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Objective:To investigate the psychology status and quality of life in patients with inflammatory bowel disease(IBD) in China, and to analyze the influencing factors.Methods:From September 2021 to May 2022, 42 hospitals in 22 provinces(autonomous regions and municipalities directly under the central government) in China, the clinical data of 2 478 IBD patients were collected, which included age, gender, weight, first visit or not, disease activity, disease course, main clinical manifestations(diarrhea, abdominal pain, hematochezia, extraintestinal manifestations), complications, treatment medication(5-aminosalicylic acid, glucocorticoids, immunosuppressive agents, and biological agents), and whether to have surgery. Anxiety, depression, sleep quality and quality of life of IBD patients were evaluated by generalized anxiety disorder-7 items, patient health questionnaire-9 items, Pittsburgh sleep quality index and inflammatory bowel disease questionnaire, and the related influencing factors were analyzed. Univariate analysis and multiple linear regression analysis were used for statistical analysis.Results:The average age of 2 478 IBD patients was 37.96 years old, and male counted for 62.43%(1 547/2 478). There were 61.82%(1 532/2 478) of the IBD patients in the active stage of disease, mostly mild or moderate(588 and 734 cases). There were 60.61%(1 502/2 478) of the IBD patients with different degrees of anxiety, 58.35%(1 446/2 478) of the IBD patients with different degrees of depression, and 48.87%(1 211/2 478) of the IBD patients had different degrees of sleep problems. The results of multiple linear regression analysis indicated that female, higher level of disease activity and longer disease course were independent risk factors of anxiety, depression and sleep quality in the IBD patients(unstandardized regression coefficient(95% confidence interval) 1.08(0.65 to 1.50), 0.45(0.23 to 0.68), 0.19(0.02 to 0.36), 0.83(0.33 to 1.32), 0.62(0.36 to 0.88), 0.28(0.08 to 0.47), 0.47(0.16 to 0.77), 0.39(0.23 to 0.55), 0.14(0.02 to 0.26); P<0.001, <0.001, =0.025 , =0.001, <0.001, =0.005, =0.003, <0.001, =0.027). The usage of biological agents was an independent protective factor of anxiety(unstandardized regression coefficient(95% confidence interval) -0.67(-1.17 to -0.17), P=0.008), and older age was an independent risk factor of sleep quality(unstandardized regression coefficient(95% confidence interval) 0.35(0.09 to 0.61), P=0.008). Higher level of disease activity, symptoms of diarrhea, abdominal pain, presence of extraintestinal manifestations, usage of 5-aminosalicylic acid and glucocorticoid, and with surgical treatment were independent risk factors of quality of life(unstandardized regression coefficient(95% confidence interval) -11.00(-12.24 to -9.76), -2.90(-5.26 to -0.55), -3.93(-6.25 to -1.61), -5.79(-9.87 to -1.71), -4.78(-7.79 to -1.76), -7.71(-11.07 to -4.35), -4.37(-8.00 to -0.73); P<0.001, =0.016, =0.001, =0.005 , =0.002, <0.001, =0.019), while the usage of biological agents was an independent protective factor of quality of life (unstandardized regression coefficient(95% confidence interval) 4.72(1.97 to 7.48), P=0.001). Conclusion:IBD patients generally have different degrees of anxiety, depression and sleep problems, which affect the quality of life of patients. Gender, disease activity and disease course are the influencing factors of mental disorders in IBD patients.
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Background/Aims@#Crohn’s disease (CD) primarily affects young female adults of reproductive age. Few studies have been conducted on this population’s ovarian reserve status. The aim of study was to investigate potential risk factors associated with low ovarian reserve, as reflected by serum anti-Müllerian hormone (AMH) in women of reproductive age with CD. @*Methods@#This was a case-control study. Cases included 87 patients with established CD, and healthy controls were matched by age, height and weight in a 1:1 ratio. Serum AMH levels were measured by enzyme-linked immunosorbent assay. @*Results@#The average serum AMH level was significantly lower in CD patients than in control group (2.47±2.08 ng/mL vs. 3.87±1.96 ng/mL, respectively, P<0.001). Serum AMH levels were comparable between CD patients and control group under 25 years of age (4.41±1.52 ng/mL vs. 3.49±2.10 ng/mL, P=0.06), however, serum AMH levels were significantly lower in CD patients over 25 years of age compared to control group (P<0.05). Multivariable analysis showed that an age greater than 25 (odds ratio [OR], 10.03; 95% confidence interval [CI], 1.90–52.93, P=0.007), active disease state (OR, 27.99; 95% CI, 6.13–127.95, P<0.001) and thalidomide use (OR, 15.66; 95% CI, 2.22–110.65, P=0.006) were independent risk factors associated with low ovarian reserve (serum AMH levels <2 ng/mL) in CD patients. @*Conclusions@#Ovarian reserve is impaired in young women of reproductive age with CD. Age over 25 and an active disease state were both independently associated with low ovarian reserve. Thalidomide use could result in impaired ovarian reserve.
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Objective:To analyze the long-term efficacy and safety of thalidomide on refractory Crohn′s disease (CD).Methods:A total of 79 patients with refractory CD in the First Affiliated Hospital of Sun Yat-sen University treated with thalidomide were enrolled in this retrospective study from September 2005 to July 2018. Clinical effects and adverse drug reactions were recorded and assessed.Results:In this cohort,69 patients were treated with thalidomide for ≥6 months. Sixty-eight patients among the 69 patients achieved complete clinical remission and were followed up for a median 33.5 months (range, 7-110 months). Seventeen cases relapsed during follow-up. The cumulative probabilities of remaining in remission at 12, 24, 60 months were 88.6% (95% CI 80.6%-96.6%), 80.7% (95% CI 70.3%-91.1%), 53.7% (95% CI 32.1%-75.3%) respectively. Disease activity was the only variable associated with relapse risk, with a hazard ratio ( HR) of 3.559 for Crohn′s disease activity index (CDAI) ≥220(95% CI 1.213-10.449, P<0.05). Adverse reactions were recorded in 42 (53.2%) patients including12 (15.2%) leading to discontinuation of thalidomide. No serious side effects were observed in all subjects. Conclusions:This study suggests a long-term benefit of maintenance treatment with thalidomide in refractory CD.Moderate to severe patients have an increased risk of relapse. The high incidence of drug adverse reactions may restrain the clinical application of thalidomide.
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Objective To explore the diagnostic efficiency of ultrasound-guided biopsy in the diagnosis of gastrointestinal lesions.Methods The study retrospectively analyzed 41 cases who underwent ultrasound-guided biopsy and diagnosis were confirmed as gastrointestinal lesions either by surgery resections or by biopsies in our hospital from January 2006 to April 2018.The detection rate and the safety in the diagnosis of gastrointestinal lesions by ultrasound-guided biopsy were evaluated and they were compared with clinical efficiency of the endoscopic biopsy.Results (1) Of the 41 cases underwent ultrasound-guided biopsies,38 cases were confirmed by pathology.A 92.7％ detection rate had achieved by ultrasound-guided biopsies.In the 38 cases,the diagnoses were grouped in benign and malignant,with 29 malignant and 9 benign.(2) Among the 13 cases examined by both of the ultrasound-guided biopsy and endoscopic biopsy,the diagnostic accuracy of ultrasound-guided biopsy was 84.6％ and 61.5％ with endoscopy.No significant difference (P =0.378) between the two modalities.(3) No complication occurred with both of methods.Conclusions Ultrasound-guided biopsy of gastrointestinal lesions is a safe and effective method.It would be an alternative solution to provide clinicians with reliable diagnosis,especially when endoscopic diagnosis is not inapplicable or failed.
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<p><b>OBJECTIVE</b>To investigate the clinical epidemiology change trend of upper gastrointestinal bleeding (UGIB) over the past 15 years.</p><p><b>METHODS</b>Consecutive patients who was diagnosed as continuous UGIB in the endoscopy center of The First Affiliated Hospital of Sun-Yat University during the period from 1 January 1997 to 31 December 1998 and the period from 1 January 2012 to 31 December 2013 were enrolled in this study. Their gender, age, etiology, ulcer classification, endoscopic treatment and hospitalization mortality were compared between two periods.</p><p><b>RESULTS</b>In periods from 1997 to 1998 and 2012 to 2013, the detection rate of UGIB was 9.99%(928/9 287) and 4.49%(1 092/24 318)(χ=360.089, P=0.000); the percentage of male patients was 73.28%(680/928) and 72.44% (791/1 092) (χ=0.179, P=0.672), and the onset age was (47.3±16.4) years and (51.4±18.2) years (t=9.214, P=0.002) respectively. From 1997 to 1998, the first etiology of UGIB was peptic ulcer bleeding, accounting for 65.2%(605/928)[duodenal ulcer 47.8%(444/928), gastric ulcer 8.3%(77/928), stomal ulcer 2.3%(21/928), compound ulcer 6.8%(63/928)],the second was cancer bleeding(7.0%,65/928), and the third was esophageal and gastric varices bleeding (6.4%,59/928). From 2012 to 2013, peptic ulcer still was the first cause of UGIB, but the ratio obviously decreased to 52.7%(575/1092)(χ=32.467, P=0.000)[duodenal ulcer 31.9%(348/1092), gastric ulcer 9.4%(103/1092), stomal ulcer 2.8%(30/1092), compound ulcer 8.6%(94/1092)]. The decreased ratio of duodenal ulcer bleeding was the main reason (χ=53.724, P=0.000). Esophageal and gastric varices bleeding became the second cause (15.1%,165/1 092, χ=38.976, P=0.000), and cancer was the third cause (9.2%,101/1 092, χ=3.352, P=0.067). The largest increasing amplitude of the onset age was peptic ulcer bleeding [(46.2±16.7) years vs. (51.9±18.9) years, t=-5.548, P=0.000), and the greatest contribution to the amplitude was duodenal ulcer bleeding [(43.4±15.9) years vs. (48.4±19.4) years, t=-3.935, P=0.000], while the onset age of esophageal and gastric varices bleeding [(49.8±14.1) years vs. (48.8±13.9) years, t=0.458, P=0.648] and cancer [(58.4±13.4) years vs. (58.9±16.7) years, t=-0.196, P=0.845] did not change significantly. Compared with the period from 1997 to 1998, the detection rate of high risk peptic ulcer rebleeding (Forrest stage I(a, I(b, II(a and II(b) increased (χ=39.958, P=0.000) in the period from 2012 to 2013. From 1997 to 1998, 54 patients underwent endoscopic treatment, and the achievement ratio of hemostasis was 79.6% (43/54). From 2012 to 2013, 261 patients underwent endoscopic treatment and the achievement ratio of hemostasis was 96.9%(253/261), which was significantly higher (χ=23.287, P=0.000). Compared to the period from 1997 to 1998, more patients with variceal bleeding or non-variceal bleeding received endoscopic treatment in time (39.0% vs. 70.3%, χ=51.930, P=0.000; 3.6% vs. 15.6%, χ=62.292, P=0.000, respectively), and higher ratio of patients staging Forrest stage I(a to II(b also received endoscopic treatment in the period from 2012 to 2013 [27.4%(26/95) vs. 68.5%(111/162), χ=40.739, P=0.000]. More qualified endoscopic hemostatic techniques were used, containing thermocoagulation (0 vs. 15.2%, χ=79.518, P=0.000), hemostatic clip (0 vs. 55.9%, χ=20.879, P=0.000), hemostatic clip combined with thermocoagulation (4.3% vs. 16.4%, χ=5.154, P=0.023), while less single injection was used (87.1% vs. 6.2%, χ=10.420, P=0.001), and single spraying for hemostasis was completely abandoned in the period from 2012 to 2013. The ratio of inpatients undergoing reoperation decreased obviously in the period from 2012 to 2013 [9.3%(86/928) vs. 6.0%(65/1092), χ=7.970, P=0.005], while no significant difference was found in mortality during hospitalization between two periods.</p><p><b>CONCLUSION</b>Compared with the period from 1997 to1998, the mean onset age of UGIB increased, and the ratio of peptic ulcer bleeding decreased due to the reduction of duodenal ulcer bleeding, the detection rate of high risk peptic ulcer rebleeding increased, the cure rate of endoscopic treatment for UGIB increased, more reasonable and immediate hemostatic methods were used, but overall mortality did not change obviously in the period from 2012 to 2013.</p>
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Adult , Aged , Female , Humans , Male , Middle Aged , Age of Onset , Electrocoagulation , Methods , Endoscopy, Digestive System , Esophageal and Gastric Varices , Pathology , Therapeutics , Esophagus , Pathology , Gastrointestinal Hemorrhage , Classification , Epidemiology , Mortality , Gastrointestinal Neoplasms , Pathology , Hemostasis, Endoscopic , Methods , Hemostatic Techniques , Hemostatics , Therapeutic Uses , Peptic Ulcer , Pathology , Therapeutics , Peptic Ulcer Hemorrhage , Pathology , Therapeutics , Reoperation , Stomach Ulcer , Pathology , Therapeutics , Surgical Instruments , Ulcer , Epidemiology , TherapeuticsABSTRACT
Objective To analyze the clinical features,clinical prognosis and predictive factors of ulcerative colitis (UC) complicated with cytomegalovirus (CMV) infection.Methods From May 2004 to November 2014,120 hospitalized patients diagnosed as UC and screened for CMV infection were enrolled.A total of 31 patients with moderate to severe UC accompanied by CMV infection were screened out.Demographics,clinical features,endoscopic appearance and treatment of patients with UC complicated with CMV infection were analyzed,and compared with 60 moderate to severe UC patients without CMV infection at the same period of hospitalization.Mann Whitney U test was performed for statistical analysis.Logistic regression analysis was used to analyze risk factors of UC complicated with CMV infection.Results Among 120 patients with UC,29 were mild or in remission period,whose CMV screening tests were all negative.Ninety-one were moderate to severe,31 patients (34.1 ％) of them had CMV infection,and 20 of 31 patients were steroid-refractory.Among the 31 patients with UC complicated with CMV infection,median age was 39 years (22 years,51 years),median disease duration was 24.0 months (6.0 months,42.0 months) which was shorter than that of patients without CMV infection (36.0 months (13.5 months,84.0 months)),and the difference was statistically significant (U=639.5,P=0.015).A total of 23 patients (74.2％) had extensive colitis and 26 patients (83.9％) had history of severe colitis.A total of 29 patients (93.5％) had history of corticosteroids treatment,12 patients (38.7％) had history of immunosuppressive agents treatment,and six patients (19.4 ％) had history of infliximab treatment.Compared with UC patients without CMV infection,fever,abdominal pain and weight loss were more common in UC patients with CMV infection.Five CMV-infected patients had mild liver dysfunction.Endoscopic appearance was longitudinal ulceration,irregular ulceration,large deep ulceration,punchedout ulceration and worm-like ulceration.Among the 25 CMV-infected patients who were treated with corticosteroids,11 patients (44.0％) had no response.Among the 39 CMV-negative patients who were treated with corticosteroids,eight patients (20.5％) had no response.The rate of patients who needed rescue therapy of the former was higher than that of the latter,and the difference was statistically significant (x2 =4.026,P=0.045).The results of multivariate Logistic regression analysis showed that hemoglobin over 100 g/L(OR=0.144,95％ confidence interval (CI) 0.040 to 0.516,P=0.003) was a protective factor of CMV infection,however corticosteroids use within a month before the onset (OR=8.946,95％oCI 2.459 to 32.541,P=0.001) was a risk factor.Conclusions UC patients treated with corticosteroids and immunomodulator therapy may predispose UC patients to CMV infection,on the other hand,CMV infection can exacerbate the severity of UC.CMV infection should be screened and monitored in UC patients,and anti viral therapy should be taken in time in case of CMV infection.
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BACKGROUND/AIMS: The past decades have seen increasing incidence and prevalence of inflammatory bowel disease (IBD) in China. This article aimed to summarize the current status and characteristics of surgical management for IBD in China. METHODS: We searched PubMed, Embase, and Chinese databases from January 1, 1990 to July 1, 2014 for all relevant studies on the surgical treatment IBD in China. Eligible studies with sufficient defined variables were further reviewed for primary and secondary outcome measures. RESULTS: A total of 74 studies comprising 2,007 subjects with Crohn's disease (CD) and 1,085 subjects with ulcerative colitis (UC) were included. The percentage of CD patients misdiagnosed before surgery, including misdiagnosis as appendicitis or UC, was 50.8%±30.9% (578/1,268). The overall postoperative complication rate was 22.3%±13.0% (267/1,501). For studies of UC, the overall postoperative complication rate was 22.2%±27.9% (176/725). In large research centers (n>50 surgical cases), the rates of emergency operations for CD (P=0.032) and in-hospital mortalities resulting from both CD and UC were much lower than those in smaller research centers (n≤50 surgical cases) (P=0.026 and P <0.001, respectively). Regarding the changes in CD and UC surgery over time, postoperative complications (P=0.045 for CD; P=0.020 for UC) and postoperative in-hospital mortality (P=0.0002 for CD; P=0.0160 for UC) both significantly improved after the year 2010. CONCLUSIONS: The surgical management of IBD in China has improved over time. However, the rates of misdiagnosis and postoperative complications over the past two decades have remained high. Large research centers were found to have relatively better capacity for surgical management than the smaller ones. Higher quality prospective studies are needed in China.
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Humans , Appendicitis , Asian People , China , Colitis, Ulcerative , Crohn Disease , Diagnostic Errors , Emergencies , Hospital Mortality , Incidence , Inflammatory Bowel Diseases , Outcome Assessment, Health Care , Postoperative Complications , Prevalence , Prospective StudiesABSTRACT
BACKGROUND/AIMS: The past decades have seen increasing incidence and prevalence of inflammatory bowel disease (IBD) in China. This article aimed to summarize the current status and characteristics of surgical management for IBD in China. METHODS: We searched PubMed, Embase, and Chinese databases from January 1, 1990 to July 1, 2014 for all relevant studies on the surgical treatment IBD in China. Eligible studies with sufficient defined variables were further reviewed for primary and secondary outcome measures. RESULTS: A total of 74 studies comprising 2,007 subjects with Crohn's disease (CD) and 1,085 subjects with ulcerative colitis (UC) were included. The percentage of CD patients misdiagnosed before surgery, including misdiagnosis as appendicitis or UC, was 50.8%±30.9% (578/1,268). The overall postoperative complication rate was 22.3%±13.0% (267/1,501). For studies of UC, the overall postoperative complication rate was 22.2%±27.9% (176/725). In large research centers (n>50 surgical cases), the rates of emergency operations for CD (P=0.032) and in-hospital mortalities resulting from both CD and UC were much lower than those in smaller research centers (n≤50 surgical cases) (P=0.026 and P <0.001, respectively). Regarding the changes in CD and UC surgery over time, postoperative complications (P=0.045 for CD; P=0.020 for UC) and postoperative in-hospital mortality (P=0.0002 for CD; P=0.0160 for UC) both significantly improved after the year 2010. CONCLUSIONS: The surgical management of IBD in China has improved over time. However, the rates of misdiagnosis and postoperative complications over the past two decades have remained high. Large research centers were found to have relatively better capacity for surgical management than the smaller ones. Higher quality prospective studies are needed in China.
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Humans , Appendicitis , Asian People , China , Colitis, Ulcerative , Crohn Disease , Diagnostic Errors , Emergencies , Hospital Mortality , Incidence , Inflammatory Bowel Diseases , Outcome Assessment, Health Care , Postoperative Complications , Prevalence , Prospective StudiesABSTRACT
AIM:To identify the serum proteins that might serve as biomarkers for predicting mucosal healing ( MH) in the patients with Crohn’ s disease ( CD) treated with infliximab ( IFX) .METHODS:We collected serum sam-ples before treatment (0 week, group A) and 14 weeks after treatment (group B) from 7 CD patients with IFX treatment who had achieved MH, as well as the serum samples from 7 CD patients who had not achieved MH (0 week, group C;14 weeks, group D) .Two-dimensional fluorescence difference gel electrophoresis was applied to analyze and compare the re-sults of serum profiles between groups A and B, C and D, A and C, B and D.Matrix-assisted laser desorption/ionization time-of-flight tandem mass spectrometry and bioinformatics tools were utilized to preliminarily identify and figure out the dif-ferentially expressed proteins.RESULTS:(1) In total, there were 44 differentially expressed spots, 36, 3, 10 and 31 differentially expressed spots were detected while comparing A with B, C with D, A with C and B with D, respectively. (2) Among those spots, 17, 2, 2 and 15 proteins were identified, respectively.In total, there were 19 differentially ex-pressed proteins, including apolipoprotein E, apolipoprotein A-I, complement factor H, and so on.(3) Protein functional association networks were carried out based on STRING database.CONCLUSION: The serum protein profiles obviously change after IFX treatment in MH CD patients, and the serum protein profiles of MH patients are different from that of non-MH patients after IFX treatment.The 19 proteins we identified may serve as potential biomarkers for predicting MH in CD patients with IFX treatment.
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Objective To analyze clinical features and prognosis of primary intestinal T cell lymphoma (ITCL)which was misdiagnosed as Crohn′s disease (CD),and summarized the key points of differentiation between ITCL and CD.Methods From January 2003 to January 2014,clinical data of patients with ITCL once misdiagnosed as CD were retrospectively analyzed,which included demographic,clinical,pathological and prognostic data.The data of 177 patients diagnosed as CD from January 2012 to January 2014 were collected. The demographic,clinical,pathological and prognostic data of these two groups were analyzed and compared. The continuous variables were compared with t test or Mann-WhitneyU test,and the differences of classification variables between two groups were analyzed by Chi-square test or Fisher exact probability method.Results A total of 18 patients (17 males and one female)with ITCL misdiagnosed as CD were enrolled in the study,and the median age at diagnosis was 38.5 (28.8 to 42.5)years and the median duration of diagnosis was 6.00 (3.75 to 13.25)months.The common primary symptoms were abdominal pain (12/18),diarrhea (13/18)and anemia (13/18).Intestinal perforation was primary symptom in two cases (2/18).However,B symptoms of lymphoma was observed in 16 patients,which included fever in 13 patients,weight loss in 16 patients and night sweat in one patient.One or more serious complications appeared in 12 patients,which included intestinal perforation in nine patients,severe gastrointestinal bleeding in seven patients and intestinal obstruction in two patients.In 177 patients with CD,104 patients were male (58.8%),and the median age at diagnosis was 22.0 (18.0 to 29.0) years.The primary symptoms were abdominal pain (88.7%,157/177),diarrhea (55.9%,99/177),anemia (63.8%,113/177),fever (33.3%,59/177)and weight loss (59.9%,106/177).During the disease course,30 patients (16.9%)had intestinal perforation (mainly chronic),12 patients (6.8%)had intestinal obstruction and seven patients (4.0%)had severe gastrointestinal bleeding.Compared to CD patients,male patients were more common in ITCL (χ2 =8.837,P <0.01),age at diagnosis was older (χ2 =314.5,P <0.01),the disease course was shorter (U=385.0,P <0.01),weight loss (χ2 =5.867,P <0.05)and fever (χ2 =10.609,P <0.01)were more common in clinical symptoms and intestinal perforation and severe gastrointestinal bleeding were more common in complications (χ2 =9.185,24.908,both P <0.01).The lesions of ITCL were multiple lesions, small bowel involved in eight cases,colon involved in 14 cases and one case with esophagus involved.Under endoscopy examination,most lesions appeared as ulcerations and were segmentally distributed.Compared to CD, lymphocyte proliferation was more common in the intestinal histopathological findings of ITCL (17/18 vs 19.7%(35/177);χ2 =42.844,P <0.01)and granuloma was rare (0 vs 42.8%(76/177),χ2 =12.665,P <0.01). Among 18 patients with ITCL,nine received chemotherapy and the median survival time was two months. Conclusions Primary ITCL had non-specific symptoms and was easily misdiagnosed as CD.More attention should be paid to the differential diagnosis of the two disease.
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Objective To observe the efficacy and safety of thalidomide in refractory Crohn's disease (CD).Methods A total of 21 moderate or severe active CD patients were enrolled,who had no response to glucocorticoid and azathioprine treatment or steroid-dependent.The patients were administrated with thalidomide 100 mg/d before sleep and followed up for one year.The clinical efficacy,endoscopic findings and safety were evaluated.Results Among 21 refractory CD patients,six patients stopped medication due to adverse effect and two because of ineffectiveness,three patients continued medication not completed one year follow-up,10 patients completed one year follow-up.The clinical remission,effective and ineffective rates were 23.8％(5/21),19.0％(4/21) and 57.1％(12/21) respectively.Under endoscope,the mucosal healing,improvement and no improvement rates were 9.5％(2/21),14.3％(3/21) and 76.2％ (16/21) respectively.The adverse effect rate was 71.4％ (15/21) including rash,conspitation,sommolence,numbness of hands and feet,leucopenia and muscular soreness.The mean time of the adverse effects onset was 3.4 weeks.Conclusions Thalidomide is effective in refractory CD treatment and could be used in patients unwilling to use biological medication or receive surgery.But the adverse effects should be noted.
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Objective To assess and compare the efficacy and safety of ecabet sodium-based quadruple therapy versus bismuth-based quadruple therapy for Helicobacter pylori (Hp) eradication.Methods A multicenter,randomized,positive controlled clinical trial was carried out.The object of the study were chronic gastritis patients at 8 hospitals in Xi'an,Beijing,Shanghai and Guangzhou from June 2009 to June 2011.All patients were divided into treatment group and control group.In treatment group,patients received ecabet sodium-based quadruple therapy (two times per day,omeprazole magnesium 20 mg,amoxicillin 1000 mg,clarithromycin 500 mg and ecabet sodium 1.0 g each time for 10 days.In control group,patients were assigned to receive bismuth-based quadruple therapy (two times per day; omeprazole magnesium 20 mg,amoxicillin 1000 mg,clarithromycin 500 mg and bismuth potassium citrate 220 mg each time) for 10 days.The Hp eradication was determined by 13C or 14C urea breath test at the 38th day after the treatment and the eradication rate was calculated.Side effects were recorded and analyzed.The data were analyzed by chi square test and Fisher's exact test.Results A total of 311 patients were recruited,and 155 patients were allatted in treatment group and 156 in control group.The per-protocol (PP) analysis indicated that the eradication rates of treatment group arid control group were 75.71％(106/140) and 77.37％(106/137) respectively,and there was no significant difference x2 =0.106,P=0.745).The intention-to-treat (ITT) analysis indicated that the eradication rates of treatment group and control group were 68.39％ (106/155) and 67.95％ (106/156) respectively,and there was no significant difference x2 =0.007,P=0.934).The side effects rates of treatment group and control group were 20.00％ (31/155) and 25.64％(40/156) respectively,and the difference was not statistically significant (Fisher's exact test,P=0.280).No serious side effect was observed in two groups.Conclusion The efficacy and safety of ecabet sodium-based quadruple therapy for Hp eradication in chronic gastritis patients may be the same as bismuth-based quadruple therapy.
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Objective To inspect the efficacy and mucosa healing condition of infliximab with azathioprine combination therapy in Crohn's disease (CD) and its correlation with prognosis.Methods A total of 20 active CD patients who received infliximab and azathioprine combination therapy at The First Affiliated Hospital of Sun Yat-sen University were objects of this study.The clinical efficacy was evaluated at 10 weeks,30 weeks,54 weeks and 2 years respectively according to CD activity index.The efficacy was evaluated under endoscopy at 10 weeks,30 weeks,54 weeks and 2 years respectively according to mucosal response situation under endoscopy.The data were analyzed by analysis of variance or Fisher's exact test between two groups.The factor affecred mucosal healing was analyzed by Logistic regression analysis.Results The clinical remission rate of patients without steroid at week 10,30,54 and 2 year were 12/20,16/20,15/20 and 15/20 respectively.Mucosal healing rate at week 10,30 and 54 weeks were 8/20,12/20 and 10/20 respectively.Logistic regression analysis indicated that age was the only factor affected mucosal healing at 30 weeks (OR =0.774,95％ CI:0.630 to 0.950).There was significant differences in clinical remission between mucosa response patients and invalid under endoscopy at 30 weeks and 2 years without steroid (at 30 weeks:14/14 vs 2/6; at 2 years:14/14 vs 1/6; all P＜0.01).Infliximab were withdrawn in 4 of 16 patients who was in non-steroid clinical remission at 30 weeks,and the other 12 patients were continued with infliximab therapy.There was no significant difference in non-steroid clinical remission rate (4/4 vs 11/12) and mucosa healing rate (2/4 vs 7/12) between withdrawal and continue of infliximab therapy (all P＞0.05).Conclusions Infliximab with azathioprine combination therapy can effectively promote and maintain mucosa healing in CD.The mucosa response patients can maintain long time non-steroid clinical remission.
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ObjectiveTo compare the efficacy of step-up and top-down infliximab therapy on patients with Crohn's disease (CD).MethodsA prospective and open-label study was performed by the First Affiliated Hospital of SUN Yat-sen University during September 2007 to December 2010.Active CD patients who were refractory to steroid/immunomodulator or who were steroid-dependent were enrolled into step-up group.Active CD patients who had no steroid or immunomodulator therapy before were enrolled into top-down group. All patients were intravenously infused with infliximab of 5 mg/kg body weight in an induction regimen of 3 doses at week 0,2 and 6,followed by maintenance dosing every 8 weeks beginning at week 14.The clinical and endoscopic follow up lasted 30 weeks.Clinical symptoms and mucosal healing status under endoscopy were evaluated by follow-up at week 10 and 30.Results Forty-one CD patients were enrolled,with 24 in step-up group and 17 in top-down group. There were significant differences in disease duration (P =0.006),combination therapy (P ＜ 0.001 ) and severity of disease ( P =0.011 ) in baseline between step-up and top-down groups.At week 10 and 30 during treatment,the clinical remission rates in step-up group were 45.8％ (11/24) and 58.3％ (14/24) respectively; the mucosal healing rates in step-up group were 33.3％ (8/24) and 54.2％ (13/24) respectively; the clinical remission rates in topdown group were 70.6％ ( 12/17)and 82.4％ (14/17) respectively; and the mucosal healing rates in topdown group were 35.3％ (6/17) and 52.9％ (9/17) respectively.No significant differences in clinical remission and mucosal healing rates at both week 10 and 30 were observed between the two groups.The prevalences of adverse events in step-up and top-down group were 41.7％ (10/24) and 29.4％ (5/17)respectively ( P =0.422).ConclusionBoth step-up and top-down infliximab therapy can induce remission in more than half of CD patients,while top-down therapy might be more benefitiary to symptom and endoscopic remission.
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Objective To evaluate the effect and mechanism of 5-aminosalicylic acid (5-ASA) on bone marrow suppression caused by thiopurines, and to explore the proper dosage of thiopurines when combined with 5-ASA for inflammatory bowel diseases (IBD) patients.MethodsThe clinical data of IBD patients who took thiopurines were retrospectively analyzed. Thiopurine methyltransferase (TPMT) activity and 6-thioguanine nucleotide (6-TGN) concentration were tested.In prospective study, patients firstly treated with azathioprine (AZA) of 50 mg/d for 4 weeks, then combined with 5-ASA of 3 g/d for another 4 weeks.The concentration of 6-TGN in red blood cells (RBC) was analyzed at the end of 4th and 8th week.Results In retrospective study, there were 45 cases in AZA/6-mercaptopurine (MP) combined with 5-ASA group, 94 patients were in AZA/6-MP.alone group.The incidence of bone marrow suppression in these two groups were 46.7％ and 16.0％, respectively.Multivariates regression analysis indicated co-administration of 5-ASA was the only risk factor of increasing bone marrow suppression incidence (OR=3.45,95％ CI 1.31 ～ 9.04).There was no significant difference of TPMT activity between AZA/6-MP combined with 5-ASA group and AZA/6-MP alone group(t=-0.351 ,P=0.734).The 6-TGN concentration was significantly higher in AZA/6-MP combined with 5-ASA group than that of AZA/6-MP alone group (the median concentration was 384.9 pmol/8× 108 RBC and 286.4 pmol/8× 108 RBC,F=29.15,P=0.00).Prospective study was completed in 8 patients.After treated with AZA of 50 mg/d for 4 weeks, the 6-TGN concentration of 7 patients was lower than 230 pmol/8 × 108 RBC.After added with 5-ASA of 3 g/d for another 4weeks, the 6-TGN concentration of 7 patients was over 230 pmol/8 × 108 RBC, three patients of those was even higher than 420 pmol/8 × 108 RBC, and bone marrow suppression occurred in 2 patients.ConclusionsThe incidence of bone marrow suppression increased in Chinese IBD patients treated with recommended routine dossage of AZA/6-MP when conbined with 5-ASA.The mechanism may be related with the increased concentration of 6-TGN in RBC.To reduce the AZA dosage may possibly keep the efficacy while decrease the incidence of bone marrow suppression.
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Objective To investigate the evaluation standard and proper time point of anti-tuberculosis trial for differential diagnosis between intestinal tuberculosis (ITB) and Crohn's disease (CD). Methods Clinical data and endoscopic changes of 28 patients with confirmed ITB and 11 with confirmed CD,who underwent anti-tuberculosis trail, were retrospectively analyzed. Results No significant difference could be found in clinical characteristics of ITB and CD patients on baseline, such as active pulmonary tuberculosis, strong positive skin test and anal fistula/perianal abscess. Clinical symptoms were relieved in both groups right after anti-tuberculosis treatment. After 3 months of treatment, the no-improvement rate in ITB group was 0, whereas that of CD group was 27.3% (P =0. 004). The disappearance rate plus improvement rate of ulcer in ITB group was 90. 9% (20/22) plus 9. 1% (2/22) and 100% ( 28/28 ) plus 0 at 3 and 6 months of treatment, respectively. The disappearance rate plus improvement rate of nodular lesion was 58. 8% (10/17) plus 41.2% (7/17) and 76. 5% (13/17) plus 23.5% (4/17), respectively. There was no obvious improvement of active ulcer or nodular transformation in CD group at any time point ( P ＜ 0. 01 ).Conclusion With deficiency of special index for differential diagnosis of ITB and CD, some cases hard to differentiate still have to accept anti-tuberculosis treatment. Three months of anti-tuberculosis treatment is a proper time point to evaluate the efficacy. Disappearance of active ulcer and nodular transformation, together with cure or obvious improvement in clinic are taken as effective for treatment trail.
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Objective To study the correlation of fecal calprotectin and lactoferrin with intestinal mucosa lesions in Crohn′s disease (CD). Methods Eighty-eight cases of diagnosed CD patients were selected as study group and 35 irritable bowel syndrome (IBS) patients were as controls. Fecal samples of CD patients were collected in one week before colonoscopy examination and of IBS patients were collected of CD patients, CD activity index (CDAI) was calculated at same visit, and CD endoscopic index (CDEI) was calculated in the subsequent endoscopic examination. The level of fecal calprotectin and lactoferrin were tested by ELISA method. Results The median levels of facal calprotectin and lactoferrin in CD patients were 277.16 mg/kg (from 96.85 to 693.57 mg/kg) and 59.68 mg/kg (from 10.75 to 100.58 mg/kg) respectively, which were significantly higher than those of IBS patients (7.6mg/kg, from 5.54 to 32.3 mg/kg and 0.65 mg/kg from 0.23 to 4.34 mg/kg), (Z=-8.301 and -7.986, respectively both P =0.000). There were no significant difference of calprotectin and lactoferrin level between CD patients with colon pathological changes and without colon pathological changes (Z=-0.424 and -0.699,P=0.672 and 0.485, respectively). There was no significant difference of calprotectin and lacoferrin level between remission and active periods in CD patients (Z=-1.491 and -1.075, P=0.136 and 0.283, respectively). The median values of calprotectin and lactoferrin of patients in moderate and severe active period judged under endoscopy were 663.11 mg/kg (from 263.45 to 2015.63 mg/kg) and 105.64 mg/kg (from 56.52 to 187.44) mg/kg respectively, in mild active period were 344.54 mg/kg (from 132.03 to 722.67 mg/kg) and 86.68 mg/kg (from 21.07 to 100.55 mg/kg) accordingly, and in remission period were 133.94 mg/kg (from 60.54 to 583.33 mg/kg) and 45.31 mg/kg (from 7.59 to 48.31 mg/kg, respectively). Both calprotectin and lactoferrin levels were significantly higher in active period than in remission period (χ2=10.63 and 8.18, while, P=0.005 and 0.017, respectively). Conclusions The level of fecal calprotectin and lactoferrin can reflect the pathological changes and severity of the intestinal mucosa.
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Objective To evaluate safety and clinical significance of single balloon enteroscopy (SBE) for small intestinal diseases. Methods Data of 83 patients with suspected or known small intestinal diseases, who underwent SBE from March 2009 to July 2010, were reviewed in terms of preparation time,procedure time, detection rate and complication occurrence. Results The 83 patients included 37 cases of digestive tract bleeding, 38 chronic abdominal pain, 1 chronic diarrhea, 2 fever and 5 incomplete ileus. A total of 94 procedures of SBE were performed, including oral route in 46 patients, anal route in 26 and both routes in 11. Excluding 6 cases with endoscopic therapy, the mean procedure time of oral approach was 29.6 ± 10. 3 min, and that of anal route was 57.1 ± 15.6 min. Abnormalities were detected in 57 ( 68.7% )of the 83 patients, with detection rate of 81.1% (30/37) in digestive tract bleeding with unknown reason,57. 8% (22/38) in chronic abdominal pain of unknown reason, 50. 0% (1/2) in fever of unknown reason and 80. 0% (4/5) in incomplete ileus. Peutz-Jeghers syndrome was diagnosed in 6 patients and endoscopic polypectomy was performed, with complicated bleeding in one patient. No other procedure-related complications were observed. Conclusion SBE is well-tolerated and safe for diagnosis of small intestine diseases,with easy manipulatiou, short procedure time, high detection rate and satisfactory location of intestinal hemorrhagic lesions.
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Objective To evaluate the efficacy and safety of azathioprine (AZA) in long term treatment of patients with active Crohn's disease (CD) in China. Methods Sixty patients with active CD,who needed to be treated with systemic steroids, were recruited. All patients initially received AZA combined with steroids therapy and AZA was maintained for treatment after withdrawal of steroids. Clinical efficacy, endoscopic healing of mucosa and adverse events were assessed at the end of the 12th, 24th, 48th, 72th and 96th weeks. Results The complete remission (CR) of the patients at the 12th, 24th, 48th, 72th and 96th weeks was 55.0%, 66. 7%, 61. 7%, 53. 3% and 53. 3%,respectively. Endoscopic examination was performed in 25 patients before treatment and at the end of the 48th week. Eight of them achieved mucosal healing that was kept to the end of 96th week (8/8).Whereas only 9 out of 17 patients without mucosal healing achieved CR at the end of 96th week (9/17,P=0. 026). The clinical features were compared between CR group and non-CR group at the end of 48th week. Logistic regression analysis showed that regaining of hs-CRP was the only independent factor for maintaining remission by AZA treatment ( P= 0. 009,OR 10.1,95 % CI 1.8 ～ 57.9). Sixteen patients (26.7 % ) had adverse events. Ten (16.7 % ) of them had to halt treatment because of serious adverse events. Leucopenia was the most common adverse event and could be occurred at any time during the treatment. Conclusion AZA combined with steroid therapy can effectively induce remission of active CD. Long term steroid-free remission is also effectively maintained by AZA treatment. The most common adverse event is leucopenia and some patients can get mucosal healing. Those who get mucosal healing may have longer duration of remission.
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Objective To investigate the effect of IVIG on pre-existing anti-HLA-A2 Ab levels and graft skin survival.Methods C57BL/6 wild type mice were sensitized to HLA-A2 by intraperitoneal injec-tion (IP) of HLA-A2 TgN mouse spleen cells (C57BL/6-TgN [HLA-2.1]1Enge SC) expressing human HLA-A2 at day 0, week 3 and 4.Sensitized mice were respectively treated with human IVIG , albumin, gly-cine, or PBS for 5 days during week 7.Skin transplantation from TgN mice to C57BL/6 wild type mice was performed at week 10 .Efficacy of IVIG DES was assessed by measuring anti-HLA Ab levels by ELISA pre-/post-Rx and graft skin survival was monitored daily post-Tx.Results Changes of HLA-A2-IgG levels:IgG HLA-A2 class I Ab levels in all groups predictably increased from baseline following spleen cell IP and peaked at week 4 ( P 0.05 ) . Conclusion However, IVIG alone does not inhibit anti-HLA class I Ab production after skin transplanta-tion or prolong SG survival , indicating combination of IVIG with other immunosuppressant or more optimal protocol for desensitization might show more efficacy and should be under explored .