Cappelli Carlo, Pirola Ilenia, Gandossi Elena, Cristiano Alessandra, Daffini Linda, Agosti Barbara, Casella Claudio, Castellano Maurizio
Department of Medical and Surgical Sciences, Endocrine and Metabolic Unit, Clinica Medica, 2nd Medicina, University of Brescia, Spedali Civili di Brescia, 25123 Brescia, Italy.
Department of Molecular and Translational Medicine, 3rd Division of General Surgery, University of Brescia, Spedali Civili di Brescia, 25123 Brescia, Italy.
Int J Endocrinol. 2016;2016:9043450. doi: 10.1155/2016/9043450. Epub 2016 May 30.
Background. Recently, it has been shown that liquid L-T4 formulation can be ingested with breakfast. This study looked to extend these findings by investigating whether a soft gel capsule formulation of L-T4 could also be ingested at breakfast time. Methods. 60 patients (18-65 yrs), previously submitted to thyroidectomy for proven benign goitre in stable euthyroidism receiving liquid L-T4 therapy ingested with breakfast, were enrolled. TSH, fT4, and fT3 levels were assessed in all the patients who were switched from liquid L-T4 to a soft gel capsule formulation at the same dosage of L-T4. After 6 months, TSH, fT4, and fT3 levels were determined again. Results. There were no differences in TSH levels, but fT3 and fT4 levels during treatment with the soft gel capsule were significantly lower than those at enrolment with the liquid L-T4 formulation (TSH median (min-max): 1.9 (0.5-4.0) versus 2.2 (0.5-4.5) mIU/L, fT3: 2.5 (2.4-3.1) versus 2.7 (2.4-3.3) pg/mL, p < 0.05, and fT4: 9.9 (8.0-13) versus 10.6 (8.6-13.8) pg/mL, p < 0.0001). Conclusion. Both liquid and soft gel formulations of L-T4 can be taken with breakfast. However, liquid L-T4 would be the preferred formulation for patients in whom even small changes in fT4 and fT3 levels are to be avoided.
背景。最近的研究表明，液态左甲状腺素（L-T4）制剂可与早餐一起服用。本研究旨在通过调查L-T4软胶囊制剂是否也能在早餐时服用，来扩展这些研究结果。方法。选取60例年龄在18至65岁之间、因确诊为良性甲状腺肿接受液态L-T4治疗且病情稳定处于甲状腺功能正常状态的患者，这些患者此前已接受甲状腺切除术，并一直将液态L-T4与早餐一起服用。对所有从液态L-T4转换为相同剂量L-T4软胶囊制剂的患者进行促甲状腺激素（TSH）、游离甲状腺素（fT4）和游离三碘甲状腺原氨酸（fT3）水平的评估。6个月后，再次测定TSH、fT4和fT3水平。结果。TSH水平无差异，但软胶囊治疗期间的fT3和fT4水平显著低于入组时液态L-T4制剂时的水平（TSH中位数（最小值-最大值）：1.9（0.5-4.0）对2.2（0.5-4.5）mIU/L，fT3：2.5（2.4-3.1）对2.7（2.4-3.3）pg/mL，p<0.05；fT4：9.9（8.0-13）对10.6（8.6-13.8）pg/mL，p<0.0001）。结论。液态和软胶囊剂型的L-T4均可与早餐一起服用。然而，对于需避免fT4和fT3水平出现哪怕微小变化的患者，液态L-T4将是首选剂型。
