KCT0000549已完成未知
Evaluation of clinical efficacy of autologous gamma-globulin therapy for the patients with recalcitrant atopic dermatitis
Ajou University Hospital0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
Tweenty adult patients with severe atopic dermatitis were treated by intramuscular injection of 50 mg autologous immunoglobulin (mainly IgG with a purity = 97%) twice a week for 4 weeks. Repeated intramuscular injections of autologous immunoglobulin significantly decreased the clinical severity and serum IgE concentration in patients with severe atopic dermatitis.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 16(Year) 至 60(Year)（—）
- 性别
- All
入选标准
- •Adult patients with recalcitrant atopic dermatitis (age = 16 years) whose clinical conditions has not been effectively controlled by current standard medical therapies (topical moisturizers, topical corticosteroids, topical calcineurin inhibitors, and oral antihistamines) for more than 2 months and who are also compatible with criteria for autologous blood donation will be recruited. Written informed consent on this study will be received from all the participating patients.
- •[Autologous blood donation criteria]
- •1) Body weight: Men =50Kg, Women = 45Kg
- •2) Blood Platelet: = 150,000/?
- •3) Hemoglobin : = 11 g/dL
- •4) Blood pressure: Systolic blood pressure 90 ~ 179 mmHg,
- •Diastolic blood pressure < 100mmHg
- •5) Pulse : 50 ~ 100 (time/minute)
- •6) Temperature : = 37.5?
排除标准
- •Exclusion criteria
- •1) Patients under the age of 16 year.
- •2) Patients who are unable to agree on their own (emergency patients, patients with mental disability, patients with limited capacity to consent due to stroke or delirium caused by diabetes).
- •3) Patients with severe disease whose expected survival duration is less than 3 months.
- •4) Pregnancy or planned pregnancy within 1 year
- •5) Skin condition not appropriate for blood sampling and transfusion
研究者
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