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.
6.Development and performance testing of a novel transcatheter tricuspid valve interventional device
Qiuji WANG ; Junfei ZHAO ; Lishan ZHONG ; Shuo XIAO ; Chaolong ZHANG ; Zhenzhong WANG ; Dou FANG ; Yuxin LI ; Yingjie KE ; Shanwen PANG ; Junqiang QIU ; Biaochuan HE ; Huanlei HUANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(06):885-890
Objective To develop a novel transcatheter tricuspid valve replacement device and test its performance. Methods The transcatheter tricuspid valve stent consisted of double-layer self-expanding nitinol stent, biotissue-derived bovine pericardial leaflets, and PTFE woven. The delivery system, mainly consisting of a handle control unit and a delivery sheath, was sent to the correct position via right atrium or jugular vein. The sheath had a visualization feature, and the handle control unit could realize the functions of stable release and partial recovery of the interventional valve. In addition, this study performed animal survival experiments on the basis of in vitro experiments. A large-white pig was used as the experimental animal. Cardiopulmonary bypass was established through median thoracotomy, then the right atrium was opened, and the interventional valve was released under direct vision without cardiac arrest. Approximately 1 month after interventional valve implantation, the maneuverability and stability of the interventional tricuspid device were evaluated by autopsy. Results Through the animal experiment, the interventional valve was successfully released, and the anchoring was satisfactory. Postoperative transthoracic echocardiography showed that the interventional valve opened and closed well, the flow rate of tricuspid valve was 0.6 m/s, and there was no obvious tricuspid regurgitation. One month after the operation, we dissected the large-white pig and found the interventional valve was not deformed or displaced, the leaflets were well aligned, and there was thrombus attachment in the groove between the inner and outer layers of the interventional valve. Conclusion Animal experiment shows that the novel device can stably and firmly attach to the tricuspid annulus, with good anchoring effect, and effectively reduce paravalvular leakage.
7.Diagnosis and treatment of chronic exertional compartment syndrome of the lower extremities: a review
Haofei WANG ; Xiaojun CHEN ; Tao WANG ; Junfei GUO ; Zhiyong HOU
Chinese Journal of Trauma 2024;40(3):266-274
Chronic exertional compartment syndrome (CECS) of the lower extremities is a common clinical condition characterized by exercise-induced pain in the extremities, which is predominantly observed in people who take an active part in sports, such as athletes. It is mainly presented as post-exercise pain in the lower extremities, probably accompanied by numbness and limb weakness, etc., affecting the patients′ life and work. The symptoms of CECS in the lower limbs are usually present after physical activities of a certain intensity, making them difficult to be identified through routine outpatient physical examination, and likely to be misdiagnosed and underdiagnosed. Furthermore, the absence of universally accepted and unified treatment standards for CECS of the lower extremities complicates the decision-making process regarding the necessity of surgical intervention and choice of surgical approach in the clinical practice. For this purpose, recent developments in the diagnosis and treatment of CECS of the lower extremities were reviewed to provide reference for its standardized diagnosis and treatment.
8.Evaluation of the 10-year protective effect and immunogenicity of quadrivalent HPV vaccination
Chenghao PAN ; Xiaoqian XU ; Tianmeng WEN ; Meiyu WANG ; Junfei MA ; Jinxiu HAN ; Shuhua LI ; Shangying HU ; Youlin QIAO ; Fanghui ZHAO
Chinese Journal of Preventive Medicine 2024;58(10):1508-1513
Objective:To evaluate the 10-year protective effect and immunogenicity of quadrivalent human papillomavirus (HPV) vaccine in Chinese women aged 20 to 45 years.Methods:From October 2019 to April 2020, a long-term follow-up study was conducted on the subjects of the Phase III clinical trial of the quadrivalent HPV vaccine (NCT00834106). Participants underwent a questionnaire survey, venous blood sampling, gynecological examination, cervical exfoliated cell pathology examination, and serum neutralizing antibody titers for HPV-6, 11, 16, and 18 were measured using a pseudovirus neutralization assay. The results of the cytological examination and the positive rate and titers of serum antibodies of different cervical exfoliated cells were compared.Results:A total of 889 subjects were followed up, including 240 in the control group, 453 in the vaccination group and 196 in the post-trial vaccination group. The age of the control group was (40±7) years old, which was higher than that of the supplementary vaccination group and the vaccination group [(38±4) and (38±6) years old, respectively] ( P<0.05). There were no statistically significant differences in condom use and sexual frequency among all groups (all P values>0.05). The abnormal proportion of cervical exfoliation cytopathology in the vaccination group was 3.7% (17/453), which was significantly lower than that in the control group [9.6% (23/240)] and post-trial vaccination group [5.6% (11/196)] ( P<0.05). There were two cases of cervical intraepithelial neoplasia (CIN) grade 1 in the vaccination group, two cases of CIN grade 1 and three cases of CIN grade 2 and above in the control group, and no CIN grade 1 and above cases in the post-trial vaccination group. The positive rate of HPV-18 antibody was 35.5% (161/453) in the vaccination group and 76.0% (149/196) in the post-trial vaccination group, which was significantly lower than that of other types ( P<0.05). The neutralizing antibody GMT ratio between the vaccination group and the control group ranged from 2.62 to 25.33 (9.05 to 83.08). Conclusion:Protective neutralizing antibodies are sustained in Chinese women aged 20 to 45 years after ten years of vaccination with quadrivalent HPV vaccine.
9.Evaluation of the 10-year protective effect and immunogenicity of quadrivalent HPV vaccination
Chenghao PAN ; Xiaoqian XU ; Tianmeng WEN ; Meiyu WANG ; Junfei MA ; Jinxiu HAN ; Shuhua LI ; Shangying HU ; Youlin QIAO ; Fanghui ZHAO
Chinese Journal of Preventive Medicine 2024;58(10):1508-1513
Objective:To evaluate the 10-year protective effect and immunogenicity of quadrivalent human papillomavirus (HPV) vaccine in Chinese women aged 20 to 45 years.Methods:From October 2019 to April 2020, a long-term follow-up study was conducted on the subjects of the Phase III clinical trial of the quadrivalent HPV vaccine (NCT00834106). Participants underwent a questionnaire survey, venous blood sampling, gynecological examination, cervical exfoliated cell pathology examination, and serum neutralizing antibody titers for HPV-6, 11, 16, and 18 were measured using a pseudovirus neutralization assay. The results of the cytological examination and the positive rate and titers of serum antibodies of different cervical exfoliated cells were compared.Results:A total of 889 subjects were followed up, including 240 in the control group, 453 in the vaccination group and 196 in the post-trial vaccination group. The age of the control group was (40±7) years old, which was higher than that of the supplementary vaccination group and the vaccination group [(38±4) and (38±6) years old, respectively] ( P<0.05). There were no statistically significant differences in condom use and sexual frequency among all groups (all P values>0.05). The abnormal proportion of cervical exfoliation cytopathology in the vaccination group was 3.7% (17/453), which was significantly lower than that in the control group [9.6% (23/240)] and post-trial vaccination group [5.6% (11/196)] ( P<0.05). There were two cases of cervical intraepithelial neoplasia (CIN) grade 1 in the vaccination group, two cases of CIN grade 1 and three cases of CIN grade 2 and above in the control group, and no CIN grade 1 and above cases in the post-trial vaccination group. The positive rate of HPV-18 antibody was 35.5% (161/453) in the vaccination group and 76.0% (149/196) in the post-trial vaccination group, which was significantly lower than that of other types ( P<0.05). The neutralizing antibody GMT ratio between the vaccination group and the control group ranged from 2.62 to 25.33 (9.05 to 83.08). Conclusion:Protective neutralizing antibodies are sustained in Chinese women aged 20 to 45 years after ten years of vaccination with quadrivalent HPV vaccine.
10.Roles of Yes-associated protein in epidermal stem cell differentiation after ionizing radiation
Libin WANG ; Junfei CHEN ; Fang YUAN ; Jingze WANG ; Lu LIU ; Xuewu WANG ; Zengqiang YUAN
Chinese Journal of Pharmacology and Toxicology 2024;38(7):511-516
OBJECTIVE To explore the role of Yes-associated protein(YAP)in epidermal stem cell(EPSC)differentiation after ionizing radiation(IR).METHODS ① A punch was used to induce skin injuries on the back of mice.The IR group received localized irradiation with 60 Co γ-rays,while the normal control group did not.Samples were collected at 0,1,3,6,9,and 12 d for RNA and protein extraction.Western blotting was used to detect changes in YAP protein expressions during wound healing.Real-time quantitative polymerase chain reaction(RT-qPCR)was performed to assess the mRNA levels of Yap and its downstream target genes,connective tissue growth factor(Ctgf),and cysteine-rich protein 61(Cyr61).② EPSCs were exposed to 60 Co γ at a dose of 4 or 8 Gy,while the control group was not irradiated.Cells were collected to detect the levels of YAP protein via Western blotting.Cells were collected at 4,12,24,and 36 h post-IR to assess the levels of YAP mRNA by RT-qPCR.③ Short hairpin RNA(shRNA)was used to establish stable YAP knockdown cell lines,and the knockdown efficiency of sh YAP was verified by Western blotting.RT-qPCR was then performed to detect the impact of YAP knockdown on mRNA levels of K1 and K10 after IR.RESULTS① Compared with the control group,the YAP protein level in the IR group during wound healing was significantly reduced(P<0.05,P<0.01),so were the mRNA levels of Yap and its downstream target genes Ctgf and Cyr61(P<0.05,P<0.01).② Compared to the cell control group,the mRNA and protein levels of YAP in the IR group cells were significantly reduced(P<0.01).③ In the sh YAP cells,the YAP protein level was significantly reduced(P<0.01).Furthermore,the mRNA levels of K1 and K10 were significantly decreased after IR in sh YAP cells(P<0.01).CONCLUSION YAP can regulate EPSC differentiation in wound healing after IR.

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