确定溃疡性结肠炎患者缓解和临床改善的终点指标

来源 :世界核心医学期刊文摘(胃肠病学分册) | 被引量 : 0次 | 上传用户:luoyanxiang
下载到本地 , 更方便阅读
声明 : 本文档内容版权归属内容提供方 , 如果您对本文有版权争议 , 可与客服联系进行内容授权或下架
论文部分内容阅读
Background and aims: Ulcerative colitis disease activity indices offer good statistical power but small changes in these indices may not be clinically important. There are no validated definitions of remission or of significant improvement for these indices. The use of clinically important end points would strengthen the validity of study outcomes. Our aims were to identify objective end points in standard disease activity indices for remission and for improvement in ulcerative colitis. Methods: Sixty six consecutive patients with ulcerative colitis provided information about remission status and their disease activity. At a return visit 1-14 months later, these patients provided information about the change in their disease activity, and non-invasive indices were measured. Results: Specific objective end points for determining remission with four standard indices and a quality of life instrument were deter mined (St Mark’s < 3.5, ulcerative colitis disease activity index < 2.5, simple clinical colitis activity index (SCCAI) < 2.5, Seo < 120, and inflammatory bowel disease quality of life index (IBDQ) >205). These cut offs also identified patients who met a regulatory definition of remission. Specific objective end points for clinical improvement in two non-invasive indices and a quality of life instrument were determined with good sensitivity and specificity (SCCAI decrease >1.5, Seo decrease >30, IBDQ increase >20). Conclusions: We found specific cut off values for disease activity indices that identify patients who have significantly improved or achieved remission in an objective, sensitive, and specific manner. These cut offs should help in the interpretation of the outcomes of clinical trials in ulcerative colitis. Background and aims: Ulcerative colitis disease activity indices offer good statistical power but small changes in these indices may not be clinically important. There are no validated definitions of remission or of significant improvement for these indices. The use of clinically important end points would enhance the validity of study outcomes. Our aims were to identify objective end points in standard disease activity indices for remission and for improvement in ulcerative colitis. Methods: Sixty six consecutive patients with ulcerative colitis provided information about remission status and their disease activity. At a return visit 1-14 months later, these patients provided information about the change in their disease activity, and non-invasive indices were measured. Results: Specific objective end points for determining remission with four standard indices and a quality of life instrument were deter mined (St Mark’s <3.5, ulcerative colitis disease activity index <2.5, simple Clinical colitis activity index (SCCAI) <2.5, Seo <120, and inflammatory bowel disease quality of life index (IBDQ)> 205). These cut offs also identify patients who met a regulatory definition of remission. Specific objective end points for clinical improvement in two non-invasive indices and a quality of life instrument were determined with good sensitivity and specificity (SCCAI decrease> 1.5, Seo decrease> 30, IBDQ increase> 20). Conclusions: We found specific cut off values ​​for disease activity indices that identify those who have significantly improved or achieved remission in an objective, sensitive, and specific manner. These cut offs should help in the interpretation of the outcomes of clinical trials in ulcerative colitis.
其他文献
随着汉武帝建元五年(前135)立五经博士,学官由经师统治之后,两汉的官方学术教育中逐渐出现一个新现象,这就是博士家法。家法从师法分起,它的实行当在昭宣之后。武帝时,博士
党的十八大报告中明确指出:“加强和改进思想政治工作,要注重人文关怀和心理疏导,培育自尊自信、理性平和、积极向上的社会心态”。语言学家指出,“正能量”本是物理学名词,
冯契认为:人类认识活动经过无知到知识、知识到智慧的两次飞跃。教育的使命不仅在于传递知识,更在于启迪、发展人的智慧。然而,智慧不能像知识一样直接传授,它需要在获取知识
自从人类历史发展由母系社会向父系社会转变,以男人为中心的人类社会延续了几千年。于是,重男轻女的观念就植根于相当国人的心中。他们以传宗接代、养儿防老的理由继续着这种
随着学习化社会的来临,全社会关注的重心已越来越多地由教学者转向学习者,其中,对学习者学习障碍的研究尤其重要。了解和研究学员在学习过程中遇到的各种困难无论对教育工作
例1男,34岁.因间歇性乏力、纳差、腹胀、尿黄3年,发热、干咳1周入院.入院时体检:体温38.3℃,精神萎靡,巩膜及皮肤深度黄染,未见肝掌及蜘蛛痣,心、肺、腹部(-),实验室检查:血清丙氨酸转氨酶(ALT)61 U/L,总胆红素(TBIL)454.86 μmol/L,直接胆红素(DBIL)439.09μmol/L,白蛋白(ALB)23.57 g/L,凝血酶原时间(PT)30 s,凝血酶原活动度(P
2012年12月8日-9日,全国思想政治教育高端论坛在厦门大学举行。来自全国60多所高校及相关期刊杂志共120多名专家学者围绕思想政治教育的理论与实践发展问题进行了深入探讨与
写在前面2011年3月,中国教育学会特教分会向全国特校发出第三届全国特校教师信息技术综合应用能力大赛的“集结令’’,全国30个省、市、自治区的766位教师参与到了大赛中。经
本文从实践经验总结出化学实验室工作方法、技巧,实用、高效,能有力地辅助好化学教学工作,服务好化学教学工作。 Based on practical experience, this article summarizes
目的基于用神经功能性电刺激的方法恢复面瘫患者闭眼功能的需要,研究健侧眼轮匝肌的功能作用状态的实时识别方法,以期能将其作为控制信号,调控对患侧眼轮匝肌的功能性电刺激