This comparative observational cohort clinical study aims to investigate the necessity of premedication for allergy prevention prior to infliximab injection, and is designed to evaluate whether non-routine administration of dexamethasone before intravenous infusion of infliximab yields greater benefits than routine prophylactic medication in patients with moderate-to-severe inflammatory bowel disease (IBD). This study is designed to optimize the prophylactic strategy prior to Infliximab treatment and advocate for risk stratification-based individualized prophylaxis regimens to avoid hormonal abuse. Additionally, it will construct a risk score using biomarkers to accurately identify high-risk populations in need of prophylaxis and establish a corresponding predictive model. The study is also intended to reduce the use of unnecessary medications, shorten infusion duration and alleviate the medical burden. It is expected to provide targeted clinical support during the early stage of the disease or the course of treatment, improve the efficacy and precision of individualized treatment for patients, and reduce the physical, psychological and economic burdens caused by ineffective treatment.
Study Type
OBSERVATIONAL
Enrollment
300
Before each infusion of infliximab, 5mg of dexamethasone was administered intravenously or an equal volume of normal saline was injected.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGThe proportion of patients experiencing infusion reactions
The rate of patients experiencing acute moderate-to-severe infusion reactions related to infliximab during the first four administrations
Time frame: up to the fourth administration of infliximab
Concentration of drug and antibody
The changes in the drug concentration and antibody concentration of infliximab during the 4th and 6th administrations, as well as their correlation with the occurrence of infusion reactions.
Time frame: the 4th and 6th administrations of infliximab
Severe infusion reactions
The incidence of severe infusion reactions related to infliximab during the first 6 administrations
Time frame: through study completion
Hormone-related side effects
The incidence of hormone-related side effects, including hormone-related infections and changes in glycated hemoglobin that occurred throughout the entire study period.
Time frame: through study completion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.