左甲状腺素单药治疗降低老年亚临床甲状腺功能减退症患者心血管疾病风险的疗效和安全性：一项多中心、开放标签、随机对照试验的研究方案

Efficacy and safety of levothyroxine monotherapy in lowering the risk of cardiovascular disease in older adults with subclinical hypothyroidism: research protocols of a multicenter, open-label, randomized controlled trial.

作者信息

Xu Chong, Zhou Hui, Lu Xiaofan, Xu Shuhang, Sun Yu

机构信息

Department of Endocrinology and Metabolism, The Affiliated Suqian Hospital of Xuzhou Medical University, Suqian, 223800, China.

Department of Endocrinology and Metabolism, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, 210028, China.

出版信息

Trials. 2025 May 15;26(1):161. doi: 10.1186/s13063-025-08857-z.

DOI:10.1186/s13063-025-08857-z

PMID:40375293

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12083150/

Abstract

OBJECTIVE

This multicenter, open-label, randomized controlled trial (RCT) aims to assess the efficacy and safety of levothyroxine monotherapy in lowering the risk of cardiovascular disease (CVD) in untreated older adults with subclinical hypothyroidism (SCH) who are diagnosed according to population-specific TSH reference values.

METHODS

A total of 254 patients with SCH who meet the diagnostic criteria will be recruited, and the baseline clinical data of the patients will be collected. Then, a total of 127 patients will be randomly divided into each of the treatment and control groups, and the treatment group will receive daily levothyroxine doses (Merck Euthyrox® levothyroxine 50 mcg tablet). Specifically, 50 µg of levothyroxine per day will be administered to patients in the treatment group (or 25 µg to patients with a body weight < 50 kg) for at least 48 weeks to maintain thyroid-stimulating hormone (TSH) levels within the normal range. The participants in the control group will be subjected only to thyroid status evaluation, and the results will be recorded. The participants will complete five visits before and after the start of the trial, and differences in the change in carotid intima-media thickness (CIMT), maximum mean change in plaque burden, and changes in lipid profiles, bone mineral densities, and incidences of fatal and nonfatal cardiovascular events between the initial visit and the last follow-up visit will be evaluated via vascular ultrasound.

DISCUSSION

We will explicitly address whether levothyroxine replacement therapy provides cardiovascular benefits for older adults with subclinical hypothyroidism.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, No. ChiCTR2400092634. Registered on 30 November 2024. Recruitment for this study began on December 1, 2024, and continues until at least until November 30, 2025.

摘要

目的

本多中心、开放标签、随机对照试验（RCT）旨在评估左甲状腺素单药治疗在降低根据特定人群促甲状腺激素（TSH）参考值诊断的未经治疗的老年亚临床甲状腺功能减退症（SCH）患者心血管疾病（CVD）风险方面的疗效和安全性。

方法

共招募254例符合诊断标准的SCH患者，收集患者的基线临床数据。然后，将127例患者随机分为治疗组和对照组，治疗组患者将接受每日左甲状腺素剂量（默克优甲乐®左甲状腺素50μg片剂）。具体而言，治疗组患者每天给予50μg左甲状腺素（体重<50kg的患者给予25μg），持续至少48周，以维持促甲状腺激素（TSH）水平在正常范围内。对照组参与者仅接受甲状腺状态评估，并记录结果。参与者将在试验开始前后完成五次访视，并通过血管超声评估初次访视和末次随访之间颈动脉内膜中层厚度（CIMT）变化、斑块负荷最大平均变化以及血脂谱、骨密度和致命及非致命心血管事件发生率的差异。