Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- the change of best corrected visual acuity (BCVA)
研究概览
简要总结
Aims of this study are to observe the correlation between ABCB1、VDR、TBX21、NR3C1 and other gene polymorphisms and the effect of glucocorticoid shock therapy on neuromyelitis optica. Investigators plan to include patients with neuromyelitis optica who will receive glucocorticoid shock therapy prospectively. The patients are divided into glucocorticoid sensitive (GS) group and glucocorticoid resistance (GR) group according to the change of central vision after treatment. Patients' clinical data will be collected and blood samples are needed for single nucleotide polymorphism (SNP) typing test. Through statistical analysis, the data differences between GS group and GR group were compared, and the effects of clinical indexes and gene polymorphisms on the efficacy of glucocorticoid shock therapy in the treatment of neuromyelitis optica should be analyzed.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of neuromyelitis optica
- •Chinese Han nationality, gender is unlimited;
- •Must be able to accept methylprednisolone pulse therapy
排除标准
- •Other optic nerve diseases, such as ischemic, compressive, invasive, traumatic, toxic and nutritional metabolic, hereditary optic neuropathy;
- •Visual path and central lesion on optic chiasma;
- •Other eye diseases, such as anterior segment lesions, retinopathy, macular lesions, ametropia, glaucoma, etc;
- •Non-organic visual impairment;
- •Treated with glucocorticoid in two weeks.
研究组 & 干预措施
glucocorticoid sensitive (GS) group
干预措施: Methylprednisolone (Drug)
glucocorticoid resistance (GR) group
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
the change of best corrected visual acuity (BCVA)
时间窗: 3 day after the treatment of methylprednisolone pulse therapy
Test BCVA before and after the treatment of methylprednisolone pulse therapy, and calculate the change value
次要结局
未报告次要终点