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.Efficacy and safety of interventional treatment for refractory bleeding caused by head,neck,and maxillofacial trauma
Lishan DING ; Qingliang CHEN ; Meng SHEN ; Hao LIANG ; Ming ZHENG ; Zhaojun LI ; Ji MA ; Tengfei LI
Journal of Chongqing Medical University 2025;50(3):376-380
Objective:To investigate the efficacy and safety of transcatheter arterial embolization(TAE)in the treatment of refractory bleeding caused by head,neck,and maxillofacial trauma.Methods:The clinical data of 26 patients with refractory bleeding caused by head,neck and maxillofacial trauma who were treated with TAE in The First Affiliated Hospital of Zhengzhou University and The Third People's Hospital of Henan Province were analyzed retrospectively,including 16 males and 10 females,with an average age of 57.96±15.52 years.All patients were treated with TAE because of the poor effect of medication,packing,and other measures and repeated bleeding.The clinical data,operation success rate,effective hemostasis rate,30-day clinical success rate,and postoperative complica-tions were analyzed.The patients were followed up for 3 to 6 months.Results:The operation success rate of TAE was 100%.The bleed-ing symptoms of all patients were effectively controlled,and the effective hemostasis rate was 100%.The hemoglobin level was in-creased from(96.21±12.42)g/L before operation to(111.38±7.70)g/L at 3 days after operation(P<0.001).After operation,3 pa-tients had slight swelling,pain,or skin color changes in the head,neck,and maxillofacial region,which were effectively relieved or dis-appeared after symptomatic treatment;2 patients died of severe traumatic brain injury and cerebral edema.No serious complications such as cerebral infarction occurred in any patients.There was no rebleeding in any patients within 3 to 6 months of post-discharge follow-up.Conclusion:TAE has definite curative effect and good safety for refractory bleeding caused by head,neck,and maxillofa-cial trauma,and has high clinical application value.
4.Prediction model of axillary lymph node metastasis of breast cancer(≤2.5 cm) based on deep learning ultrasound features
Yuyang GAN ; Dongming WEI ; Ruilong YAN ; Haiman SONG ; Jia LI ; Ziyi YIN ; Tao CHEN ; Tengfei YU
Chinese Journal of Ultrasonography 2025;34(9):751-758
Objective:To establish a model based on the characteristics of breast cancer ultrasound images through deep learning methods to predict the risk of axillary lymph node metastasis(ALNM)in patients with breast cancer(maximum diameter ≤2.5 cm)before surgery.Methods:A total of 419 patients(3 433 breast tumor ultrasound images)with breast cancer(maximum diameter ≤2.5 cm)who underwent axillary lymph node dissection at Beijing Tiantan Hospital,Capital Medical University from January 2019 to December 2024 were retrospectively included. According to the pathological results of axillary lymph nodes,they were divided into 220 cases in the ALNM occurrence group(positive group)and 199 cases in the non-ALNM occurrence group(negative group). The breast cancer ultrasound images of the two groups of cases were randomly classified into the training set(2 404 images),the validation set(687 images)and the test set(342 images)according to a ratio of 7∶2∶1. YOLOv8 was used as the basic model of You Only Look Once(YOLO)and optimized. The optimized model was applied to locate and capture the potential ultrasound features of breast cancer cases in the training set. A prediction model was constructed based on the captured ultrasound features. The model was adjusted and optimized through the validation set,and then matched with the case images in the test set. The confusion classification matrix graph and the curve graph for measuring the model performance were used to evaluate the model prediction performance and interpret the model,and the efficacy of this model in identifying breast cancer patients at risk of ALNM was analyzed.Results:There were statistically significant differences between the positive and negative groups in terms of the pathological maximum diameter of breast tumors,pathological T staging,the differentiation degree,the presence of distant metastasis,the maximum diameter measured by ultrasound,the quadrant of breast tumor occurrence,the Breast Imaging - Reporting and Data System(BI-RADS)classification of breast tumors,and the presence of abnormal ultrasound features of lymph node(all P<0.05). The established deep learning model could automatically perform bounding box localization for the breast cancer of patients.The breast tumors in the positive group had potential ultrasound features that could be captured by the model compared with those in the negative group. The mean average precision(mAP)50 was 0.883,mAP 50-95 was 0.636,PR-AUC was 0.884 5,strict PR-AUC was 0.636 4,the sensitivity was 90.5%,and the specificity was 91.2%,and it had a good predictive efficacy. Conclusions:This prediction model based on the ultrasound characteristics of breast cancer through deep learning can effectively predict breast cancer(maximum diameter ≤ 2.5 cm)with the risk of ALNM,providing an effective basis for the clinical management of axillary lymph nodes in breast cancer patients.
5.Safety and efficacy of peptide receptor radionuclide therapy with 177Lu-DOTA-TATE in patients with advanced pheochromocytoma and paraganglioma
Jintao ZHANG ; Hongyin DING ; Tengfei LI ; Yuanzhuo YAN ; Yue CHEN
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(2):71-75
Objective:To evaluate the efficacy and adverse effects of 177Lu-1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid- D-Phel-Tyr3-Thr8-octreotide (DOTA-TATE) in patients with advanced pheochromocytoma and paraganglioma (PPGL). Methods:Sixteen patients with metastatic PPGL, treated with 177Lu-DOTA-TATE in the Affiliated Hospital of Southwest Medical University between April 2020 and December 2023, were retrospectively included. Among these patients, nine were male and seven were female, with an a median age of 44.5(26.5, 51.0) years. Treatment response was assessed based on changes in blood catecholamine level and 68Ga-DOTA-TATE PET/CT imaging. Evaluation criteria included the response evaluation criteria in solid tumors (RECIST) 1.1 and the modified PET response criteria in solid tumors (PERCIST) 1.0. Treatment-related adverse events were graded according to the common terminology criteria for adverse events (CTCAE) 5.0. All patients received long-term follow-up after treatment, with endpoints including disease progression and death. Paired t-test was used to compare laboratory parameters before and after treatment. Results:The median number of treatment cycles of 177Lu-DOTA-TATE was 3(3, 4) per patient, with an average dose of (7.51±0.67) GBq per cycle. Grade 1 hematologic toxicity was observed in 4 patients (4/16), while grade 2 hematologic toxicity occurred in 2 patients (2/16), primarily manifesting as leukopenia and anemia. A slight decrease was noted post-treatment in PLT ( t=4.06, P=0.001) and Hb levels ( t=2.85, P=0.012), while WBC counts showed no statistically significant change ( t=1.57, P=0.137). No grade 3 or 4 hematologic, renal, or hepatic toxicities were observed. The glomerular filtration rate ( t=-0.29, P=0.778), creatinine ( t=0.04, P=0.697), alanine transaminase ( t=0.08, P=0.938), aspartate transaminase ( t=0.08, P=0.463), and total bilirubin ( t=-0.37, P=0.719) after treatment were not significantly different from those before treatment. According to RECIST 1.1, 13 patients achieved stable disease, 2 patients showed partial response and 1 had progression disease. Based on the modified PERCIST 1.0, stable disease was observed in 11 patients, partial response in 3 patients, and progression disease in 2 patients. Among 9 patients with catecholamine-secreting PPGL, 8 showed reduction in blood norepinephrine level. The median follow-up duration was 21.5(21.1, 42.6) months, with a median progression-free survival of 8.6(6.0, 14.6) months, and no mortality reported during the follow-up period. Conclusion:177Lu-DOTA-TATE appears to be a safe and promising therapeutic option for patients with advanced PPGL demonstrating elevated somatostatin receptor expression.
6.Natural product virtual-interact-phenotypic target characterization:A novel approach demonstrated with Salvia miltiorrhiza extract
Rui XU ; Hengyuan YU ; Yichen WANG ; Boyu LI ; Yong CHEN ; Xuesong LIU ; Tengfei XU
Journal of Pharmaceutical Analysis 2025;15(2):425-441
Natural products(NPs)have historically been a fundamental source for drug discovery.Yet the complex nature of NPs presents substantial challenges in pinpointing bioactive constituents,and corresponding targets.In the present study,an innovative natural product virtual screening-interaction-phenotype(NP-VIP)strategy that integrates virtual screening,chemical proteomics,and metabolomics to identify and validate the bioactive targets of NPs.This approach reduces false positive results and enhances the ef-ficiency of target identification.Salvia miltiorrhiza(SM),a herb with recognized therapeutic potential against ischemic stroke(IS),was used to illustrate the workflow.Utilizing virtual screening,chemical proteomics,and metabolomics,potential therapeutic targets for SM in the IS treatment were identified,totaling 29,100,and 78,respectively.Further analysis via the NP-VIP strategy highlighted five high-confidence targets,including poly[ADP-ribose]polymerase 1(PARP1),signal transducer and activator of transcription 3(STAT3),amyloid precursor protein(APP),glutamate-ammonia ligase(GLUL),and glutamate decarboxylase 67(GAD67).These targets were subsequently validated and found to play critical roles in the neuroprotective effects of SM.The study not only underscores the importance of SM in treating IS but also sets a precedent for NP research,proposing a comprehensive approach that could be adapted for broader pharmacological explorations.
7.The protein arginine methyltransferase PRMT1 ameliorates cerebral ischemia-reperfusion injury by suppressing RIPK1-mediated necroptosis and apoptosis.
Tengfei LIU ; Gan HUANG ; Xin GUO ; Qiuran JI ; Lu YU ; Runzhe ZONG ; Yiquan LI ; Xiaomeng SONG ; Qingyi FU ; Qidi XUE ; Yi ZHENG ; Fanshuo ZENG ; Ru SUN ; Lin CHEN ; Chengjiang GAO ; Huiqing LIU
Acta Pharmaceutica Sinica B 2025;15(8):4014-4029
Receptor-interacting protein kinase 1 (RIPK1) plays an essential role in regulating the necroptosis and apoptosis in cerebral ischemia-reperfusion (I/R) injury. However, the regulation of RIPK1 kinase activity after cerebral I/R injury remains largely unknown. In this study, we found the downregulation of protein arginine methyltransferase 1 (PRMT1) was induced by cerebral I/R injury, which negatively correlated with the activation of RIPK1. Mechanistically, we proved that PRMT1 directly interacted with RIPK1 and catalyzed its asymmetric dimethylarginine, which then blocked RIPK1 homodimerization and suppressed its kinase activity. Moreover, pharmacological inhibition or genetic ablation of PRMT1 aggravated I/R injury by promoting RIPK1-mediated necroptosis and apoptosis, while PRMT1 overexpression protected against I/R injury by suppressing RIPK1 activation. Our findings revealed the molecular regulation of RIPK1 activation and demonstrated PRMT1 would be a potential therapeutic target for the treatment of ischemic stroke.
8.Natural product virtual-interact-phenotypic target characterization: A novel approach demonstrated with Salvia miltiorrhiza extract.
Rui XU ; Hengyuan YU ; Yichen WANG ; Boyu LI ; Yong CHEN ; Xuesong LIU ; Tengfei XU
Journal of Pharmaceutical Analysis 2025;15(2):101101-101101
Natural products (NPs) have historically been a fundamental source for drug discovery. Yet the complex nature of NPs presents substantial challenges in pinpointing bioactive constituents, and corresponding targets. In the present study, an innovative natural product virtual screening-interaction-phenotype (NP-VIP) strategy that integrates virtual screening, chemical proteomics, and metabolomics to identify and validate the bioactive targets of NPs. This approach reduces false positive results and enhances the efficiency of target identification. Salvia miltiorrhiza (SM), a herb with recognized therapeutic potential against ischemic stroke (IS), was used to illustrate the workflow. Utilizing virtual screening, chemical proteomics, and metabolomics, potential therapeutic targets for SM in the IS treatment were identified, totaling 29, 100, and 78, respectively. Further analysis via the NP-VIP strategy highlighted five high-confidence targets, including poly [ADP-ribose] polymerase 1 (PARP1), signal transducer and activator of transcription 3 (STAT3), amyloid precursor protein (APP), glutamate-ammonia ligase (GLUL), and glutamate decarboxylase 67 (GAD67). These targets were subsequently validated and found to play critical roles in the neuroprotective effects of SM. The study not only underscores the importance of SM in treating IS but also sets a precedent for NP research, proposing a comprehensive approach that could be adapted for broader pharmacological explorations.
9.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.
10.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.

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