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Feasibility of confocal endomicroscopy in the diagnosis of pediatric gastrointestinal disorders 被引量:3
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作者 Krishnappa Venkatesh Marta Cohen +6 位作者 Clair Evans Peter Delaney Steven Thomas christopher taylor Ashraf Abou-Taleb Ralf Kiesslich Mike Thomson 《World Journal of Gastroenterology》 SCIE CAS CSCD 2009年第18期2214-2219,共6页
AIM: To evaluate the feasibility and utility of confocal laser endomicroscopy (CLE) in the description of normal gastrointestinal (GI) mucosa and in the diagnosis of GI disorders in children, in comparison to his... AIM: To evaluate the feasibility and utility of confocal laser endomicroscopy (CLE) in the description of normal gastrointestinal (GI) mucosa and in the diagnosis of GI disorders in children, in comparison to histology.METHODS: Forty-four patients (19 female) median age 10.9 years (range 0.7-16.6 years) with suspected or known GI pathology underwent esophago-gastro- duodenoscopy (OGD) (n = 36) and/or ileocolonoscopy (IC) (n = 31) with CLE using sodium fluorescein and acriflavine as contrast agents. Histological sections were compared with same site confocal images by two experienced pediatric and GI histopathologists and endoscopists, respectively.RESULTS: Duodenum and ileum were intubated in all but one patient undergoing OGD and IC. The median procedure time was 16.4 min (range 7-25 rain) for OGD and 27.9 min (range 15-45 min) for IC. A total of 4798 confocal images were compared with 153 biopsies from the upper GI tract from 36 procedures, and 4661 confocal images were compared with 188 biopsies from the ileocolon from 31 procedures.Confocal images were comparable to conventional histology both in normal and in pathological conditions such as esophagitis, Helicobacter pylori gastritis, celiac disease, inflammatory bowel disease, colonic heterotopia, and graft versus host disease.CONCLUSION: CLE offers the prospect of targeting biopsies to abnormal mucosa, thereby increasing diagnostic yield, reducing the number of biopsies, decreasing the burden on the histopathological services, and reducing costs. 展开更多
关键词 Confocal laser endomicroscopy HISTOLOGY PEDIATRIC Gastrointestinal mucosa Gastrointestinaldisorders
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持续工艺验证,生物工艺管理的重要环节
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作者 christopher taylor 《流程工业》 2023年第2期28-30,共3页
生物制品的生产过程会随着时间而变化,过程会不断改进,需要企业不断进行回顾——因此监管机构希望企业长期关注如何能确保生产工艺持续始终保持如最初验证过的一样。美国食品药品监督管理局(FDA)对此建议企业开展持续工艺验证(CPV,Conti... 生物制品的生产过程会随着时间而变化,过程会不断改进,需要企业不断进行回顾——因此监管机构希望企业长期关注如何能确保生产工艺持续始终保持如最初验证过的一样。美国食品药品监督管理局(FDA)对此建议企业开展持续工艺验证(CPV,Continued Process Verification)。 展开更多
关键词 生物工艺 工艺验证 生物制品 CPV 监管机构 生产工艺 重要环节
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