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生物标志物在炎症性肠病临床试验中的作用。

The Role of Biomarkers in Clinical Trials of Inflammatory Bowel Disease.

机构信息

Department of Medicine, Division of Gastroenterology, University of Western Ontario, London, Ontario, Canada.

Department of Medicine, Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada.

出版信息

Inflamm Bowel Dis. 2018 Jul 12;24(8):1619-1623. doi: 10.1093/ibd/izy195.


DOI:10.1093/ibd/izy195
PMID:29846593
Abstract

Clinical trials require valid outcome measures to assess the therapeutic benefit of investigational agents. Recently, regulatory authorities have mandated the use of patient-reported outcomes in combination with an objective measure of disease activity as primary outcome measures in inflammatory bowel disease trials. Endoscopy has commonly fulfilled the latter role; however, due to the costs and complexity of these assessments, interest has emerged in the use of noninvasive biomarkers. The role of C-reactive protein, fecal calprotectin, and fecal lactoferrin in clinical research is discussed.

摘要

临床试验需要有效的结局指标来评估研究药物的治疗获益。最近,监管机构已要求将患者报告的结局与疾病活动的客观测量指标联合用于炎症性肠病的临床试验作为主要结局指标。内镜检查通常满足后者的作用;然而,由于这些评估的成本和复杂性,人们对使用非侵入性生物标志物产生了兴趣。本文讨论了 C 反应蛋白、粪便钙卫蛋白和粪便乳铁蛋白在临床研究中的作用。

相似文献

[1]
The Role of Biomarkers in Clinical Trials of Inflammatory Bowel Disease.

Inflamm Bowel Dis. 2018-7-12

[2]
A meta-analysis of the utility of C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin, and fecal lactoferrin to exclude inflammatory bowel disease in adults with IBS.

Am J Gastroenterol. 2015-3-3

[3]
[Fecal lactoferrin in identifying and management of inflammatory bowel disease].

Pol Merkur Lekarski. 2014-7

[4]
Fecal lactoferrin as a noninvasive biomarker in inflammatory bowel diseases.

Drugs Today (Barc). 2012-2

[5]
Review of fecal biomarkers in inflammatory bowel disease.

Dis Colon Rectum. 2008-8

[6]
The utility of C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin and fecal lactoferrin to exclude inflammatory bowel disease in adults with IBS.

Am J Gastroenterol. 2015-8

[7]
Fecal biomarkers in inflammatory bowel disease.

J Gastroenterol Hepatol. 2017-3

[8]
The use of fecal calprotectin and lactoferrin in patients with IBD. Review.

Acta Gastroenterol Belg. 2013-9

[9]
Role of capsule endoscopy and fecal biomarkers in small-bowel Crohn's disease to assess remission and predict relapse.

Gastrointest Endosc. 2017-9-22

[10]
[Role of biological markers in inflammatory bowel disease].

Gastroenterol Hepatol. 2007-3

引用本文的文献

[1]
C-reactive Protein: An Inflammatory Biomarker and a Predictor of Neurodegenerative Disease in Patients With Inflammatory Bowel Disease?

Cureus. 2024-4-25

[2]
Fecal miR-223 is a noninvasive biomarker for estimating Crohn's disease activity.

Immun Inflamm Dis. 2023-12

[3]
Tumor Necrosis Factor Inhibition and Parkinson Disease: A Mendelian Randomization Study.

Neurology. 2021-3-23

[4]
Biomarkers Predictive of Response to Thiopurine Therapy in Inflammatory Bowel Disease.

Front Med (Lausanne). 2020-1-29

[5]
Application of Proteomics to Inflammatory Bowel Disease Research: Current Status and Future Perspectives.

Gastroenterol Res Pract. 2019-1-15

[6]
Plasma Urea Cycle Metabolites May Be Useful Biomarkers in Children With Eosinophilic Esophagitis.

Front Pediatr. 2019-1-10

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