血管紧张素受体脑啡肽酶抑制剂联合常规治疗心力衰竭患者的效果：一项系统评价随机临床试验的方案，包括荟萃分析和试验序贯分析。

The effects of adding angiotensin receptor neprilysin inhibitors to usual care in patients with heart failure: a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.

机构信息

Department of Internal Medicine - Cardiology Section, Holbæk Hospital, Holbæk, Region Zealand, Denmark.

Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark.

出版信息

Syst Rev. 2019 Oct 31;8(1):251. doi: 10.1186/s13643-019-1173-7.

DOI:10.1186/s13643-019-1173-7

PMID:31672170

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6823969/

Abstract

BACKGROUND

Heart failure is a highly prevalent disease with a global prevalence of 37 million, and the prevalence is increasing. Patients with heart failure are at an increased risk of death and morbidity. Traditionally, patients with heart failure have been treated with a beta-blocker in addition to an inhibitor of the renin-angiotensin-aldosterone system. However, new drugs are currently being added to the recommended guideline therapy. The latest drug to be added combines inhibition of the renin-angiotensin-aldosterone system pathway with inhibiting the neprilysin enzyme and is therefore classified as an ARNI. Our objective is to identify the beneficial and harmful effects of ARNIs in the treatment of patient with heart failure.

METHODS

This protocol for a systematic review was undertaken using the recommendations of the Cochrane, the Preferred Report Items of Systematic reviews with Meta-Analysis Protocols, and the eight-step assessment procedure suggested by Jakobsen and colleagues. We plan to include all relevant randomised clinical trials assessing the use of ARNIs in the treatment of patients with heart failure. We will search the Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded on Web of Science, Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Science Journal Database (VIP), and BIOSIS to identify relevant trials. We will also search for grey literature and unpublished trials. Extracted data will be analysed using Review Manager 5, STATA 5, and Trial Sequential Analysis. Our primary outcomes will be all-cause mortality and serious adverse events. We will create a 'Summary of Findings' table in which we will present our primary and secondary outcomes, and we will assess the quality of evidence using the GRADE assessment.

DISCUSSION

The present systematic review will have the potential to aid clinicians in decision-making and thereby, benefit patients with heart failure.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO CRD42019129336.

摘要

背景

心力衰竭是一种高发疾病，全球患病率为 3700 万，且患病率还在不断上升。心力衰竭患者的死亡和发病风险较高。传统上，心力衰竭患者除了接受肾素-血管紧张素-醛固酮系统抑制剂治疗外，还会接受β受体阻滞剂治疗。然而，目前正在向推荐的指南治疗中添加新的药物。最新添加的药物将肾素-血管紧张素-醛固酮系统途径的抑制与抑制 Neprilysin 酶相结合，因此被归类为 ARNI。我们的目标是确定 ARNI 在心力衰竭患者治疗中的有益和有害作用。

方法

本系统评价的方案是按照 Cochrane 的建议、系统评价与荟萃分析首选报告项目以及 Jakobsen 及其同事提出的八步评估程序进行的。我们计划纳入所有评估 ARNI 治疗心力衰竭患者的使用的相关随机临床试验。我们将在 Cochrane 对照试验中心注册库（CENTRAL）、医学文献分析与检索系统在线（MEDLINE）、医学生物学文献数据库（EMBASE）、拉丁美洲和加勒比卫生科学文献数据库（LILACS）、科学引文索引扩展版在 Web of Science 上、中国生物医学文献数据库（CBM）、中国国家知识基础设施（CNKI）、中国科技期刊数据库（VIP）和 BIOSIS 中搜索相关试验。我们还将搜索灰色文献和未发表的试验。提取的数据将使用 Review Manager 5、STATA 5 和试验序贯分析进行分析。我们的主要结局将是全因死亡率和严重不良事件。我们将在“结果总结”表中呈现我们的主要和次要结局，并使用 GRADE 评估来评估证据质量。