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Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.
The aim of this clinical study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAO |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with overall response | Overall response | 1 week after the end of treatment |
| Percentage of participants with overall response | Overall response | 24 weeks after the end of treatment |
| Percentage of participants with overall response | Overall response | 52 weeks after the end of treatment |
| Percentage of participants with overall response | Overall response | 104 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) during the treament | during the treament | |
| Change of Serum TRAb from baseline | including TRAb (IU/l) | 52 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of extraocular muscle volume and orbital fat volume by MR | 52 weeks after the end of treatment | |
| change of extraocular muscle volume and orbital fat volume by MRI | 4 weeks after the end of treatment |
Inclusion Criteria:
Exclusion Criteria:
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Moderate to severe active TAO patients who received complete medical treatment and completed assessment .
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34252869 | Background | Zhai L, Luo B, Wu H, Wang Q, Yuan G, Liu P, Ma Y, Zhao Y, Zhang J. Prediction of treatment response to intravenous glucocorticoid in patients with thyroid-associated ophthalmopathy using T2 mapping and T2 IDEAL. Eur J Radiol. 2021 Sep;142:109839. doi: 10.1016/j.ejrad.2021.109839. Epub 2021 Jul 3. | |
| 36780178 | Background |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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| Change of Serum T3,T4 level from baseline | inculde T3 (nmol/L), T4 (nmol/L) | 52 weeks after the end of treatment |
| Change of Serum lipid parameter | including TG (mmol/L), TC (mmol/L), HDL (mmol/L), LDL (mmol/L) | 52 weeks after the end of treatment |
| Change of Serum TSH level from baseline | including TSH (mIU/L) | 52 weeks after the end of treatment |
| Change of Serum FT3, FT4 level from baseline | including FT3 (pmol/L), FT4(pmol/L) | 104 weeks after the end of treatment |
| change of extraocular muscle volume and orbital fat volume by MRI | 24 weeks after the end of treatment |
| Li Z, Luo Y, Feng X, Zhang Q, Zhong Q, Weng C, Chen Z, Shen J. Application of Multiparameter Quantitative Magnetic Resonance Imaging in the Evaluation of Graves' Ophthalmopathy. J Magn Reson Imaging. 2023 Oct;58(4):1279-1289. doi: 10.1002/jmri.28642. Epub 2023 Feb 13. |
| 35092642 | Background | Hu H, Chen L, Zhang JL, Chen W, Chen HH, Liu H, Shi HB, Wu FY, Xu XQ. T2 -Weighted MR Imaging-Derived Radiomics for Pretreatment Determination of Therapeutic Response to Glucocorticoid in Patients With Thyroid-Associated Ophthalmopathy: Comparison With Semiquantitative Evaluation. J Magn Reson Imaging. 2022 Sep;56(3):862-872. doi: 10.1002/jmri.28088. Epub 2022 Jan 29. |
| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |