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薬理と治療
Abstract
Background In January 2018, esomeprazole(Nexium® capsules/granules for suspension) received additional approval for treating reflux esophagitis, gastric ulcer, duodenal ulcer, and non-erosive reflux disease in pediatric patients. We describe the results of a specified drug-use survey in Japanese pediatric patients. Methods Between May 2018 and March 2020, patients aged ≥ 1 to <15 years who had been treated for the first time with esomeprazole for gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, non-erosive gastroesophageal reflux disease, or Zollinger-Ellison syndrome were registered and observed for 4-8 weeks. Results Of 240 patients registered, safety and efficacy were analyzed in 212 and 184 patients, respectively. The mean age was 9.3 years, body weight was < 20 kg in 24.1%, and mean disease duration was 10.1 months. Adverse drug reactions occurred in 1.4% of patients. Iron deficiency anemia, abdominal pain, diarrhea, alanine aminotransferase increased, aspartate aminotransferase increased, and γ-glutamyltransferase increased occurred in 0.5%(n=1)of patients each; none were serious. The subjective and objective symptoms improved in ≥ 90% and deteriorated in ≤ 5% of patients at the final evaluation point for heartburn, acid regurgitation, epigastric pain, and upper abdominal discomfort. Heartburn, acid regurgitation, epigastric pain, and upper abdominal discomfort were eliminated in > 80% of patients. Symptoms were eliminated in ≥ 83% of patients. Endoscopic cure was achieved in both patients with peptic ulcer and endoscopic findings before and after treatment. Conclusions This study detected no new safety concerns for esomeprazole in children, with high rates of symptom improvement and elimination in actual use. (ClinicalTrials.gov: NCT03562026)
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