Effect of omeprazole in the treatment of refractory acid-related diseases in childhood: endoscopic healing and twenty-four-hour intragastric acidity.
OBJECTIVE
To determine the clinical efficacy of once-daily treatment with omeprazole in refractory acid-related diseases in children.


METHODS
Endoscopic healing and 24-hour intragastric pH values were assessed in 13 patients with refractory reflux esophagitis (n = 5), refractory and/or giant duodenal ulcer (n = 6), or giant gastric ulcer (n = 2). The mean dose of omeprazole was 0.6 mg/kg per day (range, 0.3 to 0.7 mg/kg per day). Pharmacokinetic studies of omeprazole were performed in seven patients.


RESULTS
The cumulative healing rates at 2, 4, 6, and 8 weeks of treatment were 46%, 85%, 92%, and 92%, respectively. Esophagitis in one patient did not heal despite increases in doses of up to 1.6 mg/kg per day (40 mg/day). The mean intragastric pH of omeprazole-treated patients was 5.2 (range, 3.0 to 6.6) and mean hydrogenion activity was 1.78 mmol/L (range, 0.01 to 10.42 mmol/L). There was wide interindividual variation in the reduction of gastric acid production. Mean intragastric H+ activity in omeprazole-treated patients was significantly lower than that of control subjects (p < 0.005) and that of patients treated with histamine type 2(H2)-receptor antagonists (p < 0.05). Mean intragastric H+ activity was not significantly correlated to the area under the concentration-time curve of omeprazole. No severe adverse effects were reported during treatment or at follow-up.


CONCLUSIONS
Omeprazole has a potent antisecretory effect and is a suitable alternative for short-term treatment of refractory acid-related diseases; a relatively low dose (0.6 mg/kg per day) appears to be optimal in most patients. Unhealed esophagitis at 8 weeks of treatment was considered to be refractory to omeprazole.
Kato
S
S
Department of Pediatrics, Sendal City Hospital, Japan.
Ebina
K
K
Fujii
K
K
Chiba
H
H
Nakagawa
H
H
D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016022:Case-Control Studies; D002648:Child; D004305:Dose-Response Relationship, Drug; D004381:Duodenal Ulcer / Q000188:drug therapy*; D016099:Endoscopy, Gastrointestinal; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005745:Gastric Acidity Determination; D005755:Gastrins / Q000097:blood; D006635:Histamine H2 Antagonists / Q000627:therapeutic use; D006801:Humans; D008297:Male; D009853:Omeprazole / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013276:Stomach Ulcer / Q000188:drug therapy*; D013997:Time Factors
D000897:Anti-Ulcer Agents; D005755:Gastrins; D006635:Histamine H2 Antagonists; D009853:Omeprazole