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.Successful treatment of extracorporeal membrane oxygenation bridging to lung transplantation in a patient with rapidly progressive interstitial lung disease
Yi GONG ; Xinyu LING ; Rui YAN ; Bo SUN ; Ke MA ; Guifang WANG ; Chang CHEN
Chinese Journal of Clinical Medicine 2026;33(1):154-159
A 42-year-old male with chest tightness and dyspnea was admitted to the hospital. Chest CT indicated diffuse interstitial lung infiltration. Despite receiving anti-infective therapy, glucocorticoid therapy, and immunosuppressive agents, the patient developed refractory hypoxaemia. Endotracheal intubation and invasive mechanical ventilation failed to improve oxygenation. Therefore the patient was diagnosed with rapidly progressive interstitial lung disease (RP-ILD) accompanied by type Ⅰ respiratory failure. Veno-venous (VV) extracorporeal membrane oxygenation (ECMO) was initiated, and oxygenation improved in this patient. The patient subsequently underwent bilateral lung transplantation with veno-arterio-venous (VAV) ECMO support. ECMO machine was withdrawn on day 1, and extubation was achieved on day 9 after surgery. Histopathology revealed fibrotic nonspecific interstitial pneumonia (NSIP) with hyaline membrane formation. The patient developed ICU-acquired myasthenia and received early rehabilitation, with gradual recovery of muscle strength. During follow-up, graft lung function remained stable. This case demonstrates that ECMO can serve as a bridge to lung transplantation in RP-ILD patients.
3.Spatiotemporal clustering characteristics and epidemiological trends of typhus fever in Baoshan City, Yunnan Province, 2005‒2023
Tianren LU ; Lijuan ZHAO ; Lizhong DUAN ; Kai HE ; Na WANG ; Zongqi JIANG ; Zhijie ZHANG ; Dongsheng HUANG
Shanghai Journal of Preventive Medicine 2026;38(4):274-279
ObjectiveTo analyze the incidence and spatiotemporal distribution of typhus fever in Baoshan City, Yunnan Province from 2005 to 2023, to identify high-risk populations and regions, so as to provide a scientific basis for optimizing the allocation of local prevention and control resources and developing targeted intervention measures. MethodsData of typhus fever cases in Baoshan City from 2005 to 2023 were obtained from the Infectious Disease Information Management System of the Chinese Center for Disease Control and Prevention. Descriptive epidemiological methods were used to analyze the temporal, spatial and demographic distribution of typhus fever cases. Spatial clustering was assessed using spatial dynamic window scan statistics (circular and elliptical windows), flexible spatial scan statistics, and local spatial autocorrelation methods (including local Moran’s I, local Geary’s C, and Getis-Ord Gi*). Retrospective spatiotemporal scan statistics were employed to detect spatiotemporal clusters. ResultsA total of 1 099 typhus fever cases were reported in Baoshan City from 2005 to 2023. The incidence rate peaked at 6.31/ 100 000 in 2007, followed by a decline until reaching its lowest level at 0.21/100 000 in 2015 , and subsequently rebounded during 2016‒2023. The highest proportion of cases was among children under 10 years of age (31.12%), and the top three occupations of cases were farmers, students, and children, accounting for 88.62% of all cases. Cases occurred predominantly between June and September each year. The incidence was relatively high in Jiucheng Town (62.58/100 000), Yaoguan Town (57.15/100 000), and Dianyang Town (46.81/100 000) of Shidian County. Spatial clustering analyses indicated that high-risk areas were mainly located in the southern part of Baoshan City, showing a south-to-north trend. Spatiotemporal scan analyses identified five clusters, with the most likely cluster centered around Yaoguan Town, covering ten towns (subdistricts) during the period 2007‒2010. ConclusionThe incidence of typhus fever in Baoshan City exhibits a clear seasonal and spatial clustering pattern, with peak incidence occurring in summer and autumn. Spatially, cases are primarily distributed in the southern part of Baoshan City, and high-risk clusters exhibit a south-to-north trend. Farmers, students, and children are the high-risk groups.
4.Surveillance on the density of Aedes albopictus in Baoshan District, Shanghai Municipality from 2018 to 2024
Haijian WANG ; Yingyu YANG ; Chunwei SUN ; Miaomiao HE ; Yi ZHANG
Chinese Journal of Schistosomiasis Control 2026;38(2):207-212
Objective To investigate the changes in the density of Aedes albopictus across different regions and different breeding habitats in Baoshan District, Shanghai Municipality from 2018 to 2024, so as to inform evidence-based control strategies for mosquito-borne infectious diseases in Shanghai Municipality. Methods Ae. albopictus surveillance sites were deployed in 12 subdistricts (towns) of Baoshan District, Shanghai Municipality from 2018 to 2024, and the surveillance on the density of Ae. albopictus was performed in each surveillance site once weekly during the peak activity period of Aedes mosquitoes from May to October each year from 2018 to 2024. Mosquito ovitraps were deployed in various breeding habitats in each surveillance site according to geographical locations, including residential areas, schools, government institutions, hospitals, recycling stations, and construction sites, and regularly collected, and the mosquito ovitrap index (MOI) was calculated. The changes in the Ae. albopictus density were analyzed based on MOI across years, regions, and breeding habitats. Additionally, from May to October each year between 2018 and 2024, monthly risk assessments of Aedes albopictus density were conducted in every subdistrict (town) of Baoshan District, Shanghai. Results The annual mean MOI values of Ae. albopictus were 5.88 ± 2.29, 8.19 ± 4.46, 7.43 ± 3.40, 5.44 ± 2.52, 3.97 ± 2.72, 3.82 ± 1.57, and 2.56 ± 1.11 in Baoshan District from 2018 to 2024, respectively (F = 75.886, P < 0.05), and the MOI appeared a rise followed by a reduction each year and peaked during the period between June and August. There was a significant difference in the 7-year mean MOI of Ae. albopictus across the 12 subdistricts/towns (F = 26.558, P < 0.05), and there were 6 subdistricts/towns with a 7-year mean MOI of over 5, including Songnan Town (8.44 ± 4.68), Dachang Town (7.71 ± 5.28), Gucun Town (7.13 ± 3.57), Yuepu Town (5.74 ± 1.69), Gaojing Town (5.51 ± 3.44), and Wusong Subdistrict (5.41 ± 2.04). There was a significant difference in the MOI of Ae. albopictus across breeding habitats (F = 3.843, P < 0.05), with the highest MOI seen in recycling stations (9.86 ± 4.61), which was significantly higher than in other habitats (P < 0.05), and the lowest seen in construction sites (4.90 ± 2.95), which was significantly lower than in other habitats (P < 0.05). The proportion of frequency with Ae. albopictus density transmission risk decreased from 54.17% in 2018 to 11.11% in 2024 in all subdistricts (towns) of Baoshan District, and the frequency of outbreak risks peaked in 2019 (18 instances) and declined substantially in 2021 (6 instances), with no records of outbreak or transmission risk documented across the district in 2024. Conclusions There were substantial seasonal variations in the Ae. albopictus density in Baoshan District, Shanghai Municipality from 2018 to 2024. The Ae. albopictus density peaked during the period between June and August in Baoshan District each year from 2018 to 2024, with a relatively higher density in Songnan Town and Dachang Town, and in recycling stations. Precision control measures and intensified seasonal interventions are recommended in high-risk settings in Baoshan District to reduce the transmission risk of Aedes-borne infectious diseases.
5.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.
6.In vitro inhibitory effects and safety evaluation of Nymphaea candida total fla-vonoids against Staphylococcus aureus
Baoshan HAO ; Kaixiang GAO ; Xueting ZHAO ; Wenting JIN ; Xiaolong WEI ; Han-ya GAO ; Liyina XU ; Xin WANG ; Yang WANG ; Zhanhai MAI ; Saifuding ABULA ; Adelijiang WUSI-MAN ; Wei ZHANG ; Dandan LIU
Chinese Journal of Veterinary Science 2025;45(11):2439-2446
To investigate the in vitro inhibitory mechanism of Nymphaea candida total flavonoids(NCTF)against Staphylococcus aureus(S.aureus)and its safety in mice,this study first deter-mined the antibacterial effect of NCTF on the clinically isolated strain S.aureus-C1.Subsequently,the inhibitory mechanism of NCTF on S.aureus-C1 was explored by measuring its effects on bac-terial growth curves,microstructure,intracellular AKP and LDH levels,and biofilm formation.Safety evaluation included determination of LD50 and MDT in mice,as well as analysis of serum biochemical parameters,organ indices,and histopathological observations.Results showed that NCTF effectively inhibited S.aureus-C1 proliferation,with an inhibition zone diameter of(18.98±0.67)mm and a MIC of 6.25 g/L.A concentration of 2×MIC nearly completely suppressed bacte-rial growth.Scanning electron microscopy revealed structural damage to bacterial cells,including collapse and shrinkage.AKP and LDH assays indicated significantly increased AKP activity(P<0.05)and decreased intracellular LDH activity(P<0.05)in the supernatant of drug-treated groups,demonstrating NCTF-induced disruption of cell walls and membranes leading to leakage of AKP and LDH.Crystal violet staining of biofilms showed significant inhibition rates of(43.77±9.16)%and(61.71±9.82)%at 2 × MIC and 4 × MIC concentrations,respectively(P<0.05).Safe-ty assessments indicated low toxicity of NCTF in mice,with transient effects that returned to nor-mal levels within a short period.These findings demonstrate that NCTF exhibits potent antibacte-rial activity against S.aureus-C1 by damaging bacterial cell structures,increasing cell wall/mem-brane permeability,reducing biofilm formation,and displaying low toxicity.This study provides scientific evidence for clinical drug screening against bovine mastitis and the development of Nym-phaea candida resources.
7.In vitro inhibitory effects and safety evaluation of Nymphaea candida total fla-vonoids against Staphylococcus aureus
Baoshan HAO ; Kaixiang GAO ; Xueting ZHAO ; Wenting JIN ; Xiaolong WEI ; Han-ya GAO ; Liyina XU ; Xin WANG ; Yang WANG ; Zhanhai MAI ; Saifuding ABULA ; Adelijiang WUSI-MAN ; Wei ZHANG ; Dandan LIU
Chinese Journal of Veterinary Science 2025;45(11):2439-2446
To investigate the in vitro inhibitory mechanism of Nymphaea candida total flavonoids(NCTF)against Staphylococcus aureus(S.aureus)and its safety in mice,this study first deter-mined the antibacterial effect of NCTF on the clinically isolated strain S.aureus-C1.Subsequently,the inhibitory mechanism of NCTF on S.aureus-C1 was explored by measuring its effects on bac-terial growth curves,microstructure,intracellular AKP and LDH levels,and biofilm formation.Safety evaluation included determination of LD50 and MDT in mice,as well as analysis of serum biochemical parameters,organ indices,and histopathological observations.Results showed that NCTF effectively inhibited S.aureus-C1 proliferation,with an inhibition zone diameter of(18.98±0.67)mm and a MIC of 6.25 g/L.A concentration of 2×MIC nearly completely suppressed bacte-rial growth.Scanning electron microscopy revealed structural damage to bacterial cells,including collapse and shrinkage.AKP and LDH assays indicated significantly increased AKP activity(P<0.05)and decreased intracellular LDH activity(P<0.05)in the supernatant of drug-treated groups,demonstrating NCTF-induced disruption of cell walls and membranes leading to leakage of AKP and LDH.Crystal violet staining of biofilms showed significant inhibition rates of(43.77±9.16)%and(61.71±9.82)%at 2 × MIC and 4 × MIC concentrations,respectively(P<0.05).Safe-ty assessments indicated low toxicity of NCTF in mice,with transient effects that returned to nor-mal levels within a short period.These findings demonstrate that NCTF exhibits potent antibacte-rial activity against S.aureus-C1 by damaging bacterial cell structures,increasing cell wall/mem-brane permeability,reducing biofilm formation,and displaying low toxicity.This study provides scientific evidence for clinical drug screening against bovine mastitis and the development of Nym-phaea candida resources.
8.Expert consensus on clinical treatment of acute radiation syndrome from external irradiation
Li LIANG ; Long YUAN ; Changlin YU ; Qingjie LIU ; Yulong LIU ; Wenfeng YANG ; Jin WANG ; Weixu HUANG ; Ying LIU ; Cuiping LEI ; Huifang CHEN ; Ximing FU ; Baoshan CAO ; Mopei WANG ; Zhaohui ZHANG ; Yu XIAO ; Yamei CHEN ; Quanfu SUN
Chinese Journal of Radiological Medicine and Protection 2025;45(9):827-839
China emerges as a major country in nuclear energy development and the application of nuclear and radiologic technology. The diagnosis and treatment of acute radiation syndrom (ARS) caused by external irradiation represent a core function in the country′s medical rescue of nuclear and radiological emergencies. Clinically, ARS manifests hematopoietic, gastrointestinal, cutaneous, and central nervous system syndromes, with specific clinical manifestations, signs, severity, and prognosis strongly correlated with radiation dose. China has established a number of national and provincial centers for treating radiation-induced damage. Nevertheless, most medical staff have limited experience in ARS treatment. This consensus presents a summary of recent experience in treating ARS of China. In combination with recommendations from international organizations such as the World Health Organization (WHO), this consensus proposes key evidence of critical clinical issues of ARS, covering all links in the rescue of external irradiation-induced ARS. Initially, clinical diagnosis, syndromes, and severe degrees should be determined based on clinical symptoms and dose estimates. It is necessary to normalize clinical treatment measures for hematopoietic recovery, gastrointestinal injury treatment, infection control, symptomatic treatment, and multi-organ function preservation. To this end, this consensus offers cautions. This consensus provides principles of treatment with traditional Chinese medicine, psychological intervention, and follow-up. Additionally, it highlights multidisciplinary collaboration. It is recommended that this consensus be applied in relevant treatment centers.
9.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.
10.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.

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