Randomized, double-blind, comparative study of dexrabeprazole 10 mg versus rabeprazole 20 mg in the treatment of gastroesophageal reflux disease

AIM：TO compare the efficacy and safety of dexrabe-prazole 10 mg versus rabeprazole 20 mg in the treatment of gastroesophageal reflux disease （GERD）.
METHODS： This was a randomized, double-blind clinical study. Fifty patients with GERD were randomly assigned to receive dexrabeprazole 10 mg or rabeprazole 20 mg once daily. Efficacy was assessed by evaluating improvement in visual analog scale （VAS） scores of heart-burn and regurgitation and safety was assessed by recording incidence of any adverse drug reactions. Laboratory investigations and upper gastro-intestinal endoscopy was conducted at baseline and after 28 d of therapy.
RESULTS： A total of 50 patients （n = 25 in dexrabeprazole group and rabeprazole group each） completed the study. There were no significant differences in the baseline characteristics between the two groups. The VAS score （mean 4. SD） of heartburn and regurgitation in dexrabeprazole （64.8±5.1 and 64 ± 8.1, respectively） and rabeprazole （64.4 ± 8.7 and 57.6 ± 9.7, respectively） groups significantly reduced （P 〈 0.0001） to 30 ± 11.5, 24 ± 10 and 32 ± 9.5, 29.2±11.9, respectively on d 28. A significantly higher （P = 0.002） proportion of patients showed ≥ 50% improvement in regurgitation with dexrabeprazole 10 mg （96%） compared to rabeprazole 20 mg （60%）. Onset of symptom improvement was significantly earlier with dexrabeprazole than with rabeprazole （1.8 ± 0.8 d vs 2.6 ± 1.4 d; P 〈0.05）. The incidences of esophagitis in the dexrabeprazole group and rabeprazole group before therapy were 84% and 92%, respectively （P = 0.38）. The incidence of improvement/healing of esophagitis after therapy was more （P = 0,036） in the dexrabeprazole group （95.2%） compared to the rabeprazole group （65.2%）. No adverse drug reaction was seen in either group.
CONCLUSION： In the treatment of GERD, efficacy of dexrabeprazole 10 mg is better than rabeprazole 20 mg, with regards to improvement/healing of endoscopic lesions and relief fro     

Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease: A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole

BACKGROUND: Previous studies have shown similar effects of rabeprazole and omeprazole, when used at the same dose in the treatment of reflux oesophagitis. However, such studies have been conducted as superiority studies but interpreted as equivalence ones. AIM: To properly assess the comparative efficacy of rabeprazole and omeprazole in inducing complete endoscopic healing and symptom relief in patients with reflux oesophagitis. METHODS: Patients (n=560) with Savary-Miller grade I-III reflux oesophagitis were randomised in a double-blind, double-dummy fashion to rabeprazole or omeprazole 20 mg once daily for 4-8 weeks. Then, patients endoscopically healed and symptomatically relieved were openly maintained with rabeprazole 10 mg or 2x10 mg once daily (in the event of clinical and/or endoscopic relapse) for a maximum of 48 weeks. RESULTS: After 4-8 weeks of treatment, healing (primary end-point) was observed in 228/233 (97.9%) patients in the rabeprazole group and in 231/237 (97.5%) in the omeprazole one (equivalence effect demonstrated by p<0.0001 at Blackwelder test and an upper confidence limit at 97.5% of 0.023). However, rabeprazole was faster in inducing heartburn relief than omeprazole (2.8+/-0.2 versus 4.7+/-0.5 days of therapy to reach the first day with satisfactory heartburn relief, p=0.0045 at log-rank test). In the maintenance phase, 15.2% of patients had an endoscopic and/or clinical relapse. CONCLUSION: Rabeprazole is equivalent to omeprazole in healing reflux oesophagitis, but shows a faster activity on reflux symptoms in the early treatment phase.     

Rabeprazole, 20 mg once daily or 10 mg twice daily, is equivalent to omeprazole, 20 mg once daily, in the healing of erosive gastrooesophageal reflux disease

BACKGROUND: Proton pump inhibitors are the most potent pharmacologic inhibitors of gastric acid secretion currently available, and have proven effective in the treatment of gastro-oesophageal reflux disease (GERD). The object of this study was to compare the efficacy and tolerability of a new proton pump inhibitor, rabeprazole at two different dosages, with that of omeprazole in the healing of erosive GERD. METHODS: Rabeprazole 20 mg once daily (QD) and 10 mg twice daily (BID) were compared with omeprazole 20 mg QD in a double-blind, multicentre, parallel group study involving 310 patients with erosive GERD. The primary efficacy endpoint was oesophageal mucosal healing determined by endoscopy. Secondary endpoints included reduction in symptoms and improvements in quality-of-life scores. RESULTS: The healing rates between both rabeprazole groups and the omeprazole group were equivalent in both the per-protocol and intent-to-treat populations. In the per-protocol population, rabeprazole 20 mg was noted to have a numerical trend toward more rapid daytime heartburn relief. However, by 4 and 8 weeks of treatment, no significant differences were found between groups for secondary endpoints, adverse events, or laboratory abnormalities including elevation of serum gastrin levels. CONCLUSIONS: Rabeprazole 20 mg in two different dosing schedules is as effective as omeprazole 20 mg QD with regard to efficacy and tolerability in patients with erosive GERD.     

非糜烂性胃食管反流病食管酸暴露特点和雷贝拉唑试验的诊断价值

目的探讨各型非糜烂性胃食管反流病食管酸暴漏特点及雷贝拉唑试验的诊断价值。方法选取2013年2月-2013年6月百色市人民医院收治的非糜烂性胃食管反流病患者65例,其中异常酸反流型患者25例作为观察组1,食管对酸高敏型患者22例作为观察组2,功能性烧心型患者18例作为观察组3。采用雷贝拉唑10 mg,口服,2次/d,2周为1个疗程,观察3组的酸暴漏特点、症状评分及雷贝拉唑诊断试验敏感性和特异性。结果 (1)酸暴漏特点:观察组1的24 h酸反流次数、长反流次数、p H4时间及百分比均明显高于其他两组(P0.05)。(2)症状积分:治疗前3组的典型症状积分与总积分相比,差异均无统计学意义(P0.05),观察组2的食管外症状积分明显高于其他两组(P0.05)。治疗1周和2周后,观察组1和观察组2的症状积分均较治疗前明显下降,而观察组3虽较治疗前稍有下降,但差异无统计学意义(P0.05);治疗2周后观察组1的症状积分明显优于其他两组(P0.05)。(3)雷贝拉唑诊断试验疗效:治疗1周和2周后的总有效率分别为58.5%和67.7%;观察组1最佳,其次为观察组2和观察组3,差异具有统计学意义(P0.05);观察组1和观察组2在治疗1周时其雷贝拉唑诊断试验的敏感性和特异性分别为74.5%(35/47)、83.3%(15/18),在治疗2周时分别为87.2%(41/47)、83.3%(15/18)。结论异常酸反流型患者的酸暴漏特点为酸反流和长反流的次数增多,p H4的时间延长;酸高敏型患者更容易发生食管外症状;雷贝拉唑试验诊断非糜烂性胃食管反流病简单、安全且准确率高,值得临床推广应用。     

Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis

OBJECTIVE: To compare the efficacy, pharmacokinetics and safety of etanercept 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis. METHODS: A 12-week, double-blind, placebo-controlled study compared the effects of etanercept 50 mg once weekly, etanercept 25 mg twice weekly and placebo in 356 patients with active ankylosing spondylitis (3:3:1 randomisation, respectively). The primary end point was the proportion of patients achieving a response at week 12 based on the Assessment in Ankylosing Spondylitis Working Group criteria (ASAS 20). The pharmacokinetics of etanercept 50 mg once weekly and 25 mg twice weekly were analysed. RESULTS: Baseline characteristics and disease activity were similar among the three groups: etanercept 50 mg once weekly, etanercept 25 mg twice weekly and placebo. The percentage of patients discontinuing therapy was 9.0%, 9.3% and 13.7% for the three respective groups. ASAS 20 response at 12 weeks was achieved by 74.2% of patients with etanercept 50 mg once weekly and 71.3% of those with etanercept 25 mg twice weekly, both significantly higher than the percentage of patients taking placebo (37.3%, p<0.001). Percentages of patients with ASAS 5/6 response (70.3%, 72.0% and 27.5%, respectively; p<0.001) and those with ASAS 40 response (58.1%, 53.3% and 21.6%, respectively; p<0.001) followed a similar pattern. Significant improvement (p<0.05) was seen in measures of disease activity, back pain, morning stiffness and C reactive protein levels as early as 2 weeks. Serum etanercept exposure was similar between the etanercept groups. Incidence of treatment-emergent adverse events, including infections, was similar among all three groups, and no unexpected safety issues were identified. CONCLUSIONS: Patients with ankylosing spondylitis can expect a comparable significant improvement in clinical outcomes with similar safety when treated with etanercept 50 mg once weekly or with 25 mg twice weekly.     

Pantoprazole 20 mg is an effective maintenance therapy for patients with gastro-oesophageal reflux disease

OBJECTIVES: To compare the efficacy of 20 mg with 40 mg pantoprazole in maintaining symptomatic and endoscopic remission in patients with gastro-oesophageal reflux disease (GORD). STUDY DESIGN: Patients (18-84 years old; n = 433) with healed GORD II or III were included in this prospective multi-centre, randomized, parallel, double-blind study. Pantoprazole was administered once daily for up to 1 year as either a 20 mg or 40 mg enteric-coated tablet to 221 and 212 patients, respectively. Symptoms of GORD were assessed every 3 months. Endoscopy was performed at entry, after 6 and 12 months, or when symptoms of GORD were perceived on at least three consecutive days. The primary efficacy parameter was the time until endoscopically proven relapse of GORD occurred (stage I or greater); the secondary parameters included tolerability, safety, and time until symptomatic relapse occurred. RESULTS: In the 20 mg treatment group, 87% and 75% of patients were in endoscopic remission after 6 and 12 months, respectively; the corresponding rates in the 40 mg treatment group were 91% and 78%. In both treatment groups, GORD stage I accounted for about 50% of endoscopic relapses. The symptomatic remission rates in the 20 mg group were estimated as 85% and 77% after 6 and 12 months, respectively; the corresponding values in the 40 mg group were 87% and 76%. No correlation was seen either between the endoscopically proven relapse and perception of symptoms, or between the severity of the pre-treatment stage of GORD and the maintenance dose of pantoprazole. Both doses were well tolerated. CONCLUSIONS: Both the 20 mg and 40 mg doses of pantoprazole are safe and effective in maintaining patients with healed reflux oesophagitis in remission. Moreover, for the majority of patients, the 20 mg dose provides adequate long-term therapeutic efficacy at a minimal drug exposure and lower costs.     

联合应用雷贝拉唑、铝碳酸镁和莫沙比利治疗难治性胃食管反流病202例疗效观察

目的 探讨联合应用雷贝拉唑、铝碳酸镁和莫沙比利治疗难治性胃食管反流病(rGERD)的临床疗效.方法 将202例rGERD患者随机分为A(n=72)、B(n=68)和C组(n=62),分别采用雷贝拉唑+铝碳酸镁+莫沙比利、雷贝拉唑+莫沙比利及铝碳酸镁+莫沙比利治疗.4及8周后评价临床症状,8周后评价内镜下有效率.结果 治疗4周后,A、B和C组患者临床症状总改善率分别为88.9%、79.4%和61.3%,A组与B、C组相比差异显著(X2=7.3531,P<0.05).治疗8周后,A、B和C组患者临床症状总改善率分别为97.2%、88.2%和71.0%,内镜下有效率分别为94.4%、85.3%和67.7%,A组临床症状总改善率和内镜下有效率与B、C组相比存在显著性差异(X2=9.6079,P<0.01;X2=8.6496,P<0.05).结论 雷贝拉唑联合铝碳酸镁和莫沙比利治疗rGERD有良好的临床疗效.     

A Multicenter, Randomized, Double-Blind, 8-Week Comparative Trial of Low-Dose Esomeprazole (20 mg) and Standard-Dose Omeprazole (20 mg) in Patients with Erosive Esophagitis

The objective of this trial was to compare the efficacy of esomeprazole, 20 mg, with that of omeprazole, 20 mg, in patients with erosive esophagitis (EE). In this multicenter, double-blind, parallel-group trial, 1176 patients with EE confirmed by endoscopy (Helicobacter pylori-negative by serology) were randomized to once-daily treatment with 20 mg esomeprazole or 20 mg omeprazole for 8 weeks. The primary outcome was the proportion of patients with healed EE through week 8. Secondary outcomes included diary and investigator assessments of heartburn symptoms. Cumulative life-table healing rates at week 8 were similarly high for 20 mg esomeprazole (90.6%; 95% confidence interval, 88.1%–93%) and 20 mg omeprazole (88.3%; 95% confidence interval, 85.5%–91.0%). The two treatments were comparable for other secondary measures and had similar tolerability profiles.     

Efficacy of famotidine 20 mg twice a day versus 40 mg twice a day in the treatment of erosive or ulcerative reflux esophagitis

Two different doses of famotidine (20 mg twice a day versus 40 mg twice a day) were evaluated in a double-blind, randomized multicenter study in 474 symptomatic patients with erosive ulcerative reflux esophagitis. A total of 238 patients were treated with famotidine 20 mg and 236 patients with 40 mg at breakfast and dinnertime. Relief of symptoms was significant in all patients after six and 12 weeks and not different in both treatment groups. Overall endoscopic healing was significantly better in the famotidine 40 mg twice a day group compared with 20 mg twice a day at week 6 (58% versus 43%;P<0.05) and at week 12 (76% versus 67%;P<0.05). Extending treatment to 24 weeks with 40 mg of famotidine twice a day in those patients not healed after 12 weeks did not result in further symptom relief or in significantly better overall healing. The differences in efficacy of these two doses were more pronounced with increasing severity of esophagitis. Analyzed by grade of esophagitis at entrance, healing was significantly better with famotidine 40 mg twice a day at week 6 for grade II, at week 12 for grades III and IV, and at week 24 for grade IV esophagitis. The results show that in the treatment of erosive/ ulcerative reflux patients famotidine 40 mg twice a day is more effective and achieves faster healing than famotidine 20 mg twice a day.for the Dutch Esophagitis Study Group.Participating physicians: P. Batenburg, J. Beker, J. Bellaar Spruijt, L. van Bergeijk, J. Bergmann, W. Bode, J. de Boer, H. Boot, G. Dorrepaal, J. Douma, J. Drapers, J. Ferwerda, H. Festen, A. Geraedts, J. Götz, E. van der Hoek, R. van Hogezand, J. Juttmann, M. Kloppenburg, F. Lalisang, W. Lesterhuis, D. van der Linde, G. van der Linden, J. van Maanen, J. Minkema, C. Mulder, I. van Munster, J. Nadorp, G. Nelis, J. Nicolai, R. Ouwendijk, D. Overbosch, A. van der Putten, J. Raats, F. Schuitemaker, J. Sindram, G. Slagboom, P. Snel, P. Stijnen, J. Thies, J. Thijs, H. Tuynman, B. Uyterlinde, J. ten Veen, K. te Velde, M. Vidakovic-Vukic, F. Vismans, A. Vogten, G. Vosmaer, P. de Vries, H. Walinga, S. van der Werf, I. Wesdorp, B. Westerveld, A. Wolff, R. Ypma.This study was supported by a grant from Merck Sharp & Dohme, The Netherlands.This study was presented in part at the annual meeting of the American Gastroenterology Association, May 1991 (Gastroenterology 100:63A, 1991).     

Busulphan given as four single daily doses of 150 mg/m2 is safe and effective in children of all ages

We examined the effects of busulphan (BU) dose and patient age on toxicity and outcome in 63 children with acute leukaemia given BUCY prior to allogeneic or autologous BMT. BU was administered as four single daily oral doses, based either on weight (4 x 4 mg/kg) or surface area (4 x 150 mg/m2). BU pharmacokinetic analysis was not used to dose adjust. The average daily (mg/kg) BU dose was 43% higher for the group given 150 mg/m2 compared to the 4 mg/kg dose group. This produced a median BU AUC 61% higher than with the 4 mg/kg dose. Only one child did not achieve full allogeneic donor engraftment. Regimen-related toxicity was low. Although younger children had faster BU clearance, the 4 x 150 mg/m2 dose ensured equivalent systemic exposure to BU, and resulted in a high frequency of engraftment without a significant increase in serious toxicity. BU, given as four single daily doses of 150 mg/m2, is appropriate and safe in all age groups of children. Given the reliable pharmacokinetics, low toxicity and high rate of allogeneic engraftment, there is no need for routine pharmacokinetic monitoring or dose modifications. This dosage regimen may be applicable for use with i.v. BU.     

认知行为疗法在治疗非糜烂性反流病合并疑病症患者的疗效观察

目的观察认知行为疗法在治疗非糜烂性反流病合并疑病症患者的临床疗效。方法将42例非糜烂性反流病合并疑病症患者随机分为治疗组21例和对照组21例,对照组采用雷贝拉唑10mg,po,bid、多潘立酮10mg,po,tid治疗(常规治疗),治疗组在对照组治疗的基础上,实施认知行为疗法治疗,两组疗程均为8周,比较两组治疗后症状缓解、RDQ问卷评分、症状自评量表(SCL-90)评分及明尼苏达多项人格测验(MMPI)改善情况。结果经治疗8周后,对照组中显效28.6%,总有效率47.6%;治疗组中显效61.9%,总有效率85.7%,两组总有效率差异有显著性(P<0.05);治疗前,治疗组与对照组在RDQ问卷评分、SCL-90评分及MMPI评分方面相比差异均无显著性(P>0.05),其中SCL-90评分有3个因子>2分,包括强迫、焦虑、抑郁因子,提示患者处于强迫、焦虑、抑郁状态,但从病情程度来看,未达强迫症、焦虑神经症、抑郁神经症诊断参照标准;经治疗8周后,治疗组与对照组在RDQ问卷评分、SCL-90评分及MMPI评分的T分,如疑病、抑郁、癔症、精神病态、偏执、精神衰弱方面相比差异有显著性,具有统计学意义(P<0.05)。结论认知行为疗法可以显著改善非糜烂性反流病合并疑病症患者的胃食管反流症状,同时明显改善患者疑病、焦虑、抑郁等心理障碍,明显提高患者生活质量,值得临床推广。     

雷贝拉唑联合莫沙必利对老年人难治性胃食管反流病的疗效

目的探讨雷贝拉唑联合莫沙必利治疗难治性胃食管反流病（GERD）的作用。方法采用随机对照的方法,将32例老年难治性GERD患者分为雷贝拉唑组＋莫沙必利（LM）组和莫沙必利组（M）组。LM给予雷贝拉唑（波利特,卫材）10mg口服,2次,d和莫沙必利（新络纳片,康宏）5mg口服,3次,d;M组给予莫沙必利（新络纳片,康宏）5mg,口服,3次,d,两组疗程均为14d。实验前后均行阻抗一pH监测了解反流物性质和反流次数。结果经治疗后,LM组总有效率高于M组（62．5％vs25．O％,P=O．033）,2组患者总反流次数均减少（P〈O．001）。LM组弱酸反流与治疗前比较减少,差异有高度统计学意义（P〈0．001）,非酸反流的次数减少（P=0．002）;M组患者的弱酸反流和非酸反流次数经治疗后减少,差异有高度统计学意义（P〈0．001）,但是酸反流的次数却增多,差异同样有高度统计学意义（P〈0．001）。LM组和M组患者的液体反流、液气混合反流的次数与治疗前比较减少（P=0．016,P=0．002;P=0．045,P=0．001）,气体反流减少（P〈0．001）。结论联合应用雷贝拉唑和莫沙必利能改善难治性GERD患者的症状,效果优于单用莫沙必利。反流总次数和气体反流次数的减少可能在难治性GERD患者的症状改善中起一定的作用。     

Characteristics of non-erosive gastroesophageal reflux disease refractory to proton pump inhibitor therapy

AIM:To investigate whether potent acid inhibition is effective in non-erosive reflux disease (NERD) refractory to standard rabeprazole (RPZ) treatment. METHODS:We treated 10 Japanese patients with NERD resistant to standard dosages of RPZ:10 mg or 20 mg od,20 mg bid,or 10 mg qid for 14 d. All patients completed a frequency scale for symptoms of gastroesophageal reflux disease questionnaire frequency scale for the symptoms of GERD (FSSG); and underwent 24 h pH monitoring on day 14. RESULTS:With increased dos...     

A comparison of enalapril 20 mg once daily versus 10 mg twice daily in terms of blood pressure lowering and patient compliance

OBJECTIVE: To compare enalapril 20 mg once daily with 10 mg twice daily in terms of blood pressure reduction and patient compliance. DESIGN: Cross-over study of patients randomly assigned to a sequence of enalapril 20 mg once daily or 10 mg twice daily in three 4-week periods following a 4-week placebo run-in. SETTING: General practices in the greater Belfast and Lisburn area in Northern Ireland. PATIENTS: Twenty-five hypertensive patients who had a mean diastolic blood pressure of between 90 and 110 mm Hg after receiving placebo for 4 weeks. MAIN OUTCOME MEASURES: Reduction in blood pressure and estimation of patient compliance. RESULTS: Patient compliance was superior on the once daily regimen. However, the twice daily regimen was associated with a greater blood pressure reduction which almost reached statistical significance at the 5% level. CONCLUSIONS: Enalapril 20 mg should be prescribed as 10 mg twice daily and measures taken to improve patient compliance.     

Psychometric evaluation of a daily gastro-oesophageal reflux disease symptom measure

Objective: The objective of this study was to evaluate the validity of the Heartburn Reflux Dyspepsia Questionnaire (HRDQ), a newly developed measure of gastro-oesophageal reflux disease (GORD) symptoms. Specifically, the HRDQ was developed for patients, who still experience symptoms with proton pump inhibitor (PPI) treatment.

Material and methods: The psychometric properties of HRDQ were evaluated based on data from two clinical trials of patients with GORD with a partial response to PPIs, one from the UK and one from Denmark and Germany.

Results: The HRDQ had good internal consistency (Cronbach’s alpha range .83–.88) and test–retest reliability (intraclass correlation coefficient range .71–.90). Convergent and discriminant validity were supported by high correlations with ReQuest? and ability to differentiate between groups based on ReQuest? cut-off values. Responsiveness of HRDQ was demonstrated by moderate to high correlations with ReQuest? change scores and time with symptoms. An HRDQ cut-off value of 0.70 for definition of ‘bad day’ was also evaluated.

Conclusions: Based on existing evidence, the HRDQ is a valid and reliable measure of GORD symptoms that can be used as a study outcome in clinical trials.     

Acid-suppressive effects of rabeprazole: Comparing 10 mg and 20 mg twice daily in Japanese Helicobacter pylori-negative and -positive CYP2C19 extensive metabolisers

BACKGROUND: Rabeprazole 10mg b.i.d. is often administered as therapy for eradication of Helicobacter pylori (H. pylori) and is also proposed as therapy for refractory gastro-oesophageal reflux disease. However, there has not been a comprehensive assessment of its acid-suppressive effects. AIMS: To compare the acid-suppressive effects of rabeprazole 10mg b.i.d. with 20mg b.i.d. considering H. pylori status. SUBJECTS: Thirteen H. pylori-negative and eleven H. pylori-positive Japanese CYP2C19 extensive metabolisers (<35 years). METHODS: Intragastric pH was measured for 24h three times in a randomised manner; on day 7 of the repeated administration of rabeprazole 10mg b.i.d. or 20mg b.i.d., or a placebo. RESULTS: In median intragastric pH value and percent time of pH>3.0, >4.0, >5.0, >6.0, and >7.0 for 24h, no significant differences were observed between the two doses in either H. pylori-negative or H. pylori-positive subjects. At either dose, these parameters were significantly higher in H. pylori-positive subjects than in H. pylori-negative subjects. Nocturnal acid breakthrough occurred in seven and two of the thirteen H. pylori-negative subjects and one and two of the eleven H. pylori-positive subjects at each dose, respectively. CONCLUSIONS: The effects of rabeprazole 10mg b.i.d. were equal to those of 20mg b.i.d. in H. pylori-positive subjects; whereas in H. pylori-negative subjects, 20mg b.i.d. was superior for prevention of nocturnal acid breakthrough.     

Rabeprazole is effective for bile reflux oesophagitis after total gastrectomy in a rat model

AIM:To elucidate the effect of a proton pump inhibitor(PPI,rabeparazole)on oesophageal bile reflux in oesophagitis after total gastrectomy.METHODS:Twenty-one 8-week-old male Wistar rats were studied.They were performed oesophagoduodenostomy of total gastrectomy to induce oesophageal reflux of biliary and pancreatic juice.Five rats were performed the sham operation(Sham).On post-operative day 7,they were treated with saline(Control)(n=8)or PPI(rabeprazole,30 mg/kg per day,ip)(n=8)for 2 wk.On post-operative 21,all rats were sacrificed and each oesophagus was evaluated histologically.Oesophageal injury was evaluated by macroscopic and microscopic findings as well as the expression of cyclooxygenase-2(COX2).We measured bile acid in the oesophageal lumen and the common bile duct.RESULTS:At 3 wk after surgery,a histological study analysis revealed an increase in the thickness of the epithelium,elongation of the lamina propria and basal cell hyperplasia in the oesophageal mucosa.The macroscopic ulcer score and microscopic ulcer length of the control group were significantly higher compared to those of the rabeprazole-treated group.The expression of COX2 was significantly increased according to the immunostaining in the control group compared to rabeprazole-treated group.Although there was no difference between the control and PPI groups in the total bile acid in the common bile duct,the bileacid activity in the oesophageal lumen was significantly decreased in the rabeprazole-treated group due to augmentation of the duodenal motor complex.CONCLUSION:With this model,rabeprazole is good effect for reflux esophagitis after total gastrectomy from bile reflux.Bile acid is an important factor in the mucosal lesion induced by duodenal reflux.     

Elcatonin is effective for lower back pain and the symptoms of gastroesophageal reflux disease in elderly osteoporotic patients with kyphosis

Aim: Elderly osteoporotic patients with kyphosis tend to be frequently accompanied by the symptoms of gastroesophageal reflux disease (GERD) such as heartburn and acid reflux. Elcatonin, which is effective for lower back pain of osteoporosis, has a physiological action of reducing gastric acid. We examine whether or not this drug would alleviate GERD symptoms as well as lower back pain in patients with osteoporosis. Methods: Elcatonin was administrated at a dose of 20 units once weekly for 3 months. The visual analog scale (VAS) and the frequency scale for the symptoms of GERD (FSSG) were used to evaluate lower back pain and GERD symptoms, respectively. Results: Both VAS and FSSG scores significantly decreased after 1, 2 and 3 months of elcatonin administration (at least P < 0.001). Even after the cessation of elcatonin, both scores remained significantly low for an extra 1 and 3 months, respectively. These beneficial effects were also observed in non‐steroidal anti‐inflammatory drug (NSAID) or GERD drug users. Conclusion: The present findings suggest that elcatonin could improve the symptoms of GERD as well as osteoporosis‐invoked back pain in elderly patients with kyphosis, and that these effects are long‐lasting and independent of NSAID or GERD drugs. Geriatr Gerontol Int 2011; 11: 215–220.     

Effect of esomeprazole 40 mg vs omeprazole 40 mg on 24-hour intragastric pH in patients with symptoms of gastroesophageal reflux disease

Maintenance of intragastric pH > 4 is vital for effective management of gastroesophageal reflux disease (GERD). Esomeprazole 40 mg, the first proton pump inhibitor developed as an optical isomer, demonstrates improved acid inhibition over omeprazole 20 mg. Our aim was to compare esomeprazole 40 mg with omeprazole 40 mg, once-daily, on intragastric acidity in patients with symptoms of GERD. In this open-label, crossover study, 130 patients with symptoms of GERD received esomeprazole 40 mg or omeprazole 40 mg once-daily for five days. The 24-hr intragastric pH was monitored on days 1 and 5 of each treatment period. The mean percentage of the 24-hr period with intragastric pH > 4 was significantly greater (P < 0.001) with esomeprazole 40 mg than with omeprazole 40 mg on days 1 (48.6% vs 40.6%) and 5 (68.4% vs 62.0%). Interpatient variability was significantly less with esomeprazole than omeprazole. Esomeprazole was well tolerated. In conclusion, esomeprazole 40 mg provides more effective acid control than twice the standard dose of omeprazole.     

Pantoprazole 20 mg on demand is effective in the long-term management of patients with mild gastro-oesophageal reflux disease

A total of 536 patients with endoscopically confirmed GORD grade 0/I were included in this multicentre study. In the acute phase, patients were treated with pantoprazole 20 mg o.d. for 4 weeks to obtain symptom relief. Symptom-free patients were included in the subsequent long-term phase, and were randomly treated on demand with either pantoprazole 20 mg or placebo for 6 months (antacids as rescue medication). After the 4 weeks acute phase, 439 symptom-free patients entered the long-term phase. The perceived average daily symptom load remained significantly lower during the 6-month on-demand treatment with pantoprazole 20 mg as compared to placebo. Both the rates for unwillingness to continue and number of additional antacids taken were also significantly lower with pantoprazole 20 mg than with placebo. Hence, on-demand treatment with pantoprazole 20 mg is safe and effective in maintaining control of the symptoms heartburn, acid regurgitation and pain on swallowing symptoms in patients with GORD grade 0/I with superiority to placebo.