临床随机试验：早期应用沙库比妥/缬沙坦对急性心肌梗死患者心室重塑和预后的影响

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-07-25 DOI:10.1016/j.conctc.2024.101303

Zhengfeng Liu , Kun Cui , Guangdong Wang , Wenqing Jin , Qiong Yao , Yuanzheng Zhang

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引用次数: 0

摘要

摘要] 目的探讨早期应用沙库比特利/缬沙坦对急性心肌梗死（AMI）患者心室重构及预后的影响。方法选取2019年8月-2021年8月期间该院收治的AMI患者共295例。根据治疗方法的不同，分为观察组（沙库比特利/缬沙坦钠片联合标准治疗，132例）和对照组（盐酸贝那普利片联合标准治疗，163例）。治疗前和治疗后 6 个月的血浆 N 端前脑钠肽 (NT-proBNP)、肌酐 (Cr) 和血清 K+ 水平、所有正常至正常区间的标准偏差 (SDNN)、所有正常至正常区间平均值的标准偏差 (SDANN)、比较两组相邻正常间期差的均方根/连续 R-R 差的均方根（RMSSD）、左室舒张末期容积（LVEDV）、左室射血分数（LVEF）和左室收缩末期容积（LVESV）。结果观察组NT-proBNP、Cr、K+、LVEDV、LVESV水平显著低于对照组（P< 0.05），而LVEF、SDNN、SDANN、RMSSD显著高于对照组（P< 0.05）。结论早期应用沙库比特利/缬沙坦钠可有效延缓AMI患者心室重构，改善心功能和心率变异性指标，降低NT-proBNP水平，改善预后。

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A clinical randomized trial: Effects of early application of sacubitril/valsartan on ventricular remodeling and prognosis in acute myocardial infarction patients

Objectives

To explore the effects of early application of sacubitril/valsartan on ventricular remodeling and prognosis in patients with acute myocardial infarction (AMI).

Methods

Total of 295 patients with AMI admitted to the hospital were enrolled between August 2019 and August 2021. According to different treatment methods, they were divided into observation group (sacubitril/valsartan sodium tables combined with standard treatment, 132 patients) and control group (benazepril hydrochloride tablets combined with standard treatment, 163 patients). The levels of plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), creatinine (Cr) and serum K⁺ before and at 6 months after treatment, standard deviation of all normal-to-normal intervals (SDNN), standard deviation of the average all normal-to-normal intervals (SDANN), root mean square of differences between adjacent normal-to-normal intervals/root mean square differences of successive R-R (RMSSD), left ventricular end-diastolic volume (LVEDV), left ventricular ejection fraction (LVEF) and left ventricular end-systolic volume (LVESV) in the two groups were compared. The adverse reactions during treatment and major adverse cardiac events (MACE) during 6 months of follow-up in both groups were statistically analyzed.

Results

The levels of NT-proBNP, Cr and K⁺, LVEDV and LVESV in observation group were significantly lower than those in control group (P < 0.05), while LVEF, SDNN, SDANN and RMSSD were significantly higher than those in control group (P < 0.05). The incidence of MACE in observation group was lower than that in control group during 6 months of follow-up (7.58 % vs 27.61 %, P < 0.05), but there was no significant difference in the incidence of adverse reactions (9.85 % vs 12.88 %, P > 0.05).

Conclusion

Early application of sacubitril/valsartan sodium can effectively delay ventricular remodeling, improve cardiac function and heart rate variability indexes, reduce NT-proBNP level and improve prognosis in AMI patients.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.