Graves' disease Nutritional, Metabolic, Endocrine Thyrotoxicosis [hyperthyroidism]
Conditions
Interventions
Intervention group: Participants received one application of 131I (oral), followed by a second application after 3 months, if the first was unsuccessful. The dose/activity of 131I (in MBq) was determi
Sponsors
Sun Yat-Sen University (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed hyperthyroid patients diagnosed Graves' disease 2. Patients with Graves' disease and anti thyroid drugs after 2 weeks withdrawal 3. Elevated levels of a recent set of general serum and thyroid function tests, confirming hyperthyroidism 4. 24-hour 131I-uptake greater than or equal to 40% 5. If 131I-uptake less than 40%, restriction of food or drug rich in iodine, retest until uptake was greater than or equal to 40% 6. Aged 8 years to no age limit, males and females
Exclusion criteria
Exclusion criteria: 1. Severe liver or kidney damage 2. Agranulocytosis 3. Pregnancy or lactation 4. Less than 8 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessed annually, that is every 12 months after first therapeutic intervention for each patient, ending year 12: 1. Euthyroidism 2. Hyperthyroidism 3. Recurrence 4. Hypothyroidism 5. Subclinical hypothyroidism | — |
Secondary
| Measure | Time frame |
|---|---|
| The sum dose of 131-radioiodine which was necessary to achieve therapeutic primary outcomes at the end of the study. It was assessed 3 months after inclusion and after a patient had administered or not a second treatment dose. The outcomes measure resulted from 5 groups of dose-ranges of radioiodine, beginning with a low dose-range and ending with a high dose-range. The individual dose to be adminstered was determined according to these 5 range groups modulated by a clinical 7 step score. | — |
Countries
China
Outcome results
None listed