title: Safety and efficacy of administering 0.2 mg of recombinant human TSH for two consecutive days as an adjuvant to therapy with low radioiodine doses in elderly out-patients with large nontoxic multinodular goiter.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy of recombinant human TSH (rhTSH) as an adjuvant to radioiodine therapy for nontoxic multinodular goiter (MNG) in elderly subjects.
  
  
  METHODS
  Twelve elderly out-patients with large MNG (group 1) were studied. The effect of adjuvant rhTSH administration (0.2 mg i.m. on 2 consecutive days) before low-dose (131)I was compared with that of radioiodine alone in 8 out-patients matched for age and MNG volume (group 2). The follow-up period was similar in both groups.
  
  
  RESULTS
  The number and severity of side-effects during the first month of treatment were similar in both groups. On final examination, the number of patients symptomatic for goiter was significantly lower in group 1 than in group 2 (P=0.03). In group 1, TSH levels peaked at 40.3+/-9.5 mU/L on day 3, from the baseline value of 0.5+/-0.1 mU/L (P<0.001). In group 2, baseline TSH was 0.4+/-0.1 mU/L. Although a marked increase in f-T3, f-T4 and Tg (P<0.001) was noted in both groups during the first 2 weeks of treatment, peak values were much higher in group 1 than in group 2. On final examination, a slightly significant increase (P=0.01) in TSH levels from the baseline was noted in both groups (group 1: 1.2+/-0.2 mU/L; group 2: 1.4+/-0.3 mU/L). The percentage of patients who did not need therapies to control TSH secretion at the last examination was higher in group 1 (83%) than in group 2 (38%). Only in group 1, a significant reduction was noted in mean anterior-posterior lobar width (31+/-1.7 mm) from the baseline value (24.5+/-1.7 mm, P=0.04). Thyroid volume was reduced from 78.1+/-11.7 mL to 49.4+/-13.4 mL (P=0.001) in group 1 and from 89.8+/-25.2 mL to 67.1+/-20.5 mL (P=0.04) in group 2. Six months after (131)I therapy, slight changes in thyroid length and tracheal lumen were noted in both groups.
  
  
  CONCLUSIONS
  This long-term controlled study demonstrates that 0.2 mg of rhTSH on 2 consecutive days increases the efficacy of ambulatory (131)I dosages in treating nontoxic MNG in elderly subjects. Adequate drug preparation generally prevents side-effects due to short-term but marked thyrotoxicosis that is aggravated by rhTSH administration. An increase in thyroid volume reduction seems to be the most important effect of rhTSH administered before (131)I.
authors.affiliation: Department of Endocrine and Metabolic Sciences, University of Genoa, Genoa, Italy. magius@unige.it
authors.forename: M
authors.initials: M
authors.lastname: Giusti
authors.forename: C
authors.initials: C
authors.lastname: Cappi
authors.forename: B
authors.initials: B
authors.lastname: Santaniello
authors.forename: E
authors.initials: E
authors.lastname: Ceresola
authors.forename: C
authors.initials: C
authors.lastname: Augeri
authors.forename: C
authors.initials: C
authors.lastname: Lagasio
authors.forename: F
authors.initials: F
authors.lastname: Minuto
mesh_terms: D000368:Aged; D016022:Case-Control Studies; D003131:Combined Modality Therapy / Q000379:methods; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006044:Goiter, Nodular / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008297:Male; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D013961:Thyroid Gland / Q000187:drug effects*; D013972:Thyrotropin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007457:Iodine Radioisotopes; D011994:Recombinant Proteins; D013972:Thyrotropin