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
;
Femoral Neck Fractures/diagnostic imaging*
;
Bone Screws
;
Fracture Fixation, Internal/instrumentation*
;
Male
;
Female
;
Retrospective Studies
;
Robotic Surgical Procedures/methods*
;
Middle Aged
;
Aged
;
Adult
;
Treatment Outcome
;
Operative Time
;
Fracture Healing
;
Surgery, Computer-Assisted/methods*
;
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 and Challenges in the Research of Integration Methods of Animal Experimental Evidence
Qingyong ZHENG ; Tengfei LI ; Jianguo XU ; Yongjia ZHOU ; Zhichao MA ; Na WANG ; Molan LI ; Wenjing YANG ; Peirun WU ; Haidong WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2024;44(5):567-576
Integrating evidence from animal experiments is a critical component of biomedical research, providing essential prior information for in-depth investigations of disease mechanisms and new drug development. Animal models have played an irreplaceable role in simulating human diseases. However, the integration of evidence from animal experiments has faced numerous challenges, including insufficient emphasis, significant heterogeneity in study designs, high publication bias, and discrepancies with clinical research practices. This paper first identifies existing issues in the original research evidence from animal experiments, such as the selection and applicability of animal models, considerations in the design of experimental studies, and factors influencing the translation of animal experimental evidence. It then discusses various methods for integrating this evidence, including systematic review and meta-analysis, overview of systematic review/umbrella review, scoping review, and evidence mapping, while highlighting recent advancements in their application. Finally, the paper addresses the main challenges currently encountered in the integration of evidence from animal experiments and proposes targeted improvement strategies aimed at enhancing the efficiency of translating research outcomes into clinical practice and promoting the advancement of evidence-based medicine. By continuously optimizing original experimental research protocols and evidence integration practices, this work aims to establish a more efficient and scientific environment for the synthesis of evidence from animal experiments, ultimately contributing to clinical trials and human health.
8.Clinical effect of ascending aorta banding combined with typeⅠ hybrid aortic arch repair on aortic arch diseases
Jinhui MA ; Lanlin ZHANG ; Sheng YANG ; Songbo DONG ; Yu CHEN ; Xudong PAN ; Shangdong XU ; Jun ZHENG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(09):1313-1318
Objective To assess the efficacy and safety of ascending aorta banding technique combined with typeⅠhybrid aortic arch repair for the aortic arch diseases. Methods The clinical data of patients undergoing ascending aorta banding technique combined with type Ⅰ hybrid arch repair for aortic arch diseases from March 2019 to March 2022 in Beijing Anzhen Hospital were retrospectively analyzed. The technical success, perioperative complications and follow-up results were evaluated. Results A total of 44 patients were collected, including 35 males and 9 females, with a median age of 63.0 (57.5, 64.6) years. The average EuroSCORE Ⅱ score was 8.4%±0.7%. The technical success rate was 100.0%. All patients did not have retrograde type A aortic dissection and endoleaks. One patient died of multiple organ failure 5 days after operation, the in-hospital mortality rate was 2.3%, and the remaining 43 patients survived and were discharged from hospital. The median follow-up period was 14.5 (6-42) months with a follow-up rate of 100.0%. One patient with spinal cord injury died 2 years after hospital discharge. One patient underwent thoracic endovascular aortic repair at postoperative 3 months due to new entry tears near to the distal end of the stent. Conclusion Ascending aorta banding combined with typeⅠhybrid arch repair for the aortic arch diseases does not need cardio-pulmonary bypass. Ascending aorta banding technique strengthens the proximal anchoring area of the stent to avoid risks such as retrograde type A dissection, endoleak and migration. The operation owns small trauma, rapid recovery, low mortality and a low rate of reintervention, which may be considered as a safe and effective choice in the treatment of the elderly, high-risk patients with complex complications.
9.Single Kocher-Langenbeck approach combined with anterograde channel screw technique in treatment of acetabular transverse and posterior wall fractures.
Xuepeng XU ; Jinhui LIU ; Lincong FEI ; Junwu YE
Chinese Journal of Reparative and Reconstructive Surgery 2024;38(1):35-39
OBJECTIVE:
To assess the effectiveness of the single Kocher-Langenbeck approach combined with anterograde channel screw technique for the treatment of acetabular transverse and posterior wall fractures.
METHODS:
Between March 2020 and October 2022, 17 cases of acetabular transverse and posterior wall fractures were treated with the single Kocher-Langenbeck approach combined with anterograde channel screw technique. There were 11 males and 6 females, with an average age of 53.6 years (range, 42-64 years). Causes of injury included traffic accident in 12 cases, and falling from height in 5 cases. The time from injury to operation ranged from 4 to 16 days with an average of 8.8 days. The operation time, intraoperative blood loss, and fluoroscopy frequency were recorded; X-ray films were reviewed regularly after operation to observe the fracture healing, and postoperative complications were recorded. At last follow-up, Matta score was used to evaluate the reduction of fracture, Harris score and modified Merle D'Aubigné-Postel scores system were used to evaluate the hip joint function.
RESULTS:
The operation time was 150-230 minutes (mean, 185.9 minutes), the intraoperative blood loss was 385-520 mL (mean, 446.2 mL), and the fluoroscopy frequency was 18-34 times (mean, 27.5 times). Postoperative fat liquefaction occurred in 1 case and the other incisions healed by first intention; 3 cases had limb numbness after operation, and the symptoms disappeared after active symptomatic treatment; no urogenital system and intestinal injury occurred. All patients were followed up 12-28 months (mean, 19.9 months). Bone union was achieved in all cases with an average healing time of 10.8 weeks (range, 8-14 weeks). There was no complication such as loosening and breakage of internal fixators. At last follow-up, according to Matta score, 12 cases achieved anatomic reduction, 3 satisfactory reduction, and 2 fair reduction, the satisfactory rate was 88.2%; according to Harris hip function score, 12 cases were excellent, 3 good, and 2 fair, the excellent and good rate was 88.2%; according to the modified Merle D'Aubign Aubigné-Postel scoring system, the results were excellent in 11 cases, good in 3 cases, and fair in 3 cases, with an excellent and good rate of 82.4%.
CONCLUSION
The single Kocher-Langenbeck approach combined with anterograde channel screw technique is a minimally invasive method for the treatment of acetabular transverse and posterior wall fractures with less complications, simple operation, and satisfactory effectiveness.
Male
;
Female
;
Humans
;
Middle Aged
;
Blood Loss, Surgical
;
Fracture Fixation, Internal/methods*
;
Treatment Outcome
;
Fractures, Bone/surgery*
;
Acetabulum/injuries*
;
Bone Screws
;
Hip Fractures/surgery*
;
Retrospective Studies
10. 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.

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