Objective — Using mFSSG questionnaire, to define the presences of gastrointestinal disturbances, associated with the intake of nonsteroidal anti‑inflammatory drugs (NSAIDs) in patients with moderate course of SARS‑CoV‑2 infection and to investigate ability of esomeprazole (Ezonexa, Farmak) to preventing the development of dyspeptic and reflux symptoms in these patients.
Materials and methods. All patients with the established diagnosis of coronaviral disease (n = 85), hospitalized for treatment in the Centre of Therapy of Clinical Emergency Hospital in Lviv, who signed the informed consent, became the participants of an open controlled trial of Ezonexa efficacy at this pathology. The medication was administered in a dose of 20 mg/day in the morning, 30 mins before meals, used to prevent NSAID‑induces gastropathies for 28 days. Simple blinded method was used to randomize patients into two groups. Subjects of the first group (n = 45) took esomeprazole, second group included controls (n = 40) without active prophylaxis of NSAID‑induces gastropathies. The mean patients’ age was 69.4 ± 2.6 years. The men age of male subjects was 66.4 ± 2.4 years, of females 72.3 ± 2.7 years. The follow up period lasted 4 weeks. All patients underwent standard examinations and survey to assess the dynamics of clinical manifestations of the disease against the background of the treatment of coronaviral infection. Besides, patients used mFSSG questionnaire to evaluate the intensity of dyspeptic and reflux symptoms. Examinations and survey were performed on the 1st, 10 — 14th and 28th days of follow up. The quality of life indices were assessed with the use of SF‑36 questionnaire in all patients at baseline and 4 weeks after the study start.
Results. No significant difference in mFSSG scores was reveled in the patients of both groups on the 1st day in terms of clinical manifestations of dyspepsia and reflux. At the second testing on 10 — 14th days, the assessment of dyspeptic and reflux symptoms didn’t change in patients of the 1st group, whereas in 49.6 % subjects of the control group presence of the signs of NSAID‑induced gastropathy with a pronounced dyspeptic and moderate reflux syndrome was registered. At 28th day, symptoms of both dyspepsia and reflux developed in 11.3 % of patients in the first group, and 78.6 % in the second group. No differences in age and gender ratio were reveled after comparative analysis. However, comorbid pathology, for which patients constantly took low doses of acetylsalicylic acid, was an additional aggravating risk factor of the development of NSAID‑induced gastropathy. Analysis of the baseline indices of quality of life in both groups showed the significant (р < 0.05) decrease in the majority of scores, except for the scales of physical functions and pain. Positive dynamics against the background of esomeprazole treatment was defined in all indices of the quality of life, in the most extent in the scores of pain, vitality, social and role emotional functions.
Conclusions. Esomeprazole in a dose of 20 mg demonstrated excellent protective effects in regard to the gastrointestinal mucosa in elderly patients from the high‑risk group, who are particularly sensitive to the gastroduodenal NSAID‑induced toxicity even at short therapeutic course for coronaviral infection. Ezonexa may be considered as a drug of choice to treat NSAID‑induced gastropathy; due to its prolonged and stable acid‑inhibiting ability, Ezonexa promotes prompt symptoms’ relief. Owing to the phenomenon of stereoselectivity, the drug has pharmacokinetic properties that ensure its high clinical efficacy in acid‑dependent diseases.
Keywords: COVID‑19, acid‑dependent diseases, nonsteroidal anti‑inflammatory drugs, NSAID‑induced gas
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