AIM: To clarify whether there is any difference in the symptom relief in patients with reflux esophagitis following the administration of four Proton pump inhibitors (PPIs). METHODS: Two hundred and seventy-four patie...AIM: To clarify whether there is any difference in the symptom relief in patients with reflux esophagitis following the administration of four Proton pump inhibitors (PPIs). METHODS: Two hundred and seventy-four patients with erosive reflux esophagitis were randomized to receive 8 wk of 20 mg omeprazole (n = 68), 30 mg of lansoprazole (n = 69), 40 mg of pantoprazole (n = 69), 40 mg of esomeprazole (n = 68) once a day in the morning. Daily changes in heartburn and acid reflux symptoms in the first 7 d of administration were assessed using a six-point scale (0: none; 1: mild; 2: mild-moderate; 3: moderate; 4: moderate-severe; 5: severe). RESULTS: The mean heartburn score in patients treated with esomeprazole more rapidly decreased than those receiving other PPI. Complete resolution of heartburn was also more rapid in patients treated with esomeprazole for 5 d compared with omeprazole (P = 0.0018, P = 0.0098, P = 0.0027, P = 0.0137, P = 0.0069, respectively), lansoprazole (P = 0.0020, P = 0.0046, P = 0.0037, P = 0.0016, P = 0.0076, respectively), and pantoprazole (P = 0.0006, P = 0.0005, P = 0.0009, P = 0.0031, P = 0.0119, respectively). There were no significant differences between the four groups in the rate of endoscopic healing of reflux esophagitis at week 8. CONCLUSION: Esomeprazole may be more effective than omeprazole, lansoprazole, and pantoprazole for the rapid relief of heartburn symptoms and acid reflux symptoms in patients with reflux esophagitis.展开更多
AIM To evaluate the effects of hydrotalcite combined with esomeprazole on gastric ulcer healing quality. METHODS Forty-eight patients diagnosed with gastric ulcer between June 2014 and February 2016 were randomly allo...AIM To evaluate the effects of hydrotalcite combined with esomeprazole on gastric ulcer healing quality. METHODS Forty-eight patients diagnosed with gastric ulcer between June 2014 and February 2016 were randomly allocated to the combination therapy group or monotherapy group. The former received hydrotalcite combined with esomeprazole, and the latter received esomeprazole alone, for 8 wk. Twenty-four healthy volunteers were recruited and acted as the healthy control group. Endoscopic ulcer healing was observed using white light endoscopy and narrow band imaging magnifying endoscopy. The composition of collagen fibers, amount of collagen deposition, expression of factor. and TGF-beta 1, and hydroxyproline content were analyzed by Masson staining, immunohistochemistry, immunofluorescent imaging and ELISA. RESULTS Following treatment, changes in the gastric microvascular network were statistically different between the combination therapy group and the monotherapy group (P < 0.05). There were significant differences (P < 0.05) in collagen deposition, expression level of Factor. and TGF-beta 1, and hydroxyproline content in the two treatment groups compared with the healthy control group. These parameters in the combination therapy group were significantly higher than in the monotherapy group (P < 0.05). The ratio of collagen. to collagen. was statistically different among the three groups, and was significantly higher in the combination therapy group than in the monotherapy group (P < 0.05). CONCLUSION Hydrotalcite combined with esomeprazole is superior to esomeprazole alone in improving gastric ulcer healing quality in terms of improving microvascular morphology, degree of structure maturity and function of regenerated mucosa.展开更多
AIM: To evaluate the effect of first line esomeprazole(EPZ)-based triple therapy on Helicobacter pylori(H. pylori) eradication.METHODS: A total of 80 Japanese patients with gastritis who were diagnosed as positive for...AIM: To evaluate the effect of first line esomeprazole(EPZ)-based triple therapy on Helicobacter pylori(H. pylori) eradication.METHODS: A total of 80 Japanese patients with gastritis who were diagnosed as positive for H. pylori infection by endoscopic biopsy-based or ^(13)C-urea breath tests were included in this study. The average age of the patients was 57.2 years(male/female, 42/38). These patients were treated by first-line eradication therapy with EPZ 40 mg/d, amoxicillin 1500 mg/d, and clarithromycin 400 mg/d for 7 d. All drugs were given twice per day. Correlations between H. pylori eradication, CYP2C19 genotype, and serum pepsinogen(PG) level were analyzed. This study was registered with the UMIN Clinical Trials Registry(UMIN000009642).RESULTS: The H. pylori eradication rates by EPZbased triple therapy evaluated by intention-to-treat and per protocol were 67.5% and 68.4%, respectively, which were similar to triple therapies with other first-generation proton pump inhibitors(PPIs). The eradication rates in three different CYP2C19 genotypes, described as extensive metabolizer(EM), intermediate metabolizer, and poor metabolizer, were 52.2%, 72.1%, and 84.6%, respectively. The H. pylori eradication rate was significantly lower in EM than non-EM(P < 0.05). The serum PG?Ⅰ?level and PG?Ⅰ/Ⅱ ratio were significantly increased after eradication of H. pylori(P < 0.01), suggesting that gastric atrophy was improved by H. pylori eradication. Thus, first-line eradication by EPZbased triple therapy for patients with H. pylori-positive gastritis was influenced by CYP2C19 genotype, and the eradication rate was on the same level with other firstgeneration PPIs in the Japanese population.CONCLUSION: The results from this study suggest that there is no advantage to EPZ-based triple therapy on H. pylori eradication compared to other firstgeneration PPIs.展开更多
AIM: To evaluate the efficacy and safety of esomeprazole-based triple therapy compared with lansoprazole therapy as first-line eradication therapy for patients with Helicobacter pylori (H. pylori) in usual post-market...AIM: To evaluate the efficacy and safety of esomeprazole-based triple therapy compared with lansoprazole therapy as first-line eradication therapy for patients with Helicobacter pylori (H. pylori) in usual post-marketing use in Japan, where the clarithromycin (CAM) resistance rate is 30%.展开更多
AIM： To study the effect of proton pump inhibitor （PPI） treatment on patients with reflux esophagitis and its in vivo effect on apoptosis, p53- and epidermal growth factor receptor （EGFR） expression. METHODS： Af...AIM： To study the effect of proton pump inhibitor （PPI） treatment on patients with reflux esophagitis and its in vivo effect on apoptosis, p53- and epidermal growth factor receptor （EGFR） expression. METHODS： After informed consent was obtained, gastric biopsies of the antrum were taken from patients with reflux oesophagitis prior to and after 6 mo of 20 mg omeprazole （n = 24） or 40 mg esomeprazole （n = 22） therapy. Patients did not take any other medications known to affect the gastric mucosa. All patients were Helicobacter pylori negative as confirmed by rapid urease test and histology, respectively. Cell proliferation, apoptosis, EGFR, and p53 expression were measured by immunohistochemical techniques. At least 600 glandular epithelial cells were encountered and results were expressed as percentage of total cells counted. Was considered statistically significant. RESULTS： Although there was a trend towards increase of cell proliferation and EGFR expression both in omeprazole and esomeprazole treated group, the difference was not statistically significant. Neither apoptosis nor p53 expression was affected. CONCLUSION： Long-term PPI treatment does not significantly increase gastric epithelial cell proliferation and EGFR expression and has no effect on apoptosis and p53 expression.展开更多
AIM: Esomeprazole, an oral S-form of omeprazole, has been a greater acid inhibitor over omeprazole in treating acid-related diseases. Only less published data is available to confirm its efficacy for Asian people. The...AIM: Esomeprazole, an oral S-form of omeprazole, has been a greater acid inhibitor over omeprazole in treating acid-related diseases. Only less published data is available to confirm its efficacy for Asian people. Therefore, a perspective, double-blind, randomized comparison of esomeprazole tablets 40 mg (Nexium(?)) vs omeprazole capsules 20 mg (Losec(?)) in treating Chinese subjects with erosive/ulcerative reflux esophagitis (EE) was conducted. METHODS: A total of 48 EE patients were enrolled and randomized into two treatment groups under 8-wk therapy: 25 receiving esomeprazole, while another 23 receiving omeprazole treatment. Finally, 44 completed the whole 8-wk therapy. RESULTS: The difference in healing EE between two groups was 22.7% (72.7% vs 50.0%), not reaching significant value (P = 0.204). The median of the first time needed in relieving heartburn sensation was 1 d for both groups and the remission rates for heartburn on the 1st d after treatment were 77.3% and 65%, respectively (NS). The scores of various reflux relieving symptoms evaluated either by patients or by investigators were not different. Regarding drug safety, 28% of esomeprazole group and 26.1% of omeprazole group reported at least one episode of adverse effects, while constipation and skin dryness were the common side effects in both groups (NS). CONCLUSION: Esomeprazole 40 mg is an effective and safe drug at least comparable to omeprazole in treating Chinese EE patients.展开更多
AIM To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis.METHODS We enrolled 175 adult patients with gastroesophageal reflux disease(GERD)....AIM To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis.METHODS We enrolled 175 adult patients with gastroesophageal reflux disease(GERD). The patients were randomized in a 1:1 ratio into two sequence groups to define the order in which they received single doses of dexlansoprazole(n = 88) and esomeprazole(n = 87) for an intention-to-treat analysis. The primary endpoints were the complete symptom resolution(CSR) rates at days 1, 3, and 7 after drug administration.RESULTS Thirteen patients were lost to follow-up, resulting in 81 patients in each group for the per-protocol analysis. The CSRs for both groups were similar at days 1, 3 and 7. In the subgroup analysis, the female patients achieved higher CSRs in the dexlansoprazole group than in the esomeprazole group at day 3(38.3% vs 18.4%, P = 0.046). An increasing trend toward a higher CSR was observed in the dexlansoprazole group at day 7(55.3% vs 36.8%, P = 0.09). In the esomeprazole group, female sex was a negative predictive factor for CSR on post-administration day 1 [OR =-1.249 ± 0.543; 95%CI: 0.287(0.099-0.832), P = 0.022] and day 3 [OR =-1.254 ± 0.519; 95%CI: 0.285(0.103-0.789), P = 0.016]. Patients with spicy food eating habits achieved lower CSRs on day 1 [37.3% vs 21.4%, OR =-0.969 ± 0.438; 95%CI: 0.380(0.161-0.896), P = 0.027]. CONCLUSION The overall CSR for GERD patients was similar at days 1-7 for both the dexlansoprazole and esomeprazole groups, although a higher incidence of CSR was observed on day 3 in female patients who received a single dose of dexlansoprazole.展开更多
AIM： To evaluate the efficacy and tolerability of two different preparations of esomeprazole in healing duodenal ulcers. METHODS： A total of 60 patients with active duodenal ulcers were enrolled and randomized to re...AIM： To evaluate the efficacy and tolerability of two different preparations of esomeprazole in healing duodenal ulcers. METHODS： A total of 60 patients with active duodenal ulcers were enrolled and randomized to receive esomeprazole enteric-coated capsules （40 mg） or esomeprazole magnesium （40 mg）, once daily, for 4 consecutive wk, with ulcer healing being monitored by endoscopy. Safety and tolerability were also assessed. RESULTS： Fifty seven patients completed the whole trial. The ulcer healing rates at the end of wk 2 were 86.7% and 85.2% in the esomeprazole enteric-coated capsules and esomeprazole magnesium groups, respectively （P = 0.8410）, and reached 100% at the end of wk 4 in beth groups. Symptom relief at the end of wk 2 was 90.8% in the esomeprazole enteric-coated capsules group and 86.7% in the esomeprazole magnesium group （P = 0.5406）; at the end of wk 4 symptom relief was 95.2% and 93.2%, respectively （P = 0.5786）. Adverse events occurred in 16.7% of the esomeprazole entericcoated capsules group and 14.8% of the esomeprazole magnesium group （P = 1.0000）. CONCLUSION： The efficacies of esomeprazole entericcoated capsules and esomeprazole magnesium in healing duodenal ulcer lesions and relieving gastrointestinal symptoms are equivalent. The tolerability and safety of beth drugs were comparable.展开更多
BACKGROUND The pharmacokinetics and bioequivalence of esomeprazole in healthy Chinese subjects and the effects of food on the pharmacokinetics have not been well studied.AIM To evaluate the pharmacokinetic characteris...BACKGROUND The pharmacokinetics and bioequivalence of esomeprazole in healthy Chinese subjects and the effects of food on the pharmacokinetics have not been well studied.AIM To evaluate the pharmacokinetic characteristics of esomeprazole magnesium(Eso)enteric-coated capsule in the healthy subjects in China and the bioequivalence of the two formulations.METHODS This study was conducted in the Phase I Clinical Trial Unit of the Affiliated Hospital of Changchun University of Chinese Medicine.A total of 64 healthy subjects were enrolled in the study.Thirty-two subjects fasted or fed,took the test or reference formulation Eso enteric-coated capsule by a four-cycle,two-sequence crossover of fasting/fed,self-controlled method.The liquid chromatographymass spectrometry was performed to determine the drug plasma concentration at 16 different time points within 12 h after drug administration.The pharmacokinetic parameters Cmax,area under the curve(AUC)0-t,and AUC0-inf were calculated to evaluate the bioequivalence.RESULTS Pharmacokinetic parameters were evaluated after subjects took the test formulation and control formulation under fasting status.The ratio of geometric means of Cmax was 104.15%,with a confidence interval(CI)of 98.20-110.46%.The ratio of geometric means of AUC0-t was 105.26%,with a CI of 99.80-111.01%.The ratio of geometric means of AUC0-inf was 105.37%,with a CI of 99.97-111.06%.The pharmacokinetic parameters were also evaluated after subjects took the reference formulation of Eso enteric-coated capsule after eating.The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state Cmax was-0.1689,and the point estimate was 0.9509(0.80-1.25).The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state AUC0-t was-0.1015(≤0),and the point estimate was 0.9003(0.80-1.25).The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state AUC0-inf was-0.0593(≤0),and the point estimate was 0.8453(0.80-1.25).The results indicated that the two formulations were bioequivalent under both fasting and fed states.CONCLUSION The two types of esomeprazole tablets were bioequivalent under both fasting and fed states,and both were generally well tolerated.展开更多
A high throughput ultra pressure liquid chromatography-mass spectrometry （UPLC-MS/MS） method with good sensitivity and selectivity has been developed and validated for simultaneous quantification of esomeprazole, ra...A high throughput ultra pressure liquid chromatography-mass spectrometry （UPLC-MS/MS） method with good sensitivity and selectivity has been developed and validated for simultaneous quantification of esomeprazole, rabeprazole and levosulpiride in human plasma using lansoprazole as internal standard （IS）. The extraction method based on liquid-liquid extraction technique was used to extract the analytes and IS from of 50 μL of human plasma using methyl tert-butyl ether：ethyl acetate （80：20, v/v）, which offers a high recovery. Chromatographic separation of analytes and IS was achieved on a Hypersil gold C18 column using gradient mobile phase consisting of 2 mM ammonium formate/acetonitrile. The flow rate was set at 0.5 mL/min to elute all the analytes and IS within 1.00 min runtime. Detection of target compounds was performed on a triple quadruple mass spectrometer by multiple reaction monitoring （MRM） mode via positive electrospray ionization （ESI）. Method validation results demonstrated that the developed method has good precision and accuracy over the concentration ranges of 0.1-2000 ng/mL for each analyte. Stability of compounds was established in a battery of stability studies, i.e., bench top, autosampler, dry extract and long-term storage stability as well as freeze-thaw cycles. The validated method has been successfully applied to analyze human plasma samples for application in pharmaco- kinetic studies.展开更多
AIM To compare symptom control with esomeprazoleregimens for non-erosive reflux disease and chronicgastritis in patients with a negative endoscopy.METHODS： This randomized, open-label study wasdesigned in line with c...AIM To compare symptom control with esomeprazoleregimens for non-erosive reflux disease and chronicgastritis in patients with a negative endoscopy.METHODS： This randomized, open-label study wasdesigned in line with clinical practice in China. Patientswith typical reflux symptoms for ≥ 3 mo and a negativeendoscopy who had a Gastroesophageal Reflux DiseaseQuestionnaire score ≥ 8 were randomized to initialtreatment with esomeprazole 20 mg once daily eitherfor 8 wk or for 2 wk. Patients with symptom reliefcould enter another 24 wk of maintenance/on-demandtreatment, where further courses of esomeprazole 20mg once daily were given if symptoms recurred. Theprimary endpoint was the symptom control rate at week24 of the maintenance/on-demand treatment period.Secondary endpoints were symptom relief rate, successrate （defined as patients who had symptom reliefafter initial treatment and after 24 wk of maintenancetreatment）, time-to-first-relapse and satisfaction rate.RESULTS： Based on the data collected in the modifiedintention-to-treat population （MITT; patients in the ITTpopulation with symptom relief after initial esomeprazoletreatment, n = 262）, the symptom control rate showeda small but statistically significant difference in favorof the 8-wk regimen （94.9% vs 87.3%, P = 0.0473）.Among the secondary endpoints, based on the datacollected in the ITT population （n = 305）, the 8-wkgroup presented marginally better results in symptomrelief after initial esomeprazole treatment （88.3% vs83.4%, P = 0.2513） and success rate over the wholestudy （83.8% vs 72.8%, P = 0.0258）. The 8-wkregimen was found to provide a 46% reduction in riskof relapse vs the 2-wk regimen （HR = 0.543; 95%CI：0.388-0.761）. In addition, fewer unscheduled visits andhigher patient satisfaction supported the therapeuticbenefits of the 8-wk regimen over the 2-wk regimen.Safety was comparable between the two groups, withboth regimens being well tolerated.CONCLUSION： Chinese patients diagnosed withchronic gastritis achieved marginally better control ofreflux symptoms with an 8-wk vs a 2-wk esomeprazoleregimen, with a similar safety profile.展开更多
Objective: to summarize the implementation effect of esomeprazole and the effect of effective treatment on the patient's serum index. Methods: in January of 2019 to December of this year, 98 patients coming to our...Objective: to summarize the implementation effect of esomeprazole and the effect of effective treatment on the patient's serum index. Methods: in January of 2019 to December of this year, 98 patients coming to our hospital for gastric ulcer were included for investigation and analysis. Patients were divided into two groups according to the actual situation, and 49 patients were included in treatment 1 and 2.The treatment pattern used in treatment group 1 was conventional treatment, and that used in treatment group 2 was esomeprazole. Explore and analyze the excellence and effect of the two treatment options. Results: (1) Through the analysis and statistics of this survey, the treatment composition ratio of 1 treatment group was 79.59%, which was lower than that of 97.96% of 2 treatment group. Therefore, the difference was very significant and with statistical significance and value (P-value <0.05).(2) The composition of adverse reactions in group 1 group was 20.41% and that of 4.08%, with very significant differences and statistical significance and value (P-value <0.05).Conclusion: gastric ulcer is a common disease, and esomeprazole should be the preferred regimen in disease treatment. This regimen can improve the treatment effect and clinical symptoms, which is worthy of clinical application and popularization.展开更多
Objective: to explore the clinical value of esomeprazole combined with magnesium aluminum in the treatment of gastric ulcer. Methods: a total of 80 patients with gastric ulcer admitted from April 2020 to April 2021 we...Objective: to explore the clinical value of esomeprazole combined with magnesium aluminum in the treatment of gastric ulcer. Methods: a total of 80 patients with gastric ulcer admitted from April 2020 to April 2021 were selected and divided into observation group and control group, 40 cases in each group. Control group was treated with esomeprazole alone, and observation group and control group were treated with magnesium aluminum. The two groups were compared for treatment indicators: total rate of treatment, clinical symptoms, hyperhealing effect, inflammatory factor levels, changes in exercise and stomach levels, and adverse reactions. Result: the total effective rate in the observation group was 95.00% higher than that in the control group (77.50%). Meanwhile, the improvement time of symptoms such as vomiting blood, hematochezia, abdominal pain, abdominal distension and belching was significantly shorter than that in the control group (P < 0.05). The levels of VEGF, EGF and COX and inflammatory factors (IL-6 and CRP) in gastric mucosa ulceration in 2 groups were significantly improved after treatment, and the levels of VEGF, EGF and COX in observation group were higher than those in control group, while il-6 and CRP were lower (P < 0.05). The levels of gastrin and motilin in 2 groups before treatment were significantly decreased after treatment (P > 0.05), and the levels of gastrin and motilin in observation group were significantly lower than those in control group (P < 0.05). There was no statistical difference in the rate of adverse reactions between 2 groups (P > 0.05). Conclusion: esomeprazole combined with magnesium aluminum carbonate in the treatment of gastric ulcer can achieve more ideal therapeutic effect, improve symptoms, promote gastric mucosal repair and healing, and the safety of treatment is guaranteed.展开更多
Background:An evidence gap still exists regarding the efficacy and safety of tegoprazan in patients with erosive esophagitis(EE)in China.This study aimed to verify the efficacy and safety of tegoprazan vs.esomeprazole...Background:An evidence gap still exists regarding the efficacy and safety of tegoprazan in patients with erosive esophagitis(EE)in China.This study aimed to verify the efficacy and safety of tegoprazan vs.esomeprazole in patients with EE in China.Methods:This study was a multicenter,randomized,double-blind,parallel,active-controlled,non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50 mg/day vs.esomeprazole 40 mg/day.This study was conducted in 32 sites between October 24,2018 and October 18,2019.The primary endpoint was the cumulative endoscopic healing rate at week 8.The secondary endpoint included endoscopic healing rate at week 4,changes in the reflux disease questionnaire(RDQ)and gastroesophageal reflux disease health-related quality of life(GERD-HRQL)scores,and symptom improvement.Results:A total of 261 patients were randomized:132 to the tegoprazan group and 129 to the esomeprazole group.The cumulative endoscopic healing rate at 8 weeks in the tegoprazan group was non-inferior to that of the esomeprazole group(91.1%vs.92.8%,difference:-1.7%,95%confidence interval[CI]:-8.5%,5.0%,P=0.008).There were no statistically significant differences in the changes in RDQ(total,severity,and frequency)and GERD-HRQL scores between the two groups(all P>0.05).The percentages of days without symptoms,including daytime and nighttime symptoms based on patients'diaries,were similar between the two groups(all P>0.05).In the tegoprazan and esomeprazole groups,71.5%(93/130)and 61.7%(79/128)of the participants reported adverse events(AEs),2.3%and 0 experienced serious AEs,while 70.0%and 60.2%had treatment-emergent AEs,respectively.Conclusion:Tegoprazan 50 mg/day demonstrated non-inferior efficacy in healing EE,symptom improvement,and quality of life,and it has similar tolerability compared with esomeprazole 40 mg/day.展开更多
Background:Owing to the high prevalence of antibiotic resistance in Helicobacter pylori(H.pylori)in China,bismuth-containing quadruple therapies have been recommended for H.pylori eradication.This study compared the e...Background:Owing to the high prevalence of antibiotic resistance in Helicobacter pylori(H.pylori)in China,bismuth-containing quadruple therapies have been recommended for H.pylori eradication.This study compared the efficacy and safety of quadruple regimens containing vonoprazan vs.esomeprazole for H.pylori eradication in a patient population in China.Methods:This was a phase 3,multicenter,randomized,double-blind study.Patients with confirmed H.pylori infection were randomized 1:1 to receive quadruple therapy for 14 days:amoxicillin 1000 mg and clarithromycin 500 mg after meals,bismuth potassium citrate 600 mg before meals,plus either vonoprazan 20 mg or esomeprazole 20 mg before meals,all twice daily.The primary outcome was the eradication rate of H.pylori,evaluated using a ^(13)C urea breath test at 4 weeks after treatment.The non-inferiority margin was at 10%.Results:The study included 510 patients,506 of whom completed the follow-up assessment.The primary analysis revealed eradication rates of 86.8%(210/242)and 86.7%(208/240)for vonoprazan and esomeprazole therapy,respectively(treatment difference:0.1%;95%confidence interval[CI]:-5.95,6.17;non-inferiority P=0.0009).Per-protocol analysis showed eradication rates of 87.4%for vonoprazan and 86.3%for esomeprazole(treatment difference:1.2%;95%CI:-5.03,7.36;non-inferiority P=0.0004).Vonoprazan and esomeprazole were well tolerated,with similar safety profiles.Conclusion:Vonoprazan was found to be well-tolerated and non-inferior to esomeprazole for eradicating H.pylori in patients from China.展开更多
Purpose： To compare the therapeutic effects of different doses of intravenous esomeprazole on treating trauma patients with stress ulcer bleeding. Methods： A total of 102 trauma patients with stress ulcer bleeding w...Purpose： To compare the therapeutic effects of different doses of intravenous esomeprazole on treating trauma patients with stress ulcer bleeding. Methods： A total of 102 trauma patients with stress ulcer bleeding were randomly divided into 2 groups： 52 patients were assigned to the high-dose group who received 80 mg intravenous esomeprazole, and then 8 mg/h continuous infusion for 3 days; 50 patients were assigned to the conventional dose group who received 40 mg intravenous esomeprazole sodium once every 12 h for 72 h. Results： Compared with the conventional dose group, the total efficiency of the high-dose group and conventional dose group was 98.08% and 86.00%, respectively （p 〈 0.05）, the hemostatic time was 22.10 h ± 5.18 h and 28.27 h ± 5.96 h, respectively （p 〈 0.05）. Conclusion： Both doses of intravenous esomeprazole have good hemostatic effects on stress ulcer bleeding in trauma patients. The high-dose esomeprazole is better for hemostasis.展开更多
Background The relationship between symptom elimination and normalization of esophageal acid level of gastroesophageal reflux disease （GERD） on proton-pump inhibitor （PPI） therapy has been questioned. This study a...Background The relationship between symptom elimination and normalization of esophageal acid level of gastroesophageal reflux disease （GERD） on proton-pump inhibitor （PPI） therapy has been questioned. This study aimed to evaluate the relationship between symptom response and gastro-esophageal acidity control in Chinese patients with GERD on esomeprazole therapy, and to assess the role of 24-hour esophageal pH-metry after therapy in GERD patients.Methods GERD patients with typical reflux symptoms were enrolled and received esomeprazole 40 mg once daily for 4 weeks. Patients with positive baseline 24-hour esophageal pH-metry were divided into two groups depending on an additional dual-channel 24-hour pH-metry after treatment. The pH- group achieved normalization of esophageal pH level whereas the pH＋ group did not.Results Of the 80 patients studied, 76 had abnormal baseline esophageal pH levels. Of these, 90% （52/58） of symptom-free patients and 67% （12/18） of symptom-persistent patients achieved esophageal pH normalization after therapy （P=0.030）. The mean post-therapy gastric nocturnal percent time of pH 〈4.0 was significantly higher in pH＋group than that in pH- group （P 〈0.001） after therapy. The multivariate regression analysis identified hiatus hernia （P〈0.001） and persistent reflux symptom （P=0.004） were two independent factors predicting the low post-therapy esophageal pH level.Conclusions Symptom elimination is not always accompanied by esophageal pH normalization, and vice verse.Esophageal pH-metry is recommended for GERD patients with hiatus hernia or with persistent reflux symptoms after PPI therapy.展开更多
文摘AIM: To clarify whether there is any difference in the symptom relief in patients with reflux esophagitis following the administration of four Proton pump inhibitors (PPIs). METHODS: Two hundred and seventy-four patients with erosive reflux esophagitis were randomized to receive 8 wk of 20 mg omeprazole (n = 68), 30 mg of lansoprazole (n = 69), 40 mg of pantoprazole (n = 69), 40 mg of esomeprazole (n = 68) once a day in the morning. Daily changes in heartburn and acid reflux symptoms in the first 7 d of administration were assessed using a six-point scale (0: none; 1: mild; 2: mild-moderate; 3: moderate; 4: moderate-severe; 5: severe). RESULTS: The mean heartburn score in patients treated with esomeprazole more rapidly decreased than those receiving other PPI. Complete resolution of heartburn was also more rapid in patients treated with esomeprazole for 5 d compared with omeprazole (P = 0.0018, P = 0.0098, P = 0.0027, P = 0.0137, P = 0.0069, respectively), lansoprazole (P = 0.0020, P = 0.0046, P = 0.0037, P = 0.0016, P = 0.0076, respectively), and pantoprazole (P = 0.0006, P = 0.0005, P = 0.0009, P = 0.0031, P = 0.0119, respectively). There were no significant differences between the four groups in the rate of endoscopic healing of reflux esophagitis at week 8. CONCLUSION: Esomeprazole may be more effective than omeprazole, lansoprazole, and pantoprazole for the rapid relief of heartburn symptoms and acid reflux symptoms in patients with reflux esophagitis.
文摘AIM To evaluate the effects of hydrotalcite combined with esomeprazole on gastric ulcer healing quality. METHODS Forty-eight patients diagnosed with gastric ulcer between June 2014 and February 2016 were randomly allocated to the combination therapy group or monotherapy group. The former received hydrotalcite combined with esomeprazole, and the latter received esomeprazole alone, for 8 wk. Twenty-four healthy volunteers were recruited and acted as the healthy control group. Endoscopic ulcer healing was observed using white light endoscopy and narrow band imaging magnifying endoscopy. The composition of collagen fibers, amount of collagen deposition, expression of factor. and TGF-beta 1, and hydroxyproline content were analyzed by Masson staining, immunohistochemistry, immunofluorescent imaging and ELISA. RESULTS Following treatment, changes in the gastric microvascular network were statistically different between the combination therapy group and the monotherapy group (P < 0.05). There were significant differences (P < 0.05) in collagen deposition, expression level of Factor. and TGF-beta 1, and hydroxyproline content in the two treatment groups compared with the healthy control group. These parameters in the combination therapy group were significantly higher than in the monotherapy group (P < 0.05). The ratio of collagen. to collagen. was statistically different among the three groups, and was significantly higher in the combination therapy group than in the monotherapy group (P < 0.05). CONCLUSION Hydrotalcite combined with esomeprazole is superior to esomeprazole alone in improving gastric ulcer healing quality in terms of improving microvascular morphology, degree of structure maturity and function of regenerated mucosa.
基金Supported by Research Grant of Kitasato Institute Hospital
文摘AIM: To evaluate the effect of first line esomeprazole(EPZ)-based triple therapy on Helicobacter pylori(H. pylori) eradication.METHODS: A total of 80 Japanese patients with gastritis who were diagnosed as positive for H. pylori infection by endoscopic biopsy-based or ^(13)C-urea breath tests were included in this study. The average age of the patients was 57.2 years(male/female, 42/38). These patients were treated by first-line eradication therapy with EPZ 40 mg/d, amoxicillin 1500 mg/d, and clarithromycin 400 mg/d for 7 d. All drugs were given twice per day. Correlations between H. pylori eradication, CYP2C19 genotype, and serum pepsinogen(PG) level were analyzed. This study was registered with the UMIN Clinical Trials Registry(UMIN000009642).RESULTS: The H. pylori eradication rates by EPZbased triple therapy evaluated by intention-to-treat and per protocol were 67.5% and 68.4%, respectively, which were similar to triple therapies with other first-generation proton pump inhibitors(PPIs). The eradication rates in three different CYP2C19 genotypes, described as extensive metabolizer(EM), intermediate metabolizer, and poor metabolizer, were 52.2%, 72.1%, and 84.6%, respectively. The H. pylori eradication rate was significantly lower in EM than non-EM(P < 0.05). The serum PG?Ⅰ?level and PG?Ⅰ/Ⅱ ratio were significantly increased after eradication of H. pylori(P < 0.01), suggesting that gastric atrophy was improved by H. pylori eradication. Thus, first-line eradication by EPZbased triple therapy for patients with H. pylori-positive gastritis was influenced by CYP2C19 genotype, and the eradication rate was on the same level with other firstgeneration PPIs in the Japanese population.CONCLUSION: The results from this study suggest that there is no advantage to EPZ-based triple therapy on H. pylori eradication compared to other firstgeneration PPIs.
文摘AIM: To evaluate the efficacy and safety of esomeprazole-based triple therapy compared with lansoprazole therapy as first-line eradication therapy for patients with Helicobacter pylori (H. pylori) in usual post-marketing use in Japan, where the clarithromycin (CAM) resistance rate is 30%.
基金Supported by the National Science Foundation (OTKA Grant No:T 034345)
文摘AIM： To study the effect of proton pump inhibitor （PPI） treatment on patients with reflux esophagitis and its in vivo effect on apoptosis, p53- and epidermal growth factor receptor （EGFR） expression. METHODS： After informed consent was obtained, gastric biopsies of the antrum were taken from patients with reflux oesophagitis prior to and after 6 mo of 20 mg omeprazole （n = 24） or 40 mg esomeprazole （n = 22） therapy. Patients did not take any other medications known to affect the gastric mucosa. All patients were Helicobacter pylori negative as confirmed by rapid urease test and histology, respectively. Cell proliferation, apoptosis, EGFR, and p53 expression were measured by immunohistochemical techniques. At least 600 glandular epithelial cells were encountered and results were expressed as percentage of total cells counted. Was considered statistically significant. RESULTS： Although there was a trend towards increase of cell proliferation and EGFR expression both in omeprazole and esomeprazole treated group, the difference was not statistically significant. Neither apoptosis nor p53 expression was affected. CONCLUSION： Long-term PPI treatment does not significantly increase gastric epithelial cell proliferation and EGFR expression and has no effect on apoptosis and p53 expression.
基金Supported by the Research Foundation of Digestive Medicine,Taiwan, China
文摘AIM: Esomeprazole, an oral S-form of omeprazole, has been a greater acid inhibitor over omeprazole in treating acid-related diseases. Only less published data is available to confirm its efficacy for Asian people. Therefore, a perspective, double-blind, randomized comparison of esomeprazole tablets 40 mg (Nexium(?)) vs omeprazole capsules 20 mg (Losec(?)) in treating Chinese subjects with erosive/ulcerative reflux esophagitis (EE) was conducted. METHODS: A total of 48 EE patients were enrolled and randomized into two treatment groups under 8-wk therapy: 25 receiving esomeprazole, while another 23 receiving omeprazole treatment. Finally, 44 completed the whole 8-wk therapy. RESULTS: The difference in healing EE between two groups was 22.7% (72.7% vs 50.0%), not reaching significant value (P = 0.204). The median of the first time needed in relieving heartburn sensation was 1 d for both groups and the remission rates for heartburn on the 1st d after treatment were 77.3% and 65%, respectively (NS). The scores of various reflux relieving symptoms evaluated either by patients or by investigators were not different. Regarding drug safety, 28% of esomeprazole group and 26.1% of omeprazole group reported at least one episode of adverse effects, while constipation and skin dryness were the common side effects in both groups (NS). CONCLUSION: Esomeprazole 40 mg is an effective and safe drug at least comparable to omeprazole in treating Chinese EE patients.
基金Supported by Research Foundation of Chang Gung Memorial Hospital,No.CMRPG8D1441
文摘AIM To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis.METHODS We enrolled 175 adult patients with gastroesophageal reflux disease(GERD). The patients were randomized in a 1:1 ratio into two sequence groups to define the order in which they received single doses of dexlansoprazole(n = 88) and esomeprazole(n = 87) for an intention-to-treat analysis. The primary endpoints were the complete symptom resolution(CSR) rates at days 1, 3, and 7 after drug administration.RESULTS Thirteen patients were lost to follow-up, resulting in 81 patients in each group for the per-protocol analysis. The CSRs for both groups were similar at days 1, 3 and 7. In the subgroup analysis, the female patients achieved higher CSRs in the dexlansoprazole group than in the esomeprazole group at day 3(38.3% vs 18.4%, P = 0.046). An increasing trend toward a higher CSR was observed in the dexlansoprazole group at day 7(55.3% vs 36.8%, P = 0.09). In the esomeprazole group, female sex was a negative predictive factor for CSR on post-administration day 1 [OR =-1.249 ± 0.543; 95%CI: 0.287(0.099-0.832), P = 0.022] and day 3 [OR =-1.254 ± 0.519; 95%CI: 0.285(0.103-0.789), P = 0.016]. Patients with spicy food eating habits achieved lower CSRs on day 1 [37.3% vs 21.4%, OR =-0.969 ± 0.438; 95%CI: 0.380(0.161-0.896), P = 0.027]. CONCLUSION The overall CSR for GERD patients was similar at days 1-7 for both the dexlansoprazole and esomeprazole groups, although a higher incidence of CSR was observed on day 3 in female patients who received a single dose of dexlansoprazole.
文摘AIM： To evaluate the efficacy and tolerability of two different preparations of esomeprazole in healing duodenal ulcers. METHODS： A total of 60 patients with active duodenal ulcers were enrolled and randomized to receive esomeprazole enteric-coated capsules （40 mg） or esomeprazole magnesium （40 mg）, once daily, for 4 consecutive wk, with ulcer healing being monitored by endoscopy. Safety and tolerability were also assessed. RESULTS： Fifty seven patients completed the whole trial. The ulcer healing rates at the end of wk 2 were 86.7% and 85.2% in the esomeprazole enteric-coated capsules and esomeprazole magnesium groups, respectively （P = 0.8410）, and reached 100% at the end of wk 4 in beth groups. Symptom relief at the end of wk 2 was 90.8% in the esomeprazole enteric-coated capsules group and 86.7% in the esomeprazole magnesium group （P = 0.5406）; at the end of wk 4 symptom relief was 95.2% and 93.2%, respectively （P = 0.5786）. Adverse events occurred in 16.7% of the esomeprazole entericcoated capsules group and 14.8% of the esomeprazole magnesium group （P = 1.0000）. CONCLUSION： The efficacies of esomeprazole entericcoated capsules and esomeprazole magnesium in healing duodenal ulcer lesions and relieving gastrointestinal symptoms are equivalent. The tolerability and safety of beth drugs were comparable.
文摘BACKGROUND The pharmacokinetics and bioequivalence of esomeprazole in healthy Chinese subjects and the effects of food on the pharmacokinetics have not been well studied.AIM To evaluate the pharmacokinetic characteristics of esomeprazole magnesium(Eso)enteric-coated capsule in the healthy subjects in China and the bioequivalence of the two formulations.METHODS This study was conducted in the Phase I Clinical Trial Unit of the Affiliated Hospital of Changchun University of Chinese Medicine.A total of 64 healthy subjects were enrolled in the study.Thirty-two subjects fasted or fed,took the test or reference formulation Eso enteric-coated capsule by a four-cycle,two-sequence crossover of fasting/fed,self-controlled method.The liquid chromatographymass spectrometry was performed to determine the drug plasma concentration at 16 different time points within 12 h after drug administration.The pharmacokinetic parameters Cmax,area under the curve(AUC)0-t,and AUC0-inf were calculated to evaluate the bioequivalence.RESULTS Pharmacokinetic parameters were evaluated after subjects took the test formulation and control formulation under fasting status.The ratio of geometric means of Cmax was 104.15%,with a confidence interval(CI)of 98.20-110.46%.The ratio of geometric means of AUC0-t was 105.26%,with a CI of 99.80-111.01%.The ratio of geometric means of AUC0-inf was 105.37%,with a CI of 99.97-111.06%.The pharmacokinetic parameters were also evaluated after subjects took the reference formulation of Eso enteric-coated capsule after eating.The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state Cmax was-0.1689,and the point estimate was 0.9509(0.80-1.25).The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state AUC0-t was-0.1015(≤0),and the point estimate was 0.9003(0.80-1.25).The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state AUC0-inf was-0.0593(≤0),and the point estimate was 0.8453(0.80-1.25).The results indicated that the two formulations were bioequivalent under both fasting and fed states.CONCLUSION The two types of esomeprazole tablets were bioequivalent under both fasting and fed states,and both were generally well tolerated.
文摘A high throughput ultra pressure liquid chromatography-mass spectrometry （UPLC-MS/MS） method with good sensitivity and selectivity has been developed and validated for simultaneous quantification of esomeprazole, rabeprazole and levosulpiride in human plasma using lansoprazole as internal standard （IS）. The extraction method based on liquid-liquid extraction technique was used to extract the analytes and IS from of 50 μL of human plasma using methyl tert-butyl ether：ethyl acetate （80：20, v/v）, which offers a high recovery. Chromatographic separation of analytes and IS was achieved on a Hypersil gold C18 column using gradient mobile phase consisting of 2 mM ammonium formate/acetonitrile. The flow rate was set at 0.5 mL/min to elute all the analytes and IS within 1.00 min runtime. Detection of target compounds was performed on a triple quadruple mass spectrometer by multiple reaction monitoring （MRM） mode via positive electrospray ionization （ESI）. Method validation results demonstrated that the developed method has good precision and accuracy over the concentration ranges of 0.1-2000 ng/mL for each analyte. Stability of compounds was established in a battery of stability studies, i.e., bench top, autosampler, dry extract and long-term storage stability as well as freeze-thaw cycles. The validated method has been successfully applied to analyze human plasma samples for application in pharmaco- kinetic studies.
文摘AIM To compare symptom control with esomeprazoleregimens for non-erosive reflux disease and chronicgastritis in patients with a negative endoscopy.METHODS： This randomized, open-label study wasdesigned in line with clinical practice in China. Patientswith typical reflux symptoms for ≥ 3 mo and a negativeendoscopy who had a Gastroesophageal Reflux DiseaseQuestionnaire score ≥ 8 were randomized to initialtreatment with esomeprazole 20 mg once daily eitherfor 8 wk or for 2 wk. Patients with symptom reliefcould enter another 24 wk of maintenance/on-demandtreatment, where further courses of esomeprazole 20mg once daily were given if symptoms recurred. Theprimary endpoint was the symptom control rate at week24 of the maintenance/on-demand treatment period.Secondary endpoints were symptom relief rate, successrate （defined as patients who had symptom reliefafter initial treatment and after 24 wk of maintenancetreatment）, time-to-first-relapse and satisfaction rate.RESULTS： Based on the data collected in the modifiedintention-to-treat population （MITT; patients in the ITTpopulation with symptom relief after initial esomeprazoletreatment, n = 262）, the symptom control rate showeda small but statistically significant difference in favorof the 8-wk regimen （94.9% vs 87.3%, P = 0.0473）.Among the secondary endpoints, based on the datacollected in the ITT population （n = 305）, the 8-wkgroup presented marginally better results in symptomrelief after initial esomeprazole treatment （88.3% vs83.4%, P = 0.2513） and success rate over the wholestudy （83.8% vs 72.8%, P = 0.0258）. The 8-wkregimen was found to provide a 46% reduction in riskof relapse vs the 2-wk regimen （HR = 0.543; 95%CI：0.388-0.761）. In addition, fewer unscheduled visits andhigher patient satisfaction supported the therapeuticbenefits of the 8-wk regimen over the 2-wk regimen.Safety was comparable between the two groups, withboth regimens being well tolerated.CONCLUSION： Chinese patients diagnosed withchronic gastritis achieved marginally better control ofreflux symptoms with an 8-wk vs a 2-wk esomeprazoleregimen, with a similar safety profile.
文摘Objective: to summarize the implementation effect of esomeprazole and the effect of effective treatment on the patient's serum index. Methods: in January of 2019 to December of this year, 98 patients coming to our hospital for gastric ulcer were included for investigation and analysis. Patients were divided into two groups according to the actual situation, and 49 patients were included in treatment 1 and 2.The treatment pattern used in treatment group 1 was conventional treatment, and that used in treatment group 2 was esomeprazole. Explore and analyze the excellence and effect of the two treatment options. Results: (1) Through the analysis and statistics of this survey, the treatment composition ratio of 1 treatment group was 79.59%, which was lower than that of 97.96% of 2 treatment group. Therefore, the difference was very significant and with statistical significance and value (P-value <0.05).(2) The composition of adverse reactions in group 1 group was 20.41% and that of 4.08%, with very significant differences and statistical significance and value (P-value <0.05).Conclusion: gastric ulcer is a common disease, and esomeprazole should be the preferred regimen in disease treatment. This regimen can improve the treatment effect and clinical symptoms, which is worthy of clinical application and popularization.
文摘Objective: to explore the clinical value of esomeprazole combined with magnesium aluminum in the treatment of gastric ulcer. Methods: a total of 80 patients with gastric ulcer admitted from April 2020 to April 2021 were selected and divided into observation group and control group, 40 cases in each group. Control group was treated with esomeprazole alone, and observation group and control group were treated with magnesium aluminum. The two groups were compared for treatment indicators: total rate of treatment, clinical symptoms, hyperhealing effect, inflammatory factor levels, changes in exercise and stomach levels, and adverse reactions. Result: the total effective rate in the observation group was 95.00% higher than that in the control group (77.50%). Meanwhile, the improvement time of symptoms such as vomiting blood, hematochezia, abdominal pain, abdominal distension and belching was significantly shorter than that in the control group (P < 0.05). The levels of VEGF, EGF and COX and inflammatory factors (IL-6 and CRP) in gastric mucosa ulceration in 2 groups were significantly improved after treatment, and the levels of VEGF, EGF and COX in observation group were higher than those in control group, while il-6 and CRP were lower (P < 0.05). The levels of gastrin and motilin in 2 groups before treatment were significantly decreased after treatment (P > 0.05), and the levels of gastrin and motilin in observation group were significantly lower than those in control group (P < 0.05). There was no statistical difference in the rate of adverse reactions between 2 groups (P > 0.05). Conclusion: esomeprazole combined with magnesium aluminum carbonate in the treatment of gastric ulcer can achieve more ideal therapeutic effect, improve symptoms, promote gastric mucosal repair and healing, and the safety of treatment is guaranteed.
基金This study was supported by the grant from Shanghai Excellent Academic Leaders Program(No.21XD1404900)Shanghai Public Health Key Discipline Project(No.GWVI-11.1-21)
文摘Background:An evidence gap still exists regarding the efficacy and safety of tegoprazan in patients with erosive esophagitis(EE)in China.This study aimed to verify the efficacy and safety of tegoprazan vs.esomeprazole in patients with EE in China.Methods:This study was a multicenter,randomized,double-blind,parallel,active-controlled,non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50 mg/day vs.esomeprazole 40 mg/day.This study was conducted in 32 sites between October 24,2018 and October 18,2019.The primary endpoint was the cumulative endoscopic healing rate at week 8.The secondary endpoint included endoscopic healing rate at week 4,changes in the reflux disease questionnaire(RDQ)and gastroesophageal reflux disease health-related quality of life(GERD-HRQL)scores,and symptom improvement.Results:A total of 261 patients were randomized:132 to the tegoprazan group and 129 to the esomeprazole group.The cumulative endoscopic healing rate at 8 weeks in the tegoprazan group was non-inferior to that of the esomeprazole group(91.1%vs.92.8%,difference:-1.7%,95%confidence interval[CI]:-8.5%,5.0%,P=0.008).There were no statistically significant differences in the changes in RDQ(total,severity,and frequency)and GERD-HRQL scores between the two groups(all P>0.05).The percentages of days without symptoms,including daytime and nighttime symptoms based on patients'diaries,were similar between the two groups(all P>0.05).In the tegoprazan and esomeprazole groups,71.5%(93/130)and 61.7%(79/128)of the participants reported adverse events(AEs),2.3%and 0 experienced serious AEs,while 70.0%and 60.2%had treatment-emergent AEs,respectively.Conclusion:Tegoprazan 50 mg/day demonstrated non-inferior efficacy in healing EE,symptom improvement,and quality of life,and it has similar tolerability compared with esomeprazole 40 mg/day.
文摘Background:Owing to the high prevalence of antibiotic resistance in Helicobacter pylori(H.pylori)in China,bismuth-containing quadruple therapies have been recommended for H.pylori eradication.This study compared the efficacy and safety of quadruple regimens containing vonoprazan vs.esomeprazole for H.pylori eradication in a patient population in China.Methods:This was a phase 3,multicenter,randomized,double-blind study.Patients with confirmed H.pylori infection were randomized 1:1 to receive quadruple therapy for 14 days:amoxicillin 1000 mg and clarithromycin 500 mg after meals,bismuth potassium citrate 600 mg before meals,plus either vonoprazan 20 mg or esomeprazole 20 mg before meals,all twice daily.The primary outcome was the eradication rate of H.pylori,evaluated using a ^(13)C urea breath test at 4 weeks after treatment.The non-inferiority margin was at 10%.Results:The study included 510 patients,506 of whom completed the follow-up assessment.The primary analysis revealed eradication rates of 86.8%(210/242)and 86.7%(208/240)for vonoprazan and esomeprazole therapy,respectively(treatment difference:0.1%;95%confidence interval[CI]:-5.95,6.17;non-inferiority P=0.0009).Per-protocol analysis showed eradication rates of 87.4%for vonoprazan and 86.3%for esomeprazole(treatment difference:1.2%;95%CI:-5.03,7.36;non-inferiority P=0.0004).Vonoprazan and esomeprazole were well tolerated,with similar safety profiles.Conclusion:Vonoprazan was found to be well-tolerated and non-inferior to esomeprazole for eradicating H.pylori in patients from China.
文摘Purpose： To compare the therapeutic effects of different doses of intravenous esomeprazole on treating trauma patients with stress ulcer bleeding. Methods： A total of 102 trauma patients with stress ulcer bleeding were randomly divided into 2 groups： 52 patients were assigned to the high-dose group who received 80 mg intravenous esomeprazole, and then 8 mg/h continuous infusion for 3 days; 50 patients were assigned to the conventional dose group who received 40 mg intravenous esomeprazole sodium once every 12 h for 72 h. Results： Compared with the conventional dose group, the total efficiency of the high-dose group and conventional dose group was 98.08% and 86.00%, respectively （p 〈 0.05）, the hemostatic time was 22.10 h ± 5.18 h and 28.27 h ± 5.96 h, respectively （p 〈 0.05）. Conclusion： Both doses of intravenous esomeprazole have good hemostatic effects on stress ulcer bleeding in trauma patients. The high-dose esomeprazole is better for hemostasis.
文摘Background The relationship between symptom elimination and normalization of esophageal acid level of gastroesophageal reflux disease （GERD） on proton-pump inhibitor （PPI） therapy has been questioned. This study aimed to evaluate the relationship between symptom response and gastro-esophageal acidity control in Chinese patients with GERD on esomeprazole therapy, and to assess the role of 24-hour esophageal pH-metry after therapy in GERD patients.Methods GERD patients with typical reflux symptoms were enrolled and received esomeprazole 40 mg once daily for 4 weeks. Patients with positive baseline 24-hour esophageal pH-metry were divided into two groups depending on an additional dual-channel 24-hour pH-metry after treatment. The pH- group achieved normalization of esophageal pH level whereas the pH＋ group did not.Results Of the 80 patients studied, 76 had abnormal baseline esophageal pH levels. Of these, 90% （52/58） of symptom-free patients and 67% （12/18） of symptom-persistent patients achieved esophageal pH normalization after therapy （P=0.030）. The mean post-therapy gastric nocturnal percent time of pH 〈4.0 was significantly higher in pH＋group than that in pH- group （P 〈0.001） after therapy. The multivariate regression analysis identified hiatus hernia （P〈0.001） and persistent reflux symptom （P=0.004） were two independent factors predicting the low post-therapy esophageal pH level.Conclusions Symptom elimination is not always accompanied by esophageal pH normalization, and vice verse.Esophageal pH-metry is recommended for GERD patients with hiatus hernia or with persistent reflux symptoms after PPI therapy.
