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.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.
4.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.
5.Reassessment of non-acute occlusion in intracranial flow diverter implantation: an animal experimental study based on optical coherence tomography, intravascular ultrasound, and pathological correlation
Zhuangzhuang WEI ; Qi TIAN ; Shuailong SHI ; Jie YANG ; Ji MA ; Zhen LI ; Haiqiang SANG ; Yi TANG ; Yuncai RAN ; Yong ZHANG ; Baohong WEN ; Shanshan XIE ; Jinjuan CHEN ; Enjie LIU ; Xinwei HAN ; Tengfei LI
Chinese Journal of Neurology 2025;58(6):607-614
Objective:To investigate and summarize the imaging and pathological features of non-acute occlusion following flow diverter (FD) implantation in animal models.Methods:Four experimental pigs (experimental group) that experienced non-acute occlusion (occlusion time exceeding 24 hours) within the FD stent implanted in the common carotid artery, and 19 pigs (control group) that did not experience stent occlusion during the same period were involved. Using an interventional approach under digital subtraction angiography (DSA), the 4 occluded FD lumens were mechanically opened. Optical coherence tomography (OCT), intravascular ultrasound (IVUS) and histopathological examinations were performed to evaluate the intraluminal composition and characteristics of the occlusive tissues. These findings were compared with non-occluded FD stents to summarize the imaging and pathological changes within the occluded FD lumen.Results:The occlusion times of the FD stents in the 4 experimental pigs were 16 weeks, 20 weeks, 20 weeks, and 24 weeks postoperatively. All occluded stents were successfully recanalized under DSA, with a technical success rate of 4/4. Among the 19 non-occluded FD stents, OCT and IVUS revealed uniform (16 stents) or non-uniform (3 stents) neointimal coverage of the stent struts, presenting as homogeneous high/slightly high signal intensity or medium echogenicity. Histopathological examination indicated that the neointima was primarily composed of smooth muscle cells and a small amount of fibrous connective tissues. In contrast, the 4 occluded FD stents demonstrated excessive neointimal proliferation and plaque formation, leading to luminal loss, as shown by OCT and IVUS. The occlusion tissues predominantly presented as homogeneous high signal intensity with weak attenuation (fibrous plaques) on OCT, with some regions showing blurred low signal intensity and strong attenuation (lipid plaques). IVUS presented homogeneous echogenicity (fibrous plaques) and hypoechogenic zones (lipid plaques). Histopathological examination showed that the occlusion tissues mainly consisted of smooth muscle cells, fibrous connective tissues, and lipids, accompanied by numerous foam cells and a minor presence of inflammatory cells.Conclusions:Histopathological examinations confirm that non-acute occlusion of FD is mainly caused by excessive hyperplasia of intima along with the formation of fibrous plaques and lipid plaques. OCT and IVUS have typical finding in imaging that can assist in determining the cause of stent occlusion as well as the lesion's nature, thereby providing crucial guidance for subsequent clinical treatment and drug selection.
6.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.
7.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.
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.Research progress on platelets in glioma.
Mingrong ZUO ; Tengfei LI ; Zhihao WANG ; Yufan XIANG ; Siliang CHEN ; Yanhui LIU
Chinese Medical Journal 2025;138(1):28-37
Gliomas are the most common primary neuroepithelial tumors of the central nervous system in adults, of which glioblastoma is the deadliest subtype. Apart from the intrinsically indestructible characteristics of glioma (stem) cells, accumulating evidence suggests that the tumor microenvironment also plays a vital role in the refractoriness of glioblastoma. The primary functions of platelets are to stop bleeding and regulate thrombosis under physiological conditions. Furthermore, platelets are also active elements that participate in a variety of processes of tumor development, including tumor growth, invasion, and chemoresistance. Glioma cells recruit and activate resting platelets to become tumor-educated platelets (TEPs), which in turn can promote the proliferation, invasion, stemness, and chemoresistance of glioma cells. TEPs can be used to obtain genetic information about gliomas, which is helpful for early diagnosis and monitoring of therapeutic effects. Platelet membranes are intriguing biomimetic materials for developing efficacious drug carriers to enhance antiglioma activity. Herein, we review the recent research referring to the contribution of platelets to the malignant characteristics of gliomas and focusing on the molecular mechanisms mediating the interaction between TEPs and glioma (stem) cells, as well as present the challenges and opportunities in targeting platelets for glioma therapy.
Humans
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Glioma/metabolism*
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Blood Platelets/physiology*
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Brain Neoplasms/pathology*
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Tumor Microenvironment
10.Five-year outcomes of metabolic surgery in Chinese subjects with type 2 diabetes.
Yuqian BAO ; Hui LIANG ; Pin ZHANG ; Cunchuan WANG ; Tao JIANG ; Nengwei ZHANG ; Jiangfan ZHU ; Haoyong YU ; Junfeng HAN ; Yinfang TU ; Shibo LIN ; Hongwei ZHANG ; Wah YANG ; Jingge YANG ; Shu CHEN ; Qing FAN ; Yingzhang MA ; Chiye MA ; Jason R WAGGONER ; Allison L TOKARSKI ; Linda LIN ; Natalie C EDWARDS ; Tengfei YANG ; Rongrong ZHANG ; Weiping JIA
Chinese Medical Journal 2025;138(4):493-495


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