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Reappraisal of Thyroxine Treatment in Primary Hypothyroidism

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Reappraisal of Thyroxine Treatment in Primary Hypothyroidism Archives ofDisease in Childhood 1990; 65: 1129-1132 1129 Arch Dis Child: first published as 10.1136/adc.65.10.1129 on 1 October 1990. Downloaded from Reappraisal of thyroxine treatment in primary hypothyroidism S Hodges, B P O'Malley, B N Northover, K L Woods, P G F Swift Abstract come within the reference range. We have also The optimum daily dose of thyroxine was cal- tried to determine whether the systolic time culated for 13 children aged 3-16 years with interval ratio (pre-ejection period:left ventricu- primary hypothyroidism by titrating their lar ejection time), which has been established as doses at monthly intervals. The condition of a reliable measure of end organ response to the thyroid was assessed by sensitive assay of thyroid hormones in adults,6 7 could be used as thyroid stimulating hormone concentrations, a physiological marker of adequacy of replace- as well as measurement of total and free thyr- ment in children. oid hormone concentrations and systolic time interval ratios. Serum thyroid stimulating hor- mone concentration was found to be the most Patients and methods responsive to small changes in thyroxine. The Fifteen patients with previously diagnosed calculated optimum daily replacement dose of primary hypothyroidism were investigated. thyroxine (102 A/m2 or 3-5 pg/kg) was fractio- Informed parental consent was obtained and the nally lower than that previously recom- study was approved by the local ethics commit- mended, and was more closely related to tee. surface area (coefficient of variation 8-2%) Thirteen children (nine girls and four boys) than to body weight (coefficient of variation aged between 3 and 16 years (mean age 10 3) 16.2%). completed the study. Seven had congenital Our results suggest that though monthly hypothyroidism and six had juvenile hypo- may be the optimal time interval for increases thyroidism. Nine of the 13 children were prepu- in the dose of thyroxine, any reduction in the bertal. The children were seen at monthly dose should be made more gradually. intervals. At the initial visit the weight, height, and dose of thyroxine were recorded and bone age was estimated by the method of Greulich Neonatal screening for congenital hypothyroid- and Pyle.8 A blood sample was taken by vene- ism together with adequate treatment should puncture and the serum was divided into two http://adc.bmj.com/ allow normal physical and intellectual develop- aliquots. In one aliquot thyroid stimulating hor- ment. For optimal results careful adjustment of mone (Boots Celltech IRMA) was estimated the dose of thyroxine according to age and body with seven days as a guide to dose adjustment. size is necessary. An inadequate dose may affect The second was stored at -20°C until the end of intellectual and neurological development the study when all the serum samples of each adversely,' whereas excessive replacement may patient were assayed for free triiodothyroxine lead to craniostenosis,2 3 advanced bone age, Ltd) range (T3) (Immunodiagnostics (reference on September 25, 2021 by guest. Protected copyright. and hyperactivity.4 In 1979 Rezvani and Di 3f6-7-8 pmol/l), free thyroxine (T4) (Clinical George suggested a daily dose of 105 pg/M2, or Assays 2 stage, Baxter Health Care) (reference Department of 3-8 pg/kg for hypothyroid children aged more range 7-7-20-6 pmol/l), and thyroid stimulating Child Health, than 1 year; this was less than the hormone again, in their respective single assay University of Leicester significantly S Hodges previously recommended doses. Several subse- runs. If the initial thyroid stimulating hormone Department of quent developments, paticularly the 11% concentration was within the reference range Pharmacology and increase in bioavailable thyroxine content of the (0 3-4 mU/l) (n= 12) the dose of thyroxine was Therapeutics, British Pharmaceutical Codex formulation reduced by 12-5 [ig at monthly intervals until University of Leicester the introduction B P O'Malley (British Pharmacopoeia 1980), the thyroid stimulating hormone concentration K L Woods of25 pg tablets in the same year, and the advent rose above 4 mU/l. The dose was then increased Department of of sensitive immunoradiometric assays (IRMA) by 12-5 pug at monthly intervals until the thyroid Pharmacology, for the measurement of serum thyroid stimu- stimulating hormone concentration was again Leicester Polytechnic lating hormone concentrations have justified a within the reference range. B N Northover reappraisal of the optimal doses of thyroxine for If the serum thyroid stimulating hormone Department of hypothyroid children. concentration was initially raised (>4 mU/l) Paediatrics, Leicester General After the introduction of the highly sensitive (n= 1) the dose of thyroxine was increased at Hospital thyroid stimulating hormone IRMA we became monthly intervals until it returned to the refer- P G F Swift concerned that a number of children in the cli- ence range. Correspondence to: nic had unmeasurably low concentrations, and Data are presented for four time points: point Dr B P O'Malley, Department of Pharmacology thus could be considered to be over treated. The 1, entry to the study; point 2, the last reduction and Therapeutics, aim of this study, therefore, was to determine in dose that kept the thyroid stimulating hor- Clinical Sciences Building, Leicester Royal Infirmary, the 'optimal' dose of thyroxine, defining this mone concentration within the reference range; Leicester LE2 7LX. as the minimal dose at which the thyroid stimu- point 3, the dose at which the thyroid stimulat- Accepted 23 May 1990 lating hormone was suppressed sufficiently to ing hormone concentration rose above the refer- 1130 Hodges, O'Malley, Northover, Woods, Swift ence range; and point 4, the point during the .10 incremental dose adjustment at which the Arch Dis Child: first published as 10.1136/adc.65.10.1129 on 1 October 1990. Downloaded from thyroid stimulating hormone concentration 9 returned to the reference range. 8 At each clinic attendance pre-ejection period and left ventricular ejection times were mea- 7.'- z- 0 sured according to a previously reported -30 6 E technique,9 and the systolic time interval ratio n- 5 a 0 0c was calculated. The systolic time intervals were E also calculated for 43 euthyroid children 0s 30 4 .r_0 0) 25 0 between the ages of 3 and 16 years to provide a .x 3 .1 reference range for the age group under study. 20 CD 15 2 0) Patients were asked about symptoms sugges- 012 U- tive of over replacement and under replacement I' at each attendance. Thyroxine was dispensed by IU the hospital pharmacy as 25 pg or 50 [tg tablets 1 2 3 4 and these were specially packed in accordance Time points with the monthly titration requirements of the Figure 2 Free triiodothyronine (solid circles) andfree thyroxine (open circles) concentrations at thefour time points study. Detailed instructions were given to the expressed as mean (SEM). parents. Tablets were counted at the beginning and end of each study period to assess com- pliance. The significance of differences were assessed two points. Figure 2 shows that there was no by the paired t test for all data except thyroid significant difference at points 2 and 4 either in stimulating hormone concentrations. These free triiodothyronine (6-4 compared with 6-3 were no normally distributed and therefore the pmol/l, p=0 34) or free thyroxine (24-6 com- Wilcoxon test was used. pared with 24-5 pmol/l, p=0 99). The final dose of thyroxine reached by upward titration until the thyroid stimulating Results hormone came within the reference range (point The association between the thyroxine dose 4) was not significantly different from that at given ([tg/m2/day) and the thyroid stimulating entry (102-2 [Lg/m2 compared with 109-6 [tg/m2, hormone concentration at each time point is p=0 16). The thyroid stimulating hormone shown in fig 1. At entry (time point 1) thyroid concentration was, however, significantly lower stimulating hormone was in the lower part of at point 1 than at point 4 (0 74 compared with the reference range for the group as a whole, but 3 30 mU/l, p<0 005), although neither free moved higher during downward titration of the triiodothyronine nor free thyroxine concentra- dose of thyroxine (time point 2). Further down- tions differed significantly at points 1 and 4 ward titration (until the thyroid stimulating (p=045 and 0-83, respectively). http://adc.bmj.com/ hormone for each individual patient rose above Figure 3 shows the measurements of systolic the reference range point 3) was followed by time interval of the study group at each time upward titration to suppress the thyroid sti- point in relation to the 80% prediction band cal- multing hormone of each patient until it was culated using the results from the group of 43 within the reference range (point 4). The thyr- euthyroid children. One measurement is miss- oxine dose at point 2 (91-5 p[g/M2) was signifi- ing from time points 2-4. The observed systolic cantly lower than at point 4 (102-2 time intervals at time points 1 and 4 were indis- [tg/m2, on September 25, 2021 by guest. Protected copyright. p<0005) despite the similarity in thyroid tinguishable from those of the euthyroid stimulating hormone concentrations at these population. At both time points 2 and 3, however, in a third of the study group the systo- 20 lic time intervals were clearly outside the 80% 120 prediction band, and two older children had unequivocally hypothyroid values. 1100 The precision of estimating the thyroxine dose by body weight or surface area was com- CR 90. E pared by calculating coefficients of variation for 80 C0 these two measures at thyroid hor- oD E stimulating U) 70 mone euthyroidism (points 2 and 4 pooled).
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