Baja dosis en bolo Pantoprazol Siguiendo Exitosa Tratamiento endoscópico de la úlcera péptica aguda hemorragia es efectiva: Un aleatorizado, prospectivo, doble ciego, con doble simulación estudio piloto

BACKGROUND/AIMS:

Proton pump inhibitors has high efficacy in alone or with endoscopic intervention for peptic ulcer bleeding (PUB). However, the dose and treatment duration of PPIs needed to prevent re-bleeding are not well established. Our aim is to compare highdose infusion of pantoprazole (standard treatment) and low-dose bolus pantoprazole in patients given endoscopic treatment for control of PUB.

METHODS:

This study was a singlecenter, prospective, randomized, double-blind, double-dummy, comparative pilot study. The Ethics Committee of Mersin University approved this study and all patients provided written informed consent. Patients admitted with PUB in which the bleeding was controlled by endoscopic intervention (sclerotherapy with epinephrine) were randomized to a highdose group (Pantoprazole 80 mg IV bolus followed by 8 mg/h IV infusion for 72 h) or a low dose group (Pantoprazole 80 mg IV bolus followed by 40 mg IV bolus every 12 h for 72 h). A double-dummy technique was used to keep the patients blinded, so all patients in the low-dose group received isotonic saline infusion for 3 days as placebo. After 3 days of treatment, all patients were given oral Pantoprazole (40 mg bid) until day-30. The primary endpoints were early re-bleeding (within 72 h), need for blood transfusion, surgery due to bleeding, mortality, and duration of hospitalization. Cost of treatment was also determined.

RESULTS:

Total 73 patients enrolled the study. There were 36 patients in the high-dose group and were 37 patients in the low-dose group. There were no significant differences between the two treatment groups in age, gender, reason for admission, presence of comorbid diseases, Hb level at admission, drug use, smoking, alcohol use, and Rockall score. Re-bleeding occurred in 10 patients (27.8%) in the high-dose group and in 3 patients (8.1%) in the low-dose group (p = 0.028). The mean blood transfusion dose was 4.5±4.2 units in the high dose group and 2.5±2.2 units in the low dose group (p = 0.040). Rate of surgery (2/ 1), and mortality (3/2), and duration of hospitalization (5.6±3.4 days/5.0±5.2 days) were similar in the two groups (p-values of 0.536, 0.710, and 0.575, respectively). The cost of pantoprazole per patient was 252.62 Turkish Liras (168.41 USD) in the high-dose group and 104.02 Turkish Liras (69.30 USD) in the low-dose group. There was no side effect related to any pantoprazol medications.

CONCLUSIONS:

Low-dose pantoprazole treatment after successful endoscopic therapy in PUB was as effective as high-dose. Also there was less rebleeding, and need for transfusion in low-dose group. The low-dose treatment had lower costs and was easier to administer. Thus, low-dose bolus pantoprazole administration following successful endoscopic therapy should be considered for treatment of PUB