Guglielmi Rinaldo, Grimaldi Franco, Negro Roberto, Frasoldati Andrea, Misischi Irene, Graziano Filomena, Cipri Claudia, Guastamacchia Edoardo, Triggiani Vincenzo, Papini Enrico
Department of Endocrinology and Metabolic Diseases, Ospedale Regina Apostolorum, Albano (Rome), Italy.
Endocrinology and Metabolic Disease Unit, Azienda Ospedaliero-Universitaria "S. Maria della Misericordia", Udine, Italy.
Endocr Metab Immune Disord Drug Targets. 2018;18(3):235-240. doi: 10.2174/1871530318666180125155348.
Until recently, treatment of hypothyroidism has been accomplished using monotherapy of synthetic L-thyroxine (L-T4) sodium tablets that should be taken 30-60 minutes before breakfast. Nowadays, a liquid preparation of levothyroxine is available and can effectively replace tablets without the need of waiting before having breakfast. Evidence of Quality of life (QoL) improvement when shifting from the former to the latter preparation, however, is still lacking.
The study aimed to assess changes in QoL of hypothyroid patients dissatisfied with their therapy with L-T4 sodium tablets who were switched from tablets taken 30-60 minutes before breakfast to liquid L-T4 at breakfast.
A total of 418 consecutive hypothyroid subjects treated by means of L-T4 tablets were asked about their satisfaction/dissatisfaction in order to take the medication 30-60 minutes before having breakfast. Overall, 110 patients (26.3%) complained of the timing of their L-T4 therapy (30-60 minutes before breakfast). A dedicated QoL questionnaire (ThyTSQ), taking just a few minutes to be filled in was then administered to these dissatisfied patients. They were therefore switched to L-T4 to be taken at breakfast. Aiming to avoid TSH elevation due to L-T4 tablets malabsorption caused by meal interference and gastric pH changes, patients were invited to take L-T4 liquid form, as this is claimed to be scarcely affected by the non-fasting state. The questionnaire (ThyTSQ) was administered again at the control visit 3 months later. TSH, FT4, FT3 serum concentrations and metabolic parameters were also recorded.
An improved QoL, mainly due to an easier adherence to treatment, was reported by 66.6% of 102 patients who completed the study after shifting from taking medication 30-60 minutes before breakfast to at breakfast ingestion (P<0.01). An overall 10.7% of patients found the liquid formulation distasteful. Mean values of TSH, FT4, FT3, and of metabolic parameters did not significantly change but in eight patients (7.7%) who showed a TSH increase > 2mIU/L.
In hypothyroid subjects dissatisfied with L-T4 tablets ingested 30-60 minutes before breakfast, the shift to the same dose of L-T4 in liquid form taken at breakfast improved QoL in the majority of patients, without affecting thyroid function.
直到最近，甲状腺功能减退症的治疗一直采用合成左旋甲状腺素（L-T4）钠片单一疗法，该药应在早餐前30 - 60分钟服用。如今，有了左旋甲状腺素液体制剂，无需在早餐前等待，它就能有效替代片剂。然而，从前者换成后者时生活质量（QoL）改善的证据仍然缺乏。
本研究旨在评估对L-T4钠片治疗不满意的甲状腺功能减退患者的生活质量变化，这些患者从早餐前30 - 60分钟服用片剂改为早餐时服用液体L-T4。
总共418名接受L-T4片剂治疗的连续甲状腺功能减退受试者被询问对早餐前30 - 60分钟服药的满意度。总体而言，110名患者（26.3%）抱怨L-T4治疗的时间（早餐前30 - 60分钟）。然后对这些不满意的患者发放一份只需几分钟就能填完的专门生活质量问卷（ThyTSQ）。因此他们改为早餐时服用L-T4。为避免因进餐干扰和胃内pH值变化导致L-T4片剂吸收不良而引起促甲状腺激素（TSH）升高，让患者服用L-T4液体制剂，因为据称其受非空腹状态的影响很小。3个月后的对照访视时再次发放问卷（ThyTSQ）。还记录了TSH、游离甲状腺素（FT4）、游离三碘甲状腺原氨酸（FT3）血清浓度和代谢参数。
102名完成研究的患者中，66.6%报告生活质量有所改善，主要是因为服药依从性提高，这些患者从早餐前30 - 60分钟服药改为早餐时服药（P<0.01）。总体有10.7%的患者觉得液体制剂味道不佳。TSH、FT4、FT3以及代谢参数的平均值没有显著变化，但有8名患者（7.7%）的TSH升高>2mIU/L。
对于对早餐前30 - 60分钟服用L-T4片剂不满意的甲状腺功能减退患者，改为早餐时服用相同剂量的L-T4液体制剂可使大多数患者的生活质量得到改善，且不影响甲状腺功能。
