Efficacy and safety of the immunomodulator spleen aminopeptide combined with bismuth in the treatment of Helicobacter pylori infection: A randomized controlled trial.

BACKGROUND: This study investigates the eradication rate and adverse reaction rate of immune regulator spleen aminopeptide combined with standard quadruple therapy in treating Helicobacter pylori (HP) infection and explores the mechanism of immune regulator in eradicating HP infection. METHODS: A total of 80 patients with confirmed HP infection admitted to The Sixth Hospital of Ningbo and The Second Hospital of Yinzhou District of Ningbo from September 2024 to December 2024 were assigned into the control and observation groups were assigned into the control and observation groups (40 cases per group) according to the random number table method. The control group was treated with pantoprazole, citric acid bismuth potassium, amoxicillin capsules, and furazolidone; the observation group received spleen aminopeptide oral lyophilized powder in addition to the control group's treatment. The duration was 14 days for both groups. Compare the eradication rate, adverse reaction incidence, and changes in immune function between 2 different curative schemes for treatment of HP infection. RESULTS: The eradication rate was significantly higher in the observation group than in controls (intention-to-treat: 95.00% vs 80.00%, odds ratio: 0.211, 95% confidence interval: 0.042-1.063; per-protocol: 97.44% vs 84.21%, odds ratio: 0.140, 95% confidence interval: 0.016-1.228; both P < .05). The incidence of adverse events in the observation group was markedly lower than that in control subjects (7.7% vs 26.3; P < .05). After treatment, the levels of CD4+, CD3+, and CD4+/CD8+ ratio increased in both groups, while the level of CD8+ decreased. The levels of CD4+, CD3+, and CD4+/CD8+ in the observation group were significantly higher and the level of CD8+ was significantly lower than those in controls (both P < .05). CONCLUSION: The combination of spleen aminopeptide and bismuth quadruple therapy has a high eradication rate, fewer adverse events, and better immune function improvement.