黛力新联合埃索美拉唑治疗非糜烂性胃食管反流病的疗效观察

目的探讨黛力新联合埃索美拉唑治疗非糜烂性胃食管反流病的疗效。方法 60例非糜烂性胃食管反流病患者随机分为治疗组和对照组,治疗组30例,予埃索美拉唑20 mg/次,1次/d;黛力新10.5 mg/次,1次/d;吗丁啉10 mg/次,3次/d;对照组30例,予埃索美拉唑20 mg/次,1次/d;吗丁啉10 mg/次,3次/d,疗程为8周。结果治疗后两组症状如反酸、烧心、胸痛等症状均有明显改善,治疗组总有效率为96.67%,对照组总有效率为73.33%,治疗组疗效高于对照组(P<0.05)。结论黛力新联合埃索美拉唑治疗非糜烂性胃食管反流病疗效优于同等剂量的埃索美拉唑。     

不同质子泵抑制剂治疗反流性食管炎的疗效分析

目的 比较不同剂量质子泵抑制剂治疗反流性食管炎(RE)的治愈率.方法 收集前瞻性随机对照临床试验的摘要和全文,提取相关数据,采用固定效应模型进行分析.结果 埃索美拉唑40 mg短期治疗(4周)RE的治愈率高于奥美拉唑20 mg(RR:1.14;95%CI为1.10～1.18).奥美拉唑、泮托拉唑、兰索拉唑、雷贝拉唑治疗RE的治愈率比较,均无明显差异.结论 埃索美拉唑短期治疗RE的疗效优于泮托拉唑、兰索拉唑及雷贝拉唑.     

Relationship between symptom response and the esophageal pH level on standard dose of esomeprazole treatment for gastro-esophageal reflux disease

Objective To evaluate the relationship between symptom response and gastro-esophageal acidity control in Chinese gastro-esophageal reflux disease (GERD) patients on esomeprazole therapy, and to assess the role of 24-hr 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-hr esophageal pH-metry were divided into two groups depending on an additional dual-channel 24-hr 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, 89.7% (52/58) of symptom-free patients and 66.7% (12/18) of symptom-persistent patients achieved esophageal pH normalization after therapy (P=0.030). The mean post-therapy gastric nocturnal % time of pH< 4 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 2 independent factors predicting the low post-therapy esophageal pH level. Conclusion 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.     

Effect of timing of dosing in relation to food intake on the pharmacokinetics of esomeprazole

AIM: To investigate the pharmacokinetics of esomeprazole before a high-fat meal vs. fasting. METHODS: This open-label, randomized, crossover study consisted of two 5-day dosing periods of esomeprazole 40 mg per day. On days 1 and 5, subjects received esomeprazole 15 min before a high-fat meal (fed) or 4 h before a non-high-fat meal (fasting). RESULTS: On days 1 and 5, ratio of fed to fasting area under the plasma concentration-time curve [0.56, 90% confidence interval (CI) 0.50, 0.64, and 0.78, 90% CI 0.74, 0.82, respectively] and peak plasma concentration (0.34, 90% CI 0.28, 0.41, and 0.47, 90% CI 0.41, 0.52, respectively) were outside of the limits of bioequivalence. CONCLUSIONS: Esomeprazole bioavailability was reduced when taken within 15 min before eating a high-fat meal vs. that while fasting.     

Esomeprazole in acute and maintenance treatment of reflux oesophagitis: a multicentre prospective study

INTRODUCTION: The aim of this study was to assess the efficacy and safety of esomeprazole 40 mg once daily (q.d.) in healing reflux oesophagitis at 4 and 8 weeks, and the efficacy of esomeprazole 20 mg q.d. for 12 weeks in the maintenance of remission. METHODS: A total of 235 patients with endoscopically proven reflux oesophagitis were enrolled in this study, which consisted of two phases (healing and maintenance therapy). Patients who showed complete endoscopic and symptomatic healing at the end of 4 or 8 weeks were switched to maintenance treatment with esomeprazole 20 mg q.d. for 12 weeks. The primary efficacy endpoint was healing of reflux oesophagitis at week 8. Secondary assessments included the proportion of patients with symptomatic relapse in the maintenance phase. RESULTS: At the end of week 8, 88% (95% life-table confidence intervals [CI]: 84%, 92%) of patients were healed endoscopically and 90.6% of the patients were asymptomatic. Patient age, gender and Helicobacter pylori status had no effect on the efficacy of treatment. During the 12-week maintenance treatment phase, symptomatic relapse ratios were 0.5%, 2.2%, and 0%, for the first, second, and third 4-week periods, respectively. The proportions of patients satisfied with treatment were 95% and 99.4% at the end of acute and maintenance treatment, respectively. The most common adverse effects were headache, upper respiratory tract infection and abdominal pain. CONCLUSIONS: Esomeprazole is effective in the healing of reflux oesophagitis, the resolution of heartburn, and in maintaining symptomatic remission. The effectiveness of esomeprazole in patients with gastroesophageal reflux disease is not affected by the presence of H. pylori.     

Circumferential and axial distribution of esophageal mucosal damage in reflux disease

The aim of this study was to evaluate the axial and radial distribution of histological markers including hyperplasia of the basal cell layer, elongation of the papillae and dilatation of the intercellular spaces of the squamous epithelium in patients with nonerosive reflux disease compared to controls and to relate this to the macroscopic topography in erosive reflux disease. Two different study populations were included in this report. Endoscopic esophageal biopsies were taken from 21 healthy control subjects and 21 nonerosive reflux disease patients before and after 4 weeks of esomeprazole therapy. Endoscopic still images from 50 erosive reflux disease patients were reviewed for the radial orientation of LA grade A and/or B esophagitis (Los Angeles criteria for grading of reflux esophagitis). The 3 o'clock position of the squamocolumnar junction showed significantly thicker basal cell layer (P=0.011) and more intercellular space dilatation (P=0.01) in nonerosive reflux disease patients compared to the 9 o'clock position. Only a significant difference in dilatation of the intercellular spaces (P=0.018) between nonerosive reflux disease patients and controls were observed in the 3 o'clock region at the squamocolumnar junction, whereas 1-2 cm orally, all three histological criteria differed significantly (P相似文献   

Study on the preventive effect of intravenous esomeprazole in the management of nonvarices upper gastrointestinal bleeding

This retrospective study investigated the preventive effect of intravenous esomeprazole (IVEO) in the prevention of nonvarices upper gastrointestinal bleeding (NUGIB).This study enrolled 130 patients with NUGIB and all of them underwent successful endoscopic hemostasis, of which 65 cases received routine management and IVEO (Group A) and the other 65 cases received routine management alone (Group B). The primary outcome (recurrent bleeding rate within 72-hour, 7-day, and 30-day), and secondary outcomes ((all-cause mortality, bleeding-related mortality, blood transfused, hospital stay (day), and incidence of adverse events)) were compared between 2 groups.Patients in the group A showed lower recurrent bleeding rate within 72-hour(P < .05), 7-day (P < .05), and 30-day (P < .05), than that of patients in the group B. However, no significant differences were identified in all-cause mortality(P = .26), bleeding-related mortality (P = .57), blood transfused (P = .33), and hospital stay (P = .74) between 2 groups. In addition, both groups had similar safety profile.This study found that routine management and IVEO was superior to the routine management alone for preventing the recurrent bleeding rate after successful endoscopic hemostasis in patients with NUGIB.     

胃食管反流病三种治疗方案的对比性观察

目的 研究埃索美拉唑、莫沙比利、铝碳酸镁治疗胃食管反流病（GERD）的疗效,寻找有效治疗方法.方法 90例初诊为GERD患者按随机数字表法分为A组（30例）、B组（30例）、C组（30例）三组,A组埃索美拉唑40 mg,1次/d.B组埃索美拉唑40 mg,1次/d;莫沙比利5 mg,3次/d.C组埃索美拉唑40 mg,1次/d;莫沙比利5mg,3次/d;铝碳酸镁1.0g,3次/d.治疗4周及治疗8周评价症状缓解情况.结果 治疗4周后A组、B组、C组临床症状缓解率分别为66.7％、83.3％和90.0％,治疗8周后A组、B组、C组临床症状缓解率分别为73.3％、90.0％和96.7％,治疗8周时A组与C组总有效率相比差异有统计学意义（P＜0.05）,A组与B组、B组与C组差异均无统计学意义（P＞0.05）.结论 埃索美拉唑联合莫沙比利、铝碳酸镁治疗GERD可获得较好疗效,提高症状缓解率.     

反相高效液相色谱法测定注射用埃索美拉唑钠有关物质

目的建立RP-HPLC法测定注射用埃索美拉唑钠的有关物质。方法采用Inerstil ODS-3色谱柱（150mm×4.6 mm,5μm）,以乙腈-磷酸盐缓冲液（pH=7.4）-硫酸氢四丁基铵溶液（26：69：5）为流动相,柱温30℃,流速1.0 m L·min-1,检测波长为280 nm。结果主成分与各杂质之间良好分离,杂质A、B溶液冷藏避光24 h稳定,杂质C不稳定。奥美拉唑浓度在0.063 3-2.110 8μg·mL^-1（r=1.000）、杂质A浓度在0.146 5-1.953 8μg·mL^-1（r=1.000）、杂质B浓度在0.158 7-1.983 5μg·mL^-1（r=0.999 9）、杂质C浓度在0.057 6-3.838 8μg·mL^-1（r=0.999 6）与峰面积呈良好的线性关系。3种杂质的平均回收率均在91%-105%,RSD均〈5%,均符合要求。结论本方法可用于注射用埃索美拉唑钠的质量控制。     

High-dose esomeprazole is required for intraesophageal acid control in gastroesophageal reflux disease patients with hiatus hernia

Background and Aim: The aim of this study was to assess whether the efficacy of proton pump inhibitors (PPI) therapy at a standard dose in esophageal acid control is affected by the presence of hiatus hernia in Chinese gastroesophageal reflux disease patients, and whether a higher dose of PPI is required for acid control. Methods: Consecutive gastroesophageal reflux disease patients who had typical reflux symptoms and abnormal baseline 24‐h esophageal pH and underwent upper endoscopy were enrolled to receive esomeprazole at 40 mg once daily for 4 weeks. Patients underwent the dual‐channel 24‐h pH test at the end of 4‐week therapy. If the 24‐h esophageal pH was still abnormal at the end of 4‐week therapy, then esomeprazole at 40 mg twice daily was given for another 4 weeks after a washout interval of 1 week, and a 24‐h pH test was repeated at the end of the therapy. Results: Overall, 76 patients were included, 13 with hiatus hernia. Of the 76 patients treated with a 40 mg of esomeprazole daily, esophageal acid exposure was normalized in 64 (84.2%). Normalization of acid exposure was achieved by standard PPI therapy in 53.2% (7/13) of patients with hiatus hernia and 90.5% (57/63) of those without (P = 0.004). A double dose of esomeprazole was successful in normalizing the esophageal pH in all 12 non‐responders to the standard dose of esomeprazole, including the six patients with hiatus hernia and six patients without. Conclusions: The standard‐dose of esomeprazole fails to normalize the esophageal pH in almost 50% of patients with hiatus hernia, in whom the “double‐dose” esomeprazole therapy is required.