NCT05509140已完成不适用
Clinical Analysis of 12 Cases of Juvenile Dermatomyositis Treated With Methylprednisolone Repeated Intermittent Pulse Combined With Mycophenolate Mofetil
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Change from baseline in CMAS score
研究概览
简要总结
This study aimed to investigate the clinical effectivity of intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil in the treatment of newly diagnosed juvenile dermatomyositis.
详细描述
Reviewed the clinical data of 12 juvenile dermatomyositis patients, from January 2014 to January 2017, hospitalized and treated with intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with age of JDM onset <16 years
- •newly treated cases
- •no contraindications to corticosteroids
- •provide signed informed consent form
- •regular follow-up for more than 30 months.
排除标准
- •patients with serious complications of heart, liver and kidney
- •patients with a history of contraindications and/or allergies to GC
- •patients who underwent treatment before admission
- •patients who failed to regularly follow-up
- •patients with positive anti-melanoma differentiation-associated gene 5 (MDA5) antibodies
结局指标
主要结局
Change from baseline in CMAS score
时间窗: 1, 3, 6, 12, 18, 24 and 36 months
CMAS score is an index to assess the disease activity of JDM
次要结局
- triglycerides(1, 3, 6, 12, 18, 24 and 36months)
- Changes from baseline of the patient's height percentile in the same age and sex crowd.(1, 3, 6, 12, 18, 24 and 36months)
- Changes from baseline of the patient's weight percentile in the same age and sex crowd.(1, 3, 6, 12, 18, 24 and 36months)
- intraocular pressure(1, 3, 6, 12, 18, 24 and 36months)
研究者
SiRui Yang
professor
The First Hospital of Jilin University
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