1.Research on signal mining of adverse events of tizanidine based on FAERS database
Yanxin LIU ; Changjiang DONG ; Jian ZOU ; Li CHEN ; Yamin SHU ; Xucheng HE ; Pan WU
Chinese Journal of Pharmacoepidemiology 2024;33(2):166-175
Objective Based on U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,the signal mining of tizanidine adverse drug events(ADEs)was conducted to explore the occurrence characteristics of ADE,hoping to provide references for the safe clinical application of tizanidine.Methods The reporting odds ratio(ROR)and medicines and healthcare products regulatory agency methods(MHRA)were used to analyse the ADE of tizanidine using FAERS registration data from the first quarter of 2004 to the second quarter of 2022.After valid signals were obtained,the MedDRA was used for translation and system organ classification.Results A total of 7 135 reports of tizanidine ADE were obtained,including 1 732 patients,1 304 ADE types were involved.According to the results of 2 ADE signal mining methods,at the preferred term(PT)level,177 signals were detected.There were 32 PT signals not included in the drug instructions,including potassium wasting nephropathy,cardio-respiratory arrest,and foetal growth restriction etc.In 1 732 patients,the number of ADE cases of female was 2.37 times that in male(1 057 vs.446),and the age group between 40 and 64 accounted for a large proportion(36.03%).The highest proportion(32.79%)reported by consumers.The system organ class involved mainly included various neurological diseases and psychosis.The median time to onset of tizanidine-related ADEs was 75 d(interquartile range:28-223 d),but it was necessary to be vigilant that ADE may still occur 1 year after starting the drug(13.38%).Conclusion This study aims to suggest that clinical application of tizanidin-related ADE should be paid full attention to the occurrence of ADE such as potassium-wasting nephropathy and suicidally completed,as well as key populations such as women and patients of 40-64 years old.
2.Prognostic nutritional index application value for acute-on-chronic liver failure co-infection
Yamin WANG ; Yushan LIU ; Juan LI ; Qiao ZHANG ; Taotao YAN ; Danfeng REN ; Li ZHU ; Guoyu ZHANG ; Yuan YANG ; Jinfeng LIU ; Tianyan CHEN ; Yingren ZHAO ; Yingli HE
Chinese Journal of Hepatology 2024;32(3):235-241
Objective:To explore the predictive value of the prognostic nutritional index (PNI) in concurrently infected patients with acute-on-chronic liver failure (ACLF).Methods:220 cases with ACLF diagnosed and treated at the First Affiliated Hospital of Xi'an Jiaotong University from January 2011 to December 2016 were selected. Patients were divided into an infection and non-infection group according to whether they had co-infections during the course of the disease. Clinical data differences were compared between the two groups of patients. Binary logistic regression analysis was used to screen out influencing factors related to co-infection. The receiver operating characteristic curve was used to evaluate the predictive value of PNI for ACLF co-infection. The measurement data between groups were compared using the independent sample t-test and the Mann-Whitney U rank sum test. The enumeration data were analyzed using the Fisher exact probability test or the Pearson χ2 test. The Pearson method was performed for correlation analysis. The independent risk factors for liver failure associated with co-infection were analyzed by multivariate logistic analysis. Results:There were statistically significant differences in ascites, hepatorenal syndrome, PNI score, and albumin between the infection and the non-infection group ( P ?0.05). Among the 220 ACLF cases, 158 (71.82%) were infected with the hepatitis B virus (HBV). The incidence rate of infection during hospitalization was 69.09% (152/220). The common sites of infection were intraabdominal (57.07%) and pulmonary infection (29.29%). Pearson correlation analysis showed that PNI and MELD-Na were negatively correlated ( r ?=?-0.150, P ?0.05). Multivariate logistic analysis results showed that low PNI score ( OR=0.916, 95% CI: 0.865~0.970), ascites ( OR=4.243, 95% CI: 2.237~8.047), and hepatorenal syndrome ( OR=4.082, 95% CI : 1.106~15.067) were risk factors for ACLF co-infection ( P ?0.05). The ROC results showed that the PNI curve area (0.648) was higher than the MELD-Na score curve area (0.610, P ?0.05). The effectiveness of predicting infection risk when PNI was combined with ascites and hepatorenal syndrome complications was raised. Patients with co-infections had a good predictive effect when PNI ≤ 40.625. The sensitivity and specificity were 84.2% and 41.2%, respectively. Conclusion:Low PNI score and ACLF co-infection have a close correlation. Therefore, PNI has a certain appraisal value for ACLF co-infection.
3.Extracellular volume and relative electron density based on spectral CT for identifying colon cancer invasion into serous membrane
Yijie WANG ; Wei ZHAO ; Bo HE ; Yamin LI ; Yaying YANG
Chinese Journal of Medical Imaging Technology 2024;40(7):1047-1051
Objective To observe the value of extracellular volume(ECV)and relative electron density(RED)based on dual-layer detector spectral CT(DLCT)for identifying colon cancer invasion into serous membrane.Methods Sixty-two patients with pathologically confirmed colon cancer with blurred pericolonic fat gap on CT images were retrospectively collected,including 18 cases of T4a stage tumors with serous membrane invasion and 44 cases of T2-T3 stage without serous membrane invasion.The arterial,venous and delayed phase DLCT images under 40 keV showing the largest diameter of colon cancers were analyzed.The iodine concentration(IC)and RED of the pericolonic fat around tumor-bearing and tumor-free intestines,as well as of the abdominal aorta or the common or external iliac artery were measured,while normalized IC(NIC)and difference of RED(REDdiff)of pericolonic fat around tumor-bearing and tumor-free intestines in each phase and ECV in delayed phase were calculated.The above parameters were compared between tumors with different stages,and for those with significant differences,the receiver operating characteristic curves were drawn,and the areas under the curve(AUC)were calculated to evaluate and compare the efficacies for identifying invasion of serous membrane in T4a stage colon cancer.Results Compared with T2-T3 stage colon cancers,T4a stage colon cancers were found more often occurred in patients aged <50 with higher proportion of lymph node metastases(both P<0.05),also higher values of NIC and REDdiff on images in different phases,as well as ECV in delayed phase images(all P<0.05).The AUC of arterial,venous and delayed phase NIC for differentiating T2-T3 and T4a stage colon cancers ranged from 0.868 to 0.902,while of REDdiff ranged from 0.848 to 0.903,all without significant difference(all P>0.05).The AUC of delayed phase ECV was 0.948,not significant different with that of delayed phase NIC and REDdiff,arterial phase NIC nor venous phase REDdiff(all P>0.05).Conclusion Based on DLCT,ECV and RED could be used to identifying serous membrane invasion of colon cancer when blurred pericolonic fat gaps were noticed.
4.Construction of continuous nursing program for children with congenital imperforate anus based on 5W1H analysis
Ailing YANG ; Qingna PENG ; Xiaoting WANG ; Feng HE ; Na JIANG ; Yamin FENG
Chinese Journal of Practical Nursing 2023;39(13):1012-1017
Objective:Based on the framework of 5W1H analysis, to establish the continuous nursing project by delphi expert consultation method for children with congenital imperforate anus after discharge.Methods:This study is observational. Through the literature review, qualitative interview and group discussion to establish the expert correspondence questionnaire from April 2021 to March 2022. Delphi consultation was applied to experts for two rounds of expert consultation, to evaluate the initiative, authority and coordination of expert opinions.Results:Two rounds of expert consultation were carried out with 20 experts.The response rates of two rounds of expert questionnaires were 19/20 and 20/20 respectively, the expert authority coefficients were 0.873 and 0.893 respectively, and the Kendall′s coefficients were 0.311 and 0.405 respectively. The coordination of expert opinions was statistically significant ( P<0.05); After two rounds of expert consultation, it was finally determined that the continuing care plan for children with anal atresia included three first-level indicators (composition and responsibilities of continuing care personnel, implementation methods of continuing care, and implementation content of continuing care), 23 second-level indicators, and 46 third-level indicators. Conclusions:This study have high enthusiasm and authority of experts, and concentrated expert opinions on various indicators. The results are reliable, scientific and comprehensive, which will provide a basis for clinical medical staff to carry out the continuous nursing of children with congenital imperforate anus.
5.Value of peripheral blood lymphocyte count in evaluating the short-term prognosis of patients with acute-on-chronic liver failure
Xiaohua LIU ; Shujuan YANG ; Yushan LIU ; Juan LI ; Qiao ZHANG ; Yamin WANG ; Taotao YAN ; Yuan YANG ; Yingren ZHAO ; Yingli HE
Journal of Clinical Hepatology 2023;39(10):2383-2389
ObjectiveTo investigate the influencing factors for the prognosis of patients with acute-on-chronic liver failure (ACLF), and to establish a short-term prognostic model. MethodsA retrospective analysis was performed for the baseline clinical data of 247 patients with ACLF who were hospitalized in Department of Infectious Diseases, The First Affiliated Hospital of Xi’an Jiaotong University, from January 2011 to December 2016, and the patients were divided into survival group and death group. The two groups were compared to identify the influencing factors for prognosis; a prognostic model was established, and the receiver operating characteristic (ROC) curve was used to assess its predictive efficacy and determine the optimal cut-off value. The independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U rank sum test was used for comparison of non-normally distributed continuous data between groups; the Fisher’s exact test or the Pearson’s chi-square test was used for comparison of categorical data between groups. The univariate and multivariate logistic regression analyses were used to investigate the independent risk factors for 28- and 90-day prognosis, and the Kaplan-Meier method was used to plot the 28-day survival curves. ResultsA total of 220 patients with ACLF were included based on the inclusion and exclusion criteria; there were 148 patients in the 28-day survival group and 72 patients in the 28-day death group, with a 28-day transplantation-free survival rate of 67.27%; there were 115 patients in the 90-day survival group and 105 patients in the 90-day death group, with a 90-day transplantation-free survival rate of 52.27%. The logistic regression analysis showed that female sex (odds ratio [OR]=2.149, P=0.030), high Model for End-Stage Liver Disease (MELD) score (OR=1.120, P<0.001), and low lymphocyte count (OR=0.411, P=0.002) were independent risk factors for 28-day prognosis, and an LS-MELD model for 28-day prognosis was established as Logit (28-day prognosis)=-3.432+0.765×sex-0.890×lymphocyte count×10-9+0.113×MELD(1 for male sex and 2 for female sex). The ROC curve analysis showed that this model had an optimal cut-off value of 0.35, and then the patients were divided into low LS-MELD group (≤0.35) and high LS-MELD group (>0.35); the low LS-MELD group had a significantly higher 28-day survival rate than the high LS-MELD group (P<0.001). ConclusionPeripheral blood lymphocyte count combined with sex and MELD score has a certain value in predicting the short-term prognosis of ALCF patients.
6.Determination of six arsenic species in human urine by HPLC-ICP-MS
Yi HE ; Lanxia LIU ; Liming XUE ; Libei XIONG ; Yamin FANG
Shanghai Journal of Preventive Medicine 2023;35(2):182-186
ObjectiveTo establish an High Performance Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometry (HPLC-ICP-MS) method for determination of six arsenic species in human urine,including arseniccholine (AsC), arsenobetaine (AsB), arsenite (As3+), dimethylarsinic acid (DMA5+), monomethylarsonic acid (MMA5+), and arsenate (As5+). MethodsThe pH value of mobile phase and the content of anhydrous ethanol were optimized. Ammonium carbonate (50 mmol·L-1, containing 2% anhydrous ethanol, pH-8.5) mobile phase was selected. Cl- interference was eliminated by He mode. The arsenic species in 10-fold diluted human urine samples were separated by an Hamilton PRP X-100 anionic column. A method for the determination of six arsenic species was established. ResultsSix arsenic species could be separated in 13 minutes. The linear correlation coefficients were above 0.999. The limits of detection were 0.10‒0.20 μg·L-1, and the limits of quantification were 0.30‒0.50 μg·L-1. Precision experiments showed that RSD ranged from 5.96% to 9.07% when adding concentration 0.20 μg·L-1; from 2.48% to 6.38% when adding concentration 2.00 μg·L-1; and from 1.41% to 2.57% when adding concentration 5.00 μg·L-1. Accuracy test showed that the recoveries were 80%‒125%. ConclusionThe established HPLC-ICP-MS method for determination of six arsenic species in human urine is rapid, accurate and sensitive. It can be applied to the determination of arsenic species in human urine.
7.Quality assessment of guidelines on upper gastrointestinal cancer screening
Lanwei GUO ; Jiang LI ; Yamin CHEN ; Yin LIU ; He LI ; Maomao CAO ; Siyi HE ; Shaokai ZHANG ; Wanqing CHEN
Chinese Journal of Epidemiology 2021;42(7):1318-1324
Objective:To systematically evaluate the methodological quality of screening guidelines for upper gastrointestinal cancer (including esophageal cancer and gastric cancer) both at home and abroad, and provide reference for the update of upper gastrointestinal cancer screening guidelines in China.Methods:Original articles and grey literature published as of 31 th Aug 2020 were retrieved using Chinese databases (CNKI, Wanfang, China Biomedical Literature Database and China Guideline Clearinghouse), PubMed, The Cochrane Library and Embase, as well as those from International Agency for Research on Cancer and the International Guide Collaboration Network. The inclusion criteria were being independent guidelines/recommendation documents for upper gastrointestinal cancer screening and meeting the definition of the institute of Medicine, USA. The exclusion criteria were being guideline abstracts, interpretation and evaluation literature, duplicate publications, updated original guidelines, and clinical treatment or practice guidelines for esophageal or gastric cancer. Appraisal of Guidelines for Research and Evaluation (AGREE Ⅱ) and Reporting Items for Practice Guidelines in Healthcare (RIGHT) were used to compare and evaluate the quality and reporting standard of esophageal or gastric cancer screening guidelines. Results:A total of 6 esophageal cancer screening guidelines and 5 gastric cancer screening guidelines were included. The results of the AGREE Ⅱ quality evaluation showed that the overall quality of eleven guidelines varied, including two guidelines recommended for "A", one for "B", five for "C" and three for "D". The guidelines had higher scores in the areas of scope and purpose, and clarity. The esophageal cancer screening guidelines had different scores in the areas of rigor and independence. The gastric cancer screening guidelines generally had low scores in the areas of participants and application. The RIGHT evaluation results showed that the quality of eleven guidelines should be improved. The six items with poor report quality were background, evidence, recommendations, review and quality assurance, funding and conflict of interest statement and management and others.Conclusion:The quality of the included upper gastrointestinal cancer screening guidelines is general, and the standardization needs to be strengthened.
8. The effect of WT1 expression on the prognosis of allogeneic hematopoietic stem cell transplantation in acute leukemia
Bingqian JIANG ; Yi LUO ; Yanmin ZHAO ; Yamin TAN ; Jian YU ; Xiaoyu LAI ; Yuanyuan ZHU ; Jie SUN ; Weiyan ZHENG ; Jingsong HE ; Guoqing WEI ; Zhen CAI ; He HUANG ; Jimin SHI
Chinese Journal of Hematology 2018;39(12):989-993
Objective:
To study the effect of WT1 expression on the prognosis of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in acute leukemia (AL) and its significance as molecular marker to dynamically monitor minimal residual disease (MRD) .
Methods:
Retrospectively analyzed those AL patients who underwent allo-HSCT in the First Hospital Affiliated to Zhejiang University School of Medicine during Jan 2016 to Dec 2017, a total number of 314 cases, 163 males and 151 females, median age was 30 (9-64) years old. Comparing the difference of WT1 expression at diagnosed, pre-HSCT and after HSCT. Using the receiver operating characteristic (ROC) curve to determine the WT1 threshold at different time so as to predict relapse. The threshold of WT1 expression before transplantation was 1.010%, within 3 months after HSCT was 0.079% and 6 months after HSCT was 0.375%. According to these thresholds, WT1 positive patients were divided into low expression groups and high expression groups. Analyzed the relationship between overall survival (OS) , disease-free survival (DFS) , cumulative incidence of relapse (CIR) and WT1 expression.
Results:
The OS and DFS of high expression group pre-HSCT were lower than low expression group [69.2% (9/13)
9.Effects of Enalapril Maleate Folic Acid Tablets on Carotid Atherosclerosis in H Type Hypertension Patients with Type 2 Diabetes Mellitus and Its Potential Mechanism
Yuhui LUO ; Xia MEI ; Ping JIN ; Xiangqing ZHENG ; Rui HE ; Yamin LIU
China Pharmacy 2018;29(5):670-674
OBJECTIVE: To investigate the effects of Enalapril maleate folic acid tablets on carotid atherosclerosis in H type hypertension patients with type 2 diabetes mellitus (T2DM) and its potential mechanism.METHODS: In prospective control study, 182 H type hypertension patients with T2DM were selected from Chongqing People's Hospital during Jan. 2014-Jan. 2016, and then randomly divided into observation group and control group, with 91 cases in each group. All patients received basic or hypoglycemic treatment of premixed insulin; observation group was additionally given Enalapril maleate folic acid tablets (containing enalapril maleate 10 mg, folic acid 0. 8 mg in each tablet) orally, one tablet, qd; control group was additionally given Enalapril maleate tablets (containing enalapril maleate 10 mg in each tablet) orally, one tablet, qd. Treatment course lasted for 12 months. The levels of blood pressure, plasma homocysteine (Hcy), fasting blood glucose (FBG), C-reactive protein (CRP) and carotid plaque score were detected in 2 groups before treatment, 12 months after treatment. RESULTS: Compared to before treatment, SBP and DBP of 2 groups were decreased significantly in 2 groups after 12 months of treatment (P<0. 05); there was no statistical significance between 2 groups (P>0. 05). The levels of plasma Hcy, FBG and CRP, carotid intima-media thickness and carotid plaque integral in observation group were significantly lower than control group (P<0. 05). CONCLUSIONS: Enalapril maleate folic acid tablets can relieve inflammation by reducing plasma Hcy, FBG and CRP so as to treat carotid atherosclerosis in H type hypertension patients with T2DM.
10.Clinical application of tunnel technique on endoscopic submucosal dissection for colorectal laterally spreading tumor
Qide ZHANG ; Shutang HAN ; Yamin HE ; Sufeng JIANG ; Wei GE ; Yumei HU
Chinese Journal of Digestive Endoscopy 2017;34(9):630-634
Objective To investigate the clinic effect of tunnel technique on endoscopic submucosal dissection(ESD)for massive colorectal laterally spreading tumor(LST). Methods A retrospective study was conducted on the data of patients with colorectal large area LST(the shortest diameter>4 cm) undergoing ESD by tunnel technique from January 2015 to June 2016 in Digestive Endoscopy Center of Jiangsu Province Hospital of Traditional Chinese Medicine. The size of resected specimens, operation time, complications, pathology results, the number of en bloc resection and curative resection were analyzed. Results A total of 14 cases were collected, including 7 males and 7 females. The longest diameters of resected specimens were from 4.0 to 7.0 cm with mean size of 5.18 ± 0.49 cm. The operation times were from 40 to 120 min with mean time of 63.57±12.95 min. Intraoperative perforation occurred in 2 cases but no delayed perforation and bleeding occurred. Postoperative pathology showed 1 patient with adenoma hyperplasia with crypt abscess,3 patients with low grade intraepithelial neoplasia,6 patients with high grade intraepithelial neophasia,1 patient with carcinoma in situ, 1 patient with carcinoma in M3, and 2 patients with carcinoma in SM1. The number of cases who received en bloc resection, complete resection, and curative resection were 13, 13, and 13, respectively. Conclusion ESD by tunnel technique is safe and effective in the treatment of colorectal large area LST,which is worth popularizing in clinics.

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