1.Preliminary study on an improved method for constructing internal quality control framework of ELISA
Youbin DUAN ; Rui WANG ; Le CHANG ; Changwen QIU ; Zhiqiang LI ; Gengrui CHEN ; Jingjuan YANG ; Qing HE ; Lunan WANG
Chinese Journal of Blood Transfusion 2026;39(1):103-108
Objective: To propose an improved method for constructing the internal quality control (IQC) framework for ELISA assays and validate its efficacy by statistically analyzing IQC data from nine blood center laboratories. Methods: 1) IQC data was collected from nine blood centers and analyzed using a domestic HBsAg ELISA detection kit as an example. 2) Differences between IQC values across batches within Blood Center 1 were assessed. 3) Statistical analyses were performed on batch usage, number of batches used, days of use, number of QC points, batch-specific means, and coefficients of variation (CV) across all nine centers. 4) Using the improved construction method for IQC framework, provisional and permanent frames were established for batches within Blood Center 1 and Blood Center 9, followed by outlier determination. Results: 1) Statistically significant differences were observed in IQC data between batches within Blood Center 1 (P<0.01). It is recommended that both the control material/reagents and the control chart framework be replaced simultaneously. 2) There were substantial differences among 9 blood centers regarding the control material/reagent lot numbers used, the number of QC runs per batch, and the QC values for identical lots. Therefore, individual laboratories should establish their own IQC chart frameworks. 3) The improved IQC framework construction method for ELISA assays is as follows: provisional frames are established via frame-shifting, using the pre-experimental mean and cumulative coefficient of variation (CV) from the preceding batch. For batches used >20 days with >20 QC points, permanent frames are constructed by aggregating in-control data accumulated over ≥20 days with ≥20 points to calculate cumulative mean and standard deviation. The provisional and permanent frames constructed by this method identified all 26 extreme outliers across Blood Centers 1 and 9 as out-of-control. Among the 218 general outliers, 10 were classified as normal by the provisional frames, while the remainder were designated as warnings or out-of-control. This method effectively monitors assay stability. Conclusion: Based on the statistical analysis of IQC practices across blood centers of varying scales, combined with the inherent characteristics of ELISA assays and the batch-to-batch instability of reagents/QC materials, it is recommended to reconstruct QC charts upon lot changes. The proposed method—utilizing frame-shifting for provisional frames and establishing permanent frames based on cumulative data—is applicable to blood center laboratories of differing sizes and effectively monitors the stability of the ELISA assay process.
2.Correlation between plasma concentration of voriconazole and polymorphisms in CYP2C19, CYP2C9 and CYP3A5 genes in children
Mingzhu GUI ; Jing LI ; Zhiling LI
Journal of Pharmaceutical Practice and Service 2026;44(2):76-79
Objective To explore the effects of CYP2C19, CYP2C9 and CYP3A5 genotypes on the plasma concentration of voriconazole in children. Methods Collected blood samples from 50 hospitalized children with invasive fungal infections who received intravenous voriconazole from January 2020 to December 2020. High performance liquid chromatography was used to detect the blood trough concentration of voriconazole, and the time-of-flight mass spectrometry detection system was used to detect the genotypes of CYP2C19, CYP2C9 and CYP3A5, and the effects of children’s genotyping on the plasma concentration, efficacy and adverse reactions of voriconazole were analyzed. Results The total effective rate of 50 children with IFI was 84% (42/50 cases) after voriconazole treatment. The incidence of adverse reactions was 20% (10/50 cases). The measured plasma concentration of voriconazole ranged from 0.56~7.62 μg/ml. Combined with the different mutation types of CYP2C19 gene loci, three metabolic activities were produced: fast, medium and slow, and the test results showed that there were 16 cases of fast metabolism, 27 cases of intermediate metabolism and 7 cases of slow metabolism. There was a significant difference in plasma concentrations among the three groups (F=15.359, P<0.001), and the drug concentrations in the fast metabolic group were significantly lower than those in the intermediate metabolic and slow metabolic groups. The mutations of CYP2C9 and CYP3A5 had no significant effect on the plasma concentrations of the drugs, which were (F=2.213, P=0.086 and F=0.757, P=0.475). Conclusion Voriconazole had significant efficacy in the treatment of invasive fungal infections in children, and the adverse reactions were mild. CYP2C19 genotype was significantly related to the rate of drug metabolism and was an important factor affecting blood drug concentration, the detection of drug concentration and genotype of voriconazole was helpful to adjust the effective drug dose clinically and would achieve more scientific and individualized treatment.
3.Epidemiological characteristics of human brucellosis in Baoshan City, Yunnan Province, 2020‒2023
Jidan ZHANG ; Yanping LI ; Mengfan ZHU ; Zengkan LIU ; Zhijie ZHANG ; Dongsheng HUANG
Shanghai Journal of Preventive Medicine 2026;38(3):227-230
ObjectiveTo investigate the epidemiological characteristics of human brucellosis (hereinafter referred to as brucellosis) in Baoshan City, Yunnan Province, and to provide scientific evidence for adjusting prevention and control strategies. MethodsBased on the surveillance data of reported brucellosis cases in Baoshan City from 2020 to 2023 and the information collected through individual epidemiological questionnaire surveys, the epidemic status and clinical characteristics of brucellosis in Baoshan City were analyzed using descriptive epidemiological methods. ResultsA total of 85 brucellosis cases were reported in Baoshan City from 2020 to 2023, and detailed individual information was obtained for 83 of them. Brucellosis in Baoshan City showed a clear seasonal pattern, with peak incidence from May to September. The average annual incidence rate was 0.80/100 000, with a male-to-female ratio of 7.5∶1. And 82.35% of the cases aged 30 to 60 years, with farmers being the predominant affected group. The main clinical manifestations of the cases were myalgia and arthralgia. Regarding transmission routes, 87.95% of the cases had a contact history with cattle, with livestock rearing and grazing being the main exposure modes. Most infections occurred at home. ConclusionFrom 2020 to 2023, the incidence of brucellosis in Baoshan City exhibited a fluctuating upward trend, with a peak period from May to September. Males and farmers were identified as the primary affected populations. It is recommended to strengthen livestock surveillance and control, and to enhance both awareness and self-protection capacity among high-risk groups.
4.Analysis of the hotspots and advantages of adverse drug reaction automatic monitoring system based on CiteSpace and systematic review
Yan WANG ; Le KANG ; Wen CHEN ; Qi FANG ; Zhongwang YU ; Li CAO
Journal of Pharmaceutical Practice and Service 2026;44(7):362-369
Objective To provide a reference for the establishment, development and application of the adverse drug reaction (ADR) automated monitoring system, through verifying and quantifying the research hotspots and advantages of the system by CiteSpace software and systematic review. Methods Literature on ADR automated monitoring up to December 2023 were retrieved and screened from CNKI and web of science databases. CiteSpace 6.4.R1 software was used to conduct co-occurrence, clustering and emergence analysis, and to visualize and comparatively analyze the research hotspots, rules and distribution in the field of automated monitoring of ADR at home and abroad. In compliance with the preferred reporting items for systematic reviews and Meta-analyses (PRISMA), literature covering publications in English and Chinese including detection rates of ADR collected using Incident Reporting Systems (IRSs) and/or automated monitoring systems were retrieved and screened. The advantages and disadvantages of automated monitoring systems were analyzed by comparing the differences between these two systems in terms of the number of ADR reports and the types of positive signals. Results A total of 56 articles in English and 80 articles in Chinese were indexed by CiteSpace. The research hotspots in recent years included data mining, deep learning, text classification techniques, machine learning and so on. A total of seven studies compiled with the inclusion criteria for the systematic evaluation, all of which were completed between 1991 and 2021 in hospitals in four countries. 150 526 medical records were reviewed from 15 institutions. A total of 194 ADR reports were collected by IRSs. A total of 2 090 ADR reports were collected by the automated monitoring system over the same period, indicating a 977% increase in the number of ADR reports (P=0.0156) compared with the IRSs. Conclusion The ADR automatic monitoring system had significantly improved the level of drug risk identification and reduced costs, but it was necessary to optimize the algorithm, expand the data source and carry out standardization construction to overcome the current limitations.
5.Construction of a One Health-based performance evaluation indicator system for integrated interventions for schistosomiasis control during the elimination phase
Yanyan ZHANG ; Jingshu LIU ; Xinchen LI ; Qiyu ZHANG ; Xiaoxi ZHANG ; Xiaonong ZHOU
Chinese Journal of Schistosomiasis Control 2026;38(3):240-249
Objective To construct a One Health-based performance evaluation indicator system for integrated interventions for schistosomiasis in the elimination phase, clarify the dimensions and connotations of intervention performance evaluation, and provide methodological reference for subsequent real-world performance evaluation in schistosomiasis control. Methods On the basis of literature analysis, a preliminary indicator system was developed through group discussion and expert consultation. Nineteen experts in schistosomiasis control were invited to participate in two rounds of Delphi consultation. Expert response rate, degree of consensus, coordination of opinions, and authority were assessed. The indicators were optimized and refined according to the scoring results and expert feedback, and the analytic hierarchy process was used to determine the normalized weights of indicators at each level. Results Through literature analysis, group discussion, and expert consultation, a preliminary performance evaluation indicator system for integrated interventions for schistosomiasis was developed, consisting of 4 first-level indicators, 8 second-level indicators, and 20 third-level indicators. The response rates of the two rounds of expert consultation were both 100.00%. In the first round, the ranges of the experts’ judgment coefficient, familiarity coefficient, and authority coefficient were 0.88 ~ 1.00, 0.74 ~ 0.99, and 0.82 ~ 0.99, respectively; in the second round, the corresponding ranges were 0.88 ~ 0.98, 0.73 ~ 0.98, and 0.81 ~ 0.98, respectively. In the first round, Kendall’s coefficients of concordance for the rationality, importance, and operability of the indicators were 0.201, 0.252, and 0.221, respectively; in the second round, the corresponding values were 0.267, 0.319, and 0.296, respectively. The Kendall’s coefficients of concordance in both rounds were statistically significant (χ2 = 112.063, 140.415, 123.386, 121.939, 145.393, and 135.072, all P < 0.05). After optimization and revision, the final indicator system consisted of 4 first-level indicators, 7 second-level indicators, and 14 third-level indicators. Among the first-level indicators, the normalized weights of “health performance”, “economic performance”, “ecological performance”, and “social performance” were 40.44%, 13.88%, 11.67%, and 34.01%, respectively. Among the second-level indicators, the normalized weights of “disease burden level” and “promotion of health equity” were both 100.00%; those of “resource consumption” and “production capacity” were both 50.00%; and those of “water and soil regulation”, “atmospheric environmental regulation”, and “species conservation” were all 33.33%. Conclusions A One Health-based performance evaluation indicator system was constructed for integrated interventions for schistosomiasis in the elimination phase. The system incorporates performance evaluation indicators across multiple dimensions, including health, economic, ecological, and social domains, and provides a tool for evaluating the performance of cross-sector collaborative governance in integrated schistosomiasis interventions.
6.Risk factors for concurrent myocardial injury before intervention in patients with primary hepatic carcinoma and construction of a nomogram prediction model
Lingfen DENG ; Jinyu XIANG ; Lixian CHANG ; Yingling WANG ; Wenjing JI ; Chunyun LIU ; Li LIU
Journal of Clinical Hepatology 2026;42(9):2143-2153
ObjectiveTo investigate the independent risk factors for concurrent myocardial injury before intervention in patients with primary hepatic carcinoma (PHC), to construct and validate a nomogram prediction model for the early identification of such patients, and to provide a basis for early clinical prevention and management. MethodsA retrospective analysis was performed for the clinical data of 1 822 patients with PHC in two medical institutions from January 2019 to June 2025, among whom the 1 518 patients from The Third People’s Hospital of Kunming were used as the training set to construct the nomogram prediction model, and the 304 patients from The Second People’s Hospital of Baoshan were used as the validation set. According to the result of high-sensitivity cardiac troponin T measurement before intervention, the patients with PHC were divided into myocardial injury group and non-myocardial injury group. The univariate analysis, the LASSO regression analysis, and the multivariate Logistic regression analysis were used to identify the risk factors of concurrent myocardial injury in PHC patients before intervention, and then a nomogram prediction model was constructed based on these findings. The independent data of the 304 patients in the validation set were used for external validation, and the area under the receiver operating characteristic curve (AUC), the Hosmer-Lemeshow test, the calibration curve, decision curve analysis, and clinical impact curve were used to assess model performance. ResultsIn the training set, there were 346 patients in the myocardial injury group and 1 172 patients in the non-myocardial injury group, and the prevalence rate of concurrent myocardial injury was 22.79%. The mean age was 56.44±9.45 years, and the male patients accounted for 81.49%. The patients with drinking, smoking, chronic hepatitis B, chronic hepatitis C, hypertension, diabetes, Child-Pugh class A liver disease, BCLC stage B liver disease, or abnormal electrocardiographic findings accounted for 49.34%, 57.44%, 61.73%, 32.48%, 22.66%, 17.19%, 50.53%, 33.86%, and 62.12%, respectively. The univariate analysis, the LASSO regression analysis, and the multivariate Logistic regression analysis showed that age (odds ratio [OR]=1.051, 95% confidence interval [CI]: 1.036 — 1.067, P<0.001), history of diabetes (OR=1.862, 95%CI: 1.346 — 2.574, P<0.001), electrocardiographic findings (OR=1.446, 95%CI: 1.077 — 1.940, P=0.014), hemoglobin (HGB) (OR=0.993, 95%CI: 0.988 — 0.998, P=0.003), albumin (Alb) (OR=0.951, 95%CI: 0.930 — 0.972, P<0.001), and creatinine (Cr) (OR=1.021, 95%CI: 1.016 — 1.026, P<0.001) were independent influencing factors for myocardial injury in PHC patients. A regression equation was established as Logit(Y)=-3.406+0.050×age+0.621×history of diabetes+0.369×electrocardiogram-0.007×HGB-0.051×Alb+0.021×Cr, and a nomogram prediction model was constructed based on these factors. The Bootstrap internal validation of the model yielded an AUC of 0.743 (95%CI: 0.707 — 0.778), and the model had an AUC of 0.766 (95%CI: 0.738 — 0.794) in the training set and 0.730 (95%CI: 0.688 — 0.793) in the validation set. The Hosmer-Lemeshow goodness-of-fit test yielded a P value of 0.716 for the training set and 0.408 for the validation set, suggesting that the model had a good degree of fitting. Calibration curves, decision curve analysis, and clinical impact curves in both the training set and the validation set showed that the model had a good clinical application value. ConclusionAge, history of diabetes, electrocardiographic findings, HGB, Alb, and Cr are independent influencing factors for myocardial injury in patients with PHC, and the nomogram prediction model constructed based on these factors has good discriminatory ability, accuracy, and clinical practicability.
7.Analysis on the use of medicines in treatment of benign prostatic hyperplasia in sample hospitals under the national volume-based procurement policy
Rui LI ; Qianqian ZHANG ; Ruidong WANG ; Xiaofeng GAO
Journal of Pharmaceutical Practice and Service 2025;43(1):41-46
Objective To explore the impact of national volume-based procurement policies on the use of medicines in treatment of benign prostatic hyperplasia (BPH) and provide data support for the rational clinical use of medicines in BPH treatment. Methods Data on the use of BPH treatment medications from 2019 to 2023 were extracted from the Chinese Medicine Economic Information Network (CMEI), covering 892 hospitals (including 645 tertiary hospitals and 247 secondary hospitals). The changes in various indicators, including the consumption sum, Defined daily doses (DDDs), Defined daily dose cost (DDDc), and the ranking ratio (B/A) of these drugs were analyzed and compared. Results From 2019 to 2023, due to the influence of relevant policies, the overall consumption sums of medicines used in the sample hospitals in BPH treatment showed a trend of decreasing first and then rising steadily. The DDDs showed an overall upward trend, while the DDDc demonstrated a gradual decline. Tamsulosin and finasteride consistently ranked first and second in DDDs. The B/A value for tamsulosin was significantly higher than that of other BPH treatment medications. Conclusion The implementation of national centralized drug volume-based procurement policies and other policies from 2019 to 2023 had effectively reduced the economic burden of patients with benign prostatic hyperplasia. Tamsulosin and finasteride, which had the highest B/A in the two categories of α-blockers and 5α-reductase inhibitors, dominated the market for BPH treatment. The clinical use of BPH treatment medications was relatively rational.
8.Recommendations for Standardized Reporting of Systematic Reviews and Meta-Analysis of Animal Experiments
Qingyong ZHENG ; Donghua YANG ; Zhichao MA ; Ziyu ZHOU ; Yang LU ; Jingyu WANG ; Lina XING ; Yingying KANG ; Li DU ; Chunxiang ZHAO ; Baoshan DI ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(4):496-507
Animal experiments are an essential component of life sciences and medical research. However, the external validity and reliability of individual animal studies are frequently challenged by inherent limitations such as small sample sizes, high design heterogeneity, and poor reproducibility, which impede the effective translation of research findings into clinical practice. Systematic reviews and meta-analysis represent a key methodology for integrating existing evidence and enhancing the robustness of conclusions. Currently, however, the application of systematic reviews and meta-analysis in the field of animal experiments lacks standardized guidelines for their conduct and reporting, resulting in inconsistent quality and, to some extent, diminishing their evidence value. To address this issue, this paper aims to systematically delineate the reporting process for systematic reviews and meta-analysis of animal experiments and to propose a set of standardized recommendations that are both scientific and practical. The article's scope encompasses the entire process, from the preliminary preparatory phase [including formulating the population, intervention, comparison and outcome (PICO) question, assessing feasibility, and protocol pre-registration] to the key writing points for each section of the main report. In the core methods section, the paper elaborates on how to implement literature searches, establish eligibility criteria, perform data extraction, and assess the risk of bias, based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement, in conjunction with relevant guidelines and tools such as Animal Research: Reporting of in Vivo Experiments (ARRIVE) and a risk of bias assessment tool developed by the Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE). For the presentation of results, strategies are proposed for clear and transparent display using flow diagrams and tables of characteristics. The discussion section places particular emphasis on how to scientifically interpret pooled effects, thoroughly analyze sources of heterogeneity, evaluate the impact of publication bias, and cautiously discuss the validity and limitations of extrapolating findings from animal studies to clinical settings. Furthermore, this paper recommends adopting the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to comprehensively grade the quality of evidence. Through a modular analysis of the entire reporting process, this paper aims to provide researchers in the field with a clear and practical guide, thereby promoting the standardized development of systematic reviews and meta-analysis of animal experiments and enhancing their application value in scientific decision-making and translational medicine.
9.Effect of miR-145 targeting ADAM17 on the growth of triple-negative breast cancer xenografts in nude mice and associated mechanism
Yaning MIAO ; Guannan YANG ; Xuepeng ZHANG ; Hongzhou SHANG ; Baoshan HU ; Li YAN
Journal of Chongqing Medical University 2025;50(8):1047-1052
Objective:To investigate the effect of applying the analog of miR-145(agomiR-145)to target a disintegrin and metallopro-tease 17(ADAM17)on the growth of triple-negative breast cancer(TNBC)xenograft tumors in nude mice and the underlying mecha-nism.Methods:A subcutaneous xenograft tumor model was established in nude mice with MDA-MB-231 cells(n=30).The 30 nude mice were randomly divided into agomiR group,agomiR-NC group,and control group to receive intratumoral injection of 100 μL of agomiR-145(0.33 g/L),agomiR-NC(0.33 g/L),and normal saline,respectively.We examined tumor tissue morphology with HE stain-ing;measured the expression of miR-145,ADAM17,and epidermal growth factor receptor(EGFR)in tumor tissues by real-time poly-merase chain reaction(RT-PCR);and determined the protein expression of ADAM17,EGFR,and p-EGFR in tumor tissues by immu-nohistochemistry and Western blot.Results:The tumor growth in the agomiR group was slow,with a significantly smaller tumor volume than those in the control group and the agomiR-NC group(P<0.05).The results of HE staining showed more severe necrosis and hem-orrhage within tumor tissues in the control group and the agomiR-NC group than in the agomiR group.RT-PCR results showed that the expression level of miR-145 in the agomiR group was significantly higher than those in the agomiR-NC and control groups(P<0.001);the agomiR group had a significantly lower mRNA expression level of ADAM17 than the other two groups(P<0.05);and there was no significant difference in EGFR mRNA expression between the three groups(P>0.05).Immunohistochemistry and Western blot detected significantly lower protein expression levels of ADAM17 and EGFR in the agomiR group than in the agomiR-NC group and the control group(P<0.05).Conclusion:AgomiR-145 inhibits the growth of TNBC xenografts in nude mice by targeted suppression of ADAM17-EGFR activity.
10.Iodine nutrition among children aged 8-10 in Baoshan City from 2018 to 2024
LI Yanping, LIU Guihua, WANG Anwei, LIU Zengkan, JIANG Zongqi, HUANG Dongsheng
Chinese Journal of School Health 2025;46(11):1559-1563
Objective:
To analyze the iodine nutritional status of children aged 8-10 in Baoshan City, so as to comprehensively evaluate the effectiveness of eliminating and consolidating iodine deficiency disorders in Baoshan City.
Methods:
From 2018 to 2024, a stratified random sampling method was used to sample 7 363 non boarding children aged 8-10 from 35 survey sites in 5 counties of Baoshan City (Longyang County, Shidian County, Changning County, Tengchong City, Longling County). The salt iodine content and urinary iodine concentration were detected, and the thyroid volume of children was measured by ultrasound. Group comparison was conducted by using Mann-Whitney U test, Kruskal-Wallis H test, and Chi square test. Spearman rank correlation analysis was used to investigate the correlation of salt iodine, urinary iodine and thyroid volume.
Results:
A total of 7 361 samples of household edible salt for children were detected. The iodized salt coverage rate was 99.70%, the qualified iodized salt consumption rate was 97.02 %. The proportion of unqualified iodized salt fluctuated and decreased from 3.14% in 2018 to 2.14% in 2024. The median iodine content of household edible salt for children was 23.70 (21.60, 25.80) mg/kg. The median urinary iodine of children was 217.41 (152.40, 294.59) μg/L, and the proportions of iodine deficiency, adequate iodine, and iodine excess were 9.75 %, 66.66%, and 23.58%, respectively. There were statistically significant differences in the median urinary iodine of children among different years, ages, genders and before and after the supply of non iodized salt ( Z/H =134.88, 11.04,-4.28,-2.66, all P < 0.01). An average thyroid volume of children was 3.32 (2.77, 3.93) mL, with a goiter rate of 1.91%. Before and after the implementation of non iodized salt supply in Baoshan City in 2023, there were no statistically significant differences in the median iodine content of household edible salt and the goiter rate of children ( Z/χ 2=-1.54, 3.25, both P >0.05), but there were statistically significant differences in the qualified status of iodized salt, the median urinary iodine, and the frequency distribution of urinary iodine ( χ 2/Z =15.53,-2.66, 10.14, all P <0.05). Salt iodine was positively correlated with urinary iodine ( r =0.04) and negatively correlated with thyroid volume ( r =-0.07), and urinary iodine was negatively correlated with thyroid volume ( r =-0.03) (all P < 0.05 ). The thyroid volume of children consuming iodized salt was larger than that of children consuming non iodized salt ( H = 9.99 ), and there were statistically significant differences in thyroid volume among children with different urinary iodine levels ( H =15.13) (both P <0.01).
Conclusions
From 2018 to 2024, the overall iodine nutritional level of children aged 8-10 in Baoshan City is at an adequate level. The elimination status of iodine deficiency disorders has been continuously consolidated.


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