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.Consistency verification of reverse screening strategy for syphilis in maternal and child populations and assocliation between S/CO value and false positive rate of CLIA
Weiming LU ; Jiewen LI ; Chunming GU ; Junfei GUO ; Kefeng LAI ; Xianhua ZHENG ; Mingyong LUO
The Journal of Practical Medicine 2025;41(20):3249-3255
Objective To compare the diagnostic performance of two syphilis reverse testing protocols recommended by the U.S.Centers for Disease Control and Prevention(USCDC)and the European Centre for Disease Prevention and Control(ECDC)within maternal and child populations,and to explore the factors contributing to false-positive results in chemiluminescent immunoassays(CLIA).Methods A retrospective analysis was performed on serological test results from 109,003 patients collected between 2021 and 2023.All participants were initially screened for specific syphilis antibodies using CLIA,and those with positive results underwent confirmatory testing with both the toluidine red unheated serum test(TRUST)and the Treponema pallidum particle agglutination assay(TPPA).The kappa statistic was employed to assess the diagnostic agreement between the USCDC and ECDC protocols,while also analyzing the distribution patterns of CLIA false-positive results across varying S/CO value ranges and demographic groups.Results Both protocols achieved a syphilis positivity rate of 0.34%.The hospital's high-prevalence syphilis screening program identified no cases with CLIA-positive or TRUST-positive but TPPA-negative results,suggesting high specificity in this population.The two protocols demonstrated perfect agreement with a Kappa value of 1.0,indicating no significant difference in diagnostic performance between maternal and child populations.CLIA exhibited a true positive rate of 71.04%,which was positively correlated with S/CO values:21.88%when 1.010.The highest false positive rate for CLIA(38.75%)was observed among young adults,while the largest proportion of false positives-reaching 40.00%—was associated with pregnancy and abortion status.Conclusions The two reverse detection methods for syphilis exhibit comparable diagnostic efficacy in women and children from populations with low syphilis prevalence.CLIA demonstrates high sensitivity;however,when the S/CO ratio is less than 10,particularly in adult women of childbearing age,clinicians should remain vigilant for potential false-positive results to prevent misdiagnosis and unnecessary medical interventions.
3.Consistency verification of reverse screening strategy for syphilis in maternal and child populations and assocliation between S/CO value and false positive rate of CLIA
Weiming LU ; Jiewen LI ; Chunming GU ; Junfei GUO ; Kefeng LAI ; Xianhua ZHENG ; Mingyong LUO
The Journal of Practical Medicine 2025;41(20):3249-3255
Objective To compare the diagnostic performance of two syphilis reverse testing protocols recommended by the U.S.Centers for Disease Control and Prevention(USCDC)and the European Centre for Disease Prevention and Control(ECDC)within maternal and child populations,and to explore the factors contributing to false-positive results in chemiluminescent immunoassays(CLIA).Methods A retrospective analysis was performed on serological test results from 109,003 patients collected between 2021 and 2023.All participants were initially screened for specific syphilis antibodies using CLIA,and those with positive results underwent confirmatory testing with both the toluidine red unheated serum test(TRUST)and the Treponema pallidum particle agglutination assay(TPPA).The kappa statistic was employed to assess the diagnostic agreement between the USCDC and ECDC protocols,while also analyzing the distribution patterns of CLIA false-positive results across varying S/CO value ranges and demographic groups.Results Both protocols achieved a syphilis positivity rate of 0.34%.The hospital's high-prevalence syphilis screening program identified no cases with CLIA-positive or TRUST-positive but TPPA-negative results,suggesting high specificity in this population.The two protocols demonstrated perfect agreement with a Kappa value of 1.0,indicating no significant difference in diagnostic performance between maternal and child populations.CLIA exhibited a true positive rate of 71.04%,which was positively correlated with S/CO values:21.88%when 1.010.The highest false positive rate for CLIA(38.75%)was observed among young adults,while the largest proportion of false positives-reaching 40.00%—was associated with pregnancy and abortion status.Conclusions The two reverse detection methods for syphilis exhibit comparable diagnostic efficacy in women and children from populations with low syphilis prevalence.CLIA demonstrates high sensitivity;however,when the S/CO ratio is less than 10,particularly in adult women of childbearing age,clinicians should remain vigilant for potential false-positive results to prevent misdiagnosis and unnecessary medical interventions.
4.Early outcomes of self-expanding interventional pulmonary valve in transthoracic implantation: A prospective clinical study
Ying HUANG ; Ziqin ZHOU ; Yong ZHANG ; Xiaohua LI ; Nianjin XIE ; Hongwen FEI ; Hui LIU ; Junfei ZHAO ; Jian ZHUANG ; Jimei CHEN ; Shusheng WEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(06):872-877
Objective To evaluate early outcomes of transthoracic pulmonary valve implantation for the treatment of moderate and severe pulmonary regurgitation by using homemade self-expanding valve (SalusTM). Methods Patients with severe pulmonary regurgitation who underwent transthoracic pulmonary valve implantation in Guangdong Provincial People’s Hospital from September 2, 2021 to November 25, 2022 were prospectively enrolled. The early postoperative complications and improvement of valve and heart function were summarized and analyzed. Results A total of 25 patients were enrolled, including 16 males and 9 females, with an average age of 24.5±1.5 years and an average weight of 57.0±3.0 kg. The mean systolic diameters of the bifurcation near the main pulmonary artery, the stenosis of the middle segment of the aorta and near the valve of the right ventricular outflow tract of the patients were 31.8±7.4 mm, 30.6±5.9 mm and 38.4±8.0 mm, respectively. All patients were successfully implanted with valves, and there were no serious complications such as death, coronary compression, stent fracture, valve displacement and infective endocarditis in the early postoperative period. The indexed left atrial longitudinal diameter, indexed right atrial longitudinal diameter, and indexed right ventricular outflow tract anteroposterior diameter decreased significantly after the operation. The degree of tricuspid and pulmonary valve regurgitation and the indexed regurgitation area decreased significantly. The above differences were statistically significant (P<0.05). Conclusion The early outcomes of transthoracic pulmonary valve implantation with homemade self-expanding pulmonary valve (SalusTM) in the treatment of severe pulmonary regurgitation is relatively good, and the long-term outcomes need to be verified by the long-term follow-up studies with large samples.
5.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.
6.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.
7.Value of SHOX2 and RASSF1A Gene Methylation in Alveolar Lavage Fluid in Patients with Pulmonary Nodules or Masses in the Diagnosis of Lung Cancer
Dongping ZHU ; Haifeng LI ; Junfei FENG ; Qiuheng TANG ; Jing LENG
Journal of Kunming Medical University 2024;45(3):106-111
Objective The diagnostic efficacy of the two gene methylation indexes was verified by lung biopsy or postoperative disease examination results.Methods A prospective study was conducted to collect 99 patients diagnosed with pulmonary nodules and masses in the Third People's Hospital of Yunnan Province from March 2019 to March 2020.After bronchoscopy and BALF samples were collected,regular follow-up,lung puncture biopsy and post-operative disease examination were performed.Results Ninety-nine patients with pulmonary nodules and masses were divided into lung cancer group(n = 50)and benign lung disease group(n = 49)after pathological diagnosis.The age of patients in the lung cancer group was(62.64±9.71)years,and that of the benign lung disease group was(60.48±13.69)years,and there was a statistical difference between the two groups(P = 0.032).In the diagnosis of lung cancer,the sensitivity and specificity of SHOX2 and RASSF1A genes alone were found to be 72%and 58%,respectively,and 92.3%and 95.9%,respectively.The combined test of the two genes showed a higher sensitivity in the diagnosis of lung cancer,0.84,compared to 0.102 in the benign disease group(P<0.001).ROC curve analysis showed that the sensitivity of the two genes could be increased to 84%when methylation was combined.Conclusion The methylation test of SHOX2 and RASS1A gene in alveolar lavage fluid has a good value in the diagnosis of lung cancer patients with pulmonary nodules and masses and SHOX2 combined with RASSF1A can be an important supplementary tool for early diagnosis of lung cancer when imaging and histological diagnosis are unclear.
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.Isolation,culture and characterization of neural crest cells from lung tissue of mT/mG;Wnt1-Cre mice
Xiaowen DONG ; Yongxin LI ; Xiaoxue GONG ; Lingfang FENG ; Junfei CHEN ; Jiahui YAO ; Jianlin LOU
Basic & Clinical Medicine 2024;44(11):1510-1515
Objective To isolate and culture neural crest cells(NCCs)from lung tissue of mice and to identify the characteristics of the cells in order to provide a new cell model for studying lung injury and injure repair.Methods The mT/mG dual-fluorescence reporter mice and Wnt1-Cre transgenic mice were hybridized,and mT/mG;Wnt1-Cre transgenic mice were screened to obtain enhanced green fluorescent protein(EGFP)permanently labeled NCCs.Cell suspension of mouse lung tissue was prepared by enzymolysis.EGFP+cells(namely NCCs)were har-vested by flow cytometry.Primary culture was performed with DMEM/F12 culture medium optimized in the labora-tory,NCCs was characterized by immunofluorescence microscopy.Then NCCs differentiation was directed by mouse bone marrow mesenchymal stem cells osteogenic induction.Results The mT/mG of EGFP permanently labeled NCCs was successfully obtained by hybridization and high-purity NCCs were isolated from Wnt1-Cre transgenic mice lung tissue.They can be cultured in vitro and with spindle morphology which was,similar to fibroblast adherent proliferation.NCCs expressed the neural crest stem cell marker Sox10 and induced to differentiate into osteoblasts.Conclusions NCCs isolated and cultured from lung tissue of mT/mG;Wnt1-Cre transgenic mice show stable prolif-eration and have the characteristics of neural crest stem cells,which may function as a potential cell model for re-search on lung tissue injury and the mechanism of repair.
10.Comparison of different laparoscopic treatments for upper urinary tract urothelial carcinoma
Meng ZHU ; Junfei GU ; Yuepeng LIU ; Zihao LI ; Chao MA ; Lixin REN
Journal of Modern Urology 2024;29(7):597-601
Objective To compare the clinical efficacy of peritoneolaparoscopic single position nephreteral total length resection(PSPNTLR)and posterior laparoscopic subabdominal incision technique(PLSIT)in the treatment of upper urothelial carcinoma(UTUC).Methods A total of 82 UTUC patients treated in our hospital during Jan.2018 and Feb.2021 were divided into the observation group(n=41,treated with PSPNTLR)and control group(n=41,treated with PLSIT)according to the random number table method.Perioperative indicators,pain degree,inflammatory factors,bladder recurrence and distant metastasis were compared between the two groups.Results The operation time[(122.15±15.14)min vs.(160.88±17.26)min],hospitalization time[(10.07±2.14)d vs.(12.22±3.13)d]and postoperative exhaust time[(1.46±0.57)d vs.(3.10±0.88)d]were significantly shorter,the intraoperative blood loss[(42.85±4.88)mL vs.(78.22±8.17)mL]and drainage volume[(53.61±9.74)mL vs.(81.56±11.06)mL]were significantly less in the observation group than in the control group(P<0.05).The visual analogue score(VAS)of the observation group at 6,12 and 24 h after operation was significantly lower than that of the control group(P<0.05).The levels of interleukin-6(IL-6)and C-reactive protein(CRP)were increased in both groups one day after surgery,but the indexes were increased more significantly in the control group(P<0.05).During the 2-year follow-up after surgery,there were no statistical difference in bladder recurrence(12.20%vs.14.63%)and distant metastasis(9.76%vs.4.88%)between the two groups(P>0.05).Conclusion Both PSPNTLR and PLSIT have good therapeutic safety,but PSPNTLR is more effective in improving perioperative indicators,reducing postoperative pain,and inhibiting inflammatory factors.

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