Efficacy and Safety of Dexlansoprazole for Injection in the Treatment of Upper Gastrointestinal Bleeding due to Acute Gastric and/or Duodenal Ulcers
Objective:The purpose of this study is to compare the efficacy and safety of dexlansopra-zole with lansoprazole in treating upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcers.Method:A total of 202 patients with upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcer from 31 research centers in China were randomly assigned to either the experimental group(Dexlansoprazole for Injection)or the positive control group(Lansoprazole for injection)in 1∶1 ratio.The primary efficacy endpoint was the rate of 72 hour effective hemostasis,and was evaluated for non-inferiori-ty using a cut-off value of 10%.Results:For efficacy,the results of the full analysis dataset(FAS)showed that after 72 hours of treatment,the effective hemostasis rate was 96.08%(98/102)in the dexlan-soprazole group and 98.00%(98/100)in the lansoprazole group,respectively.The difference between the two groups was-1.92%(95%CI-6.58;2.74).There was no significant difference in the 72 hour effective hemostasis rates between the two groups(P=0.6829).The lower limit of the 95%confidence interval for the rate difference was-6.58%,which was higher than-10%.Thus,the 72 hour effective hemostasis rate of dexlansoprazole for injection was found to be non-inferior to that of lansoprazole for injection.Addition-ally,there was no significant difference in the incidence of adverse events and adverse reactions between the dexlansoprazole group and lansoprazole group,and no unexpected or serious adverse reactions were re-ported.The main adverse reactions observed were decreased white blood cell count and neutrophil count.Conclusion:Dexlansoprazole for injection 15 mg q12 h has been shown to be just as effective as lansopra-zole for injection 30 mg q12 h in treating upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcers,with a good safety record.This suggests that dexlansoprazole for injection may offer a new clinical alternative for managing acute upper gastrointestinal bleeding.
DexlansoprazoleGastric ulcer bleedingDuodenal ulcer bleedingClinical research
万方数据
维普
