ABSTRACT
BACKGROUND: Double common bile duct ligation plus section in rats is used as a model for bacterial translocation, a phenomenon that has been correlated with the degree of liver damage. This study analyzes whether a simpler variant of the technique is also a valid model to study bacterial translocation. METHODS: Fifty-six male Sprague Dawley rats underwent one of three surgical interventions: a) proximal double ligation and section of the common bile duct; b) proximal simple ligation of the bile duct; and c) sham operation. Bacterial translocation was measured by cultures of mesenteric lymph nodes, blood, spleen and liver. Stool culture and histological analysis of liver damage were also performed. RESULTS: The incidence of bacterial translocation in SBL and DBDL groups was 23,5% and 25% respectively. Mortality was similar between ligation groups (11.2% versus 10%). Liver cirrhosis developed in the group of double ligation and section (100% of the animals at 4 weeks), while portal hypertension appeared starting at week 3. None of the animals submitted to simple ligation developed liver cirrhosis. CONCLUSIONS: Simple bile duct ligation is associated with a similar incidence of bacterial translocation as double ligation, but without cirrhosis or portal hypertension.
Subject(s)
Bacterial Translocation , Bile Ducts/surgery , Postoperative Complications/epidemiology , Animals , Common Bile Duct/surgery , Disease Models, Animal , Ligation , Male , Rats, Sprague-DawleyABSTRACT
BACKGROUND: Frequently, decisions about the safety of drugs are based on isolated cases of patients that develop a disease, while they have been taken a drug. A new method to detect, using spontaneous reporting, increases in agranulocytosis risk among patients treated with calcium dobesilate is shown. METHOD: Using data of dobesilate sales, the maximum number of patients treated in a year was calculated. Spontaneous reports of agranulocytosis associated to dobesilate notified along the period 1985-2000 were identified. The number and the maximum number of cases explained by the agranulocytosis risk in a general population were calculated using the distribution of Poisson, assuming several reporting rates. Similarly, the influence of number of patients older than 60 and the duration of exposure to the drug were analysed. RESULTS: The number of spontaneously reporting cases of agranulocytosis associated to dobesilate, in the period 1985-2000 was not greater than the maximum number of cases predicted by the agranulocytosis risk in a general population. Probably, a high number of dobesilate-treated patients had an advanced age and/or took the drug during several months. In these conditions, it is more difficult to identify an increase of risk associated to drug. CONCLUSIONS: To calculate the risk of agranulocytosis associated to a drug is required to consider the basal risk of agranulocytosis in a general population as well as its possible modifications in the population of patients treated with the drug.
Subject(s)
Adverse Drug Reaction Reporting Systems , Agranulocytosis/chemically induced , Calcium Dobesilate/adverse effects , Aged , Aged, 80 and over , Agranulocytosis/epidemiology , Algorithms , Case-Control Studies , Europe/epidemiology , Female , Follow-Up Studies , Humans , Israel/epidemiology , Male , Middle Aged , Multicenter Studies as Topic , Poisson Distribution , Prospective Studies , Risk Assessment , Spain/epidemiologyABSTRACT
Fundamento: Con frecuencia es necesario decidir sobre la seguridad de los fármacos basándose en casos aislados de pacientes que desarrollan un cuadro clínico mientras toman un fármaco. Se presenta una aproximación desarrollada para detectar, a partir de notificaciones espontáneas, si una población de pacientes tratados con dobesilato de calcio sufre un aumento del riesgo de agranulocitosis. Método: Con los datos de consumo de dobesilato se estimó el número máximo de pacientes tratados. Se identificaron las notificaciones espontáneas de agranulocitosis por dobesilato en el período 1985-2000.Asumiendo diferentes tasas de notificación se calculó, usando la distribución de Poisson y el riesgo de agranulocitosis en la población general, el número probable y el número máximo de casos de agranulocitosis esperable en los pacientes tratados. Los mismos cálculos se repitieron estudiando la influencia del porcentaje de pacientes con edad mayor de 60 años y de la duración del tratamiento. Resultados: El número de casos de agranulocitosis por dobesilato, notificados espontáneamente durante 1985-2000, no se diferencia del número máximo de casos explicables por el riesgo basal en la población general. El probable gran número de pacientes de edad avanzada tratados con dobesilato y/o que tomaron el fármaco durante varios meses, hace todavía más difícil identificar un aumento de riesgo por el fármaco. Conclusiones: La valoración del riesgo de agranulocitosis por un fármaco exige controlar el riesgo basal de este problema en la población general, y las posibles modificaciones de dicho riesgo por factores particulares de las poblaciones de pacientes tratados con el fármaco (AU)
Background: Frequently, decissions about the safety of drugs are based on isolated cases of patients that develop a disease, while they have been taken a drug. A new method to detect, using spontaneous reporting, increases in agranulocytosis risk among patients treated with calcium dobesilate is shown. Method: Using data of dobesilate sales, the maximum number of patients treated in a year was calculated. Spontaneous reports of agranulocytosis associated to dobesilate notified along the period 1985-2000 were identified. The number and the maximum number of cases explained by the agranulocytosis risk in a general population were calculated using the distribution of Poisson, assuming several reporting rates. Similarly, the influence of number of patients older than 60 and the duration of exposure to the drug were analysed. Results: The number of spontaneously reporting cases of agranulocytosis associated to dobesilate, in the period 1985 - 2000 was not greater than the maximum number of cases predicted by the agranulocytosis risk in a general population. Probably, a high number of dobesilate - treated patients had an advanced age and/or took the drug during several months. In these conditions, it is more difficult to identify an increase of risk associated to drug. Conclusions: To calculate the risk of agranulocytosis associated to a drug is required to consider the basal risk of agranulocytosis in a general population as well as its possible modifications in the population of patients treated with the drug (AU)
Subject(s)
Middle Aged , Aged , Aged, 80 and over , Male , Female , Humans , Adverse Drug Reaction Reporting Systems , Spain , Multicenter Studies as Topic , Case-Control Studies , Poisson Distribution , Risk Assessment , Prospective Studies , Calcium Dobesilate , Algorithms , Agranulocytosis , Israel , Europe , Follow-Up StudiesABSTRACT
OBJECTIVE: To assess the cost-effectiveness of H. pylori eradication in patients with duodenal ulcer in Spain. METHODS: A decision model was used to compare the cost per cured patient and the cost per patient without recurrence in one year for four treatment strategies: 1) intermittent antisecretory therapy, 2) initial antisecretory therapy and H. pylori eradication if ulcer recurrence, 3) initial H. pylori eradication with antibiotics and antisecretory drugs, 4) antisecretory therapy followed by continuous maintenance therapy with ranitidine. Clinical variables were obtained from published studies made in Spain. RESULTS: Initial H. pylori eradication is the cheapest strategy (74,702-82,028 ptas per cured patient) and the most effective (83.3-85.2% patients without recurrence in one year). Intermittent antisecretory therapy is one of the most expensive (94,891-105,324 ptas per cured patient) and the less effective (12% patients without recurrence in one year). CONCLUSION: Initial eradication of H. pylori is the treatment of choice in patients with duodenal ulcer.
