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甲状腺素治疗心力衰竭伴亚临床甲状腺功能减退症患者的疗效和安全性:系统评价和荟萃分析方案。

Efficacy and safety of thyroxine therapy on patients with heart failure and subclinical hypothyroidism: A protocol for systematic review and meta-analysis.

机构信息

Shandong University of Traditional Chinese Medicine.

Department of Traditional Chinese Medicine, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, ShanDong, China.

出版信息

Medicine (Baltimore). 2021 Jan 22;100(3):e23947. doi: 10.1097/MD.0000000000023947.

DOI:10.1097/MD.0000000000023947
PMID:33545971
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7837952/
Abstract

BACKGROUND

Subclinical hypothyroidism (SCH) can increase the risk of heart failure (HF) clinically. However, thyroxine therapy for patients with HF and SCH has the risk of developing tachyarrhythmias. At present, there is no sufficient evidence-based medical evidence for levothyroxine in the therapy of this situation, and the treatment issue is still controversial. Therefore, our meta-analysis aims to assess the effectiveness and safety of thyroxine therapy for patients with HF and SCH.

METHODS

We searched the related randomized controlled trials that have been published in the following 7 electronic databases: PubMed, Cochrane Library, EMBASE, Chongqing VIP, China National Knowledge Infrastructure, Chinese biomedical literature database, and Wan Fang database. The treatment group was treated with routine HF therapy plus thyroxine, while the control group was treated with HF routine therapy. Main outcome measures effective rate and New York Heart Association classification; Secondary outcome measures included: left ventricular ejection fraction, quality of life score, brain natriuretic peptide / N-terminal pro brain natriuretic peptide, 6-minute walk test, and adverse events. After screening studies and extracting data, we will use Cochrane collaborative tools to evaluate the risk of bias to assess the methodological quality of the included randomized controlled trials. We will use STATA 14.0 software for data synthesis and statistical analysis. Both subgroup analysis and sensitivity analysis will be used to detect potential sources of heterogeneity. In addition, we will use sensitivity analysis to test the stability of the outcomes. If possible, we will perform a funnel chart and Eggers test evaluate publication bias. The quality of the evidence will be evaluated through the grades of recommendations assessment, development, and evaluation system.

RESULTS

Our findings will be published in peer-reviewed journals.

CONCLUSION

This research will provide evidence about the efficacy and safety of thyroxine in the treatment of patients with HF and SCH. Objective to provide evidence-based medicine basis for thyroxine treatment of patients with SCH and HF.

REGISTRATION NUMBER

INPLASY2020100062.

摘要

背景

亚临床甲状腺功能减退症(SCH)可使心力衰竭(HF)患者的临床风险增加。然而,HF 伴 SCH 患者的甲状腺素治疗有发生心动过速的风险。目前,对于这种情况的左甲状腺素治疗尚无充分的循证医学证据,治疗问题仍存在争议。因此,我们的荟萃分析旨在评估 SCH 伴 HF 患者甲状腺素治疗的有效性和安全性。

方法

我们检索了以下 7 个电子数据库中已发表的相关随机对照试验:PubMed、Cochrane 图书馆、EMBASE、重庆 VIP、中国国家知识基础设施、中国生物医学文献数据库和万方数据库。治疗组采用常规 HF 治疗加甲状腺素治疗,对照组采用 HF 常规治疗。主要观察指标为有效率和纽约心功能分级;次要观察指标包括:左心室射血分数、生活质量评分、脑钠肽/氨基末端脑钠肽前体、6 分钟步行试验和不良反应。经过筛选研究和提取数据后,我们将使用 Cochrane 协作工具评估偏倚风险,以评估纳入的随机对照试验的方法学质量。我们将使用 STATA 14.0 软件进行数据合成和统计分析。将进行亚组分析和敏感性分析,以检测潜在的异质性来源。此外,我们将使用敏感性分析来测试结果的稳定性。如果可能,我们将进行漏斗图和 Eggers 检验评估发表偏倚。证据质量将通过推荐评估、开发和评估系统的等级进行评估。

结果

我们的研究结果将发表在同行评议的期刊上。

结论

本研究将提供关于甲状腺素治疗 SCH 伴 HF 患者的疗效和安全性的证据。目的是为 SCH 伴 HF 患者的甲状腺素治疗提供循证医学依据。

注册号

INPLASY2020100062。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3963/7837952/6a4fc64ccdd4/medi-100-e23947-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3963/7837952/6a4fc64ccdd4/medi-100-e23947-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3963/7837952/6a4fc64ccdd4/medi-100-e23947-g001.jpg

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