The Associations of Plasminogen Activator Inhibitor-1 Gene Polymorphisms With Crohn's Disease in Chinese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 906
- 试验地点
- 1
- 主要终点
- the genotypes of PAI-1
研究概览
简要总结
From January 2020 to January 2025, Crohn's disease (CD) patients and gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. The aim of this research is to explore the associations of plasminogen activator inhibitor-1 (PAI-1) gene polymorphisms with the risk and clinicopathological characteristics of CD, and to analyze the effects of PAI-1 gene variantions on the clinical response of ustekinumab (UST) treatment in CD patients at week 8.
详细描述
From January 2020 to January 2025, a total of 311 CD patients and 495 gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University.The genotypes of PAI-1 were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Unconditional logistic regression was employed to analyze the distribution of PAI-1 gene polymorphisms between CD group and normal control group, as well as their influences on the clinicopathological characteristics of CD patients. Multi-model logistic regression was used to explore the effect of PAI-1 gene variation on the clinical response of CD patients in the treatment of UST at week 8.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosed CD based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results
排除标准
- •rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.
研究组 & 干预措施
CD patients
Some CD patients received sufficient UST (6 mg/kg) intravenous infusion at week 0, followed by one subcutaneous (SC) dose of 90 mg UST at 8 weeks. Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks.
干预措施: Ustekinumab - Standard Dosage (Biological)
结局指标
主要结局
the genotypes of PAI-1
时间窗: Baseline
multiplex polymerase chain reaction-ligase detection reaction technique
次要结局
- clinical response of ustekinumab (UST) treatment(week 8)