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临床试验/NCT04564638
NCT04564638已完成不适用

Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids

Tampere University Hospital0 个研究点目标入组 217 人开始时间: 2015年3月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
217
主要终点
Responce to Corticosteroid

研究概览

简要总结

All episodes of patients with acute UC admitted to Tampere University Hospital and treated with intravenous corticosteroids between January 2007 and January 2016 were identified from patient records and reviewed. The risks for colectomy and for continuous use of corticosteroids were evaluated. Predictive factors were analysed.

详细描述

Data collected included epidemiological (gender, age at index flare, smoking status), clinical (UC duration, extent of the disease, prior Cs usage, disease severity, laboratory results at index flare) and treatment data (occurrence of new flares, need for further Cs therapy; CyA, thiopurines, biologics or colectomy during follow-up). The diagnosis of UC was made on basis of clinical history, symptoms, endoscopic and histological features. Disease extent was categorized by the Montreal classification and the severity of the flare was assessed by Mayo scoring system based on clinical and endoscopic characteristics. ASUC was characterized by more than six bloody stools/day along with any of the following: tachycardia, elevated temperature, anemia and/or ESR >30 mm/h (Truelove and Witt´s criteria)5. Alleviation of UC was defined as clinical response to intravenous corticosteroids with no need for colectomy or rescue therapy at the same hospitalization as the index flare. Relapse was defined as requiring further corticosteroid treatment, rehospitalization, rescue-therapy, or colectomy later in follow-up.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Acute severe ulcerative colitis treated first time with iv corticosteroids
  • Follow-up for at least six months after hospitalization or until colectomy.
  • Under 16 year of age

排除标准

  • 未提供

结局指标

主要结局

Responce to Corticosteroid

时间窗: Admission on index flare

Responce to first intravenous corticosteroid was defined as no need for colectomy or rescue therapy within admission.

Colectomy

时间窗: Long-term follow-up. Years 2007-2016. Mean follow-up of 7.5 years.

We reviewed patient records for data on need for surgery within follow-up. We identified patients who had emergency colectomy and patients who needed surgery within 1 year of index flare or within follow-up.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heli T Eronen

MD, specialist in internal medicine and gastroenterology

Tampere University Hospital

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