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.Comparative analyses of the detection performance of five multiplex polymerase chain reaction nucleic acid detection kits for respiratory pathogens
Fang YUAN ; Lei BI ; Jiajing LIU ; Huanru WANG ; Jun FENG ; Yuan ZHUANG ; Min CHEN ; Zheng TENG
Shanghai Journal of Preventive Medicine 2026;38(2):165-169
ObjectiveTo evaluate the detection specificity for clinical samples and the detection capability for standard substances of five commercially available multiplex polymerase chain reaction (PCR) nucleic acid detection kits (hereinafter referred to as the kits) for respiratory pathogens, and to provide a reference for selecting appropriate detection kits for multi-pathogen nucleic acid testing of respiratory infections. MethodsA total of 60 respiratory pathogen-positive clinical samples with known redults were selected and tested using the five kits (labeled as A, B, C, D, and E). The detection rates and Kappa coefficients were calculated to evaluate the consistency between the results from these kits and those from single-pathogen PCR kits. According to the limit of detection (LOD) provided by the kits, standard substances of respiratory pathogens (including 12 types such as influenza virus, Mycoplasma pneumoniae, and Bordetella pertussis) were diluted to four concentrations (250, 500, 1 000, and 2 000 copies·mL⁻¹). All five kits were used for detection to evaluate their respective detection capabilities. ResultsCompared with the results from single-pathogen PCR kits, the five tested kits demonstrated good consistency (all Kappa >0.80). Among them, Kit A had the highest detection rate (100.00%), followed by Kits C and E (98.33%), and then Kits B and D (95.00%). All five kits showed a relatively low false negative rate (FNR) for samples with a cycle threshold (Ct) value ≤35 (≤2.38%). However, for samples with Ct values>35, the FNR increased accordingly(average FNR=6.67%, P=0.029). Kit C exhibited the highest detection sensitivity for the tested standard substances (average LOD: 458.33 copies·mL⁻¹), followed by Kit D, then Kits A/E, and finally Kit B. ConclusionThe five multiplex PCR kits showed good consistency with single-pathogen detection results, but each had its own performance emphasis. Kit A, with the highest detection rate and high throughput, is suitable for targeted viral screening. Kit B, covering the broadest pathogen spectrum (including fungi/bacteria), is suitable for comprehensive respiratory pathogen screening. Kits C, D and E, are applicable for rapid detection. It is important to note that the detection efficacy of all kits decreases for low viral load samples with Ct values >35. In practical application, selection should be based on specific screening objectives, throughput requirements, and sample types.
3.A Case of Tuberous Sclerosis Complex with Multiple Organ Involvement Caused by TSC2 Gene Mutation
Hongli ZHANG ; Jiayuan DAI ; Yan WANG ; Weihong ZHANG ; Wenbin MA ; Hanhui FU ; Chunxia HE ; Jun ZHENG ; Wenda WANG ; Wei ZUO ; Yaping LIU ; Min SHEN
JOURNAL OF RARE DISEASES 2026;5(1):60-67
Tuberous sclerosis complex (TSC) is an autosomal dominant genetic disorder primarily caused by pathogenic variants in the
4.Quality of leukoreduced pooled concentrated platelets prepared from whole blood under different storage temperatures and durations
Huijuan AN ; Hong SHAN ; Zheng LIU ; Jiaojiao ZHANG ; Jiaojie WANG ; Lili BIE ; Min LIU
Chinese Journal of Blood Transfusion 2026;39(5):603-609
Objective: To compare the in vitro quality differences of leukoreduced pooled concentrated platelets prepared from whole blood preserved at different temperatures and for various durations, determine the safe time window for refrigerated whole blood in platelet preparation, and provide experimental evidence for optimizing blood component preparation procedures and improving the comprehensive utilization rate of blood resources. Methods: A total of 324 units of 400 mL ACD-B anticoagulated whole blood were randomly divided into two groups and stored at 4℃ and 22℃, respectively. The buffy coat was separated at three time intervals: <6 h, 6-12 h, and >12 h (≤18 h) post-collection, and allowed to rest overnight at 22℃. On the following day, the buffy coats from each group were pooled to prepare leukoreduced pooled platelet concentrates (LPPCs). Cell counts were performed, and metabolic parameters including pH, glucose, and lactate levels were measured to evaluate metabolic status. Platelet in vitro function and activation were assessed by thromboelastography (TEG), platelet aggregation rate, and the expression of PAC-1 and CD62P. The differences between the two groups were compared. Results: For pooled concentrated platelets prepared from whole blood stored at 4℃ and 22℃ for <6 h and 6-12 h, there were no significant differences in platelet count, pH, glucose levels, lactic acid levels, thromboelastography (TEG), platelet aggregation rate, or platelet activation rate (P>0.05). With prolonged refrigeration time of whole blood, compared with pooled concentrated platelets prepared from whole blood stored at 22℃ for >12 h but ≤18 h, those prepared from whole blood stored at 4℃ for >12 h but ≤18 h showed a decreased platelet count (1 152.83±180.08 vs 1 368.83±134.86, P=0.040), a significantly increased ADP-induced aggregation rate (26.82±6.59 vs 13.88±10.21, P=0.030), and significantly elevated expression rates of PAC-1 and CD62P (72.64±6.74 vs 63.28±5.97, P=0.030). However, there were no significant differences in pH, glucose content, lactate content, or thromboelastography (P>0.05). Conclusion: There was no significant difference in the in vitro count, function, or activation of pooled concentrated platelets prepared from whole blood stored at 4℃ and 22℃ within 12 hours. However, statistically significant differences were observed between the mixed concentrated platelets prepared from whole blood stored at 4℃ and those stored at 22℃ for more than 12 hours but not exceeding 18 hours. These findings can provide a reference for the preparation methods and clinical application of refrigerated platelets.
5.Interpretation of the CONSORT 2025 statement: Updated guideline for reporting randomized trials
Geliang YANG ; Xiaoqin ZHOU ; Fang LEI ; Min DONG ; Tianxing FENG ; Li ZHENG ; Lunxu LIU ; Yunpeng ZHU ; Xuemei LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(06):752-759
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.
6.Hydrogen Sulfide Alleviates Lipid Peroxidation-Mediated Carbonyl Stress in Uranium-Intoxicated Kidney Cells via Nrf2/ARE Signaling.
Jia Lin LIU ; Min WANG ; Rui ZHANG ; Ji Fang ZHENG ; Xi Xiu JIANG ; Qiao Ni HU
Biomedical and Environmental Sciences 2025;38(4):484-500
OBJECTIVE:
To explore the protective effects and underlying mechanisms of H 2S against lipid peroxidation-mediated carbonyl stress in the uranium-treated NRK-52E cells.
METHODS:
Cell viability was evaluated using CCK-8 assay. Apoptosis was measured using flow cytometry. Reagent kits were used to detect carbonyl stress markers malondialdehyde, 4-hydroxynonenal, thiobarbituric acid reactive substances, and protein carbonylation. Aldehyde-protein adduct formation and alcohol dehydrogenase, aldehyde dehydrogenase 2, aldo-keto reductase, nuclear factor E2-related factor 2 (Nrf2), and cystathionine β-synthase (CBS) expression were determined using western blotting or real-time PCR. Sulforaphane (SFP) was used to activate Nrf2. RNA interference was used to inhibit CBS expression.
RESULTS:
GYY4137 (an H 2S donor) pretreatment significantly reversed the uranium-induced increase in carbonyl stress markers and aldehyde-protein adducts. GYY4137 effectively restored the uranium-decreased Nrf2 expression, nuclear translocation, and ratio of nuclear to cytoplasmic Nrf2, accompanied by a reversal of the uranium-decreased expression of CBS and aldehyde-metabolizing enzymes. The application of CBS siRNA efficiently abrogated the SFP-enhanced effects on the expression of CBS, Nrf2 activation, nuclear translocation, and ratio of nuclear to cytoplasmic Nrf2 and concomitantly reversed the SFP-enhanced effects of the uranium-induced mRNA expression of aldehyde-metabolizing enzymes. Simultaneously, CBS siRNA reversed the SFP-mediated alleviation of the uranium-induced increase in reactive aldehyde levels, apoptosis rates, and uranium-induced cell viability.
CONCLUSION
H 2S induces Nrf2 activation and nuclear translocation, which modulates the expression of aldehyde-metabolizing enzymes and the CBS/H 2S axis. Simultaneously, the Nrf2-controlled CBS/H 2S axis may at least partially promote Nrf2 activation and nuclear translocation. These events form a cycle-regulating mode through which H 2S attenuates the carbonyl stress-mediated NRK-52E cytotoxicity triggered by uranium.
NF-E2-Related Factor 2/genetics*
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Animals
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Hydrogen Sulfide/pharmacology*
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Rats
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Signal Transduction/drug effects*
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Lipid Peroxidation/drug effects*
;
Cell Line
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Uranium/toxicity*
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Antioxidant Response Elements
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Kidney/metabolism*
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Oxidative Stress/drug effects*
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Cell Survival/drug effects*
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Apoptosis/drug effects*
7.Bone loss in patients with spinal cord injury: Incidence and influencing factors.
Min JIANG ; Jun-Wei ZHANG ; He-Hu TANG ; Yu-Fei MENG ; Zhen-Rong ZHANG ; Fang-Yong WANG ; Jin-Zhu BAI ; Shu-Jia LIU ; Zhen LYU ; Shi-Zheng CHEN ; Jie-Sheng LIU ; Jia-Xin FU
Chinese Journal of Traumatology 2025;28(6):477-484
PURPOSE:
To investigate the incidence and influencing factors of bone loss in patients with spinal cord injury (SCI).
METHODS:
A retrospective case-control study was conducted. Patients with SCI in our hospital from January 2019 to March 2023 were collected. According to the correlation between bone mineral density (BMD) at different sites, the patients were divided into the lumbar spine group and the hip joint group. According to the BMD value, the patients were divided into the normal bone mass group (t > -1.0 standard deviation) and the osteopenia group (t ≤ -1.0 standard deviation). The influencing factors accumulated as follows: gender, age, height, weight, cause of injury, injury segment, injury degree, time after injury, start time of rehabilitation, motor score, sensory score, spasticity, serum value of alkaline phosphatase, calcium, and phosphorus. The trend chart was drawn and the influencing factors were analyzed. SPSS 26.0 was used for statistical analysis. Correlation analysis was used to test the correlation between the BMD values of the lumbar spine and bilateral hips. Binary logistic regression analysis was used to explore the influencing factors of osteoporosis after SCI. p < 0.05 was considered statistically significant.
RESULTS:
The incidence of bone loss in patients with SCI was 66.3%. There was a low concordance between bone loss in the lumbar spine and the hip, and the hip was particularly susceptible to bone loss after SCI, with an upward trend in incidence (36% - 82%). In this study, patients with SCI were divided into the lumbar spine group (n = 100) and the hip group (n = 185) according to the BMD values of different sites. Then, the lumbar spine group was divided into the normal bone mass group (n = 53) and the osteopenia group (n = 47); the hip joint group was divided into the normal bone mass group (n = 83) and the osteopenia group (n = 102). Of these, lumbar bone loss after SCI is correlated with gender and weight (p = 0.032 and < 0.001, respectively), and hip bone loss is correlated with gender, height, weight, and time since injury (p < 0.001, p = 0.015, 0.009, and 0.012, respectively).
CONCLUSIONS
The incidence of bone loss after SCI was high, especially in the hip. The incidence and influencing factors of bone loss in the lumbar spine and hip were different. Patients with SCI who are male, low height, lightweight, and long time after injury were more likely to have bone loss.
Humans
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Spinal Cord Injuries/complications*
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Male
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Female
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Retrospective Studies
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Incidence
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Adult
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Bone Density
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Middle Aged
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Case-Control Studies
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Osteoporosis/etiology*
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Lumbar Vertebrae
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Bone Diseases, Metabolic/etiology*
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Aged
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Risk Factors
8.Efficacy of endoscopic-assisted resection of congenital first and second branchial cleft malformations in children with external fistula incision approach.
Dongjihui ZHAO ; Bin LI ; Sijun ZHAO ; Min HUANG ; Guangliang LIU ; Zheng ZHOU
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(2):137-146
Objective:To explore the feasibility of endoscopic-assisted resection of congenital first and second branchial cleft malformations in children via the external fistula incision approach. Methods:A retrospective analysis was conducted on 20 children with congenital first and second branchial cleft malformations who were admitted to the Department of Otolaryngology Head and Neck Surgery of Hu'nan Children's Hospital from January 2020 to January 2024 and whose families voluntarily consented to endoscopic surgery. Clinical data were collected. There were 12 males and 8 females, aged from 10 months to 12 years. The surgical methods and experiences of endoscopic-assisted resection of congenital first and second branchial cleft malformations in children via the external fistula incision approach were summarized. Results:All 20 children underwent endoscopic-assisted resection of congenital first and second branchial cleft malformations via the external fistula incision approach. For children with second branchial cleft malformations whose internal fistula openings were located on the pharyngeal arch mucosa or palatine tonsils, the tonsils were preserved, the internal fistula openings were ligated at a high position, the fistula tubes were removed, and the residual ends were cauterized with bipolar electrocoagulation to destroy the residual fistula epithelial cells. There were no obvious complications after the operation. During the 12-month follow-up, no recurrence of the fistula tubeswas observed, and the recovery was good. Conclusion:Congenital first and second branchial cleft fistulas in children are rare, and surgical resection is the preferred treatment method. The endoscopic-assisted resection of congenital first and second branchial cleft malformations in children via the fistula incision approach offers a clear surgical field, an ideal cosmetic effect, and a satisfactory curative effect.
Humans
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Female
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Male
;
Branchial Region/surgery*
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Retrospective Studies
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Child
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Infant
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Child, Preschool
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Endoscopy/methods*
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Fistula/surgery*
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Craniofacial Abnormalities/surgery*
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Treatment Outcome
;
Pharyngeal Diseases
9.Ablation of macrophage transcriptional factor FoxO1 protects against ischemia-reperfusion injury-induced acute kidney injury.
Yao HE ; Xue YANG ; Chenyu ZHANG ; Min DENG ; Bin TU ; Qian LIU ; Jiaying CAI ; Ying ZHANG ; Li SU ; Zhiwen YANG ; Hongfeng XU ; Zhongyuan ZHENG ; Qun MA ; Xi WANG ; Xuejun LI ; Linlin LI ; Long ZHANG ; Yongzhuo HUANG ; Lu TIE
Acta Pharmaceutica Sinica B 2025;15(6):3107-3124
Acute kidney injury (AKI) has high morbidity and mortality, but effective clinical drugs and management are lacking. Previous studies have suggested that macrophages play a crucial role in the inflammatory response to AKI and may serve as potential therapeutic targets. Emerging evidence has highlighted the importance of forkhead box protein O1 (FoxO1) in mediating macrophage activation and polarization in various diseases, but the specific mechanisms by which FoxO1 regulates macrophages during AKI remain unclear. The present study aimed to investigate the role of FoxO1 in macrophages in the pathogenesis of AKI. We observed a significant upregulation of FoxO1 in kidney macrophages following ischemia-reperfusion (I/R) injury. Additionally, our findings demonstrated that the administration of FoxO1 inhibitor AS1842856-encapsulated liposome (AS-Lipo), mainly acting on macrophages, effectively mitigated renal injury induced by I/R injury in mice. By generating myeloid-specific FoxO1-knockout mice, we further observed that the deficiency of FoxO1 in myeloid cells protected against I/R injury-induced AKI. Furthermore, our study provided evidence of FoxO1's pivotal role in macrophage chemotaxis, inflammation, and migration. Moreover, the impact of FoxO1 on the regulation of macrophage migration was mediated through RhoA guanine nucleotide exchange factor 1 (ARHGEF1), indicating that ARHGEF1 may serve as a potential intermediary between FoxO1 and the activity of the RhoA pathway. Consequently, our findings propose that FoxO1 plays a crucial role as a mediator and biomarker in the context of AKI. Targeting macrophage FoxO1 pharmacologically could potentially offer a promising therapeutic approach for AKI.
10.Expert consensus on imaging diagnosis and analysis of early correction of childhood malocclusion.
Zitong LIN ; Chenchen ZHOU ; Ziyang HU ; Zuyan ZHANG ; Yong CHENG ; Bing FANG ; Hong HE ; Hu WANG ; Gang LI ; Jun GUO ; Weihua GUO ; Xiaobing LI ; Guangning ZHENG ; Zhimin LI ; Donglin ZENG ; Yan LIU ; Yuehua LIU ; Min HU ; Lunguo XIA ; Jihong ZHAO ; Yaling SONG ; Huang LI ; Jun JI ; Jinlin SONG ; Lili CHEN ; Tiemei WANG
International Journal of Oral Science 2025;17(1):21-21
Early correction of childhood malocclusion is timely managing morphological, structural, and functional abnormalities at different dentomaxillofacial developmental stages. The selection of appropriate imaging examination and comprehensive radiological diagnosis and analysis play an important role in early correction of childhood malocclusion. This expert consensus is a collaborative effort by multidisciplinary experts in dentistry across the nation based on the current clinical evidence, aiming to provide general guidance on appropriate imaging examination selection, comprehensive and accurate imaging assessment for early orthodontic treatment patients.
Humans
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Malocclusion/diagnostic imaging*
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Child
;
Consensus

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