八段锦运动对左心室射血分数保留的心力衰竭（HFpEF）的有效性和安全性：一项系统评价与荟萃分析方案
Effectiveness and safety of Baduanjin exercise (BDJE) on heart failure with preserved left ventricular ejection fraction (HFpEF): A protocol for systematic review and meta-analysis.
作者信息
Chen Mingtai, Ou Lijun, Chen Yingnan, Men Ling, Zhong Xiaoling, Yang Shudong, Luan Jienan
机构信息
Department of Cardiovascular Disease.
Nephrology Department.
出版信息
Medicine (Baltimore). 2020 Nov 13;99(46):e22994. doi: 10.1097/MD.0000000000022994.
BACKGROUND
Nearly half of the heart failure (HF) patients have been classified as HF with preserved left ventricular ejection fraction (HFpEF) and the prevalence has been increasing over time. The subject of this study is to assess the clinical effectiveness and safety of Baduanjin exercise (BDJE), as a kind of traditional Chinese exercises, for HFpEF patients.
METHODS
A systematic literature search for articles up to September 2020 will be performed in following electronic databases: PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP) Database, Chinese Biomedical Database (CBM), Chinese Biomedical Literature Service System (SinoMed) and Wanfang Database. Inclusion criteria are randomized controlled trials of BDJE applied on HFpEF patients. The primary outcome measures will be exercise capacity (cardiopulmonary exercise test or 6-minute walking test) and quality of life. The secondary outcomes will be as the following: blood pressure, heart rate, echocardiography, endothelial function, arterial stiffness and hypersensitive C-reactive protein and N-Terminal pro-B-type natriuretic peptide. The safety outcome measures will be adverse events, liver and kidney function. RevMan 5.3 software will be used for data synthesis, sensitivity analysis, subgroup analysis and risk of bias assessment. A funnel plot will be developed to evaluate reporting bias. Stata 12.0 will be used for meta-regression and Egger tests. We will use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to assess the quality of evidence.
CONCLUSION
The study will give an explicit evidence to evaluate the effectiveness and safety of BDJE for HFpEF patients.
ETHICS AND DISSEMINATION
This systematic review does not require ethics approval and will be submitted to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
PROSPERO CRD42020200324.
背景
近一半的心力衰竭（HF）患者被归类为左心室射血分数保留的心力衰竭（HFpEF），且其患病率随时间不断上升。本研究的主题是评估八段锦锻炼（BDJE）作为一种传统中医疗法，对HFpEF患者的临床有效性和安全性。
方法
将在以下电子数据库中系统检索截至2020年9月的文章：PubMed、Embase、Cochrane图书馆、中国知网（CNKI）、维普中文科技期刊数据库（VIP数据库）、中国生物医学数据库（CBM）、中国生物医学文献服务系统（SinoMed）和万方数据库。纳入标准为应用于HFpEF患者的BDJE随机对照试验。主要结局指标将是运动能力（心肺运动试验或6分钟步行试验）和生活质量。次要结局如下：血压、心率、超声心动图、内皮功能、动脉僵硬度、超敏C反应蛋白和N末端B型脑钠肽前体。安全性结局指标将是不良事件、肝肾功能。将使用RevMan 5.3软件进行数据合成、敏感性分析、亚组分析和偏倚风险评估。将绘制漏斗图以评估报告偏倚。将使用Stata 12.0进行meta回归和Egger检验。我们将使用推荐分级评估、制定和评价（GRADE）系统来评估证据质量。
结论
本研究将为评估BDJE对HFpEF患者的有效性和安全性提供明确证据。
伦理与传播
本系统评价无需伦理批准，并将提交给同行评审期刊。
试验注册号
PROSPERO CRD42020200324。
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