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Mucosal Immunol. 2018 Sep;11(5):1290-1298. doi: 10.1038/s41385-018-0036-1. Epub 2018 Jul 9.
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儿童内镜研究中的安全性与伦理学:来自赞比亚比奇研究的证据

Safety and Ethics in Endoscopic Studies in Children: Evidence From the BEECH Study in Zambia.

作者信息

Chandwe Kanta, Amadi Beatrice, Chipunza Miyoba, Zyambo Masuzyo, Kelly Paul

机构信息

Tropical Gastroenterology & Nutrition group, University of Zambia School of Medicine, 10101 Lusaka, Zambia.

Department of Anaesthesia, University of Zambia School of Medicine, 10101 Lusaka, Zambia.

出版信息

J Trop Pediatr. 2021 Jan 29;67(1). doi: 10.1093/tropej/fmaa074.

DOI:10.1093/tropej/fmaa074
PMID:33188430
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7948385/
Abstract

BACKGROUND

Environmental enteropathy is an example of a poorly-understood intestinal disorder affecting millions of children worldwide, characterized by malabsorption and stunting. Although there is increasing interest in non-invasive means of assessing intestinal structure and function, the potential value of intestinal biopsy for histology, immunostaining, RNA sequencing and epigenetic work means that endoscopic biopsy remains extremely valuable. We here report our experience in the BEECH (Biomarkers of Environmental Enteropathy in CHildren) study of stunting in Zambia, in the belief that it may help address the knowledge gap regarding the safety of endoscopic biopsy in vulnerable young children.

METHODS

We report our experience of safety in 119 children undergoing endoscopic biopsy in the BEECH study in Lusaka Children's Hospital, Lusaka, and discuss ethical considerations in this light.

RESULTS

Upper gastrointestinal endoscopy was performed on children with stunting (length-for-age z score -2 or less) not responsive to nutritional interventions. Conscious sedation was provided by anaesthetists. Of 119 children, 5 (4%) developed transient desaturation, but no serious adverse events were experienced; no clinical, demographic or anaesthetic characteristics were identified as predictive of desaturation. Two children derived clinically useful information from the endoscopy, one life-saving. Of 105 lactase tests, 59 (54%) showed hypolactasia.

DISCUSSION

Children with stunting underwent endoscopy safely, and some derived clinical benefit. Safety and the possibility of clinical benefit are usually felt to be preconditions for the ethical justification for endoscopy for research in children, and we believe that these conditions were met in this study.

摘要

背景

环境性肠病是一种全球数百万儿童受影响但了解甚少的肠道疾病,其特征为吸收不良和发育迟缓。尽管人们对评估肠道结构和功能的非侵入性方法越来越感兴趣,但肠道活检对于组织学、免疫染色、RNA测序和表观遗传学研究的潜在价值意味着内镜活检仍然极具价值。我们在此报告我们在赞比亚开展的儿童环境性肠病发育迟缓研究(BEECH研究)中的经验,相信这可能有助于填补关于内镜活检在脆弱幼儿中的安全性方面的知识空白。

方法

我们报告在卢萨卡儿童医院开展的BEECH研究中119例接受内镜活检儿童的安全性经验,并据此讨论伦理考量。

结果

对营养干预无反应的发育迟缓儿童(年龄别身长Z评分≤-2)进行了上消化道内镜检查。由麻醉师实施清醒镇静。119例儿童中,5例(4%)出现短暂性低氧血症,但未发生严重不良事件;未发现临床、人口统计学或麻醉特征可预测低氧血症。2例儿童从内镜检查中获得了临床有用信息,其中1例挽救了生命。105次乳糖酶检测中,59次(54%)显示乳糖酶缺乏。

讨论

发育迟缓儿童接受内镜检查安全,部分儿童获得了临床益处。安全性和临床获益可能性通常被认为是儿童研究中内镜检查伦理合理性的前提条件,我们认为本研究满足了这些条件。