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随机对照试验对性结肠炎常规临床护理的概括性
Tarun Chhibba1, Alexandra Frolkis2, Levi R Stein3
1Division of Gastroenterology, Department of Medicine, University of Toronto, 6 Queen's Park Crescent West, Third Floor, Toronto, ON M5S 3H2, Canada.
许多开始先进治疗的性结肠炎患者有资格参加临床试验,但疾病活动往往会排除他们. 这影响了性结肠炎 (UC) 护理中的随机对照试验 (RCT) 的概括性.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验 临床试验
- 炎症性肠道疾病是什么
背景情况:
- 对于性结肠炎 (UC) 的随机对照试验 (RCT) 面临着关于它们对真实世界患者群体的概括性的批评.
- 评估接受先进疗法的UC患者在第三阶段注册RCT中的资格至关重要.
研究的目的:
- 确定启动先进治疗的性结肠炎患者中符合第三阶段UCRCT的资格标准的比例.
- 确定影响常规护理环境中试验资格和资格不符合因素.
主要方法:
- 在两家IBD诊所的125名UC患者的回顾性队列分析中,开始使用vedolizumab,ustekinumab或tofacitinib.
- 将患者数据 (图表,内镜,实验室) 与五个主要UC RCT (GEMINI-I,UNIFI,OCTAVE,ELEVATE,LUCENT) 的纳入/排除标准进行比较.
主要成果:
- 62.4%的患者有资格参加至少一个评估的RCT.
- 符合条件的患者较年轻,先前免疫抑制剂暴露较少,炎症标志物 (CRP,便calprotectin) 高.
- 疾病活动不足 (梅奥得分<2或没有直肠出血) 是最常见的排除标准;LUCENT试验具有最高的资格比例 (45.6%).
结论:
- 大约一半的性结肠炎患者在常规临床实践中开始先进治疗,可能符合第三阶段RCT的资格标准.
- 疾病活动是限制患者参与UC临床试验的主要因素,影响了概括性.
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