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.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.
3.The efficacy of individualized endovascular interventional treatment for extracranial carotid artery pseudoaneurysms
Tengfei LI ; Chengcheng SHI ; Sun YU ; Ji MA ; Ling WANG ; Quanhui ZHANG ; Xinwei HAN
Chinese Journal of Radiology 2025;59(6):712-718
Objective:To investigate the efficacy and safety of different endovascular interventional treatments for extracranial carotid artery pseudoaneurysms.Method:The clinical data of 48 patients with extracranial carotid artery pseudoaneurysms treated with multiple endovascular procedures were retrospectively analyzed in the First Affiliated Hospital of Zhengzhou University from February 2012 to February 2024. The patients presented with a total of 48 extracranial carotid pseudoaneurysms, ranging in diameter from 2.5 to 34.2 mm [mean (12.0±9.6) mm]. The lesions were distributed as follows: 25 in the internal carotid artery, 16 in the external carotid artery and 7 in the common carotid artery. The selection of endovascular interventional techniques was tailored to individual cases according to the pseudoaneurysm size, anatomical location, morphological configuration, and specific features of the parent artery. Perioperative adverse events were monitored, and the efficacy of individualized endovascular interventional therapy was evaluated based on immediate postoperative and 6-month follow-up digital subtraction angiography (DSA) findings, including aneurysm occlusion and in-stent patency.Result:The treatment modalities included parent artery coiling occlusion ( n=16), overlapping braided carotid stent implantation ( n=3), covered stent placement ( n=23), combined implantation of covered stent and braided carotid stent implantation ( n=4) and flow-diverting stent implantation ( n=2) based on the characteristics of the pseudoaneurysms. Endovascular interventional procedures were successfully completed in 47 patients (technical success rate: 97.9%). Immediate postoperative DSA revealed residual pseudoaneurysm at the distal end of the stent in 1 case. Among the remaining cases, complete aneurysm obliteration or faint opacification was observed, with stent lumen patency confirmed in 31 cases and complete parent artery occlusion achieved in 16 cases. In one case involving a patient who underwent flow-diverting stent implantation, a pulsatile vascular murmur reappeared in the neck one week postoperatively. Follow-up DSA revealed stent migration into the aneurysm sac. After retrieval and removal of the displaced stent, combined implantation of a covered stent and a braided carotid artery stent was performed. Postoperative angiography confirmed complete aneurysm occlusion and patent parent artery blood flow. No severe perioperative adverse events (e.g., aneurysm rupture) were observed. During a postoperative follow-up period of 6.2-24.2 months, DSA at 6 months revealed mild in-stent or distal segment stenosis in 2 patients who underwent covered stent implantation. The remaining 46 patients exhibited complete aneurysm occlusion with no significant stenosis observed within the stent lumen. At the final follow-up, all patients demonstrated resolution or significant alleviation of clinical symptoms. Conclusion:Individualized endovascular interventional therapy demonstrates favorable safety and efficacy profiles in managing extracranial carotid artery pseudoaneurysms.
4.Research progress on the value of splenomegaly in the diagnosis and treatment of biliary atresia
Xingyuan KE ; Jiaying LIU ; Yanran ZHANG ; Tengfei LI ; Jianghua ZHAN
Chinese Journal of Hepatobiliary Surgery 2025;31(11):867-871
Biliary atresia is often complicated with portal hypertension, which induces a series of hemodynamic changes leading to splenomegaly. Splenomegaly is a common in patients with biliary atresia, which indicates the status of portal hypertension, esophageal varices, and the progression of hepatic fibrosis. Furthermore, it can help monitor the native liver survival status after Kasai procedure and the need for liver transplantation. For patients with biliary atresia presenting splenomegaly and/or hypersplenism, the treatment strategy, involving the pharmacological or surgical options, should be individually selected based on specific clinical condition. This article reviews the value of splenomegaly in the diagnosis and management of biliary atresia, aiming to provide references for clinical practice.
5.Correlation and mechanism between lumbar disc degeneration and paraspinal muscle changes
Jiashun LIU ; Hongru XIE ; Yunkai SUN ; Shujin LI ; Tengfei MAO ; Yaoyao AN ; Qin ZHANG
Chinese Journal of Tissue Engineering Research 2025;29(27):5897-5906
BACKGROUND:Paraspinal muscle degeneration is one of the main causative factors of low back pain,and the changes in the paraspinal muscles are closely related to its occurrence and development.At present,clinical practitioners focus on the changes of paraspinal muscles in degenerative lumbar diseases to prevent and treat lumbar diseases,but ignore the connection and related mechanisms between lumbar intervertebral disc degeneration and paraspinal muscles.OBJECTIVE:To comprehensively summarize the interaction between paraspinal muscles and lumbar intervertebral discs,and to review the relationship and mechanisms between lumbar intervertebral disc degeneration and paraspinal muscles,in order to provide a reference for clinical prevention and treatment.METHODS:Chinese keywords"lumbar intervertebral disc,paraspinal muscle,multifidus muscle,low back pain,degeneration,imaging,magnetic resonance imaging"were used to search the relevant literature in Chinese databases such as CNKI,VIP,and WanFang.English keywords"lumbar disc,paraspinal muscle,multifidus muscle,low back pain,degeneration,imaging,MRI"were used to search the relevant literature in databases such as Medline,PubMed,and Web of Science.After preliminary screening of titles and abstracts,68 articles were finally selected for result analysis according to the inclusion and exclusion criteria.RESULTS AND CONCLUSION:(1)Researchers have used various methods to evaluate the degree of paraspinal muscle degeneration,and at the same time evaluated the degree of lumbar intervertebral disc degeneration according to the Pfirrmann grading system.It is found that clinical diagnosis and treatment should pay attention to gender differences,and the influence of factors such as obesity on the degeneration of intervertebral discs and muscles,in order to develop more individualized treatment plans.(2)There is a certain correlation between lumbar intervertebral disc degeneration and paraspinal muscle fat infiltration,but the research results are controversial.Most studies have found that fat infiltration of the paraspinal muscles(especially the multifidus muscle)is positively correlated with the degree of lumbar intervertebral disc degeneration.(3)It is currently believed that the three mechanisms of disuse atrophy,denervation,and inflammatory factors may interact with each other to jointly lead to structural and functional changes in the paraspinal muscles,which are closely related to the occurrence of lumbar intervertebral disc degeneration and low back pain.(4)Clinically,attention should be paid to the changes of the muscles at the level below the affected nerve root segment,which is helpful for the diagnosis and localization of lumbar radiculopathy.At the same time,inhibition of inflammatory factors may become a potential target for treatment.(5)Clinically,the first step is to correct nerve root compression through appropriate medication or surgery to control inflammatory reactions and nerve root pain,and then carry out targeted muscle rehabilitation training.If necessary,consider using new treatment methods such as interferential current electrical stimulation to improve the patient's symptoms and prognosis.
6.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.
7.Efficacy of inspiratory muscle training combined with external diaphragm pacing in elderly patients with chronic heart failure
Su LIU ; Tengfei JI ; Dan LIU ; Juanli ZHANG ; Hong WEN ; Li LI ; Shuguang QIN
The Journal of Practical Medicine 2025;41(13):2011-2017
Objective To investigate the therapeutic efficacy of inspiratory muscle training(IMT)combined with external diaphragm pacing(EDP)in elderly patients with chronic heart failure(CHF).Methods 147 patients with CHF admitted to the Department of Cardiology of the Second Affiliated Hospital of Xi'an Jiaotong University from March 2024 to October 2024 were selected,of which 38 patients were in the conventional drug therapy group(standard care group),52 patients were in the conventional drug therapy+EDP therapy(dual therapy group),and 57 patients were in the conventional drug therapy+EDP therapy+IMT therapy(triple therapy group).Com-parative analyses were performed for maximum inspiratory pressure(MIP),maximum expiratory pressure(MEP),handgrip strength,6-minute walk distance(6MWD),modified Medical Research Council(mMRC)scores,resting heart rate,and blood pressure before treatment and 4 weeks post-intervention.Results After treatment,The dual therapy group demonstrated higher MIP,6MWD,and lower mMRC scores than the standard care group(P<0.05).The triple therapy group exhibited superior improvements in MIP,MEP,handgrip strength,6MWD,and lower mMRC scores compared to both standard care and dual therapy groups(P<0.05),with additional benefits including lower resting systolic blood pressure versus dual therapy group(P<0.05)and reduced resting heart rate compared to standard care group(P<0.05).Conclusion The combined IMT and EDP significantly enhances respiratory and upper limb muscle strength in CHF patients,effectively improves cardiopulmonary function,alleviates dys-pnea,and reduces resting heart rate and blood pressure,thus improving the quality of life.It is worthy of clinical promotion and application.
8.Differentiating bronchiolar adenoma from minimally invasive adenocarcinoma based on high-resolution CT features
Ziqian ZHAO ; Dan HAN ; Haiyan YANG ; Tengfei KE ; Wenyan WEI ; Yan WU ; Ying TAO ; Xinhui YANG ; Fengyi LI ; Wen ZHAO
Journal of Practical Radiology 2025;41(10):1633-1638
Objective To explore the pathological features of bronchiolar adenoma(BA)and its specific high-resolution computed tomography(HRCT)signs,and to differentiate BA from minimally invasive adenocarcinoma(MIA)using a non-invasive preoperative method.Methods A total of 80 patients with BA and 130 patients with MIA were retrospectively selected,and the clinical information and HRCT features were compared.All cases were divided into development set and test set at a 7︰3 ratio.Logistic regression analysis was used to screen the independent predictors of MIA and construct a model.Results There were significant differences in age,lobe distribution,density,vacuole sign,tumor-related vessels number(TVN),and distance to pleura(DTP)between BA and MIA patients(P<0.05).Age,density,TVN,DTP and long diameter were identified as independent predictors of MIA.A model was constructed,with area under the curve(AUC)of 0.887 and 0.884 in the development and test sets,respectively.Conclusion The model based on HRCT morphological features of BA and MIA demonstrates superior diagnostic performance compared to individual CT morphological features.
9.Epidemiological status of knee joint tuberculous arthritis in patients and risk factors for recurrence after treatment
Linming YAO ; Xin LIU ; Li ZHANG ; Tengfei GAO
Chinese Journal of Primary Medicine and Pharmacy 2025;32(4):533-538
Objective:To investigate the epidemiological status of knee joint tuberculous arthritis in 52 patients and to identify risk factors for recurrence after treatment.Methods:A retrospective analysis was conducted involving 52 patients with knee joint tuberculous arthritis who received treatment at Shaanxi Provincial Tuberculosis Prevention and Control Hospital from January 2018 to June 2023. Patients concurrently diagnosed with knee joint tuberculous arthritis were identified from the hospital's records, and their clinical data were collected. Logistic regression analysis was performed to determine the risk factors associated with recurrence of knee joint tuberculous arthritis.Results:The incidence of knee joint tuberculous arthritis is higher in males than in females, with the most affected age group being 40-60 years old. The most common form of the disease is total knee joint tuberculosis. The positive rate of Mycobacterium tuberculosis culture is 100%, indicating high diagnostic value. Logistic regression analysis results show that the following are independent risk factors for recurrence of knee joint tuberculous arthritis: age > 45 years ( OR = 3.080, 95% CI: 1.445-6.564, P = 0.004), body mass index < 18.5 kg/m2 ( OR = 6.062, 95% CI: 1.621-22.671, P = 0.007), smoking ( OR = 2.649, 95% CI: 1.032-6.799, P = 0.043), diabetes ( OR = 3.629, 95% CI: 1.799-7.321, P = 0.007), duration of tuberculosis symptoms > 6 months ( OR = 5.507, 95% CI: 1.210-25.055, P = 0.027), non-compliance with anti-tuberculosis medication ( OR = 3.152, 95% CI: 1.149-8.649, P = 0.026), elevated erythrocyte sedimentation rate ( OR = 3.297, 95% CI: 1.223-8.889, P = 0.018), and elevated C-reactive protein ( OR = 2.519, 95% CI: 1.025-6.194, P = 0.044). Conclusions:Knee joint tuberculous arthritis is more prevalent in males, with the most affected age group being 40-60 years old. Clinically, a comprehensive diagnosis that includes clinical evaluation, imaging, and bacterial culture is necessary. Lesion excision surgery can result in a good prognosis. Independent risk factors for the recurrence of knee joint tuberculous arthritis include age > 45 years, body mass index < 18.5 kg/m2, smoking, diabetes, duration of tuberculosis symptoms > 6 months, non-compliance with anti-tuberculosis medication, elevated serum erythrocyte sedimentation rate, and elevated C-reactive protein.
10.Analysis on Clinical Trial Registration Status of TCM for the Treatment of Diabetic Nephropathy
Jiawei ZHANG ; Zhifen ZHAO ; Xiangge REN ; Peidong ZHAO ; Shoudao LI ; Tengfei SONG ; Wensheng ZHAI
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(10):73-79
Objective To analyze the current status of clinical trial registration in the TCM treatment of diabetic nephropathy(DN);To provide references for the registration and implementation of relevant clinical trials.Methods Clinical trials about TCM treatment for DN registered in the Chinese Clinical Trial Registry(ChiCTR)and the U.S.Clinical Trial Registry(ClinicalTrials.gov)from their inception to August 18,2024 were retrieved.The following information was analyzed:registration year,geographical distribution,funding sources,TCM syndrome patterns of participants,number of research centers,sample size,study type,study design,randomization method,blinding method,intervention measures,outcome indicators and safety indicators.Results A total of 88 clinical trials were included,comprising 79 interventional studies and 9 observational studies.The number of registrations has increased annually.The domestic registered trials were distributed across 17 provincial-level administrative regions in China,with Beijing and Shanghai having the highest number of registrations.The primary sources of funding were local and national government funds.The most common TCM syndrome pattern among participants was qi-yin deficiency with blood stasis.Most trials were single-center studies,with the majority having a sample size between 31 and 60.The predominant study type was interventional,mostly randomized controlled trials(RCTs),with simple randomization being the most frequently used method.31 trials reported blinding methods,with double-blinding being the most common.The intervention measures were mostly oral Chinese patent medicines or TCM compounds,and the outcome indicators were mainly efficacy indicators,with less safety indicators.Conclusion The number of registered clinical trials on TCM treatment for DN has increased annually;however,the overall number remains limited.There is uneven regional distribution and incomplete registration information for various factors such as randomization methods,blinding methods,number of research centers,intervention measures,and outcome indicators.

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