Peroni Elena, Vigone Maria Cristina, Mora Stefano, Bassi Lorenzo Andrea, Pozzi Clara, Passoni Arianna, Weber Giovanna
Department of Pediatrics, San Raffaele Scientific Institute, Vita-Salute University, Milan, Italy.
Horm Res Paediatr. 2014;81(1):50-4. doi: 10.1159/000356047. Epub 2013 Nov 12.
To compare the effects of liquid and tablet formulations of levothyroxine (L-T4) in 78 newborns with congenital hypothyroidism (CH).
39 patients received liquid L-T4 (group A) and 39 patients received tablets (group B). Thyroid-stimulating hormone (TSH) and free thyroxine (fT4) were measured and L-T4 dose recorded at onset of therapy and during the first year of treatment. Developmental quotient (DQ) was assessed by Griffiths' mental development scales at 12 months of age.
Gestational age, birth weight, screening TSH, etiology and severity of CH, age at onset of therapy and median initial L-T4 dose were similar in both groups. fT4 concentration normalized before 10 days of treatment in all patients. Normalization of TSH concentration was achieved after 7-10 days of therapy in 87% of group A patients and in 82% of group B patients. Group A patients had significantly lower TSH values compared with those of group B at 7-10 days (p = 0.05) and 6-8 months (p = 0.043) of treatment, despite similar L-T4 dose and fT4 concentration. Mean DQ scores were within normal range in all patients.
We confirmed the efficacy and safety of both formulations. The TSH inhibition trend when using liquid L-T4 may be linked to a higher absorption in comparison to the tablets.
比较左甲状腺素(L-T4)液体制剂和片剂对78例先天性甲状腺功能减退症(CH)新生儿的影响。
39例患者接受L-T4液体制剂(A组),39例患者接受片剂(B组)。在治疗开始时及治疗的第一年测量促甲状腺激素(TSH)和游离甲状腺素(fT4),并记录L-T4剂量。在12个月大时通过格里菲斯智力发育量表评估发育商(DQ)。
两组的胎龄、出生体重、筛查TSH、CH的病因和严重程度、治疗开始时的年龄以及初始L-T4剂量中位数相似。所有患者的fT4浓度在治疗10天前恢复正常。A组87%的患者和B组82%的患者在治疗7 - 10天后TSH浓度恢复正常。尽管L-T4剂量和fT4浓度相似,但A组患者在治疗7 - 10天(p = 0.05)和6 - 8个月(p = 0.043)时的TSH值显著低于B组。所有患者的平均DQ评分均在正常范围内。
我们证实了两种制剂的有效性和安全性。与片剂相比,使用L-T4液体制剂时TSH的抑制趋势可能与更高的吸收率有关。