Intravenous Rabeprazole Sodium for Treatment of Duodenobulbar Ulcer Bleeding:A Multicenter,Randomized, Double-blind,Positive Drug Parallel-group Controlled Clinical Study / 胃肠病学

ABSTRACT

Background:To date,clinical studies on intravenous rabeprazole sodium for treatment of duodenobulbar ulcer bleeding are still lacking.Aims:To evaluate the efficacy and safety of intravenous rabeprazole sodium with different doses and times of administration in treating patients with duodenobulbar ulcer bleeding.Methods:A multicenter,randomized, double-blind,positive drug parallel-group controlled trial was performed.One hundred and five patients with duodenobulbar ulcer bleeding proved by gastroscopy were randomly divided into four groups.Patients in group A,B and C were treated with intravenous rabeprazole sodium 20 mg qd,40 mg qd and 20 mg bid for 5 days,respectively.Patients in control group received intravenous omeprazole sodium 40 mg bid for 5 days.Hemostatic rate was the primary endpoint,hemostatic time and amount of blood transfusion were the secondary endpoints.Results:Hemostatic rates in group A,B,C and control group were 96.2% (25 /26),92.6% (25 /27),100.0% (26 /26)and 100.0% (26 /26),respectively,no significant difference was seen between the four groups (P >0.05).Median hemostatic time in group A,B,C and control group were 24 (24,72)h,24 (24,72)h,24 (24,48)h and 24 (24,48)h,respectively,no significant difference was seen between the four groups (P >0.05).No patient need blood transfusion during the treatment course.Slight leucopenia was the exclusive adverse effect seen in one case in group C after accomplishment of treatment.Conclusions:Three intravenous rabeprazole sodium regimens with different doses and times of administration were all effective and safe for treatment of mild to moderate duodenobulbar ulcer bleeding.Administration with 20 mg bid seems more effective among the three regimens.