Optimizing of duodenogastric reflux therapy in patients with chronic gastritis
Background. The known methods of duodenogastric reflux treatment which include prokinetics administration against the background of chronic gastritis standard therapy, as a rule, have the low therapeutic efficacy. The aim of the research was to assess the efficacy and safety of metoclopramide and sulpiride combination (dual prokinetic treatment) for duodenogastric reflux in comprehensive treatment of patients with chronic gastritis. Materials and methods. The study is based on the retrospective analysis of the findings obtained while examining and managing 30 patients with duodenogastric reflux and chronic gastritis aged from 22 to 45 years. The patients received treatment in accordance with the Standardized Clinical Protocol of Primary Care “Dyspepsia”, approved by the Order of the Ministry of Health of Ukraine No. 600 of August 3, 2012, and recommended by Maastricht III (2005) and Maastricht IV (2010). The basic therapy for chronic gastritis was combined with two drugs of synergistic effect, namely, prokinetic metoclopramide and sulpiride with prokinetic properties by similar principle in the regimen of short-term step therapy. The statistical processing of data was carried out according to the algorithm for qualitative data analysis with MedCalc 2019 software package. The study includes the analysis of manifestation incidence of qualitative binary variables with calculation of 95% confidence interval. When determining the effect of dual prokinetic treatment on the change of clinical syndromes manifestation incidence, we used McNemar test for related groups. The study evaluated the risk of side effects of metoclopramide and eglonil combination on the basis of assessment the significance value 95% confidence interval, considering binominal distribution of a sign (presence or absence of complication). The study presented formulation of the null and alternative statistical hypotheses. Results. The manifestations of dyspeptic, abdominal and astheno-vegetative syndromes were detected in 24 ((80.0 ± 7.3) %; 95% CI 51.26–119.03 %), 13 ((43.00 ± 9.04) %; 95% CI 23.07–74.10 %) and 18 patients ((60.00 ± 8.94) %; 95% CI 35.56–94.83 %), respectively. After 20 days of dual prokinetic treatment, the statistically significant changes in the incidence of dyspeptic, abdominal and astheno-vegetative syndromes manifestations were observed in patients against the background of endoscopic signs of bile reflux elimination (bilateral values p < 0.0001; p = 0.0005 and p < 0.0001, respectively, according to the McNemar test). The synergism of metoclopramide and eglonil effect as dopamine receptor antagonists and prokinetic effect potentiation in combination with standard therapy contribute to the rapid elimination of the most clinical manifestations of the bile reflux syndrome, make it possible to achieve clinical and endoscopic recovery and ensure steady and long-term remission. The tolerability of drug combinations was good in all patients; they did not present with side effects. Moreover, the risk of side effects did not exceed 12 % with 95% probability. Conclusions. The short-term administration of metoclopramide and sulpiride combination in step therapy regimen is not only effective but also safe, which corresponds to the alternative statistical hypothesis.
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