Objective To analyze the short-term clinical efficacy and influencing factors of ustekinumab monoclonal antibody(UST)in the treatment of Crohn′s disease(CD).Methods Retrospective cohort study was used to collect the clinical data of CD patients treated with UST in the 10th People′s Hospital affiliated to Tongji University from December 2020 to October 2022.The main analysis is the short-term clinical efficacy and influencing factors of UST treatment for CD at weeks 8 and 16,And analyze the endoscopic response rate of some patients.Results A total of 91 CD patients who first used UST were included.The 8-week clinical response rate of UST treat-ment for CD was 61.5%,and the clinical response rate was 45%;The clinical response rate at 16 weeks was 71.4%,and the clinical response rate was 54.9%.56 cases underwent endoscopic re-examination in our hospital,and the endoscopic response rate at 16 weeks was 41.1%.Univariate analysis showed that fistula(including anal fistula,personal history of anal fistula,and intestinal skin fistula)is associated with clinical remission in Crohn′s disease patients at 8/16 weeks.Further multivariate COX regression analysis showed that the presence of a history of anal fistula surgery was an independent protective factor affecting clinical remission in CD patients treated with UST at 8 weeks(HR = 0.04,95%CI:0.00～0.38;P = 0.005)and 16 weeks(HR = 0.04,95%CI:0.01～0.34;P = 0.003)compared to those without fistula;Narrow lesions are an independent risk factor for 16 week clinical remission in CD patients compared to non-narrow and non-penetrating lesions(HR = 1.75,95%CI:1.08～2.84;P = 0.023).No patients were found to have stopped medication due to serious adverse reactions.Conclusions UST can improve the clinical remission and response of CD patients at 8/16 weeks,and has good short-term clinical efficacy.CD patients with a personal history of anal fistula are recommended to use UST monoclonal antibodies,while patients with stenotic lesions should be cautious in using UST monoclonal antibodies.Whether the patient has undergone surgical treatment in the past,as well as whether UST has been used on the first or non-first line,has no significant impact on clinical remission.

Objective:To evaluate the efficacy and safety of adalimumab (ADA) in the treatment of Crohn′s disease (CD), and to analyze the predictive factors of ADA efficacy.Methods:From January 2020 to December 2020, 49 CD patients treated with ADA at the Department of Gastroenterology, Tenth People′s Hospital of Tongji University of Shanghai were enrolled. The clinical data before treatment were collected. During 12 weeks of ADA treatment, the patients were followed up every 2 weeks, the laboratory examinations were conducted every 4 weeks, and colonoscopy examination was rechecked at the 12th week. The improvement of the main symptoms of patients was assessed at 2nd, 4th, and 6th week during ADA treatment. At the 12th week after ADA treatment, the clinical response (Crohn′s disease activity index (CDAI) score decreased ≥70 points from baseline), clinical remission (CDAI score < 150 points), endoscopic response (simple endoscopic score for Crohn′s disease (SES-CD) decreased >50% from baseline) and endoscopic remission (SES-CD ≤2 points or Rutgeerts score ≤1 point), closure of anal fistula of CD patients complicated with anal fistula and occurrence of adverse reactions during treatment were recorded. The predictive factors of clinical remission of CD patients after ADA treatment for 12 weeks were analyzed. The Mann-Whitney U test and binary logistic regression analysis were used for statistical analysis. Results:The main symptom improved rates of 49 CD patients received ADA treatment at 2nd, 4th and 6th week were 75.5% (37/49), 95.9% (47/49) and 98.0% (48/49), respectively, and the main symptom improved time was 14.0 d (7.0 d, 17.0 d). After ADA treatment for 12 weeks, the clinical remission rate was 55.1% (27/49), the clinical response rate was 73.5% (36/49), the endoscopic remission rate was 43.3% (13/30), the endoscopic response rate was 55.6% (15/27), the anal fistula closure rate was 7/18, and the overall incidence of adverse reactions was 24.5% (12/49). The baseline of fecal calprotectin (FC) level of patients in the clinical remission group (27 cases) was lower than that of the patients in the active disease group (22 cases) (111.0 μg/g, 26.3 μg/g to 125.6 μg/g vs. 540.5 μg/g, 420.2 μg/g to 866.9 μg/g), and the difference was statistically significant ( Z=-4.44, P<0.001). The results of binary logistic regression analysis showed that baseline FC level was an independent predictive factor of clinical remission in CD patients treated with ADA for 12 weeks ( OR=1.08, 95%confidence interval 1.02 to 1.14, P=0.013). When the baseline FC cut-off value was 172.39 g/g, the sensitivity and specificity of it in predicting clinical remission in CD patients treated with ADA for 12 weeks were 81.48% and 90.91%, and the area under the receiver operator characteristic curve was 0.87 ( P<0.001). Conclusions:ADA is safe and effective in the treatment of CD. The baseline FC level is an independent predictive factor of clinical remission in CD patients treated with ADA for 12 weeks.

Objective:To screen the risk factors of psychology problems and quality of life of patients with inflammatory bowel disease (IBD) by questionnaire, and to explore the impact of anxiety and depression on the quality of life and disease of IBD patients, in order to guide the treatment of IBD.Methods:From June 15 to July 15 in 2019, 171 IBD patients diagnosed in the Department of Gastroenterology, the Tenth People′s Hospital of Tongji University in Shanghai were investigated by internet questionnaire. Finally 136 IBD patients (IBD group) were enrolled. During the same period 121 healthy individuals with no difference in age and gender were selected as healthy control group. IBD clinical questionnaire, the generalized anxiety disorder (GAD)-7, patient health questionnare (PHQ)-9 depression screening and the short form 36-item health survey (SF-36) quality of life evaluation scale were used in IBD group. General situation questionnaire, GAD-7, PHQ-9 and SF-36 scale were conducted in healthy control group. Chi-square test, Binary logistic regression analysis, Ordinal logistic regression analysis, and Pearson correlation analysis were used for statistical analysis.Results:In IBD group, 87(64.0%) were males and 49(36.0%) were females; 25 cases (18.4%) were ulcerative colitis (UC) and 111 cases (81.6%) were Crohn′s disease (CD); and the median age was (32(26, 40)) years old. In healthy control group, 68 (56.2%) were males and 53(43.8%) were females; the median age was (32(26, 37)) years old. The incidence of anxiety in UC patients and CD patients was 64.0%(16/25) and 64.9%(72/111), respectively, and the incidence of depression in UC and CD was 72.0%(18/25) and 58.6%(65/111), respectively. There were no significant differences in the incidence of anxiety and depression between UC patients and CD patients (both P>0.05). Role-emotional (odds ratio ( OR)=0.965, 95% confidence interval ( CI) 0.937 to 0.994, P=0.017) and mental health ( OR=0.940, 95% CI 0.896 to 0.985, P=0.010) may be the independent factors of depression. Physiological function ( OR=1.040, 95% CI 1.010 to 2.730, P=0.022) was the independent factors of depression. There was no significant correlation between the duration of disease and the quality of life ( P>0.05). There was no significant correlation between disease activity and quality of life, however it was related to physiological function ( r=0.15, P=0.046). The physiological function of IBD patients in remission stage was better than that of patients in activity stage. Depression was negatively correlated with quality of life ( r=-0.55, P<0.01), and with a linear relationship ( r=19.429, intercept was 744.455, P<0.01). Anxiety was not correlated with quality of life ( P>0.05). Depression was negatively correlated with changes of physical function, role-physical function, physical pain, general health, vitality, social function, emotional function, mental health, and reported health transition ( r=-0.234, -0.358, -0.454, -0.449, -0.566, -0.485, -0.441, -0.597, and -0.193, all P<0.05). Conclusions:IBD patients are prone to anxiety and depression. Depression is negative correlated with quality of life. It is very important to screen and intervene mental disorders in IBD patients, especially in patients with depression. Controlling the activity of IBD and relieving the clinical symptoms of patients may be effective in improving anxiety and depression. The treatment of IBD itself is the basis of IBD psychotherapy.

Background: Colonoscopy has been widely applied in clinic because of its value in screening, diagnosis and treatment of colorectal diseases. Discomfort and pain account for a great part of incomplete intubation during sedation-free colonoscopy. Aims: To identify the predictive factors for difficult sedation-free colonoscopy. Methods: Patients aged 18-80 years old undergone sedation-free colonoscopy at the Tenth People's Hospital of Tongji University from January to December in 2017 were enrolled. The clinical data and medical history were collected. Each patient completed the Eysenck Personality Questionnaire (EPQ) with the help of nurse before colonoscopy. Sedation-free colonoscopy was performed by experienced endoscopist. The Ottawa bowel preparation scale and Visual Analog Scale were used to evaluate the quality of bowel cleansing and pain during the procedure. Results: The total cecum intubation rate was 97.1% (198/204), and 192 patients completing the EPQ were enrolled for analyses. Twenty-four patients had a difficult colonoscopy (intubation time prolonged to >10 min). By univariate analysis, gender, age, body mass index (BMI), history of surgery, pain level and score of Extraversion-Introversion Scale of EPQ (EPQ-E) were associated with difficulty during colonoscopy (all P<0.05). Multivariate analysis revealed that history of pelvic surgery was a risk factor for difficult colonoscopy (OR=6.833, 95% CI: 2.396-19.488, P<0.001), whereas overweight (OR=0.190, 95% CI: 0.038-0.962, P=0.045) and score of EPQ-E ranged from 8-15 (OR=0.367, 95% CI: 0.150-0.896, P=0.028) were protective factors. Conclusions: History of pelvic surgery, lower BMI and extraversion or introversion personality may increase the difficulty during sedation-free colonoscopy. EPQ-E might be used for selecting candidates of sedation-free colonoscopy when it is performed by an inexperienced endoscopist.

Objective To investigate the independent association of serum Fetuin-B with metabolic syndrome in obese Chinese adults.Methods Cross-sectional data on socio-demographic,lifestyle,clinical characteristics, and serum Fetuin-B were collected for 1 318 Chinese adults with central obesity.Associations of serum Fetuin-B with metabolic syndrome and insulin resistance were analyzed using multivariable Logistic regression analysis.Results A total of 820(62.2%)individuals were identified as metabolic syndrome.Subjects with metabolic syndrome showed significantly increased levels of serum Fetuin-B than those with non-metabolic syndrome[(4.18 ±1.39 vs 4.02 ± 1.35)μg/ml,P=0.043].Increased serum Fetuin-B were significantly associated with increased fasting plasma glucose and insulin levels, as well as prevalences of non-alcoholic fatty liver disease(NAFLD)and insulin resistance.After adjustment for potential confounders, serum Fetuin-B was significantly associated with increased risks of metabolic syndrome and insulin resistance(OR=1.19,95%CI 1.06-1.34,P=0.004;OR=1.15,95%CI 1.01-1.30,P=0.031 respectively).Conclusion Serum Fetuin-B level was significantly associated with NAFLD;and elevated serum Fetuin-B was significantly associated with increased risk of metabolic syndrome.

Objective To evaluate the efficacy of 9 μ g tiotropium inhalation once daily in patients with moderate to severe chronic obstructive pulmonary disease(COPD).Methods One hundred seventy-one patients with moderate to severe COPD were divided into two groups by random digits table methods:86 patients in test group who used 9 μ g tiotropium powder inhaler once daily,and 85 patients in control group who used the recommended dose 18 μ g once daily,both for 6 months.Patients' pulmonary function and 6-minute walk test were measured before treatment,3 months after treatment and 6 months after treatment.Results Two groups were compared 6 months after treatment.The level of forced expiratory volume in first second(FEV1) in the control group increased an average of (0.21 ± 0.12) L,and the rising rate was (19.31 ± 10.61)％.The level of FEV1 in test group increased (0.22 ±0.13) L,and the rising rate was (19.25 ± 11.52)％.The level of forced vital capacity (FVC) in control group increased an average of (0.22 ±0.10) L,and the rising rate was (11.63 ±5.31)％.The level of FVC in test group increased (0.23 ± 0.15) L,and the rising rate was (11.62 ± 6.45)％.The distance of 6-minute walk test in control group increased an average of (29.24 ± 11.92) m after treatment for 6 months,and the rising rate was (18.30 ± 3.77)％.The distance of 6-minute walk test in test group increased an average of (29.14 ± 11.89) m,and the rising rate was (18.20 ± 3.85)％.The number of acute exacerbations and rehospitalizations in two groups at these period had no significant difference (P ＞ 0.05).As for the test group,though the number of acute exacerbations and rehospitalizations decreased,there were no significant differences (P ＞ 0.05).Conclusions The effect of inhalation therapy of 9 μ g tiotropium once daily is more or less the same with that of 18 μ g once daily.

The molecular descriptors of impurities with known structure in cefdinir were calculated, selected and associated with the chromatographic retention behavior to establish a model. This quantitative structure retention relationships (QSRR) model for the related substances of cefdinir was established under specific chromatographic condition and verified by other impurities. 12 molecular descriptors were used to establish the QSRR model, F_AFRBWF, Blbn_J, SsCH3, SssCH2, SsNH2, SssNH, SssS, SHdCH2, EEM_AFc, EEM_AFpl, EEM_XFpl and Pi_MaxQ. The relativity between true values and predictions in QSRR of cefdinir is R2 = 0.9836 (n = 18), ΔRRT is no more than 0.154, as 10.17% in RRT. The results indicate that the QSRR model for the related substances of cefdinir can be used to evaluate the analysis methods for related substances and predict the chromatographic behavior of new impurities, which will provide a new way for the evaluation of the effectiveness for drug quality control.

Objective To study the strain difference in response to the antidepressant fluoxetine in mouse tail suspension test.Methods Two outbred mouse strains (KM and ICR) and three inbred mouse strains (C57BL/6,Balb/c and DBA/2) were used in this study.They were treated with the selective serotonin reuptake inhibitor (SSRI) fluoxetine or saline and the immobility time in tail suspension test was recorded.Results There was significant difference of baseline immobility time among different stains with C57BL/6 the most immobile((145.0 ±16.8) s) and DBA/2 the least ((34.5 ± 6.1)s).Fluoxetine significantly decreased the immobility time in C57BL/6 ((116.0 ± 10.3) s vs (145.0 ± 16.8) s) of control),Balb/c ((44.3 ± 6.2) s vs (75.3 ± 10.3) s) of control) and DBA/2 mice ((16.6 ± 4.3) s vs (34.5 ± 6.1) s) of control),while the immobile time of KM and ICR mice was not influenced by fluoxetine.Conclusion The effects of fluoxetine in tail suspension test are strain dependent.Fluoxetiue exhibits antidepressant effects in C57BL/6,Balb/c and DBA/2 mice,but not in KM and ICR mice.

Objective To investigate the expression of microRNA (miRNA)-10a in the intestinal mucosa,serum and peripheral blood mononuclear cell (PBMC) of patients with inflammatory bowel disease (IBD) and explore its role and relevance in the pathogenesis of the disease.Methods The intestinal or colonic mucosal biopsy specimens of nine active ulcerative colitis (UC) patients,11 active Crohn's disease (CD) patients and eight patients with negative colonoscopy result as control were collected.The sera of 12 active UC patients,13 active CD patients and nine healthy controls were collected.The PBMC of nine active UC patients,11 active CD patients and eight healthy controls were collected.The expression of miRNA-10a in the intestinal mucosa,sera and PBMC and the expression of IL-12/IL-23 p40 in the intestinal mucosa were detected by real-time polymerase chain reaction (PCR).Each 8 cases of active UC and CD patients were collected.The intestinal mucosa before infliximab (IFX) treatment and six weeks after three times of IFX treatment were collected.And at same time,the intestinal mucosa of 11 active UC patients and 10 active CD patients were collected and cultured for 18 hours stimulated with IFX in vitro and then the expression of miRNA-10a in the intestinal mucosa was tested.One-way analysis of variance was used for comparison in three samples.Paired t-test was used for two samples comparison.Spearman test was used for correlation analysis.Results Compared with healthy controls,the expression of miRNA-10a in the intestinal mucosa,serum and PBMC of UC and CD patients significantly decreased (F=38.45,30.46 and 14.74,all P＜0.05).There was no statistic significance between UC and CD groups.The expression of IL-12/IL-23 p40 in the intestinal mucosa of UC and CD patients significantly increased (F=32.90,P＜0.05).The expression of IL-12/IL-23 p40 was negatively correlated with the expression of miRNA-10a in the intestinal mucosa of CD patients.After three times of IFX treatment,the expression of miR-10a in the intestinal mucosa of IBD patients significantly increased (t=3.341,3.382,both P＜0.05).After stimulated with IFX in vitro,the expression of miRNA-10a in the intestinal mucosa significantly increased (t=3.095,7.193,both P＜0.05).Conclusions miRNA-10a was closely correlated with the inflammation of IBD patients and with the role of targeting IL-12/IL-23 p40.miRNA-10a might be a new target for the IBD treatment.

Objective To investigate the changes of interleukin-21 (IL 21) and interleukin-21 receptor (IL 21R) expression level in Crohn's disease (CD) patients before and after accepted infliximab (IFX) treatment.Methods From June 2009 to July 2011,twenty-two CD patients met the research criteria were recruited at Tenth People's Hospital of Tongji University.Patients were treated with infliximab at weeks 0,2,6,and 16 healthy individuals were set as healthy control group at same time.Peripheral blood of healthy control group was taken at regular physical examination and blood of CD patients was taken before treatment and 10 weeks after treatment,intestinal mucosa biopsy samples were taken under colon endoscopy examination.The changes of Crohn's disease activity index (CDAI),erythrocyte sedimentation rate (ESR),C-reactive protein (CRP) in CD patients were observed.The change of IL-21R in peripheral blood CD4+ T lymphocytes was detected by flow cytometry.The change of IL-21 expression at mRNA level in intestinal mucosa was determined by realtime quantitative polymerase chain reaction (PCR).The data were analyzed by t test.Results Before treatment,the level of IL21R in peripheral blood CD4+ T lymphocytes of CD patients (12.25％±3.25％) and the expression of IL-21 at mRNA level in inflamed intestinal mucosa (1.38±0.32) were both significantly higher than those of healthy controls (4.25 ％ ± 1.41％,0.44±0.18),the differences were statistically significant (F=15.88,6.75 ; both P＜0.05).At 10th week,the level of IL-21R in peripheral blood CD4+ T lymphocytes of CD patients (8.12％ ± 2.05％) and the expression of IL-21 at mRNA level in intestinal mucosa (0.77 ± 0.24) were both significantly lower than those before treatment,the differences were statistically significant ( t=4.880,8.019; both P＜0.01).Before treatment,ESR,CRP and CDAI of CD patients was (46.8±11.4) mm/1 h,(52.4±11.5) mg/L and 319±74,which was (23.5±9.0) mm/1 h,(11.6±4.6) mg/L and 113±42 after treatment,the differences were statistically significant (t=9.485,16.458,11.100; all P＜0.05).Conclusion The IL-21 expression of active CD patients decreases after IFX treatment,which indicates that IL-21 may involve in IFX induced clinical remission of active CD.