Effects of Evening vs Morning Levothyroxine Intake A Randomized Double-blind Crossover Trial
Effects of Evening vs Morning Levothyroxine Intake A Randomized Double-blind Crossover Trial
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DOI：
10.1001/archinternmed.2010.436
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发表时间：
2010-12-13
影响因子：
--
通讯作者：
Berghout, Arie
中科院分区：
文献类型：
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作者：
Bolk, Nienke;Visser, Theo J.;Berghout, Arie
背景：左旋甲状腺素钠被广泛用于治疗原发性甲状腺功能减退症。人们一致认为，左旋甲状腺素应该在早上空腹服用。一项初步研究表明，睡前摄入左旋甲状腺素显著降低促甲状腺激素水平，增加游离甲状腺激素和总三碘甲腺原氨酸水平。到目前为止，还没有大型随机试验研究左旋甲状腺素的最佳摄入时间，包括生活质量评估。方法：为了确定在睡前而不是在早上摄入左旋甲状腺素是否能改善甲状腺激素水平，在2007年4月1日至2008年11月30日期间，在荷兰鹿特丹马斯塔医院连续105名原发性甲状腺功能减退症患者中进行了随机双盲交叉试验。在6个月的时间里，患者被告知早上服用一粒胶囊，睡前服用一粒胶囊(一粒含有左旋甲状腺素，另一粒是安慰剂)，3个月后更换。主要结果是甲状腺激素水平；次要结果指标是肌酐和血脂水平、体重指数、心率和生活质量。结果：90名患者完成试验并可供分析。睡前服用左旋甲状腺素的直接疗效为促甲状腺激素水平下降1.25mIU/L(95%可信区间0.60~1.89mIU/L；P
Background: Levothyroxine sodium is widely prescribed to treat primary hypothyroidism. There is consensus that levothyroxine should be taken in the morning on an empty stomach. A pilot study showed that levothyroxine intake at bedtime significantly decreased thyrotropin levels and increased free thyroxine and total triiodothyronine levels. To date, no large randomized trial investigating the best time of levothyroxine intake, including quality-of-life evaluation, has been performed.Methods: To ascertain if levothyroxine intake at bedtime instead of in the morning improves thyroid hormone levels, a randomized double-blind crossover trial was performed between April 1, 2007, and November 30, 2008, among 105 consecutive patients with primary hypothyroidism at Maasstad Hospital Rotterdam in the Netherlands. Patients were instructed during 6 months to take 1 capsule in the morning and 1 capsule at bedtime (one containing levothyroxine and the other a placebo), with a switch after 3 months. Primary outcome measures were thyroid hormone levels; secondary outcome measures were creatinine and lipid levels, body mass index, heart rate, and quality of life.Results: Ninety patients completed the trial and were available for analysis. Compared with morning intake, direct treatment effects when levothyroxine was taken at bedtime were a decrease in thyrotropin level of 1.25 mIU/L (95% confidence interval [CI], 0.60-1.89 mIU/L; P