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.Study on the effect and mechanism of Qiwei dongqingye powder against bronchial asthma based on transcriptomics
Jiacheng JIN ; Wenyan CHEN ; Xin LI ; Qing XU ; Hangyu WANG ; Ke ZHANG ; Pinghua SUN ; Jinhui WANG
China Pharmacy 2026;37(5):595-601
OBJECTIVE To investigate the therapeutic effect and mechanism of Qiwei dongqingye powder (QDP) on bronchial asthma in mice. METHODS The mice were divided into blank group (normal saline), model group (normal saline), dexamethasone group (2 mg/kg), and QDP low-, medium-, and high-dose groups (200, 400, 800 mg/kg), with 14 mice in each group. Except for the blank group, mice in all other groups were given ovalbumin via intraperitoneal injection followed by aerosol inhalation to induce a bronchial asthma model. During the modeling process, mice in each group were administered corresponding drug solutions or normal saline intragastrically/intraperitoneally. After the last medication, the number of cells in the bronchoalveolar lavage fluid (BALF) of the mice was observed and counted; the pathological changes of the bronchus and lung tissue were observed; the levels of malondialdehyde (MDA), nitric oxide (NO), total superoxide dismutase (T-SOD), and glutathione peroxidase (GSH-Px) in the lung tissue of the mice were determined, and the level of interleukin-17 (IL-17) in the BALF and serum was determined. Transcriptomics was employed to predict and validate the mechanism of action of QDP against bronchial asthma. RESULTS Compared with the model group, the total cell count, neutrophil count, lymphocyte count, and macrophage counts in the BALF of the QDP high-dose group were all significantly reduced ( P <0.05); the levels of MDA and NO in the lung tissue, and the levels of IL-17 in the BALF and serum were all decreased significantly ( P <0.05); the levels of T-SOD and GSH-Px were significantly increased ( P <0.05); the arrangement of lung tissue cells tended to normalize, with reduced infiltration of inflammatory cells and decreased exfoliation of bronchial simple columnar epithelial cells. The transcriptomic results revealed that the differentially expressed genes were B-cell receptor signaling pathway, nuclear factor κB (NF-κB) signaling pathway, ferroptosis signaling pathway, and others. Further validation revealed that, compared with the model group, the expression levels of NF-κB p65 and chemokine ligand 20, as well as the phosphorylation level of NF-κB inhibitor protein α, were significantly decreased in the lung tissues of the mice in all QDP groups ( P <0.05). Conversely, the protein expression of nuclear factor erythroid 2-related factor 2 (Nrf2) and heme oxygenase 1 (HO-1) were significantly increased ( P <0.05). CONCLUSIONS QDP can effectively alleviate bronchial asthma by inhibiting the NF-κB signaling pathway, activating the Nrf2/HO-1 signaling pathway, regulating oxidative stress, and reducing inflammatory responses.
3.Improving the Certainty of Evidence in Animal Experiment Systematic Review/Meta-Analysis: An Empirical Study of the GRADE Method
Tengfei LI ; Qingyong ZHENG ; Jianguo XU ; Yiyi LI ; Yongjia ZHOU ; Caihua XU ; Mingyue ZHANG ; Jiexiang TIAN ; Gang WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(1):101-111
Animal experiments are essential tools in biomedical research, serving as a bridge between basic research and clinical trials. Systematic reviews and meta-analyses (SRs/MAs) of animal experiments are crucial methods for integrating evidence from animal experiment, which can facilitate the translation of findings into clinical research, reduce translational risks, and promote resource integration in basic research. With the continuous development of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology, its application in SRs/MAs of animal experiments has gained increasing attention. This article first outlines the principles and specific applications of the GRADE methodology in SRs/MAs of animal experiments, including qualitative descriptive systematic reviews, meta-analyses, and network meta-analyses. It then deeply analyzes the misuse of the GRADE methodology in practice, including incorrect evidence grading, improper classification of evidence, misapplication in qualitative systematic reviews, inconsistencies between the documentation of the upgrading and downgrading process and results, and inappropriate use for making recommendations. Furthermore, this article comprehensively discusses the factors influencing the grading of evidence certainty in SRs/MAs of animal experiments, including the impact of bias risk, indirectness, inconsistency, imprecision, and publication bias on evidence downgrading, as well as the role of large effect sizes and cross-species consistency in evidence upgrading. Finally, in response to the issues discussed, improvement strategies are proposed, including further research and optimization of the GRADE methodology for SRs/MAs of animal experiments, the development of reporting guidelines tailored to the characteristics of SRs/MAs in animal experiment research, and enhanced professional training for researchers in the GRADE methodology. This article aims to improve the quality of evidence in SRs/MAs of animal experiments, strengthen their reliability in clinical decision-making, and promote the more efficient translation of findings from animal experiment research into clinical practice.
4.Analysis of effectiveness of Holosight robot navigation-assisted percutaneous cannulated screw fixation in treatment of femoral neck fractures.
Weizhen XU ; Zhenqi DING ; Hui LIU ; Jinhui ZHANG ; Yuanfei XIONG ; Jin WU
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(6):673-679
OBJECTIVE:
To investigate the effectiveness of Holosight robotic navigation-assisted percutaneous cannulated screw fixation for femoral neck fractures.
METHODS:
A retrospective analysis was conducted on 65 patients with femoral neck fractures treated with cannulated screw fixation between January 2022 and February 2024. Among them, 31 patients underwent robotic navigation-assisted screw placement (navigation group), while 34 underwent conventional freehand percutaneous screw fixation (freehand group). Baseline characteristics, including age, gender, fracture side, injury mechanism, Garden classification, Pauwels classification, and time from injury to operation, showed no significant differences between the two groups ( P>0.05). The operation time, intraoperative blood loss, fluoroscopy frequency, fracture healing time, and complications were recorded and compared, and hip function was evaluated by Harris score at last follow-up. Postoperative anteroposterior and lateral hip X-ray films were taken to assess screw distribution accuracy, including deviation from the femoral neck axis, inter-screw parallelism, and distance from screws to the femoral neck cortex.
RESULTS:
No significant difference was observed in operation time between the two groups ( P>0.05). However, the navigation group demonstrated superior outcomes in intraoperative blood loss, fluoroscopy frequency, deviation from the femoral neck axis, inter-screw parallelism, and distance from screws to the femoral neck cortex ( P<0.05). No incision infections or deep vein thrombosis occurred. All patients were followed up 12-18 months (mean, 16 months). In the freehand group, 1 case suffered from cannulated screw dislodgement and nonunion secondary to osteonecrosis of femoral head at 1 year after operation, 1 case suffered from screw penetration secondary to osteonecrosis of femoral head at 5 months after operation; and 1 case suffered from nonunion secondary to osteonecrosis of femoral head at 6 months after operation in the navigation group. All the 3 patients underwent internal fixators removal and total hip arthroplasty. There was no significant difference in the incidence of complications between the two groups ( P>0.05). The fracture healing time and hip Harris score at last follow-up in the navigation group were significantly better than those in the freehand group ( P<0.05).
CONCLUSION
Compared to freehand percutaneous screw fixation, Holosight robotic navigation-assisted cannulated screw fixation for femoral neck fractures achieves higher precision, reduced intraoperative radiation exposure, smaller incisions, and superior postoperative hip function recovery.
Humans
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Femoral Neck Fractures/diagnostic imaging*
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Bone Screws
;
Fracture Fixation, Internal/instrumentation*
;
Male
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Female
;
Retrospective Studies
;
Robotic Surgical Procedures/methods*
;
Middle Aged
;
Aged
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Adult
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Treatment Outcome
;
Operative Time
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Fracture Healing
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Surgery, Computer-Assisted/methods*
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Fluoroscopy
5.Discovery of a novel AhR-CYP1A1 axis activator for mitigating inflammatory diseases using an in situ functional imaging assay.
Feng ZHANG ; Bei ZHAO ; Yufan FAN ; Lanhui QIN ; Jinhui SHI ; Lin CHEN ; Leizhi XU ; Xudong JIN ; Mengru SUN ; Hongping DENG ; Hairong ZENG ; Zhangping XIAO ; Xin YANG ; Guangbo GE
Acta Pharmaceutica Sinica B 2025;15(1):508-525
The aryl hydrocarbon receptor (AhR) plays a crucial role in regulating many physiological processes. Activating the AhR-CYP1A1 axis has emerged as a novel therapeutic strategy against various inflammatory diseases. Here, a practical in situ cell-based fluorometric assay was constructed to screen AhR-CYP1A1 axis modulators, via functional sensing of CYP1A1 activities in live cells. Firstly, a cell-permeable, isoform-specific enzyme-activable fluorogenic substrate for CYP1A1 was rationally constructed for in-situ visualizing the dynamic changes of CYP1A1 function in living systems, which was subsequently used for discovering the efficacious modulators of the AhR-CYP1A1 axis. Following screening of a compound library, LAC-7 was identified as an efficacious activator of the AhR-CYP1A1 axis, which dose-dependently up-regulated the expression levels of both CYP1A1 and AhR in multiple cell lines. LAC-7 also suppressed macrophage M1 polarization and reduced the levels of inflammatory factors in LPS-induced bone marrow-derived macrophages. Animal tests showed that LAC-7 could significantly mitigate DSS-induced ulcerative colitis and LPS-induced acute lung injury in mice, and markedly reduced the levels of multiple inflammatory factors. Collectively, an optimized fluorometric cell-based assay was devised for in situ functional imaging of CYP1A1 activities in living systems, which strongly facilitated the discovery of efficacious modulators of the AhR-CYP1A1 axis as novel anti-inflammatory agents.
6.Effects of meropenem exposure and degradation levels on clinical efficacy in patients with purulent meningitis
Tongtong LI ; Jiantong SUN ; Xianglong CHEN ; Peng DENG ; Yanping XUE ; Yao XIAO ; Lijuan YANG ; Jinhui XU ; Yanxia YU ; Lian TANG
China Pharmacy 2025;36(24):3084-3090
OBJECTIVE To explore the effects of meropenem exposure and degradation levels on clinical efficacy in patients with purulent meningitis (PM). METHODS A total of 131 PM patients treated with meropenem at the Affiliated Suzhou Hospital of Nanjing Medical University from January 2022 to June 2025 were prospectively included. Relevant data were collected and divided into a cured group (91 cases) and a non-cured group (40 cases) based on the efficacy. High-performance liquid chromatography-tandem mass spectrometry was used to determine the concentration of meropenem and its open-loop metabolites. Risk factors that affect efficacy were screened, and their predictive power and correlation were evaluated by univariate analysis, and multivariate Logistic regression analysis, receiver operating characteristic (ROC) curves, and correlation analysis. RESULTS Univariate analysis showed that serum creatinine, creatinine clearance rate, minimum inhibitory concentration of meropenem ≥16 μg/mL, cerebrospinal fluid red blood cell count, cerebrospinal fluid white blood cell count, cerebrospinal fluid glucose content, blood trough concentration, blood open-loop metabolite concentration/trough concentration ratio, and intrathecal injection were all correlated with efficacy (P<0.05). The results of multiple Logistic regression analysis showed that serum creatinine blood open-loop metabolite concentration/trough concentration ratio, intrathecal injection, and cerebrospinal fluid glucose content were influencing factors for suboptimal anti-infective ltt efficacy (P<0.05). ROC curve analysis showed that when the blood open-loop metabolite concentration/trough concentration ratio was greater than 2.854 (AUC=0.647), serum creatinine was less than 59.5 μmol/L (AUC=0.647), and cerebrospinal fluid glucose content was less than 3.37 mmol/L (AUC=0.709), the risk of treatment failure significantly increased (P<0.05). Correlation analysis showed that the blood trough concentration of meropenem was positively correlated with the concentration of its open-loop metabolites (R 2=0.134 5, P<0.000 1). CONCLUSIONS Insufficient exposure level and rapid degradation of meropenem are key mechanisms affecting the anti-infective efficacy of PM. Elevated blood open-loop metabolite concentration/ trough concentration ratio, low serum creatinine level, lack of intrathecal injection, and low cerebrospinal fluid glucose content are independent risk factors for poor efficacy.
7.Advances in the study of mesenchymal stem cells in obstructive sleep apnea hypoventilation syndrome
Jinhui XU ; Hongmei YUE ; Yating LI ; Miaomiao LIU ; Xingdong WU ; Haobin ZHU
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(1):114-120
Mesenchymal stem cells(MSCs)are self-regenerating,rapidly proliferating pluripotent stem cells that depend primarily on their derived pro-angiogenic,inflammatory regulatory,and tro-phic factors to exert beneficial effects that attenu-ate deleterious inflammatory responses,reduce vascular damage,and promote tissue repair and re-generation.Obstructive sleep apnea hypoventila-tion syndrome(OSAHS)is a chronic disorder marked by oropharyngeal collapse during sleep,re-sulting in transient reduced airflow,large fluctua-tions in intrathoracic pressure,and intermittent hy-poxia and hypercapnia.OSAHS subsequently cyto-kine-mediated inflammatory cascades,oxidative stress,and ischemia,recruit MSCs from inflamed and damaged tissues through MSCs-derived of anti-inflammatory and pro-angiogenic factor activity,re-duce hypoxia,suppress inflammation,promote re-generation,and prevent fibrosis in OSAHS-injured tissues.In this paper,we will describe the patho-genesis of inflammation,oxidative stress,fibrosis and ischemia from the perspective of OSAHS,high-lighting the current research progress on MSCs-de-pendent regulation of OSAHS-related pathology.
8. Research progress of pharmacologic therapy in obstructive sleep apnea
Xingdong WU ; Hongmei YUE ; Haobin ZHU ; Miaomiao LIU ; Yating LI ; Jinhui XU ; Hongmei YUE
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(2):215-229
Obstructive sleep apnea (OSA) is a common sleep disordered breathing disorder. As a major global public health problem, untreated OSA can lead to a variety of adverse health outcomes, including various cardiovascular and cerebrovascular diseases, metabolic disorders, and psychiatric disorders such as anxiety and depression. Traditional OSA therapies such as positive airway pressure (PAP), weight loss, oral appliance, upper airway surgery, and postural therapy focus on the anatomical factors of OSA. However, the pathogenesis of OSA is heterogeneous, and non-anatomical factors also play an important role in most patients. Although there is no drug with exact efficacy for the treatment of OSA, with the deepening understanding of the pathophysiological mechanism of OSA, more and more clinical studies are devoted to the study of drug treatment of OSA and its complications, and a series of results have been achieved. The following is a review of the relevant studies on drug treatment of OSA in recent years, hoping to provide literature support and theoretical basis for future research on drug treatment of OSA.
9.Evaluation of the hygiene status of teaching environment in primary and secondary schools in Beijing City from 2016 to 2020
ZHAO Jinhui, QIN Ran, WANG Wenxin, XU Huiyu, GAO Ruoyi, GUO Xin
Chinese Journal of School Health 2024;45(3):431-436
Objective:
To understand the trend of changes of hygiene status in the teaching environment among primary and secondary schools in Beijing City during 2016-2020, so as to provide basis for further improving the teaching environment and campus hygiene conditions in primary and secondary schools.
Methods:
A proportional systematic sampling method covered over 50% of schools selected annually in Beijing from 2016 to 2019, and 34% were selected in 2020. Two representative classrooms were selected from each selected school for testing based on their structure and other factors, with 6 196 classrooms supervised, from 2016 to 2020,1 330,1 312,1 384,1 322,848 classrooms were monitored for each year.
Results:
From 2016 to 2020, the overall lighting qualification rate of classrooms (lighting coefficient 72.8%, window to floor area ratio 41.8%, rear wall reflectance ratio 42.2%, blackboard reflection ratio 37.4%), the overall qualification rate of average blackboard illumination and uniformity (50.6%, 34.9 %), and the overall qualification rate of desk and chair allocation (58.6%) were all below 80%. The overall qualification rate of per capita classroom area (87.5%), blackboard size (83.2%), average desk illumination ( 80.1% ), average desk illumination and uniformity (82.9%), the distance between lamp and desk (99.1%), carbon dioxide ( 86.6% ), temperature (84.9%), and noise (96.6%) were all above 80%. The following indicators, blackboard size, the distance between lamp and desk, average blackboard illumination, lighting coefficient, blackboard reflectance, rear wall reflectance, carbon dioxide, temperature, and noise ( χ 2=78.38, 9.71, 11.76, 320.59, 37.63, 58.45, 236.45, 1 347.56, 101.97), had statistically significance between years. Among those indicators, the qualified rates of blackboard size, blackboard reflectance, lighting coefficient, and noise had been increasing year by year ( χ 2 trend =69.98, 15.82, 240.02, 5.77) ( P <0.05). The qualified rates of per capita classroom area, window to floor area ratio, and blackboard reflection ratio in primary schools (81.6%, 39.8%, 36.3%) were all lower than those in secondary schools (94.9%, 44.5%, 40.3%) ( χ 2=246.32, 12.03, 10.51, P <0.05). The qualified rates of blackboard size, average blackboard illumination, average blackboard illumination and uniformity, and desk and chair allocation (89.3%, 55.6% , 36.0%, and 60.2%) were all higher than those in secondary schools (75.4%, 44.1%, 33.3%, and 56.5%) ( χ 2=209.33, 78.41, 4.44, 8.22) ( P <0.05). The qualified rates of average desk illumination and uniformity, average blackboard illumination, rear wall reflectance ratio, desk and chair allocation, carbon dioxide, temperature, and noise indicators in urban area (82.9%, 84.1% , 51.9%, 45.0%, 60.9%, 91.2%, 89.5%, 97.8%) were all higher than those in suburban area (77.3%, 81.7%, 49.2%, 39.5%, 56.3%, 82.3%, 80.4%, 95.5%) ( χ 2=31.16, 6.28, 4.36, 16.40, 13.39, 105.29, 98.23, 24.66, P <0.05). The qualified rates of the distance between lamp and desk, lighting coefficient, window to floor area ratio, blackboard size, blackboard reflection ratio, average blackboard illumination and uniformity, and per capita classroom area in urban areas (98.8%, 65.2%, 34.3%, 76.7%, 35.9%, 30.1%, 84.6%) were all lower than those in suburban areas (99.4%, 81.4%, 49.8%, 89.7%, 40.2%, 39.6%, 90.3%) ( χ 2=6.80, 171.67, 132.43, 188.46 , 12.45, 60.28, 44.82) ( P <0.05).
Conclusions
The main problems in the teaching environment of schools in Beijing are classroom lighting, as well as desk and chair allocation. The findings suggest technical rationality and operability of relevant standard should be considered when under revision, and standard training and supervision management should be strengthened, with the aim of teaching environment improvement.
10.Role of Neutrophil Extracellular Traps in Chronic Obstructive Pulmonary Disease
Jinhui XU ; Hongmei YUE ; Miaomiao LIU ; Yating LI ; Xingdong WU ; Haobin ZHU
Medical Journal of Peking Union Medical College Hospital 2024;15(1):153-159
Chronic obstructive pulmonary disease (COPD), a respiratory disease characterized by inflammation due to neutrophil infiltration, has become the third leading cause of death worldwide. After the occurrence of COPD, the persistent accumulation of neutrophils can promote the excessive formation of neutrophil extracellular traps (NETs), which plays an important role in local capture and clearance of pathogens, rapid control of infection, and immune regulation. This article mainly introduces the mechanism of COPD occurrence and NETs formation as well as the research progress of NETs in COPD, and summarizes the relevant drug targets for COPD treatment based on NETs, aiming to provide a reference for further research.


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