Partial substitution of thyroxine (T4) with tri-iodothyronine in patients on T4 replacement therapy: Results of a large community-based randomized controlled trial
Partial substitution of thyroxine (T4) with tri-iodothyronine in patients on T4 replacement therapy: Results of a large community-based randomized controlled trial
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DOI：
10.1210/jc.2004-1672
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发表时间：
2005-02-01
影响因子：
5.8
通讯作者：
Dayan, CM
中科院分区：
文献类型：
--
作者：
Saravanan, P;Simmons, DJ;Dayan, CM
最近发表了关于联合T-4和T-3治疗甲状腺功能减退症患者的益处的证实结果。然而，这些研究可能没有足够的力量来检测与T-4替代相关的心理健康差异。我们在697名甲状腺功能减退患者中进行了一项大型、双盲、随机对照试验，用10 μ g T-3部分替代50 μ g T-4与原始剂量的T-4。甲状腺功能显示TSH升高（132%），游离T-4下降（35%，P < 0.001），基础游离T无变化。水平（P = 0.92）。在3个月时，与基线相比，对照组中由一般健康问卷（GHQ）12评分定义的精神病病例有较大（39%）的安慰剂效应改善，并且这种改善在12个月时持续。与干预组（T-3）相比，GHQ病例数的改善更为温和（比值比，0.61; 95%置信区间，0.42，0.90; P = 0.01）和3个月时的医院焦虑和抑郁量表焦虑评分（P < 0.03），但没有GHQ Likert评分，医院焦虑和抑郁，焦虑抑郁，甲状腺症状，或情绪的视觉模拟量表，最初的差异在12个月时消失。这些结果可能与T部分替代后表现出短暂改善的患者亚组一致。但没有提供T-4替代患者中T-3部分替代T-4的具体益处的结论性证据。他们还强调了甲状腺激素给药变化后产生的巨大而持续的安慰剂效应。
Conflicting results have recently been published about the benefits of combined T-4 and T-3 in treating hypothyroid patients. However, these studies may have been underpowered to detect differences in psychological well-being specifically related to T-4 replacement. We conducted a large, double-blind, randomized controlled trial of partial substitution of 50 mug T-4 by 10 mug T-3 vs. the original dose of T-4 in 697 hypothyroid patients. Thyroid function showed a rise in TSH (132%), a fall in free T-4 (35%, P < 0.001), and unchanged basal free T. levels (P = 0.92). At 3 months, there was a large (39%) placebo effect improvement in psychiatric caseness defined by the General Health Questionnaire (GHQ) 12 score in the control group compared with baseline, and this was sustained at 12 months. Differences vs. the intervention (T-3) group were more modest with improvements in GHQ caseness (odds ratio, 0.61; 95% confidence interval, 0.42, 0.90; P = 0.01) and Hospital Anxiety and Depression questionnaire-anxiety scores at 3 months (P < 0.03) but not GHQ Likert scores, Hospital Anxiety and Depression questionnaire-depression, thyroid symptoms, or visual analog scales of mood and the initial differences were lost at 12 months. These results may be consistent with a subgroup of patients showing transient improvement after partial substitution with T. but do not provide conclusive evidence of specific benefit from partial substitution of T-4 by T-3 in patients on T-4 replacement. They also emphasize the large and sustained placebo effect that can follow changes in thyroid hormone administration.