日本 1-14 岁患有慢性胃酸相关疾病的儿科患者长期服用埃索美拉唑的有效性和安全性

IF 1.3 Q3 PEDIATRICS Pediatric Gastroenterology, Hepatology & Nutrition Pub Date : 2024-09-01 Epub Date: 2024-09-09 DOI:10.5223/pghn.2024.27.5.274
Masaaki Mori, Yoshiko Nakayama, Shigeo Nishimata, Tadafumi Yokoyama, Ryo Matsuoka, Reiko Hatori, Masaki Shimizu, Katsuhiro Arai, Yuri Etani, Tsuyoshi Sogo, Tomoko Ishizu, Masahiro Nii, Ryosuke Nakashima, Toshiaki Shimizu
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引用次数: 0

摘要

目的:评估日本儿科患者在使用非甾体抗炎药(NSAID)或小剂量阿司匹林(LDA)的同时,长期使用埃索美拉唑进行反流性食管炎(RE)维持治疗和预防胃溃疡(GU)和/或十二指肠溃疡(DU)的情况:这项多中心、开放标签、平行分组的III期研究(NCT03553563)纳入了根据体重给药的埃索美拉唑患者(体重为10-20公斤和≥20公斤的患者分别为10毫克/天[第1组和第3组]和最多20毫克/天[第2组和第4组])。第1组和第2组(痊愈RE的维持治疗)以及第3组和第4组(预防长期使用非甾体抗炎药/LDA引起的GU/DU)的疗效结果分别为有无RE复发和GU/DU复发:结果:埃索美拉唑作为维持疗法,RE复发率较低,与体重或剂量无关。第一组和第二组的RE复发率分别为0.0%和5.3%。对于曾因长期使用非甾体抗炎药/LDA而被诊断为GU和/或DU的患者,第3组和第4组在0-32周期间的GU/DU复发率分别为11.1%和0.0%:结论:在日本儿童患者中,长期使用10或20毫克、每日一次的埃索美拉唑在预防RE和抑制继发于非甾体抗炎药或LDA治疗的GU和/或DU复发方面显示出良好的效益-风险平衡。未发现新的安全性问题。埃索美拉唑可能是日本儿科患者控制RE、预防GU和DU的可行选择。
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Efficacy and Safety of Long-Term Administration of Esomeprazole in Japanese Pediatric Patients Aged 1-14 Years with Chronic Gastric Acid-Related Disease.

Purpose: To evaluate prolonged esomeprazole use in Japanese pediatric patients for reflux esophagitis (RE) maintenance therapy and prevention of gastric (GU) and/or duodenal ulcers (DU) while using non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA).

Methods: This multicenter, open-label, parallel-group, phase III study (NCT03553563) included patients who were administered esomeprazole according to body weight (10 mg/day [Groups 1 and 3] and up to 20 mg/day [Groups 2 and 4] for patients weighing 10-20 kg and ≥20 kg, respectively). Efficacy outcomes for Groups 1 and 2 (maintenance therapy for healed RE) and Groups 3 and 4 (prevention of long-term NSAID/LDA use-associated GU/DU) were the presence/absence of RE relapse and GU/DU recurrence, respectively.

Results: Esomeprazole as maintenance therapy was associated with a low RE recurrence rate, independent of body weight or dosage. Recurrence rates of RE were 0.0% and 5.3% for Groups 1 and 2, respectively. In patients previously diagnosed with GU and/or DU due to long-term NSAID/LDA use, the recurrence rates of GU/DU during weeks 0-32 were 11.1% and 0.0% in Groups 3 and 4, respectively.

Conclusion: Long-term use of 10- or 20-mg, once-daily esomeprazole demonstrated a favorable benefit-risk balance in preventing RE and suppressing recurrence of GU and/or DU secondary to NSAID or LDA therapy in Japanese pediatric patients. No new safety concerns were identified. Esomeprazole may be a viable option for managing RE and preventing GU and DU in Japanese pediatric patients.

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来源期刊
CiteScore
3.90
自引率
0.00%
发文量
43
期刊介绍: Pediatric Gastroenterology, Hepatology and Nutrition (Pediatr Gastroenterol Hepatol Nutr), an official journal of The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition, is issued bimonthly and published in English. The aim of Pediatr Gastroenterol Hepatol Nutr is to advance scientific knowledge and promote child healthcare by publishing high-quality empirical and theoretical studies and providing a recently updated knowledge to those practitioners and scholars in the field of pediatric gastroenterology, hepatology and nutrition. Pediatr Gastroenterol Hepatol Nutr publishes review articles, original articles, and case reports. All of the submitted papers are peer-reviewed. The journal covers basic and clinical researches on molecular and cellular biology, pathophysiology, epidemiology, diagnosis, and treatment of all aspects of pediatric gastrointestinal diseases and nutritional health problems.
期刊最新文献
Correction: Efficacy and Safety of Long-Term Administration of Esomeprazole in Japanese Pediatric Patients Aged 1-14 Years with Chronic Gastric Acid-Related Disease. Establishment and Characterization of Patient-Derived Intestinal Organoids from Pediatric Crohn's Disease Patients. Expression of IL-7RαlowCX3CR1+ CD8+ T Cells and α4β7 Integrin Tagged T Cells Related to Mucosal Immunity in Children with Inflammatory Bowel Disease. Is a Training Program in Pediatric Abdominal Ultrasonography Necessary for Pediatricians? Oral Nutrition During Continuous Albuterol for Pediatric Critical Asthma: A Matched Cohort Study.
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