ObjectiveTo investigate the efficacy and safety of a branched-chain oral amino acids granules (BCAA-G) on the cirrhotic hypoproteinemia. Methods172 patients with cirrhotic hypoproteinemia from 6 hospitals in Shanghai area were studied. BCAA-G and control drug (amino acids capsule) were used respectively for 9 weeks. Symptoms、plasma protein、albumin and Fisher score were evaluated at 4 and 9 weeks to assess the efficacy and safety of BACC-G. ResultsAfter 4 and 9 weeks' therapy, symptoms of two groups improved (P＜ 0.05). Compared with the control group, fatigue was significantly improved (P = 0.03) in BCAA-G group. Plasma protein and albumin increased in BCAA-G group (P = 0.0001). The Fisher score in BCAA-G group improved after 4 weeks ( P = 0. 0005 ) and 9 weeks ( P = 0. 0001 ), while no marked change was found in the control group. The side effect rate was 7.50 % in the BCAA-G group and 3.85 % in the control group, respectively. ConclusionBCAA-G is effective and safe in the treatment of cirrhotic hypoproteinemia.

ObjectiveThrough the examination of Clostridium difficile (Cd) in the stool of inflammatory bowel disease (IBD) patients to investigate its infection status in IBD patients and the relationship with IBD.MethodsFrom December 2009 to January 2011,a total of 130 diagnosed IBD patients were collected in the Department of Gastroenterology,Ruijin Hospital,Shanghai Jiaotong University School of medicine,including 60 ulcerative colitis (UC) patients and 70 Crohn's disease (CD) patients.At same time.60 irritable bowel syndrome patients and 60 healthy volunteers were collected as control.Stool samples were tested by PCR and Cd toxin A/B test kit (CDTK).SPSS statistical software was used for statistical analysis.ResultsIn 130 enrolled IBD patients,16 cases (12.3％) were Cd infected,of which 10 were UC cases (16.7％) and 6 were CD cases (8.6％).No Cd infection was found positive in control group (x2 =15.779,P=0.000).The infection rate of Cd in the patients of active stage was higher than that in the patients of inactive stage (x2 =10.092,P=0.001).The infection rate of coion-type CD patients was 4/14,which was significantly higher than those of other types CD patients (x2 =13.125,P=0.001).The infection rate of Cd was 4.5％ in mild UC patients,14.3％ in moderate and 6/17 in severe (x2 =6.667,P=0.037) ; the infection rate were 0％ in mild CD patients,4.2％ in moderate and 5/16 in severe.The infection rate increased along with the increase of The disease severity (x2 =13.907,P=0.000).There was no significant difference in the infection rate of Cd between broad-spectrum antibiotics used and not used patients (x2 =1.414,P =0.378), or between patients with broad-spectrum antibioticsused aloneand combinedwith immunosuppressant (x2 =0.330,P=0.962).ConclusionsThere was certain infection rate of Cd in IBD patients,especially the patients in active stage. The infection rate increased along with the increase of the IBD severity.

Objective To investigate the clinical characteristics between elderly and non-elderly patients with ulcerative colitis (UC) in Shanghai, so as to improve the diagnosis and management of the disease. Methods The clinical and endoscopic data from 214 patients with UC,who were admitted to Shanghai Ruijin Hospital between 1998 and 2009,were retrospectively analyzed. The database was established and according to onset age,the patients were divided into elderly group (n= 28, ≥60 years of age) and non-elderly group (n = 128, ＜60 years of age), The comparisons between two groups were performed using Chi square test for non-quantitative variables, and student's t test and nonparametric tests for quantitative variables. Logistic regression was used to analyze the risk factor.Results Onset peak of UC was found in patients ranged from 40 to 49 years of age, and elderly patients were accounted for 13.08 % in Shanghai. There was no significant difference between two groups with respect to clinical manifestation, complications, Truelove and Witts criteria index, or endoscopic score. In active phase, elevated peripheral platelet counts were seen in more elderly patients than those in non-elderly patients (75% vs 29%, F= 4. 4, P= 0. 043). However, high level of peripheral platelet was found in non-elderly patients (Z= -2.6, P=0. 008). Endoscopic examination revealed that the colonic lesion in elderly patients was limited and was more common in left-sided colon and protosigmoid (F=5. 8, P = 0. 012). More non-elderly patients were treated with steroid in comparison to elderly patients with mild or severe UC (28. 6% vs 55.7%, F=7.7,P=0. 007). In addition, the high mortality was found in elderly patients when compared with non-elderly patients (20.8 % vs 2.84%, F= 12. 8, P = 0. 008). Conclusion The differences existed between elderly and non-elderly UC patients with respect to clinical manifestation, lab investigation, involved extent of colon, medication and prognosis.

Objective To investigate the putative relationship between peroxisome proliferators activated receptor gamma (PPARγ) and nuclear factor (NF)-κB in cerulein-treated pancreatic aeinar AR42J cells. Methods The AR42J cells were allocated to control group, pioglitazone group (treated with 40 μmol/L of pioglitazone), pioglitazone + cerulein group (treated with 40 μmol/L of pioglitazone+ 10~(-8) mol/L of cerulein) and pioglitazone + cerulein + PPARγ antagonist (GW9662) group (treated with 40 μmol/L of pioglitazone + 5 μmol/L of GW9662 + 10~(-8) mol/L of cerulein). Activity of NF-κB and PPARγ expression were detected 30 minuts after stimulated by cerulein with or without the presence of pioglitazone. The protein expressions of NF-κB and PPARγ, antibody to IκBα phosphorylation, the differential expression between IκB kinase (IKK)β and IκBa, the IKKβ activity as well as changes of pIκBa were examined by Western blotting. The nuclear accumulation of NF-κB (p65 and p50 subunits) was determined by immunofluorescence and Western blotting. The interaction between NF-κB p65 and IκBα was observed by immunopreeitation. Results Treatment of AR42J cells with pioglitazone attenuated cerulein induced cytosolic activity of IKK protein (1.6 : 3.7)or IκBa phosphorylation (0.9 : 1.5), strengthened the integration of IκBα and NF-κB (0.8:0.3), inhibited transcription activity of p50 and p65 NF-κB dimer and nuclear accumulation (P<0.01). Adversely, the inhibitory effect of pioglitazone on NF-κB activity induced by cerulein was almost reversed by GW9662 (P<0.05). Conclusion These findings provide evidence for the involvement of PPARγ in the activity of NF-κB in cerulein treated AR42J cells.

Objective To assess the characteristics of biochcmical parameters of bone metabolism in patients with inflammatory bowel disease (IBD) and the relationship between osteoporosis and the reduction of bone mass so as to identify the risk factors for osteoporosis in IBD. Methods Sixty-nine patients with IBD[49 with Crohn disease (CD) and 20 with ulcerative colitis (UC)] and 20 sex- and age-matched healthy subjects (control group) from the medical examination centre in 2007 were enrolled in the study. The disease activity was estimated according to CD active index and Truelove-Witts score. The biochemical markers of bone metabolism including ostecalcin (OC), 25-bydroxycholecalciferol[-25 (OH)Ds-] and cross-linked N-telopeptides of type I collagen(NTX) were tested using enzyme immunoassay. The body mass index (BMI) and bone mineral density (BMD) were also measured. Results The concentration of 25(OH)D3 was significantly lower in both CD[(44.45±39.38) nmol/L] and UC patients[(34.67±23.79) nmol/L] compared with controls[(98.42±25.84) nmol/L] (P <0.05), while NTX level was significantly higher in both CD [(58.41±15.15) nmol BCE/mmol Cr] and UC[(57. 67±10. 75) nmol BCE/mmol Cr] patients compared with controls[(30. 38±13.35) nmol BCE/mmol Cr] (P<0.05). The levels of OC and 25 (OH)D3 in patients treated with steroids[(17. 3±13. 43) ng/ml and (26. 99 ± 9. 12) nmol/L, respectively] were lower than those in patients untreated with steroids[(27.33 ± 16.86) ng/ml and (45.33±39.03) nmol/L,respectively] . BMD examination revealed that the incidence of osteoporosis in CD or UC groups were 14.3%(7/49) or 3/20,respectively, with no difference between two groups (P>0. 05). The T score of lumbar spine in patients treated with steroids (-1.19±0. 93) was significantly lower than that in patients untreated with steroids (-0.80±1.29) (P<0.05), but there was no difference in T score of femoral between two groups (P>0.05). Stepwise regression analysis revealed that advanced age and reduced BMI were risk factors for osteoporosis in CD patients.Conclusions The lower BMI in patients with IBS contributes to prevalence of osteoporosis, and advanced age and reduced BMI are risk factors for osteoporosis in CD patients. NTX and 25 (OH)D3are important bone metabolic markers to predict osteoporosis in patients with IBD.

Objective To investigate the clinical characteristics of imflamatroy bowel disease (IBD) and the risk factors in developing eoloreetal cancers. Methods Five hundred and thirteen patients with IBD were consecutive collected from Jan. 1996 to Oct. 2007. The history database of these patients was established. The items including demography features, morbidity, diagnosis, the related risk factors, the treatment and outcomes were analyzed. Results Two hundred and forty two out of 513 patients were ulcerative colitis (UC). Of which 4 patients (1.65%) developed cancer and 4 (1.650%) were confirmed with precancer. But none of the 271 patients with Crohn's disease (CD) de-veloped cancer. The Logistic regression analysis showed that weight loss, complications and relapse might be the potential risk factors of the cancer. Conclusions In clinical, the probability that develope to cancer in patients with UC is higher than that in patients with CD. The main risk factors are frequent relapse, weight lost and complications.

Objective To investigate the effects of pioglitazone,a peroxisome proliferation activated receptor(PPAR)γ agonist on oxidative stress process and the therapeutic effects on severity of acute pancreatitis(AP).Methods Thirty male Sprague-Dawley rats were randomly divided into five groups with 6 in each:control group,eerulein plus pioglitazone group,cerulein group,cerulein plus vehicle group,cerulein plus pioglitazone and GW9662 group.Rats were sacrificed at 30 min after the induction of pancreatitis.Pathologic changes of the pancreas were observed under light microscope.The ratios of pancreatic wet/body weight of rat were determined in each group.Serum amylase,pancreatic nitric oxide synthase(NOS),inducible nitric oxide synthase(iNOS),malondialdehyde(MDA),and myeloperoxidase (MPO)were determined by chromometry.Results The serum amylase,pancreatic wet/body weight and the score of pathologic damage increased after the induction of pancreatitis,AP samples were characterized by increased pancreatic MDA,MPO,NOS and iNOS(P＜0.01).Pioglitazone(20 mg/kg and 40 mg/kg)exhibited a protective effect against oxygen free radicals reflected by lower serum amylase,less severe pancreatic lesions,normal pancreatic MDA,MPO and NOS levels(P＜0.05).GW9662 reversed the effects against oxidative stress of pioglitazone(40 mg/kg)(P＜0.05).Conclusions Pretreatment with pioglitazone may exert its therapeutic effect on AP by lowering pancreatic oxidative free radicals and reducing pancreatic tissue infiltration of neutrophils.

Objective To evaluate the efficacy and safety of rabeprazole sodium injection in the treatment of non-esophageal variceal upper gastrointestinal bleeding in comparison with the positive control,omeprazole.Methods From January 2010 to January 2011,231 patients with non-esophageal variceal upper gastrointestinal bleeding from 20 hospitals were divided into rabeprazole group and omeprazole group in this multicenter,randomized,blind,parallel-group,positive drug controlled clinical trial.Hemostasis rate in 72 hours was the primary endpoint.Hemostasis rate in 120 hours,time to hemostasis,blood transfusion volume and the rate of switching treatments were the secondary endpoint.And safety was also analyzed.Chi square test and Wilcoxon rank sum test were performed for statistical analysis.Results At 72 hours after treatment,the hemostasis rates of rabeprazole group and omeprazole group were 98.20％(109/111)and 98.25％(112/114), respectively, and the difference was not statistically significant (P＞0.05).The 95％ confidence interval (CI) of the rate difference between the two group was-3.50 ％ to 3.40 ％.The result of non-inferiority test indicated that the lower limit of the 95％CI of the rate difference between the two groups was-2.95％ (U=5.652,P＜0.01),and rabeprazole group was not inferior to omeprazole group.At 12 hours after treatment,the hemostatic rates of rabeprazole group and omeprazole group were 63.06％(70/111) and 53.51％(61/114),respectively,and there was no statistically significant difference (P＞0.05).At 120 hours after treatment,the hemostasis rates of rabeprazole group and omeprazole group were 99.10 ％ (110/111) and 98.25 ％ (112 /114),and there was no statistically significant difference (P＞0.05).The median time of hemostasis of two groups was 24 hours.During the treatment,there were two cases and seven cases of rabeprazole group and omeprazole group received blood transfusions,respectively;there were 0.90％ (1/111) and 2.63 ％ (3/114) patients switched to other treatment,and no statistically significant difference was found (P＞0.05).The rates of adverse event of rabeprazole group and omeprazole group were 11.61％ (13/112) and 5.26％ (6/114),respectively.The rates of adverse reaction were 6.25％ (7/112) and 4.39％ (5/114),respectively.The differences in the rates of adverse event and adverse reaction between two groups were not statistically significant(both P＞0.05).Conclusion Rabeprazole sodium injection is an effective and safe drug in the treatment of non-esophageal variceal upper gastrointestinal bleeding.

Pancreatic cancer (PC)is one of common malignant digestive diseases.It is mostly diagnosed at advanced stage,with an ex-tremely poor progression.The relationship between diabetes and PC was shown by numerous epidemiological studies for decades.Retrospec-tive clinical studies and research on molecular mechanisms in recent years have led to a new understanding of the relationship between diabe-tes,especially new-onset diabetes,and PC,the effect of antidiabetic medication on PC,and the molecular mechanisms underlying the con-nection between diabetes and PC.It is suggested by recent data that long-standing diabetes is one of the risk factors for PC development, new-onset diabetes may facilitate early diagnosis of PC,diabetes may have an impact on the prognosis of PC,the option of antidiabetic medication may influence the incidence of PC,and exploring the molecular mechanisms underlying the association between diabetes and PC may help to identify the new therapeutic target for PC.

Objective To evaluate the efficacy and safety of mesalazine modified-release tablets in the treatment of mild and moderate active ulcerative colitis (UC).Methods This study was a multicenter,single-blinded and randomized controlled study.A total of 251 active UC patients in 18 hospitals were enrolled into this study from November 2010 to January 2012.The subjects were divided into the mesalazine modified-release tablets group (n=123) and the mesalazine enteric-coated tablets group (n=128),three times daily,each of which took mesalazine modified-release tablets or mesalazine enteric coated tablets 800 mg,respectively,and the course of treatment was eight weeks.The difference of UC disease activity index (UC-DAI),UC-DAI at the beginning minus UC-DAI at the final evaluation,was calculated at final evaluation.And this was the primary efficacy parameter.Complete remission rate and effective rate were considered as the secondary efficacy parameter.Adverse drug reactions rates of two groups were calculated and taken as safety evalution.If the lower limit of the 95 ％ confidence interval was more than-0.1 in the difference of the decrease in UC-DAI between the two groups,the non-inferiority of mesalazine modified release tablets to mesalazine enteric-coated tablets was demonstrated.The analysis of covariance model was used for the primary efficacy parameter and the sub-group analysis.And chisquare test was used for the comparison between the two groups in the secondary efficacy parameter and in the adverse drug reactions.Results At the final evaluation,the decrease in UC-DAI of mesalazine modified-release tablets group was 2.84 and that of mesalazine enteric-coated tablets group was 2.56.The reduction degree was 0.27.The lower limit of the 95 ％ confidence interval in the difference of the decrease in UC DAI between the two groups was-0.34,which demonstrated the non-inferiority of mesalazine modified release tablets to mesalazine enteric-coated tablets.The complete remission rates of mesalazine modified release tablets group and mesalazine enteric-coated tablets group were 48.33％ (58/120) and 55.65％ (69/124) and the effective rates were 63.33％ (76/120) and 66.94％ (83/124),and there was no statistically significant difference between the two groups (all P＞ 0.05).At final evaluation,the decrease in UC DAI of mild patients (UC DAI 3 to 5 at enrollment) of mesalazine modified-release tablets group and mesalazine enteric-coated tablets group were 2.16 and 2.05,respectively; the difference of mesalazine modified release tablets group and mesalazine enteric coated tablets group of reduction degree of UC-DAI was 0.11,that of moderate patients (UC-DAI 6 to 8 at enrollment) were 3.49 and 3.03,respectively,the difference of mesalazine modified-release tablets group and mesalazine enteric-coated tablets group of reduction degree of UC DAI was 0.46,and there was no statistically significant difference between the groups (all P＞0.05).The adverse drug reactions rates of mesalazine modified-release tablets group and mesalazine enteric coated tablets group were 6.61％ (8/121) and 10.24％ (13/127),and there was no statistically significant difference between the two groups (P＞ 0.05).No serious adverse drug reactions were found in two groups.Conclusion Mesalazine modified release tablets has good efficacy and high safety in the treatment of mild to moderate active UC.