Combined Tribenoside/Lidocaine Rectal Cream (Procto-Glyvenol^®) Promotes Tissue Repair in a Preclinical Model of Acute...

Background/Objectives: The objective of this study was to evaluate the efficacy of a rectal cream containing tribenoside and lidocaine (TL) in a rat model of anal fissure (AF) and to investigate the potential mechanisms of its therapeutic action compared with those of a standard care rectal cream containing 2% diltiazem (D). Methods: Treatment efficacy was assessed via macroscopic methods. The levels of the inflammatory factors IL-6 and IL-10 in the tissues were measured via ELISA. Histology assessment was performed with standard hematoxylin/eosin stain, Masson's trichrome method and picrosirius stain. The levels of NF-κB, VEGF, TGF-beta 1, HIF-1α and E-cadherin were measured via densitometric immunoblot analysis. Results: The results of this study show that the medical product TL has therapeutic efficacy in a preclinical model of acute complicated AF, which is likely related to its complex composition. The severity of pathology in the TL group was significantly lower than that in the control pathology (CP) group on the eighth day of treatment and remained significantly lower on the 11th and 12th days. There was no statistically significant difference between the TL group and the CP group (p = 0.186 for IL-6 and p = 0.078 for IL-10). The efficacy of TL and D groups showed no statistically significant difference. At the end of the experiment, after 12 days of treatment, the level of the proinflammatory marker NF-κB in the CP group was greater than that in the intact control (IC) group. In turn, the NF-κB level in the TL group was lower than that in the CP group and significantly lower than that in the D group. Other important markers evaluated in this study demonstrated a similar tendency. The histopathological analysis showed that TL ointment promoted superior tissue repair, resulting in healthier anodermal architecture with minimal scarring and reduced fibrosis. Conclusions: This study confirms the potential for conducting further pharmacological studies of the mechanism of action and further clinical trials of the rectal cream TL, which has certain advantages in terms of effectiveness in a model of acute complicated AF.