荷兰莱顿大学医学中心Jacobijn Gussekloo团队在最新研究中,分析了80岁及以上亚临床甲状腺功能减退症患者左甲状腺素治疗与甲状腺相关症状的关系。相关论文2019年10月30日在线发表在《美国医学会杂志》上。
目前,尚未清楚左甲状腺素治疗80岁及以上亚临床甲状腺功能减退(甲减)患者是否可临床获益。
2013年4月至2018年5月,研究组进行了一项前瞻性的随机临床试验,招募社区内251名80岁及以上患有亚临床甲减的居民,将其随机分为两组,其中112名接受左甲状腺素进行治疗,139名接受安慰剂治疗。采用甲状腺疾病患者生活质量(ThyPRO)调查问卷对参与者的甲减症状和疲劳程度进行评估,0-100分,分数越高表示生活质量越差。
Title: Association Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism
Author: Simon P. Mooijaart, Robert S. Du Puy, David J. Stott, Patricia M. Kearney, Nicolas Rodondi, Rudi G. J. Westendorp, Wendy P. J. den Elzen, Iris Postmus, Rosalinde K. E. Poortvliet, Diana van Heemst, Barbara C. van Munster, Robin P. Peeters, Ian Ford, Sharon Kean, Claudia-Martina Messow, Manuel R. Blum, Tinh-Hai Collet, Torquil Watt, Olaf M. Dekkers, J. Wouter Jukema, Johannes W. A. Smit, Peter Langhorne, Jacobijn Gussekloo
Issue&Volume: October 30, 2019
Abstract:
Importance It is unclear whether levothyroxine treatment provides clinically important benefits in adults aged 80 years and older with subclinical hypothyroidism.
Objective To determine the association of levothyroxine treatment for subclinical hypothyroidism with thyroid-related quality of life in adults aged 80 years and older.
Design, Setting, and Participants Prospectively planned combined analysis of data involving community-dwelling adults aged 80 years and older with subclinical hypothyroidism. Data from a randomized clinical trial were combined with a subgroup of participants aged 80 years and older from a second clinical trial. The trials were conducted between April 2013 and May 2018. Final follow-up was May 4, 2018.
Exposures Participants were randomly assigned to receive levothyroxine (n = 112; 52 participants from the first trial and 60 from the second trial) or placebo (n = 139; 53 participants from the first trial and 86 from the second trial).
Main Outcomes and Measures Co-primary outcomes were Thyroid-Related Quality of Life Patient-Reported Outcome (ThyPRO) questionnaire scores for the domains of hypothyroid symptoms and tiredness at 1 year (range, 0-100; higher scores indicate worse quality of life; minimal clinically important difference, 9).
Results Of 251 participants (mean age, 85 years; 118 [47%] women), 105 were included from the first clinical trial and 146 were included from the second clinical trial. A total of 212 participants (84%) completed the study. The hypothyroid symptoms score decreased from 21.7 at baseline to 19.3 at 12 months in the levothyroxine group vs from 19.8 at baseline to 17.4 at 12 months in the placebo group (adjusted between-group difference, 1.3 [95% CI, −2.7 to 5.2]; P = .53). The tiredness score increased from 25.5 at baseline to 28.2 at 12 months in the levothyroxine group vs from 25.1 at baseline to 28.7 at 12 months in the placebo group (adjusted between-group difference, −0.1 [95% CI, −4.5 to 4.3]; P = .96). At least 1 adverse event occurred in 33 participants (29.5%) in the levothyroxine group (the most common adverse event was cerebrovascular accident, which occurred in 3 participants [2.2%]) and 40 participants (28.8%) in the placebo group (the most common adverse event was pneumonia, which occurred in 4 [3.6%] participants).
Conclusions and Relevance In this prospectively planned analysis of data from 2 clinical trials involving adults aged 80 years and older with subclinical hypothyroidism, treatment with levothyroxine, compared with placebo, was not significantly associated with improvement in hypothyroid symptoms or fatigue. These findings do not support routine use of levothyroxine for treatment of subclinical hypothyroidism in adults aged 80 years and older.
DOI: 10.1001/jama.2019.17274
Source: https://jamanetwork.com/journals/jama/article-abstract/2753909
JAMA-Journal of The American Medical Association:《美国医学会杂志》,创刊于1883年。隶属于美国医学协会,最新IF:51.273
官方网址:https://jamanetwork.com/
投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex