Primary studies included in this systematic review

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Primary study

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Journal Alimentary pharmacology & therapeutics
Year 2012
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BACKGROUND: The optimal dosage of intravenous proton pump inhibitors (PPIs) for the prevention of peptic ulcer rebleeding remains unclear. AIM: To compare the rebleeding rate of high-dose and standard-dose PPI use after endoscopic haemostasis. METHODS: A total of 201 patients with bleeding ulcers undergoing endoscopic treatment with epinephrine injection and heater probe thermocoagulation were randomised to receive a high-dose regimen (80 mg bolus, followed by pantoprazole 8 mg/h infusion, n = 100) or a standard-dose regimen (pantoprazole 40 mg bolus daily, n = 101). After 72 h, all patients were given 40 mg pantoprazole daily orally for 27 days. RESULTS: There were no statistical differences in mean units of blood transfused, length of hospitalisation ≦5 days, surgical or radiological interventions and mortality within 30 days between two groups. Bleeding recurred within 30 days in six patients [6.2%, 95% confidence interval (CI) 1.3-11.1%] in the high-dose group, as compared to five patients (5.2%, 95% CI 0.6-9.7%) in the standard-dose group (P = 0.77). The stepwise Cox regression analysis showed end-stage renal disease, haematemesis, chronic obstructive pulmonary disease (hazard ratio: 37.15, 10.07, 9.12, 95% CI: 6.76-204.14, 2.07-49.01, 1.66-50.00 respectively) were independent risk factors for rebleeding and Helicobacter pylori infection was associated with lower risk of rebleeding (hazard ratio: 0.20, 95% CI: 0.04-0.94). CONCLUSIONS: Following combined endoscopic haemostasis of bleeding ulcers, co-morbidities, haematemesis and H. pylori Status, but not PPI dosage, are associated with rebleeding (http://www.Clinical Trials.gov.ID: NCT00709046).

Primary study

Unclassified

Journal Journal of gastroenterology and hepatology
Year 2009
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Background and Aim: The lowest effective dose of proton pump inhibitors (PPI) for prevention of peptic ulcer rebleeding remains unclear. The objective of the present study was to evaluate whether low-dose PPI has a similar efficacy to high-dose i.v. administration for maintaining intragastric pH above 6. Methods: Sixty-one patients with bleeding ulcers were randomized into one of three groups after endoscopic hemostasis: pantoprazole 80 mg bolus followed by 8 mg/h; 40 mg, 4 mg/h infusion; and bolus injection of 40 mg every 24 h. Intragastric pH values and rebleeding rates were measured. In addition, pharmacokinetic parameters and association with CYP2C19 polymorphisms and H. pylori infection were assessed. Results: Mean percentage of time with intragastric pH > 6, and the proportion of patients with pH > 6 for more than 60% of the time were significantly higher in the 40 mg, 4 mg/h infusion group compared to the 40 mg bolus injection. There was no significant difference between the 80 mg, 8 mg/h and the 40 mg, 4 mg/h groups. In the H. pylori (-) group, only 40% of patients that received continuous infusion reached the target pH > 6 for more than 60% of the time; this was significantly lower than the H. pylori (+) group, 87.5% (P = 0.026). Conclusions: A continuous infusion, regardless of high or low dose, was more effective for acid suppression than a 40 mg bolus PPI injection in Korea. H. pylori infection was an important factor for the maintenance of an intragastric pH > 6. © 2009 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd.

Primary study

Unclassified

Journal Journal of gastroenterology and hepatology
Year 2006
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BACKGROUND AND AIM: Following successful endoscopic therapy in patients with peptic ulcer bleeding, rebleeding occurs in 20% of patients. Rebleeding remains the most important determinant of poor prognosis. We investigated whether or not administration of pantoprazole infusion would improve the outcome in ulcer bleeding following successful endoscopic therapy. METHODS: In this double-blind, placebo-controlled, prospective trial, patients who had gastric or duodenal ulcers with active bleeding or non-bleeding visible vessel received combined endoscopy therapy with injection of epinephrine and heater probe application. Patients who achieved hemostasis were randomly assigned to receive pantoprazole (80 mg intravenous bolus followed by an infusion at a rate of 8 mg per hour) or placebo for 72 h. The primary end-point was the rate of rebleeding. RESULTS: Rebleeding was lower in the pantoprazole group (8 of 102 patients, 7.8%) than in the placebo group (20 of 101 patients, 19.8%; P = 0.01). Patients in the pantoprazole group required significantly fewer transfusions (1 +/- 2.5 vs 2 +/- 3.3; P = 0.003) and days of hospitalization (5.6 +/- 5.3 vs 7.7 +/- 7.3; P = 0.0003). Rescue therapies were needed more frequently in the placebo group (7.8% vs 19.8%; P = 0.01). Three (2.9%) patients in the pantoprazole group and eight (7.9%) in the placebo group required surgery to control their bleeding (P = 0.12). Two patients in the pantoprazole group and four in the placebo group died (P = 0.45). CONCLUSION: In patients with bleeding peptic ulcers, the use of high dose pantoprazole infusion following successful endoscopic therapy is effective in reducing rebleeding, transfusion requirements and hospital stay.

Primary study

Unclassified

Authors Cheng HC , Kao AW , Chuang CH , Sheu BS
Journal Digestive diseases and sciences
Year 2005
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This study sought to determine if high-dose omeprazole infusion could improve the control of rebleeding in patients with comorbid illnesses and bleeding peptic ulcers. After achieving hemostasis by endoscopy, 105 patients were randomized into high-dose (n = 52) and low-dose (n = 53) groups, receiving 200 and 80 mg/day omeprazole, respectively, as a continuous infusion for 3 days. Thereafter, oral omeprazole, 20 mg/day, was given. The cumulative rebleeding rates comparatively rose in both groups (high-dose vs. low-dose group), beginning on day 3 (15.4% vs. 11.3%), day 7 (19.6% vs. 20%), and day 14 (32.7% vs. 28.9%), until day 28 (35.4% vs. 33.3%), and were not significantly different between the two groups (P > 0.50). Multiple logistic regression confirmed that a serum albumin level <3 g/dL was an independent factor associated with rebleeding (P = 0.002). For patients with comorbidities, 3-day omeprazole infusion, despite increasing the daily dose from 80 to 200 mg, was not adequate to control peptic ulcer rebleeding.

Primary study

Unclassified

Authors Chiu PW , Lam CY , Lee SW , Kwong KH , Lam SH , Lee DT , Kwok SP
Journal Gut
Year 2003
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AIM: Recurrent bleeding after initial haemostasis is an important factor that directly relates to the outcome in the management of peptic ulcer bleeding. Conflicting reports have been published concerning the effectiveness of scheduled second therapeutic endoscopy on ulcer rebleeding. We investigate the use of scheduled second endoscopy with appropriate therapy on peptic ulcer rebleeding. METHODS: From August 1999 to January 2001, we prospectively randomised patients who had endoscopically confirmed bleeding peptic ulcer with stigmata of acute bleeding, visible vessel, or adherent clot into two groups. Endoscopic therapy was standardised to initial epinephrine injection and subsequent heater probe application. The study group (n = 100) received scheduled second endoscopy 16-24 hours after initial haemostasis, and further therapy was applied if endoscopic stigmata persisted, as above. The control group (n = 94) were observed closely. Those patients that developed rebleeding in either group underwent operation if further endoscopic therapy failed. Outcome measures included ulcer rebleeding, transfusion, duration of stay, and mortality. RESULTS: After initial endoscopic haemostasis, 194 eligible patients were randomised into two groups. Thirteen patients in the control group developed recurrent bleeding within 30 days while five patients in the study group sustained recurrent bleeding (p = 0.0314) (relative risks 0.33, 95% confidence interval 0.1-0.96). The number of patients that required surgery for recurrent bleeding was six in the control group and one in the study group (p = 0.05). There was no difference in duration of hospital stay, transfusion, or mortality between the two groups. CONCLUSIONS: A scheduled repeat endoscopy with appropriate therapy 16-24 hours after initial endoscopic haemostasis reduces the number of cases of recurrent bleeding.

Primary study

Unclassified

Journal The New England journal of medicine
Year 2000
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BACKGROUND: After endoscopic treatment of bleeding peptic ulcers, bleeding recurs in 15 to 20 percent of patients. METHODS: We assessed whether the use of a high dose of a proton-pump inhibitor would reduce the frequency of recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. Patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels were treated with an epinephrine injection followed by thermocoagulation. After hemostasis had been achieved, they were randomly assigned in a double-blind fashion to receive omeprazole (given as a bolus intravenous injection of 80 mg followed by an infusion of 8 mg per hour for 72 hours) or placebo. After the infusion, all patients were given 20 mg of omeprazole orally per day for eight weeks. The primary end point was recurrent bleeding within 30 days after endoscopy. RESULTS: We enrolled 240 patients, 120 in each group. Bleeding recurred within 30 days in 8 patients (6.7 percent) in the omeprazole group, as compared with 27 (22.5 percent) in the placebo group (hazard ratio, 3.9; 95 percent confidence interval, 1.7 to 9.0). Most episodes of recurrent bleeding occurred during the first three days, which made up the infusion period (5 in the omeprazole group and 24 in the placebo group, P<0.001). Three patients in the omeprazole group and nine in the placebo group underwent surgery (P=0.14). Five patients (4.2 percent) in the omeprazole group and 12 (10 percent) in the placebo group died within 30 days after endoscopy (P=0.13). CONCLUSIONS: After endoscopic treatment of bleeding peptic ulcers, a high-dose infusion of omeprazole substantially reduces the risk of recurrent bleeding.