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| Name | Class |
|---|---|
| The Fifth Affiliated Hospital of Southern Medical University | OTHER |
| Huadu District People's Hospital of Guangzhou | OTHER |
| Zhujiang Hospital | OTHER |
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For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is not satisfied. Investigators established a novel classification of TAO for the first time to assess more precisely for better personal treatment.
TAO is one of most common extra thyroid manifestation of dysfunctional thyroid disease. Since the morbidity of TAO has been increasing rapidly, Investigators' team is intended to verify the feasibility of the new type of classification system established by the related parameters of orbital MRI scan. Based on classification, investigators compare the efficacy of two GCs therapy. According to MRI,investigators measure the optimal T2 signal intensity ratio (SIR) for the treatment of TAO, which may help to find a better treatment time for therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Ia | Experimental | I:The increase of fat volume dominates . a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks. |
|
| Group Ib | Experimental | I:The increase of fat volume dominates. b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months. |
|
| Group IIa | Experimental | II:The increase of extraocular muscles volume dominates . a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks. |
|
| Group IIb | Experimental | II:The increase of extraocular muscles volume dominates . b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucocorticoids | Drug | Intravenous Glucocorticoids (GCs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients defined as Response for the Glucocorticoids Treatment based on the 7 parameters of eye assessment | "Response" was defined as at least three of the following outcome measures:
| 2years |
| Number of patients defined as Deterioration for the Glucocorticoids Treatment based on the 7 parameters of eye assessment | "Deterioration" of each parameter was defined as follows:
| 2years |
| Number of patients defined as Unchange for the Glucocorticoids Treatment based on the 7 parameters of eye assessment | "Unchanged" was defined as no change or changes smaller than previously defined in any of the mentioned parameters. | 2years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Shen, Doctor | Contact | 13808893818 | shenjiedr@163.com | |
| Zhangfang Li, Master | Contact | 13427525514 | leecandy520@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third Affiliated Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37579198 | Derived | Li Z, Luo Y, Huang Q, Chen Z, Song D, Pan D, Hu S, Jiang W, Cai Q, Feng X, Zhang Q, Weng C, Zhong Q, Zhao T, Li C, Zhang T, Shen J. A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy. J Clin Endocrinol Metab. 2023 Dec 21;109(1):36-45. doi: 10.1210/clinem/dgad476. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 11, 2023 | |
| Reset | Mar 20, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 11, 2023 | Mar 20, 2024 |
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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| ID | Term |
|---|---|
| D005938 | Glucocorticoids |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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| 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 |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |