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.

ObjectiveTo investigate the association between the maintenance treatment of modified Yiqi Huoxue Jiedu Formula （益气活血解毒方） or poly ADP ribose polymerase （PARP） inhibitors and the recurrence and metastasis of advanced ovarian cancer. MethodsA case-control study design was employed， dividing patients with advanced ovarian cancer into two groups based on the occurrence of recurrence and metastasis following first-line maintenance treatment. Patients with recurrence and metastasis comprised the case group， while those without recurrence and metastasis served as the control group. The previous first-line maintenance treatment method was set as the exposure factor in the study （with the use of modified Yiqi Huoxue Jiedu Formula defined as exposed and PARP inhibitors defined as unexposed）. Basic information was collected for both groups， including the achievement of satisfactory R0 surgery， age， stage， neoadjuvant chemotherapy， lymph node metastasis， germline BRCA1/2 mutations， homologous recombination deficiency positivity， first-line maintenance treatment method （modified Yiqi Huoxue Jiedu Formula or PARP inhibitors）， and CA125 levels after the last chemotherapy. The baseline data of the two groups were assessed for differences. If there exists difference， a 1∶1 nearest neighbor matching method was used for propensity score matching. Univariate and multivariate logistic regression analyses were employed to evaluate the association between the modified Yiqi Huoxue Jiedu Formula or PARP inhibitors and the recurrence and metastasis of ovarian cancer. ResultsA total of 201 patients with advanced ovarian cancer were included， with 97 in the case group and 104 in the control group. Both groups showed statistically significant differences in R0 surgery， stage， neoadjuvant chemotherapy， and CA125 levels after the last chemotherapy （P＜0.05）， indicating baseline imbalance. After propensity score matching， there were 71 patients in both the case and control groups， achieving baseline balance （P＞0.05）. Univariate logistic regression analysis indicated that the achievement of satisfactory R0 surgery （P = 0.006）， disease stage （P = 0.001）， the use of neoadjuvant chemotherapy （P = 0.024）， treatment modality （P = 0.006）， and CA125 levels after the last chemotherapy （P = 0.013） were associated with the recurrence and metastasis of ovarian cancer. Multivariate logistic regression analysis revealed that disease stage was an independent influencing factor for the recurrence and metastasis of ovarian cancer （P = 0.030）， whereas the P-value for the correlation between first-line maintenance treatment and ovarian cancer was 0.188. ConclusionFirst-line maintenance treatment of ovarian cancer patients with the use of modified Yiqi Huoxue Jiedu Formula or PARP inhibitors does not correlate with the recurrence and metastasis of ovarian cancer.

Objective To investigate the five-circuit and six-qi features at conception and at birth in the patients with endometrial cancer.Methods From June 2020 to August 2024,the information about the conception time and birth time of 1 099 patients with endometrial cancer admitted to Guang'anmen Hospital of China Academy of Chinese Medical Sciences was collected from the electronic medical record system.The circuit-qi information at conception and at birth of the patients was statistically analyzed,and then the congenital endowment characteristics of the patients were explored.Results The results showed that most of the patients suffering endometrial cancer were born in winter,and the dominant qi at birth of the patients was predominated by taiyang cold-water,and the differences of the distribution of dominant qi at birth were statistically significant(P＜0.05).There were no significant differences in the distribution of yearly circuit,guest qi,and sitian-zaiquan at birth,and in the distribution of seasons,yearly circuit,dominant qi,guest qi,and sitian-zaiquan at conception(P＞0.05),and only an obvious trend of differences was presented.Conclusion There is a certain correlation between the prevalence of endometrial cancer and the five-circuit and six-qi features at conception and at birth.The congenital endowment of patients with endometrial cancer is characterized by yang deficiency with predominant coldness,and the prevalence is related to jueyin wind wood.

Objective To investigate traditional Chinese medicine(TCM)syndrome characteristics associated with immunotherapy efficacy in cervical cancer using propensity score matching(PSM),aiming to identify the population benefiting from immunotherapy.Methods A retrospective analysis was conducted in 253 cervical cancer patients,who received the treatment with programmed death receptor 1(PD-1)inhibitors at Guang'anmen Hospital,China Academy of Chinese Medical Sciences from January 2020 to October 2024.Clinical data and TCM four-examination data were collected.After balancing the confounders via PSM(1∶1 matching)and with therapeutic efficacy as the dependent variable,multivariate logistic regression was performed to analyze the characteristics of TCM syndrome in the immunotherapy-response group and then a predictive model was constructed.Results(1)After matching with PSM,198 cases were included,99 cases in response group and 99 cases in non-response group.(2)Analysis of the distribution of TCM syndrome elements showed that the differences in the pathogenic syndrome elements of qi deficiency,qi stagnation,blood stasis,heat and phlegm between the two groups were statistically significant(P＜0.05 or P＜0.01),while there were no statistically significant differences in the disease-location syndrome elements of uterus,kidneys,lungs,spleen,liver,and heart,as well as in the pathogenic syndrome elements of blood deficiency,yin deficiency,yang deficiency,cold,and dampness(P＞0.05).The main pathogenic syndrome elements in the response group were qi deficiency,blood deficiency and heat,while those in the non-response group were qi stagnation,heat and phlegm.(3)The results of univariate regression analysis showed that targeted therapy(P=0.040),programmed cell death-ligand 1(PD-L1)expression level(P＜0.001),qi deficiency(P=0.009),blood deficiency(P＜0.001),yang deficiency(P＜0.001),yin deficiency(P＜0.001),qi stagnation(P=0.003),blood stasis(P＜0.001),cold(P＜0.001),cold(P＜0.001),heat(P＜0.001),phlegm(P＜0.001),and dampness(P＜0.001)were the factors associated with the efficacy of PD-1 inhibitors.(4)The results of multivariate logistic regression analysis showed that previous targeted therapy(OR=0.36,95%CI:0.16-0.83)and pathogenic syndrome elements of qi stagnation(OR=0.23,95%CI:0.10-0.49),phlegm(OR=0.28,95%CI:0.13-0.61)were the risk factors of associated with the efficacy of PD-1 inhibitors,while PD-L1 expression level(OR=15.27,95%CI:2.60-89.63),and pathogenic syndrome element qi deficiency(OR=2.90,95%CI:1.42-5.89)were the protective factors associated with the efficacy of PD-1 inhibitors in cervical cancer.(5)Receiver operating characteristic(ROC)curve analysis demonstrated that the area under the ROC curve(AUC)of the predictive model for evaluating PD-1 inhibitor efficacy in cervical cancer was 0.78(95%CI:0.71-0.84),indicating certain predictive value.Conclusion PD-L1 expression level and TCM pathogenic syndrome elements such as qi deficiency,qi stagnation,and phlegm are the independent factors influencing PD-1 inhibitor efficacy in cervical cancer,providing insights for optimizing integrated TCM-western medicine treatment strategies.

Cancer toxin is a specific pathogenesis leading to the heterogeneity of breast cancer.The nature and virulence of the cancer toxin determine the differences in the heterogeneity of breast cancer,which can dynamically evolve over time and space,resulting in varying invasion abilities and characteristics of the tumor.Cancer cells in the primary lesion possess"toxicity"that targets specific organs for metastasis,and cancer toxins can influence the metastatic propensity of different types of breast cancer.Therefore,breast cancer treatment strategies based on the theory of cancer toxins emphasize the continuous eradication of the cancer toxin,focusing on differentiating its strength and nature,protecting unaffected areas first,identifying the state based on symptoms,and targeting accordingly to combat resistance arising from tumor heterogeneity.This article aims to provide a new theoretical basis for the treatment strategies of different types of breast cancer.

Objective To summarize the current research status and cutting-edge trends of the off-label drug use in China,with a view to providing reference for researchers in this field.Methods CNKI and SinoMed databases were searched to collect research of the off-label drug use in China,and used Microsoft Excel 2021,the R software Bibliometric,and VOSviewer 1.6.18 to visualize the time and trend of publication,province,issuing authors and units,journals,keywords,and topic evolution of the included studies.Results 1 475 papers were included in the research.A total of 2 808 authors from 31 provinces,cities and regions had conducted relevant studies on over-the-counter medication,with an overall increasing trend in the number of publications.Among them,Guangdong province published the most studies related to this field,the Straits Pharmacy Journal and China Pharmacy published the most studies in this field.Proprietary Chinese medicines,antimicrobials,antitumor drugs,and other drugs were the research hotspots.In addition,the patients in pediatrics,outpatient emergency,obstetrics and gynecology,psychiatry and other departments as a special sick population,the clinical use of medication exists in the overspecification situation was also a future research trend.Conclusion At present,research in this field focuses more on OLDU for special populations,special diseases,special drugs,etc.In the future,researchers should conduct evidence-based evaluation of drugs on the basis of more high-quality evidence in order to seek the best evidence for guiding the clinical use of medication.At the same time,drug administration and medical institutions should also develop standardized management policies and systems to promote the rational and safe use of medication in healthcare institutions.

Objective To evaluate the risk of recurrence or metastasis of breast cancer by LNG-IUS via meta-analysis. Methods We searched literature in the PubMed, Web of Science, Cochrane, EMBASE, CBM, CNKI, VIP, and WanFang database.The retrieval period was from January 2014 to October 2021.Data extraction and quality evaluation were conducted for the included randomized controlled study (RCT) to analyze whether LNG-IUS can increase the risk of recurrence or metastasis of breast cancer. Results A total of 1309 Chinese and English studies were retrieved; 5 RCTs were included in this study, and 446 patients were enrolled.The combined total effect value in the fixed-effect model with RD (95%CI)0.03(-0.03-0.08), Z=1.05, P=0.29) indicated that the LNG-IUS+tamoxifen group did not increase the risk of recurrence or metastasis of breast cancer compared with the tamoxifen group.The funnel diagram was basically symmetrical, suggesting that the publication bias was small. Conclusion Wearing the LNG-IUS does not increase the risk of relapse or metastasis of breast cancer significantly, and it provides certain safety for patients with breast cancer.