Clinical Trial
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[Cycle and maintenance treatments in patients with reflux esophagitis after gastrectomy or gastric resection].

AIM: To evaluate the efficiency and safety of Livodexa monotherapy in patients with reflux esophagitis (RE) after gastric resection or gastrectomy.

SUBJECTS AND METHODS: The investigators examined 30 patients (16 men, 14 women) after gastrectomy (n = 15) or gastric resection (n = 15) who had anacidity as shown by pH-metry and the clinical and/or endoscopic signs of RE. During 4 months, Groups 1 and 2 patients received the drug in doses of 10 and 15 mg/kg/day, respectively. Maintenance treatment was performed for 2 months. The maintenance therapy group included 25 patients, including 12 patients who took Livodexa in a dose of 2.5 mg/kg/day (Group 1) and 13 patients who had 5 mg/kg/day (Group 2) during 2 months.

RESULTS: Treatment with ursodeoxycholic acid (Livodexa) resulted in the significantly reduced frequency and intensity of the major symptoms of the disease (heartburn, retrosternal pain, bitter eructation), by achieving a maximum effect at 4 months of therapy. Endoscopic remission was observed in 63.3 and 83.3% of the patients at 4 and 6 months of treatment, respectively. There was a significant and steady rise in the quality of life as evidenced by a visual analogue scale. The ursodeoxycholic acid dose of 10 mg/kg was effective in patients with grade 1 RE (single erosions) while it should be increased up to 15 mg/kg in those with more significant esophageal mucosal injury (grades 2-3 RE). Some patients receiving a maintenance dose of 2.5 mg/kg/day were recorded to have recurrent reflux disease with a relapse of clinical manifestations and a morphological substrate as catarrhal esophagitis. The group of patients receiving maintenance therapy (5 mg/kg/day) retained the achieved clinical and morphological remission.

CONCLUSION: The findings suggest that Livodexa is effective in patients of this category.

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