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接受左甲状腺素治疗的老年患者年龄相关血清促甲状腺激素参考范围:一项随机对照可行性试验(SORTED 1)

Age-Related Serum Thyroid-Stimulating Hormone Reference Range in Older Patients Treated with Levothyroxine: A Randomized Controlled Feasibility Trial (SORTED 1).

作者信息

Razvi Salman, Ryan Vicky, Ingoe Lorna, Pearce Simon H, Wilkes Scott

机构信息

Institute of Genetic Medicine, Newcastle University, Newcastle, United Kingdom.

Department of Endocrinology, Gateshead Health NHS Foundation Trust, Gateshead, United Kingdom.

出版信息

Eur Thyroid J. 2020 Jan;9(1):40-48. doi: 10.1159/000504047. Epub 2019 Nov 21.

DOI:10.1159/000504047
PMID:32071901
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7024859/
Abstract

INTRODUCTION

Serum thyroid-stimulating hormone (TSH) increases with age but target TSH is similar in younger and older hypothyroid patients on treatment. It is unknown if quality of life (QoL), hypothyroid symptoms and cardiovascular risk factors change in older hypothyroid patients treated to an age-appropriate reference range.

OBJECTIVE

To assess if a higher target serum TSH of 4.01-8.0 mU/L is feasible in, and acceptable to, older treated hypothyroid patients.

METHODS

A single-blind (participant) randomised controlled feasibility trial involving 48 hypothyroid patients aged ≥80 years on established and stable levothyroxine (LT4) therapy with serum TSH levels within the standard reference range (0.4-4.0 mU/L) was conducted. Standard (0.4-4.0 mU/L) or higher (4.1-8.0 mU/L) TSH target (standard TSH [ST] or higher TSH [HT] groups) LT4 for 24 weeks was administered. The outcome measures evaluated were thyroid function tests, QoL, hypothyroid symptoms, cardiovascular risk factors and serum marker of bone resorption in participants that completed the trial ( = 21/24 ST group, = 19/24 HT group).

RESULTS

At 24 weeks, in the ST and HT groups, respectively, median (interquartile range) serum TSH was 1.25 (0.76-1.72) and 5.50 (4.05-9.12) mU/L, mean (± SD) free thyroxine (FT4) was 19.4 ± 3.5 and 15.9 ± 2.4 pmol/L, and daily LT4 dose was 82.1 ± 26.4 and 59.2 ± 23.9 µg. There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed.

CONCLUSIONS

In hypothyroid patients aged ≥80 years on LT4 therapy for 24 weeks, there was no evidence that a higher target serum TSH was associated with an adverse impact on patient reported outcomes, cardiovascular risk factors or bone resorption marker over 24 weeks. Longer-term trials assessing morbidity and mortality outcomes and health-utility in this age group are feasible and should be performed.

摘要

引言

血清促甲状腺激素(TSH)水平随年龄增长而升高,但接受治疗的年轻和老年甲状腺功能减退患者的目标TSH水平相似。对于接受治疗至适合其年龄的参考范围的老年甲状腺功能减退患者,生活质量(QoL)、甲状腺功能减退症状和心血管危险因素是否会发生变化尚不清楚。

目的

评估将较高的目标血清TSH设定为4.01 - 8.0 mU/L对接受治疗的老年甲状腺功能减退患者是否可行且可接受。

方法

进行了一项单盲(参与者)随机对照可行性试验,纳入48例年龄≥80岁、正在接受稳定左旋甲状腺素(LT4)治疗且血清TSH水平在标准参考范围(0.4 - 4.0 mU/L)内的甲状腺功能减退患者。给予标准(0.4 - 4.0 mU/L)或更高(4.1 - 8.0 mU/L)TSH目标(标准TSH [ST]组或更高TSH [HT]组)的LT4治疗24周。对完成试验的参与者(ST组21/24例,HT组19/24例)评估的结局指标包括甲状腺功能测试QoL、甲状腺功能减退症状、心血管危险因素和骨吸收血清标志物。

结果

24周时,ST组和HT组的血清TSH中位数(四分位间距)分别为1.25(0.76 - 1.72)mU/L和5.50(4.05 - 9.12)mU/L,游离甲状腺素(FT4)均值(±标准差)分别为19.4 ± 3.5和15.9 ± 2.4 pmol/L,每日LT4剂量分别为82.1 ± 26.4和59.2 ± 23.9 μg。在评估的任何结局方面,均未提示HT组较高的血清TSH有不良影响。

结论

在接受LT4治疗24周的≥80岁甲状腺功能减退患者中,没有证据表明较高的目标血清TSH在24周内会对患者报告的结局、心血管危险因素或骨吸收标志物产生不良影响。评估该年龄组发病率、死亡率结局和健康效用的长期试验是可行的,应该进行。

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