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レボチロキシン(チラーヂンS)の服用時間による効果の差ー夜と朝の効果の違い

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2010年12月19日(Sun) 08:40

これまで何回も議論されてきた、甲状腺ホルモン薬(レボサイロシキン)の
服用時間の問題です。

これまでの結果では、従来通り朝空腹時服用が、吸収が安定し、
結果として甲状腺機能も安定する、というものでした。

今回の論文は、夜(就寝時)服用のほうが、
甲状腺機能が良い値を示す、という結果を出しています。

研究としては対象群(解析は90例)がそれほど多くありませんが、
質の高い研究での結果ですので、信頼性は高いと言えます。

ただし、18歳以上の対象群で、平均年齢が47~48歳ですから、
小児患者にそのまま適用できるわけではありません。

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Effects of Evening vs Morning Levothyroxine Intake
レボチロキシン(チラーヂンS)の服用時間による効果の差ー夜と朝の効果の違い

A Randomized Double-blind Crossover Trial

Nienke Bolk, MD; Theo J. Visser, PhD; Judy Nijman, BSc; Ineke J. Jongste, RN;
Jan G. P. Tijssen, PhD; Arie Berghout, MD, PhD, FRCP

Arch Intern Med. 2010;170(22):1996-2003. doi:10.1001/archinternmed.2010.436

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.

オランダで2007年4月1日~2008年11月30日に、
105例の原発性甲状腺機能低下症を対象に、
無作為化対照試験として行われた。

甲状腺ホルモン薬か偽薬どちらかの含まれたカプセルを、
朝晩1カプセルずつ服用(つまり朝ホルモン薬+夜偽薬、
あるいは朝偽薬+夜ホルモン薬どちらか、患者は知らない)。

甲状腺ホルモン濃度、脂質代謝や生活の質を効果の指標とした。

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 < .001), an increase in free thyroxine level of 0.07 ng/dL
(0.02-0.13 ng/dL; P = .01), and an increase in total triiodothyronine level of 6.5 ng/dL
(0.9-12.1 ng/dL; P = .02) (to convert thyrotropin level to micrograms per liter,
multiply by 1.0; free thyroxine level to picomoles per liter, multiply by 12.871; and
total triiodothyronine level to nanomoles per liter, multiply by 0.0154). Secondary
outcomes, including quality-of-life questionnaires (36-Item Short Form Health Survey,
Hospital Anxiety and Depression Scale, 20-Item Multidimensional Fatigue Inventory,
and a symptoms questionnaire), showed no significant changes between morning vs bedtime
intake of levothyroxine.

最終的に95例のデータで、
夜(就寝時)服用のほうがTSHが低値で、T4高値、二次指標に差はなかった。

Conclusions  Levothyroxine taken at bedtime significantly improved thyroid hormone levels.
Quality-of-life variables and plasma lipid levels showed no significant changes with
bedtime vs morning intake. Clinicians should consider prescribing levothyroxine intake at bedtime.

レボチロキシンは夜(就寝時)服用が勧められる。

Trial Registration  isrctn.org Identifier: ISRCTN17436693 (NTR959).


Author Affiliations: Department of Internal Medicine, Maasstad Hospital Rotterdam, Rotterdam
(Drs Bolk and Berghout and Mss Nijman and Jongste), Department of Endocrinology, Erasmus Medical
Center Rotterdam, Rotterdam (Dr Visser), and Department of Cardiology, Academic Medical Center,
University of Amsterdam, Amsterdam (Dr Tijssen), the Netherlands.


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