| Summary: | 碩士 === 國立成功大學 === 臨床藥學研究所 === 88 === Background: The majority of patients with chronic or recurrent dyspepsia do not have a peptic ulcer or any other recognized structural or biochemical abnormality that definitely explains the symptoms, these patients are thus defined as non-ulcer dyspepsia (NUD). The exact pathophysiological mechanisms remains unexplained. Some studies have shown a higher prevalence of H. pylori organisms in patients with NUD as compared with asymptomatic controls. H. pylori infection and hypergastrinemia may be associated with the clinical symptoms of NUD. Up to now, as no available literature discussed about the role of proglumide, a gastrin antagonist, in H. pylori infection patients. We thus test whether proglumide can be helpful to improve the clinical symptoms of H. pylori-infection NUD.
Methods: This study was a prospective, double-blind, randomized, placebo-controlled trial. The NUD patients were confirmed have H. pylori infection by positive results of rapid urease test and histology. All the enrolled patients received a course of triple therapy, then randomized into either Proglumide or Placebo control groups. The symptom scores (range: 0-10) were collected on enrollment, and the ends of the 1st, 5th, and 9th weeks after triple therapy. As well, serial serum samples were collected on enrollment, and the ends of the 5th and 9th weeks. On the end of the 9th week, 13C-urea breath test (UBT) was carried on each patient to survey the outcome of H. pylori eradication.
Result: Forty-eight NUD patients with H. pylori infection were enrolled into this study. A total of 38 patients have completed the study protocol (the Proglumide vs. control groups: 23 vs. 21 patients). There was no significant difference between groups in the H. pylori eradication rate (15/21 vs. 15/16, p = NS). After triple therapy usage, the 1st week symptom score had significantly decreased as compared with the score of enrollment (p<0.001). Once H. pylori could be eradicated, the symptom scores at 1st,5th, and 9th weeks of both groups were not significantly different. However, among patients without successful H. pylori eradication, the patients in the Proglumide group also have improvement in the symptom score as compared with those of the Placebo group. The gastrin level at the 9th week had significant decrease in both groups. However, the decrease of gastrin level was more significantly found in patients with successful eradication than in patients without eradication (55.9 vs. 80.1 pg/ml, p<0.001). No significant difference in events of the adverse effects between two study groups.
Conclusion: Triple therapy for H. pylori eradication had a significant benefit to improve the clinical symptom of NUD at least up to 2 months. Once H. pylori was successfully eradicated, the further supplement of proglumide will have no additional benefit for the improvement of symptoms of NUD. However, among patients without H. pylori eradication, the supplement usage of proglumide will be helpful to improve the short-term symptoms of NUD before the assessment for eradication.
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