A feasibility double-blind trial of levothyroxine vs. levothyroxine-liothyronine in postsurgical hypothyroidism.

IF 3.9 2区医学 Q2 ENDOCRINOLOGY & METABOLISM

Frontiers in Endocrinology Pub Date : 2025-03-10 eCollection Date: 2025-01-01 DOI:10.3389/fendo.2025.1522753

Giao Q Phan, Sahzene Yavuz, Angeliki M Stamatouli, Ritu Madan, Shanshan Chen, Amelia C Grover, Naris Nilubol, Pablo Bedoya, Cory Trankle, Roshanak Markley, Antonio Abbate, Francesco S Celi

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引用次数: 0

Abstract

Context: Despite normalization of Thyrotropin (TSH), some patients with hypothyroidism treated with Levothyroxine (LT4) report residual symptoms which may be attributable to loss of endogenous triiodothyronine (T3).

Objective: Feasibility trial LT4/liothyronine (LT3) combination vs. LT4/placebo in post-surgical hypothyroidism.

Design: Double-blind, placebo-controlled, 24-week study.

Setting: Academic medical center.

Patients: Individuals with indications for total thyroidectomy and replacement therapy.

Interventions: LT4/LT3 5 mcg (twice daily) vs. LT4/placebo (twice daily). LT4 was adjusted at 6- and 12-weeks with the goal of baseline TSH ± 0.5 mcIU/ml.

Main outcome measures: Changes in body weight, cholesterol, TSH, total T3, free tetraiodothyronine (T4). Cardiovascular function, energy expenditure, and quality of life (ThyPRO-39) were assessed in patients who completed at least the 3-month visit, last measure carried-forward.

Results: Twelve patients (10 women and 2 men), age 51 ± 13.8 years (7 LT4/placebo, 5 LT4/LT3), were analyzed. No significant differences were observed in TSH. Following thyroidectomy, LT4/placebo resulted in higher free T4 + 0.26 ± 0.15 p<0.005 and lower total T3 -18 ± 9.6 ng/dl p<0.003, respectively, not observed in the LT4/LT3 group. The LT4/placebo group had a non-significant increase in body weight, +1.7 ± 3.8 Kg, total- and LDL-cholesterol +43.1 ± 72.8 and +32.0 ± 64.4 mg/dl. Conversely the LT4/LT3 group changes were -0.6 ± 1.9 Kg, -28.8 ± 49.0 and -19.0 ± 28.3 mg/dl, respectively, all non-significant. Non-significant improvement were observed in ThyPRO-39 measures in both groups, while energy expenditure, and diastolic function increased in the LT4/LT3 group.

Conclusions: In this group of patients with post-surgical hypothyroidism LT4 replacement alone does not normalize free T4 and total T3 levels and is associated with non-significant increase in weight and cholesterol. LT4/LT3 combination therapy appears to prevent these changes.

Clinical trial registration: Clinicatrials.gov, identifier NCT05682482.

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左甲状腺素与左甲状腺素-碘甲状腺原氨酸治疗术后甲状腺功能减退的可行性双盲试验。

背景：尽管促甲状腺素（TSH）恢复正常，一些接受左旋甲状腺素（LT4）治疗的甲状腺功能减退患者仍报告残留症状，这可能是由于内源性三碘甲状腺原氨酸（T3）的丢失。目的：探讨LT4/碘甲状腺原氨酸（LT3）联合用药与LT4/安慰剂治疗术后甲状腺功能减退的可行性。设计：双盲，安慰剂对照，为期24周的研究。环境：学术医疗中心。患者：有甲状腺全切除术和替代治疗适应症的个体。干预措施：LT4/LT3 5微克（每日2次）vs LT4/安慰剂（每日2次）。在第6周和第12周调整LT4，目标是基线TSH±0.5 mcIU/ml。主要观察指标：体重、胆固醇、TSH、总T3、游离四碘甲状腺原氨酸（T4）的变化。对完成至少3个月随访的患者的心血管功能、能量消耗和生活质量（ThyPRO-39）进行评估。结果：12例患者（女性10例，男性2例），年龄51±13.8岁（LT4/安慰剂组7例，LT4/LT3组5例）。TSH无明显差异。在甲状腺切除术后，LT4/安慰剂导致更高的游离T4 + 0.26±0.15 p结论：在这组术后甲状腺功能减退患者中，单独更换LT4不能使游离T4和总T3水平正常化，并且与体重和胆固醇的无显著增加相关。LT4/LT3联合治疗似乎可以预防这些变化。临床试验注册：clinatrials .gov，标识符NCT05682482。

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来源期刊

Frontiers in Endocrinology Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

5.70

自引率

9.60%

发文量

3023

审稿时长

14 weeks

期刊介绍： Frontiers in Endocrinology is a field journal of the "Frontiers in" journal series. In today’s world, endocrinology is becoming increasingly important as it underlies many of the challenges societies face - from obesity and diabetes to reproduction, population control and aging. Endocrinology covers a broad field from basic molecular and cellular communication through to clinical care and some of the most crucial public health issues. The journal, thus, welcomes outstanding contributions in any domain of endocrinology. Frontiers in Endocrinology publishes articles on the most outstanding discoveries across a wide research spectrum of Endocrinology. The mission of Frontiers in Endocrinology is to bring all relevant Endocrinology areas together on a single platform.