Multiplexed cytokine profiling of serum for detection of colorectal cancer.

AIM: To evaluate the concentrations of eight cytokines in order to identify potential biomarkers for assisting in the detection of colorectal cancer. MATERIALS & METHODS: The concentrations of IFN-γ, IL-10, IL-6, IL-8, TNF-α, MMP-2, MMP-7 and MMP-9 were detected in the sera of 69 healthy controls, 93 colorectal adenoma patients and 149 colorectal cancer (CRC) patients. RESULTS: Multivariate logistic regression analyses, which included CEA, CA199, IL-8, TNF-α and MMP-7, were used to evaluate the diagnostic value for differentiating between colorectal adenoma and CRC. The area under the curve was 0.945 (95% CI: 0.909-0.981). The sensitivity and specificity were 85.86 and 96.78%, respectively. Compared with the conventional biomarkers CEA and CA199, multivariate logistic regression showed significant improvement. CONCLUSION: Our data demonstrated that testing using a panel of three serum cytokines, CEA and CA199 may have strong potential to assist in the detection of CRC.

Comparing 3-hour pH monitoring in esophagus with 24-hour pH monitoring to diagnose GERD.

BACKGROUND/AIMS: Ambulatory pH monitoring is an invasive method and it would bring some discomfort for patients to wear the probe for prolonged periods. A short time pH monitoring may be more acceptable with high compliance. Our aim is to determine whether analyzing a 3-hour (prandial and postprandial) period from an ambulatory 24-hour pH monitoring in esophagus would be as sensitive as the routine test. METHODOLOGY: Patients had been called for esophageal manometry and ambulatory 24-hour pH monitoring. 3-hour data were analyzed from the standard ambulatory 24-hour pH recording. GERD was confirmed if pH was less than 4.0 for more than 4% of 24 hours, the data were then reanalyzed by determining the percent time of pH < 4.0 during a 3-hour period. Kappa test and Mc-nemar test were used in the study. RESULTS: Two hundred twenty-one patients met the entrance criterion. The 3-hour test had a sensitivity of 86% when compared to the 24-hour test and a specificity of 84%. Kappa test and Mc-nemar test verified the two monitor periods were considerable consistency. CONCLUSION: 3-hour analysis is sensitive and specific test for demonstrating GERD. By using this test, patients can suffer less discomfort and appear enhanced compliance.

Alteration of Fungal Microbiota After 5-ASA Treatment in UC Patients.

The effect of treatment regimens on fungal microbiota is unclear in ulcerative colitis (UC) patients. Here, we aimed to clarify the effect of 5-aminosalicylic acid (5-ASA) treatment on gut fungal microbiota in UC patients. Fifty-seven UC patients, including 20 treatment-naïve and 37 5-ASA-treated, were recruited into an exploration study. We compared the gut fungal profiles of these 2 groups of patients using ITS1-2 rDNA sequencing. Ten out of 20 treatment-naïve UC patients were followed up and enrolled for a validation study and underwent a 5-ASA treatment. We assessed the longitudinal differences of fungal microbiota in these patients before and after 5-ASA treatment. Results acquired from the validation study were accordant to those from the exploration study. Ascomycota was the dominant phylum in both noninflamed and inflamed mucosae. At the phylum level, Ascomycota decreased in inflamed mucosae before 5-ASA treatment. At the genus level, pathogens such as Scytalidium, Morchella, and Paecilomyces increased, and Humicola and Wickerhamomyces decreased in inflamed mucosae. After 5-ASA treatment, Ascomycota and Wickerhamomyces increased and Scytalidium, Fusarium, Morchella, and Paecilomyces decreased in both noninflamed and inflamed mucosae. Additionally, the balanced bacteria-fungi correlation was interrupted in inflamed mucosae, and 5-ASA treatment altered group-specific fungal microbiota and restored bacteria-fungi correlation in UC patients. Our results demonstrated that fungal diversity and composition were altered and the bacteria-fungi correlation was restored in inflamed mucosae after 5-ASA treatment.

Advances in predicting efficacy and prognostic markers of immunotherapy for gastric cancer / 国际肿瘤学杂志

The high intra- and inter-tumor heterogeneity of gastric cancer leads to a great difference in the immunotherapy efficacy and the prognosis among patients. Several biomarkers, including programmed death-ligand 1, human epidermal growth factor receptor 2, the features of tumor microenvironment, the peripheral blood inflammatory markers and Claudin18.2 have predictive value in the immunotherapy efficacy and the prognosis of gastric cancer patients, which might help the clinicians find the potential patients who will benefit from immunotherapy, and achieve the goal of precision medicine.

Clinical remission and transmural healing of ustekinumab in patients with Crohn's disease / 北京大学学报(医学版)

Objective:To treat the Crohn's disease(CD)patients with ustekinumab(UST),to eva-luate their clinical and endoscopic remission,and to evaluate their transmural response(TR)and trans-mural healing(TH)condition using intestinal ultrasonography(IUS).Methods:Retrospective analysis was made on patients diagnosed with CD in Peking University People's Hospital from January 2020 to Au-gust 2022,who were treated with UST for remission induction and maintenance therapy.All the patients were evaluated on both week 8 and week 16/20 after treatment,including clinical,biochemical indica-tors,colonoscopy and IUS examination.Results:A total of 13 patients were enrolled in this study,inclu-ding 11 males and 2 females.The minimum age was 23 years,the maximum age was 73 years and the mean age was 36.92 years.All the patients were in the active stage of disease before treatment,and the average Best Crohn's disease activity index(Best CDAI)score was 270.12±105.55.In week 8,the Best CDAI score of the patients decreased from 270.12±105.55 to 133.16±48.66(t=4.977,P＜0.001).Eight patients achieved clinical remission while 5 patients remained in the active stage.Nine patients underwent colonoscopy evaluation.The average simple endoscopic score for Crohn's disease(SES-CD)score decreased from 10.71±7.14 before treatment to 6.00±7.81(t=2.483,P=0.048)in week 16/20.Four patients achieved endoscopic remission while 5 patients did not.In week 8,5 pa-tients achieved TR,2 patients achieved TH,the other 6 patients did not get TR or TH.In week 16/20,6 patients achieved TR,3 patients achieved TH while the other 4 patients did not get TR or TH.There was no significant statistical difference in the TR effect of UST between small intestine and colon lesions(Fisher test,P＞0.999).The rate of UST transmural response in the patients who had had previous bio-logical agent therapy was lower than those with no previous biological agent therapy,but there was no sig-nificant statistical difference(Fisher test,P=0.491).Conclusion:After treatment of UST,the clinical and endoscopic conditions of the CD patients had been improved,and some patients could achieve clini-cal remission and endoscopic remission.UST had good TR and TH effects on CD.TR might appear in week 8,and the TR effect increased in week 16/20.There was no significant statistical difference in the TR effect between small intestine and colon lesions.TR effect of UST was better in the patients who had no previous biological agent therapy than those who had had other biological agents,but the result had no significant statistical difference.

Pharmaceutical care in a case of myocardial infarction complicated with antithrombotic therapy after tricuspid valve repair / 药学实践与服务

Objective To investigate the antithrombotic therapy for acute myocardial infarction patients after PCI stenting combined with tricuspid valve repair. Methods The risk of bleeding and embolization was evaluated, relevant data were reviewed, professional knowledges of pharmacy were utilized through the whole treatment process, individualized medication plan for patients was designed and used. Results A better therapeutic effect was achieved through the implementation of pharmaceutical care and medication education to the patients. Conclusion Clinical pharmacists carry out pharmaceutical care in antithrombotic drugs utilities，which could improve the safety level of drug use and provide basis for clinical rational drug use.

The value of laboratory parameters in predicting endoscopic manifestations of ulcerative colitis after treatment / 中华消化杂志

Objective:To explore the significance of laboratory parameters in predicting the endoscopic manifestations of ulcerative colitis (UC) after treatment.Methods:From January 2015 to December 2020, the clinical data of 68 patients with UC hospitalized and treated in Peking University People′s Hospital were retrospectively and continuously collected. According to the degree of bleeding, vascular pattern, erosion and ulcer under endoscopy before and after treatment, they were divided into progressive group (post-treatment ulcerative colitis endoscopic index of severity (UCEIS) score higher than pre-treatment) and non-progressive group (post-treatment UCEIS score equal to or lower than pre-treatment). The baseline platelet count, platelet volume, platelet hematocrit, platelet distribution width, serum albumin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and related laboratory parameters were compared between the two groups. And analyzed the significance of related laboratory indexes in predicting the endoscopic manifestations of UC after treatment. Independent sample t test and receiver operating characteristic curve (ROC) analysis were used for statistical analysis. Results:According to the degree of bleeding under endoscopy before and after treatment, the patients were divided into progressive group (12 cases) and non-progressive group (56 cases). The baseline platelet count and platelet volume of the progressive group were higher than those of the non-progressive group ((375.58±154.30) ×10 9/L vs. (288.22±103.76) ×10 9/L, (9.29±1.13) fL vs.(8.52±1.29) fL), and the differences were statistically significant ( t=2.40 and 2.08, P=0.019 and 0.049). According to the degree of vascular texture under endoscopy before and after treatment, the baseline platelet volume and serum albumin level of the progressive group (9 cases) were higher than those of the non-progressive group (59 cases) ((9.58±1.18) fL vs. (8.54±1.26) fL, (41.49±5.08) g/L vs. (36.63±6.14) g/L), and the baseline CRP of the progressive group was lower than that of the non-progressive group (2.26 mg/L(0.95 mg/L) vs.8.64 mg/L (26.08 mg/L) ), and the differences were statistically significant ( t=2.32, 2.32, and z=-2.27, P=0.022, 0.047 and 0.045). According to the degree of erosion and ulcer under endoscopy before and after treatment, CRP and ESR of the progressive group (16 cases) were lower than those of the non-progressive group (52 cases) ((2.21 mg/L(5.26 mg/L) vs. 10.63 mg/L(29.97 mg/L), 14.50 mm/1 h (15.25 mm/1 h) vs.17.00 mm/1 h (11.00 mm/1 h)), and the differences were statisticaly significant ( z=-3.64 and -2.42, P=0.001 and 0.020). The cutoff value of baseline platelet count to assess the progression of bleeding under endoscopy after treatment was 336×10 9/L (sensitivity=0.636, specificity=0.852, area under the curve=0.698). The cutoff value of baseline CRP to assess the progression of erosion and ulcer under endoscopy after treatment was 3.44 mg/L (sensitivity=0.750, specificity=0.727, area under the curve=0.727). Conclusions:The baseline platelet volume, serum albumin and ESR are suggestive of endoscopic mucosal changes in patients with UC after treatment. The baseline platelet count and CRP can predict the efficacy in patients with UC.

Efficacy analysis of endoscopic submucosal dissection and transanal endoscopic microsurgery in the treatment of rectal neuroendocrine tumors / 中华消化杂志

Objective:To compare the short- and long-term efficacy and safety of endoscopic submucosal dissection (ESD) and transanal endoscopic microsurgery (TEM) in the treatment of rectal neuroendocrine tumor (NET) with maximum diameter ≤20 mm.Methods:From January 1, 2014 to June 30, 2022, the clinical data of 111 patients with rectal NET with maximum diameter ≤20 mm treated by ESD or TEM at Peking University People′s Hospital were retrospectively analyzed. According to the treatment of ESD or TEM, 111 patients with rectal NET were divided into ESD group (76 cases) and TEM group (35 cases). The clinicopathological characteristics (age, distance from anal margin, depth of invasion, etc.) were compared between patients with tumor maximum diameter<10 mm and 10 to 20 mm, and between ESD group patients and TEM group patients. The clinical efficacy and prognosis were also compared between ESD group and TEM group. The follow-up time was 41 months (16 months, 76 months). The propensity score matching (PSM) method was used to balance the differences of clinical characteristics between ESD and TEM groups. Independent sample t test, Wilcoxon rank-sum and chi-square test were used for statistical analysis. The risk factors of lymph node or distant metastasis were analyzed by univariate and multivariate binary logistic regression. Results:The maximum tumor diameter of 111 patients with rectal NET was (6.6±0.3) mm (ranged from 2 to 20 mm). The maximum tumor diameter of 85 cases (76.6%) was <10 mm and that of 26 cases (23.4%) was between 10 mm and 20 mm. There were statistically significant differences in age, distance from the anal margin and incidence of submucosal infiltration between patients with tumor maximum diameter<10 mm and patients with tumor maximum diameter 10 to 20 mm ((49.8±11.6 ) years old vs. (56.8±13.8) years old; 5.0 cm (4.0 cm, 8.0 cm) vs. 8.0 cm (5.0 cm, 8.0 cm); 69.4%, 59/85 vs. 96.2%, 25/26; t=2.58, Z=-2.23, χ2=6.35, P=0.011, 0.026 and 0.012). The en block resection rate of rectal NET treated with ESD or TEM was 100.0%(111/111), the complete resection rate was 93.7% (104/111), and the postoperative bleeding rate was 2.7% (3/111). There were no postoperative perforation or other major complications. During the follow-up period, there was no local recurrence. The metachronous recurrent rate was 0.9% (1/111), 3.6% (4/111) patients had lymph node or distant metastasis, and there was no death. Compared with patients with tumor maximum diameter<10 mm, more patients with tumor maximum diameter of 10 to 20 mm selected TEM (57.7%, 15/26 vs. 23.5%, 20/85), and the difference was statistically significant ( χ2=10.76, P=0.001). Before PSM, a total of 7 patients in the ESD group had positive vertical margins, and during the follow-up of 21 months (15 months, 48 months), 2 patients had lymph node or distant metastasis and received surgery. The proportion of patients with tumor maximum diameter of 10 to 20 mm and submucosal invasion in TEM group were both higher than those in ESD group (42.9%, 15/35 vs. 14.5%, 11/76; 88.6%, 31/35 vs. 69.7%, 53/76), and the differences were statistically significant( χ2=10.76 and 3.65, P=0.001 and 0.032). After PSM, there were no statistically significant differences in the complete resection rate, postoperative bleeding rate, metachronous recurrence rate, lymph node or distant metastasis rate between ESD group and TEM group (89.3%, 25/28 vs.100.0%, 28/28; 3.6%, 1/28 vs. 0, 0/28; 3.6%, 1/28 vs. 0, 0/28; 0, 0/28 vs.3.6%, 1/28; all P>0.05). However, the operation time and hospital stay of the ESD group were both shorter than those of the TEM group (27.0 min (25.0 min, 30.0 min) vs. 39.0 min (32.0 min, 45.0 min); 5.0 d (4.0 d, 5.0 d) vs. 6.0 d (3.0 d, 9.0 d)), and the differences were statistically significant ( Z=-3.38 and -2.23, P=0.001 and 0.021). Conclusion:The efficacy of ESD and TEM in rectal NET with maximum diameter ≤ 20 mm is equal, however, ESD has the advantage of shorter procedure time and hospital stay.

Efficacy and influencing factors of ursodeoxycholic acid in the treatment of cholesterol gallstone / 中华消化杂志

Objective:To study the efficacy and influencing factors of ursodeoxycholic acid (UDCA) in the treatment of cholesterol gallstone, so as to provide reference for the treatment of cholesterol gallstone by internal medicine.Methods:From March 1, 2017 to March 31, 2018, at outpatient department of gastroenterology of 9 Beijing medical centers including Peking University People′s Hospital, the Sixth Medical Center of PLA General Hospital, Beijing Huaxin Hospital, PLA Rocket Force Characteristic Medical Center, Peking University Aerospace Center Hospital, Beijing Youan Hospital of Capital Medical University and Beijing Tiantan Hospital of Capital Medical University, Beijing Tongren Hospital of Capital Medical University, and Beijing Shijitan Hospital of Capital Medical University, the data of patients with cholesterol gallstone treated by UDCA were collected. The inclusion criteria were that the largest diameter of stone was ≤10 mm and the stone was not detected under X-ray. The treatment plan was taking UDCA orally for 6 months at a dose of 10 mg·kg -1·d -1. The basic information of patients, the ultrasound examination results before treatment and 6 months after treatment, and scores of biliary abdominal pain and dyspepsia symptom were collected. Univariate and multivariate logistic regression were used to analyze the influencing factors of the efficacy in gallstrone dissolution by UDCA, and Wilcoxon signed rank test was used for statistical analysis. Results:A total of 215 patients were enrolled. The complete dissolution rate of gallstone was 19.5% (42/215) and partial dissolution rate was 50.7% (109/215), and the total effective rate was 70.2% (151/215). The complete dissolution rate of sandy stone was significantly higher than that of lumped stones (37.0%(17/46) vs. 14.8%(25/169); OR=3.377, 95% confidence interval (95% CI) 1.621 to 7.035, P=0.001). In lumped stones, the complete dissolution rate of the stones with diameter ≤5 mm was significantly higher than that of the stones with diameter >5 mm (37.5%(9/24) vs. 11.0%(16/145); OR=4.837, 95% CI 1.823 to 12.839, P=0.002). The complete dissolution rate of patients with higher body mass index ( OR=0.872, 95% CI 0.764 to 0.995, P=0.043) and longer disease course ( OR=0.942, 95% CI 0.912 to 0.973, P<0.001) was low. The results of multivariate logistic analysis indicated that long disease course of gallstone ( OR=0.940, 95% CI 0.908 to 0.974, P=0.001), rough gallbladder wall ( OR=0.438, 95% CI 0.200 to 0.962, P=0.040) and lumped stone ( OR=0.236, 95% CI 0.101 to 0.550, P=0.001) were independent risk factors of influencing the efficacy of stone dissolution by UDCA. As for lumped stones, the independent risk factors included long disease course of gallstone ( OR=0.926, 95% CI 0.877 to 0.978, P=0.006) and stone diameter >5 mm ( OR=0.142, 95% CI 0.043 to 0.470, P=0.001). After 6 months of UDCA treatment, score of biliary abdominal pain decreased from 0 (0 to 6) to 0 (0 to 0) and the score of dyspepsia symptom decreased from 1 (0 to 2) to 0 (0 to 0), and the differences between before treatment and after treatment were statistically significant ( Z=-8.50, and -9.13, both P<0.001). Conclusions:UDCA has a certain efficacy in cholesterol gallstone dissolution and can ease biliary abdominal pain and dyspepsia symptom. Long disease course of gallstone, rough gallbladder wall and stone diameter >5 mm are independent risk factors of poor efficacy in gallstone dissolution by UDCA.

Safety analysis of endoscopic retrograde cholangiopancreatography and its associated treatments in the elderly / 中华老年医学杂志

Objective:To investigate the safety of endoscopic retrograde cholangiopancreatogra-phy(ERCP)and its associated treatments in the elderly aged 65 years and over, and analyze the related factors leading to postoperative complications.Methods:Totally 512 patients who received ERCP and its associated treatments in the Department of Gastroenterology, Peking University People's Hospital from January 2013 to January 2019 were included retrospectively.The clinical data, operative procedures and postoperative complications were collected.The differences in underlying diseases, operative procedures and postoperative complications between the elderly group(≥65 years old, n=301)and the non-elderly group(n=211)were compared, and the correlations between them were analyzed.Results:The proportion of hypertension, diabetes, heart disease and diverticulum beside the nipple was higher in the elderly group than in the non-elderly group(all P<0.01). The proportion of preoperative medication of anticoagulant and antiplatelet drugs was higher in the elderly group than in the non-elderly group(all P<0.01). There were no significant differences in cholelithiasis, history of biliary surgery, history of ERCP, immunity disease and tumor between the two groups(all P>0.05). Endoscopic sphincterotomy was the most common ERCP-associated treatments in both groups, followed by the order of endoscopic balloon dilation of the nipple, endoscopic biliary stent drainage, pancreatic duct intubation, and pancreatic duct stenting.The proportions of endoscopic papillary balloon dilation and endoscopic biliary stent drainage were 34.6%(104 cases)and 18.9%(57 cases)respectively, in the elderly group, which were statistically significantly higher than 25.6%(54 cases)and 11.4%(24 cases)in the non-elderly group(all P<0.05). The common bile duct diameter and maximum stone diameter were(1.32±0.43)cm and(1.04±0.53)cm, respectively in the elderly group, which were statistically significantly higher than those in the non-elderly group(1.16±0.40)cm and(0.81±0.03)cm respectively, ( t values were -4.23 and -4.76, respectively, all P<0.01). The proportions of endoscopic papillary balloon dilation and biliary stent drainage were statistically significantly higher in elderly patients than in non-elderly patients(all P<0.05). The incidence of intraoperative bleeding was 4.0%(12 cases)and 5.7%(12 cases)in the elderly group and non-elderly group, respectively, with no statistical significance( χ2=0.08, P>0.05). There was no significant difference in the incidence of postoperative pancreatitis, bleeding, perforation, infection and contrast agent-related complications(all P>0.05). Conclusions:Clinically widely used high-risk endoscopic papillary balloon dilation and endoscopic biliary stent drainage(ERCP-associated treatments)are frequently performed in elderly patients, and do not increase intraoperative bleeding and postoperative complications in the elderly.Therefore, ERCP-associated treatments are safe for the elderly.

Diagnosis of routine endoscopic images of gastric lesions through a deep convolutional neural network / 中华消化内镜杂志

Objective:To develop a deep convolutional neural network (CNN) to automatically detect gastric lesions in endoscopic images.Methods:A CNN-based diagnostic system was constructed based on ResNet-34 residual network structure and DeepLabv3 structure, and trained by using 17 217 routine gastroscopy images.These images were from 1 121 gastric lesions of five types acquired in Peking University People′s Hospital between 2012 and 2018, namely peptic ulcer (PU), early gastric cancer (EGC) and high-grade intraepithelial neoplasia (HGIN), advanced gastric cancer (AGC), gastric submucosal tumors (SMTs), and normal gastric mucosa without lesions. The trained CNN was evaluated through a test dataset that contained 1 091 routine gastroscopy images of 237 gastric lesions. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the CNN were calculated.Results:The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the CNN-assisted diagnosis of EGC and HGIN were 78.6% (33/42), 84.4% (27/32), 60.0% (6/10), 87.1% (27/31), and 54.5% (6/11), respectively. The accuracy, sensitivity, and specificity of CNN-assisted diagnosis of PU were 90.4% (47/52), 92.7% (38/41), and 81.8% (9/11), respectively, the outcomes of AGC were 88.1% (52/59), 91.8% (45/49), and 70.0% (7/10), respectively, and those of gastric SMTs were 86.0% (43/50), 89.7% (35/39), and 72.7% (8/11), respectively. The CNN′s recognition time for all images of the test set was 42 seconds.Conclusion:The constructed CNN system, as a rapid and accurate auxiliary diagnostic instrument, can detect not only EGC and HGIN but also other gastric lesions.

Analytical Solution and Finite Element Analysis of Coronary Stent under Vascular Systolic Pressure / 医用生物力学

Objective To deduce analytic solution of the displacement and stress distributions for the coronary stent based on reasonable assumptions, and to investigate the influence from the wave number of support bars on stress distributions by combining the results of finite element analysis. Methods A local cylindrical coordinate system was established to deduce analytical solution of the displacement and stress components of the periodic support bar of the rectangular-wave type vascular stent under vascular systolic pressure. The support bar model was established by using ANSYS, to calculate the numerical results of stress analysis. By analyzing the consistency of stress curves obtained from the two methods, the accuracy and applicability of analytical solutions were verified. The influence from the number of wave crests for support bars on the stress under systolic pressure was investigated by analytic solution. Results The analytical stress curves were basically in conformity with those from the ANSYS results. When the number of wave crests was 6, there were both tensile and compressive stresses in circumferential direction of the cross bar. Conclusions When the number of wave crests was 6, such stents could effectively prevent restenosis in blood vessels during working. The derived analytical solution could be used to analyze mechanical properties of one-cycle support bars of rectangular-wave type stent, and the research findings provided a new idea to further recognize and study the stress distributions on coronary stent to reduce the restenosis rate of interventional therapy.

Corticosteroid therapy for autoimmune pancreatitis / 临床肝胆病杂志

Autoimmune pancreatitis (AIP) is a special type of autoimmune-mediated chronic pancreatitis and has unique imaging, serological, and histopathological features. According to current international guidelines, AIP is classified into type I and type II. Studies have shown that glucocorticoids have a good clinical effect in the treatment AIP, and the guidelines recommend oral glucocorticoids as the preferred treatment regimen for patients without contraindications. However, no consensus has been reached on initial dosage of glucocorticoids and treatment regimens after recurrence. Therefore, with reference to recent research advances and recommendations in guidelines, this article elaborates on the selection of treatment regimens for AIP from the aspects of the selection and treatment of previously untreated AIP patients and the treatment of patients with recurrence.

Improving the management level of clinical trial based on the establishment of drug clinical trial center pharmacy / 中华医学科研管理杂志

Objective To discuss our drug clinical trial institution's experience and findings during the process of establishing drug clinical trial central pharmacy.Methods Analyze the previous key issues identified during the drug management under different modes,discuss the necessity and feasibility of establishing drug clinical trial central pharmacy.Meanwhile,discuss the planning and construction of hardware including location site of the central pharmacy,equipment and facilities,staff,as well as software such as electronic management system and standard operation procedures.Results After the adoption of central trial pharmacy,space and energy are saved,manpower and material resources are saved,the quality of clinical trials also improved.Conclusions Standardized and unified management of investigational drugs through establishing drug clinical trial central pharmacy,is the strong guarantee for the drug safety of human subject,as well as the accuracy and scientificity of trial results.

The clinical characteristics and endoscopic findings in the elderly patients with cirrhosis and variceal bleeding / 中华普通外科杂志

Objective To analyze the clinical characteristics and endoscopic findings in the elderly cirrhotic patients with variceal bleeding.Method In this study,181 cirrhotic patients with variceal bleeding cltnically and endoscopically diagnosed from May 2011 to May 2016 were divided into ≥60 years of age group (58 cases) and control group (＜ 60 years of age,123 cases).Clinical data and endoscopic findings were compared retrospectively.Results The cirrhosis caused by virus and alcohol (15/58,62/123) was less in elderly group,but autoimmune disease and non-alcoholic fatty liver disease was more common (14/58,12/58)(x2 =7.452,P =0.004).The incidence rate of hypertension and coronary artery disease was higher in elderly group (20/58,7/58,x2 =6.124,12.764,P =0.012,0.001).However,there was no difference in the incidence rate of diabetes between the two groups (P ＜ 0.05).Gastric varices bleeding was higher in the elderly group (x2 =3.965,P =0.049).The gastric varices located in cardia were more in the elderly group (37.93％,22/58) than control (34.96％,43/123),(x2 =4.124,P =0.044).The rate of EIS was higher in the elderly group and cyanoacrylate injection was less than control (x2 =3.621,P =0.046).Conclusions Compared with those of ＜ 60 years of age,the causes and endoscopic findings and treatment are different cirrhotic variceal bleeding in patients ≥60 years of age.

Clinical characteristics and endoscopic findings in patients with cirrhotic upper gastrointestinal variceal bleeding / 中华普通外科杂志

Objective To analyze the clinical characteristics and endoscopic findings in patients with cirrhosis and upper gastrointestinal variceal bleeding (UGIB) and to evaluate the risk factors of rebleeding after endoscopic therapy.Method Between May 2010 and May 2017,383 patients who diagnosed with cirrhosis and UGIB were enrolled.Results The incidence of rebleeding was 8.88％ (n =34).In the univariate analysis,advanced age (P =0.362,OR =0.662),male (P =0.036,OR =2.975),cause of cirrhosis (P =0.047,OR =2.512),Child-Pugh scores (P =0.026,OR =1.852),prothrombin time (P =0.017,OR =3.746),thrombocytopenia (P =0.445,OR =0.577),severe varices (P =0.314,OR =0.745),red color sign (P =0.016,OR =4.013),portal vein diameter (P =0.365,OR =1.026),portal thrombosis (P =0.027,OR =1.954) were risk factors for rebleeding following endoscopic therapy.In the non-condition multivariate logistic regression analysis,male (P =0.036,OR =2.975),autoimmune liver disease (P =0.047,OR =2.512),Child-Pugh scores (P =0.026,OR =1.852),prothrombin time (P =0.017 OR =3.746),red color sign (P =0.016,OR =4.013),portal thrombosis (P =0.027,OR =1.954) were independent risk factors for rebleeding following endoscopic therapy.Conclusions Esophagogastric variceal rebleeding is common after a successful initial endoscopic therapy.Independent risk factors for rebleeding are male,autoimmune liver disease,elevated Child-Pugh scores,prolonged thrombin time,portal vein thrombosis and red color sign.

Clinical Study on Treatment of Decreased Ovarian Reserve by Yishen Huayu Decoction / 中国中医药信息杂志

Objective To observe the clinical efficacy of Yishen Huayu Decoction for decreased ovarian reserve (DOR). Methods Eighty cases of DOR were randomly divided into 2 groups, with 40 cases in each group. The treatment group was treated with oral administration of Yishen Huayu Decotion, one dose a day. The control group was given DHEA, a time of 1 tablet, 3 times a day. 2 groups were observed for 3 menstrual cycles. The levels of basic follicle stimulating hormone (bFSH), basal estradiol (bE2), luteinizing hormone (LH) and serum anti-Müllerian hormone (AMH) were measured. The number of basal follicles and the peak systolic velocity (PSV) were monitored by transvaginal sonography. Quality of life assessment and basal body temperature were measured. Results The total effective rate was 85.00% (34/40) in the treatment group and 62.50% (25/40) in the control group, with statistical significance (P<0.05). After treatment, the levels of bE2 and bFSH decreased, and the levels of AMH, ovarian antral follicles and PSV increased, which were significantly different from those before treatment (P<0.05). After treatment, the levels of bE2 and bFSH in the treatment group were lower than those in the control group, and the levels of AMH, ovarian antral follicle and PSV were higher than those in the control group, with statistical significance (P<0.05). The recovery rate of basal body temperature was 77.50%(31/40) in the treatment group and 52.50%(21/40) in the control group, with statistical significance (P<0.01). After treatment, the scores of four dimensions of life quality, daily activities, health status and self-perception were significantly improved (P<0.01), and the treatment group was higher than the control group (P<0.01). Conclution Yishen Huayu Decotion can improve the ovarian reserve function and the life quality of patients with DOR.

Clinical, endoscopic, pathologic and prognostic factors of primary gastric lymphoma / 中华消化杂志

Objective To explore the clinical,endoscopic,pathologic and prognostic characteristics of primary gastric lymphoma (PGL) and to improve the level of diagnosis and treatment.Methods Sixtythree patients who were confirmed as PGL with operation and endoscopic biopsy pathology during January 2001 to December 2010 were retrospectively analyzed with respects of clinical,endoscopic and pathologic features.Survival analysis and prognosis were evaluated by kaplan-Meier and Cox proportional hazard model,respectively.Results In 63 PGL patients,the numbers of male and female were 40 and 23,respectively,and the average age was (59.8±13.3)years.The major symptoms were abdominal pain,abdominal distension,and gastrointestinal hemorrhage,accounting for 47.6 ％ (30/63),17.5 ％ (11/63),and 17.5 ％ (11/63),respectively.There were 39 (61.9 ％) PGL patients with endoscopic performance for ulcers,34 (54.0 ％) cases involved the gastric stomach antrum.The most immunohistochemistry analyses were diffuse large B-cell lymphoma (DLBCL) (71.4 ％,45/63),followed by mucosa-associated lymphoid tissue (MALT) lymphoma (22.2％,14/63).The frequency of Helicobacter pylori (H.pylori) positivity was lower in patients with DLBCL than that in patients with MALT lymphoma (37.8％(17/45) vs 10/14,x2 =4.872,P=0.027).The accumulate survival rates of one,three and five years were 74.6％,63.5％,55.6％,respectively,and the average survival time was (41.5±3.0) months (95％ confidence interval (CI) 35.7 to 47.4 months) in PGL patients.There was no difference in the average survival time between DLBCL patients treated with surgery combined chemotherapy and those with surgery or chemotherapy alone (38.33±5.21) months vs (50.17±8.98) months vs (41.39±4.40) months,P＞0.05).The patients diagnosed as DLBCL with H.pylori positive had longer average survival time than those with H.pylori negative ((51.90±4.30) months vs (33.30±4.50) months,t=-4.004,P＜0.01).Conclusions Male patients with PGL are slightly more than female.Abdominal pain is the most frequent symptom.Ulcerative lesions are the most common endoscopic demonstrations mostly at stomach sinus.DLBCL is the most pathologic characteristic.There is no significant difference in the survival rate between patients treated with surgery combined with chemotherapy and those treated with surgery or chemotherapy alone.

Association between glycosylated hemoglobin and non-alcoholic fatty liver disease in health examination population / 中南大学学报(医学版)

Objective:To investigate associations between glycosylated hemoglobin (HbA1c) levels and nonalcoholic fatty liver disease (NAFLD) in population who underwent periodic heath examination.Methods:A total of 912 subjects were selected from the health examination adults in University of Hong Kong Shenzhen Hospital from June to November 2013,and they were assigned into a NAFLD group,an else hepatic disease group,and a control group.The physical examination results of these subjects were analyzed retrospectively.Results:The prevalence of NAFLD was 29.7％.The related factors such as age,body mass index,and the levels of systolic blood pressure,diastolic blood pressure,total cholesterol,triglyceride,low density lipoprotein cholesterol,fasting glucose,HbA1c and alanine aminotransferase in the NAFLD group were higher than those in the else hepatic disease group and the control group (P＜0.05).Aspartate aminotransferase levels in the NAFLD group were higher than those in the control group (P＜0.05).High density lipoprotein cholesterol levels in the NAFLD group were lower than those in the else hepatic disease group and the control group (P＜0.05).According to the quartile of HbAlc level,these subjects were divided into 4 groups,Q1,Q2,Q3,and Q4,and the prevalence of NAFLD in the Q1,Q2,Q3,and Q4 were 17.5％,21.5％,31％,and 59.4％,respectively.The prevalence of NAFLD increased along with the increase in the level of HbAlc (x2=100.092,P＜0.05).Logistic regression analysis showed that the risk factor for NAFLD was increased in the subjects of Q4 as compared with the subjects of Q1 after adjusting for the related factors including age,gender,body mass index,etc.Conclusion:There is a positive correlation between the prevalence of NAFLD and HbAlc level,and the risk of NAFLD increases with the elevating level of HbA1c.High HbA1c level is an independent risk factor for NAFLD.Thus it should be listed as a routine medical test in the health examination.

Clinical significance of liver biopsy in diagnosis of non-viral liver diseases / 中华消化杂志

Objective To observe the clinical characteristics of non-viral liver diseases which were examined by ultrasound guided liver biopsy in order to explore the significance of liver biopsy.Methods From January 2006 to December 2015,patients with non-viral liver diseases who received liver biopsy were retrospectively enrolled.Etiology,pathological diagnosis and clinical diagnosis of the patients were analyzed;the differences in disease types between male and female,among different age (less than 60 years and over 60 years)were compared;and the consistency of two pathologists in the pathological diagnosis was analyzed.Chi-square test was performed for statistical analysis.Results Among 182 patients,there were 73 (40.1％) males and 109 (59.9％) females.The most common etiology were autoimmune liver disease (68 cases,37.4％),non-alcoholic fatty liver disease (NAFLD) (40 cases,22.0％) and drug-induced liver injury (DILI) (29 cases,15.9％).The differences in etiology between male and female,between age less than 60 years and over 60 years were statistically significant (X2 =7.31 and 5.87,both P ＜ 0.05).The consistency of two pathologists in the diagnosis of NAFLD,alcoholic liver disease,hereditary metabolic disease and neoplastic disease was good (Kappa=0.85,0.88,0.75 and 1.00).The consistency rates of two pathologists in the diagnosis of autoimmune disease,NAFLD and DILI were 52.9％ (36/68),75.0％ (30/40) and 48.3％ (14/29),respectively.The consistency rate was highest in NAFLD,and the difference was statistically significant (X2 =7.68,P=0.023).However,there was no significant difference in consistency rates of two pathologists in the diagnosis of autoimmune liver disease and DILI (X2 =0.12,P=0.859).The consistency rates between pathological diagnosis and clinical diagnosis in autoimmune liver disease,NAFLD and DILI were 60.3％ (41/68),85.0％ (34/40) and 55.2％ (16/29),respectively,and the difference was statistically significant (X2 =8.98,P=0.011).The consistency rate in NAFLD was highest.However,there was no significant difference in consistency rates between pathological diagnosis and clinical diagnosis in autoimmune liver disease and DILI (X2 =0.22,P=0.639).Conclusions The liver biopsy may guide the clinical diagnosis of NAFLD.However,to improve the diagnostic rates of autoimmune liver disease and DILI,biopsy results,history and laboratory results should be combined.