Crohn Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALUstekinumab - Standard Dosage
Some CD patients received sufficient UST (6 mg/kg) intravenous infusion at week 0, followed by one subcutaneous dose of 90 mg UST at week 8.Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks.
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
diagnosed CD based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results
Exclusion criteria
rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the genotypes of PAI-1 | Baseline | multiplex polymerase chain reaction-ligase detection reaction technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical response of ustekinumab (UST) treatment | week 8 | the changes of Crohn's disease activity index (CDAI) |
Countries
China
Outcome results
None listed