Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Efficiency of experimental group comparing with control group during 14 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (受试者)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 18-70 years patients with Moderate and severe subacute thyroiditis
排除标准
- 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.
研究组 & 干预措施
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.
干预措施: Prednisone 6 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.
干预措施: Prednisone 1 week (Drug)
结局指标
主要结局
The Efficiency of experimental group comparing with control group during 14 days
时间窗: 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.
次要结局
- Adrenal insufficiency after withdraw in experimental group and control group.(42 days)
- Change of blood pressure in experimental and control group during medication.(42 days)
- recurrence rate(180 days)
- hypothyroidism(180 days)
- Change of Lipids in experimental and control group during medication.(42 days)
- Bone metabolism after withdraw in experimental group and control group.(42 days)
- Change of blood glucose in experimental group and control group.(42 days)
研究者
Lian Duan
Clinical Doctor
Xinqiao Hospital of Chongqing
研究点 (1)
标识符
- NCT 编号
- NCT01837433
- 其他研究编号
- XinqiaoH-001
日期
- 首次提交
- (13年前)
- 首次发布
- (13年前)
- 主要完成日期
- 研究完成日期
- 最近核实
- 最近更新
- (11年前)
监管与共享
- FDA 监管药物
- 否
- 是否有结果
- 否