Comparison of the efficacy and safety of ebrotidine in the treatment of duodenal ulcer. A multicentre, double-blind, placebo-controlled phase II study.

Ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]-4 -thiazoly]methyl]thio]ethyl]amino]methylene]-4-bromo-benzenesulfon amide, CAS 100981-43-9, FI-3542) is a new H2-receptor antagonist characterized by its high receptor affinity and gastroprotective effect. This Phase II study has been undertaken to establish the efficacy and safety of ebrotidine, administered in four dosages as a single evening dose versus placebo in the treatment of duodenal ulcer. A total of 110 duodenal ulcer patients were studied in a randomized, double-blind, placebo-controlled, multicentre clinical trial. The patients were assigned to 5 groups: placebo, 200 mg, 400 mg, 600 mg and 800 mg of ebrotidine once daily. Controls were performed at baseline and every two weeks at four follow-up visits unless ulcer healed before. Endoscopic examination was the main parameter for the assessment of treatment efficacy and ulcer healing rate. Vital signs and blood/ urine analysis were used to establish safety. The three groups treated with higher dosages (400 to 800 mg of ebrotidine daily) showed an endoscopic ulcer healing rate of 90-95%, significantly higher than 55% achieved with placebo (p < 0.05), whilst the differences between these three dosages of ebrotidine were not statistically significant. Healing rate in the group treated with 200 mg of ebrotidine daily was not significantly different from that in the placebo group. The development of symptoms, number of episodes of ulcer-related pain, total ulcerated surface area or subjective ratings by the patients and investigators also differed significantly between ebrotidine (400, 600 and 800 mg daily) and placebo, and again, no marked differences were found between these three doses of ebrotidine. As far as tolerance is concerned, no clinically or statistically significant changes were observed in vital signs and analytical parameters. The incidence of side effects was less than that presented by the placebo group, possibly due to a greater consumption of antacids in this group. Results showed that a daily dose of 400 mg ebrotidine is effective and safe in the treatment of duodenal ulcers.

Arterioportal fistula and hemobilia with associated acute cholecystitis: a complication of percutaneous liver biopsy.

Complications attributable to percutaneous liver biopsy, including hemobilia and arterioportal fistula, are uncommon. In this report, we present the case of a patient who underwent percutaneous liver biopsy and, as a consequence of this procedure, developed an arterioportal fistula and hemobilia with associated acute cholecystitis. The diagnosis of hemobilia was possible with abdominal ultrasound and upper endoscopy, but the patient required cholecystectomy. Hepatic angiography was performed, demonstrating the arterioportal fistula and hemobilia. Transcatheter embolization occluded the fistula, resolving the hemobilia. We recommend ultrasound and upper endoscopy as initial diagnostic procedures, but angiography and selective embolization must not be delayed if arterioportal fistula and/or hemobilia is suspected since these measures may help to prevent further complications.

[Liver transplant in fibrolamellar hepatocarcinoma: apropos of a case. Review of the literature]. / Trasplante hepático en hepatocarcinoma fibrolamelar: a propósito de un caso. Revisión de la literatura.

A case is presented of fibrolamellar hepatocarcinoma in a 12 year-old male treated by liver transplantation; there is no evidence of tumoral recurrence at 28 months. Donos and receptor were ABO incompatible. The immunosuppressive regimen used was cyclosporine A and low doses of steroids. Fibrolamellar hepatocarcinoma is an infrequent histologic variety that usually affects young people and is generally not associated with hepatitis B infection or cirrhosis. It is often a single tumor, is more susceptible to surgical resection than other varieties of hepatocarcinoma, and is characterized by a relatively unagressive tumoral biology.

In vitro immune cell function in six cases of immunoproliferative small intestinal disease after long term remission.

We have studied several parameters of in vitro immune cell function in peripheral blood mononuclear cells from six patients with immunoproliferative small intestinal disease after long term remission. We have observed two groups of patients with different patterns of response. (a) After stimulation with pokeweed mitogen (PWM) and Staphylococcus aureus, three patients showed a significant reduction of the Ig synthesis (A, G and M) and the proliferative response. In two of them, we found increased spontaneous suppressor T cell activity. In the third case, the diminished response could not be attributed, according to our assays, either to suppressor T cells, lack of T helper activity (although the number of OKT4+ cells was diminished) or an intrinsic B cell defect. The three patients showed normal or augmented NK activity and an inversion of the OKT4+/OKT8+ ratio was detected in two of them. (b) The remaining three patients showed a normal Ig synthesis after stimulation with PWM and a slightly depressed IgM synthesis in response to S. aureus. They expressed a normal T helper cell function and did not show increased spontaneous suppressor T cell activity. They had low levels of natural killer cytotoxicity and the OKT4+/OKT8+ ratio was not significantly altered. Taken together, our data indicate that significant alterations of the in vitro immune response can be found in peripheral blood mononuclear cells of some immunoproliferative small intestinal disease patients after long term remission.

Radiological characteristics of primary intestinal lymphoma of the "Mediterranean" type: observations on twelve cases.

Radiological findings in 12 cases of "Mediterranean" lymphoma are analyzed, 4 of which are associated with gammapathy. These findings have not permitted differentiation of this type of lymphoma from those classically described, although there are two signs that strongly suggest this diagnosis: extension of the lesions along wide areas of the small intestine, almost always including the duodenum, and spiculation of the mucosal fold edges, representing massive plasmocyte infiltration of the lamina propria. The principal clinical, immunological, and pathological aspects are described, as well as the radiological differential diagnosis.