Efficacy of low-dose lansoprazole in the treatment of non-erosive gastrooesophageal reflux disease. Influence of infection by Helicobacter pylori.

INTRODUCTION: Proton pump inhibitors (PPIs) are the most effective drugs to cure peptic esophagitis and control the symptoms of gastroesophageal reflux disease (GERD). In most patients with GERD esophagitis is not detected by endoscopy, which represents GERD with a negative endoscopy or non-erosive reflux disease (NERD). The influence of infection by H. pylori in the evolution of GERD is controversial since a protective action is identified by some studies, but not all. We conducted a clinical trial to assess the efficacy of lansoprazole 15 mg/day in the initial control of NERD symptoms, and as a secondary endpoint the impact of H. pylori infection on response to treatment. PATIENTS AND METHODS: A pilot, single-center clinical trial was conducted--single-blind regarding the experimental medication (unknown to patients), and double-blind regarding the information concerning H. pylori infection. Sixty (60) patients with NERD were initially included, who had suffered from daytime or nocturnal heartburn for 1-2 days in each of the last two weeks. Nine patients were excluded for failing to comply with the study protocol. The 51 remaining patients, 35 women and 16 men, with a mean age of 49 years, comprised the per protocol analysis population. Patients received treatment for two weeks with a capsule of the study medication (15 mg/day of lansoprazole), with daily controls on the presence and severity of daytime and nocturnal heartburn. Treatment was considered effective when, upon completion, patients referred a maximum of one episode of mild heartburn as defined in the protocol, or answered the following question in the affirmative: "Does the medication you are receiving satisfactorily control the symptoms of your disease?". During diagnostic endoscopy we obtained biopsies of the gastric body and antrum to investigate infection by H. pylori by means of a urease test. Treatment efficacy was assessed with no patients or doctors responsible for the study being aware of urease test results. RESULTS: 41 patients (80.3%) reported that treatment had satisfactorily controlled their symptoms, and 34 patients (66.6%) had a maximum of one episode of mild heartburn in the last week. Forty-two (42) patients (82.3%) had infection by H. pylori. No significant differences were observed in the response to treatment between patients with or without H. pylori infection. CONCLUSIONS: With the limitations of a pilot study, these results suggest that lansoprazole 15 mg/day is an effective treatment in the control of NERD symptoms, that it may be a good initial therapeutic strategy, and that, according to data available, H. pylori infection has no significant effect on the response to treatment.

Eficacia de lansoprazol a dosis bajas en el tratamiento de la enfermedad por reflujo gastroesofágico no erosiva. Influencia de la infección por Helicobacter pylori / Efficacy of low-dose lansoprazole in the treatment of non-erosive gastrooesophageal reflux disease. Influence of infection by Helicobacter pylori

Introducción: los inhibidores de la bomba de protones (IBP) son los fármacos más eficaces en la curación de la esofagítis péptica y en el control de los síntomas de la enfermedad por reflujo gastroesofágico (ERGE). En la mayoría de los pacientes con ERGE no se detecta esofagitis al practicarse endoscopia presentando una ERGE con endoscopia negativa o no erosiva (ERNE). La influencia de la infección H. pylori en la evolución de la ERGE es controvertida, ya que mientras que unos estudios le asignan una acción protectora, otros se la niegan. Hemos realizado un ensayo clínico para valorar la eficacia de lansoprazol 15 mg/día en el control inicial de los síntomas de la ERNE y, como objetivo secundario, la influencia de la infección H. pylori en la respuesta al tratamiento. Pacientes y métodos: se realiza un ensayo clínico piloto, unicéntrico, simple ciego en cuanto a la medicación experimental, no conocida por los pacientes, y doble ciego en cuanto a la información de la infección por H. pylori. Se incluyeron inicialmente 60 pacientes con ERNE que presentaban al menos dos días con pirosis diurna o nocturna en cada una de las dos últimas semanas. Se excluyeron 9 pacientes por incumplimiento del protocolo del estudio. Los 51 pacientes restantes, 35 mujeres y 16 hombres, con edad media de 49 años, constituyeron la población de análisis por protocolo. Los pacientes recibieron tratamiento durante dos semanas con una cápsula de la medicación de estudio (15 mg/día de lansoprazol), realizándose en este tiempo un seguimiento diario de la presencia e intensidad de la pirosis diurna y nocturna. Se consideró que el tratamiento era eficaz cuando a su finalización los pacientes referían haber presentado como máximo un episodio de pirosis de intensidad leve, según definición del protocolo, o bien respondían afirmativamente a la siguiente pregunta: “¿la medicación que recibe le controla de forma satisfactoria los síntomas de su enfermedad?”. Durante la endoscopia diagnóstica se obtuvieron biopsias de cuerpo y antro gástrico para investigar, mediante test de la ureasa, la infección por H. pylori. Se valoró la eficacia del tratamiento sin conocerse por los pacientes y médicos responsables del estudio los resultados de los test de ureasa. Resultados: cuarenta y un pacientes (80,3%) referían que el tratamiento les controlaba de forma satisfactoria la sintomatología y 34 pacientes (66,6%) habían presentado como máximo un episodio de pirosis de intensidad leve en la última semana. Cuarenta y dos pacientes (82,3%) presentaban infección por H. pylori. No se observaron diferencias significativas en la respuesta al tratamiento en los pacientes con o sin infección por H. pylori. Conclusiones: con las limitaciones propias de un estudio piloto, estos resultados, orientan a que lansoprazol 15 mg/día es un tratamiento eficaz en el control de la sintomatología de la ERNE, pudiendo ser una buena estrategia terapéutica inicial y que, con los datos disponibles, la infección por H. pylori no influye de forma significativa en la respuesta al tratamiento

Introduction: proton pump inhibitors (PPIs) are the most effective drugs to cure peptic esophagitis and control the symptoms of gastroesophageal reflux disease (GERD). In most patients with GERD esophagitis is not detected by endoscopy, which represents GERD with a negative endoscopy or non-erosive reflux disease (NERD). The influence of infection by H. pylori in the evolution of GERD is controversial since a protective action is identified by some studies, but not all. We conducted a clinical trial to assess the efficacy of lansoprazole 15 mg/day in the initial control of NERD symptoms, and as a secondary endpoint the impact of H. pylori infection on response to treatment. Patients and methods: a pilot, single-center clinical trial was conducted –single-blind regarding the experimental medication (unknown to patients), and double-blind regarding the information concerning H. pylori infection. Sixty (60) patients with NERD were initially included, who had suffered from daytime or nocturnal heartburn for 1-2 days in each of the last two weeks. Nine patients were excluded for failing to comply with the study protocol. The 51 remaining patients, 35 women and 16 men, with a mean age of 49 years, comprised the per protocol analysis population. Patients received treatment for two weeks with a capsule of the study medication (15 mg/day of lansoprazole), with daily controls on the presence and severity of daytime and nocturnal heartburn. Treatment was considered effective when, upon completion, patients referred a maximum of one episode of mild heartburn as defined in the protocol, or answered the following question in the affirmative: “Does the medication you are receiving satisfactorily control the symptoms of your disease?”. During diagnostic endoscopy we obtained biopsies of the gastric body and antrum to investigate infection by H. pylori by means of a urease test. Treatment efficacy was assessed with no patients or doctors responsible for the study being aware of urease test results. Results: 41 patients (80.3%) reported that treatment had satisfactorily controlled their symptoms, and 34 patients (66.6%) had a maximum of one episode of mild heartburn in the last week. Forty-two (42) patients (82.3%) had infection by H. pylori. No significant differences were observed in the response to treatment between patients with or without H. pylori infection. Conclusions: with the limitations of a pilot study, these results suggest that lansoprazole 15 mg/day is an effective treatment in the control of NERD symptoms, that it may be a good initial therapeutic strategy, and that, according to data available, H. pylori infection has no significant effect on the response to treatment

[Influence of nonsteroidal antiinflammatory drugs in gastrointestinal bleeding due to gastroduodenal ulcers or erosions in patients with liver cirrhosis]. / Influencia de los antiinflamatorios no esteroideos en la hemorragia digestiva por úlceras o erosiones gastroduodenales en pacientes con cirrosis hepática.

INTRODUCTION: Peptic ulcer disease, with or without complications, is more common in patients with liver cirrhosis than in the general population. Factors associated with portal hypertension are involved in its pathogenesis. The prevalence of Helicobacter pylori infection in patients with liver cirrhosis and the general population is similar. The aim of the present study was to determine the influence of nonsteroidal antiinflammatory drugs (NSAIDs) in the etiology of bleeding peptic ulcer disease in patients with liver cirrhosis. PATIENTS AND METHODS: We studied 35 patients with liver cirrhosis and gastrointestinal bleeding due to gastroduodenal ulcers or erosions (group A), 125 noncirrhotic patients with gastrointestinal bleeding due to gastroduodenal ulcers or erosions (group B), and 70 patients with liver cirrhosis who were admitted to hospital without gastrointestinal bleeding (group C). All patients were questioned about NSAID consumption, including aspirin, during the week prior to hospital admission. RESULTS: NSAID consumption was reported by 15 patients (42.8%) in group A, 102 patients (58.2%) in group B, and 6 patients (8.5%) in group C. Statistically significant differences were obtained when the results for group A were compared with those for group C. CONCLUSIONS: NSAID consumption in patients with liver cirrhosis without gastrointestinal bleeding was low (8.5%) and was much lower than that observed in patients with cirrhosis admitted to hospital for bleeding due to gastroduodenal ulcers or erosions (42.8%). As occurs in the general population, NSAIDs play a significant role in the pathogenesis of bleeding due to peptic ulcer disease in patients with liver cirrhosis and portal hypertension.

Influencia de los antiinflamatorios no esteroideos en la hemorragia digestiva por úlceras o erosiones gastroduodenales en pacientes con cirrosis hepática / Influence of nonsteroidal antiinflammatory drugs in gastrointestinal bleeding due to gastroduodenal ulcers or erosions in patients with liver cirrhosis

Introducción: La enfermedad péptica gastroduodenal, con o sin complicaciones, es más frecuente en los pacientes con cirrosis hepática que en la población general y en su patogenia influirían factores dependientes de la hipertensión portal. La prevalencia de la infección por Helicobacter pylori en la población con cirrosis hepática es similar a la existente en la población general. Se objetiva conocer la influencia de los antiinflamatorios no esteroideos (AINE) en la etiología de la patología péptica gastroduodenal con hemorragia digestiva de los pacientes con cirrosis hepática. Pacientes y métodos: Se incluyó a 35 pacientes con cirrosis hepática con hemorragia digestiva por úlceras o erosiones gastroduodenales (grupo A), 125 pacientes no cirróticos, con hemorragia digestiva por úlceras o erosiones gastroduodenales (grupo B) y 70 pacientes con cirrosis hepática que ingresan sin hemorragia digestiva (grupo C). En todos los pacientes, mediante encuesta dirigida, se investiga el consumo de AINE, incluido ácido acetilsalicílico (AAS), en la semana previa al ingreso hospitalario. Resultados: Referían consumo de AINE 15 pacientes (42,8%) del grupo A, 102 pacientes (58,2%) del grupo B y 6 pacientes (8,5%) del grupo C. Se obtuvieron diferencias significativas al comparar los resultados del grupo A con el grupo C. Conclusiones: El consumo de AINE en los pacientes con cirrosis hepática sin hemorragia digestiva es bajo (8,5%), muy inferior al observado en los pacientes con cirrosis que ingresan con hemorragia por úlceras o erosiones gastroduodenales (42,8%). Se puede considerar que los AINE, como sucede en la población general, desempeñarían un importante papel en la patogenia de la hemorragia digestiva por patología péptica en la población con cirrosis hepática e hipertensión portal

Introduction: Peptic ulcer disease, with or without complications, is more common in patients with liver cirrhosis than in the general population. Factors associated with portal hypertension are involved in its pathogenesis. The prevalence of Helicobacter pylori infection in patients with liver cirrhosis and the general population is similar. The aim of the present study was to determine the influence of nonsteroidal antiinflammatory drugs (NSAIDs) in the etiology of bleeding peptic ulcer disease in patients with liver cirrhosis. Patients and methods: We studied 35 patients with liver cirrhosis and gastrointestinal bleeding due to gastroduodenal ulcers or erosions (group A), 125 noncirrhotic patients with gastrointestinal bleeding due to gastroduodenal ulcers or erosions (group B), and 70 patients with liver cirrhosis who were admitted to hospital without gastrointestinal bleeding (group C). All patients were questioned about NSAID consumption, including aspirin, during the week prior to hospital admission. Results: NSAID consumption was reported by 15 patients (42.8%) in group A, 102 patients (58.2%) in group B, and 6 patients (8.5%) in group C. Statistically significant differences were obtained when the results for group A were compared with those for group C. Conclusions: NSAID consumption in patients with liver cirrhosis without gastrointestinal bleeding was low (8.5%) and was much lower than that observed in patients with cirrhosis admitted to hospital for bleeding due to gastroduodenal ulcers or erosions (42.8%). As occurs in the general population, NSAIDs play a significant role in the pathogenesis of bleeding due to peptic ulcer disease in patients with liver cirrhosis and portal hypertension

Influencia de los antiinflamatorios no esteroideos en la hemorragia digestiva por úlceras o erosiones gastroduodenales en pacientes con cirrosis hepática / Influence of nonsteroidal antiinflammatory drugs in gastrointestinal bleeding due to gastroduodenal ulcers or erosions in patients with liver cirrhosis

Introducción: La enfermedad péptica gastroduodenal, con o sin complicaciones, es más frecuente en los pacientes con cirrosis hepática que en la población general y en su patogenia influirían factores dependientes de la hipertensión portal. La prevalencia de la infección por Helicobacter pylori en la población con cirrosis hepática es similar a la existente en la población general. Se objetiva conocer la influencia de los antiinflamatorios no esteroideos (AINE) en la etiología de la patología péptica gastroduodenal con hemorragia digestiva de los pacientes con cirrosis hepática. Pacientes y métodos: Se incluyó a 35 pacientes con cirrosis hepática con hemorragia digestiva por úlceras o erosiones gastroduodenales (grupo A), 125 pacientes no cirróticos, con hemorragia digestiva por úlceras o erosiones gastroduodenales (grupo B) y 70 pacientes con cirrosis hepática que ingresan sin hemorragia digestiva (grupo C). En todos los pacientes, mediante encuesta dirigida, se investiga el consumo de AINE, incluido ácido acetilsalicílico (AAS), en la semana previa al ingreso hospitalario. Resultados: Referían consumo de AINE 15 pacientes (42,8%) del grupo A, 102 pacientes (58,2%) del grupo B y 6 pacientes (8,5%) del grupo C. Se obtuvieron diferencias significativas al comparar los resultados del grupo A con el grupo C. Conclusiones: El consumo de AINE en los pacientes con cirrosis hepática sin hemorragia digestiva es bajo (8,5%), muy inferior al observado en los pacientes con cirrosis que ingresan con hemorragia por úlceras o erosiones gastroduodenales (42,8%). Se puede considerar que los AINE, como sucede en la población general, desempeñarían un importante papel en la patogenia de la hemorragia digestiva por patología péptica en la población con cirrosis hepática e hipertensión portal

Introduction: Peptic ulcer disease, with or without complications, is more common in patients with liver cirrhosis than in the general population. Factors associated with portal hypertension are involved in its pathogenesis. The prevalence of Helicobacter pylori infection in patients with liver cirrhosis and the general population is similar. The aim of the present study was to determine the influence of nonsteroidal antiinflammatory drugs (NSAIDs) in the etiology of bleeding peptic ulcer disease in patients with liver cirrhosis. Patients and methods: We studied 35 patients with liver cirrhosis and gastrointestinal bleeding due to gastroduodenal ulcers or erosions (group A), 125 noncirrhotic patients with gastrointestinal bleeding due to gastroduodenal ulcers or erosions (group B), and 70 patients with liver cirrhosis who were admitted to hospital without gastrointestinal bleeding (group C). All patients were questioned about NSAID consumption, including aspirin, during the week prior to hospital admission. Results: NSAID consumption was reported by 15 patients (42.8%) in group A, 102 patients (58.2%) in group B, and 6 patients (8.5%) in group C. Statistically significant differences were obtained when the results for group A were compared with those for group C. Conclusions: NSAID consumption in patients with liver cirrhosis without gastrointestinal bleeding was low (8.5%) and was much lower than that observed in patients with cirrhosis admitted to hospital for bleeding due to gastroduodenal ulcers or erosions (42.8%). As occurs in the general population, NSAIDs play a significant role in the pathogenesis of bleeding due to peptic ulcer disease in patients with liver cirrhosis and portal hypertension

[Effects of pepstatin A on neutrophils; cross-deactivation with FMLP]. / Efectos de la pepstatina A sobre los neutrófilos; desactivación cruzada con el FMLP.

The ability of pepstatin A, a protease inhibitor produced by Streptomyces testaceus, to elicit a number of responses by the human PMN has been studied. In lysozyme and beta-glucuronidase release, pepstatin A 10(-5)M is equivalent to the synthetic oligopeptide N-formyl-methionyl-leucyl-phenylalanine (FMLP) 10(-7)M. In superoxide release, pepstatin A 10(-5)M produces 80% of that originated by FMLP 10(-7). After two minutes of incubation the superoxide release is important, there being no further increase after 10 minutes. Preincubation of the cells with cytochalasin B before stimulation with pepstatin A elicits a noticeable increase in O2- release. In chemotaxis, pepstatin A 10(-6) originates the same cell motility as FMLP 10(-9). Pepstatin A produces a cross deactivation with FMLP which adds further evidence to the hypothesis that both stimuli compete for the same receptor in the PMN.