BACKGROUND/AIMS: Proton pump inhibitor (PPI) is generally prescribed to prevent post endoscopic submucosal dissection (ESD) bleeding. However, there was no consensus about the effectiveness of intravenous (IV) or oral PPI. We conducted this investigation to evaluate whether oral PPI can be also safely and effectively used to prevent post-ESD bleeding by measurement of intragastric pH. MATERIALS AND METHODS: Patients were assigned in the fixed order to IV pantoprazole by 40 mg every 12 hours and oral lansoprazole fast disintegrating tablet (LFDT) by 30 mg every 8 hours. We checked intragastric pH and hemoglobin (Hb) levels at pre and post-ESD procedure. RESULTS: A total of 10 patients (LFDT group: 6 patients, IV pantoprazole group: 4 patients) were included. There was no difference of baseline Hb level between two groups (LFDT, 14.38+/-0.46 mg/dL; IV pantoprazole, 13.85+/-0.83 mg/dL; P=0.18). After 24 hours, change of Hb level was not different between LFDT (0.95+/-0.30 mg/dL) and IV pantoprazole group (0.98+/-0.45 mg/dL; P=0.96). Baseline intragastric pH was 3.72+/-0.19 with LFDT and 4.31+/-0.41 with IV pantoprazole group (P=0.18). After 24 hours, there was no significant difference of the extent of pH increase between LFDT (2.38+/-0.28) and IV pantoprazole group (2.17+/-0.21; P=0.60). CONCLUSIONS: There was no difference in both the increase of post-24 hour intragastric pH and decrease of post-24 hour Hb between LFDT and IV pantoprazole group. Oral PPI regimen may be able to replace IV PPI therapy for the prevention of post-ESD bleeding and LFDT might be superior to IV PPIs in the aspect of cost-effectiveness.
Consensus ; Hemorrhage* ; Humans ; Hydrogen-Ion Concentration ; Lansoprazole* ; Proton Pump Inhibitors ; Proton Pumps

BACKGROUND/AIMS: Proton pump inhibitor (PPI) is generally prescribed to prevent post endoscopic submucosal dissection (ESD) bleeding. However, there was no consensus about the effectiveness of intravenous (IV) or oral PPI. We conducted this investigation to evaluate whether oral PPI can be also safely and effectively used to prevent post-ESD bleeding by measurement of intragastric pH. MATERIALS AND METHODS: Patients were assigned in the fixed order to IV pantoprazole by 40 mg every 12 hours and oral lansoprazole fast disintegrating tablet (LFDT) by 30 mg every 8 hours. We checked intragastric pH and hemoglobin (Hb) levels at pre and post-ESD procedure. RESULTS: A total of 10 patients (LFDT group: 6 patients, IV pantoprazole group: 4 patients) were included. There was no difference of baseline Hb level between two groups (LFDT, 14.38+/-0.46 mg/dL; IV pantoprazole, 13.85+/-0.83 mg/dL; P=0.18). After 24 hours, change of Hb level was not different between LFDT (0.95+/-0.30 mg/dL) and IV pantoprazole group (0.98+/-0.45 mg/dL; P=0.96). Baseline intragastric pH was 3.72+/-0.19 with LFDT and 4.31+/-0.41 with IV pantoprazole group (P=0.18). After 24 hours, there was no significant difference of the extent of pH increase between LFDT (2.38+/-0.28) and IV pantoprazole group (2.17+/-0.21; P=0.60). CONCLUSIONS: There was no difference in both the increase of post-24 hour intragastric pH and decrease of post-24 hour Hb between LFDT and IV pantoprazole group. Oral PPI regimen may be able to replace IV PPI therapy for the prevention of post-ESD bleeding and LFDT might be superior to IV PPIs in the aspect of cost-effectiveness.
Consensus ; Hemorrhage* ; Humans ; Hydrogen-Ion Concentration ; Lansoprazole* ; Proton Pump Inhibitors ; Proton Pumps

BACKGROUND/AIMS: Although some previous studies reported that a treatment combined with mucoprotective agent could improve the eradication rate in dual or triple therapy, there are other reports that question the efficacy of combining these drugs in concomitant therapy (CoCTx). The aim of this study was to investigate the effects of rebamipide or ecabet on the Helicobacter pylori (H. pylori) eradication combined with CoCTx. METHODS: We retrospectively reviewed the medical records of 277 patients with proven H. pylori infection. They were assigned to one of 3 regimens for 10 days, twice daily: (a) CoCTx (n=118): lansoprazole 30 mg, amoxicillin 1 g, metronidazole 500 mg, and clarithromycin 500 mg; (b) CoCTx+rebamipide (100 mg) (n=85); (c) CoCTx+ecabet (1 g) (n=74). RESULTS: The baseline characteristics were not significantly different. H. pylori eradication rates were 82.2% (97/118) in CoCTx, 90.6% (77/85) in CoCTx+rebamipide, and 89.2% (66/74) in CoCTx+ecabet (p=0.17), which were statistically insignificant. Overall adverse events were more frequently reported in the CoCTx+rebamipide (50.6%. 43/85) and CoCTx+ecabet (44.6%, 33/74) groups than in the CoCTx (32.2%, 38/118) (p = 0.03) group. Drug compliances were not different between three groups (CoCTx: 95.8%, 113/118; CoCT+rebamipide: 92.9%, 79/85; CoCTx+ecabet 98.6%,73/74) (p=0.209). Multivariate analysis showed that the risk of eradication failure was significantly increased with decreased drug compliance (odds ratio 3.52, 95% confidence interval 1.00–12.32; p=0.05). CONCLUSIONS: Addition of these mucoprotective agent was not superior to CoCTx alone for eradicating H. pylori infection with frequent adverse events. Rather, drug compliance is the most related factor affecting the eradication rate. Our data suggest the importance of drug compliance over the drugs used.
Amoxicillin ; Clarithromycin ; Compliance ; Helicobacter pylori* ; Helicobacter* ; Humans ; Lansoprazole ; Medical Records ; Metronidazole ; Multivariate Analysis ; Retrospective Studies ; Sodium*

BACKGROUND/AIMS: This nationwide, multicenter prospective randomized controlled trial aimed to compare the efficacy and safety of 10-day concomitant therapy (CT) and 10-day sequential therapy (ST) with 7-day clarithromycin-containing triple therapy (TT) as first-line treatment for Helicobacter pylori infection in the Korean population. METHODS: Patients with H. pylori infection were assigned randomly to 7d-TT (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 7 days), 10d-ST (lansoprazole 30 mg and amoxicillin 1 g twice daily for the first 5 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg twice daily for the remaining 5 days), or 10d-CT (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 10 days). The primary endpoint was eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. RESULTS: A total of 1,141 patients were included. The 10d-CT protocol achieved a markedly higher eradication rate than the 7d-TT protocol in both the ITT (81.2% vs 63.9%) and PP analyses (90.6% vs 71.4%). The eradication rate of the 10d-ST protocol was superior to that of the 7d-TT protocol (76.3% vs 63.9%, ITT analysis; 85.0% vs 71.4%, PP analysis). No significant differences in adherence or serious side effects were found among the three treatment arms. CONCLUSIONS: The 10d-CT and 10d-ST regimens were superior to the 7d-TT regimen as standard first-line treatment in Korea.
Amoxicillin ; Arm ; Clarithromycin ; Disease Eradication ; Helicobacter pylori ; Helicobacter ; Humans ; Korea ; Lansoprazole ; Metronidazole ; Prospective Studies

PURPOSE: Following a pancreatoduodenectomy, atrophy of the distal pancreas commonly occurs. It has been demonstrated that gastrin stimulates the regeneration of the pancreas in animals. This study was undertaken to determine whether gastrin has a similar effect in humans and in particular, whether it prevents the atrophy of the distal pancreas after a pylorus preserving pancreatoduodenectomy (PPPD). METHODS: Between March 1999 and May 2000, a randomized prospective study was performed in 56 patients who underwent PPPD for periampullary neoplasms. The patients were allocated to either a lansoprazole group (LG) or a control group (CG). The LG members were given oral lansoprazole (30 mg/day) over 12 weeks postoperatively to induce hypergastrinemia. During the study period, 19 patients were excluded for various reasons. Therefore, a total of 37 patients (LG: n=18; CG: n=19) were eligible for this study. The volume of the distal pancreas was determined using thin sectioned spiral CT data, the nutritional status, the endocrine (insulin level, glucose tolerance test) and exocrine function (stool elastase) of the pancreas. In addition, the serum gastrin level were measured prior to the operation and 3 months after the operation. The two groups were clinically comparable. RESULTS: The serum gastrin level was higher in the LG (P<0.05). In this group, the mean volume of the distal pancreas was reduced by 10% (63,954 mm3+/-57,069 mm3) after PPPD, whereas severe pancreatic atrophy occurred in the CG (71,446 mm3+/-39,753 mm3) (P<0.01). The postoperativeinsulin and stool elastase levels were higher in the LG than in the CG (insulin: 21.1milliunit/ml vs 6.9milliunit/ml; elastase: 59 microgram/g vs 23microgram/g). CONCLUSION: Induced hypergastrinemia prevents pancreatic atrophy after PPPD. This is probably because of the stimulated regenerative activity of the pancreas by gastrin. This has never been previously demonstrated in humans.
Animals ; Atrophy* ; Gastrins ; Glucose ; Humans* ; Lansoprazole ; Nutritional Status ; Pancreas ; Pancreatic Elastase ; Pancreaticoduodenectomy* ; Prospective Studies ; Pylorus ; Regeneration ; Tomography, Spiral Computed

This work aimed to set up a high performance liquid chromatography (HPLC) method to determine the concentration of lansoprazole in human plasma and study the pharmacokinetic characters of lansoprazole in Chinese healthy volunteers after intravenous (IV) infusion. In accordance with double 3 x 3 Latin square design with self-crossover design, 12 volunteers were randomly divided into six groups, with half males and half females. The volunteers were administered with single dose of 15, 30, 60 mg of lansoprazole by IV infusion at a constant speed respectively, to study the clinical pharmacokinetics of lansoprazole. The linear range of lansoprazole in human plasma was 0.020-4.970 microg/ml (r = 0.9999); The intra-day and inter-day RSD were less than 10%. After receiving single doses of 15, 30 and 60 mg of lansoprazole, t(1/2) were (1.663 +/- 0.405) h, (1.541 +/- 0.339)h and (1.747 +/- 0.156) h; Cmax were (1.065 +/- 0.094) microg/ml, (2.104 +/- 0.312) microg/ml and (3.786 +/- 0.356) microg/ml; AUC(0-infinity) were (2.376 +/- 0. 432) microg x h/ ml, (4.722 +/- 0.753) microg x h/ml and (10.495 +/- 2.129) microg x h/ml respectively. The improved HPLC method is simple, rapid and reproducible. It could be used for determination of the concentration of lansoprazole in human plasma. The pharmacokinetics of lansoprazole for injection was found to fit the linear dynamics in vivo within the dose range of 15 to 60 mg. In addition, the results suggested that gender had no statistic significant effect on the pharmacokinetic process of lansoprazole after IV infusion of single dose.
2-Pyridinylmethylsulfinylbenzimidazoles ; administration & dosage ; blood ; pharmacokinetics ; Chromatography, High Pressure Liquid ; methods ; Female ; Humans ; Infusions, Intravenous ; Lansoprazole ; Male ; Proton Pump Inhibitors

BACKGROUND: There are only a few studies on Helicobacter pylori (H. pylori) for its eradication rates of lansoprazole-based triple therapy in Korea, and the results are controversial. Therefore, we undertook to investigate the eradication rate of lansoprazole-based triple therapy, and compare the concordance rate of urea breath test (UBT) and rapid urease test (RUT) in evaluating H. pylori eradication. METHODS: Patients with acute peptic ulcer who were H. pylori-positive were recruited by prospective, consecutive manner. They received lansoprazole 30 mg b.d., amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. for 1 week. Upper endoscopy was performed after 4 weeks to check for ulcer healing, and UBT and RUT were performed to evaluate H. pylori eradication status. RESULTS: A total of 46 patients were recruited, and they were all compliant. H. pylori eradication rate was 87.0% (40/46) and ulcer healing rate was 91.3% (42/46). Forty one patients showed negative in both UBT and RUT, and 4 patients revealed positive in both tests, therefore, the concordance rate of UBT and RUT was 97.8% (45/46). CONCLUSION: Our study showed that 1-week lansoprazole-based triple therapy was effective in H. pylori eradication and ulcer healing. UBT can be an effective, noninvasive method for evaluating H. pylori status after H. pylori eradication.
Amoxicillin ; Breath Tests* ; Clarithromycin ; Endoscopy ; Helicobacter pylori* ; Helicobacter* ; Humans ; Korea ; Lansoprazole ; Peptic Ulcer* ; Prospective Studies ; Ulcer ; Urea* ; Urease

BACKGROUND: There are only a few studies on Helicobacter pylori (H. pylori) for its eradication rates of lansoprazole-based triple therapy in Korea, and the results are controversial. Therefore, we undertook to investigate the eradication rate of lansoprazole-based triple therapy, and compare the concordance rate of urea breath test (UBT) and rapid urease test (RUT) in evaluating H. pylori eradication. METHODS: Patients with acute peptic ulcer who were H. pylori-positive were recruited by prospective, consecutive manner. They received lansoprazole 30 mg b.d., amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. for 1 week. Upper endoscopy was performed after 4 weeks to check for ulcer healing, and UBT and RUT were performed to evaluate H. pylori eradication status. RESULTS: A total of 46 patients were recruited, and they were all compliant. H. pylori eradication rate was 87.0% (40/46) and ulcer healing rate was 91.3% (42/46). Forty one patients showed negative in both UBT and RUT, and 4 patients revealed positive in both tests, therefore, the concordance rate of UBT and RUT was 97.8% (45/46). CONCLUSION: Our study showed that 1-week lansoprazole-based triple therapy was effective in H. pylori eradication and ulcer healing. UBT can be an effective, noninvasive method for evaluating H. pylori status after H. pylori eradication.
Amoxicillin ; Breath Tests* ; Clarithromycin ; Endoscopy ; Helicobacter pylori* ; Helicobacter* ; Humans ; Korea ; Lansoprazole ; Peptic Ulcer* ; Prospective Studies ; Ulcer ; Urea* ; Urease

Anaphylaxis to proton pump inhibitors (PPIs) has rarely been reported. Different patterns of cross-reactivity between PPIs have also been demonstrated using skin tests. Here, we report a case of anaphylaxis to lansoprazole with tolerance to other commercially available PPIs, which was proved by skin tests and oral provocation tests (OPTs). A 47-year-old female patient visited our Emergency Department with a sudden onset of whole body urticaria, facial swelling, dyspnea, and loss of consciousness that developed 1 hour after ingestion of 30 mg of lansoprazole for her episodic epigastric soreness. The skin prick test (SPT) and the intradermal test (IDT) with lansoprazole, esomeprazole, rabeprazole, and pantoprazole were performed. Lansoprazole showed positive reactions in both the SPT (3 mg/mL) and the IDT (0.003 mg/mL). Rabeprazole (3 mg/mL) showed a positive reaction only in IDT. The SPT and the IDT with esomeprazole and pantoprazole were all negative. The OPT with 30 mg of lansoprazole was positive (showing generalized rash and facial swelling 30 minuites after ingestion), while OPTs with esomeprazole, pantoprazole, and rabeprazole were all negative. Other PPIs could be safe alternatives in cases of anaphylaxis to 1 PPI. Skin tests seem to be helpful to define cross-reactivity between PPIs.
Anaphylaxis* ; Dyspnea ; Eating ; Emergency Service, Hospital ; Esomeprazole ; Exanthema ; Female ; Humans ; Intradermal Tests ; Lansoprazole* ; Middle Aged ; Proton Pump Inhibitors* ; Rabeprazole ; Skin ; Skin Tests ; Unconsciousness ; Urticaria

BACKGROUND: The aim of this study was to compare the cost-effectiveness of proton pump inhibitors (PPI) and ranitidine in gastroesophageal reflux disease (GERD) in Korea. METHODS: We assessed the cost-effectiveness two ways. First, mean costs for the complete healing of one patient with GERD within one year were calculated. Second, Markov (state-transition) models were used to simulate a cohort of patients with GERD, taking one of following strategies for 5 years : 1) PPI (rabeprazole 10 mg, omeprazole 20 mg, or lansoprazole 30 mg), 2) ranitidine 300 mg per day. Data on healing rate, relapse rate, surgical complication rate, success rate of surgery were taken from the literature. Direct medical costs of each strategy and surgical complications were calculated. Health effects were expressed as quality-adjusted life years (QALYs). Sensitivity analyses using various ranges of probability of healing rates and costs were performed. Costs and health outcomes were discounted at a rate of 3 % per year. RESULTS: The mean costs for complete healing of one case within one year was 475,836 in PPI and 1,064,704 in ranitidine, respectively. In the base case analysis using Markov model, the treatment costs of PPI were 155,238 and 214,781 in ranitidine and the effects were 4.81 QALYs and 4.26 QALYs, respectively; PPI strategy was more effective and less costly than ranitidine strategy. The sensitivity analyses using varying ranges of probability, cost, discount rate and utility were robust. CONCLUSION: PPI was superior to ranitidine in terms of cost-effectiveness in the treatment of GERD.
Cohort Studies ; Cost-Benefit Analysis ; Esophagitis ; Gastroesophageal Reflux* ; Health Care Costs ; Humans ; Korea ; Lansoprazole ; Omeprazole ; Proton Pump Inhibitors* ; Proton Pumps* ; Protons* ; Quality-Adjusted Life Years ; Ranitidine* ; Recurrence