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

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

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

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

OBJECTIVETo investigate the antimicrobial activity of Pariet, Tekpron, Nexium, respectively, against Helicobacter pylori (H. pylori) in vitro.

METHODSAntimicrobial effects of these medicines were evaluated through detection of MICs for 3 H. pylori strains isolated from different countries.

RESULTSThe MIC(99) contents were 2.25 mg/L, 42.5 mg/L and 360 mg/L, respectively, for the three medicines. The strains under testing exhibited the same susceptibility to each medicine. Nexium did not inhibit the bacteria under the concentration of 3.6 - 36 mg/L with more and bigger H. pylori colonies seen when compared with controls.

CONCLUSIONSThe growth inhibitory activity appeared to be different among the three PPI medicines under investigation, with Rabeprazole the most potential agent of the three. Data suggested that the action of growth inhibition in vitro was resting on the characteristic of the given PPI as well as the supplements of the medicine.

2-Pyridinylmethylsulfinylbenzimidazoles ; Benzimidazoles ; pharmacology ; Enzyme Inhibitors ; pharmacology ; Esomeprazole ; analogs & derivatives ; pharmacology ; Helicobacter pylori ; drug effects ; Lansoprazole ; Microbial Sensitivity Tests ; Proton Pump Inhibitors ; Rabeprazole

PURPOSE: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. MATERIALS AND METHODS: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). RESULTS: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. CONCLUSIONS: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).
Drug Therapy ; Follow-Up Studies ; Hemorrhage* ; Humans ; Incidence ; Lansoprazole ; Primary Prevention ; Prospective Studies ; Proton Pump Inhibitors ; Proton Pumps* ; Protons* ; Stomach Neoplasms*