1.Association of diabetes and risk of tuberculosis in community population in Shanghai
Jin LI ; Qi ZHAO ; Jinyan ZOU ; Yong LI ; Genming ZHAO ; Yonggen JIANG ; Liping LU
Journal of Public Health and Preventive Medicine 2025;36(4):42-46
Objective To explore the association of diabetes status with the development of tuberculosis (TB) among the community population in Shanghai, and to provide evidence for the formulation of tuberculosis prevention and control strategies. Methods This population-based cohort study was based on Shanghai Suburban Adult Cohort and Biobank (SSACB) in China. The baseline data were acquired by questionnaires, physical examinations and blood biochemistry tests. TB incidence was obtained by matching with TB management information system data. A Cox proportional risk model was established to assess the risk of tuberculosis. Results A total of 36 014 research subjects were included, with an average age of 56.3±11.3 years, of which 14 587 (40.5%) were male. Over 6 years of follow-up, 47 individuals progressed to tuberculosis (incidence rate: 19.8 per 100 000 person-year, 95% CI: 14.6 -26.4). An increased risk of TB was observed in participants with newly diagnosed diabetes compared with those without diabetes (adjusted hazard ratio [aHR], 2.73; 95% CI, 1.19 - 6.28). Conclusion The risk of tuberculosis in newly diagnosed diabetic patients is significantly increased, and strengthening tuberculosis screening for this population should be considered in practical work.
2.Professional competence tiered training of elderly caregivers in care homes
Mengxi GU ; Qi LU ; Juan LIU ; Amo SHAO ; Zhuohong LYU ; Jinyan ZENG
Modern Hospital 2025;25(3):488-492
Objective In response to the prevalent issue of insufficient professional quality among nursing staff working in care homes,this study aims to conduct a foundational assessment using the"Medical and Elderly Care Integration Institution Elderly Care Staff Professional Quality Assessment Scale"based on the job competency theory,and then investigate the effective-ness of the"333"tiered training model following the initial assessment.Methods A convenience sampling method was used to select 160 caregivers from care homes in Wuxi.The caregivers were equally divided into an experimental group and a control group.A baseline assessment of professional competence was conducted using the professional quality assessment indicator system before training.The experimental group was treated with a tiered training model and training program,which were proposed using literature research and questionnaire survey methods and according to the results of baseline professional quality assessment.The control group did not undergo tiered training,but took the same training program as in the experimental group.SPSS 21.0 soft-ware was used for analysing the training outcome data.Results By comparison,the experimental group showed significantly re-duced learning time and had significantly higher assessment scores.The satisfaction degree of the elderly people and the caregiv-ers of the experimental group was significantly higher than that of the control group.The satisfaction ratings with training course design,training methods,and information-based teaching in the experimental group were significantly higher than those in the control group.Conclusion Assessing the professional quality of medical and elderly caregivers is essential for tired training.Tiered training is an effective way to improve the quality and efficiency of training,and a complete training organization system and a sound management mechanism are essential guarantees for implementing tiered training.
3.Evidence map analysis of Chinese medicine treatment of premature ovarian insufficiency
Kan CHEN ; Li WAN ; Fang WANG ; Yingxue LIU ; Jinyan TANG ; Lu HAN
Chinese Journal of Pharmacoepidemiology 2025;34(5):556-566
Objective To explore the evidence for Traditional Chinese Medicine(TCM)in the treatment of premature ovarian insufficiency(POI)based on evidence map and re-evaluation of systematic reviews.Methods CNKI,WanFang Data,VIP,SinoMed,PubMed,Embase,Cochrane Library and Web of Science database were electronically searched to collect systematic reviews(SR)/Meta-analysis on the treatment of POI with TCM from the inception to March 31,2025.The reporting quality,methodological quality,and evidence quality of the included studies were evaluated using the PRISMA 2020 Statement,AMSTAR 2 Checklist,and GRADE system,respectively.The interventions,number of studies,and evidence grades were comprehensively displayed using evidence map.Results A total of 15 SR/Meta-analysis were included,comprising 9 Chinese articles and 6 English articles.The PRISMA 2020 checklist evaluation revealed that 8 articles had certain deficiencies in reporting,while 7 articles demonstrated relatively complete reporting.Based on the AMSTAR 2 checklist,5 articles were rated as high-level and 10 as very low-level.A total of 10 primary outcome indicators were involved,reported 133 times.When classified using the GRADE system,there were 20 pieces of moderate-quality evidence,58 pieces of low-quality evidence,and 55 pieces of very low-quality evidence.The evidence map showed that TCM alone or in combination with hormone therapy could effectively treat POI,reduce follicle-stimulating hormone and luteinizing hormone levels,increase estradiol levels,and improve clinical manifestations and TCM syndrome manifestations.Conclusion TCM has certain advantages in the treatment of POI,enhancing the overall treatment effect,alleviating clinical symptoms of low estrogen,and regulating sex hormone levels to some extent.However,there are deficiencies in methodological quality and reporting quality,and the level of evidence is not high.Therefore,the findings should be used with caution in clinical practice.
4.Development and Validation of a Nomogram Prediction Model for Subtherapeutic Voriconazole Concentrations in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Hongchun WANG ; Meng LI ; Wenli SUN ; Rui LIU ; Ying ZHAO ; Jinyan GUO ; Guangze LU ; Yang XUE ; Ruigeng YANG ; Lei WANG
Journal of Modern Laboratory Medicine 2025;40(6):74-79,85
Objective To identify determinants of subtherapeutic voriconazole(VRCZ)concentrations in allogeneic hematopoietic stem cell transplantation(allo-HSCT)recipients and to develop/validate a nomogram-based risk prediction model.Methods This study retrospectively analyzed 310 VRCZ therapeutic drug monitoring(TDM)measurements from allo-HSCT recipients at 310 patients who under went allo-HSCT surgery at Hebei Yanda Ludaopei Hospital from October 2022 to October 2024 and received VRCZ for the prevention and treatment of invasive fungal infections before transplantion were selected as the study subjects.Cases were stratified into target-concentration group(0.5~5.0μg/ml)and subtherapeutic group(<0.5μg/ml).Through single factor and multiple factor Logistic regression analysis,indeipendent predictive factors forvecz plasma concentration non-compliance were screened,and a column chart prediction model(NPM)was constructed.The performance of the model was evaluateding area under the receiver operating characteristic curve(AUC),Hosmer-Lemeshow(H-L)goodness-of-fit test,and decision curve analysis(DCA).Results Among 310 VRCZ-TDM measurements,71.61%(222/310)achieved target concentrations.Multivariate analysis showed that CYP2C19 intermediate metabolite,daily dose of cyclosporine A(CSA),daily dose of VRCZ,creatinine(Cr)>97 μmol/L,albumin(Alb)and C-reactive protein(CRP)were independent influencing factors for VRCZ blood drug concentration non-compliance(Wald χ2=4.046~13.221,all P<0.05).The nomogram demonstrated excellent discrimination,calibration(H-L goodness of fit test χ2=2.663,P=0.954),and clinical utility with net benefit across 0.05~0.96 risk thresholds.Conclusion The nomogram incorporating CYP2C19 gene phenotype,daily CSA dosing,daily VRCZ dosing,Cr levels,Alb and CRP provides a validated tool for optimizing VRCZ therapy in allo-HSCT recipients,enabling precision dosing strategies.
5.Development and Validation of a Nomogram Prediction Model for Subtherapeutic Voriconazole Concentrations in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Hongchun WANG ; Meng LI ; Wenli SUN ; Rui LIU ; Ying ZHAO ; Jinyan GUO ; Guangze LU ; Yang XUE ; Ruigeng YANG ; Lei WANG
Journal of Modern Laboratory Medicine 2025;40(6):74-79,85
Objective To identify determinants of subtherapeutic voriconazole(VRCZ)concentrations in allogeneic hematopoietic stem cell transplantation(allo-HSCT)recipients and to develop/validate a nomogram-based risk prediction model.Methods This study retrospectively analyzed 310 VRCZ therapeutic drug monitoring(TDM)measurements from allo-HSCT recipients at 310 patients who under went allo-HSCT surgery at Hebei Yanda Ludaopei Hospital from October 2022 to October 2024 and received VRCZ for the prevention and treatment of invasive fungal infections before transplantion were selected as the study subjects.Cases were stratified into target-concentration group(0.5~5.0μg/ml)and subtherapeutic group(<0.5μg/ml).Through single factor and multiple factor Logistic regression analysis,indeipendent predictive factors forvecz plasma concentration non-compliance were screened,and a column chart prediction model(NPM)was constructed.The performance of the model was evaluateding area under the receiver operating characteristic curve(AUC),Hosmer-Lemeshow(H-L)goodness-of-fit test,and decision curve analysis(DCA).Results Among 310 VRCZ-TDM measurements,71.61%(222/310)achieved target concentrations.Multivariate analysis showed that CYP2C19 intermediate metabolite,daily dose of cyclosporine A(CSA),daily dose of VRCZ,creatinine(Cr)>97 μmol/L,albumin(Alb)and C-reactive protein(CRP)were independent influencing factors for VRCZ blood drug concentration non-compliance(Wald χ2=4.046~13.221,all P<0.05).The nomogram demonstrated excellent discrimination,calibration(H-L goodness of fit test χ2=2.663,P=0.954),and clinical utility with net benefit across 0.05~0.96 risk thresholds.Conclusion The nomogram incorporating CYP2C19 gene phenotype,daily CSA dosing,daily VRCZ dosing,Cr levels,Alb and CRP provides a validated tool for optimizing VRCZ therapy in allo-HSCT recipients,enabling precision dosing strategies.
6.Professional competence tiered training of elderly caregivers in care homes
Mengxi GU ; Qi LU ; Juan LIU ; Amo SHAO ; Zhuohong LYU ; Jinyan ZENG
Modern Hospital 2025;25(3):488-492
Objective In response to the prevalent issue of insufficient professional quality among nursing staff working in care homes,this study aims to conduct a foundational assessment using the"Medical and Elderly Care Integration Institution Elderly Care Staff Professional Quality Assessment Scale"based on the job competency theory,and then investigate the effective-ness of the"333"tiered training model following the initial assessment.Methods A convenience sampling method was used to select 160 caregivers from care homes in Wuxi.The caregivers were equally divided into an experimental group and a control group.A baseline assessment of professional competence was conducted using the professional quality assessment indicator system before training.The experimental group was treated with a tiered training model and training program,which were proposed using literature research and questionnaire survey methods and according to the results of baseline professional quality assessment.The control group did not undergo tiered training,but took the same training program as in the experimental group.SPSS 21.0 soft-ware was used for analysing the training outcome data.Results By comparison,the experimental group showed significantly re-duced learning time and had significantly higher assessment scores.The satisfaction degree of the elderly people and the caregiv-ers of the experimental group was significantly higher than that of the control group.The satisfaction ratings with training course design,training methods,and information-based teaching in the experimental group were significantly higher than those in the control group.Conclusion Assessing the professional quality of medical and elderly caregivers is essential for tired training.Tiered training is an effective way to improve the quality and efficiency of training,and a complete training organization system and a sound management mechanism are essential guarantees for implementing tiered training.
7.Evidence map analysis of Chinese medicine treatment of premature ovarian insufficiency
Kan CHEN ; Li WAN ; Fang WANG ; Yingxue LIU ; Jinyan TANG ; Lu HAN
Chinese Journal of Pharmacoepidemiology 2025;34(5):556-566
Objective To explore the evidence for Traditional Chinese Medicine(TCM)in the treatment of premature ovarian insufficiency(POI)based on evidence map and re-evaluation of systematic reviews.Methods CNKI,WanFang Data,VIP,SinoMed,PubMed,Embase,Cochrane Library and Web of Science database were electronically searched to collect systematic reviews(SR)/Meta-analysis on the treatment of POI with TCM from the inception to March 31,2025.The reporting quality,methodological quality,and evidence quality of the included studies were evaluated using the PRISMA 2020 Statement,AMSTAR 2 Checklist,and GRADE system,respectively.The interventions,number of studies,and evidence grades were comprehensively displayed using evidence map.Results A total of 15 SR/Meta-analysis were included,comprising 9 Chinese articles and 6 English articles.The PRISMA 2020 checklist evaluation revealed that 8 articles had certain deficiencies in reporting,while 7 articles demonstrated relatively complete reporting.Based on the AMSTAR 2 checklist,5 articles were rated as high-level and 10 as very low-level.A total of 10 primary outcome indicators were involved,reported 133 times.When classified using the GRADE system,there were 20 pieces of moderate-quality evidence,58 pieces of low-quality evidence,and 55 pieces of very low-quality evidence.The evidence map showed that TCM alone or in combination with hormone therapy could effectively treat POI,reduce follicle-stimulating hormone and luteinizing hormone levels,increase estradiol levels,and improve clinical manifestations and TCM syndrome manifestations.Conclusion TCM has certain advantages in the treatment of POI,enhancing the overall treatment effect,alleviating clinical symptoms of low estrogen,and regulating sex hormone levels to some extent.However,there are deficiencies in methodological quality and reporting quality,and the level of evidence is not high.Therefore,the findings should be used with caution in clinical practice.
8.Analysis of mini-CEX Scores and influencing factors after teaching"fundamentals of nursing"in the elderly service management program
Aili CEN ; Liping HUANG ; Jinyan ZENG ; Yuhuan DU ; Xin YAO ; Li LU
Modern Hospital 2024;24(10):1614-1617
Objective To investigate the current status of mini-CEX scores among students in the Elderly Service Man-agement program after completing the"Fundamentals of Nursing"course and analyze the influencing factors.Methods A total of 99 students from the Elderly Service Management program at the Wuming campus of Guangxi Medical University were selected as the study subjects.Assessment tools included a general information questionnaire,the Chinese version of the Mini Clinical E-valuation Exercise(mini-CEX),the Self-Rating Scale of Self-Directed Learning(SRSSDL),and a self-learning ability assess-ment scale.Stepwise linear regression analysis was employed to explore the factors affecting mini-CEX scores.Results The total mini-CEX score for the 99 students was 49.00(44.00,55.00).Stepwise linear regression analysis revealed that being a student leader,SRSSDL scores,self-learning ability,and teaching model were significant factors(P<0.05),explaining 56.8%of the total variance.Conclusion The clinical comprehensive ability of students in the Elderly Service Management program requires enhancement,influenced by multiple factors including teaching model,self-learning ability,and self-directed learning capacity.
9.Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial
Yan ZHAO ; Jianzhong ZHANG ; Bin YANG ; Jingyi LI ; Yangfeng DING ; Liming WU ; Litao ZHANG ; Jinyan WANG ; Xiaohong ZHU ; Furen ZHANG ; Xiaohua TAO ; Yumei LI ; Chunlei ZHANG ; Linfeng LI ; Jianyun LU ; Qingchun DIAO ; Qianjin LU ; Xiaoyong MAN ; Fuqiu LI ; Xiujuan XIA ; Hao CHENG ; Yingmin JIA ; Guoqing ZHAO ; Jinchun YAN ; Bo CHEN
Chinese Medical Journal 2024;137(2):200-208
Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.
10.Methodological study and clinical application of HPLC-MS/MS for the determination of olverembatinib in the plasma of leukemia patients
Jinyan GUO ; Wenli SUN ; Rui LIU ; Guangze LU ; Hongxing LIU ; Lei WANG
China Pharmacist 2024;28(11):472-480
Objective To establish a high-performance liquid chromatography tandem mass spectrometry(HPLC-MS/MS)method for determining the plasma concentration of olverembatinib in leukemia patients,apply it to clinical drug monitoring,and provide reliable basis for rational drug use in clinical practice.Methods Ponatinib-d8 was used as an internal standard,and methanol was used to precipitate plasma proteins and extract olverembatinib.The chromatographic column was Welch Ultimate XB-C18 cloumn(50 mmx4.6 mm,5 μm),with a column temperature of 60 ℃.The mobile phase consisted of an aqueous solution(containing 0.1%formic acid+2 mmol/L ammonium acetate)-methanol solution(containing 0.1%formic acid),with a flow rate of 0.8 mL/min and gradient elution.Electrospray positive ion mode was used,with multiple reaction monitoring scanning.The quantitative ion pair of olverembatinib was m/z 533.3→260.1,the qualitative ion pair was m/z 533.3→433.3,and the internal standard ion pair was m/z 541.1 →260.2.The plasma samples of 40 leukemia patients taking olverembatinib were monitored and analyzed for concentration,and IBM SPSS Statistics 27.0 and OriginPro 2021 softwares were used for statistical analysis of the results.Results The linear range of olverembatinib was 1-250 ng/mL(r=0.998 0),the lower limit of quantification was 1 ng/mL,the extraction recovery rate was 100.28%~101.27%,the intra-day precision RSD was 1.15%~3.87%,and the inter-day precision RSD was 2.32%~3.68%.Conclusion This method is easy to operate,highly specific and sensitive,and can be used to determine the blood concentration of olverembatinib in leukemia patients.


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