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.

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.

Methodological quality assessment is a pivotal link between primary studies and reliable evidence-based practice,and an essential pathway for operationalizing the core principles of the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition).A prevalent challenge in practice,however,is the conflation of appraising methodological robustness(risk of bias assessment)with verifying reporting transparency(adherence to reporting guidelines).This paper systematically addresses this fundamental challenge,beginning with a clear distinction between the essence and boundaries of these two concepts.On this basis,the article provides a comprehensive review of mainstream quality assessment tools,covering the methodological features and evolutionary trajectory of numerous instruments for interventional(e.g.,RoB 2,ROBINS-I),observational(e.g.,NOS,the JBI/SIGN/NIH series),secondary(e.g.,AMSTAR 2),and other specific types of studies such as health economic evaluations.Furthermore,a complete case study is used to illustrate the practical application of the ROBINS-I tool.The paper's central thesis advocates for an"appraisal-informed design"philosophy,urging a conceptual shift from the retrospective critique of existing literature to the prospective quality control of new research by internalizing appraisal standards as design principles,while also exploring the emerging paradigm of artificial intelligence in assisting assessment.This paper provides a comprehensive methodological reference for researchers and practitioners to prudently select appropriate assessment tools and to conduct rigorous critical appraisals of pharmacoepidemiological evidence.

Methodological quality assessment is a pivotal link between primary studies and reliable evidence-based practice,and an essential pathway for operationalizing the core principles of the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition).A prevalent challenge in practice,however,is the conflation of appraising methodological robustness(risk of bias assessment)with verifying reporting transparency(adherence to reporting guidelines).This paper systematically addresses this fundamental challenge,beginning with a clear distinction between the essence and boundaries of these two concepts.On this basis,the article provides a comprehensive review of mainstream quality assessment tools,covering the methodological features and evolutionary trajectory of numerous instruments for interventional(e.g.,RoB 2,ROBINS-I),observational(e.g.,NOS,the JBI/SIGN/NIH series),secondary(e.g.,AMSTAR 2),and other specific types of studies such as health economic evaluations.Furthermore,a complete case study is used to illustrate the practical application of the ROBINS-I tool.The paper's central thesis advocates for an"appraisal-informed design"philosophy,urging a conceptual shift from the retrospective critique of existing literature to the prospective quality control of new research by internalizing appraisal standards as design principles,while also exploring the emerging paradigm of artificial intelligence in assisting assessment.This paper provides a comprehensive methodological reference for researchers and practitioners to prudently select appropriate assessment tools and to conduct rigorous critical appraisals of pharmacoepidemiological evidence.

Metabolic syndrome(MS)is a complex syndrome based on metabolic disorders in the human body,and is a risk factor for cardiovascular diseases and even certain tumors,with a complicated etiology and unclear pathogenesis.Helicobacter pylori(Hp)is one of the most common pathogenic bacteria,closely associated with the occurrence and development of various diseases.Currently,there are numerous studies both domestically and internationally on the relationship between Hp and MS and its components.Most studies suggest that there is an association between Hp and MS and Hp influences the occurrence and development of MS through multiple pathways.Eradicating Hp may become a new option for treating MS.Based on recent studies from both domestic and international sources,this paper discusses the association between Hp and MS,analyzes the effects of Hp on obesity,blood glucose,blood lipids,and blood pressure,and aims to provide new ideas for the prevention and treatment of MS.

Objective To investigate the efficacy of proton pump inhibitors (PPI) combined with flupethixol melitracen in the treatment of non-erosive gastroesophageal reflux disease (NERD) with anxiety and depression.Methods Fifty six NERD patients with anxiety and depression were evenly divided into the positive treatment group and positive control group.Thirty NERD patients without anxiety and depression were set as negative control group.Both flupethixol melitracen (20 mg per day after breakfast) and PPI esomeprazole magnesium (20 mg per day,20 minutes before breakfast) were administrated in positive treatment group.Only esomeprazole magnesium was given in positive control group and negative control group and the dosage was same as that of positive treatment group.The treatment course of three groups was eight weeks.Before and after the treatment,the symptoms of patients were scored according to gastroesophageal reflux disease questionnaire (GERDQ),Hamilton anxiety scale (HAMA),Hamilton depression scale (HAMD) and Pittsburgh sleep quality index (PSQI).Adverse effects were also observed.Variance analysis was performed for the comparison among three groups.Variance analysis or Post-hoc analysis were used for comparison between two groups.Results The differences of different score value before and after treatment of three groups were statistically significant in total score of GERD Q,score of type A,score of type C,score of HAMA,score of HAMD and PSQI (F=6.32,3.93,5.63,49.61,78.69 and 7.07,all P＜ 0.05).The differences of the score value before and after treatment of positive treatment group in total score of GERD Q,score of type A,score of type C,score of HAMA,score of HAMD and PSQI (4.24±2.05,3.16±1.46,1(0,3),9.32±3.21 and 8.88±2.92) were all higher than those of positive control group (2.38±2.22,1.68±1.33,0(0,2),3.72±2.95 and 3.84±1.97) and negative control group (2.32±2.18,2.48±1.34,0(0,1),2.36±1.25 and 2.36±0.79).And the differences were statistically significant (positive treatment group vs positive control group:Post-hoc analysis,P=0.002,0.022,0.003,0.002 and 0.002; positive treatment group vs negative control group:Post-hoc analysis,P=0.001,0.021,0.004,0.001 and 0.001).The difference of the score value before and after treatment of positive treatment group in PSQI (4 (2,6)) was higher than that of negative control group (2 (1,3),Post-hoc analysis,P=0.001).Two cases of positive treatment group had mild dizziness and the symptom relieved after three to four days.Conclusions For NERD patients with anxiety and depression,anti-depression drug flupenthixol melitracen can be used and the effect is superior to using PPI alone.