Oral vs Intravenous and Proton Pump Inhibitor (PPI）for Peptic Ulcer Bleeding (PUB)

• Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  recurrent bleeding before discharge and within 14 days
  
  

• hospital stay [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  we measure the above item in high risk patients during hospitalization and within one month
  
  
• volume of blood transfusion [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  we measure the above item in high risk patients during hospitalization and within one month
  
  
• numbers of operation [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  we measure the above item in high risk patients during hospitalization and within one month
  
  
• numbers of death [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  we measure the above item in high risk patients during hospitalization and within one month
  
  

A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers (1) and is now recommended as the first hemostatic modality for these patients (1, 2).

In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, two consensus statements and two meta-analysis (3-8). To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. In our study, the investigators used 40 mg omeprazole intravenous bolus followed by 160 mg/day continuously infusion for three days. The mean intragastric pH rose to 6.0 one hour after the initial bolus of omeprazole in the omeprazole group; it persisted around this value for the rest of the 24 hours.7 The rebleeding rates were much lower in the PPI as compared with H2RA group (Day 3: 0/50 vs 8/50, p<0.01; Day 14: 2/50 vs 12/50, p<0.01) (4).

How about the route of PPI usage? Oral or IV is the preferred route? Laine et al used oral lansoprazole in patients with peptic ulcer bleeding.9 They were randomly assigned to intravenous lansoprazole (90-mg bolus followed by 9-mg/h infusion) or oral lansoprazole (120-mg bolus followed by 30 mg every 3 hours). A pH was recorded for 24 hours. Mean pH rose above 6 after 2-3 hours of intravenous PPI and 3-4 hours of oral PPI. They concluded that frequent oral PPI may be able to replace the currently recommended intravenous bolus plus infusion PPI therapy in patients with bleeding ulcers. In one recent article, Javid et al also proved that there was no significant difference among various PPIs (omeprazole, pantoprazole, and rabeprazole) given through different routes (IV and oral routes) on raising intragastric pH above 6 for 72 h after successful endoscopic hemostasis in bleeding peptic ulcer.10 In our recent study, the investigators have proved that oral rabeprazole and IV omeprazole are equally effective in preventing rebleeding (13/78 in rabeprazole vs 12/78 in omeprazole, p>0.1) in high-risk bleeding peptic ulcers.11 All secondary outcomes between the two groups were similar, including the amount of blood transfusion, hospital stay, need for surgery and mortality.

The objectives of this study are to assess the outcomes of two different regimens of oral lansoprazole vs high dose of intravenous nexium after endoscopic therapy in patients with peptic ulcer bleeding.