An Observational Cohort Study on the Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- GBS disability score
研究概览
简要总结
Guillain-barre syndrome (GBS) is an acute immune-mediated polyneuropathy. Intravenous Gamma globulin is an effective therapy.Although high doses of gamma globulin are clinically effective, the patient's recovery and clinical prognosis vary. The establishment of a cohort study on the therapeutic effect of gamma globulin in Guillain-barre Syndrome is beneficial to the diagnosis of the disease and to the understanding of the natural course of the disease and the efficacy of drug treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the Brighton Guillain-Barre Syndrome diagnosis criteria in 2014;
- •Patients with AIDP, AMAN and AMSAN;
- •IVIG was treated within 2 weeks of onset;
- •GBS disability scale>2;
- •Cooperate with patients who were followed up for 180 days and sign the informed consent;
- •Exclusion criteria:
- •Pregnant or nursing women;
- •Patients with Chronic inflammatory demyelinating multiple peripheral neuropathy;
- •Combined with other types of immune system diseases;
- •Accept drugs that affect the function of the immune system within 5 or 3 months;
- •Concomitant neoplastic diseases.
- •The patient or guardian refused to sign the informed consent.
排除标准
- 未提供
结局指标
主要结局
GBS disability score
时间窗: 6 months
GBS disability scale ( Guillain-Barré syndrome disability scale) was defined as follows: 0: healthy state; 1: minor symptoms and capable of running; 2: able to walk 5 meters or more without assistance but unable to run; 3: able to walk 5 meters across an open space with help; 4: bedridden or chair-bound; 5: requiring assisted ventilation for at least part of the day; 6: dead
次要结局
- Respiratory function(6 months)
研究者
Ning Wang, MD., PhD.
Director
First Affiliated Hospital of Fujian Medical University