1.Data mining of hematological adverse events related to antibody-drug conjugate based on FAERS
Huijie DENG ; Xia LIU ; Bing LI ; Qing SHAN ; Yan CHEN ; Yuhang GUO ; Jinmin GUO
Chinese Journal of Pharmacoepidemiology 2024;33(2):158-165
Objective Based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,data mining was conducted on hematological adverse events related to antibody drug conjugates(ADC),providing reference for the safe use of ADC drugs in clinical practice.Methods The report data from the third quarter of 2011 to the fourth quarter of 2022 were retrieved from the FAERS database.After data cleaning such as deduplication and name standardization,extract hematological adverse events related to ADC,and use report odds ratio method and the information component method for signal detection.Results A total of 101 610 adverse event reports were extracted,with 8 ADC drugs as the primary suspected drugs,and 5 768 ADC related hematological adverse event reports.Among them,3 423 cases of agranulocytosis were involved,and the signal intensity from strong to weak were sacituzumab govitecan(SG),gemtuzumab ozogamicin(GO),brentuximab vedotin(BV),polatuzumab vedotin(PV),enfortumab vedotin(EV),trastuzumab deruxtecan(TD),inotuzumab ozogamicin(IO)and ado-trastuzumab emtansine(TDM-1).There were 2 327 cases hematopoietic cell deficiency,with signals ranging from strong to weak were IO,SG,BV,EV,PV,TD,TDM-1,and GO.Report with clinical outcome of death of ADC drug related hematological adverse events included BV 179(16.84%),TDM-1 102(13.01%),TD 88(27.08%),GO 12(16.90%),IO 8(11.59%),EV 54(24.32%),PV 22(27.16%),and SG 84(21.05%).Adverse event time analysis showed that the number of events on the first day of TD,IO,and SG medication accounts for ≥ 40%of the total number of cases.The median time of hematological adverse events in TD,GO,IO,EV,PV,and SG was within one treatment course(21 days).Conclusion Attention should be paid to the risk of ADC drug-related hematological adverse event,during the clinical medication process,blood cell count changes should be closely monitored,and any abnormalities should be promptly diagnosed and treated.
2.Effect of oxygen blowing combined with clostridium butyricum and bifidobacterium powders in neonatal diaper dermatitis
Xia WANG ; Huijie XU ; Lin YANG
China Pharmacist 2024;28(11):445-450
Objective To explore the clinical efficacy of oxygen blowing combined with clostridium butyricum and bifidobacterium powders in neonatal diaper dermatitis(DD).Methods Data of neonatal DD patients admitted to the Department of Pediatrics of the Affiliated Hospital of Hangzhou Normal University from January 2019 to June 2021 were retrospectively analyzed.They were divided into the control group(oxygen blowing)and the experimental group(oxygen blowing combined with clostridium butyricum and bifidobacterium powders)according to whether or not they received clostridium butyricum and bifidobacterium powders treatment.The primary efficacy index of the study was the treatment efficiency,and the secondary efficacy indexes were the severity of DD(Neonatal Rash Scale score,DD score,and lesion area score),time to erythema resolution,time to vesicle resolution,and time to healing.Results A total of 99 patients were included in the study,with 42 in the experimental group and 57 in the control group.The treatment efficiency of the experimental group was significantly higher than that of the control group(P<0.05).With regard to the severity of DD,the papule and pustule scores,dermatitis extent scores,erythema severity scores,skin damage scores and lesion area scores of the experimental group were significantly lower than those of the control group(P<0.05);the proportions of moderate and severe syndrome in the experimental group were lower than those of the control group(P<0.05).The time for erythema to subside,the time for vesicles to subside and the time for healing were shorter in the experimental group than in the control group(P<0.05).Conclusion Oxygen blowing combined with clostridium butyricum and bifidobacterium powders can significantly improve the clinical effect of neonatal DD,but the specific mechanism still needs to be explored.
3.Bidirectional relationship between type 2 diabetes mellitus and coronary artery disease: Prospective cohort study and genetic analyses
Wenqiang ZHANG ; Li ZHANG ; Chenghan XIAO ; Xueyao WU ; Huijie CUI ; Chao YANG ; Peijing YAN ; Mingshuang TANG ; Yutong WANG ; Lin CHEN ; Yunjie LIU ; Yanqiu ZOU ; Ling ZHANG ; Chunxia YANG ; Yuqin YAO ; Jiayuan LI ; Zhenmi LIU ; Xia JIANG ; Ben ZHANG
Chinese Medical Journal 2024;137(5):577-587
Background::While type 2 diabetes mellitus (T2DM) is considered a putative causal risk factor for coronary artery disease (CAD), the intrinsic link underlying T2DM and CAD is not fully understood. We aimed to highlight the importance of integrated care targeting both diseases by investigating the phenotypic and genetic relationships between T2DM and CAD.Methods::We evaluated phenotypic associations using data from the United Kingdom Biobank ( N = 472,050). We investigated genetic relationships by leveraging genomic data conducted in European ancestry for T2DM, with and without adjustment for body mass index (BMI) (T2DM: Ncase/ Ncontrol = 74,124/824,006; T2DM adjusted for BMI [T2DM adjBMI]: Ncase/ Ncontrol = 50,409/523,897) and for CAD ( Ncase/ Ncontrol = 181,522/984,168). We performed additional analyses using genomic data conducted in multiancestry individuals for T2DM ( Ncase/ Ncontrol = 180,834/1,159,055). Results::Observational analysis suggested a bidirectional relationship between T2DM and CAD (T2DM→CAD: hazard ratio [HR] = 2.12, 95% confidence interval [CI]: 2.01–2.24; CAD→T2DM: HR = 1.72, 95% CI: 1.63–1.81). A positive overall genetic correlation between T2DM and CAD was observed ( rg = 0.39, P = 1.43 × 10 -75), which was largely independent of BMI (T2DM adjBMI–CAD: rg = 0.31, P = 1.20 × 10 –36). This was corroborated by six local signals, among which 9p21.3 showed the strongest genetic correlation. Cross-trait meta-analysis replicated 101 previously reported loci and discovered six novel pleiotropic loci. Mendelian randomization analysis supported a bidirectional causal relationship (T2DM→CAD: odds ratio [OR] = 1.13, 95% CI: 1.11-1.16; CAD→T2DM: OR = 1.12, 95% CI: 1.07-1.18), which was confirmed in multiancestry individuals (T2DM→CAD: OR = 1.13, 95% CI: 1.10-1.16; CAD→T2DM: OR = 1.08, 95% CI: 1.04-1.13). This bidirectional relationship was significantly mediated by systolic blood pressure and intake of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, with mediation proportions of 54.1% (95% CI: 24.9-83.4%) and 90.4% (95% CI: 29.3-151.5%), respectively. Conclusion::Our observational and genetic analyses demonstrated an intrinsic bidirectional relationship between T2DM and CAD and clarified the biological mechanisms underlying this relationship.
4.Status quo of nursing clinical support system in tertiary hospitals in Shenzhen City and its influencing factors analysis
Shu WU ; Juan XIA ; Yanting NING ; Liqiong LIU ; Hongfu DING ; Huijie ZHAO ; Wanru WU ; Peipei ZHANG
Chongqing Medicine 2024;53(13):2033-2038
Objective To investigate the evaluation of the nursing staff of the tertiary hospitals in Shenzhen City on the status quo of the nursing clinical support system,and to analyze its influencing factors so as to provide reference and basis for perfecting the nursing clinical support system.Methods The nursing staffs in 16 hospitals of 8 districts of Shenzhen City from December 2022 to January 2023 were selected as the survey subjects,and the general data questionnaire and the nursing clinical support system questionnaire were used for conducting the survey.Results A total of 572 questionnaires were collected,and 520 questionnaires were valid,with an effective recovery rate of 90.9%.The scores of each dimension in the nursing clinical sup-port system scale were(1.87±0.81)points for equipment and appliance support,(1.07±0.62)points for aux-iliary staff support,(1.91±0.80)points for the logistics departments support,(0.88±0.67)points for the auxiliary departments support.The results of univariate analysis showed that there were statistical differences in the equipment and appliance support scores among the nurses with different ages,different professional ti-tles and different education levels(P<0.01);the scores of 4 dimensions had statistical differences among the nursing staffs with different departments(P<0.01).All factors had statistically significant differences in the dimension of auxiliary department support(P<0.05).Conclusion The popularity degree of nursing clinical support system in tertiary hospitals in Shenzhen City is high,and equipment and appliance show the character-istics of advancement and diversity.The hospital managers should strengthen the force of nursing clinical sup-port system and reduce the nursing staff to engage in non-nursing work.
5.Analysis of iodine nutrition status of children aged 8 - 10 and pregnant women in Fushun City, Liaoning Province in 2021
Fang PAN ; Yanan HU ; Huijie XIA ; Xinqing LIU ; Di GAO
Chinese Journal of Endemiology 2023;42(6):483-487
Objective:To study the iodine nutrition status of children aged 8 to 10 and pregnant women and thyroid of children in Fushun City, Liaoning Province, and to provide data for formulation of prevention and control programs on iodine deficiency disorders in Fushun.Methods:In 2021, according to population probability proportional sampling method (PPS), 1 street (township) was selected from 7 districts and counties (Dongzhou District, Wanghua District, Dongzhou District, Xinfu District, Fushun County, Xinbin County and Qingyuan County) in Fushun City according to 5 directions (east, south, west, north and middle) and 1 primary school was selected from each street (township). Forty to 50 children aged 8 to 10 from each primary school and 20 pregnant women were selected from each street (township). Urine samples and salt samples of children and pregnant women were collected for urine iodine and salt iodine levels detection, and thyroid gland of children was examined to calculate the goiter rate. Urine iodine was determined by "Determination of Iodine in Urine Part 1: Method for Determination of Iodine in Urine by As 3+-Ce 4+ Eatalytic Spectrophotometry", salt iodine was determined by "General Test Method in Salt Industry - Determination of Iodine", and children's thyroid was examined by Doppler B-ultrasound. Children iodine nutrition criteria: urinary iodine median < 100 μg/L was iodine deficiency; 100 - < 200 μg/L was suitable for iodine; 200 - < 300 μg/L was more than the appropriate amount of iodine; ≥300 μg/L was iodine excess. Pregnant women iodine nutrition criteria: urinary iodine median < 150 μg/L was iodine deficiency; 150 - < 250 μg/L was suitable for iodine. 250 - < 500 μg/L was more than the appropriate amount of iodine; ≥500 μg/L was iodine excess. Criteria for iodized salt: 18 - 33 mg/kg was qualified iodized salt; < 5 mg/kg was non-iodized salt; 5 - < 18 or > 33 mg/kg was unqualified iodized salt. Results:A total of 1 647 children aged 8 to 10 years were selected, including 829 males and 818 females. The median urinary iodine of children was 203.4 μg/L. The median urinary iodine of children by district and county ranged from 151.6 to 232.4 μg/L, and the difference was statistically significant ( H = 24.227, P < 0.001). A total of 700 urine samples were collected from pregnant women. The median urine iodine was 164.7 μg/L. The median urine iodine of pregnant women by district and county ranged from 131.3 to 193.0 μg/L, and the difference was statistically significant ( H = 48.516, P < 0.001). A total of 2 347 salt samples were collected, including 2 329 iodized salt samples, with iodized salt coverage rate of 99.23% (2 329/2 347). There were 2 254 qualified iodized salt samples, and the rate of qualified iodized salt was 96.04% (2 254/2 347). There was no correlation between total urinary iodine level and salt iodine content ( r = 0.129, P > 0.05). The thyroid gland of 1 439 children was examined, and 25 children of them had goiter, with an enlargement rate of 1.74% (25/1 439), lower than the national standard for elimination of iodine deficiency disorders (< 5%), and the difference between counties and districts was statistically significant (χ 2 = 31.692, P < 0.01). Conclusion:The iodine nutrition of 8 to 10 years old children and pregnant women in Fushun City, Liaoning Province in 2021 is basically at an appropriate level, the rate of qualified iodized salt is high, and the goiter rate of children conforms to the national elimination standards of iodine deficiency disorders.
6.Application practice of case surveillance system for healthcare-associated infections
Wenhui MA ; Lihong WANG ; Jingli ZHANG ; Xia ZHAO ; Huijie ZHAO ; Xu HAN
Chinese Journal of Hospital Administration 2019;35(5):395-397
The healthcare-associated infections (HAI) cases monitoring system, automatic access to the medical record homepage and HAI early warning application of untreated early warning information interception and other means of information are introduced into the hospital. These means ensure the accuracy and integrity of the medical record homepage diagnostic and statistical data base information, and HAI consistency as well. Closed loop management of HAI cases provides accurate information for the hospital business intelligence platform, serving hospital administration and clinical management with accurate data. Hence precise decision-making basis can be provided for the improvement of medical quality of the hospital.
7.Tetracycline-resistant Neisseria gonorrhoeae strains isolated in a GradeⅢhospital in eastern China:molecular characteristics and genetic diversity
Zhou ZHENG ; Han CHEN ; Tongyang DENG ; Huijie WU ; Hong XIA ; Fangyou YU
Chinese Journal of Microbiology and Immunology 2019;39(2):114-119
Objective To analyze the genotypes of Neisseria gonorrhoeae ( N. gonorrhoeae) epi-demic strains in Wenzhou, eastern China, and to study the mechanism of tetracycline resistance in these strains. Methods A total of 77 N. gonorrhoeae strains were isolated from patients with gonorrhea. Antimi-crobial susceptibility of these strains to penicillin, tetracycline, ciprofloxacin, spectinomycin, ceftriaxone and azithromycin was analyzed using E-test. PCR and DNA sequencing were used to detect the genes associ-ated with tetracycline resistance, such as Tet-M, mtrR promoter region and mtrR coding region. N. gonor-rhoeae multi-antigen sequence typing ( NG-MAST) and multilocus sequence typing ( MLST) were used to determine the molecular characteristics of all clinical isolates and tetracycline-resistant isolates, respectively. Results Among the 77 N. gonorrhoeae isolates, 74 (96. 10%), 27 (35. 06%) ,70 (90. 91%) and 15 (19. 48%) were resistant to penicillin, tetracycline, ciprofloxacin and azithromycin, respectively. All tested isolates were susceptible to spectinomycin and ceftriaxone. Nineteen isolates were resistant to tetracycline and all of them carried Tet-M gene. Among them, 17 had one deletion mutation of base A in mtrR promoter region and three had G45D mutation in mtrR coding region. NG-MAST classified the 19 tetracycline-resistant isolates into 11 different sequence types (ST). ST14781, ST1766 and ST1866 each accounted for 15. 79%(three strains). Two ST (10. 52%, 2/19) found in the present study had not been reported previously in the NG-MAST database. MLST showed the 19 tetracycline-resistant isolates belonged to 12 different STs, in which ST10899 accounted for 26. 32% (five strains) and ST1600 accounted for 15. 79% (three strains). Conclusions Mutations in mtrR promoter region and carrying Tet-M gene were associated with tetracycline resistance in N. gonorrhoeae. Clinical strains isolated in Wenzhou showed considerable molecular diversity. Measures should be implemented to monitor the spread of NG-MAST ST1766 and MLST ST1600 N. gonor-rhoeae clones with high resistance to tetracycline in Wenzhou.
8.Closed-loop of workflow-based hospital infection control network
Wenhui MA ; Lihong WANG ; Jingli ZHANG ; Xia ZHAO ; Huijie ZHAO
Chinese Journal of Hospital Administration 2017;33(4):305-307
Routine supervision on hospital infection control was normally fed back on paper-based media,plagued by low efficiency and poor traceability.A feedback process developed with Workflow technology,can loop the entire process ranging from routine supervision to identifying loopholes,to hospital infection and joint development of correctional measures clinically,all the way to implementation of infection control practice and sustained improvement.The closed-loop PDCA cycle management features greater efficiency and traceability in hospital management of its infection control,and builds a quality improvement model featuring close communication between infection control department and clinical departments.
9.Simultaneous Determination of 12 Nonsteroidal Anti-inflammatory Drugs Illegally Added into Antirheumatic TCM Preparations by UPLC-MS/MS
Huijie YAN ; Wei LIU ; Qingsong XIA ; Yuanhu PAN
China Pharmacy 2017;28(27):3871-3875
OBJECTIVE:To develop a method for simultaneous determination of 12 nonsteroidal anti-inflammatory drugs (NSAIDs) illegally added into antirheumatic TCM preparations.METHODS:UPLC-MS/MS was adopted.The determination was performed on Hypersil Golden C18 column with mobile phase consisted of 5 mmol/L ammonium formate solution-methanol (gradient elution) at the flow rate of 0.2 mL/min.The column temperature was 40 ℃,and the sample size was 2 μL.A tandem quadrupole mass spectrometer equipped with electrospray ionization source was used in positive-negative ion mode:curtain gas of 25 kPa,atomizing gas of 60 kPa,auxiliary gas of 55 kPa,electrospray voltage of 4 500 V,ion source temperature of 650 ℃.The multiple reaction monitoring mode was performed.RESULTS:The linear ranges of acetaminophen,acetylsalicylic acid,aminopyrine,meloxicam,ibuprofen,naproxen,lam acid,nimesulide,diclofenac,indomethacin,ketoprofen and celecoxib were 0.01-2.0 μg/ rnL (r=0.995 6),0.05-5.0 μg/mL (r=0.997 6),0.01-2.0 μg/mL (r =0.998 7),0.02-5.0 μg/mL (r=0.995 0),0.02-5.0 μg/mL (r =0.995 3),0.02-5.0 μg/mL(r=0.996 5),0.05-5.0 μg/mL(r=0.995 4),0.02-5.0 μg/mL(r=0.996 0),0.05-5.0 μg/mL(r=0.995 9),0.02-5.0 μg/mL(r=0.995 7),0.02-5.0 μg/mL(r=0.996 8),0.01-2.0 μg/mL(r=0.998 7),respectively.The limits of quantitation were no more than 0.20 mg/g,and the limits of detection were no more than 0.05 mg/g.RSDs of precision,stability and reproducibility tests were all lower than 5.0%.The recoveries were 80.8%-114.2% (RSD was 3.85%-7.32%,n=9).CONCLUSIONS:The established method is simple,accurate,stable and reproducible,and can be used for simultaneous determination of 12 NSAIDs illegally added into antirheumatic TCM preparations.
10.Characteristics of healthcare-associated infection in elderly hospitalized patients
Lihong WANG ; Xia ZHAO ; Jin HAO ; Jingli ZHANG ; Wenhui MA ; Huijie ZHAO
Chinese Journal of Infection Control 2017;16(1):6-9
Objective To investigate the characteristics of healthcare-associated infection(HAI) in elderly hospitalized patients,and analyze the risk factors for HAL Methods Incidences of HAI in elderly(elderly group) and non-elderly hospitalized patients (control) in a tertiary first-class hospital were investigated,the underlying diseases,infection sites,department distribution and so on between two groups of patients were compared.Results The incidence of HAI in elderly group was higher than that in control group(3.38 % vs 1.45 %,P<0.05);the proportions of hypertension and diabetes mellitus in elderly group was higher than control group,while cerebrovascular disease was lower than control group.The proportion of lower respiratory tract infection,urinary system infection and antimicrobial-associated diarrheal in the elderly were higher than control group(41.62% vs 28.00%,15.44% vs 12.02%,6.03% vs 3.15%,respectively).The incidence of catheter-associated urinary tract infection in the elderly group was higher than that in control group(6.85‰ vs 3.95‰,RR95%CI =1.209-2.485,P<0.05).The proportion of HAI in the elderly group in internal medicine departments was higher than that in control group (52.71% vs 40.03%),while in intensive care unit was lower than control group (33.52% vs 41.19%).Conclusion The characteristics of HAI in elderly patients are closely related to their demographic characteristics,early prevention of HAI in key sites should be carried out according to its characteristics.

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