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©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
Italian survey on non-steroidal anti-inflammatory drugs and gastrointestinal bleeding in children
Sabrina Cardile, Massimo Martinelli, Arrigo Barabino, Paolo Gandullia, Salvatore Oliva, Giovanni Di Nardo, Luigi Dall'Oglio, Francesca Rea, Gian Luigi de' Angelis, Barbara Bizzarri, Graziella Guariso, Enzo Masci, Annamaria Staiano, Erasmo Miele, Claudio Romano
Sabrina Cardile, Claudio Romano, Gastroenterology and Endoscopic Unit, Department of Pediatrics, University of Messina, 98100 Messina, Italy
Massimo Martinelli, Annamaria Staiano, Erasmo Miele, Department of Translational Medical Science, Section of Pediatrics, University of Naples “Federico II”, 80131 Naples, Italy
Arrigo Barabino, Paolo Gandullia, Department of Pediatric Gastroenterology, Gaslini Institute, 16148 Genoa, Italy
Salvatore Oliva, Giovanni Di Nardo, Department of Pediatrics and Infantile Neuropsychiatry, Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, 00185 Rome, Italy
Luigi Dall'Oglio, Francesca Rea, Digestive Surgery and Endoscopy Unit, Bambino Ges¨´ Children¡¯s Hospital, 00165 Rome, Italy
Gian Luigi de' Angelis, Barbara Bizzarri, Gastroenterology and Endoscopy Service, University of Parma, 43126 Parma, Italy
Graziella Guariso, Unit of Paediatric Gastroenterology, Digestive Endoscopy, Hepatology, and Care of Children with Liver Transplantation, Department of Women’s and Children’s Health, University Hospital of Padova, 35128 Padova, Italy
Enzo Masci, Gastrointestinal Endoscopy, Azienda Ospedaliera San Paolo University Hospital, University of Milan, 20142 Milan, Italy
Author contributions: Cardile S and Martinelli M contributed equally to this study, who performed review of the literature and drafted the manuscript; the other authors provided the data of patients, and participated in the design of the study and in the revision of manuscript; Romano C conceived and coordinated the study; all authors have read and approved the final manuscript to be published.
Institutional review board statement: The study was reviewed and approved by the Scientific Committee of the coordinating Unit (University of Messina). Prot. E 37/12, 07/09/2012.
Informed consent statement: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained in verbal form from all individual participants included in the study.
Conflict-of-interest statement: All authors declare that they have no conflict of interest. The data presented, the statements made, and the views expressed are solely the responsibility of the authors.
Data sharing statement: Consent was not obtained but the presented data are anonymized and risk of identification is low.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Claudio Romano, MD, Gastroenterology and Endoscopic Unit, Department of Pediatrics, University of Messina, Via Consolare Valeria, 98100 Messina, Italy.
romanoc@unime.it
Telephone: +39-90-22129189 Fax: +39-90-2213877
Received: August 28, 2015
Peer-review started: September 5, 2015
First decision: September 29, 2015
Revised: October 13, 2015
Accepted: November 13, 2015
Article in press: November 13, 2015
Published online: February 7, 2016
Processing time: 140 Days and 17.5 Hours
AIM: To investigate gastrointestinal complications associated with non-steroidal anti-inflammatory drug (NSAIDs) use in children.
METHODS: A retrospective, multicenter study was conducted between January 2005 and January 2013, with the participation of 8 Italian pediatric gastroenterology centers. We collected all the cases of patients who refer to emergency room for suspected gastrointestinal bleeding following NSAIDs consumption, and underwent endoscopic evaluation. Previous medical history, associated risk factors, symptoms and signs at presentation, diagnostic procedures, severity of bleeding and management of gastrointestinal bleeding were collected. In addition, data regarding type of drug used, indication, dose, duration of treatment and prescriber (physician or self-medication) were examined.
RESULTS: Fifty-one patients, including 34 males, were enrolled (median age: 7.8 years). Ibuprofen was the most used NSAID [35/51 patients (68.6%)]. Pain was the most frequent indication for NSAIDs use [29/51 patients (56.9%)]. Seven patients had positive family history of Helicobacter pylori (H. pylori) infection or peptic ulcer, and 12 had associated comorbidities. Twenty-four (47%) out of 51 patients used medication inappropriately. Hematemesis was the most frequent symptom (33.3%). Upper gastrointestinal endoscopy revealed gastric lesions in 32/51 (62%) patients, duodenal lesions in 17 (33%) and esophageal lesions in 8 (15%). In 10/51 (19.6%) patients, a diagnosis of H. pylori gastritis was made. Forty-eight (94%) patients underwent medical therapy, with spontaneous bleeding resolution, while in 3/51 (6%) patients, an endoscopic hemostasis was needed.
CONCLUSION: The data collected in this study confirms that adverse events with the involvement of the gastrointestinal tract secondary to NSAID use are also common in children
Core tip: It is known that non-steroidal anti-inflammatory drug (NSAIDs) are one of the most extensively used medications. Adverse effects associated with their use are commonly reported in the gastrointestinal tract. Data on children are limited and evidence is based mainly on case reports, and relatively small cohort studies. Our manuscript represents the first Italian survey focusing on gastrointestinal bleeding occurrences following NSAIDs consumption in a pediatric population. A high number of self-prescriptions and inappropriate use represent the most alarming data. Our data show that the risk of adverse events seems to be related to improper use rather than to NSAIDs safety profile.
