Rabeprazole sodium injection in the treatment of non-esophageal variceal upper gastrointestinal bleeding: a randomized,blind and positive drug parallel-group controlled clinical multicenter study / 中华消化杂志

ABSTRACT

Objective To evaluate the efficacy and safety of rabeprazole sodium injection in the treatment of non-esophageal variceal upper gastrointestinal bleeding in comparison with the positive control,omeprazole.Methods From January 2010 to January 2011,231 patients with non-esophageal variceal upper gastrointestinal bleeding from 20 hospitals were divided into rabeprazole group and omeprazole group in this multicenter,randomized,blind,parallel-group,positive drug controlled clinical trial.Hemostasis rate in 72 hours was the primary endpoint.Hemostasis rate in 120 hours,time to hemostasis,blood transfusion volume and the rate of switching treatments were the secondary endpoint.And safety was also analyzed.Chi square test and Wilcoxon rank sum test were performed for statistical analysis.Results At 72 hours after treatment,the hemostasis rates of rabeprazole group and omeprazole group were 98.20％(109/111)and 98.25％(112/114), respectively, and the difference was not statistically significant (P＞0.05).The 95％ confidence interval (CI) of the rate difference between the two group was-3.50 ％ to 3.40 ％.The result of non-inferiority test indicated that the lower limit of the 95％CI of the rate difference between the two groups was-2.95％ (U=5.652,P＜0.01),and rabeprazole group was not inferior to omeprazole group.At 12 hours after treatment,the hemostatic rates of rabeprazole group and omeprazole group were 63.06％(70/111) and 53.51％(61/114),respectively,and there was no statistically significant difference (P＞0.05).At 120 hours after treatment,the hemostasis rates of rabeprazole group and omeprazole group were 99.10 ％ (110/111) and 98.25 ％ (112 /114),and there was no statistically significant difference (P＞0.05).The median time of hemostasis of two groups was 24 hours.During the treatment,there were two cases and seven cases of rabeprazole group and omeprazole group received blood transfusions,respectively;there were 0.90％ (1/111) and 2.63 ％ (3/114) patients switched to other treatment,and no statistically significant difference was found (P＞0.05).The rates of adverse event of rabeprazole group and omeprazole group were 11.61％ (13/112) and 5.26％ (6/114),respectively.The rates of adverse reaction were 6.25％ (7/112) and 4.39％ (5/114),respectively.The differences in the rates of adverse event and adverse reaction between two groups were not statistically significant(both P＞0.05).Conclusion Rabeprazole sodium injection is an effective and safe drug in the treatment of non-esophageal variceal upper gastrointestinal bleeding.