Rebamipide efficacy in chronic atrophic gastritis (OPLOT study results)

Rebamipide efficacy in chronic atrophic gastritis (OPLOT study results)

I.G. Bakulin¹, A.G. Sushilova¹, A.V. Zharkov^1,2

¹I.I. Mechnikov North-Western State Medical University, St. Petersburg, Russian Federation

²Leningrad Region Health Committee, Saint Petersburg, Russian Federation

Aim: to evaluate the efficacy of rebamipide administration over a 12-month period in patients with chronic atrophic gastritis (CAG).

Materials and Methods: this article presents the final results of the OPLOT study, conducted at I.I. Mechnikov North-Western State Medical University involving 178 patients (mean age 57 (48–65) years). The efficacy of rebamipide was assessed separately within each etiological group: autoimmune CAG (AAG), post-eradication CAG, and CAG of mixed etiology (post-eradication + AAG). Each group was subsequently randomized into subgroups: the main subgroup (rebamipide 300 mg/day for 12 months) and the control subgroup (no rebamipide therapy). After 12 months, levels of pepsinogen I (PG-I), pepsinogen II (PG-II), gastrin-17 (G-17), and the PG-I/PG-II ratio in blood were measured, and repeat esophagogastroduodenoscopy with biopsy according to the OLGA system was performed.

Results: among individuals with AAG, both subgroups (main and control) demonstrated a statistically significant increase in PG-I levels (p<0.001) and the PG-I/PG-II ratio (p<0.001) after 12 months of follow-up. These serological changes correlated with positive morphological trend, specifically, a tendency toward reduction of atrophy stage (p=0.020); however, no significant differences between the subgroups were identified (p=0.608). Notably, a significant improvement in the inflammatory extent in biopsy specimens was observed in the rebamipide subgroup with AAG (p=0.002).

In the post-eradication CAG group, positive trend was observed in morphological parameters (inflammatory extent and atrophy stage) and serological markers in the rebamipide subgroup (increases in PG-I and PG-II levels, p<0.05).

In patients with CAG of mixed etiology, no changes in atrophy stage were detected in the rebamipide subgroup (p=0.360), whereas a significant reduction in inflammation was noted (p=0.005). Both subgroups exhibited positive changes in PG-I and PG-II levels (p<0.05), without statistically significant differences between the subgroups.

Conclusion: 12-month use of rebamipide promotes improvement in serological markers of atrophy and reduces the severity of inflammatory processes in patients with AAG. In patients with post-eradication CAG, reductions in inflammation and regression of atrophy were observed, as confirmed by both serological and morphological data, with no significant differences between groups. In patients with CAG of mixed etiology, a decrease in inflammation was found according to both serological and histological data, regardless of rebamipide administration; however, signs of atrophy regression were absent.

Keywords: rebamipide, autoimmune gastritis, chronic atrophic gastritis, functional serology.

For citation: Bakulin I.G., Sushilova A.G., Zharkov A.V. Rebamipide efficacy in chronic atrophic gastritis (OPLOT study results). Russian Medical Inquiry. 2025;9(9):580–586 (in Russ.). DOI: 10.32364/2587-6821-2025-9-9-7