Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Numerical changes in markers such as tryptase, TLR4, and anti-NR2A antibodies in blood and cerebrospinal fluid
研究概览
简要总结
Tryptase, TLR4, and anti-NR2A antibodies were measured in serum, cerebrospinal fluid, and subjects and other markers to assess their relevance to disease activity, aiming to find new therapeutic targets,Timely intervention to improve the prognosis of SLE and improve the quality of life of patients with SLE.
详细描述
This study is a prospective cohort study: it is proposed to be divided into 3 groups, namely healthy control group and SLE group, NPSLE epilepsy group; Fifteen cases were included in each group, with the consent of the subjects and signed to know Consent form, record all subjects' clinical and laboratory test data, and test subjects' blood. Markers such as cerebrospinal fluid tryptase, TLR4 and anti-NR2A antibodies, follow-up 2 year, the patient's disease activity is evaluated every year, the change of indicators is dynamically observed, and statistical points are made divide.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy control group
- •Voluntary signing of informed consent;
- •Healthy volunteers older than 18 years old and less than 50 years old, regardless of gender;
- •No systemic diseases or neurological symptoms or signs;
- •According to the judge's judgment, healthy volunteers matching the NPSLE epilepsy group in terms of gender, age, and education level were selected as the control group.
- •Voluntary signing of informed consent;
- •Age greater than 18 years old, less than 50 years old, gender is not limited;
- •Patients with SLE who meet diagnostic criteria.
- •NPSLE Epilepsy Group
- •Voluntary signing of informed consent;
- •Age greater than 18 years old, less than 50 years old, gender is not limited;
- •Patients with NPSLE epilepsy who meet diagnostic criteria.
排除标准
- •patients with SLE with other autoimmune diseases;
- •Previous seizures, psychiatric abnormalities and other manifestations;
- •MR of the head has obvious abnormal signals in the skull or EEG shows abnormal signals;
- •History of use of hormones and immunosuppressants;
- •The investigators judged that it was not suitable to participate in this study.
- •NPSLE Epilepsy Group
- •prior history of epilepsy or clear cranial MR findings suggesting structural abnormalities;
- •Presence of precipitating seizures such as sleep deprivation, high fever, infection, long-term abstinence from alcoholism
- •Interrupt, patients with systemic diseases such as hypoglycemia, severe electrolyte disorders, malignant lesions, progressive or degenerative diseases, severe liver and kidney insufficiency and other metabolic diseases;
- •The investigators judged that it was not suitable to participate in this study.
结局指标
主要结局
Numerical changes in markers such as tryptase, TLR4, and anti-NR2A antibodies in blood and cerebrospinal fluid
时间窗: Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24
Changes in disease activity index
时间窗: Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24
SLEDAI
次要结局
未报告次要终点
研究者
HUNAG QIN
Clinical Professor
Nanfang Hospital, Southern Medical University