1.Herbal Textual Research on Bambusae Succus in Famous Classical Formulas
Yu SHI ; Feng ZHOU ; Yihan WANG ; Yanmeng LIU ; Ming YANG ; Zhiping CHEN ; Jiangshan ZHANG ; Conglong XU ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):231-239
This article systematically reviews and examines the historical evolution of Bambusae Succus as a medicinal material, covering aspects such as nomenclature, origin, geographical distribution, harvesting and processing methods, quality assessment, therapeutic effects and indications, by consulting ancient herbal texts, medical compendia, and modern literature. The aim is to provide a reference for the development and utilization of famous classical formulas containing this herb. Research indicated that Bambusae Succus was first documented in the Shennong Bencaojing during the Han dynasty, with Zhuli being the standard name used throughout history, alongside aliases like Zhuzhi, Zhuyou and Huoquan. Historically, the primary source of Bambusae Succus has been Phyllostachys nigra var. henonis(Danzhu), although other species such as Pleioblastus amarus and Bambusa emeiensis have also been used medicinally. Ancient records predominantly noted its origin in Yizhou(present-day Chengdu and surrounding areas in Sichuan) and the Wuling region(between present-day Hunan, Guangdong, Guangxi and Jiangxi provinces), while contemporary sources are mainly from regions south of the Yangtze River and southwestern China. Traditionally, Bambusae Succus was harvested from bamboo that had grown for exactly one year, today, it can be collected year-round without strict age requirements. Ancient preparation methods included direct fire roasting or dry distillation, whereas modern industrial production employs dry distillation, reflux extraction, and percolation. In terms of quality evaluation, ancient texts considered a sweet taste to be superior, while today, clarity and transparency are prioritized. Historically, Bambusae Succus was characterized as sweet and cold nature, targeting the lung and stomach meridians, with uses evolving from clearing heat and resolving phlegm to nourishing Yin, moistening dryness, and relaxing tendons and unblocking meridians. Modern descriptions classify it as sweet, bitter, and cold in nature, affecting the heart, liver, and lung meridians, with functions including clearing heat, resolving phlegm, and facilitating orifices. It is indicated for conditions such as stroke with phlegm confusion, lung heat with phlegm congestion, convulsions, epilepsy, excessive phlegm in febrile diseases, high fever with thirst, irritability during pregnancy, and tetanus, with more clearly defined applications. Based on the results of the research, it is recommended that when developing and utilizing famous classical formulas containing Bambusae Succus, the one-year-old Phyllostachys nigra var. Henonis, which has been highly praised throughout history, should be selected as the source material. Industrial production should adopt the dry distillation method. Furthermore, in-depth research should be conducted on the modern technological characterization of the traditional quality control indicator of sweet taste, and reasonable modern quality control standards should be established.
2.Mechanisms of Shenqi Wenfei Prescription in Intervening in Chronic Obstructive Pulmonary Disease in Rats Based on ROS/TXNIP/NLRP3 Signaling Pathway
Di WU ; Mengyao SHI ; Lu ZHANG ; Tong LIU ; Jiabing TONG ; Cheng YANG ; Zegeng LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):78-87
ObjectiveTo investigate the effects and underlying mechanisms of Shenqi Wenfei prescription (SQWF) on chronic obstructive pulmonary disease (COPD). MethodsA rat model of COPD with lung Qi deficiency was established using lipopolysaccharide (LPS) combined with cigarette smoke. Forty-eight SD rats were randomly divided into a blank group, a model group, low-, medium-, and high-dose SQWF groups (2.835, 5.67, 11.34 g·kg-1), and a Yupingfeng group (1.35 g·kg-1). Drug administration began on day 29 after modeling and continued for 2 weeks. The general condition of the rats was observed, and the lung function in each group was assessed. Hematoxylin-eosin (HE) staining was used to observe pathological changes in lung tissue. The proportion of inflammatory cells in bronchoalveolar lavage fluid (BALF) was measured. Apoptosis in lung tissue was examined by terminal deoxynucleotidyl transferase-mediated dUTP nick end-labeling (TUNEL) staining. The release level of lactate dehydrogenase (LDH) in BALF was detected by a microplate assay. Reactive oxygen species (ROS) levels in lung tissue were detected using fluorescent probes. The levels of malondialdehyde (MDA), total superoxide dismutase (SOD), and reduced glutathione (GSH) in BALF were measured by biochemical methods. Ultrastructural changes in lung cells were observed via transmission electron microscopy. Double immunofluorescence staining was performed to detect the expression of thioredoxin-interacting protein (TXNIP) and nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) in lung tissue. Western blot analysis was used to detect the protein expression of TXNIP, NLRP3, apoptosis-associated speck-like protein containing a CARD (ASC), cysteinyl aspartate-specific protease-1 (Caspase-1), Caspase-1 p20, gasdermin D (GSDMD), GSDMD N-terminal active fragment (GSDMD-N), interleukin-1β (IL-1β), and IL-18 in lung tissue. Serum IL-1β and IL-18 levels were measured by ELISA. ResultsCompared with the blank group, the model group showed lassitude, fatigue, tachypnea, and audible phlegm sounds, and lung function significantly declined (P0.01). Pulmonary emphysema and inflammatory cell infiltration were obvious. The level of inflammatory cells in BALF increased significantly (P0.05). The number of TUNEL-positive cells increased (P0.01). Levels of LDH, ROS, and MDA in BALF increased significantly (P0.01), while GSH and SOD activities decreased significantly (P0.01). Lung tissue cells showed irregular morphology, swollen mitochondria, disrupted cell membranes, and abundant vesicles, i.e., pyroptotic bodies. Protein levels of TXNIP, NLRP3, ASC, Caspase-1, Caspase-1 p20, GSDMD, GSDMD-N, IL-1β, and IL-18 in lung tissue were significantly elevated (P0.01), and serum IL-1β and IL-18 levels also increased significantly (P0.01). Compared with the model group, each medication group showed alleviation of qi deficiency symptoms and improved lung function (P0.01). Pulmonary emphysema and inflammatory cell infiltration were reduced. Inflammatory cell levels decreased (P0.05). The number of TUNEL-positive cells decreased significantly (P0.01). Levels of LDH, ROS, and MDA decreased significantly (P0.05), while GSH and SOD activities significantly increased (P0.01). Morphological and structural damage in lung tissue was improved to varying degrees. Protein levels of TXNIP, NLRP3, ASC, Caspase-1, Caspase-1 p20, GSDMD, GSDMD-N, IL-1β, and IL-18 in lung tissue significantly decreased (P0.01), and serum IL-1β and IL-18 levels also decreased significantly (P0.05). ConclusionSQWF can improve lung function and alleviate inflammatory responses in COPD rats. Its mechanism may be related to regulating the ROS/TXNIP/NLRP3 pathway and inhibiting pyroptosis.
3.Mechanisms of Shenqi Wenfei Prescription in Intervening in Chronic Obstructive Pulmonary Disease in Rats Based on ROS/TXNIP/NLRP3 Signaling Pathway
Di WU ; Mengyao SHI ; Lu ZHANG ; Tong LIU ; Jiabing TONG ; Cheng YANG ; Zegeng LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):78-87
ObjectiveTo investigate the effects and underlying mechanisms of Shenqi Wenfei prescription (SQWF) on chronic obstructive pulmonary disease (COPD). MethodsA rat model of COPD with lung Qi deficiency was established using lipopolysaccharide (LPS) combined with cigarette smoke. Forty-eight SD rats were randomly divided into a blank group, a model group, low-, medium-, and high-dose SQWF groups (2.835, 5.67, 11.34 g·kg-1), and a Yupingfeng group (1.35 g·kg-1). Drug administration began on day 29 after modeling and continued for 2 weeks. The general condition of the rats was observed, and the lung function in each group was assessed. Hematoxylin-eosin (HE) staining was used to observe pathological changes in lung tissue. The proportion of inflammatory cells in bronchoalveolar lavage fluid (BALF) was measured. Apoptosis in lung tissue was examined by terminal deoxynucleotidyl transferase-mediated dUTP nick end-labeling (TUNEL) staining. The release level of lactate dehydrogenase (LDH) in BALF was detected by a microplate assay. Reactive oxygen species (ROS) levels in lung tissue were detected using fluorescent probes. The levels of malondialdehyde (MDA), total superoxide dismutase (SOD), and reduced glutathione (GSH) in BALF were measured by biochemical methods. Ultrastructural changes in lung cells were observed via transmission electron microscopy. Double immunofluorescence staining was performed to detect the expression of thioredoxin-interacting protein (TXNIP) and nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) in lung tissue. Western blot analysis was used to detect the protein expression of TXNIP, NLRP3, apoptosis-associated speck-like protein containing a CARD (ASC), cysteinyl aspartate-specific protease-1 (Caspase-1), Caspase-1 p20, gasdermin D (GSDMD), GSDMD N-terminal active fragment (GSDMD-N), interleukin-1β (IL-1β), and IL-18 in lung tissue. Serum IL-1β and IL-18 levels were measured by ELISA. ResultsCompared with the blank group, the model group showed lassitude, fatigue, tachypnea, and audible phlegm sounds, and lung function significantly declined (P0.01). Pulmonary emphysema and inflammatory cell infiltration were obvious. The level of inflammatory cells in BALF increased significantly (P0.05). The number of TUNEL-positive cells increased (P0.01). Levels of LDH, ROS, and MDA in BALF increased significantly (P0.01), while GSH and SOD activities decreased significantly (P0.01). Lung tissue cells showed irregular morphology, swollen mitochondria, disrupted cell membranes, and abundant vesicles, i.e., pyroptotic bodies. Protein levels of TXNIP, NLRP3, ASC, Caspase-1, Caspase-1 p20, GSDMD, GSDMD-N, IL-1β, and IL-18 in lung tissue were significantly elevated (P0.01), and serum IL-1β and IL-18 levels also increased significantly (P0.01). Compared with the model group, each medication group showed alleviation of qi deficiency symptoms and improved lung function (P0.01). Pulmonary emphysema and inflammatory cell infiltration were reduced. Inflammatory cell levels decreased (P0.05). The number of TUNEL-positive cells decreased significantly (P0.01). Levels of LDH, ROS, and MDA decreased significantly (P0.05), while GSH and SOD activities significantly increased (P0.01). Morphological and structural damage in lung tissue was improved to varying degrees. Protein levels of TXNIP, NLRP3, ASC, Caspase-1, Caspase-1 p20, GSDMD, GSDMD-N, IL-1β, and IL-18 in lung tissue significantly decreased (P0.01), and serum IL-1β and IL-18 levels also decreased significantly (P0.05). ConclusionSQWF can improve lung function and alleviate inflammatory responses in COPD rats. Its mechanism may be related to regulating the ROS/TXNIP/NLRP3 pathway and inhibiting pyroptosis.
4.Risk factors related to intradural lumbar disc herniation analyzed by propensity score matching
Haoran GAO ; Heling ZHANG ; Fanglin JIA ; Di GUO ; Li JING ; Yaozhou SHI ; Hanlin SONG ; Xiao GAO ; Hu FENG
Chinese Journal of Tissue Engineering Research 2025;29(15):3199-3205
BACKGROUND:According to different locations of lumbar disc herniation,it can be classified into many types.Among them,patients with intradural sac type lumbar disc herniation have severe clinical symptoms,which greatly affect their quality of life.Therefore,this article studies the risk factors for its onset,and improving the preoperative diagnostic rate is of great significance for the treatment and prevention of this disease.OBJECTIVE:To explore the risk factors for intradural lumbar disc herniation.METHODS:A retrospective analysis was conducted on 15 patients with intradural lumbar disc herniation(herniation group)admitted to three hospitals in Xuzhou city from May 2014 to November 2022.Propensity score matching was used to match patients with lumbar disc herniation who did not protrude into the dura mater in a ratio of 1:4.A total of 59 patients were selected and included in the non-herniation group.Clinical data were observed in the two groups.Univariate and binary logistic regression analysis,multiple linear regression,and PROBIT regression analysis were utilized to identify the relevant risk factors for intradural lumbar disc herniation.RESULTS AND CONCLUSION:(1)The results of univariate analysis showed that the average disease course,proportion of segments,modified Pfiirmann grading,sacral tilt angle,proportion of previous lumbar spine surgery history,and proportion of heavy manual workers,proportion of lumbar spinal stenosis,redundancy of the cauda equina,and ossification of the posterior longitudinal ligament all showed statistical differences in the herniation and non-herniation groups(P<0.05).(2)Multivariate regression analysis showed that duration of disease,protruding segment,history of lumbar surgery,modified Pfiirmann grading,cauda equina redundancy,and lumbar spinal stenosis were independent risk factors for intradural lumbar disc herniation.(3)Based on the influencing factors,an receiver operating characteristic curve was constructed,with an area under curve of 0.956(95%CI:0.913-0.998),indicating good discrimination.(4)There was a significant correlation between the duration of the disease,the protruded segment,the history of lumbar spine surgery,the modified Pfirmann classification,cauda equina redundancy,lumbar spinal canal stenosis,and the incidence rate of intradural lumbar disc herniation.
5.Correlation study on influenza epidemic in representative 5 cities in the middle and lower reaches of the Yangtze River based on detection of oseltamivir metabolite in wastewater
Chen SHI ; Manlei ZHANG ; Xinxin ZHOU ; Mengyi CHEN ; Chenzhi HOU ; Bin DI
Journal of China Pharmaceutical University 2025;56(2):155-159
By selecting stable and detectable drug prototypes or metabolites in sewage samples, near real-time detection of disease conditions can be achieved. This study selected oseltamivir carboxylate, the primary metabolite of first-line antiviral oseltamivir, as a biomarker. Based on the concentration of oseltamivir carboxylate in wastewater, the consumption and usage rate of oseltamivir were calculated by reverse engineering. Quarterly sampling was conducted at 46 urban sewage treatment plants in representative 5 cities in the middle and lower reaches of the Yangtze River, from November 2022 to December 2023. The concentration range of oseltamivir acid in sewage samples is 1.270−1 279 ng/L, the daily mass load of oseltamivir per 1 000 inhabitants in the surveyed cities ranged from 9.560 to 544.7 mg/d, and the average utilization rate is 0.06‰−3.63‰. The research results indicate that in March 2023, Wuxi City experienced a spring influenza peak, while Bengbu, Tongling, Suzhou, and Changzhou City experienced a small summer influenza peak in May. In November and December 2023, Wuxi, Changzhou, and Bengbu City experienced a winter influenza peak, the results are consistent with the official statistics of the National Center for Disease Control and Prevention and the National Influenza Center, which reflect the influenza epidemic situation in southern cities. The integration of this methodology with clinical diagnostic rates could provide near real-time data support for future influenza prevention and control strategies.
6.Microbial community mediated by microbial agents improves the quality of Epimedium pubescens Maxim.
Kunyang LAI ; Xiufu WAN ; Jiancai XIAO ; Hongyang WANG ; Shangxuan SHI ; Binbin YAN ; Chaogeng LYU ; Chengcai ZHANG ; Yufei ZHANG ; Feng YUAN ; Zhe ZHAO ; Shoudong ZHU ; Chuanzhi KANG ; Yan ZHANG
Science of Traditional Chinese Medicine 2025;3(3):270-281
Background: Optimizing cultivation techniques for traditional Chinese medicine has become a crucial means to improve the quality of medicinal materials. Microbial agents, as environmentally friendly and efficient plant growth promoters and soil conditioners, have increasingly attracted attention in eco-agriculture research. Objective: Our understanding remains limited regarding how the application of microbial agents, alone or in combination, affects changes in the rhizosphere microbiome and its association with the bioactive components of medicinal materials. Methods: In this study, Epimedium pubescens Maxim. was employed as a model plant to examine the effects of 2 microbial agents(Paenibacillus mucilaginosus and Bacillus subtilis) applied individually and in combination on plant growth and the accumulation of bioactive components. Additionally, this study explored the relationship between the rhizosphere microbiome and plant development. Results: The application of microbial agents increased the yield of E. pubescens leaves by 20.30% to 33.66% and enhanced the total flavonol glycosides content by 11.40% to 29.94%. Meanwhile, microbial treatments reshaped the rhizosphere microbiome, promoted the enrichment of beneficial microorganisms (e.g., Frankia and Paenibacillus), suppressed phytopathogenic fungi such as Didymella and Scytalidium, and enhanced the stability of the soil microbial co-occurrence network. The partial least squares path model suggested that microbial agents not only directly impact the quality of medicinal herbs but also indirectly alter the accumulation of bioactive components by modulating the soil microbiome. Conclusion: These findings deepen our understanding of the relationship between medicinal plant quality and rhizosphere microbiomes as mediated by microbial agents. They also provide a basis for designing and manipulating synthetic microbial communities to promote sustainable development in eco-agriculture.
7.Determination of Organic Fluorinated Amines in Oral Care Products by Ultra Performance Liquid Chromatography-Charged Aerosol Detector Coupled with Solid-Phase Extraction
Xiao-Fang LI ; Yan PENG ; Di XIN ; Wei ZHOU ; Xiao-Hong QIAO ; Hua-Jin SHI ; Lei ZHANG ; Guo-Qiang CAI ; Ying LIU
Chinese Journal of Analytical Chemistry 2025;53(8):1362-1370,中插100-中插105
The major components of Olaflur raw material were characterized using ultra performance liquid chromatography-quadrupole time-of-flight-mass spectrometry(UPLC-Q-TOF/MS).The results revealed that cetyl amine fluoride(C16-AmF),octadecene amine fluoride(C18:1-AmF),and octadecyl amine fluoride(Olaflur)were the main components.The contents of C16-AmF,C18:1-AmF,and Olaflur in oral care products were determined via ultra performance liquid chromatography-charged aerosol detector coupled with solid-phase extraction(SPE-UPLC-CAD).The oral care sample was dispersed evenly with a 50%ethanol aqueous solution,and then vortexed with ethanol.The supernatant was collected by centrifugation,concentrated to near dryness,and redissolved with ultrapure water.The re-dissolved sample was loaded onto a Poly-Sery HLB Pro SPE column for purification and elution.The acetonitrile eluate was collected and concentrated to 1.0 mL.Finally,a prepared test solution was separated on a Thermo Acclaim Surfactant Plus chromatographic column(2.1 mm×150 mm,3 μm).Acetonitrile and 100 mmol/L acetic acid-ammonium acetate aqueous solution(pH=4.8)were used as the mobile phases for gradient elution.The flow rate was 0.3 mL/min and cloumn temperature was maintained at 40℃.The sample was detected using a charged aerosol detector,and quantified using an external standard method.The experimental results indicated that the three organic fluorinated amines showed good linear relationship in their respective concentration ranges.The correlation coefficients(r)were greater than 0.99.The limit of detection(LOD)and the limit of quantification(LOQ)of C16-AmF were 2.0 and 8.0 μg/mL,respectively.The LOD and LOQ of C18:1-AmF were 2.0 and 8.0 μg/mL,respectively.The LOD and LOQ of Olaflur were 3.0 μg/mL and 10.0 μg/mL,respectively.The spiked recoveries of the three organic fluorinated amines were 84.3%-104.2%,with relative standard deviations(RSDs)of 4.93%-5.82%.The 28 batches of commercial oral care samples were detected by this method and the results indicated that three organic fluorinated amines were detected in 18 samples and the total content were 22.2-11477.8 μg/g.This method had high sensitivity and good reproducibility.It was suitable for verifying the authenticity of the claims of oral care products promoted with Olaflur as the main efficacy ingredient and selling point,and provided a valuable reference for establishing and improving the standard analytical method for Olaflur.
8.Epidemiological dynamics and spatiotemporal diffusion trend of brucellosis in China from 2010 to 2024
Yunfei ZHANG ; Xinlou LI ; Qiang XU ; Di MU ; Yue SHI ; Xi CHEN ; Haijian ZHOU ; Tian QIN ; Biao KAN ; Canjun ZHENG ; Liqun FANG
Chinese Journal of Preventive Medicine 2025;59(6):884-891
Objective:To investigate the epidemiological dynamics and spatiotemporal diffusion trend of brucellosis in China from 2010 to 2024.Methods:Data on reported human brucellosis cases in mainland China from January 1, 2010, to December 31, 2024, were collected via the"China Information System for Disease Control and Prevention", including detailed information on the date of onset, gender, age, occupation, and residential address of the cases. The Joinpoint regression and spatial interpolation techniques were used to investigate the spatiotemporal dynamics and population distribution characteristics of human brucellosis in pastoral/semi-pastoral areas and other regions, as well as urban and rural areas, and explore the epidemic trends of the disease.Results:From 2010 to 2024, pastoral/semi-pastoral regions reported 252 094 brucellosis cases, with a mean annual incidence rate of 36.57±7.28 per 100 000. In contrast, other regions cumulatively recorded 519 748 cases during the same period, demonstrating a significantly lower mean annual incidence rate of 2.54±0.74 per 100 000. The incidence rate of human brucellosis in pastoral/semi-pastoral regions exhibited a declining-rebounding-declining trend. Specifically, the incidence rate decreased significantly from 2010 to 2017 (APC=-7.20; P<0.001) and increased notably from 2017 to 2021 (APC=18.00; P=0.015) with a decline again from 2021 to 2024 (APC=-7.53; P=0.027). In other regions, the incidence rate showed a fluctuating upward trend. Specifically, the incidence rate increased significantly from 2010 to 2015 (APC=20.37; P<0.001) and decreased notably from 2015 to 2018 (APC=-21.78; P<0.001), followed by an increase again from 2018 to 2024, a significant upward trend in incidence rate from 2018 to 2021 (APC=26.73; P<0.001) and a non-significant decline from 2021 to 2024 (APC=-0.99; P=0.735), resulting in the maintenance of a relatively high incidence level. Rural areas demonstrated significantly higher brucellosis incidence rates than urban settings (all P<0.001). Brucellosis exhibited a diffusion trend from the northern epidemic areas of China to neighboring regions, along with sporadic diffusion in southern regions between 2010 and 2024. The age structure of patients in pastoral/semi-pastoral areas differed significantly from that in other regions. Specifically, in pastoral/semi-pastoral areas, the incidence rate was higher among the 35-49 age groups, while in other regions, the incidence rate was higher among those aged 55-64. Conclusion:There are notable disparities in the incidence of human brucellosis between pastoral/semi-pastoral areas and other regions in China. Human brucellosis exhibits a diffusion trend from the northern epidemic areas of China to neighboring regions, along with sporadic diffusion in southern regions.
9.Microbial community mediated by microbial agents improves the quality of Epimedium pubescens Maxim.
Lai KUNYANG ; Wan XIUFU ; Xiao JIANCAI ; Wang HONGYANG ; Shi SHANGXUAN ; Yan BINBIN ; Lyu CHAOGENG ; Zhang CHENGCAI ; Zhang YUFEI ; Yuan FENG ; Zhao ZHE ; Zhu SHOUDONG ; Kang CHUANZHI ; Zhang YAN
Science of Traditional Chinese Medicine 2025;3(3):270-281
Background:Optimizing cultivation techniques for traditional Chinese medicine has become a crucial means to improve the quality of medicinal materials.Microbial agents,as environmentally friendly and efficient plant growth promoters and soil conditioners,have increasingly attracted attention in eco-agriculture research.Objective:Our understanding remains limited regarding how the application of microbial agents,alone or in combination,affects changes in the rhizosphere microbiome and its association with the bioactive components of medicinal materials.Methods:In this study,Epimedium pubescens Maxim.was employed as a model plant to examine the effects of 2 microbial agents(Paenibacillus mucilaginosus and Bacillus subtilis)applied individually and in combination on plant growth and the accumulation of bioactive components.Additionally,this study explored the relationship between the rhizosphere microbiome and plant development.Results:The application of microbial agents increased the yield of E.pubescens leaves by 20.30%to 33.66%and enhanced the total flavonol glycosides content by 11.40%to 29.94%.Meanwhile,microbial treatments reshaped the rhizosphere microbiome,promoted the enrichment of beneficial microorganisms(e.g.,Frankia and Paenibacillus),suppressed phytopathogenic fungi such as Didymella and Scytalidium,and enhanced the stability of the soil microbial co-occurrence network.The partial least squares path model suggested that microbial agents not only directly impact the quality of medicinal herbs but also indirectly alter the accumula-tion of bioactive components by modulating the soil microbiome.Conclusion:These findings deepen our understanding of the relationship between medicinal plant quality and rhizosphere micro-biomes as mediated by microbial agents.They also provide a basis for designing and manipulating synthetic microbial communities to promote sustainable development in eco-agriculture.
10.Construction of laboratory biosafety evaluation index system for emergency public health events in medical institutions from the perspective of integrating routine and emergency measures
Di ZHANG ; Fangchao LIU ; Fengling MI ; Zihui LI ; Hairong HUANG ; Liping PAN ; Guangli SHI ; Guanglu JIANG ; Junhua PAN
Chinese Journal of Medical Science Research Management 2025;38(3):182-190
Objective:To construct a biosafety evaluation index system for major emergency public health events in medical institutions.Methods:Based on previous laboratory biosafety evaluation work, relevant regulations and standards on biosafety in China were collected through literature research and expert consultations. Candidate indicators for constructing the biosafety evaluation system for major emergency public health events in medical institutions were selected, and a framework was established. Two rounds of expert questionnaires were conducted to determine the content of the index system based on experts′ evaluation, and each indicator′s relevance and importance were scored. Finally, two rounds of Delphi consultations were carried out, and the Analytic Hierarchy Process (AHP) was applied to calculate the weights of indicators.Results:The response rates for the total four rounds of questionnaire surveys were all 100%. The first two rounds focused on determining the framework, while the latter two focused on determining the weights for each indicator. The authority coefficients of the expert consultations for the two rounds of weights were 0.65 and 0.70, respectively, indicating the reliability of the research results. In the final round of survey, the Kendall′s coefficients of concordance at each level were all greater than 0.1. Through statistical testing, the P-values were all less than 0.05, indicating good coordination of expert opinions. Ultimately, we established an operational biosafety evaluation system for major emergency public health events in medical institutions, consisting of 4 primary indicators, 26 secondary indicators, and 119 tertiary indicators, with additional deduction items, bonus items, unacceptable items, and monitoring indicators.Conclusions:Based on scientific theory, a biosafety evaluation system for major emergency public health events in medical institutions was constructed, achieving the integration of routine and emergency measures. This system can be used for self-assessment of laboratory biosafety during emergency public health events, addressing the lack of unified standards in biosafety evaluation. Through regular self-assessment, it can enhance the level of biosafety management in medical institution laboratories, to realize the value of application and dissemination.

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