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.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.
3.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.
4.Chemical knockdown of Keap1 and homoPROTAC-ing allergic rhinitis.
Jianyu YAN ; Tianyu WANG ; Ruizhi YU ; Lijuan XU ; Hongming SHAO ; Tengfei LI ; Zhe WANG ; Xudong CHA ; Zhenyuan MIAO ; Chengguo XING ; Ke XU ; Huanhai LIU ; Chunlin ZHUANG
Acta Pharmaceutica Sinica B 2025;15(8):4137-4155
Allergic rhinitis (AR), a globally prevalent immune-mediated inflammatory condition, is still an incurable disease. In the present study, we have validated the impact of the Kelch-like ECH associated protein 1 (Keap1)-related oxidative stress and inflammatory response in clinical AR patient peripheral blood and nasal swab samples, emphasizing the biological relevance of Keap1 and AR. Targeting Keap1 -nuclear factor erythroid 2-related factor 2 (Nrf2) related anti-oxidative stress may be effective for AR intervention. Drawing inspiration from the Keap1 homodimerization and the E3 ligase characteristics, we herein present a design of novel bivalent molecules for chemical knockdown of Keap1. For the first time, we characterized ternary complexes of Keap1 dimer and one molecule of bivalent compounds. The best bivalent molecule 8 encompasses robust capacity to degrade Keap1 as a homoPROTACKEAP1. It efficaciously suppresses inflammatory cytokines in extensively different cells, including human nasal epithelial cells. Moreover, in an AR mouse model, we confirmed that the chemical degradation induced by homoPROTACKEAP1 led to therapeutic benefits in managing AR symptoms, oxidative stress and inflammation. In summary, our findings underscore the efficacy of targeting the Keap1 system through the homoPROTAC-ing technology as an innovative and promising treatment strategy for the incurable allergic disorders.
5.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):101101-101101
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 efficiency 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.
6.A preliminary study on the quality and conversion potential of hospital patents based on the formulation mechanism
Tengfei XU ; Dan XIE ; Shulong YANG ; Xia WANG ; Zhaohai ZHOU
Chinese Journal of Medical Science Research Management 2025;38(2):120-126
Objective:Due to the large number of patents, wide distribution of technical fields, limited management resources, differences in the nature of different patent holders and so on, this study aims to find a fast and reliable evaluation mechanism for identifying the quality and transfer potential of patents supported by the fund.Methods:Through literature review, expert consultation, analysis and discussion of existing mechanisms and technical issues in the field of patent evaluation, we further determined patent evaluation mechanisms and their primary indicators with better applicability.Results:A drafting mechanism was proposed, that patents which had not yet found evidence of fatal evaluation or have abandoned evaluation can be temporarily given a reliable quality evaluation.Conclusions:Compared with high cost methods such as patent invalidation or infringement investigation, there are more economical and efficient negative evaluation indicators, which make different evaluation tool users to believe that patents do not have conversion value when negative evidence is found. It can also enable different evaluation tool users to temporarily give reliable evaluations of patent conversion prospects based on a hypothetical mechanism without discovering negative evidence temporarily. This evaluation mechanism is suitable for assessing patent quality and conversion potential, and is more scientific and efficient.
7.A preliminary study on the quality and conversion potential of hospital patents based on the formulation mechanism
Tengfei XU ; Dan XIE ; Shulong YANG ; Xia WANG ; Zhaohai ZHOU
Chinese Journal of Medical Science Research Management 2025;38(2):120-126
Objective:Due to the large number of patents, wide distribution of technical fields, limited management resources, differences in the nature of different patent holders and so on, this study aims to find a fast and reliable evaluation mechanism for identifying the quality and transfer potential of patents supported by the fund.Methods:Through literature review, expert consultation, analysis and discussion of existing mechanisms and technical issues in the field of patent evaluation, we further determined patent evaluation mechanisms and their primary indicators with better applicability.Results:A drafting mechanism was proposed, that patents which had not yet found evidence of fatal evaluation or have abandoned evaluation can be temporarily given a reliable quality evaluation.Conclusions:Compared with high cost methods such as patent invalidation or infringement investigation, there are more economical and efficient negative evaluation indicators, which make different evaluation tool users to believe that patents do not have conversion value when negative evidence is found. It can also enable different evaluation tool users to temporarily give reliable evaluations of patent conversion prospects based on a hypothetical mechanism without discovering negative evidence temporarily. This evaluation mechanism is suitable for assessing patent quality and conversion potential, and is more scientific and efficient.
8.Evaluation of the accuracy of three-dimensional data acquisition from liquid-inter-ference surfaces assisted by a scanner head with a compressed airflow system
Xinkai XU ; Jianjiang ZHAO ; Sukun TIAN ; Zhongning LIU ; Xiaoyi ZHAO ; Xiaobo ZHAO ; Tengfei JIANG ; Xiaojun CHEN ; Chao MA ; Yuchun SUN
Journal of Peking University(Health Sciences) 2025;57(1):121-127
Objective:To quantitatively evaluate the accuracy of data obtained from liquid-interference surfaces using an intraoral 3D scanner(IOS)integrated with a compressed airflow system,so as to pro-vide clinical proof of accuracy for the application of the compressed airflow system-based scanning head in improving data quality on liquid-interference surfaces.Methods:The study selected a standard model as the scanning object,adhering to the"YY/T 1818-2022 Dental Science Intraoral Digital Impression Scanner"guidelines,a standard that defined parameters for intraoral scanning.To establish a baseline for accuracy,the ATOS Q 12M scanner,known for its high precision,was used to generate true reference values.These true values served as the benchmark for evaluating the IOS performance.Building on the design of an existing scanner,a new scanning head was developed to integrate with a compressed airflow system.This new design aimed to help the IOS capture high-precision data on sur-faces where liquid-interference,such as saliva,might otherwise degrade scanning accuracy.The tradi-tional scanning method,without airflow assistance,was employed as a control group for comparison.The study included five groups in total,one control group and four experimental groups,to investigate the effects of scanning lens obstruction,airflow presence,liquid media,and the use of the new scan-ning head on scanning process and accuracy.Each group underwent 15 scans,generating ample data for a robust statistical comparison.By evaluating trueness and precision in each group,the study as-sessed the impact of the compressed airflow system on the accuracy of IOS data collected from liquid-interference surfaces.Additionally,we selected Elite and Primescan scanners as references for numeri-cal accuracy values.Results:The scanning accuracy on liquid-interference surfaces was significantly reduced in terms of both trueness and precision[Trueness:18.5(6.5)vs.38.0(6.7),P<0.05;Preci-sion:19.1(8.5)vs.31.7(15.0),P<0.05].The use of the new scanning head assisted by the com-pressed airflow system significantly improved the scanning accuracy[Trueness:22.3(7.6)vs.38.0(6.7),P<0.05;Precision:25.8(9.6)vs.31.7(15.0),P<0.05].Conclusion:The scanning head based on the compressed airflow system can assist in improving the accuracy of data obtained from liquid-inter-ference surfaces by the IOS.
9.The application of percutaneous puncture renal fascia suspension in laparoscopic partial nephrectomy
Qi LI ; Pei ZHENG ; Yusheng WANG ; Guangyuan JING ; Mingrui WANG ; Bo ZHAO ; Tengfei XU ; Xiaoli WANG ; Kaidong WANG ; Xiao PAN ; Fen YIN
Chinese Journal of Urology 2024;45(1):53-54
When partial nephrectomy is performed by posterior abdominal approach, the surgical field is poorly exposed, resulting in increased surgical difficulty and risk of injury.In this study, 28 patients with T 1a stage kidney tumors underwent retroperitoneal laparoscopic partial nephrectomy. Intraoperatively, exposure of the surgical field was achieved using the percutaneous puncture of the renal fascia suspension technique. There were no dissatisfactory exposures due to peritoneal damage during the surgery, no additional tubes were inserted, and no conversions to open surgery were needed. The operation time was (76.5±20.3) minutes, blood loss was (92.1±18.7) ml, renal artery clamping time was (19.5±4.3) minutes. Postoperatively, there were no complications such as bleeding, infection, or hematuria.
10.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.

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