在完全切除甲状腺的受试者中,随机双盲,安慰剂控制的Levothyroxine和Liothyronine联合治疗试验:LEVOLIO研究
Giulia Brigante1,2, Daniele Santi1,2, Gisella Boselli1
1Unit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, 41124 Modena, Italy.
European journal of endocrinology
|December 21, 2023
概括
每天两次使用levothyroxine (LT4) 和liothyronine (LT3) 的联合治疗并没有改善皮质功能低下患者的外周组织标志物或生活质量. 结合疗法没有显示出与标准治疗相比显著的益处,尽管改变了甲状腺激素的比率.
科学领域:
- 内分泌学 在内分泌学.
- 甲状腺学 甲状腺学
- 药理学 药理学是指药理学的学科.
背景情况:
- 许多甲状腺功能低下的患者仍然对利沃甲状腺素 (LT4) 单疗法不满意,即使甲状腺刺激激素 (TSH) 水平正常.
- 作为一种替代方案,正在探索使用LT4和liothyronine (LT3) 的组合疗法,但其对外围组织和生活质量的影响需要进一步研究.
研究的目的:
- 在完全切除甲状腺的患者中,评估每天两次联合治疗 (LT4 + LT3) 与LT4单疗对外周组织标记物,特别是性激素结合球蛋白 (SHBG) 的影响.
- 评估其他组织标志物的变化,生活质量,以及遗传变异 (DIO2,MCT10) 对治疗结果的影响.
主要方法:
- 这是一项双盲,随机,安慰剂对照试验,涉及141名完全切除甲状腺的患者.
- 参与者接受了LT4 + LT3 (每天两次) 或LT4 +安慰剂6个月,TSH水平指导剂量调整.
- 评估包括垂体-甲状腺轴补偿,临床参数,生活质量,组织标记 (SHBG,脂质,骨标记) 和DIO2和MCT10多态的基因定型.
主要成果:
- 6个月后,在LT4 + LT3和安慰剂组之间没有观察到SHBG,其他组织标志物或生活质量的显著差异.
- 组合疗法需要更频繁的剂量调整来维持TSH水平,但没有甲状腺功能障碍的迹象.
- 与LT4+安慰剂组相比,LT4+LT3组表现出明显更高的FT3/FT4比率,这表明外围激素转化发生了变化.
结论:
- 六个月每天两次使用LT3的联合治疗,剂量调整为TSH,在甲状腺切除患者中没有显著改善周围组织反应或生活质量.
- 尽管fT3/fT4比率增加,但组合疗法在这个队列中没有比标准LT4治疗提供明显的优势.
- 基因变异DIO2和MCT10似乎没有影响组合治疗的结果.
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