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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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)

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.

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.

Antiulcerogenic effect of Capparis cartillaginea decne on indomethacin induced gastric ulcer in wistar rats

Background: Peptic ulcer disease is a non-malignant, mucosal lesion of the stomach or duodenum. The mucosal defect reaches the muscularis mucosa and sometimes, beyond causing life threatening complications, including haemorrhage, perforations, gastrointestinal obstruction and malignancy.Methods: The animals were pre-treated with omeprazole 20 mg/kg and 300 mg/kg of Capparis cartillaginea decne orally for 14 days. On the 15th day, ulcers were induced using indomethacin 30 mg/kg and 4 hours post ulcer induction, they were sacrificed. Ulcer index, pH, total acidity and volume were determined.Results: Extensive lesions were seen in indomethacin ulcerated rats with mean ulcer score of (1.260±0.18). In comparison, there were minimal areas of erosion on animals pre-treated with omeprazole (0.14±0.025) and plant extracts (0.280±0.097). Indomethacin-induced ulcer treated animals showed the highest volume of gastric juice output (3.14±0.21 ml), whereas the animals pre-treated with omeprazole had lower gastric juice output (2.20±0.2 9ml). This was comparable to animals pre-treated with the plant extract (1.80±0.13 ml). The pH was high in animals pre-treated with omeprazole (5.02±0.53). This was also seen in animals pre-treated with the extract (4.82±0.31). This was in comparison to the low pH seen in indomethacin ulcerated animals (2.20±0.16). Indomethacin-induced ulcer treated animals showed high levels of total acidity (88.64±1.71 mEq/L). Whereas the animals pre-treated with omeprazole had lower total acidity (55.26±3.77 mEq/L), which was also mirrored in animals pre-treated with the plant extracts (61.44±2.42 mEq/L).Conclusions: The extracts of Capparis cartillaginea decne showed anti-ulcer effect on indomethacin induced ulcers in Wistar rats.

Prevalence of Side Effects, Drug Interaction among Patients Taking Statin in Turaif, Saudi Arabia

Background:Statins perceived to have favorable safety profile. Although many people on statin therapy do well but no drug is without potential for side effects. Awareness about risks as well as benefits of drugs is needed particularly drugs which are used on wide scale like statins because even uncommon side effects can have significant health impact. Objectives of the Study: To determine side effects occurrence among Saudi patients taking statins and to evaluate drug-drug interactions in Saudi patients taking statins.Methodology:Self administered cross sectional study conducted during a period of four months from October 2018 to January 2019 in Turaif general hospital, Saudi Arabia on random sample of 500 Saudi patients out of which 330 participants were included in the study which were taking different types of statins medication using self-administered questionnaire in Arabic language specially designed for the research purpose after obtaining verbal consent and the data analyzed by SPSS program.Results:A total of 330 patients; 128 (39%) females and 202 (61%) males—participated in the study. The majority 165 (50%) were in the age-group of 50 –59 years. Simvastatin was the most commonly used statin among study participants 136 (41%) followed by rosuvastatin114 (35%). Among the participants, there were some patients who take drugs which have drug interactions with statins; there were 64 (19%) take Amlodipine with simvastatin, 13 (4%) and 6 (2%) take esomeprazole and ompeprazole respectively with statins. Only 9 (3%) reported that they were advised by pharmacist to avoid grape fruit. Majority of participants 309 (94%) reported neck pain, difficulty in walking, frequently fatigue after starting on statin. Also majority of participants 320 (97%) suffer from muscle pain after starting statins medications. Conclusion:The percentage of statin related side effects in this study population is high especially myopathy. Also some patients in this study taking medications that have drug interaction with statins, Counseling to patient regarding statin therapy appear to be insufficient. So, this study indicate that there's a need for more efforts from the physicians and pharmacist to avoid prescribing or dispensing medication that have drug-drug interaction with statins and provide counseling to patients regarding their statin therapy

Pharmaceutical intervention in the rational use of intravenous omeprazole / Intervenção farmacêutica no uso racional de omeprazol intravenoso

ABSTRACT Objective: To describe the pharmaceutical interventions of a vertical clinical pharmacy service to promote the rational use of intravenous omeprazole. Methods: A prospective and descriptive study carried out at a university hospital in the Midwestern Region of Brazil, from November 2014 to May 2015. The service consisted of the analysis of adequacy of the route of administration of omeprazole in relation to the clinical conditions of the patient, as well as the use of the appropriate diluent. Interventions were recorded in medical records and subsequently evaluated for acceptance. Results: A total of 770 prescriptions were evaluated. Interventions related to diluent replacement were more accepted (p<0.001), and surgeons were the specialty that used the intravenous route inappropriately (p<0.001). Conclusion: Although partially accepted, pharmaceutical interventions could contribute to improve patient safety, since they allowed the use of a safer route of administration.

RESUMO Objetivo: Descrever as intervenções farmacêuticas de um serviço farmacêutico clínico vertical, para a promoção do uso racional do omeprazol intravenoso. Métodos: Estudo prospectivo e descritivo realizado em um hospital universitário da região Centro-Oeste do Brasil, no período de novembro de 2014 a maio de 2015. O serviço consistia na análise da adequabilidade da via de administração do omeprazol em relação às condições clínicas do paciente, bem como a utilização do diluente adequado. As intervenções eram registradas em prontuário e, posteriormente, avaliadas quanto à aceitação. Resultados: Foram avaliadas 770 prescrições. As intervenções relacionadas à substituição do diluente foram mais aceitas (p<0,001), e os cirurgiões foram a especialidade que utilizou a via intravenosa de maneira inadequada (p<0,001). Conclusão: Embora parcialmente aceitas, as intervenções farmacêuticas puderam contribuir com a melhoria da segurança dos pacientes, uma vez que permitiram a utilização de uma via de administração mais segura.

Chronic use of proton pump inhibitors and the quantity of g, d, and ecl cells in the stomach / Uso crônico de inibidores de bomba de prótons e a quantidade de células g, d e ecl no estômago

ABSTRACT Background: Acid inhibition from chronic proton pump inhibitor use and a possible increase in gastrin can lead to changes in the regulation of hydrochloric acid production. However, it has not known whether such chronic use changes the presence of gastrin, delta, and enterochromaffin-like cells in the stomach or the relationship between gastrin and delta cells. Aim: To analyze the number of gastrin-producing gastrin cells, somatostatin-producing cells, and histamine-producing cells in patients who were chronic users of proton pump inhibitor, with or without related Helicobacter pylori infection. Methods: Biopsies from 105 patients, including 81 chronic proton pump inhibitor users (experimental group) and 24 controls, were processed immunohistochemically and subjected to counting of gastrin, delta, and enterochromaffin-like cells in high-magnification microscopic fields and in 10 glands. Results: Gastrin cell, delta cell, and enterochromaffin-like cells counts were similar across the groups and appeared to be unaffected by Helicobacter pylori infection. The ratio between gastrin cells and delta cells was higher in the chronic users of proton pump inhibitor group than in controls. Conclusion: Chronic users of proton pump inhibitor does not affect gastrin cell, delta cell, and enterochromaffin-like cell counts significantly, but may alter the ratio between gastrin cells and delta cells.

RESUMO Racional: A inibição ácida pelo uso crônico de inibidores de bomba de prótons e o possível aumento da gastrina podem ser seguidos de alterações na regulação da produção do ácido clorídrico. Ainda não está definido se o uso crônico altera a quantidade de células G, D e ECL no estômago ou a razão células G/D. Objetivo: Avaliar o número de células G - produtoras de gastrina -, células D - produtoras de somatostatina - e células ECL - produtoras de histamina -, em pacientes com uso crônico de inibidores de bomba de prótons, com ou sem infecção pelo Helicobacter pylori. Método: Trata-se de estudo retrospectivo avaliando 105 pacientes, 81 usadores crônicos de inibidores de bomba de prótons e 24 controles, através de biópsias com contagem das células G, D e ECL por estudo imunoistoquímico, de forma quantitativa onde havia maior número de células positivas por campo microscópico de grande aumento e em 10 glândulas. Resultados: Não houve diferença estatística comparando-se o número de células G, D e ECL. A razão entre as células G e D foi maior nos pacientes usadores crônicos de inibidores de bomba de prótons. Conclusão: O uso crônico de inibidores de prótons parece não interferir na contagem das células G, D e ECL, porém, interfere na razão entre as células G e D.

Omeprazole and adenocarcinoma in the stomach of rats submitted to duodenogastric reflux. Is there a protective effect?

Abstract Purpose: To investigate the role of omeprazole and nitrites on the gastric mucosa of rats submitted to specific techniques to induce duodenogastric reflux. Methods: One hundred and twenty Wistar rats were divided into three groups: Group I (n=40) -gastrotomy; Group II (n=40) - duodenogastric reflux after gastrojejunoanastomosis latero-lateral (DGR); Group III (n=40) - retrograde duodenogastric reflux through the pylorus (DGR-P). The groups were divided into 4 subgroups of 10 animals, respectively treated for 16 weeks with water, omeprazole 1.6 mg / rat / day, nitrite 600 mg / kg / day and omeprazole plus nitrite simultaneously. Results: The proliferative lesions found were: squamous hyperplasia - 69.1%, adenomatous hyperplasia in the anastomosis - 29.1% and prepyloric adenomatous hyperplasia - 42.5%. Adenocarcinomas were registered in 7 animals (5.8%): one in Group I (omeprazole plus nitrite), two in Group II (omeprazole and nitrite plus omeprazole) and four in Group III (water, nitrite, omeprazole and omeprazole plus nitrite). Conclusions: The occurrence of squamous hyperplasia, adenomatous hyperplasia and adenocarcinoma increased after gastrojejunal anastomoses, which cause duodenogastric reflux. The association of omeprazole did not protect the development of proliferative lesions and cancer induced by duodenogastric reflux in rats.