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Intravenous glucocorticoid (IVGC) is an accessible and effective therapy for Graves orbitopathy (GO); the 4.5-g weekly protocol is well studied, but many details of treatment protocols need to be clarified. The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO. Researchers will compare daily protocol to weekly protocol to see if daily protocol works to treat GO.
The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | The daily scheme was as follows: 0.5 g methylprednisolone i.v. daily for 5 consecutive days, followed by oral prednisone for 6 months. Oral prednisone started at 40 mg/day for 4 weeks and then the dose was tapered by 5 mg/day every 2-4 weeks. |
|
| Group B | Active Comparator | The weekly protocol was as follows: 0.5 g methylprednisolone i.v. weekly for 6 weeks and then the dose was tapered by 0.25 g/week over the following 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone(daily scheme) | Drug | 0.5 g methylprednisolone i.v. daily for 5 consecutive days, followed by oral prednisone for 6 months. Oral prednisone started at 40 mg/day for 4 weeks and then the dose was tapered by 5 mg/day every 2-4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| the overall response rate at 24 week | "Response" was defined as an improvement in at least two of the following four criteria were present, and the contralateral eye disease did not worsen: (1) the width of the eyelid was reduced by ≥2 mm; (2) The five scores of eyelid congestion, eyelid edema, conjunctival congestion, conjunctival edema and carunculae lacrimalis swelling in CAS decreased by ≥1 point; (3) The regression of exophthalmos ≥2 mm; (4) Increased eye movement ≥8° or improved diplopia ≥ grade I (continuous to interrupted, interrupted to brief, brief to none). | 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of clinical activity score (CAS) from baseline to 24 week | changes of clinical activity score (CAS) from baseline to 24 week | 24 week |
| changes of quality of life score (QoF-s) from baseline to 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of blood pressure from baseline to 24 week | Changes of blood pressure from baseline to 24 week | 24 week |
| Changes of weight from baseline to 24 week | Changes of weight from baseline to 24 week |
Inclusion Criteria:
Exclusion Criteria:
(1) severe cardiac, liver and renal insufficiency (2) acute or chronic viral hepatitis or tuberculosis (3) optic neuropathy (4) received immunosuppressive and glucocorticoid therapy for any reason within the past 3 months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuo Lin | Contact | 020-85253408 | linshuo3@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shuo Lin | Third Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
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Participants with active moderate-to-severe GO were randomized at a ratio of 1:1 to receive glucocorticoid therapy for 12 weeks on a weekly protocol or daily scheme.
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|
| methylprednisolone(weekly scheme) | Drug | 0.5 g methylprednisolone i.v. weekly for 6 weeks and then the dose was tapered by 0.25 g/week over the following 6 weeks. |
|
changes of quality of life score (QoF-s )
| 24 week |
| changes of exophthalmos from baseline to 24 week | changes of exophthalmos from baseline to 24 week | 24 week |
| changes of width of the eyelid from baseline to 24 week | changes of width of the eyelid from baseline to 24 week | 24 week |
| changes of diplopia grade from baseline to 24 week | changes of diplopia grade from baseline to 24 week | 24 week |
| 24 week |
| Changes of fasting blood glucose from baseline to 24 week | Changes of fasting blood glucose from baseline to 24 week | 24 week |
| Changes of serum low density lipoprotein cholesterol | Changes of low density lipoprotein cholesterol from baseline to 24 week | 24 week |
| Changes of serum triglyceride | Changes of serum triglyceride from baseline to 24 week | 24 week |
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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