Objective To evaluate the efficacy and safety of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding.Methods It was designed as a multi-center,stratified randomized,double-blind,positive drug parallel controlled and non-inferiority study.From October 2014 to April 2015,at 40 hospitals,patients with peptic ulcer hemorrhage confirmed by gastroendoscopy were enrolled and divided into the ilaprazde sodium group (10 mg ilaprazole sodium for injection every 24 h,the first dose doubled) and the positive control group (40 mg of omeprazole sodium for injection every 12 h).The course of both treatment was 72 h.The hemostasis rate of overall group at 72 h,the clinical rebleeding rate at four to seven days,the blood transfusion rate,the incidence of switching to other treatments and the incidence of adverse reactions were compared between the two groups.A chi-square test or Fisher's exact probability method were performed for statistical analysis.Results A total of 533 patients with peptic ulcer bleeding were enrolled,355 patients in the ilaprazole sodium group and 178 patients in the positive control group.The hemostasis rates of ilaprazole sodium group and positive control group at 72 h were 97.69 ％ (339/347) and 97.14 ％ (170/175),respectively,and the difference was not statistically significant (P＞0.05).There were no rebleeding patients in both groups at four to seven days.The blood transfusion rates of ilaprazole sodium group and positive control group were 5.07 ％ (18/355) and 3.37 ％ (6/178).The incidence of switching to other treatments was 0.56％ (2/355) and 0.56％ (1/178),respectively,and the differences were not statistically significant (both P＞ 0.05).The incidence of adverse reactions in the ilaprazole sodium group was 3.94％ (14/355),which was lower than that of positive control group (8.43％,15/178).And the difference was statistically significant (Fisher's exact probability method,P=0.042).Conclusions The efficacy of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding is similar to that of omeprazole sodium for injection.Moreover,the smaller the dose,the lower the frequency of administration and the better the safety.

BACKGROUNDHelicobacter pylori (Hp) is a common and potentially curable cause of gastric mucosa lesion. This study investigated the relationship of Hp infection with histological changes in gastric mucosa and gastric cancer in Hp-positive patients compared with Hp-eradication patients followed up for ten years.

METHODSFrom an initial group of 1 006 adults, 552 Hp-positive subjects were randomly assigned to a treatment group (T; n = 276) or a placebo group (P; n = 276). In the randomized, double-blind, placebo-controlled, parallel trial, T group subjects received oral doses of omeprazole, amoxicillin and clarithromycin for 1 week; those in the P group received a placebo. One month after treatment ended, a 13C urea breath test was performed, and Hp was undetectable in 88.89% of the T group. All subjects were followed at 1, 5, 8, and 10 years after treatment, with endoscopy and biopsies for histological examination.

RESULTSGastric mucosa inflammation was significantly milder in the T group than that in the P group one year after Hp eradication and this persisted for 10 years. Glandular atrophy and intestinal metaplasia (IM) had deteriorated in both groups during ten years. However, the increased score of glandular atrophy at both the gastric antrum and corpus, and IM only at the gastric antrum, in the P group was more obvious than that in the T group. During the 10 years, 9 patients were diagnosed with gastric cancer (2 in the T group; 7 in the P group; P = 0.176). When mucosal atrophy was absent at the gastric antrum and corpus when entering the study, the incidence of gastric cancer in the P group (n = 6) was much higher than that in the T group (n = 0, P = 0.013).

CONCLUSIONSHp eradication may significantly diminish and help halt progression of gastric mucosal inflammation and delay the development of IM and atrophy gastritis. Hp eradication is helpful for reducing the risk for gastric cancer, especially in the early stage of Hp infection.

Adult ; Aged ; Amoxicillin ; therapeutic use ; Anti-Bacterial Agents ; therapeutic use ; Clarithromycin ; therapeutic use ; Double-Blind Method ; Female ; Follow-Up Studies ; Gastric Mucosa ; drug effects ; pathology ; Gastritis, Atrophic ; diagnosis ; drug therapy ; Helicobacter Infections ; drug therapy ; Helicobacter pylori ; pathogenicity ; Humans ; Male ; Middle Aged ; Omeprazole ; therapeutic use ; Stomach Neoplasms ; diagnosis ; prevention & control

Objective To explore the clinical significance of typical reflux symptoms in the diagnosis of gastroesophageal reflux disease (GERD).Methods Consecutive patients older than 16 years,who initially visited department of gastroenterology at clinic of Peking University Third Hospital from May 9,2012 to Dec 31,2012,were required to complete a self-reported GERD questionnaire.Upper endoscopy was performed in some selected patients.Results A total of 18 987 patients were enrolled with a response rate of 91.5％.The prevalence of symptom-defined GERD was 13.6％ (2 579/18 987).A total of 4 357 (22.9％) patients underwent the upper endoscopy,and the diagnostic rates of reflux esophagitis,Barrett's esophagus,peptic ulcer disease,and upper gastrointestinal malignancy were 13.1％ (572/4 357),1.8％ (78/4 357),10.5％ (456/4 357),and 1.7％ (75/4 357),respectively.The incidence of reflux esophagitis was 22.7％ (216/951) in patients with reflux symptoms and 10.5％ (356/3 406) (P ＜0.001) in patients without reflux symptoms,2.7％ (26/951) and 1.5 ％ (52/3 406),respectively (P =0.013) for Barrett's esophagus; 6.8％ (65/951) and 11.5％ (391/3 406),respectively (P＜0.001) for peptic ulcer disease; 1.7％ (16/951) and 1.7％ (59/3 406),respectively (P =0.917) for upper gastrointestinal malignancy.Conclusions GERD is one of the major diseases at gastroenterology clinic.Typical reflux symptoms suggest a diagnosis of GERD.But some patients with peptic ulcer disease or upper gastrointestinal malignancy can also present typical reflux symptoms.Upper endoscopy is valuable to avoid the misdiagnosis of other disorders.

Objective By analysing the clinical features of Indigo Naturalis-associated ischemic lesion of colon mucosa to improve the precautionary and therapeutic level of the disease.Methods Thirteen patients diagnosed as Indigo Naturalis-associated ischemic lesion of colon mucosa in Peking University Third Hospital from 2005 to 2010 were reviewed.The endoscopic and clinical features were analysed.Results The 13 patients with an average age of(60.6±14.1)years old were prescribed Chinese traditional medicine containing Indigo Naturalis for psoriasis or idiopathic thrombocytopenic purpura(ITP).The ratio of males to females was 1:1.6.The typical manifestations were abdominal pain and bloody stool with watering diarrhea before bloody stool in 61.5%patients.Endoscopic and pathological characteristics were coincident with ischemic lesion and more like a chronic index.Vasodilatic medicine was effective and the average hemostatic time was(1.7±0.8)days.The prognosis was well and no recurrence was found during 3 months follow-up.Conclusions Patients having psoriasis or ITP treated with Chinese traditional medicine containing Indigo Naturalis have an inclination to colon mucosa lesions, even ischemic lesion. Careful assessment and observation before prescribing arc necessary in these patients.

Objective To evaluate the influence of Helicobacter pylori (Hp) eradication on clinical manifestations, endoscopic features and pathological findings of chronic gastritis. Methods This was a multiple-center, prospective and randomized cohort study. Patients with non-atrophy chronic gastritis from January 2009 to December 2010 were randomized into 3 groups as Hp positive group with eradication, Hp positive group without eradication and Hp negative group. Clinical manifestations, endoscopic findings and pathologic changes of inflammation were compared before and after administration of gastric mucosal protective agent for 8 weeks. Results A total of 211 patients were recruited. Changes of symptom score, endoscopic erosion and mucosal inflammation were significantly different before and after treatment in 3 groups. The decrease in symptom scores of eradication group was ( 3.56 ± 1.37 ), which was significantly higher than that of non-eradication group (2. 80 ± 1.30, P ＜0. 01 ). The decrease of mucosal inflammation and inflammatory activity scores in eradicate group was 1.08 ± 1.34 and 1.42 ± 1.09, respectively, which were also significantly higher than those of the eradication group (0. 49 ± 1.47 and 0. 61 ± 1.34, P ＜0. 01 ). But the improvement of endoscopic erosion in 2 groups showed no significant difference. There were no significant differences in these variables between non-eradication group and Hp-negative group ( P ＞ 0. 05 ). Conclusion For chronic non-atrophic gastritis patients with positive Hp infection, combination of mucosal protective agents and Hp eradication can achieve better improvement in symptoms and gastric inflammation repair.

ObjectiveTo investigate the endoscopic and clinical characteristics of gastrointestinal Behcet's disease (BD). MethodsWe analyzed the clinical and follow-up data of 27 patients with gastrointestinal BD retrospectively.Results Most common locations involved were esophagus and ileocecum,74. 1％ (20/27) and 59. 3％ (16/27), respectively. The most common parenteral symptoms were oral ulcers (85.2％), genital ulcers (25.9％), ophthalmitis (7. 4％ ) and skin damage (7. 4％ ). The most common gastrointestinal symptom was chest pain (48. 1％, 13/27). Ulcer was the basic endoscopic feature,most of which were with uneven bottom and peripheral inflammatory response. There was no difference in endoscopic features between typical BD and atypical BD. Pathology showed typical small vasculitis (44. 4％,12/27). ConclusionClinical manifestations of intestinal BD vary. Symptoms are not necessarily consistent with the involved locations. A small number of patients with BD present with gastrointestinal symptoms as the first and only symptom, with serious complications in some patients. Physicians need to be fully aware of the disease.

Objective To evaluate the clinical significance of intercellular space diameters (ISD)of squamous epithelium by light microscopy (LM) in lower esophagus of erosive reflux esophagitis (ERD),non-erosive reflux disease ( NERD), Barrett esophagus (BE) and healthy controls. Methods A total of 21 ERD and 21 NERD patients with reflux symptoms and confirmed with 24-hour esophageal pH monitoring, 13 BE patients diagnosed by gastroscopy and biopsy, and 20 other healthy controls were enrolled in the study.Samples of ERD, NERD and control group were collected at 2 cm above dentate line, and made HE slides in the conventional way. Images for measurement of ICS were acquired with oil lens ( × 1000). ICS of squamous epithelium was quantitatively measured by computer-assisted morphometry. Ten cells were taken for each sample, 10 consecutive ISD for each cell, i.e. 100 ISD for each subject. Mean ISD was calculated.Results Mean ISDs by LM in control, BE, ERD, and NERD groups were 0. 59, 0. 99, 1.29 and 1.06 μm, respectively. The mean ISDs in BE, ERD, and NERD group were much greater than that in control (P＜0. 05). The mean, maximal and minimal ISDs of group ERD were greater than those of NERD and BE (P = 0. 000). However, the ISDs of NERD and BE are of no significant difference ( P ＞ 0. 05 ). The cut-off value of mean ISD for diagnosis of gastro-esophageal reflux disease (GERD) was 0. 85 μm. Diagnostic sensitivity and specificity for ERD, NERD and BE were 89. 1% and 100. 0%, with reference to clinical symptoms, endoscopy and ISDs above the cut-off value. Conclusion Larger ISDs in lower esophagus by using LM will be found in all subgroups of GERD, including ERD, NERD and BE. Increased ISDs may be one of the markers for diagnosis of ERD, NERD and BE.

Objective Collagenous gastritis is a rare entity, characterized by the deposition of a subepithelial collagen band with an inflammatory infiltrate in the mucosa.This report describes the first case of collagenous gastritis occurring in a young Chinese woman and reviews the literatures.Methods The patient underwent the gastroscopy screening, and the biopsy specimens were treated with HE staining, Masson staining, Congo red staining and Warthin-Starry staining.Patients' clinical data was discussed and followed up.Results A twenty-year-old girl had intermittent epigastric pain for 4 years, abdominal distention, hiccup and weight loss for two months.The gastric endoscopy revealed diffuse white nodular appearance of the mucosa in angular incisure and antrum.Pathologic examination of the gastric biopsies from the antrum and angular showed a subepithelial collagen deposition with moderate infiltrates of lymphoplasma cells and eosinophils of the lamina propria.The collagen band measured up to 120.3 μm (mean 43.8 μm).Prednisone 20 mg/d for 4 weeks led to clinical remission and weight gain.Conclusion There are about 40 cases in literatures to date, and the cause and pathogenesis of collagenous gastritis remain unknown.According to the clinical and pathological characteristics, the patient in this article is the subtype of collagenous gastritis that occurring in children and young adults.Specific therapy has not been established, the gluten-free diet and glucocorticosteroid may be helpful to relieve symptoms in collagenous gastritis patients.

Objective To investigate the potential mechanism for symptoms related to epigastric discomfort in patients without Helicobacter pylori (H.pylori) infection.Methods Patients who underwent gastric endoscopy and conformed H.pylori negative by histologic examination were enrolled.Among them,232 adult patients were collected between August 2006 and November 2006 and 31 children were collected between September 2005 and August 2009.All patients showed no apparent abnormality by endoscopic examination.The endoscopic biopsy was examined with HE or Warthin-Starry staining.Results In adult group,arteriole obstruction was found in 16 (8.8%) cases and focal haemorrhage in 82 (45.6%) cases.Both were existed in 82 (45.6%) cases.The histopathologic findings showed that arteriole obstruction in transition zone (65.2 %,P = 0.159) was common,whereas the focal haemorrhage in gastric fundus and corpus (65.6%,P=0.001) was in predominance.The symptom of heartburn was less in patients with arteriole obstruction and/or focal haemorrhage in comparison with those without these changes (x2 =8.564,P=0.003).In adolescent group,arteriole obstruction and/or focal haemorrhage accounted for 96.8% (30/31).Conclusion Gastric mucosa ischemic resulted from arteriole obstruction are commonly seen in both adult and adolescent patients,which is an important reason for epigastric discomfort in H.pylori negative patients.

Objective To evaluate the effect of ilaprazole enteric tablets on intragastric pH in duodenal ulcer patients. Methods A randomized, double blind, positive controlled clinical trial was carried out. A total of forty-two patients with duodenal ulcer were randomized into low dose ilaprazole group (5 mg/d), medium dose ilaprazole group (10 mg/d), high dose ilaprazole group(20 mg/d) and omeprazole group(20 mg/d). An ambulatory 24 hour intragastric pH study was performed at the fifth treatment day. Fraction time pH above 3, 4 or 5, median values of 24 hour diurnal pH and 12 hour nocturnal pH, the percentage of patients with total time pH above 3, 4 or 5 at least for 18 hours were evaluated. Results There were no significant differences of fraction time pH above 3 or 4, median values of 24 hour diurnal pH and 12 hour nocturnal pH and the percentage of patients with total time pH above 3, 4 or 5 at least for 18 hours among all the groups with different doses of ilaprazole and the omeprazole group. The fraction time pH above 5 in medium and high dose ilaprazole groups were (87.96 ± 12. 29)% and (89.86±15. 18)% respectively, which was higher than that in low dose ilaprazole group [(67. 17± 30. 16)%] and omeprazole group[(76. 14 ± 16. 75)%], P <0. 05. Conclusion Ilaprazole has a strong effect on intragastric acid control with a dose dependent trend.