Short-term Prednisone to Treat STA Study(SPTSS)

Study Overview
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Brief Summary
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Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis The investigators hypothesize that less adverse reactions will be observed, comparing with the guidelines recommend. The recurrence rate, adrenal insufficiency, temporary and permanent hypothyroidism aren't significant difference.

Detailed Description
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Comparing with the guidelines recommend, short-term (one week)prednisone and nsaids following up next week to treat moderate and severe subacute thyroiditis will be assessed. The patients in wards will be assessed from temperature,erythrocyte sedimentation rate,C-reactive protein,local pain and goiter.The random treatment will be executed in moderate and severe SAT after informed consent be signed. Subjects will be monitored once every 2 weeks.If patients complained of pain in their neck or if the erythrocyte sedimentation rate is still high,after discontinuation of prednisone, prednisone treatment will be resumed in moderate and severe subject and non-steroidal anti-inflammatory drugs will be used in mild subject.Anti-ulcer drugs will be administered to all patients. The endpoint of the study are efficiency and safety of short-term prednisone treating. The investigators will assess adrenal insufficiency (such as anorexia, nausea, vomiting, abdominal pain),steroid withdrawal syndrome, recurrence rate and hypothyroidism. The investigators will observe erythrocyte sedimentation rate,pain,steroid level and thyroid function.

Official Title
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Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis

Conditions
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Subacute Thyroiditis

Intervention / Treatment
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* Drug: Prednisone 1 week
* Drug: Prednisone 6 weeks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years patients with Moderate and severe subacute thyroiditis Exclusion Criteria: adrenal cortical dysfunction, use of corticosteroids in nearly three months, mild subacute thyroiditis, non-onset STA, family history of diabetes, gastric ulcer, the special medication history, heart，liver and renal insufficiency, tumors, tuberculosis and poor compliance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisone 1 week<br>Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks. | Drug: Prednisone 1 week<br>* Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.<br>* Other names: Glucocorticoid;|
| Active Comparator: Prednisone 6 weeks<br>Oral 30 mg/day of prednisone will be administered as the initial dose for the treatment of SAT in first week,then tapered by 5mg every 1 week,the duration of prednisone will be 6 weeks. | Drug: Prednisone 6 weeks<br>* Guidelines recommend<br>* Other names: Glucocorticoid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficiency of experimental group comparing with control group during 14 days | We will observe change of erythrocyte sedimentation rate from >20mm/h to normal,C-reactive protein,pain and goiter disappear after 14 days. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate | The recurrence will be defined:local tenderness, goiter, inflammatory factors such as erythrocyte sedimentation rate, C-reactive protein increased during 180 days. | 180 days | 
| hypothyroidism | change in thyroid function:from hyperthyroidism on baseline to hypothyroidism after 180 days. | 180 days | 
| Adrenal insufficiency after withdraw in experimental group and control group. | The Symptom such as anorexia, nausea, vomiting, abdominal pain, fatigue, weakness, collapse, muscle pain, joint pain, weight loss, orthostatic hypotension, lethargy and depression. | 42 days | 
| Change of blood glucose in experimental group and control group. | Glucose change when taking medicine:from normal blood glucose on baseline to hyperglycemia at the special time during medication. | 42 days | 
| Change of blood pressure in experimental and control group during medication. | We will measure blood pressure before and after withdraw prednisone in experimental and control group. | 42 days | 
| Bone metabolism after withdraw in experimental group and control group. | We will measure Bone metabolism markers before and after withdraw prednisone in experimental and control group. | 42 days | 
| Change of Lipids in experimental and control group during medication. | We will measure Lipids before and after withdraw prednisone in experimental and control group. | 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy, safety, short, term, subacute thyroiditis