Azizi F, Moeini A S, Mehran L, Masoumi S, Abdi H, Foroutan S M, Saghafinia A E, Amouzegar A
Endocrine Research Center, Research Institute for Endocrine Disorders, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
J Clin Transl Endocrinol. 2025 Apr 23;40:100395. doi: 10.1016/j.jcte.2025.100395. eCollection 2025 Jun.
Some patients with hypothyroidism lack satisfaction with levothyroxine (LT4) monotherapy, which may be related to lower serum triiodothyronine (T3) and T3/T4 ratios compared to control individuals. This study aimed to evaluate the efficacy and safety of a combination therapy of slow-release T3 (SRT3) and LT4 in patients with primary hypothyroidism compared with LT4 monotherapy.
Thirty-two hypothyroid women were randomized into two groups of SRT3 + LT4 combination and LT4 monotherapy. Group one received a combination of 15 µg SRT3 and 75 µg LT4, and group two received 100 µg LT4 daily for 8 weeks. Clinical and biochemical measurements were performed at baseline and 4 to 8 weeks after intervention.
There were no significant changes in serum levels of fT4, T3, TSH, and T3/fT4 ratio in the LT4 group at the end of 4 to 8 weeks of study. A statistically significant decrease in fT4 and TSH, and an increase in serum T3 and the T3/fT4 ratio, were observed in the SRT3 + LT4 group. The T3/fT4 ratio reached comparable values to those in normal subjects, 93.63 ± 23.25 vs 95.06 ± 19.44 ng/ng, respectively. The rise in the T3/fT4 ratio 8 weeks after SRT3 + LT4 treatment was between 21 % and 90 % in 10 patients and 1 % and 13 % in 5 patients, with no change in one patient.
The novel combination of SRT3 + LT4 therapy resulted in a significant increase in serum T3 and the T3/fT4 ratio in hypothyroid patients compared to those receiving LT4 monotherapy. The rise in the T3/fT4 ratio was ≥ 21 % in two-thirds of patients; the lack of a significant increase in the T3/fT4 ratio in some patients during SRT3-LT4 combination therapy demands further investigation.
一些甲状腺功能减退患者对左甲状腺素（LT4）单药治疗不满意，这可能与血清三碘甲状腺原氨酸（T3）水平及T3/T4比值低于对照组个体有关。本研究旨在评估与LT4单药治疗相比，缓释T3（SRT3）与LT4联合治疗原发性甲状腺功能减退患者的疗效和安全性。
32名甲状腺功能减退女性被随机分为SRT3 + LT4联合治疗组和LT4单药治疗组。第一组接受15μg SRT3与75μg LT4联合治疗，第二组每天接受100μg LT4治疗，为期8周。在基线及干预后4至8周进行临床和生化指标检测。
在研究的4至8周结束时，LT4组患者的血清游离甲状腺素（fT4）、T3、促甲状腺激素（TSH）水平及T3/fT4比值均无显著变化。在SRT3 + LT4组中，观察到fT4和TSH显著降低，血清T3及T3/fT4比值升高。T3/fT4比值达到了与正常受试者相当的值，分别为93.63±23.25与95.06±19.44 ng/ng。SRT3 + LT4治疗8周后，10名患者的T3/fT4比值升高21%至90%，5名患者升高1%至13%，1名患者无变化。
与接受LT4单药治疗的患者相比，SRT3 + LT4联合治疗这种新方法使甲状腺功能减退患者的血清T3及T3/fT4比值显著升高。三分之二的患者T3/fT4比值升高≥21%；在一些患者中，SRT3 - LT4联合治疗期间T3/fT4比值缺乏显著升高，这需要进一步研究。
