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.Multimodal Assessment of a Hypoxic Pulmonary Hypertension Mouse Model
Hongzhi DU ; Jin FAN ; Xiaolu WEI ; Lianmei WANG ; Yan LIU ; Weiya CHEN ; Tengfei CHEN ; Yunhang GAO ; Ling SONG ; Guangping ZHANG ; Hongping HOU
Laboratory Animal and Comparative Medicine 2026;46(4):476-486
ObjectiveTo establish a mouse model of hypoxic pulmonary hypertension (HPH) through intermittent hypoxia induction, and to develop a comprehensive and reliable evaluation system for the HPH model, thereby providing experimental evidence for mechanistic studies and translational applications related to this disease. MethodsTwenty-four male specific pathogen-free (SPF) BALB/c mice were randomly divided into a control group and a model group, with 12 mice per group. Mice in the model group were placed in a hypobaric oxygen chamber control system to establish the HPH model, whereas mice in the control group received no intervention. After 28 days of modeling, a comprehensive evaluation of the pathophysiological characteristics of both groups was performed using a general condition scoring scale, echocardiography, hemodynamic measurements, blood gas analysis, hematological tests, organ coefficient determination, histopathological examination, and enzyme-linked immunosorbent assay (ELISA). In addition, correlation analyses were conducted among echocardiographic parameters, the contents of endothelin‑1 (ET‑1) and N‑terminal pro‑B‑type natriuretic peptide (NT‑proBNP) in lung tissue, and other measured indices. ResultsWith prolonged modeling duration time, body weight, water intake, and activity level of mice in the model group were significantly decreased compared with the control group (P<0.05). Echocardiography showed that, compared with the control group, the model group exhibited increased right ventricular dimensions (P<0.01), right ventricular anterior wall thickening (P<0.01), and widened main pulmonary artery diameter (P<0.01), whereas the peak systolic velocity across the pulmonary valve, tricuspid annular plane systolic excursion, and peak systolic velocity of the tricuspid annulus were significantly decreased (P<0.001); tricuspid regurgitation was observed in some model animals. Hemodynamic results revealed that right ventricular systolic pressure was elevated in the model group compared with the control group (P<0.001). Blood gas analysis showed that pH, partial pressure of oxygen, oxygen saturation, actual bicarbonate, and total carbon dioxide were all decreased in the model group compared with the control group (P<0.01). Hematological indices demonstrated that lymphocyte counts (P<0.05) and reticulocyte counts (P<0.001) were decreased in the model group compared with the control group. Compared with the control group, the organ coefficients of heart and lung in the model group were significantly increased (P<0.05 and P<0.001). Pathological examination revealed that the right ventricular hypertrophy index was significantly increased in the model group (P<0.001), with varying degrees of damage to the right ventricle, pulmonary artery, and pulmonary vessels; both the pulmonary artery wall thickness percentage and the pulmonary wall area percentage were significantly elevated (P<0.001). ELISA results showed that the levels of ET‑1 and NT‑proBNP in lung tissues were significantly increased in the model group compared with the control group (P<0.05 and P<0.001, respectively). Correlation analysis indicated that some echocardiographic parameters were highly correlated with multiple indices in the development of HPH (P<0.05). ConclusionEchocardiography can accurately assess a series of hemodynamic changes in HPH, including right ventricular structural, functional impairment, and pulmonary hypertension. Laboratory tests not only help verify whether the model has been successfully established, but also provide deeper insights into the pathogenesis of HPH, evaluate the effects of interventions, and offer scientific evidence for clinical outcomes. Pathological examination can further confirm the alterations in pulmonary vascular remodeling and increased right heart load. This multimodal analysis provides a reliable animal model and evaluation paradigm for both basic and translational research on HPH, and is of great significance for exploring disease mechanisms and developing precision therapeutic strategies.
5.Methodological Considerations on Constructing Intelligent Diagnosis and Treatment Agent for Integrated Chinese and Western Medicine Diagnosis and Treatment Based on Clinical Practice Guidelines
Feng ZHOU ; Tengfei CHEN ; Wandi ZHANG ; Haoyuan LI ; Xingyu ZONG ; Jiahao LIN ; Qingquan LIU ; Guozhen ZHAO
Journal of Traditional Chinese Medicine 2026;67(17):1853-1857
Developing an intelligent agent for integrated traditional Chinese and western medicine diagnosis and treatment based on clinical practice guidelines is a key approach to advancing the standardization and intelligent deve-lopment of traditional Chinese medicine (TCM) and to supporting clinical decision-making. This paper argues for the necessity of building a knowledge base using guidelines as the sole data source, systematically identifies five core methodological challenges across the entire process, and proposes corresponding solutions. An ontology framework capable of distinguishing between TCM and western medicine concepts should be designed to address the difficulty of knowledge integration. A closed-loop "algorithm-based extraction-expert review" model is adopted to reduce data extraction errors. Expert consensus is incorporated to address decision gaps in specific clinical scenarios outlined in the guidelines, while a multi-stage, standardized output process for the AI system is established to eliminate model hallucinations. Furthermore, an evaluation framework reflecting clinical applicability is developed to enhance the AI system's accuracy and stability. Throughout the research process, it is essential to ensure the in-depth and continuous participation of multidisciplinary experts, strictly control the selection and quality evaluation of guidelines, and rely on the expert consensus method to address decision gaps in the knowledge base. Additionally, continuous validation and iterative optimization of intelligent agents are required to ensure the accuracy and stability of generated outputs. Limitations remain in the mechanisms for real-time knowledge synchronization in intelligent diagnostic and treatment systems, and further validation through large-scale real-world studies is warranted.
6.Mechanism of action and clinical research progress of Shugan yiyang capsule in the treatment of erectile dysfunction
Shengnan LI ; Chongfu ZHONG ; Tengfei CHEN ; Hongyan CHEN
China Pharmacy 2026;37(19):2602-2607
Erectile dysfunction (ED) is a common chronic andrological disease that seriously impairs men’s physical and mental health and reduces their quality of life. Shugan yiyang capsule is a compound formula of traditional Chinese medicine for the clinical treatment of erectile dysfunction, with core effects of soothing the liver, relieving depression, promoting blood circulation, and nourishing the kidneys. This paper systematically reviewed the mechanisms of action and clinical research progress of Shugan yiyang capsule in the treatment of ED. Accumulated evidence indicated that this capsule exerted its therapeutic effects by modulating signaling pathways such as nitric oxide synthase/cyclic guanosine monophosphate and phosphoinositide 3-kinase/protein kinase B, inhibiting phosphodiesterase-5 (PDE-5) expression and oxidative stress, regulating hypothalamic-pituitary-testicular axis function, and improving penile hemodynamics. In terms of clinical application, Shugan yiyang capsule used alone improved erectile function and related clinical indicators in patients with ED. When combined with PDE-5 inhibitors or surgical operation, Shugan yiyang capsule also demonstrated certain synergistic and efficacy-enhancing effects, with generally good tolerability. However, existing studies were still limited by insufficient investigation of the pharmacodynamic material basis of the formula, inadequate elucidation of the interactions among different signaling pathways, a lack of direct experimental validation for some potential mechanisms, and relatively small sample sizes and limited levels of clinical evidence. Future studies will integrate serum pharmacochemistry, multi-omics approaches, and pharmacokinetic techniques to further characterize the absorbed constituents, key pharmacologically active components, and multi-target synergistic mechanisms of Shugan yiyang capsule. Meanwhile, multicenter, large-sample randomized controlled trials with long-term follow-up will be conducted to strengthen the quality of clinical evidence and facilitate the precise use of Shugan yiyang capsule in the treatment of ED.
7.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.
8.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.
9.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.
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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