Long-term Outcome of Patients With Acute Ulcerative Colitis Treated With Cyclosporine Rescue Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 主要终点
- Response
研究概览
简要总结
The efficacy and safety of Cyclosporine A as rescue therapy for acute severe ulcerative colitis in long-term follow-up.
详细描述
All UC patients treated with CyA in Tampere University Hospital between 2009 and 2018 were reviewed from patient records and analyzed. Amelioration of UC was defined as clinical response for rescue therapy with no need for colectomy or third-line rescue therapy at the same hospitalization as index flare. Relapse was defined as requiring further Cs treatment, re-hospitalization, biologicals, small molecules, or colectomy later in follow-up. Patients were followed-up from the date of index flare until colectomy, death, or the end of observation period. Adverse events related to treatment were assessed throughout the duration of treatment. Surgical complications were defined by using Clavien-Dindo classification (grade III-V classified as severe complications). The surgical complications in Cyclosporine-treated patients were compared to all patients operated for treatment refractor UC in Tampere University Hospital within the same follow-up period.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to hospital for acute flare of UC and treated with CyA rescue therapy.
- •Age 16 or over
排除标准
- 未提供
结局指标
主要结局
Response
时间窗: From january 2009 to december 2018
Clinical response for CyA with no need for colectomy or further enhancement of treatment with infliximab at the same hospitalization ad index flare
Surgical complications
时间窗: From January 2009 to December 2018
Reported surgical complications.
Remission
时间窗: From january 2009 to december 2018
Remission was defined as no need for further corticosteroids, re-hospitalization, enhancement of treatment with biologicals or small molecules or colectomy within follow-up.
Adverse events
时间窗: From january 2009 to december 2018
Reported treatment related adverse events.
次要结局
未报告次要终点
研究者
Heli T Eronen
MD
Kanta-Häme Central Hospital
