PRECLINICAL STUDY OF THE PHARMACODYNAMICS OF FISSARIO IN AN EXPERIMENTAL MODEL OF HEMORRHOIDS AND ANAL FISSURE

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DOI: https://doi.org/None
Issue: 
5
Year: 
2017

E.M. Karpova, PhD, D.M. Manuilov OOO «Novamedica», 29, First Brestskaya St., Moscow, 125047, Russian Federation

ntroduction. Fissario is a combination containing 0.3% nifedipine and 2% lidocaine in the new dosage form as a rectal ointment. The medication has been designed to treat acute and chronic anal fissures and to reduce the symptoms of acute hemorrhoids, the mechanism of its action is due to the additive effect of the components. The agent has been previously found to have a good tolerability, a high safety profile and no allergenic effect. Objective: to conduct a preclinical study of the specific pharmacological activity of Fissario in an experimental model of hemorrhoids and anal fissures. Material and methods. The specific pharmacological activity of the medication was studied via its rectal application to male rats at different doses after simulation of an anal fissure and hemorrhoids. Its efficacy was evaluated in a model of an anal fissure from the wound area. The hematological indices were determined in the peripheral blood. Rectal mucosal changes were evaluated macroscopically. Hemorrhoidal changes were histologically analyzed and hemorrhoids were integrally evaluated. Results. Fissario promotes healing of anal fissures and exerts an anti-inflammatory effect. It was established that there was a dose-dependent decrease of hyperemia and edema of the wound edges and no discharge from the rectal wound surface; leukocytosis, lymphocytosis, and neutrophilia were eliminated and a pain response was relieved during the cycle application of the agent. There were no pathological changes in the rectal mucosa and muscular tunic; Fissario was observed to have dose-dependent venotonic and angioprotective effects. Conclusion. The preclinical studies of the pharmacodynamics of the reference agent Fissario showed that it was effective in treating an anal fissure and hemorrhoids.
Keywords: 
Fissario
nifedipine
lidocaine
pharmacodynamics
experimental model
preclinical study
anal fissure
hemorrhoids
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