Subacute Thyroiditis
Conditions
Keywords
Efficacy, safety, short, term, subacute thyroiditis
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.
Interventions
DRUGPrednisone 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.
DRUGPrednisone 6 weeks
Guidelines recommend
Sponsors
Xinqiao Hospital of Chongqing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 Lipids in experimental and control group during medication. | 42 days | We will measure Lipids before and after withdraw prednisone in experimental and control group. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other side effects of prednisone | 42 days | Such as,cushing appearance; female hirsutism, menstrual disorders, impotence in men; gastrointestinal ulcers; psychiatric symptoms: anxiety, agitation, fatigue |
Countries
China
Outcome results
None listed