Short-term Prednisone to Treat STA Study(SPTSS)
Mots clés
Abstrait
La 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.
Rendez-vous
| Dernière vérification: | 04/30/2015 |
| Première soumission: | 04/05/2013 |
| Inscription estimée soumise: | 04/21/2013 |
| Première publication: | 04/22/2013 |
| Dernière mise à jour soumise: | 05/17/2015 |
| Dernière mise à jour publiée: | 05/19/2015 |
| Date de début réelle de l'étude: | 02/28/2013 |
| Date d'achèvement primaire estimée: | 11/30/2014 |
| Date estimée d'achèvement de l'étude: | 11/30/2014 |
Condition ou maladie
Intervention / traitement
Drug: Prednisone 1 week
Drug: Prednisone 6 weeks
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Experimental: 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. | Drug: 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. |
| Active Comparator: 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. | Drug: Prednisone 6 weeks Guidelines recommend |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | All |
| Accepte les bénévoles en santé | Oui |
| Critères | 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. |
Résultat
Mesures des résultats primaires
1. The Efficiency of experimental group comparing with control group during 14 days [14 days]
Mesures des résultats secondaires
1. recurrence rate [180 days]
2. hypothyroidism [180 days]
3. Adrenal insufficiency after withdraw in experimental group and control group. [42 days]
4. Change of blood glucose in experimental group and control group. [42 days]
5. Change of blood pressure in experimental and control group during medication. [42 days]
6. Bone metabolism after withdraw in experimental group and control group. [42 days]
7. Change of Lipids in experimental and control group during medication. [42 days]
Autres mesures des résultats
1. Other side effects of prednisone [42 days]
