Inhibidores de la bomba de protones: el impacto en la salud cognitiva de los adultos mayores / Proton pump inhibitors: the impact on cognitive health in older adults

RESUMEN Los inhibidores de la bomba de protones (IBP) son los medicamentos más potentes para inhibir la secreción gástrica ácida, y se utilizan en el tratamiento de la mayor parte de las afecciones inflamatorias de la mucosa gástrica. Forman parte de los fármacos más recetados y sobreprescritos en todo el mundo; por ejemplo, en los Estados Unidos, según la Encuesta nacional de salud y nutrición, casi duplicaron su uso en los adultos de 40 años de un 4,9 % hasta un 8,3 %, entre los años 1999 a 2012. Aunque, en general, se consideran bien tolerados, algunos estudios epidemiológicos ―que extraen información a partir de grandes bases de datos― han reportado una serie de efectos adversos asociados con su uso prolongado, entre los cuales están el deterioro cognitivo, la enfermedad renal crónica, el infarto de miocardio, el accidente cerebrovascular, las fracturas óseas e incluso la muerte, entre otros. El objetivo fue realizar una revisión narrativa de la literatura acerca de los efectos del uso crónico de los IBP sobre el deterioro cognitivo en los adultos mayores. Se revisaron artículos a partir de una búsqueda en las bases de datos Pudmed, Scopus y Scielo con las palabras clave y términos Mesh/DeCS relacionados tanto en inglés como en español. Los efectos secundarios a nivel neurológico inducidos por el uso crónico de los IBP pueden estar relacionados indirectamente con la presencia de alteraciones sistémicas secundarias (deficiencia de magnesio y vitamina B12) o con efectos directos sobre el funcionamiento neuronal después de pasar a través de la barrera hematoencefálica. Si bien se han descrito varios mecanismos neurobiológicos por medio de los cuales los IBP podrían favorecer el desarrollo de la demencia ―que comprenden el funcionamiento de la proteína tau, la acumulación de beta amiloide (βA) y la deficiencia de cobalamina, entre otros―, la mayor parte de la evidencia clínica disponible no ha encontrado una asociación significativa entre el uso de los IBP y el riesgo de demencia o el deterioro cognitivo. Para establecer de una manera más clara los efectos clínicos adversos del uso crónico de los IBP, en especial, en el funcionamiento cerebral, se necesitan estudios de cohorte bien diseñados, con tamaños de muestra grandes y periodos de seguimiento prolongados, con un método confiable para ajustar los factores de confusión estandarizados y, además, realizar análisis por subgrupos.

ABSTRACT Proton pump inhibitors (PPIs) are the most potent drugs to inhibit gastric acid secretion, being used in the treatment of most inflammatory conditions of the gastric mucosa. They are among the most prescribed and overprescribed medications worldwide; for example, in the United States, according to the National Health and Nutrition Examination Survey, they almost doubled their use in adults aged 40 years and older from 4.9 % to 8.3 % between 1999 and 2012. Although they are generally considered well tolerated, some epidemiological studies extracting information from large databases have reported a number of adverse effects associated with their prolonged use, including cognitive impairment, chronic kidney disease, myocardial infarction, stroke, bone fractures and even death, among others. The objective was to conduct a narrative review of the literature on the effects of chronic use of PPIs on cognitive impairment in older adults. Articles were reviewed based on a search in the PubMed, Scopus and SciELO databases using both English and Spanish keywords and related MeSH/DeCS terms. Neurological side effects induced by chronic PPI use may be indirectly related to secondary systemic disorders (magnesium and vitamin B12 deficiency) or to direct effects on neuronal functioning after passing through the blood-brain barrier. Although several neurobiological mechanisms by which PPIs could favor the development of dementia-which involve Tau protein function, beta-amyloid [βA] accumulation and cobalamin deficiency, among others-have been described, most of the available clinical evidence has not shown a significant association between PPI use and the risk of dementia or cognitive impairment. To establish the adverse clinical effects of chronic PPI use more clearly, especially on brain functioning, well-designed cohort studies with large sample sizes and long follow-up periods, with a reliable method to adjust for standardized confounders, as well as subgroup analyses are needed.

Omeprazole combined with different probiotics regulates intestinal microbiota to alleviate functional dyspepsia in children / 基础医学与临床

Objective To explore the effect of omeprazole combined with different probiotics on regulating intestinal flora in reducing functional dyspepsia(FD)in children.Methods Two hundreds children with FD admitted to the Pediatric Department of Foshan Maternal and Child Health Hospital from January 2022 to February 2023 were se-lected as the study subjects.They were randomly divided into omeprazde(omep)group,groups of omeprazole+yeast(yeast group),+clostridium butyricum(clos group),and+bifidobacterium(bifi group)respectively.Results After treatment,serum level of IL-6,TNF-α,IL-1β,hs-CRP,VIP,SS,Enterobacter and Enterococcus in all groups significantly decreased as compared with the finding before treatment(P<0.05).Those targets in the three combined treatment groups were significantly lower compared to the ome group;After treatment,the serum MOT level,bifidobacteria,and lactobacilli in each group were significantly increased(P<0.05),and the results from three combined treatment groups demonstrated notably higher levels compared to the omep group(P<0.05);The scores of symptoms in all groups showed a significant alleviation after the treatment(P<0.05).Additionally,the three combined treatment groups exhibited significantly lower symptom scores than the group treated with omeprazole alone(P<0.05).There was no difference in the incidence of adverse reactions during treatment among the groups.Conclusions Omeprazole combined with different probiotics have achieved good results in the treatment of FD in children.

The clinical efficacy of sivelestat sodium combined with ulinastatin for sepsis-induced acute respiratory dis-tress syndrome / 实用医学杂志

Objective To observe the clinical efficacy of sivelestat sodium combined with ulinastatin in the treatment of sepsis-induced acute respiratory distress syndrome(ARDS).Methods One hundred and four patients with sepsis-induced ARDS had admitted to our hospital from January 2020 to May 2023 were selected and randomly divided into a control group(routine treatment plus sivelestat sodium)and combination group(routine treatment plus sivelestat sodium and ulinastatin)by a computer random number generator,52 in each group.Murray lung injury score(MLIS),sequential organ failure assessment(SOFA)score,extravascular lung water index(ELWI),arterial blood oxygen partial pressure/fraction of inspired oxygen(PaO2/FiO2),white blood cell count(WBC),neutrophil percentage(NEUT%),and levels of endothelial cell specific molecule-1(ESM-1),soluble urokinase-type plasminogen activator receptor(suPAR)and interleukin-6(IL-6)were compared between the two groups before and after treatment.The recovery speed,prognosis and adverse reactions were compared between the two groups.Results T-test showed there were no significant differences in MLIS score,SOFA score,ELWI,PaO2/FiO2,WBC,NEUT%,ESM-1,suPAR and IL-6 levels between the control group and the combination group before treatment(P>0.05).After treatment,MLIS score,SOFA score,ELWI,WBC,NEUT%,ESM-1,suPAR and IL-6 levels in the combination group were lower than those in the control group(P<0.05),and PaO2/FiO2 was higher than that in the control group(P<0.05).Time to mechanical ventilation and length of ICU stay in the combination group were shorter than those in the control group(P<0.05),and the 28-day mortality rate was lower than that in the control group(P<0.05).No serious adverse reactions occurred in both groups during the treatment period.Conclusion Sivelestat sodium combined with ulinastatin can reduce lung injury and inflammatory response,accelerate recovery speed,improve lung function and prognosis in patients with sepsis-induced ARDS,and the therapy has higher safety.

Omeprazole Enhances Cisplatin Sensitivity Through Inhibition of miR-214-3p Mediated Autophagy in Epithelial Ovarian Cancer Cells / 华中科技大学学报(医学版)

Objective To investigate whether omeprazole(OME)can enhance the sensitivity of epithelial ovarian cancer(EOC)cells to cisplatin(DDP)by inhibition of autophagy and to elucidate its possible mechanism.Methods Color in situ hy-bridization(CISH)and immunohistochemistry were applied to detect the expression of miR-214-3p and autophagy specific mark-ers p62 in EOC tissues,respectively.Pearson analysis showed the correlation between miR-214-3p and p62 expression levels in EOC.The half concentration(IC50)of DDP was determined by CCK-8 method.The mRNA expressions of miR-214-3p and multi-drug resistance gene 1(MDR1),the protein levels of p-gp and p62 were measured by using real-time quantitative PCR(qRT-PCR)and Western blot,respectively.Results In 43 cases,the expressions of miR-214-3p and p62 were 53.5％(23/43)and 60.5％(26/43)in patients with ovarian carcinoma,respectively.miR-214-3p was downregulated in platinum-relatively resistant OC tissue(P＜0.05).On the contrary,p62 was upregulated in platinum-relatively resistant OC tissue(P＜0.01).In ovarian cancer,the negative expression of miR-214-3p was closely related with p62(r=0.238,P＜0.05).After OME(150 μmol/L)pre-treatment,varying degrees of decrease was observed in cisplatin IC50 OV2008 and C13K cells,especially cisplatin resistant strain C13K(P＜0.01).After DDP treatment,qRT-PCR results revealed that the expression of miR-214-3p was decreased,the mRNA and protein expressions of MDR1 were greatly increased,and the protein levels of p62 were increased in C13K and OV2008 cells,compared to the blank control C13K and OV2008 cells(all P＜0.01).Compared with the blank control C13K and OV2008 cells,the IC50 of DDP was decreased after pretreatment with OME(150 μmol/L).The sensitivity of C13K and OV2008 cells to DDP was increased after OME(150 μmol/L)pretreatment,the relative expression of miR-214-3p was significantly increased,the expression of MDR1 protein and mRNA was decreased,and the expression of p62 protein was decreased(all P＜0.05).Conclu-sion OME pretreatment might enhance the sensitivity of ovarian cancer cells to DDP by downregulating miR-214-3p mediated autophagy.

Omeprazole-induced cardiac arrhythmia – A case report

Omeprazole, a Proton pump inhibitor, is widely prescribed in patients with chronic gastroesophageal reflux. Patients continue to use omeprazole for long period of time even without the supervision of the doctor. The authors report a 50-year-old male patient with a 5-year history of omeprazole use, who complained of chest discomfort. ECG on admission showed atrial fibrillation. Laboratory findings showed hypomagnesaemia, hypocalcaemia, and hypokalemia. The case report emphasizes the importance of patient education regarding the use and adverse drug reactions of the prescribed medications.

Incorporação de esomeprazol em um hospital universitário: uma análise de custo-minimização / Incorporation of esomeprazole in a university hospital: a cost-minimization analysis

Introdução: Inibidores de bomba de prótons (IBP) são amplamente utilizados na profilaxia de úlceras de estresse. O omeprazol é o IBP mais prescrito no Brasil, porém, sua formulação oral convencional é inadequada para administração por sonda devido ao risco de obstrução. A apresentação injetável de omeprazol possui custo muito superior à formulação oral. O esomeprazol, por ser constituído de microgrânulos, é uma alternativa ao omeprazol injetável, pois pode ser administrado por sonda e ainda possibilitaria redução de custos. Objetivo: Analisar por meio de custo-minimização o impacto financeiro da incorporação do esomeprazol em um hospital universitário secundário. Material e Métodos: Estudo observacional transversal retrospectivo para identificar e analisar o consumo e custo relacionado ao uso de omeprazol injetável e esomeprazol nos anos de 2021 e 2022. A partir dos dados levantados, foi realizada análise de custo-minimização e determinado o impacto financeiro após incorporação do esomeprazol. Resultados: Houve redução de 76,7% no consumo de omeprazol injetável no ano de 2022. A análise de custo-minimização apontou um custo real de R$20.374,96 no ano de 2022, referente às 906 doses utilizadas no período, destas, 46,4% eram de omeprazol injetável e 53,6% de esomperazol. Considerando o cenário com terapia exclusiva com omeprazol injetável, o custo simulado foi de R$ 41.252,05. O impacto financeiro foi de R$ -20.877,09, resultando em economia de recursos de 50,6%. Conclusão: A incorporação de esomeprazol no elenco de medicamentos de um hospital universitário gerou redução significativa de custo, implicando em economia de mais de 50% no consumo global de IBP e de mais de 70% no consumo de omeprazol injetável, no ano de 2022.

Introduction: Proton pump inhibitors (PPIs) are widely used in stress ulcers prophylaxis. Omeprazole is the most prescribed PPI in Brazil, but its conventional oral formulation is unsuitable for administration through a tube due to the risk of obstruction. The injectable presentation of omeprazole has a much higher cost than the oral formulation. Esomeprazole, composed of microgranules, is an alternative to injectable omeprazole as it can be administered through a tube and could potentially lead to a cost reduction. Objective: To analyze, through cost minimization, the financial impact of incorporating esomeprazole in a secondary university hospital. Material and Methods: A retrospective cross-sectional observational study was conducted to identify and analyze the consumption and cost related to the use of injectable omeprazole and esomeprazole in the years 2021 and 2022. Cost-minimization analysis was performed based on the collected data, to determine the financial impact after incorporating esomeprazole. Results: There was a 76.7% reduction in the consumption of injectable omeprazole in 2022. The cost-minimization analysis indicated a real cost of R$20,374.96 in 2022 for the 906 doses used during the period, of which 46.4% were injectable omeprazole and 53.6% were esomeprazole. Considering the scenario with exclusive therapy using injectable omeprazole, the simulated cost was R$41,252.05. The financial impact was R$-20,877.09, resulting in a resource saving of 50.6%. Conclusion: The incorporation of esomeprazole into the list of medications at a university hospital led to a significant cost reduction, resulting in over 50% savings in PPI consumption and over 70% in injectable omeprazole consumption, in 2022.

Clinical study on modified Guipi Decoction combined with omeprazole in the treatment of acute non-variceal upper gastrointestinal bleeding with failure of the spleen to control blood vessels syndrome / 国际中医中药杂志

Objective:To investigate the clinical efficacy of modified Guipi Decoction combined with omeprazole in the treatment of acute non-variceal upper gastrointestinal bleeding (ANVUGIB) with failure of the spleen to control blood vessels syndrome.Methods:Prospective cohort study. A total of 120 patients from January 2018 to December 2021 Taihe County Hospital of Traditional Chinese Medicine with ANVUGIB of failure of the spleen to control blood vessels syndrome were selected, and the patients were divided into observation group and control group according to the random number table method, with 60 cases in each group. The control group was treated with a large dosage of proton pump inhibitor (omeprazole injection was injected intravenously first, and then omeprazole enteric coated tablets were taken); the observation group took Guipi Decoction on the basis of the control group, and both groups were treated for 7 days. TCM syndrome score, Hemoglobin (Hb) and hematocrit (HCT) levels were measured by colorimetry before and after the treatment. BUN was detected by urease glutamate dehydrogenase method. Prothrombin time (PT), activated partial thromboplastin time (APTT) and fibrinogen (FIB) levels were detected by immunoturbidimetry. The adverse reactions during treatment were recorded and the clinical efficacy was evaluated.Results:Two patients in the observation group and two patients in the control group dropped out of the study. After treatment, the scores of main symptoms, secondary symptoms and total scores in the observation group were lower than those in the control group ( t values were respectively 10.73, 4.45, 7.98, P<0.05). After treatment, the levels of HCT [(41.25 ± 5.03)% vs. (38.19 ± 5.26)%, t=2.95], Hb [(81.09 ± 5.23) g/L vs. (78.39 ± 5.37) g/L, t=2.74] in the observation group were higher than those in the control group ( P<0.01), and BUN [(4.38±0.96) mmol/L vs. (5.39 ± 1.13) mmol/L, t=5.19] was lower than that in the control group ( P<0.01); PT [(12.48 ± 0.67) s vs. (13.22 ± 0.73) s, t=5.69], APTT [(24.66 ± 2.29) s vs. (27.78 ± 2.04) s, t=7.75] were lower than those in the control group ( P<0.01), and FIB [(3.68 ± 0.62) g/L vs. (3.41 ± 0.74) g/L, t=2.13] level was higher than that in the control group ( P<0.05). The total effective rate of the observation group was 93.1% (54/58), and that of the control group was 79.3% (46/58), with statistical significance ( χ2=4.64, P=0.031). During the treatment, the incidence of adverse reactions in the control group was 3.4% (2/58), while that in the observation group was 1.7% (1/58), without statistical significance ( χ2=0.34, P=0.559). Conclusion:High-dosage omeprazole treatment with the addition of internal administration of Guipi Decoction can significantly improve coagulation function, correct the signs and symptoms associated with insufficient blood volume in the body circulation, improve hemostatic efficiency, and reduce the risk of bleeding in patients with ANVUGIB, without increasing the risk of patient safety with the drug.

Curative effects of omeprazole combined with amoxicillin on chronic gastritis in 175 patients / 中国基层医药

Objective:To investigate the curative effects of omeprazole combined with amoxicillin on chronic gastritis and patients' quality of life.Methods:A total of 350 patients with chronic gastritis who received treatment in Jinan Seventh People's Hospital from May 2018 to August 2020 were included in this study. They were randomly divided into control and observation groups ( n = 175/group). The control group was treated with omeprazole, and the observation group was treated with omeprazole combined with amoxicillin. Curative effects, inflammatory factor levels, gastric motility, quality of life score, and the incidence of adverse reactions were compared between the two groups. Results:The response rate in the observation group was significantly higher than that in the control group [95.43% (167/175) vs. 86.86% (155/175), χ2 = 5.59, P = 0.018). Before treatment, there were no significant differences in C-reactive protein, interleukin-6, and tumor necrosis factor-α levels between the two groups (all P > 0.05). After treatment, C-reactive protein, interleukin-6, and tumor necrosis factor-α levels in the observation group were (47.97 ± 8.59) mg/L, (38.82 ± 6.29) μg/L, and (38.77 ± 5.92) μg/L, respectively, which were significantly lower than (51.34 ± 9.77) mg/L, (41.20 ± 7.53) μg/L, (41.09 ± 6.85) μg/L in the control group ( t = 3.42, 3.20, 3.39, all P < 0.05). Before treatment, there were no significant differences in serum gastrin-17 and motilin levels between the two groups (both P > 0.05). After treatment, serum gastrin-17 and motilin levels in the observation group were (380.49 ± 61.27) ng/L and (514.42 ± 68.73) ng/L, respectively, which were significantly higher than (362.25 ± 50.16) ng/L and (495.43 ± 61.36) ng/L in the control group ( t = 3.04, 2.72, both P < 0.05). After treatment, the quality of life score in the observation group was significantly higher than that in the control group ( P < 0.05). There was no significant difference in the incidence of adverse reactions between the two groups ( P > 0.05). Conclusion:Omeprazole combined with amoxicillin is highly effective on chronic gastritis. The combined therapy can reduce inflammatory responses, improve gastric motility, improve patients' quality of life, and is highly safe.

Efficacy and safety of dual drug regimen in patients with hantavirus hemorrhagic fever with renal syndrome and upper gastrointestinal bleeding / 中国医师杂志

Objective:To explore the efficacy and safety of dual drug regimen in the treatment of Hantavirus hemorrhagic fever with renal syndrome with upper gastrointestinal bleeding.Methods:Sixty patients with hantavirus hemorrhagic fever with renal syndrome and upper gastrointestinal bleeding admitted to the Eighth Medical Center of the 301 Hospital from January 2020 to January 2022 were selected as the research objects. They were randomly divided into the control group (30 cases) and the observation group (30 cases). They were treated with omeprazole and omeprazole combined with octreotide respectively for 72 hours. The clinical efficacy, hemostasis time, hospital stay, hemoglobin, serum glucagon levels, adverse reactions and rebleeding rate were compared between the two groups.Results:The total effective rate of clinical treatment in the observation group was 93.33%(28/30), significantly better than 76.67%(23/30) in the control group, with a statistically significant difference ( P<0.05). The hemostasis time and hospitalization time in the observation group were significantly shorter than those in the control group (all P<0.05). After treatment, the hemoglobin level in both groups was higher than that before treatment, and the serum glucagon level was lower than that before treatment, the difference was statistically significant (all P<0.05); After treatment, the hemoglobin level in the observation group was higher than that in the control group, and the serum glucagon level was lower than that in the control group (all P<0.05). There was no statistically significant difference in the incidence of adverse reactions between the two groups (all P>0.05). The 48 hour rebleeding rate in the observation group was 3.33%(1/30), lower than the 26.67%(8/30) in the control group, with a statistically significant difference ( P<0.05). Conclusions:The dual drug regimen for Hantavirus hemorrhagic fever with renal syndrome with upper gastrointestinal bleeding can effectively control the bleeding symptoms, improve the hemostasis effect, lower the serum glucagon level, reduce the risk of rebleeding, and its safety is worthy of recognition.

Effect of omeprazole on pharmacokinetic parameters of imatinib in rats / 中国药房

OBJECTIVE To investigate the effects of omeprazole on pharmacokinetic parameters of imatinib in rats. METHODS According to body weight， the rats were divided into imatinib+low-dose， medium-dose， and high-dose omeprazole groups， imatinib group， with 6 rats in each group. They were given omeprazole suspension at the doses of 1.8， 3.6 and 7.2 g/kg， or 0.5% sodium carboxymethyl cellulose solution intragastrically respectively； one hour later， imatinib suspension was administered by oral gavage at a the dose of 10 mg/kg. Blood sample （100 μL） was taken from the orbit before and 0.5， 1， 2， 2.5， 3， 4， 5， 6， 8， 12， 24 and 36 hours after intragastric administration of imatinib. Using imatinib-d3 as internal standard， the plasma concentrations of imatinib and its metabolite N-desmethyl imatinib in rat were determined by high performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters were calculated by DAS 2.0 software and compared. RESULTS Compared with imatinib group， AUC0－∞ and AUMC0－∞ of imatinib in rat plasma of imatinib+medium-dose omeprazole group， cmax， t1/2， AUC0－∞ and AUMC0－∞ of imatinib in rat plasma of imatinib+high-dose omeprazole group were all increased or prolonged significantly （P＜0.05）. Compared with imatinib group， AUC0－∞ and AUMC0－∞ of N-desmethyl imatinib in rat plasma of imatinib+medium-dose omeprazole group， and cmax and AUC0→∞ of N-desmethyl imatinib in rat plasma of imatinib+high-dose omeprazole group were decreased significantly （P＜0.05）. CONCLUSIONS Omeprazole may increase the plasma concentration of imatinib in rats and reduce the plasma concentration of N-desmethyl imatinib in rats， which may be associated with inhibiting the metabolism of imatinib.

Análise farmacoeconômica do uso de omeprazol por idosos em uma das unidades básicas de saúde do Brasil / Pharmacoeconomic Analysis of the Use of Omeprazole by Elderly Patients in One of the Primary Healthcare Centers in Brazil

O omeprazol é inibidor de bomba de prótons mais prescrito no Brasil e é indicado para o tratamento de doenças por refluxos gastroesofágicos, úlcera péptica, esofagite erosiva, erradicação de Helicobacter pylori, síndrome de Zollinger-Ellison, gastrinomas, gastrite e distúrbios hipersecretores e prevenção de úlcera péptica. O uso indiscriminado e desnecessário, principalmente por idosos, é uma importante questão de saúde pública a ser tratada. Apesar de ser conhecida a existência do uso indiscriminado do omeprazol, identifica-se a necessidade de se verificar como ocorre a prescrição desse medicamento no contexto do Sistema Único de Saúde (SUS) do Brasil. Além disso, acredita-se que estudos que analisam de modo famacoeconômico a prescrição do omeprazol podem contribuir para a revisão ou implementação de diretrizes e protocolos que envolvam o uso desse medicamento. O objetivo foi caracterizar e realizar análise farmacoeconômica do uso do omeprazol em Unidade de Atenção Primária a Saúde (UAPS) em Minas Gerais, Brasil. Trata-se de estudo descritivo com análise das prescrições de 41 pacientes idosos atendidos no período de abril/maio de 2018 e foram identificadas as seguintes variáveis: idade, sexo, dose, indicação, realização de endoscopia, demais medicamentos em uso e custo do tratamento. Na análise farmacoeconômica realizou-se o cálculo do custo médio da quantidade de omeprazol prescrita por paciente e considerou-se a realização ou não de endoscopia. Na população estudada, 29 (70,3%) do sexo feminino com mediana de idade: 69 anos. Apenas em 4 prontuários (9,8%) havia indicação para uso e em 18 (43,9%) pacientes, a utilização era feita há mais de dois anos e em 7 (17,1%) a mais de cinco anos. Apenas 3 (7,3%) realizaram endoscopia e foram utilizados 371 meses totalizando um valor financeiro de R$35.657,23. Os achados sugerem prescrições em longo prazo e sem registro da indicação em prontuário. O custo referente às prescrições poderia ser otimizado com a realização de endoscopia e suspensão do uso, quando constatada ausência de indicação.

Omeprazole is the most prescribed proton pump inhibitor in Brazil and is indicated for the treatment of diseases caused by gastroesophageal reflux, peptic ulcer, erosive esophagitis, eradication of Helicobacter pylori, Zollinger-Ellison syndrome, gastrinomas, gastritis, and hypersecretory disorders, as well as peptic ulcer prevention. The indiscriminate and unnecessary use, mainly by the elderly, is an important public health issue to be addressed. Despite the existence of indiscriminate use of omeprazole being known, there is a need to verify how this medication is prescribed in the context of the Unified Health System (UHS) in Brazil. In addition, it is believed that studies that aim to analyze the prescription of omeprazole in a pharmacoeconomic way can contribute to the review or implementation of guidelines and protocols involving the use of this drug. The objective of this study was to characterize and perform a pharmacoeconomic analysis of the use of omeprazole in a Primary Healthcare Centers (PHC) in Minas Gerais, Brazil. This is a descriptive study analyzing the prescriptions of 41 elderly patients treated in the period of April/May 2018 and the following variables were identified: age, sex, dose, indication, endoscopy, other medications in use, and cost of treatment. In the pharmacoeconomic analysis, the average cost of the amount of omeprazole prescribed per patient was calculated and whether or not endoscopy was performed was considered. In the studied population, 29 (70.3%) were female with a median age: 69 years. Only in 4 medical records (9.8%) was there indication for use, and 18 (43.9%) patients had been using omeprazole for more than two years and 7 (17.1%) for more than five years. Only 3 (7.3%) patients underwent endoscopy, and 371 months-worth of omeprazole were used, totaling a financial value of R$35,657.23. The findings suggest long-term prescriptions and no record of their indication on medical records. The cost related to prescriptions could be optimized by performing endoscopy and discontinuing its use when no indication is found.

Comparación del efecto de omeprazol como monoterapia y su combinación con bicarbonato de sodio en el tratamiento de la pirosis moderada a severa: ensayo clínico controlado, aleatorizado y doble ciego / Comparison of the effect of omeprazole monotherapy and its combination with sodium bicarbonate in the treatment of moderate to severe heartburn: a double-blind, randomized controlled clinical trial

Heartburn occurs in 75% of patients with digestive discomfort of any origin and is one of the main symptoms of gastroesophageal reflux disease. Treatment focuses on lifestyle modification and symptomatology management with various drugs; when heartburn is moderate to severe, a proton pump inhibitor is more suitable. Omeprazole (OMZ) combined with sodium bicarbonate (BC) has demonstrated significant and sustained suppression of acid secretion. The objective was to compare the effect of sequential OMZ/BC therapy compared to OMZ monotherapy for the improvement of heartburn in Mexican individuals. The study was a double-blind, randomized, controlled, multicenter clinical study including 277 subjects with moderate to severe heartburn. Patients received 7 days of OMZ/BC and 7 days of OMZ (OMZ/BC7) or 14 days of OMZ (OMZ14). The primary endpoint was defined as the change in the number of days a week that the patient has heartburn, it was evaluated at 14 days. Both treatments reduced time (days) with heartburn by less than 4 days (OMZ14 3.9 vs. 4.2 days OMZ/BC7), as well as duration, number of events and intensity of heartburn. The treatments improved the quality of life, and the control of the symptoms. The proportion of adverse events was lower with OMZ/BC. The non-inferiority of OMZ/BC7 with respect to OMZ14 was verified.

La pirosis se presenta en el 75% de los pacientes con molestias digestivas de cualquier origen y es uno de los principales síntomas de la enfermedad por reflujo gastroesofágico. El tratamiento se enfoca en la modificación del estilo de vida y el manejo de la sintomatología con diversos fármacos; cuando la pirosis es moderada a severa, un inhibidor de la bomba de protones es más adecuado. El omeprazol (OMZ) combinado con bicarbonato de sodio (BC) ha demostrado supresión significativa y sostenida de la secreción ácida. El objetivo fue comparar el efecto de la terapia secuencial de OMZ/BC en comparación con el tratamiento continuo de OMZ para la mejoría de la pirosis en individuos mexicanos. Estudio clínico multicéntrico, doble ciego, controlado, aleatorizado que incluyó 277 sujetos con pirosis moderada a severa. Los pacientes recibieron 7 días de OMZ/BC y 7 días de OMZ (OMZ/BC7) o 14 días de OMZ (OMZ14). La variable primaria fue definida como el cambio del número de días a la semana que el paciente presenta pirosis, se evaluó a los 14 días. Ambos tratamientos redujeron los días con pirosis en menos 4 días (OMZ14 3,9 vs. 4,2 días OMZ/BC7), así como la duración, el número de eventos e intensidad de la pirosis. Los tratamientos mejoraron los indicadores de calidad de vida, y el control del padecimiento. La proporción de eventos adversos fue menor con OMZ/BC. Se comprobó la no-inferioridad de OMZ/BC7 respecto OMZ14.

Profilaxis para sangrado gastrointestinal en pacientes del servicio de medicina interna de un hospital universitario / Gastrointestinal bleeding prophylaxis in internal medicine patients of a univeristy hospital

Introducción: Los medicamentos antiulcerosos son utilizados frecuentemente en pacientes hospitalizados, sin embargo, a menudo este uso no está indicado. Objetivo: Describir la frecuencia de prescripción e indicación de medicamentos para prevenir el sangrado gastrointestinal en pacientes hospitalizados. Materiales y métodos: Estudio de corte trasversal, descriptivo, prospectivo del servicio de Medicina Interna de la Sociedad de Cirugía de Bogotá- Hospital de San José de Bogotá, Colombia. Se excluyeron pacientes con diagnóstico de sangrado gastrointestinal o antecedente de alergia a los medicamentos antiulcerosos. Se recolectaron datos demográficos, así como fármacos prescritos. Se determinó si la indicación del fármaco era adecuada y se identificó el tipo de error de prescripción. Resultados: Se incluyeron 179 pacientes, 102 (57%) mujeres. Promedio de edad de 61,3 años (±20,2). El principal diagnóstico de ingreso fue enfermedad infecciosa 76 (42,4%). Del total de pacientes, 165 (92,17%) recibieron medicamento para prevención del sangrado gastrointestinal. La indicación fue adecuada en 75 pacientes (41,89%). El error más frecuente fue el uso en pacientes de bajo riesgo de sangrado, 101 (97,1%). Conclusión: Un alto porcentaje de los pacientes recibió medicación para la prevención del sangrado gastrointestinal. En aproximadamente la mitad de estos no estaba indicada.

Introduction: Anti-ulcer medications are frequently used in hospitalized patients, yet their use is not usually indicated. Objective: To describe the frequency of prescription and indication of medications to prevent gastrointestinal bleeding in hospitalized patients. Materials and methods: A cross-sectional, descriptive, prospective study was carried out in the Internal Medicine service of the Surgery Society of Bogota-San Jose Hospital of Bogota (Colombia). Excluded patients were those with either a gastrointestinal bleeding diagnosis or a history of allergy to anti-ulcer medications. Demographic data and information regarding prescribed medications were collected. It was determined whether the medicine indication was adequate and the type of prescription error was identified. Results: 179 patients were included in the study, 57% (102) of which were women. The average age was 61.3 (±20.2) years old. Infectious disease was the main admission diagnosis (76; 42.4%). A 92.17% (165) of the total number of patients received medications to prevent gastrointestinal bleeding. This indication was adequate for 75 (41.89%) patients. The most frequent error was their use in bleeding low-risk patients (101; 97.1%). Conclusion: A high percentage of patients received medication to prevent gastrointestinal bleeding. However, in about half of these patients it was not indicated.

Erosive esophagitis secondary to radiotherapy: Case report / Esofagitis erosiva secundaria a radioterapia: reporte de un caso

Abstract Introduction: Erosive esophagitis secondary to radiotherapy is an unusual complication in the oncological treatment of thoracic tumors. This pathological entity is associated with multiple complications, which is a clinical challenge for health workers unfamiliar with the clinical manifestations. Clinical case: A 64-year-old woman with a 3-day clinical picture of chest pain radiating to the epigastrium with 10/10 intensity. On physical examination, she was tachycardic, hypotensive, and with intense pain in the upper hemiabdomen region; she had no signs of peritoneal irritation on deep palpation. Paraclinical tests showed no signs of local or disseminated infection, but endoscopy of the digestive tract reported post-radiation esophagitis. Discussion: Erosive esophagitis after radiotherapy occurs in less than 1 % of cases, and clinical manifestations such as dysphagia, odynophagia, and abdominal pain are common. Initial symptomatic management is preserved, with supportive measures such as intravenous hydration and proton pump inhibitors (PPIs). In case of intolerance to the oral route, therapy with nutritional support is indicated via nasogastric tube or gastrostomy in the most severe cases.

Resumen Introducción: la esofagitis erosiva secundaria a la radioterapia es una complicación inusual del tratamiento oncológico de los tumores torácicos. Esta entidad patológica está asociada con múltiples complicaciones, lo que resulta un reto clínico para los profesionales en salud que están poco familiarizados con las manifestaciones clínicas. Caso clínico: mujer de 64 años con cuadro clínico de 3 días de dolor torácico irradiado al epigastrio con intensidad 10/10. En el examen físico se encontró taquicárdica, hipotensa, con dolor intenso en la región hemiabdominal superior; a la palpación profunda no tenía signos de irritación peritoneal. Los paraclínicos no mostraron signos de infección local o diseminada, pero la endoscopia de vías digestivas reportó esofagitis posirradiación. Discusión: la esofagitis erosiva posterior a la radioterapia se presenta en menos del 1 % de los casos, las manifestaciones clínicas como disfagia, odinofagia y dolor abdominal son frecuentes; el manejo sintomático inicial es conservado, con medidas de soporte como hidratación intravenosa e inhibidores de la bomba de protones (IBP). En caso de intolerancia a la vía oral se indica terapia con soporte nutricional por sonda nasogástrica o gastrostomía en los casos más graves.

Bridging the structure gap between pellets in artificial dissolution media and in gastro-intestinal tract in rats

Changes in structure of oral solid dosage forms (OSDF) elementally determine the drug release and its therapeutic effects. In this research, synchrotron radiation X-ray micro-computed tomography was utilized to visualize the 3D structure of enteric coated pellets recovered from the gastrointestinal tract of rats. The structures of pellets in solid state and in vitro compendium media were measured. Pellets in vivo underwent morphological and structural changes which differed significantly from those in vitro compendium media. Thus, optimizations of the dissolution media were performed to mimic the appropriate in vivo conditions by introducing pepsin and glass microspheres in media. The sphericity, pellet volume, pore volume and porosity of the in vivo esomeprazole magnesium pellets in stomach for 2 h were recorded 0.47, 1.55 × 108 μm3, 0.44 × 108 μm3 and 27.6%, respectively. After adding pepsin and glass microspheres, the above parameters in vitro reached to 0.44, 1.64 × 108 μm3, 0.38 × 108 μm3 and 23.0%, respectively. Omeprazole magnesium pellets behaved similarly. The structural features of pellets between in vitro media and in vivo condition were bridged successfully in terms of 3D structures to ensure better design, characterization and quality control of advanced OSDF.

Efficacy of omeprazole and sodium bicarbonate suspension in the treatment of peptic ulcer: a multicenter clinical trial / 中华消化杂志

Objective:To evaluate the efficacy and safety of omeprazole and sodium bicarbonate suspension in the treatment of peptic ulcer.Methods:This present study was a multicenter, randomized, double-blind, double-dummy, positive drug parallel controlled phase Ⅱ clinical trial. According to different indications, the trial was divided into gastric ulcer (GU) and duodenal ulcer (DU) studies. Patients were stratified-block randomly divided with a 1∶1 ratio into experimental group and control group. The patients in the experimental group were administrated with omeprazole and sodium bicarbonate suspension omeprazole (20 mg for DU or 40 mg for GU, and 1 680 mg sodium bicarbonate) once a day. The patients in the control group received omeprazole magnesium enteric-coated tablet20 mg for DU or 40 mg for GU once a day. The treatment period was 4 weeks for DU and 8 weeks for GU. The main efficacy indicator was ulcer healing rate under endoscopy. The time of pain disappearance and the total effective rate of clinical symptom relief were used as the secondary efficacy indicators, and the incidence of adverse reactions was used as the safety indicator. The data set included full analysis set (FAS), per-protocol set (PPS) and safety set (SS). Independent sample t test, Wilcoxon rank sum test, chi square test, Fisher exact test method and non-inferiority test were used for statistical analysis. Results:Two hundred and seventy two DU patients and 237 GU patients were included in the FAS, 247 DU patients and 201 GU patients were included in the PPS, and 272 DU patients and 235 GU patients were included in the SS. The results of FAS analysis showed that after 4 weeks treatment, the healing rate of DU under endoscopy in the experimental group was 91.91% (125/136) and that in the control group was 94.85% (129/136), and the difference was not statistically significant ( P>0.05). After 8 weeks treatment the healing rate of GU under endoscopy in the experimental group was 86.44% (102/118) and that in the control group was 87.39% (104/119), and the difference was not statistically significant ( P>0.05). The results of non-inferiority analysis showed the lower limit of 95% confidence interval of difference in effective rate between the two groups was over -10% (-8.84% for DU and -9.54% for GU), which indicated that the effective rate of experimental group was not inferior to that of the control group. The results of PPS analysis were consistent with the results of FAS. The results of FAS analysis showed the median time of abdominal pain disappearance of DU patients in the experimental group and the control group was both 6 d, and the difference was not statistically significant ( P>0.05). The median time of abdominal pain disappearance of GU patients in the experimental group and the control group was both 8 d, and the difference was not statistically significant ( P>0.05). After 4 weeks of treatment, the total effective rates of clinical symptom relief of DU of the trial group and the control group were 95.59% (130/136) and 97.79% (133/136), respectively, and the difference was not statistically significant ( P>0.05). After 8 weeks of treatment, the total effective rates of clinical symptom relief of GU of the experimental group and the control group were 95.76% (113/118) and 93.28% (111/119), respectively, and the difference was not statistically significant ( P>0.05). The results of SS analysis showed that the incidence of adverse reactions of DU patients in the trial group and the control group was 5.15% (7/136) and 2.21% (3/136), respectively, and the difference was not statistically significant ( P>0.05). The incidence of adverse reactions of GU patients in the experimental group and the control group was 12.71% (15/118) and 6.84% (8/117), respectively, and the difference was not statistically significant ( P>0.05). Conclusions:Omeprazole and sodium bicarbonate suspension is not inferior to omeprazole magnesium enteric-coated tablet in healing efficacy under endoscopy in peptic ulcer, and has a good safety.

Hipocalcemia, hipomagnesemia y uso crónico de inhibidores de la bomba de protones / Hypocalcemia, hypomagnesemia, and chronic use of proton pump inhibitors

Introducción: Los inhibidores de la bomba de protones son fármacos usados en múltiples gastropatías. El omeprazol pertenece a este grupo de medicamentos y es aprobado y catalogado como indispensable por la Organización Mundial de la Salud. Esto ha causado que su uso se vuelva constante y hasta cierto punto equívoco. Pese a ser medicamentos seguros muestran efectos secundarios, dentro de los cuales uno ocasional es el trastorno hidroelectrolítico. Objetivo: Presentar un caso clínico en el cual se constató la presencia de efectos secundarios tras el uso de un fármaco de uso constante por la comunidad médica: el omeprazol. Caso clínico: Se presenta a continuación el caso clínico de un paciente masculino con antecedente de hipertensión arterial y gastropatía crónica que muestra uso por 8 años consecutivos de inhibidores de la bomba de protones, al cual se le diagnostica hipomagnesemia e hipocalcemia. Se obtuvieron resultados de laboratorio normales tras administración de suplementos orales y uso de ranitidina con supresión de terapéutica con omeprazol. Conclusiones: Un control constante de los fármacos que usan los pacientes crónicos es fundamental en atención primaria de salud. El uso de inhibidores de la bomba de protones se ha convertido en rutinario y es necesario corroborar siempre la dosis y el tiempo de uso de los fármacos además de la relación con otros medicamentos que use el paciente(AU)

Introduction: Proton-pump inhibitors are drugs used in multiple gastropathies. Omeprazole belongs to this group of medicines; it is approved and classified as essential by the World Health Organization. This has permitted for its use to become constant and, to some extent, misleading. Despite being safe drugs, they show side effects, among which an occasional one is fluid and electrolyte disorders. Objective: To present a clinical case in which the occurrence of side effects was verified after the administration of a drug constantly used by the medical community. Clinical case: The following is a clinical case of a male patient with a history of arterial hypertension and chronic gastropathy, characterized by the usage of proton-pump inhibitors for eight consecutive years, diagnosed with hypomagnesemia and hypocalcemia. Normal laboratory results were obtained after oral supplementation and usage of ranitidine with suppression of omeprazole therapy. Conclusions: Constant control of the drugs used by chronic patients is essential in primary health care. The usage of proton-pump inhibitors has become a routine. It is always necessary to check the dose and time for using the drugs as well as the relationship with other drugs used by the patient(AU)

Efficacy and safety of ulinastatin for treatment of upper gastrointestinal ulcer complicated with hemorrhage in children / 中华全科医师杂志

From January 2018 to August 2019, 87 children aged 2 to 8 years with upper gastrointestinal ulcer bleeding were admitted to the Department of Pediatrics of Shangqiu First People′s Hospital. Patients were randomly assigned in two groups, 45 cases received omeprazole for treatment (group A) and 42 cases received ulinastatin and omeprazole for treatment (group B). The omeprazole 10 mg/d was administrated orally for 2 to 4 weeks in two groups, while in group B additional ulinastatin injection (10 000-50 000 IU·kg -1·d -1 was given for 1 week. The effective rate in group B was 95.2% (40/42), which was significantly higher than that in group A (80.0%, 36/45) (χ2=4.567, P=0.03). After treatment, gastroscopy showed that the time of hemostasis, the time of stopping hematemesis, the time of fecal occult blood turning negative, and the length of hospital stay in group B were significantly shorter than those in group A ( P<0.05). The results of flow cytometry showed that the percentages of CD3 + and CD4 + increased and the percentages of CD8 + decreased significantly after treatment in the two groups, while the changes in group B were more marked than those in group A ( P<0.05). Serum inflammatory factors (serum procalcitonin, high-sensitivity C-reactive protein and tumor necrosis α) were significantly reduced after treatment in the two groups, while the above indicators in group A were significantly lower than those in group A (all P<0.05). In group A, there was 1 case of nausea and vomiting, 1 case of abdominal pain and diarrhea, and 1 case of lethargy; in group B, there was 1 case of nausea and vomiting and 1 case of abdominal pain and diarrhea. The study suggests that ulinastatin combined with omeprazole has a better effect than omeprasole alone in treatment of children with upper gastrointestinal ulcer bleeding without increasing adverse effects.

Clinical analysis and literature review of 6 cases of burning mouth syndrome-like symptoms caused by the long-term oral administration of omeprazole / 口腔疾病防治

Objective @#To analyze the oral adverse drug reactions induced by omeprazole and provide a reference for rational clinical drug use.@*Methods@#From January 2019 to June 2020, the clinical data of patients with burning mouth syndrome caused by omeprazole were collected and analyzed. Additionally, the related literature was reviewed. @*Results@#Among the six patients, omeprazole was taken orally for as little as 6 months and as long as more than 5 years. The symptoms of burning mouth syndrome were mainly burning sensation in the mouth and paresthesia on the tongue that might be accompanied by extremity numbness. Vitamin and trace element supplementation was administered. The patient discontinued omeprazole, and symptoms disappeared after symptomatic treatment for 1 month to half a year. Literature review suggests that the reason may be associated with peripheral or central nervous system injury, altered saliva composition, and impaired vitamin and micronutrient intake caused by omeprazole.@*Conclusion @# The cause of burning mouth syndrome-like symptoms may be related to peripheral nerve injury caused by omeprazole and saliva changes. The main treatment is withdrawal and symptomatic treatment.

Omeprazole prescriptions for older adults in health care units in Curitiba, Brazil: an analysis based on Beers Criteria / Prescrições de omeprazol para idosos em unidades de saúde de Curitiba: análise segundo os Critérios de Beers

OBJECTIVE: To evaluate omeprazole prescriptions for older adults based on the Beers Criteria, with an analysis of indications and duration of use longer than eight weeks. METHODS: In this retrospective cross-sectional study, data were collected from the electronic medical records of older adults with an omeprazole prescription seen at two health care units in Curitiba, Brazil, between June and August 2019. Data were subjected to descriptive statistical analysis, Student t and χ2 tests. RESULTS: Medical records of 386 patients were analyzed, and 69.95% were female. The mean age was 71 (SD, 8.15) years. Most patients had incomplete primary education (50.52%) and income level ranging from one to two Brazilian minimum monthly wages (39.90%). No indication for omeprazole prescription was found in 23.83% of medical records. Use longer than eight weeks was predominant for all indications in 96.60% of medical records. Duration of use more extended than the Beers Criteria recommendation was independent of sex (p = 0.327), education (p = 0.805), and income level (p = 0.629). A relationship between polypharmacy and long-term drug use was demonstrated (p < 0.001). CONCLUSION: The results of this study suggest the need for periodic review of omeprazole prescriptions considering deprescribing when they appropriate.

OBJETIVO: Avaliar as prescrições de omeprazol para idosos de acordo com os Critérios de Beers, por meio das indicações e do tempo de uso do medicamento por período superior a oito semanas. METODOLOGIA: Estudo transversal, retrospectivo, no qual foram coletados dados dos prontuários eletrônicos de idosos com prescrição de omeprazol atendidos entre junho e agosto de 2019 em duas unidades de saúde em Curitiba. Os dados foram submetidos à análise estatística descritiva e aos testes t de Student e do χ2 . RESULTADOS: Foram analisados prontuários de 386 usuários, sendo 69,95% do sexo feminino. A média de idade foi de 71 anos (DP, 8,15). A maioria dos usuários tem ensino fundamental incompleto (50,52%) e faixa de renda de um a dois salários mínimos (39,90%). Não foi encontrada a indicação para a prescrição de omeprazol em 23,83% dos prontuários. O uso por período superior a oito semanas foi predominante, para todas as indicações, em 96,60% dos prontuários. Demonstrou-se que o tempo de uso superior ao recomendado nos Critérios de Beers independe do sexo (p = 0,327), da escolaridade (p = 0,805) e da faixa de renda (p = 0,629). Evidenciou-se a relação entre polifarmácia e uso do medicamento por períodos prolongados (p < 0,001). CONCLUSÃO: Os resultados deste estudo apontam para a necessidade de revisão periódica das prescrições de omeprazol, considerando-se a desprescrição quando apropriado.