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六分钟步行试验作为心肌病临床试验的临床终点,包括ATTR-CM:系统文献回顾。

Six-minute walk test as clinical end point in cardiomyopathy clinical trials, including ATTR-CM: a systematic literature review.

机构信息

Department of Transplant, Mayo Clinic, Jacksonville, FL 32224, USA.

Division of Cardiovascular Imaging, University Hospital Münster, 48149, Münster, Germany.

出版信息

J Comp Eff Res. 2024 Jul;13(7):e230158. doi: 10.57264/cer-2023-0158. Epub 2024 Jun 13.

DOI:10.57264/cer-2023-0158
PMID:38869839
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11234454/
Abstract

The six-minute walk test (6MWT) is a common measure of functional capacity in patients with heart failure (HF). Primary clinical study end points in cardiomyopathy (CM) trials, including transthyretin-mediated amyloidosis with CM (ATTR-CM), are often limited to hospitalization and mortality. To investigate the relationship between the 6MWT and hospitalization or mortality in CM, including ATTR-CM. A PRISMA-guided systematic literature review was conducted using search terms for CM, 6MWT, hospitalization and mortality. Forty-one studies were identified that reported 6MWT data and hospitalization or mortality data for patients with CM. The data suggest that a greater 6MWT distance is associated with a reduced risk of hospitalization or mortality in CM. The 6MWT is an accepted alternative end point in CM trials, including ATTR-CM.

摘要

六分钟步行试验(6MWT)是心力衰竭(HF)患者功能能力的常用测量方法。原发性心肌病(CM)试验的主要临床研究终点通常仅限于住院和死亡率。为了研究 6MWT 与包括转甲状腺素介导的淀粉样变性伴心肌病(ATTR-CM)在内的 CM 患者住院或死亡率之间的关系。使用 CM、6MWT、住院和死亡率的搜索词进行了 PRISMA 指导的系统文献综述。确定了 41 项研究,这些研究报告了患有 CM 的患者的 6MWT 数据和住院或死亡率数据。数据表明,6MWT 距离越大,CM 患者住院或死亡率的风险越低。6MWT 是包括 ATTR-CM 在内的 CM 试验的可接受替代终点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/161a/11234454/4898c0150d49/cer-13-230158-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/161a/11234454/4898c0150d49/cer-13-230158-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/161a/11234454/4898c0150d49/cer-13-230158-g1.jpg

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