1.Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies
Qingyong ZHENG ; Yongjia ZHOU ; Tengfei LI ; Jianguo XU ; Chen TIAN ; Hui LIU ; Min TIAN ; Ziyu ZHOU ; Caihua XU ; Yating CUI ; Junfei WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2026;46(1):138-148
Animal experimentation constitutes a critical link between basic research and clinical application, making its research quality and translational efficiency paramount. Although considerable progress has been made in standardizing operational procedures and ethical guidelines, the standardization of outcome evaluation systems has significantly lagged, creating a key bottleneck that constrains the quality of biomedical research and evidence synthesis. This deficiency is manifested by pronounced heterogeneity in outcome selection across similar studies, incomplete methodological reporting, and disparate criteria for result interpretation, which severely impairs the comparability of findings and the evidence integration. To cope with this challenge, this paper systematically introduces a mature methodological tool from clinical research–the core outcome set (COS)–and explores its construction strategies and application potential in the field of animal experimentation. Given the extensive diversity of animal experiments, a pragmatic strategy of "focusing on key areas, implementing phased pilots, and promoting gradual expansion" should be adopted. This approach prioritizes the development of domain-specific COS for disease areas characterized by high research volume, urgent translational needs, and well-established animal models. A multi-source integration pathway for COS development is detailed, comprising systematic literature searches, methodological appraisals, and expert consensus, with the feasibility of leveraging artificial intelligence (AI) to enhance efficiency also being examined. The development and promotion of such COS are not intended to restrict scientific exploration; rather, they aim to establish a new, tiered evaluation paradigm consisting of "core outcomes" (mandatory), "recommended outcomes" (encouraged), and "exploratory outcomes" (optional). This framework is expected not only to enhance research quality through standardization and to adhere to the "3R" principles but also to accelerate the accumulation of high-quality evidence. This, in turn, provides a solid foundation for higher-level evidence synthesis, ultimately facilitating the effective translation of basic research findings into clinical practice and providing an essential methodological framework for scientific advancement in relevant disciplines.
2.Discussion on the Treatment of Acute Respiratory Distress Syndrome from the Theory of "Qi Loses Its Regulatory Function,Fluids and Blood Follow the Same Path"
Hui WENG ; Bo CHEN ; Tengfei CHEN ; Chengjian YE ; Wenhe ZHENG
Journal of Traditional Chinese Medicine 2026;67(7):792-797
Acute respiratory distress syndrome (ARDS) is believed to primarily result from a disorder of the qi movement, with qi dysfunction occurring first, followed by changes in fluids and blood. The disease is located in the lungs, with its root in qi and pathological changes in fluids and blood, aligning with the theory of "qi loses its regulatory function, fluids and blood follow the same path". Accordingly, ARDS is divided into three stages, the early stage with qi congestion, counterflow, fluids and blood obstruction, severe stage with qi collapse, yang depletion, fluids and blood out of control), and recovery stage with qi consumption and fluids damage, residual pathogen retention. For the corresponding treatments, in the early stage, the focus is on diffusing the lung qi, opening the block, dissol-ving phlegm, and eliminating fluid retention, using Tingli Dazao Xiefei Decoction (葶苈大枣泻肺汤) and Xuanbai Chengqi Decoction (宣白承气汤) / Shegan Mahuang Decoction (射干麻黄汤) with modifications. In the severe stage, the priority is to reinforce qi, stabilize collapse, and promote diuresis and blood circulation, with modified Zhenwu Decoction (真武汤) and Shenge Powder (参蛤散). During recovery stage, the emphasis shifts to replenishing qi and body fluids while clearing residual pathogens, with Shashen Maidong Decoction (沙参麦冬汤) and Bufei Decoction (补肺汤). At the same time, from the perspective of "qi loses its regulatory function, fluids and blood follow the same path", the mechanism of prone position ventilation (PPV) is explored. It is believed that the effect of "qi reaching the blood" via PPV by restoring the qi movement and unblocking qi, blood and water retention, which offers insights for the diagnosis and treatment of ARDS with integrated traditional Chinese and western medicine.
3.Incidence and risk factors of sarcopenia in non-dialysis patients with stage 5 chronic kidney disease
Feng LI ; Changqing MAO ; Hui JIA ; Yanling MAO ; Ying LI ; Tengfei CHEN ; Dong LI ; Chunxia SHAO
Chinese Journal of Clinical Medicine 2026;33(3):493-498
Objective To explore the incidence and risk factors of sarcopenia in non-dialysis patients with stage 5 chronic kidney disease (CKD). Methods Non-dialysis stage 5 CKD patients in Jiading District Central Hospital Affiliated Shanghai University of Medicine & Health Sciences from October 2023 to October 2024 were enrolled and divided into the non-sarcopenia group and the sarcopenia group according to lean tissue index (LTI) and handgrip strength (HGS). Demographic data of patients were collected and biochemical indicators were detected. Serum advanced glycation end products (AGEs) were detected by competitive ELISA. Multivariate logistic regression analysis was conducted to analyze the risk factors of sarcopenia in these patients. The diagnostic efficacy of the risk factors was evaluated by the receiver operating characteristic (ROC) curve. Results A total of 102 non-dialysis stage 5 CKD patients with (68.52±7.39) years, were enrolled, including 61 male (59.8%). Among them, 24 were diagnosed with sarcopenia (23.5%). Compared with patients in non-sarcopenia group, patients in sarcopenia group were older and had higher interleukin-6 (IL-6) and AGEs, lower body mass index (BMI) and lower serum albumin (sAlb; P<0.05). Multivariate logistic regression showed that advanced age (OR=1.153, 95%CI 1.045–1.273, P=0.005), higher IL-6 (OR=1.165, 95%CI 1.042–1.302, P=0.007)、lower sAlb (OR=0.675, 95%CI 0.542–0.840, P=0.001), and higher serum AGEs (OR=1.105, 95%CI 1.013–1.206, P=0.024) were independent risk factors of sarcopenia in non-dialysis CKD 5 patients. The areas under the curve (AUC) for the age, IL-6, sAlb, and serum AGEs were 0.896, 0.643, 0.658, and 0.724, respectively. Conclusions Sarcopenia is common in non-dialysis stage 5 CKD patients, and the risk of sarcopenia is higher in non-dialysis stage 5 CKD patients with advanced age, higher IL-6, lower sAlb, and higher serum AGEs.
4.Ultrasonic manifestations of local recurrence of breast cancer after surgery
Na ZHAO ; Shuai ZHENG ; Zhiguang CHEN ; Kai DU ; Liqian WANG ; Lijuan DU ; Tengfei YU ; Wei ZHANG
Chinese Journal of Medical Imaging Technology 2025;41(2):258-262
Objective To observe the ultrasonic manifestations of local recurrence(LR)of breast cancer after surgery.Methods Totally 82 female breast cancer patients with local hypoechoic in surgical area who underwent ultrasound follow-up were enrolled and divided into LR group(n=18)and non LR group(n=64)according to the local hypoechoic was LR or not.Clinical data and ultrasonic manifestations of primary lesion before operation and postoperative local hypoechoic were observed and compared between groups.Results Significant differences of surgical resection type,molecular subtype,status of smooth muscle actin,Calponin status,Ki-67 status,clinical staging,the maximum diameter and posterior echo of the primary lesion,as well as of involved tissue layer,location,long axis parallel to the skin or not,edge,internal echo,posterior echo,skin change and Adler blood flow grading of local hypoechoic in resection area were found between groups(all P<0.05).Conclusion Ultrasonic manifestations of LR of breast cancer after surgery had certain characteristics.
5.Comparative research of inflammatory factors in different specimens from a rat model of aspiration pneumonia induced by lipopolysaccharide
Ling SONG ; Yunhang GAO ; Han LI ; Tengfei CHEN ; Hongping HOU ; Zuguang YE ; Guangping ZHANG
Acta Laboratorium Animalis Scientia Sinica 2025;33(1):89-98
Objective To investigate the changes of inflammatory factors in bronchoalveolar lavage fluid(BALF),lung tissue,and serum of a rat pneumonia model induced by inhalation of lipopolysaccharides(LPS).Methods Three days after modeling by LPS 4 mg/mL inhalation,15 min/d,was conducted while monitoring the particle size distribution and aerosol concentration of LPS,the degree of inflammation in lung tissues of rats in each group was observed via HE staining,and neutrophils in BALF were counted by microscope.The contents of interferon gamma(IFN-γ),interleukin-1 beta(IL-1 β),IL-4,IL-5,IL-6,IL-10,IL-13,tumor necrosis factor alpha(TNF-α),and KC/GRO in lung tissue,serum,and BALF were detected by Meso Scale Discovery.Results The lung histopathology of model rats displayed focal and diffuse alveolar epithelial necrosis with shedding and the aggregation and infiltration of inflammatory cells.The particle size distribution of atomized LPS was as follows,Dv(10)=0.6974μm,Dv(50)=3.387 μm,Dv(90)=8.836 μm.The aerosol concentration of LPS was 4.08 g/m3,and the calculated inhalation dose for rats was 47.10 mg/kg.The neutrophil count(P<0.01)and contents of IL-1β,IL-6,and TNF-α(P<0.05,P<0.001,P<0.001)in the BALF,and the contents of IL-1β,IL-6,and KC/GRO in lung tissue(P<0.01,P<0.05,P<0.01),of model rats were significantly increased.No biologically significant changes were observed in inflammatory factor levels in the serum.Conclusions In the acute pneumonia model induced by inhalation of LPS,significant changes in inflammatory factors such as IL-1β,IL-6,KC/GRO,and TNF-α were observed in both lung tissue and bronchoalveolar lavage fluid(BALF),while no notable changes in these inflammatory factors were detected in serum.This indicates that the inflammation responses are primarily localized in the lungs.
6.Research progress on oxidative stress mechanism and traditional Chinese medicine intervention in varicocele-induced infertility
Shengnan LI ; Hongyan CHEN ; Tengfei CHEN ; Boxian GAO ; Chongfu ZHONG
China Pharmacy 2025;36(12):1536-1541
Varicocele-induced infertility(VCI)is a common andrological disease in clinical practice.Oxidative stress represents the primary mechanism through which varicocele causes male infertility.Traditional Chinese medicine(TCM)treatment,characterized by its multi-target,multi-component,multi-system,and multi-pathway actions,has achieved favorable outcomes in the field of VCI treatment.This paper summarizes the underlying oxidative stress mechanism of VCI and the relevant signaling pathways involved.By reviewing the current research status on how monomers,active fractions,compound formulas,and related preparations of TCM can intervene in oxidative stress through the regulation of these signaling pathways to improve VCI,it is found that the nuclear factor-erythroid 2-related factor 2(Nrf2)signaling pathway,the mitogen-activated protein kinase(MAPK)signaling pathway,and the hypoxia-inducible factor-1α(HIF-1α)signaling pathway are closely related to the development of VCI.TCM monomers and active fractions(flavonoids from Cuscutae Semen,polysaccharides from Astragali Radix,curcumin,ginsenoside Rg1,hyperin and echinacoside),as well as compound formulas and related preparations of TCM(modified Dahuang zhechong granules,Shengjing huoxue formula,modified Tianxiong san,Tongjingling,Bushen huoxue formula,Mailuoshutong pill,Zishen yutai pill,Danhong tongjing formula)can alleviate oxidative stress,reduce lipid peroxidation damage,improve mitochondrial dysfunction,decrease sperm DNA fragmentation,and inhibit apoptosis by activating the Nrf2 signaling pathways and inhibiting the MAPK and HIF-1α signaling pathways,thereby improving reproductive function.
7.Effects of Shenyuan Yiqi Huoxue Capsules on Cardiopulmonary Exercise Function and Quality of Life in Patients with Ischemic Cardiomyopathy
Zhuhua ZHANG ; Tengfei LI ; Xiao XIE ; Wenlong XING ; Yingzhe CHEN ; Mei DAI ; Jiaping CHEN
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(10):142-147
Objective To explore the effects of Shenyuan Yiqi Huoxue Capsules on cardiopulmonary exercise function and quality of life in patients with ischemic cardiomyopathy.Methods Totally 66 patients with ischemic cardiomyopathy were divided into treatment group and control group using random number table method,with 33 cases in each group.Both groups received standardized Western medicine treatment,and the treatment group was additionally given Shenyuan Yiqi Huoxue Capsules,the control group was given Shenyuan Yiqi Huoxue Capsules simulator,three capsules per time,three times a day,orally.The observation period was 30 days.To evaluate the efficacy of TCM syndrome in two groups.The observation indicators included baseline data,TCM syndrome scores,cardiopulmonary exercise test detection indicators,MLHFQ score,SF-36 score,echocardiographic indicators,N-terminal pro-B-type natriuretic peptide(NT-pro BNP)and safety indicators.Results The total effective rate of the treatment group was 93.94%(31/33),while that of the control group was 78.79%(26/33).The treatment group was significantly better than the control group(P<0.05).Compared with before treatment,the TCM syndrome scores of the two groups of patients decreased(P<0.05),and after treatment,the TCM syndrome score of the treatment group was lower than that of the control group(P<0.05).Compared with before treatment,the peak oxygen uptake(peak VO2),anaerobic threshold(AT)and peak oxygen pulse(peak O2 pulse)of both groups of patients increased,while the carbon dioxide ventilation equivalent slope(VE/VCO2 slope)decreased(P<0.05).After treatment,the treatment group had higher peak VO2,AT and peak O2 pulse than the control group,while the VE/VCO2 slope was lower than the control group(P<0.05).Compared with before treatment,both groups of patients showed a decrease in MLHFQ score and an increase in SF-36 score(P<0.05);after treatment,the MLHFQ score in the treatment group was lower than that in the control group,and the SF-36 score was higher than that in the control group(P<0.05).Compared with before treatment,both groups of patients showed a decrease in left ventricular end systolic diameter,left ventricular end diastolic diameter and NT-pro BNP levels,while myocardial motion index and left ventricular ejection fraction increased(P<0.05);after treatment,the treatment group showed a decrease in left ventricular end systolic diameter,left ventricular end diastolic diameter and NT-pro BNP levels,while myocardial motion index and left ventricular ejection fraction increased(P<0.05).During the treatment period,no adverse reactions such as dizziness,nausea,vomiting or diarrhea were found in both groups of patients.Conclusion Shenyuan Yiqi Huoxue Capsules can significantly improve the clinical efficacy of ischemic cardiomyopathy patients,alleviate TCM symptoms,improve their cardiorespiratory function and quality of life.
8.Correlation between serum homocysteine, folic acid and sperm DNA fragmentation index
LE Yun ; ZHU Yurong ; ZHU Mengyi ; WANG Tengfei ; SHAO Shengsheng ; CHEN Xiaojun ; YANG Sheng
Journal of Preventive Medicine 2025;37(4):400-403
Objective:
To analyze the correlation between serum homocysteine (Hcy) and both folic acid (FA) and sperm DNA fragmentation index (DFI), so as to provide the evidence for male fertility assessment.
Methods:
Males who visited and measured the serum Hcy in the Reproductive Medicine Center of Huzhou Maternal and Child Health Care Hospital from September 2022 to September 2023 were selected as the study subjects. Sperm quality parameters and sperm DFI were analyzed by collecting sperm. Hcy and FA were measured by collecting venous blood. Participants were stratified into a high Hcy group (Hcy≥15.0 μmol/L) and a normal group (Hcy<15.0 μmol/L). The correlations between serum Hcy and FA and sperm DFI were evaluated using linear regression models.
Results:
A total of 173 participants were enrolled, including 39 in the high Hcy group and 134 in the normal group. The sperm concentration in the high Hcy group was significantly lower than that in the normal group [(91.77±61.11)×106/mL vs. (144.21±106.82)×106/mL, P<0.05]. No statistically significant differences were observed in semen volume, sperm motility, curvilinear velocity, straight-line velocity, average path velocity, or sperm morphology normal rate (all P>0.05). The FA level in the high Hcy group was lower than that in the normal group [(4.44±1.79) nmol/L vs. (7.64±3.68) nmol/L, P<0.05]. The sperm DFI in the high Hcy group was higher than that in the normal group [(19.21±8.85)% vs. (13.07±6.43)%, P<0.05]. Serum Hcy level showed a negative correlation with FA level (r=-0.369, P<0.05) and a positive correlation with sperm DFI (r=0.351, P<0.05).
Conclusion
Serum Hcy level is associated with sperm concentration, FA and sperm DFI, suggesting that serum Hcy may affect sperm quality.
9.Comparative research of inflammatory factors in different specimens from a rat model of aspiration pneumonia induced by lipopolysaccharide
Ling SONG ; Yunhang GAO ; Han LI ; Tengfei CHEN ; Hongping HOU ; Zuguang YE ; Guangping ZHANG
Acta Laboratorium Animalis Scientia Sinica 2025;33(1):89-98
Objective To investigate the changes of inflammatory factors in bronchoalveolar lavage fluid(BALF),lung tissue,and serum of a rat pneumonia model induced by inhalation of lipopolysaccharides(LPS).Methods Three days after modeling by LPS 4 mg/mL inhalation,15 min/d,was conducted while monitoring the particle size distribution and aerosol concentration of LPS,the degree of inflammation in lung tissues of rats in each group was observed via HE staining,and neutrophils in BALF were counted by microscope.The contents of interferon gamma(IFN-γ),interleukin-1 beta(IL-1 β),IL-4,IL-5,IL-6,IL-10,IL-13,tumor necrosis factor alpha(TNF-α),and KC/GRO in lung tissue,serum,and BALF were detected by Meso Scale Discovery.Results The lung histopathology of model rats displayed focal and diffuse alveolar epithelial necrosis with shedding and the aggregation and infiltration of inflammatory cells.The particle size distribution of atomized LPS was as follows,Dv(10)=0.6974μm,Dv(50)=3.387 μm,Dv(90)=8.836 μm.The aerosol concentration of LPS was 4.08 g/m3,and the calculated inhalation dose for rats was 47.10 mg/kg.The neutrophil count(P<0.01)and contents of IL-1β,IL-6,and TNF-α(P<0.05,P<0.001,P<0.001)in the BALF,and the contents of IL-1β,IL-6,and KC/GRO in lung tissue(P<0.01,P<0.05,P<0.01),of model rats were significantly increased.No biologically significant changes were observed in inflammatory factor levels in the serum.Conclusions In the acute pneumonia model induced by inhalation of LPS,significant changes in inflammatory factors such as IL-1β,IL-6,KC/GRO,and TNF-α were observed in both lung tissue and bronchoalveolar lavage fluid(BALF),while no notable changes in these inflammatory factors were detected in serum.This indicates that the inflammation responses are primarily localized in the lungs.
10.Guidelines for the Digital Ancient Books of TCM Indexing
Weina ZHANG ; Bing LI ; Bin LI ; Jing XIE ; Yan DONG ; Wei LONG ; Chuchu ZHANG ; Tong WEI ; Sihong LIU ; Yang WU ; Hongtao LI ; Lin TONG ; Guangkun CHEN ; Fei DONG ; Rui WANG ; He LU ; Meng LI ; Jingpeng DENG ; Tengfei WANG ; Xiaoying LI ; Di ZHANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(3):1-11
Guidelines for Digital Ancient Books of TCM Indexing(T/CIATCM 119-2024)is based on the theoretical knowledge,disciplinary methods,and practical applications of TCM classical cataloging.Taking digital ancient books of TCM as the object,it systematically reveals the content of TCM knowledge,which is an essential indexing processing standard for building an intelligent retrieval system for TCM ancient books,and can provide support for the deep development and innovative utilization of TCM knowledge.It can not only promote the co-construction and sharing of ancient book resources in the TCM industry,but also promote the standardization construction and application of TCM information.This standard specifies the principles,methods,and examples of free indexing of digital ancient books of TCM based on their original content.It is applicable to the indexing and processing of digital ancient books of TCM for TCM professional libraries and related institutions,and to the data processing and construction of various types of TCM ancient book databases.


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