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.

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.

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.

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.

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.

Vertebral refracture following percutaneous vertebral augmentation (PVA) is commonly seen in elderly patients with osteoporotic thoracolumbar compression fractures (OTLCF). It can lead to recurrent pain, loss of vertebral height, progression of kyphosis, and even neurological dysfunction, significantly impairing patients′ quality of life. Current diagnosis and treatment face multiple challenges, including high misdiagnosis rate, difficulty in choosing between surgical and non-surgical treatment options, lack of standardized surgical protocols, interference from intralesional bone cement during procedures, inadequate stability of internal fixation in osteoporotic bone, and suboptimal compliance of anti-osteoporotic therapy. Establishing a standardized diagnostic and therapeutic framework is urgently needed. To standardize the management process and improve outcomes for vertebral refractures after PVA in elderly OTLCF patients, Spinal Trauma Group of the Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field to develop Guideline for the diagnosis and treatment of vertebral refracture after percutaneous vertebral augmentation in elderly patients with osteoporotic thoracolumbar compression fractures ( version 2025), based on current literature and clinical experience, and adhering to principles of scientific rigor and clinical applicability. A total of 11 recommendations were proposed, encompassing diagnosis, treatment, and rehabilitation of vertebral refracture after PVA in elderly patients with OTLCF, aiming to provide a foundation for a standardized management.

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.

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.

ObjectiveTo analyze the epidemiological and clinical characteristics of pertussis in Baoshan District, Shanghai from 2017 to 2024, so as to provide an evidence-based reference for optimizing prevention and control strategies. MethodsData on pertussis cases were collected from the China Disease Prevention and Control Information System, Shanghai Integrated Management and Immunization Service Information System, and follow-up epidemiological investigations. Descriptive epidemiological analyses were performed to analyze the epidemiological characteristics, clinical manifestations, and vaccine effectiveness. Joinpoint regression analyses were used to examine the temporal trends in incidence rates, and a Poisson model was constructed for spatiotemporal scan analyses. ResultsA total of 1 634 pertussis cases were reported in Baoshan District from 2017 to 2024, with a male-to-female ratio of 1.08∶1. More cases were observed in males than in females, with the age ranged from 20 days to 81 years. Among them, 59.92% were in the 6‒<11 years age group, and 63.34% were students. Low-level sporadic incidence persisted during 2017‒2023, followed by a sharp increase in 2024 (71.37/100 000). Starting in January 2024, the incidence rate showed an upward trend, peaking in May before declining. The majority of cases occurred between April and June. The trend in reported pertussis incidence rates in Baoshan District from 2017 to 2023 showed no statistically significant change (APC=10.039%, t=2.586, P=0.150). Incidence rate rose from January 2024, peaked in May (APC=133.641%, t=3.841, P=0.006), then declined significantly (APC=-47.816%, t=2.586, P<0.001). The 12 subdistricts of Baoshan District were divided into low, medium, and high population density areas, with an average annual reported incidence rate of 6.09/100 000, 8.19/100 000 and 11.96/100 000, respectively. The reported incidence rate increased with an increase in population density. Spatiotemporal scan analyses showed that cases clustered in the southwest and northeast of Baoshan District. Epidemiological follow-up investigations of 1 520 cases revealed that the main clinical symptoms were cough (97.63%) and sputum production (41.58%), and 98.13% of the cases were confirmed by positive nucleic-acid test results. Among the 1 475 cases with immunization records, 83.53% had completed the four-dose pertussis vaccine before onset. The complication incidence rates, from high to low, were in the 0-dose vaccination group, 1‒3-dose vaccination group and 4-dose vaccination group. The duration of cough, from long to short, was observed in the the 0-dose vaccination group, 1‒3-dose vaccination group and 4-dose vaccination group, correspondingly. ConclusionIt is recommended to improve the pertussis surveillance system in medical institutions and establish an active monitoring network, prioritizing deployment in school settings and areas with high population density. Enhancing diphtheria-tetanus-pertussis (DTP) vaccination coverage among 6-year-old children and further optimizing the pertussis immunization strategies are essential to prevent and reduce the risk of pertussis among school-aged children.

Objective: To investigate the mechanism by which icariin ( ICA) inhibits the invasion and metastasis of human triple-negative breast cancer ( TNBC) cells via downregulation of the transforming growth factor-β/ Smad ( TGF-β/ Smad) signaling pathway． Methods: TNBC cells ( MDA-MB-231 and MDA-MB-468) were cultured in vitro and divided into four groups: an experimental group treated with 15 μmol / L ICA; a model group treated with 10 μmol / L TGF-β receptor inhibitor LY2109761; a combination group ( LY2109761 + ICA) treated with both 15 μmol / L ICA and 10 μmol / L LY2109761; and a control group．Cell proliferation，migration，and invasion were as- sessed using CCK-8，colony formation，5-ethynyl-2 '-deoxyuridine ( EdU) ，wound healing，and Transwell assays． The expression levels of epithelial-mesenchymal transition ( EMT) -related proteins，as well as TGF-β1，Smad2， and phosphorylated Smad2 ( P-Smad2) were detected by immunofluorescence and Western blot． Results: CCK-8 results showed that cell proliferation decreased gradually with increasing concentrations of ICA ( P＜0. 05) ．Colony formation and EdU assays indicated significantly inhibited proliferation in the ICA-treated group compared to the control ( P＜0. 05) ．Wound healing and Transwell assays demonstrated reduced migration and invasion capabilities in the experimental group relative to the control ( P＜0. 05) ．Compared to the model group，the LY2109761 + ICA group exhibited further suppression of invasion ( P＜0. 05) ．Immunofluorescence revealed decreased Vimentin ex- pression in the experimental group ( P＜0. 05) ，with an even more pronounced reduction in the LY2109761 + ICA group ( P＜0. 01) ．Western blot analysis showed that the protein levels of N-cadherin，matrix metalloproteinase-9( MMP9) ，Vimentin，TGF-β1，Smad2，and P-Smad2 were downregulated in the experimental group compared to the control ( P＜0. 05) ．These proteins were further suppressed in the LY2109761 + ICA group compared to the model group ( P＜0. 05) ． Conclusion ICA inhibits TNBC cells proliferation，invasion，metastasis，and EMT by downregulating the TGF-β/ Smad signaling pathway．