Abstract
This study was designed to assess the safety of long-term maintenance treatment with ranitidine in 50 patients with duodenal ulcer disease. All patients had received continuous treatment with ranitidine for 5 years or more and were asymptomatic. No abnormalities were found on physical examination, and results of routine biochemical and haematologic screening were normal. No clinically significant abnormalities of fasting or post-prandial gastrin concentrations were observed. Endoscopic examination detected four duodenal ulcers and two benign gastric ulcers. Histology of gastric biopsy specimens showed mild superficial inflammatory cell infiltrate of the fundic mucosa but more extensive infiltration with atrophy of mucosal glands in the antral mucosa. Patchy type-I intestinal metaplasia was observed in 18 patients; one patient showed type-HI intestinal metaplasia but without dysplasia. Therefore, after 5 years' maintenance treatment with ranitidine, patients remain healthy and have no evidence of pre-malignant or malignant change in the gastric mucosa.