SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) Versus Non-ICIs in Chinese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors Medications
研究概览
简要总结
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a severe adverse drug reaction, characterized by extensive skin detachment. With the increasing use of immune checkpoint inhibitors (ICIs) in oncology, it is crucial to understand the differences in SJS/TEN induced by ICIs compared to other drugs. This study aims to compare the clinical manifestations and outcomes of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (ICIs), versus other types of drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.
详细描述
Introduction:
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a severe adverse drug reaction characterized by extensive skin detachment. With the increasing use of immune checkpoint inhibitors (ICIs) in oncology, it is crucial to understand the differences in SJS/TEN induced by ICIs compared to other drugs. This study aims to compare the clinical manifestations and outcomes of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (ICIs) versus other type drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.
Methods:
- Study Design: Retrospective cohort study or cross-sectional study.
- Participants: 60 patients with ICI-induced SJS/TEN and 100 to 500 patients with other drug-induced SJS/TEN.
- Data Collection: Detailed medical records were reviewed to extract information.
- Statistical Analysis: analysis using appropriate statistical tests (e.g., t-test, chi-square test).
Results:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of SJS/TEN induced by any drugs
- •Have the immune-related cutaneous adverse events
排除标准
- •Incomplete medical records
- •Unknown the specific culprit drugs
结局指标
主要结局
Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors Medications
时间窗: January 2015 to May 2024
Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.
次要结局
未报告次要终点
研究者
Chao Ji
Vice President of the Dermatology Branch of the First Affiliated Hospital of Fujian Medical University
First Affiliated Hospital of Fujian Medical University