Comparación de dos dosis de pantoprazol por vía intravenosa en la hemorragia por úlcera péptica

AIM: To compare the effect of two doses of intravenous pant0prazole (PAN), 40 mg injection once daily for 3 days (low dose) and 40 mG initial followed by continuous infusion of 8 mg/h for 3 days (high dose), in the prevention of peptic ulcer rebleeding. METHODS: Maximally 1 h after endoscopic haemostasis (adrenaline) of peptic ulcer bleeding Forrest la, lb and Ila, 68 inpatients of either sex were randomized to receive intravenous PAN therapy with either low dose or high dose for 3 days in this multicenter, double-blind, parallel-group comparison. Initial H. pylori status was assessed. An endoscopy was routinely repeated 72 h after initial endoscopic hemostasis or on suspicion of rebleeding. Patients were followed for 14 days after initial endoscopy. RESULTS: 82 patients were included in the low dose group and 86 patients in the high dose group (intention-to-treat), of which 74 low dose patients and 76 high dose patients completed the study per-protocol. Both treatment groups were comparable with respect to sex, H. pylori status, age, alcohol consumption, smoking, weight, height, body-mass-index and Forrest stages of peptic ulcer bleeding. The 72-h rebleeding rates were 12% (9/74) in the low dose group and 13% (10/76) in the high dose group (Cochran-Mantel-Haenszel test: n. s.: per-protocol). No influence of the initial H. pylori status on the clinical outcome of rebleeding was apparent. Need for blood transfusions over 72 h was similar in both treatments. The mortality rates after 14 days were 2.5% (2/78) in the low dose group and 2.4% (2/80) in the high dose group {Fisher's Exact Test: n. s.; intention-to-treat). Adverse events were more frequent in the low dose group. CONCLUSIONS: The results of this pilot study indicate that after initial endoscopic haemostasis both pantoprazole continuous infusion following an initial loading dose and repeated injections are similarly effective in the prevention of peptic ulcer rebleeding.