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.Comparative analyses of the detection performance of five multiplex polymerase chain reaction nucleic acid detection kits for respiratory pathogens
Fang YUAN ; Lei BI ; Jiajing LIU ; Huanru WANG ; Jun FENG ; Yuan ZHUANG ; Min CHEN ; Zheng TENG
Shanghai Journal of Preventive Medicine 2026;38(2):165-169
ObjectiveTo evaluate the detection specificity for clinical samples and the detection capability for standard substances of five commercially available multiplex polymerase chain reaction (PCR) nucleic acid detection kits (hereinafter referred to as the kits) for respiratory pathogens, and to provide a reference for selecting appropriate detection kits for multi-pathogen nucleic acid testing of respiratory infections. MethodsA total of 60 respiratory pathogen-positive clinical samples with known redults were selected and tested using the five kits (labeled as A, B, C, D, and E). The detection rates and Kappa coefficients were calculated to evaluate the consistency between the results from these kits and those from single-pathogen PCR kits. According to the limit of detection (LOD) provided by the kits, standard substances of respiratory pathogens (including 12 types such as influenza virus, Mycoplasma pneumoniae, and Bordetella pertussis) were diluted to four concentrations (250, 500, 1 000, and 2 000 copies·mL⁻¹). All five kits were used for detection to evaluate their respective detection capabilities. ResultsCompared with the results from single-pathogen PCR kits, the five tested kits demonstrated good consistency (all Kappa >0.80). Among them, Kit A had the highest detection rate (100.00%), followed by Kits C and E (98.33%), and then Kits B and D (95.00%). All five kits showed a relatively low false negative rate (FNR) for samples with a cycle threshold (Ct) value ≤35 (≤2.38%). However, for samples with Ct values>35, the FNR increased accordingly(average FNR=6.67%, P=0.029). Kit C exhibited the highest detection sensitivity for the tested standard substances (average LOD: 458.33 copies·mL⁻¹), followed by Kit D, then Kits A/E, and finally Kit B. ConclusionThe five multiplex PCR kits showed good consistency with single-pathogen detection results, but each had its own performance emphasis. Kit A, with the highest detection rate and high throughput, is suitable for targeted viral screening. Kit B, covering the broadest pathogen spectrum (including fungi/bacteria), is suitable for comprehensive respiratory pathogen screening. Kits C, D and E, are applicable for rapid detection. It is important to note that the detection efficacy of all kits decreases for low viral load samples with Ct values >35. In practical application, selection should be based on specific screening objectives, throughput requirements, and sample types.
3.A Case of Multidisciplinary Treatment for Inflammatory Myofibroblastic Tumor Complicated by ANCA-Associated Vasculitis
Shaoying WANG ; Linyi PENG ; Ke ZHENG ; Zhiwei WANG ; Dachun ZHAO ; Xia ZHANG ; Lin ZHAO ; Wenhui WANG ; Weiqing WANG ; Zhenzhen ZHU ; Jin XU ; Min SHEN
JOURNAL OF RARE DISEASES 2026;5(1):43-51
A 51-year-old male presented with nasal obstruction, followed by progressive hearing loss and blurred vision. Imaging identified space-occupying lesions in the paranasal sinuses, orbits, and paraspinal regions, while laboratory tests confirmed positive anti-proteinase 3 anti-neutrophil cytoplasmic antibody(PR3- ANCA) immunoglobulin G (IgG)and markedly elevated serum IgG4. Despite treatment with corticosteroids, immunosuppressants, and radiotherapy, the patient exhibited steroid dependency with relentless disease progression. Following multidisciplinary consultation, a diagnosis of inflammatory myofibroblastic tumor (IMT) coexisting with ANCA- associated vasculitis (AAV) was favored, though IgG4-related disease remained a critical differential. Ultimately, profound immunosuppression precipitated a severe herpesvirus infection, leading to disseminated intravascular coagulation and multiple organ dysfunction syndrome. This case underscores the rarity and diagnostic complexity of concurrent IMT and AAV, highlights the therapeutic dilemma of balancing primary disease control against fatal opportunistic infections, and emphasizes the critical role of multidisciplinary collaboration in the diagnosis and treatment of complex diseases.
4.A Case of Tuberous Sclerosis Complex with Multiple Organ Involvement Caused by TSC2 Gene Mutation
Hongli ZHANG ; Jiayuan DAI ; Yan WANG ; Weihong ZHANG ; Wenbin MA ; Hanhui FU ; Chunxia HE ; Jun ZHENG ; Wenda WANG ; Wei ZUO ; Yaping LIU ; Min SHEN
JOURNAL OF RARE DISEASES 2026;5(1):60-67
Tuberous sclerosis complex (TSC) is an autosomal dominant genetic disorder primarily caused by pathogenic variants in the
5.Bone loss in patients with spinal cord injury: Incidence and influencing factors.
Min JIANG ; Jun-Wei ZHANG ; He-Hu TANG ; Yu-Fei MENG ; Zhen-Rong ZHANG ; Fang-Yong WANG ; Jin-Zhu BAI ; Shu-Jia LIU ; Zhen LYU ; Shi-Zheng CHEN ; Jie-Sheng LIU ; Jia-Xin FU
Chinese Journal of Traumatology 2025;28(6):477-484
PURPOSE:
To investigate the incidence and influencing factors of bone loss in patients with spinal cord injury (SCI).
METHODS:
A retrospective case-control study was conducted. Patients with SCI in our hospital from January 2019 to March 2023 were collected. According to the correlation between bone mineral density (BMD) at different sites, the patients were divided into the lumbar spine group and the hip joint group. According to the BMD value, the patients were divided into the normal bone mass group (t > -1.0 standard deviation) and the osteopenia group (t ≤ -1.0 standard deviation). The influencing factors accumulated as follows: gender, age, height, weight, cause of injury, injury segment, injury degree, time after injury, start time of rehabilitation, motor score, sensory score, spasticity, serum value of alkaline phosphatase, calcium, and phosphorus. The trend chart was drawn and the influencing factors were analyzed. SPSS 26.0 was used for statistical analysis. Correlation analysis was used to test the correlation between the BMD values of the lumbar spine and bilateral hips. Binary logistic regression analysis was used to explore the influencing factors of osteoporosis after SCI. p < 0.05 was considered statistically significant.
RESULTS:
The incidence of bone loss in patients with SCI was 66.3%. There was a low concordance between bone loss in the lumbar spine and the hip, and the hip was particularly susceptible to bone loss after SCI, with an upward trend in incidence (36% - 82%). In this study, patients with SCI were divided into the lumbar spine group (n = 100) and the hip group (n = 185) according to the BMD values of different sites. Then, the lumbar spine group was divided into the normal bone mass group (n = 53) and the osteopenia group (n = 47); the hip joint group was divided into the normal bone mass group (n = 83) and the osteopenia group (n = 102). Of these, lumbar bone loss after SCI is correlated with gender and weight (p = 0.032 and < 0.001, respectively), and hip bone loss is correlated with gender, height, weight, and time since injury (p < 0.001, p = 0.015, 0.009, and 0.012, respectively).
CONCLUSIONS
The incidence of bone loss after SCI was high, especially in the hip. The incidence and influencing factors of bone loss in the lumbar spine and hip were different. Patients with SCI who are male, low height, lightweight, and long time after injury were more likely to have bone loss.
Humans
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Spinal Cord Injuries/complications*
;
Male
;
Female
;
Retrospective Studies
;
Incidence
;
Adult
;
Bone Density
;
Middle Aged
;
Case-Control Studies
;
Osteoporosis/etiology*
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Lumbar Vertebrae
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Bone Diseases, Metabolic/etiology*
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Aged
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Risk Factors
6.Ablation of macrophage transcriptional factor FoxO1 protects against ischemia-reperfusion injury-induced acute kidney injury.
Yao HE ; Xue YANG ; Chenyu ZHANG ; Min DENG ; Bin TU ; Qian LIU ; Jiaying CAI ; Ying ZHANG ; Li SU ; Zhiwen YANG ; Hongfeng XU ; Zhongyuan ZHENG ; Qun MA ; Xi WANG ; Xuejun LI ; Linlin LI ; Long ZHANG ; Yongzhuo HUANG ; Lu TIE
Acta Pharmaceutica Sinica B 2025;15(6):3107-3124
Acute kidney injury (AKI) has high morbidity and mortality, but effective clinical drugs and management are lacking. Previous studies have suggested that macrophages play a crucial role in the inflammatory response to AKI and may serve as potential therapeutic targets. Emerging evidence has highlighted the importance of forkhead box protein O1 (FoxO1) in mediating macrophage activation and polarization in various diseases, but the specific mechanisms by which FoxO1 regulates macrophages during AKI remain unclear. The present study aimed to investigate the role of FoxO1 in macrophages in the pathogenesis of AKI. We observed a significant upregulation of FoxO1 in kidney macrophages following ischemia-reperfusion (I/R) injury. Additionally, our findings demonstrated that the administration of FoxO1 inhibitor AS1842856-encapsulated liposome (AS-Lipo), mainly acting on macrophages, effectively mitigated renal injury induced by I/R injury in mice. By generating myeloid-specific FoxO1-knockout mice, we further observed that the deficiency of FoxO1 in myeloid cells protected against I/R injury-induced AKI. Furthermore, our study provided evidence of FoxO1's pivotal role in macrophage chemotaxis, inflammation, and migration. Moreover, the impact of FoxO1 on the regulation of macrophage migration was mediated through RhoA guanine nucleotide exchange factor 1 (ARHGEF1), indicating that ARHGEF1 may serve as a potential intermediary between FoxO1 and the activity of the RhoA pathway. Consequently, our findings propose that FoxO1 plays a crucial role as a mediator and biomarker in the context of AKI. Targeting macrophage FoxO1 pharmacologically could potentially offer a promising therapeutic approach for AKI.
7.Expert consensus on imaging diagnosis and analysis of early correction of childhood malocclusion.
Zitong LIN ; Chenchen ZHOU ; Ziyang HU ; Zuyan ZHANG ; Yong CHENG ; Bing FANG ; Hong HE ; Hu WANG ; Gang LI ; Jun GUO ; Weihua GUO ; Xiaobing LI ; Guangning ZHENG ; Zhimin LI ; Donglin ZENG ; Yan LIU ; Yuehua LIU ; Min HU ; Lunguo XIA ; Jihong ZHAO ; Yaling SONG ; Huang LI ; Jun JI ; Jinlin SONG ; Lili CHEN ; Tiemei WANG
International Journal of Oral Science 2025;17(1):21-21
Early correction of childhood malocclusion is timely managing morphological, structural, and functional abnormalities at different dentomaxillofacial developmental stages. The selection of appropriate imaging examination and comprehensive radiological diagnosis and analysis play an important role in early correction of childhood malocclusion. This expert consensus is a collaborative effort by multidisciplinary experts in dentistry across the nation based on the current clinical evidence, aiming to provide general guidance on appropriate imaging examination selection, comprehensive and accurate imaging assessment for early orthodontic treatment patients.
Humans
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Malocclusion/diagnostic imaging*
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Child
;
Consensus
8.Preliminary Clinical Application Study on the Imaging Effects of Novel Cardiac Sympathetic Nerve Imaging Agent 18F-FPMBBG
Min JU ; Wanjie REN ; Ke WANG ; Zongyao ZHANG ; Kai HAN ; Xiaodi WANG ; Yumin ZHENG ; Lei WANG ; Wei FANG
Chinese Circulation Journal 2025;40(3):234-239
Objectives:To evaluate the imaging effects of the novel sympathetic nerve imaging agent 18F-FPMBBG in healthy volunteers and heart failure patients.Methods:Four healthy volunteers and four heart failure patients were selected to undergo 18F-FPMBBG positron emission tomography/computed tomography(PET/CT)dynamic imaging,the radioactivity distribution characteristics of 18F-FPMBBG in the heart and adjacent organs of the two groups were observed,and the uptake of 18F-FPMBBG by the left ventricular myocardium was compared in the two groups.Results:No adverse effects were observed in all subjects after intravenous injection of 18F-FPMBBG.In healthy volunteers,the heart uptake was rapid and stable,lung uptake was very low,and the blood pool and liver clearance were fast.The heart/liver uptake ratios at 30,60,and 90 minutes after injection were 2.33±0.81,3.29±0.90 and 3.80±1.07,respectively.The average standard uptake value(SUVmean)of 18F-FPMBBG in the heart failure group was significantly lower than that in the healthy volunteer group(P=0.003).The washout rate(WR)was significantly higher in the heart failure group([16.53±2.76]%vs.[3.88±4.51]%,P=0.003).Conclusions:18F-FPMBBG showed good imaging and diagnostic effects in the preliminary imaging of healthy subjects and heart failure patients,and it has the potential to become an ideal cardiac sympathetic nerve imaging agent.
9.Biomechanical Characteristics of Different Types of Lumbar Disc Herniation Based on Finite Element Analysis
Linling ZHANG ; Huihao WANG ; Zhongxiang YU ; Min ZHANG ; Yuxin ZHENG ; Hongsheng ZHAN
Journal of Medical Biomechanics 2025;40(3):706-712
Objective To explore the biomechanical characteristics of different types of lumbar disc herniation(LDH),and provide a theoretical basis for the clinical classification,diagnosis,and treatment of LDH.Methods A normal lumbar spine model with spinal nerves and four types of LDH models(central type,paracentral type/lateral recess type,intervertebral foramen type,extreme type)were constructed,and the biomechanical characteristics of the intervertebral discs and nerve roots in neutral posture and under six degrees of freedom conditions were analyzed.Results In neutral position,the stress of normal intervertebral disc was carger than that of the herniated intervertebral disc,and the stress ratio of annulus fibrosus and nucleus pulposus in normal model was greater than that of annulus fibrosus and nucleus pulposus in herniated models.In neutral position,the disc stress was mainly concentrated at the incisor between the protrusion and normal part,and recruitment occurred at outer edge of the disc.In flexion and extension position,the stress of the herniated intervertebral disc shifted to the right side.The maximum stress of herniated intervertebral disc appeared during right flexion,and the nerve root stress on the right side was carger than that on the left side.The stress of the herniated intervertebral disc during right rotation was slightly lower than that during right flexion,and the stress of nerve root on the right side was smaller than that on the left side.Conclusions The intervertebral disc is important in maintaining lumbar dynamic and static stability and flexibility.Different positions have an obvious effect the intervertebral disc stress.For patients with LDH,forward bending,flexion of the affected side and large extension should be avoided.Appropriate rotation of the affected side can help relieve the symptoms of nerve root compression.
10.Application review of wearable devices in auxiliary detection and diagnosis of acute mountain sickness
Hui-quan WANG ; Shuai MA ; Guo-sheng CHEN ; Yu GUO ; Jin-han YU ; Zheng-xu YAN ; Ming-hu LIU ; Xin-min DONG
Chinese Medical Equipment Journal 2025;46(9):100-107
The pathological mechanisms and related physiological indicators of acute mountain sickness(AMS)were introduced,and the present situation of wearable devices applied in AMS auxiliary detection and diagnosis were reviewed.The challenges and future development directions of wearable devices applied in auxiliary detection and diagnosis were pointed out.[Chinese Medical Equipment Journal,2025,46(9):100-107]

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