RESUMEN
CONTEXT: High doses of (131)I are usually needed in the treatment of multinodular goitre (MNG) for effective thyroid volume (TV) reduction. Recombinant human thyroid-stimulating hormone (rhTSH) is an adjuvant to enhance (131)I uptake, allowing a decrease in radiation activity and enhancing (131)I efficacy. OBJECTIVE: To evaluate whether rhTSH increases the efficacy of a fixed activity of (131)I for the treatment of MNG. DESIGN: Two-year, observational, placebo-controlled study. SETTING: Patients received 0.1 mg rhTSH (A), 0.005 mg rhTSH (B) or placebo (C). A fixed activity of 1.11 GBq of (131)I was administered 24 h after rhTSH or placebo. PATIENTS: A total of 28 outpatients (26 females and two males) with MNG. MEASUREMENTS: TSH, free T4, T3, thyroglobulin (Tg) and TV. RESULTS: Basal radioactive iodine uptake and TV values were comparable among all groups. After rhTSH or placebo, peak levels of TSH, free T4, T3 and Tg were higher in A than in B or in C (p < 0.05). Hyperthyroidism was observed in A (n = 2), B (n = 6) and C (n = 4). Thyroid enlargement was reported in A (n = 3) and B (n = 6). After 24 months, 10 patients developed hypothyroidism (four in A, three in B and three in C). TV reduction was similar between A and B (37.2 +/- 25.5% vs. 39.3 +/- 27.9%, p = 0.88), but different from the non-significant reduction in C (15.3 +/- 28.3%, p = 0.08). CONCLUSIONS: Followed by 1.11 GBq, a very low dose of 0.005 mg rhTSH was equally safe and effective as 0.1 mg rhTSH. Both doses increased the efficacy of radioiodine. Adverse events were mild, transient and readily treatable.
Asunto(s)
Bocio Nodular/terapia , Radioisótopos de Yodo/uso terapéutico , Tirotropina/uso terapéutico , Anciano , Terapia Combinada , Relación Dosis-Respuesta en la Radiación , Femenino , Humanos , Radioisótopos de Yodo/efectos adversos , Masculino , Persona de Mediana Edad , Proteínas Recombinantes/uso terapéutico , Tirotropina/efectos adversos , Resultado del TratamientoAsunto(s)
Bocio Nodular/tratamiento farmacológico , Bocio Nodular/radioterapia , Radioisótopos de Yodo/uso terapéutico , Glándula Tiroides/patología , Glándula Tiroides/fisiopatología , Tirotropina/uso terapéutico , Terapia Combinada , Estudios de Seguimiento , Bocio Nodular/patología , Bocio Nodular/fisiopatología , Humanos , Tamaño de los Órganos/efectos de los fármacos , Tamaño de los Órganos/efectos de la radiación , Ensayos Clínicos Controlados Aleatorios como Asunto , Proteínas Recombinantes/uso terapéutico , Glándula Tiroides/efectos de los fármacos , Glándula Tiroides/efectos de la radiación , Resultado del TratamientoRESUMEN
Recombinant human thyroid-stimulating hormone (rhTSH) enhances 131I uptake, permitting a decrease in radiation for the treatment of multinodular goiter (MNG). Our objective was to evaluate the safety and efficacy of a single 0.1-mg dose of rhTSH, followed by 30 mCi 131I, in patients with MNG. Seventeen patients (15 females, 59.0 ± 13.1 years), who had never been submitted to 131I therapy, received a single 0.1-mg injection of rhTSH followed by 30 mCi 131I on the next day. Mean basal thyroid volume measured by computed tomography was 106.1 ± 64.4 mL. 131I 24-h uptake, TSH, free-T4, T3, thyroglobulin, anti-thyroid antibodies, and thyroid volume were evaluated at regular intervals of 12 months. Mean 131I 24-h uptake increased from 18.1 ± 9.7 to 49.6 ± 13.4 percent (P < 0.001), a median 2.6-fold increase (1.2 to 9.2). Peak hormonal levels were 10.86 ± 5.44 mU/L for TSH (a median 15.5-fold increase), 1.80 ± 0.48 ng/dL for free-T4, 204.61 ± 58.37 ng/dL for T3, and a median of 557.0 ng/mL for thyroglobulin. The adverse effects observed were hyperthyroidism (17.6 percent), painful thyroiditis (29.4 percent) and hypothyroidism (52.9 percent). Thyroid volume was reduced by 34.3 ± 14.3 percent after 6 months (P < 0.001) and by 46.0 ± 14.6 percent after 1 year (P < 0.001). Treatment of MNG with a single 0.1-mg dose of rhTSH, followed by a fixed amount of radioactivity of 131I, leads to an efficacious decrease in thyroid volume for the majority of the patients, with a moderate incidence of non-serious and readily treatable adverse effects.
Asunto(s)
Femenino , Humanos , Masculino , Persona de Mediana Edad , Bocio Nodular/radioterapia , Radioisótopos de Yodo/administración & dosificación , Tirotropina/administración & dosificación , Terapia Combinada , Estudios de Seguimiento , Bocio Nodular/tratamiento farmacológico , Proteínas Recombinantes/administración & dosificación , Resultado del TratamientoRESUMEN
Recombinant human thyroid-stimulating hormone (rhTSH) enhances 131I uptake, permitting a decrease in radiation for the treatment of multinodular goiter (MNG). Our objective was to evaluate the safety and efficacy of a single 0.1-mg dose of rhTSH, followed by 30 mCi 131I, in patients with MNG. Seventeen patients (15 females, 59.0 +/- 13.1 years), who had never been submitted to 131I therapy, received a single 0.1-mg injection of rhTSH followed by 30 mCi 131I on the next day. Mean basal thyroid volume measured by computed tomography was 106.1 +/- 64.4 mL. 131I 24-h uptake, TSH, free-T4, T3, thyroglobulin, anti-thyroid antibodies, and thyroid volume were evaluated at regular intervals of 12 months. Mean 131I 24-h uptake increased from 18.1 +/- 9.7 to 49.6 +/- 13.4% (P < 0.001), a median 2.6-fold increase (1.2 to 9.2). Peak hormonal levels were 10.86 +/- 5.44 mU/L for TSH (a median 15.5-fold increase), 1.80 +/- 0.48 ng/dL for free-T4, 204.61 +/- 58.37 ng/dL for T3, and a median of 557.0 ng/mL for thyroglobulin. The adverse effects observed were hyperthyroidism (17.6%), painful thyroiditis (29.4%) and hypothyroidism (52.9%). Thyroid volume was reduced by 34.3 +/- 14.3% after 6 months (P < 0.001) and by 46.0 +/- 14.6% after 1 year (P < 0.001). Treatment of MNG with a single 0.1-mg dose of rhTSH, followed by a fixed amount of radioactivity of 131I, leads to an efficacious decrease in thyroid volume for the majority of the patients, with a moderate incidence of non-serious and readily treatable adverse effects.
Asunto(s)
Bocio Nodular/radioterapia , Radioisótopos de Yodo/administración & dosificación , Tirotropina/administración & dosificación , Terapia Combinada , Femenino , Estudios de Seguimiento , Bocio Nodular/tratamiento farmacológico , Humanos , Masculino , Persona de Mediana Edad , Proteínas Recombinantes/administración & dosificación , Resultado del TratamientoRESUMEN
The use of 131I in the treatment of multinodular goiters (MNG) is well established. We evaluated the effect of 30 microCi 131I (1.11 GBq) in 18 patients with MNG with the aid of two injections of 0.1 mg recombinant human TSH (rhTSH), given on d 1 and 2. A dose of 30 microCi 131I was given on d 3. TSH, T3, free T4, and thyroglobulin were measured on d 1, 2, 3, 5, 10, 30, 60, 90, and 180, and antithyroid antibodies were measured on d 1, 30, 90, and 180. Twenty-four-hour 131I uptake measured 1-3 months before rhTSH increased from 12.3 +/- 6.2 to 53.5 +/- 10.9% (P < 0.0001), free T4 from 1.3 +/- 0.2 to peak 3.2 +/- 1.1 ng/dl levels (P < 0.0001), T3 from 113.9 +/- 35.0 to peak 332.2 +/- 123.0 ng/dl levels (P < 0.0001), TSH from 0.76 +/- 0.71 to peak 18.9 +/- 5. 3 mU/liter levels (P < 0.0001), and thyroglobulin from 280.9 +/- 370.0 to peak 1838.5 +/- 1360.7 ng/dl levels (P = 0.001). Painful thyroiditis (33%) and mild thyrotoxicosis (39%) constituted minor side effects. There were no changes in echocardiographic parameters, done before and after rhTSH administration, on d 3. Hypothyroidism developed in 65%. Mean goiter size, measured by computed tomography, decreased from 97.9 +/- 45.4 to 65.5 +/- 47.3 ml (P < 0.0001; reduction: 39 +/- 19%) after 6 months. We conclude that rhTSH is a safe and efficient therapeutic tool in the treatment of MNG allowing the use of outpatient therapeutic 131I doses.