Περίληψη:
Objectives The aim of the current prospective randomized control study
was to assess efficacy, safety, and non-inferiority of a new liquid
L-thyroxine formulation dissolved in glycerol and water (T4(R) drops,
produced by a Greek pharmaceutical Company, Uni-Pharma, Athens, Greece)
in comparison to the standard Tablets form (T4(R) tablets, Uni-Pharma,
Athens, Greece) in the substitutive treatment of children with
congenital hypothyroidism (CH). Methods Thirty-nine children with CH,
aged 3-12 years old, were enrolled in the study, after parental Informed
Consent has been obtained, while three patients were lost from
follow-up. At baseline, all participants had normal thyroid-stimulating
hormone (TSH) and Free T4 values. Patients were randomly subdivided
according to the assigned treatment in Group A (n=17)-Tablet Form and
Group B (n=19)-Liquid Form. TSH and Free T4 levels were evaluated at 0,
2, 4, and 6 months. Results TSH values showed a statistically
significant difference (p=0.017) between groups only at six months
(Group A having higher TSH levels than Group B, albeit within the normal
range), while Free T4 levels had no statistical difference throughout
the six month study period and were always within the normal range.
Moreover, dose adjustments were more frequent in Group A (p=0.038)
during the six months. Liquid L-thyroxine substitutive treatment
exhibited no statistically significant adverse effects in comparison to
the widely used tablets. Conclusions Levothyroxine (LT4) as liquid
solution formulation is safe and noninferior to the widely used
L-thyroxine Tablets, with less need for dose adjustment, and can
therefore be safely used in the treatment of children with CH.
Συγγραφείς:
Tzifi, Flora
Iliadi, Alexandra
Voutetakis, Antonis
Platis,
Dimitris
Girginoudis, Panagiotis
Kanaka-Gantenbein, Christina
