basis of the control group.After 8 weeks of treatment,the clinical efficacy was compared between the two groups,as well as cardiac function indexes[left ventricu-lar ejection fraction(LVEF),left ventricular end-systolic diameter(LVESD),left ventricular end-diastolic diameter(LVEDD)],heart rate variability indexes[standard deviation of RR interval with 24 h(SDNN),percentage of 24 h adja-cent normal R-R interval difference>50 ms(RNN50)],inflammatory factors[serum interleukin(IL)-1β,IL-8],vascular endothelial function[nitric oxide(NO),endothelin-1(ET-1)]before and after treatment.At the same time,the incidence of adverse reactions during treatment and the rehospitalization rate after 3 months of treatment were compared between the two groups.Results After 8 weeks of treatment,the total effective rate in the combination group was 92.59%,which was significantly higher than 70.37%in the control group(P<0.05).After 8 weeks of treatment,the LVEF,RNN50,and SDNN in the combination group were(61.11±5.03)%,(12.01±2.24)%,and(112.20±12.23)ms,respectively,which were significantly higher than(58.85±4.72)%,(10.31±1.89)%,(103.34±10.18)ms in the control group,while the LVESD and LVEDD in the combination group were(40.37±4.12)mm and(47.71±4.55)mm,respectively,significantly lower than(45.17±4.38)mm and(50.52±4.67)mm in the control group(P<0.05).After 8 weeks of treatment,the serum levels of IL-1β,IL-8,and ET-1 in the combination group were(9.94±1.25)ng/L,(53.53±5.04)ng/L,and(82.26±7.05)ng/L,respectively,which were significantly lower than(15.76±2.21)ng/L,(76.67±7.11)ng/L,(88.18±8.24)ng/L in the control group,while the se-rum NO level was(89.65±7.53)μmol/L,significantly higher than(70.52±6.61)μmol/L in the control group(P<0.05).Dur-ing the treatment period,the overall complication rate in the combination group was 12.96%,which was slightly higher than 9.26%in the control group,but the difference was not statistically significant(P>0.05).After 3 months of follow-up,the rehospitalization rate in the combination group was 3.70%,which was significantly lower than 16.67%in the control group(P<0.05).Conclusion Sacubactril valsartan sodium combined with conventional symptomatic treatment in HF-pEF can further improve patients'heart function,heart rate variability,and vascular endothelial function,alleviate inflam-matory state,reduce the rehospitalization rate,with definite clinical efficacy and high safety.
作者 张小丹 张巧玲 朱志勇 闫菲 ZHANG Xiao-dan;ZHANG Qiao-ling;ZHU Zhi-yong;YAN Fei(Department of Cardiology,Xuchang Hospital,Xuchang 461000,Henan,CHINA;Department of Coronary Heart Disease Intensive Care Unit,Fuwai Central China Cardiovascular Hospital,Zhengzhou 451460,Henan,CHINA;The Second Department of Cardiology,General Hospital of Pingmei Shenma Medical Group,Pindingshan 467002,Henan,CHINA;Department of Coronary Heart and Pulmonary Function,Fuwai Central China Cardiovascular Hospital,Zhengzhou 451460,Henan,CHINA)
出处 《海南医学》 2024年第2期174-178,共5页 Hainan Medical Journal
基金 2020年河南省医学科技攻关计划联合共建项目(编号:LHGJ20200089)。
关键词 射血分数保留心力衰竭 沙库巴曲缬沙坦钠 心功能 心率变异 疗效 安全性 Heart failure with preserved ejection fraction Sacubactril valsartan sodium Heart function Heart rate variation Curative effect Safety
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