Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease: an Open-label, Retrospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- disease activity assessment after one year treatment
研究概览
简要总结
Mesalazine, steroid, immunosuppressants and biologic agents are main medical treatments in treating inflammatory bowel diseases. Yet some patients develop severe side effects or initial invalid to conventional therapies. Some studies have already showed that tarcolimus and methotrexate are both effective in inducing and maintaining disease remission. Here we conduct a retrospective study to compare the efficancy of tarcolimus and methotrexate in treating refractory inflammatory bowel diseases as rescue therapy.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tarcolimus or methotrexate was used in refractory inflammatory bowel disease patents
排除标准
- •Pregnant woman
结局指标
主要结局
disease activity assessment after one year treatment
时间窗: one year
Disease activity is assessed through blood test, radiology and clinical for both Crohn's disease and ulverative colitis. We evaluate clinical response based on Crohn's disease activity index (CDAI) for CD and Mayo score for UC at the end of one year observation.
次要结局
- The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events.(one year)
研究者
Zhanghan Dai
attending physician
Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China