Short-term Prednisone to Treat STA Study(SPTSS)
- Conditions
- Subacute Thyroiditis
- Interventions
- Registration Number
- NCT01837433
- Lead Sponsor
- Xinqiao Hospital of Chongqing
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 18-70 years patients with Moderate and severe subacute thyroiditis
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prednisone 1 week Prednisone 1 week Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks. Prednisone 6 weeks Prednisone 6 weeks 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.
- Primary Outcome Measures
Name Time Method The Efficiency of experimental group comparing with control group during 14 days 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.
- Secondary Outcome Measures
Name Time Method Adrenal insufficiency after withdraw in experimental group and control group. 42 days The Symptom such as anorexia, nausea, vomiting, abdominal pain, fatigue, weakness, collapse, muscle pain, joint pain, weight loss, orthostatic hypotension, lethargy and depression.
Change of blood pressure in experimental and control group during medication. 42 days We will measure blood pressure before and after withdraw prednisone in experimental and control group.
recurrence rate 180 days The recurrence will be defined:local tenderness, goiter, inflammatory factors such as erythrocyte sedimentation rate, C-reactive protein increased during 180 days.
hypothyroidism 180 days change in thyroid function:from hyperthyroidism on baseline to hypothyroidism after 180 days.
Change of Lipids in experimental and control group during medication. 42 days We will measure Lipids before and after withdraw prednisone in experimental and control group.
Bone metabolism after withdraw in experimental group and control group. 42 days We will measure Bone metabolism markers before and after withdraw prednisone in experimental and control group.
Change of blood glucose in experimental group and control group. 42 days Glucose change when taking medicine:from normal blood glucose on baseline to hyperglycemia at the special time during medication.
Trial Locations
- Locations (1)
The Second Affiliated Hospital, Third Military Medical University
🇨🇳Chongqing, Chongqing, China