Negro Roberto, Valcavi Roberto, Agrimi Daniela, Toulis Konstantinos A
Division of Endocrinology, "V. Fazzi" Hospital, Lecce, Italy.
Division of Endocrinology, Istituto di Ricovero e Cura a Carattere Scientifico, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.
Endocr Pract. 2014 Sep;20(9):901-6. doi: 10.4158/EP13378.OR.
Although replacement treatment with L-thyroxine (LT4) seems easy to manage, about one-third of hypothyroid patients show thyroid-stimulating hormone (TSH) values outside the normal range.
To explore whether LT4 liquid formulation (monodose vials or drops) affects TSH stability values and to assess its ability to maintain TSH within the normal range compared to tablets.
A total of 100 hypothyroid patients on replacement treatment with LT4 liquid solution were enrolled (Liquid Group) at a follow-up visit (revisit). The inclusion criteria were 1) treatment for surgical hypothyroidism for at least 2 years or autoimmune hypothyroidism for at least 5 years, 2) normal TSH at the previous visit 12 months before enrollment (baseline visit), and 3) maintenance of the same LT4 dosage during the time interval between the baseline and the follow-up visit. Using the same selection process, we also enrolled 100 hypothyroid patients on replacement treatment with LT4 tablets (Tablet Group).
At the follow-up visit, 19 patients of the Tablet Group and 8 patients of the Liquid Group had abnormal TSH values (P = .023). Weekly and daily LT4 dosage per kilogram were higher in Tablet Group (P = .016 and .006, respectively). The magnitude of TSH change from baseline to follow-up visit was greater in the Tablet Group (P<.001).
The use of LT4 liquid formulation compared to tablet resulted in a significantly higher number of hypothyroid patients who maintained the euthyroid state in a 12-month follow-up period and a reduced variability in TSH values.
尽管左甲状腺素(LT4)替代治疗似乎易于管理,但约三分之一的甲状腺功能减退患者的促甲状腺激素(TSH)值超出正常范围。
探讨LT4液体制剂(单剂量瓶或滴剂)是否会影响TSH稳定性值,并评估其与片剂相比将TSH维持在正常范围内的能力。
共有100名接受LT4液体制剂替代治疗的甲状腺功能减退患者在随访就诊时被纳入(液体组)。纳入标准为:1)因手术导致的甲状腺功能减退治疗至少2年或自身免疫性甲状腺功能减退治疗至少5年;2)入组前12个月(基线就诊)TSH正常;3)在基线和随访就诊期间维持相同的LT4剂量。采用相同的筛选过程,我们还纳入了100名接受LT4片剂替代治疗的甲状腺功能减退患者(片剂组)。
在随访就诊时,片剂组有19名患者,液体组有8名患者的TSH值异常(P = 0.023)。片剂组每千克体重的每周和每日LT4剂量更高(分别为P = 0.016和0.006)。从基线到随访就诊时TSH变化的幅度在片剂组中更大(P<0.001)。
与片剂相比,使用LT4液体制剂导致在12个月的随访期内维持甲状腺功能正常状态的甲状腺功能减退患者数量显著增加,且TSH值的变异性降低。