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Objective:To evaluate the efficacy and safety of omeprazole and sodium bicarbonate suspension in the treatment of peptic ulcer.Methods:This present study was a multicenter, randomized, double-blind, double-dummy, positive drug parallel controlled phase Ⅱ clinical trial. According to different indications, the trial was divided into gastric ulcer (GU) and duodenal ulcer (DU) studies. Patients were stratified-block randomly divided with a 1∶1 ratio into experimental group and control group. The patients in the experimental group were administrated with omeprazole and sodium bicarbonate suspension omeprazole (20 mg for DU or 40 mg for GU, and 1 680 mg sodium bicarbonate) once a day. The patients in the control group received omeprazole magnesium enteric-coated tablet20 mg for DU or 40 mg for GU once a day. The treatment period was 4 weeks for DU and 8 weeks for GU. The main efficacy indicator was ulcer healing rate under endoscopy. The time of pain disappearance and the total effective rate of clinical symptom relief were used as the secondary efficacy indicators, and the incidence of adverse reactions was used as the safety indicator. The data set included full analysis set (FAS), per-protocol set (PPS) and safety set (SS). Independent sample t test, Wilcoxon rank sum test, chi square test, Fisher exact test method and non-inferiority test were used for statistical analysis. Results:Two hundred and seventy two DU patients and 237 GU patients were included in the FAS, 247 DU patients and 201 GU patients were included in the PPS, and 272 DU patients and 235 GU patients were included in the SS. The results of FAS analysis showed that after 4 weeks treatment, the healing rate of DU under endoscopy in the experimental group was 91.91% (125/136) and that in the control group was 94.85% (129/136), and the difference was not statistically significant ( P>0.05). After 8 weeks treatment the healing rate of GU under endoscopy in the experimental group was 86.44% (102/118) and that in the control group was 87.39% (104/119), and the difference was not statistically significant ( P>0.05). The results of non-inferiority analysis showed the lower limit of 95% confidence interval of difference in effective rate between the two groups was over -10% (-8.84% for DU and -9.54% for GU), which indicated that the effective rate of experimental group was not inferior to that of the control group. The results of PPS analysis were consistent with the results of FAS. The results of FAS analysis showed the median time of abdominal pain disappearance of DU patients in the experimental group and the control group was both 6 d, and the difference was not statistically significant ( P>0.05). The median time of abdominal pain disappearance of GU patients in the experimental group and the control group was both 8 d, and the difference was not statistically significant ( P>0.05). After 4 weeks of treatment, the total effective rates of clinical symptom relief of DU of the trial group and the control group were 95.59% (130/136) and 97.79% (133/136), respectively, and the difference was not statistically significant ( P>0.05). After 8 weeks of treatment, the total effective rates of clinical symptom relief of GU of the experimental group and the control group were 95.76% (113/118) and 93.28% (111/119), respectively, and the difference was not statistically significant ( P>0.05). The results of SS analysis showed that the incidence of adverse reactions of DU patients in the trial group and the control group was 5.15% (7/136) and 2.21% (3/136), respectively, and the difference was not statistically significant ( P>0.05). The incidence of adverse reactions of GU patients in the experimental group and the control group was 12.71% (15/118) and 6.84% (8/117), respectively, and the difference was not statistically significant ( P>0.05). Conclusions:Omeprazole and sodium bicarbonate suspension is not inferior to omeprazole magnesium enteric-coated tablet in healing efficacy under endoscopy in peptic ulcer, and has a good safety.
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Objective To evaluate the efficacy and safety of Houpu Paiqi mixture in treatment of functional dyspepsia (FD)with abdominal distension symptom.Methods From July 2014 to June 2015 , in nine centers,a total of 162 FD patients with abdominal distension symptom and met Rome Ⅲpostprandial distress syndrome (PDS)diagnostic criteria were enrolled.All patients were randomly divided into trial group and control group,81 patients in either group.The patients of trial group and control group took Houpu Paiqi mixture or placebo,respectively,25 mL per time,twice daily,and both the courses of treatment were two weeks.Before and after the treatment,the improvement of main symptoms,total clinical efficacy rate and efficacy of traditional medicine between two groups were compared.Chi square test,Fisher exact probability method and Wilcoxon test were performed for statistical analysis.Results According to the results of per-protocol (PP)analysis,the total efficacy rate of trial group and control group was 69.4% (50/72)and 59.2% (42/71),respectively,and there was no statistically significant difference in total efficacy rate between the two groups (χ2 =1 .650,P =0.199 ). And there was no statistically significant difference in the improvement of PDS main symptoms(postprandial fullnessand early satiety)between the two groups (56.3% ±27.9% vs 54.4% ±32.1%,t =0.606,P =0.727 ).For those with baseline symptom score over 14,median early satiety score of trial group after the treatment was 0,which was lower than that of control group,and the difference was statistically significant (Z =-2.370,P =0.018).The total efficacy rate of traditional medicine of trial group was 80.8% (59/73 )and that of control group was 72.0% (54/75 ),and the difference was not statistically significant (χ2 = 0.676,P =0.411 ).Conclusion Houpu Paiqi mixture has certain efficacy in FD with abdominal distension,and could be used for the treatment of PDS-predominant FD.
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<p><b>BACKGROUND</b>The role of gastro-protecting agents on symptomatic chronic gastritis is unclear. This multicenter, open, randomized trial was designed to compare the comprehensive effects of gefarnate with sucralfate on erosive gastritis with dyspeptic symptoms.</p><p><b>METHODS</b>Totally 253 dyspepsia patients confirmed with erosive gastritis were enrolled from six centers in China. They randomly received either daily 300 mg gefarnate or 3 g sucralfate for six weeks. The primary endpoint was the effective rate of both treatments on endoscopic erosion at week six.</p><p><b>RESULTS</b>Gefarnate showed an effective rate of 72% and 67% on endoscopic score and dyspeptic symptom release, which is statistically higher than sucralfate (40.1% and 39.3%, P < 0.001, intension-to-treat). For histological improvement, gefarnate showed both effective in decreasing mucosal chronic inflammation (57.7% vs. 24.8%, P < 0.001, intension-to-treat) and active inflammation (36.4% vs. 23.1%, P < 0.05, intension-to-treat) than the control. A significant increase of prostaglandins and decrease of myeloperoxidase in mucosa were observed in gefarnate group. Severity of erosion is non-relevant to symptoms but Helicobacter pylori (H. pylori) status does affect the outcome of therapy.</p><p><b>CONCLUSIONS</b>Gefarnate demonstrates an effective outcome on the mucosal inflammation in patients with chronic erosive gastritis. Endoscopic and inflammation score should be the major indexes used in gastritis-related trials.</p>
Subject(s)
Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Anti-Ulcer Agents , Therapeutic Uses , Dyspepsia , Drug Therapy , Gastritis , Drug Therapy , Gefarnate , Therapeutic Uses , Sucralfate , Therapeutic Uses , Treatment OutcomeABSTRACT
Objective To explore the efficacy and safety of endoscopic balloon dilatation of small bowel stricture in Crohn′s disease with single balloon enteroscopy (SBE).Methods Seven Crohn′s disease patients (four males and three females with a mean age of 37 years) were underwent 10 times dilatation.Before performance,Crohn′s disease with varying degrees of intestinal obstruction was confirmed by image and pathological examinations.There were 8 severe strictures,6 strictures in jejunum.The dilatation was performed step by step with controlled radial expansiondilator (CRE) balloon.After dilatation,the scope could reach the further small bowel was taken as a standard.Results The overall suecess rate was 8 of 10.The average diameter of intestinal stricture was expanded from (4.1 ± 2.5) mm before therapy to (10.2 ±1.5) mm (P＜0.01),and the average distance of the further small bowel that the scope reached was 62 cm.Two patients underwent twice and three times of dilatation.After the performance,all patients′ symptoms of abdominal pain and obstruction relieved obviously and there were no severe complication of bleeding or perforation.After the performance,the average follow-up time was 14 months,two patients were treated by surgery and the other two underwent dilatation treatment again because of the recurrence of symptoms.The median symptom-free time was 15 months and 70％ of patients were without symptom recurrence in one year.Conclusion Endoscopic balloon dilatation of small bowel stricture with SBE is a new technology of endoscopic treatment,which is safe and effective in the treatment of Crohn's diseasecomplicated with intestinal obstruction.
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Objective To investigate the effect of compound azintamide enteric-coated tablet on abdominal fullness in patients with functional dyspepsia, chronic cholecystitis with gallbladder stones, or liver cirrhosis. Methods Twenty patients with functional dyspepsia, 20 with chronic cholecystitis and gallbladder stones, and 20 with liver cirrhosis were enrolled in the study. Compound azintamide enteric-coated tablets were given 2 tablets 3 times daily for 4 weeks. The changes of symptom scores of abdominal fullness were investigated after the treatment. Water loading tests were carried out in patients with functional dyspepsia and chronic cholecystitis with gallbladder stones before and after the medication. Results Compound azintamide enteric-coated tablets greatly improved the symptom of abdominal fullness in each group of patients. Symptom scores were significantly decreased in 2 and 4 weeks (P