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临床试验/NCT06041451
NCT06041451招募中4 期

Early and Late Prognosis in Patients With Guillain-Barre Syndrome

First Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2013年1月2日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
450
试验地点
1
主要终点
the severity of Guillain-barre syndrome

研究概览

简要总结

The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.

详细描述

This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome.

排除标准

  • nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome

研究组 & 干预措施

immunoglobulin group

Experimental

This group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days

干预措施: Intravenous Immunoglobulins, Human (Drug)

methylprednisolone group

Experimental

This group of patients was treated with methylprednisolone 500 MG Injection

干预措施: Methylprednisolone 500 MG Injection (Drug)

mixed group

Experimental

This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.

干预措施: Intravenous Immunoglobulins, Human (Drug)

mixed group

Experimental

This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.

干预措施: Methylprednisolone 500 MG Injection (Drug)

结局指标

主要结局

the severity of Guillain-barre syndrome

时间窗: baseline, at 1 week, at 26 weeks

The Guillain-barre syndrome disability score is a wide scale for the severity of Guillain-barre syndrome (0, optimal health; 1, minor symptoms, able to run; 2, able to walk unaided 10 m, unable to run; 3, able to walk 10 m across an open space with help; 4 bedridden or wheelchair users; 5, require assisted ventilation; 6, dead).The higher the score, the worse the prognosis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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