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.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
;
Male
;
Branchial Region/surgery*
;
Retrospective Studies
;
Child
;
Infant
;
Child, Preschool
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Endoscopy/methods*
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Fistula/surgery*
;
Craniofacial Abnormalities/surgery*
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Treatment Outcome
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Pharyngeal Diseases
3.Relationship between short-term prognosis and symptoms of vertigo and vestibular function in patients with unilateral flat descending sudden sensorineural hearing loss.
Jingyi ZHU ; Sihan HUANG ; Shuna LI ; Jianyong CHEN ; Guiliang ZHENG ; Qing ZHANG ; Yuan ZHOU ; Yulian JIN ; Jun YANG ; Min LIANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(10):930-940
Objective:To investigate the relationship between symptoms of vertigo and vestibular functions and short-term hearing outcomes in patients with flat descending sudden sensorineural hearing loss (SSNHL). Methods:A retrospective review was conducted of the vestibular symptoms observed in 48 patients with unilateral flat-down sudden sensorineural hearing loss treated at the Department of Otolaryngology Head and Neck Surgery, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Symptoms of vertigo and the results of cervical vestibular-evoked myogenic potentials (cVEMP), ocular VEMP (oVEMP), caloric test and video head-impulse test (vHIT) were collected to determine whether these factors could predict therapeutic efficacy. Results:The symptoms of vertigo was not correlated with prognosis (P>0.05) or with abnormal vestibular functions (P>0.05). Patients with abnormal cVEMP, oVEMP, caloric test or vHIT showed significantly lower effective rates (32.0%, 44.0%, 32.0%, and 24.0%, respectively); the greater the number of abnormal tests, the poorer the outcome. Patients with all four tests abnormal gained only (3.13±15.97) dB HL in hearing recovery, whereas those with normal cVEMP, oVEMP, caloric test or vHIT showed better chances of hearing improvements by (29.22±20.31), (31.18±21.59), (26.17±21.31), and (26.38±24.05) dB HL, respectively. Conclusion:Vestibular function effectively predicts prognosis in flat descending SSNHL. Patients with abnormal vestibular tests, regardless of symptoms of vertigo, responded poorly to treatment, whereas those with normal cVEMP, oVEMP, caloric test and vHIT results achieved better hearing recovery. Abnormal vestibular function implies more extensive and severe inner-ear lesions in patients with SSNHL.
Humans
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Male
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Female
;
Retrospective Studies
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Prognosis
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Adult
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Middle Aged
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Vertigo/diagnosis*
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Hearing Loss, Sensorineural/diagnosis*
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Young Adult
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Hearing Loss, Sudden/diagnosis*
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Adolescent
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Aged
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Vestibular Evoked Myogenic Potentials
4.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
5.Genetic evolution characteristics and their influence on disease transmission in sandflies in various environments in China
Lei CUI ; Ya-qi HE ; Zheng-bin ZHOU ; Yuan FANG ; Zhong-qiu LI ; Yuan-yuan LI ; Li-min YANG ; Yi ZHANG
Chinese Journal of Zoonoses 2025;41(5):501-507
This study analyzed the genetic evolutionary characteristics of sandflies and their effects on the spread of kala-azar in various environments in endemic provinces in China,to provide a scientific basis for kala-azar disease prevention and control.Sand-flies were collected in kala-azar endemic areas such as southern Xinjiang,the large hilly areas of southern Gansu,the northern Sich-uan and Taihang Mountains,and surrounding small hills.The cytochrome c oxidase subunit I and cytochrome b gene fragments of mito-chondrial DNA were amplified to identify sandfly species.The COI and Cytb gene sequences of sandflies from southern Xinjiang and Si-chuan recorded in NCBI were also collected.The intraspecific and interspecific genetic differences of sandflies were calculated in MEGA11.0,and a phylogenetic tree was constructed through the neighbor-joining method,for analysis of the genetic and evolutionary characteristics of sandfly populations and their effects on disease transmission.A total of 155 sandflies were collected from nine sam-pling sites in seven provinces of China;the species included Phlebotomus chinensis,Phlebotomus wui,and Sergentomyia squamirostris.Five sandfly species belonging to two genera were collected:P.chinensis,P.wui,and Phlebotomus alexandri in the genus Phleboto-mus,and S.squamirostris in the genus Sergentomyia.Genetic evolution analysis based on COI and Cytb gene sequences indicated intra-specific genetic distances of 0-0.062 and 0-0.056,respectively,and interspecific genetic distances of 0.126-0.176 and 0.110-0.171,respectively.The phylogenetic tree indicated that P.wui,P.alexandri,Phlebotomus longiductus,and S.squamirostris clus-tered into one branch.The sequences of P.chinensis in the large and small hilly areas clustered into two geographical clades.In the small hilly areas,the sequences of P.chinensis aggregates showed small genetic differences,the pathogen infection was consistent,and the cases showed an epidemic spread trend.Large genetic differences at the molecular level were observed among sandflies in dif-ferent ecological regions,thus indicating key effects on leishmaniasis transmission.On the basis of these findings,prevention and con-trol strategies should be adapted to local conditions,and precise and effective prevention and control measures should be formulated according to the genetic evolution characteristics of sandflies in different regions,to better control the transmission of Kala-azar.
6.Protective effect of Sanfeng Tongqiao Dropping Pills against house dust mite-induced allergic asthma in mice
Tong-wen ZUO ; Xiao-qun GU ; Shu-xian SUN ; Lin LI ; Ya-jun SONG ; Fu-man HUANG ; Qian ZHAO ; Kang ZHOU ; Jie ZHENG ; Min HONG
Chinese Traditional Patent Medicine 2025;47(8):2542-2549
AIM To investigate the protective effect of Sanfeng Tongqiao Dropping Pills against house dust mite(HDM)-induced allergic asthma in mice.METHODS Compared to the intact BALB/c mice in the blank control group,the BALB/c mice randomly assigned into the model group,the dexamethasone group(0.67 mg/kg),and the low-dose,medium-dose,and high-dose Sanfeng Tongqiao Dropping Pills groups(15,30 and 60 mg/kg),were induced into acute allergic asthma models via weekly intraperitoneal sensitization with 0.1 mL HDM solution(0.5 mg/mL)for three weeks followed by three consecutive daily intranasal challenges with 10 μL HDM solution(2.5 mg/mL)starting in the third week.The drug administered continuously 7 days after the last excitation.The mice had their airway reactive Penh value detected,their pulmonary pathological changes observed by HE staining,their blood eosinophils(EOS)counted,their Th2 cytokines in lung tissue and serum IgE levels detected by ELISA,and their number of peripheral blood mononuclear cells(PBMC)and pulmonary Th2 cells detected by flow cytometry.Chronic allergic asthma was induced in grouped BALB/c mice through repeated intranasal challenges with 10 μL HDM solution(2.5 mg/mL)administered five times weekly for five consecutive weeks.Drug treatment continued for 14 days following the final challenge.After the final treatment,the mice had their pulmonary pathological changes observed by HE staining,and their levels of Th2 cytokines in B ALF and lung tissue and serum IgE detected by ELISA.RESULTS Compared to the blank control group,the acute allergic asthma model group exhibited increases in Penh value,EOS count and IgE level in serum,IL-4 and IL-5 levels in lung tissue(P<0.01);obvious pulmonary inflammatory cells infiltration,and thickened airway wall;and increase in pulmonary number of Th2 cells(P<0.01).Compared to the model group,the groups intervened with Sanfeng Tongqiao Dropping Pills demonstrated decreased Penh value,serum EOS count,IgE level and IL-5 level in lung tissue(P<0.05,P<0.01);reduced pulmonary inflammatory infiltration and alleviated airway wall thickening;and decreased number of pulmonary Th2 cells.Compared to the blank group,the chronic allergic asthma model group showed obvious pulmonary inflammatory infiltration and airway wall thickening;and increased EOS count and IgE level in serum,IL-4 and IL-13 in lung tissue and IL-14 in BALF(P<0.05,P<0.01).Compared to the model group,the groups intervened with either medium-dose or high-dose Sanfeng Tongqiao Dropping Pills demonstrated reduced pulmonary inflammatory infiltration;and decreased serum EOS count,IgE level,IL-13 in lung tissue and IL-14 in BALF(P<0.05,P<0.01).CONCLUSION Sanfeng Tongqiao Dropping Pills reduce Th2 cells in peripheral blood and lung tissue,suppress type 2 inflammation,and thereby alleviate allergic asthma.
7.Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique (version 2025)
Sihao HE ; Junchao XING ; Tongwei CHU ; Zhengqi CHANG ; Xigao CHENG ; Fei DAI ; Xiaobing JIANG ; Jie HAO ; Jiang HU ; Jinghui HUANG ; Tianyong HOU ; Fei LUO ; Bo LIAO ; Changqing LI ; Lei LIU ; Guodong LIU ; Peng LIU ; Sheng LU ; Weishi LI ; Yang LIU ; Zhen LIU ; Wei MEI ; Peifu TANG ; Bing WANG ; Bing WANG ; Ce WANG ; Hongli WANG ; Liang WANG ; Shengru WANG ; Xiaobin WANG ; Yang WANG ; Yingfeng WANG ; Zheng WANG ; Jianzhong XU ; Guoyong YIN ; Haiyang YU ; Qiang YANG ; Zhaoming YE ; Bin ZHANG ; Chengmin ZHANG ; Jun ZOU ; Qiang ZHOU ; Min ZHAO ; Rui ZHOU ; Xiaojun ZHANG ; Yongfei ZHAO ; Zhongrong ZHANG ; Zehua ZHANG ; Yingze ZHANG
Chinese Journal of Trauma 2025;41(11):1035-1047
For middle-aged and elderly patients with conditions such as spinal fractures and degenerative spinal diseases, spinal internal fixation is a core surgical procedure for reconstructing spinal stability, heavily relying on the biomechanical stability provided by pedicle screw systems. Whereas, these patients are often complicated by osteoporosis that can significantly compromise the stability of the bone-pedicle screw interface, leading to a marked increase in pedicle screw loosening and surgical failure rates. The bone cement-augmented pedicle screw technique, which involves injecting bone cement into the vertebral body or screw trajectory to optimize the mechanical properties of the bone-pedicle screw composite, has been proven to significantly enhance fixation strength and effectively prevent screw-related failures, thereby reducing the incidence of internal fixation failure in high-risk populations undergoing spinal fusion. However, the widespread clinical application of this technique has faced challenges such as inaccurate clinical decision-making (indication and contraindication selection), non-standardized operative practices, and insufficient awareness of complication prevention, resulting in considerable variability in clinical outcomes and even severe complications. To address this, Prof. Luo Fei from First Affiliated Hospital of Army Medical University initiated the project and the Chinese Association Orthopaedic Surgeons organized relevant experts to develop the Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique ( version 2025), based on current evidence. The guidelines put forward 8 recommendations regarding the clinical value, scope of application, and operational standards of the technique, aiming to provide evidence-based medical support and technical standardization for clinical decision-making.
8.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.
9.Transcriptomic analysis of key genes involved in sex differences in intellectual development.
Jia-Wei ZHANG ; Xiao-Li ZHENG ; Hai-Qian ZHOU ; Zhen ZHU ; Wei HAN ; Dong-Min YIN
Acta Physiologica Sinica 2025;77(2):211-221
Intelligence encompasses various abilities, including logical reasoning, comprehension, self-awareness, learning, planning, creativity, and problem-solving. Extensive research and practical experience suggest that there are sex differences in intellectual development, with females typically maturing earlier than males. However, the key genes and molecular network mechanisms underlying these sex differences in intellectual development remain unclear. To date, Genome-Wide Association Studies (GWAS) have identified 507 genes that are significantly associated with intelligence. This study first analyzed RNA sequencing data from different stages of brain development (from BrainSpan), revealing that during the late embryonic stage, the average expression levels of intelligence-related genes are higher in males than in females, while the opposite is observed during puberty. This study further constructed interaction networks of intelligence-related genes with sex-differential expression in the brain, including the prenatal male network (HELP-M: intelligence genes with higher expression levels in prenatal males) and the pubertal female network (HELP-F: intelligence genes with higher expression levels in pubertal females). The findings indicate that the key genes in both networks are Ep300 and Ctnnb1. Specifically, Ep300 regulates the transcription of 53 genes in both HELP-M and HELP-F, while Ctnnb1 regulates the transcription of 45 genes. Ctnnb1 plays a more prominent role in HELP-M, while Ep300 is more crucial in HELP-F. Finally, this study conducted sequencing validation on rats at different developmental stages, and the results indicated that in the prefrontal cortex of female rats during adolescence, the expression levels of the intelligence genes in HELP-F, as well as key genes Ep300 and Ctnnb1, were higher than those in male rats. These genes were also involved in neurodevelopment-related biological processes. The findings reveal a sex-differentiated intelligence gene network and its key genes, which exhibit varying expression levels during the neurodevelopmental process.
Female
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Intelligence/physiology*
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Male
;
Sex Characteristics
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Animals
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Brain/growth & development*
;
E1A-Associated p300 Protein/physiology*
;
beta Catenin/physiology*
;
Transcriptome
;
Rats
;
Gene Expression Profiling
;
Genome-Wide Association Study
10.Diagnostic value of electromyographic tremor indicators for Parkinson's disease based on Logistic regression model
Zeng ZHOU ; Jing XU ; Zhaohai FENG ; Yingwei ZHENG ; Min CUI ; Zongyu WANG ; Fang FANG ; Meiying LI
Journal of Clinical Medicine in Practice 2025;29(1):33-38
Objective To investigate the diagnostic value of electromyographic(EMG)tremor indicators for Parkinson's disease(PD)using the Logistic regression model.Methods A total of 65 patients with PD(PD group)and 39 patients with essential tremor(ET)(ET group)were enrolled and underwent EMG tremor analysis.General information,disease-related data,and EMG tremor characteristics were compared between the two groups.Multivariate Logistic regression analysis was performed to screen for independent influencing factors of PD,and receiver operating characteristic(ROC)curves were plotted.The area under the curve(AUC)was used to evaluate the diagnostic value of EMG tremor indicators for PD.Results Compared with the ET group,the PD group had a higher proportion of patients with unilateral onset and those with tremor spectrum frequency≥2 times,and a lower proportion of patients with a family history of tremor(P<0.05).The tremor peak frequencies in the resting,postural,and weight-bearing(1 000 g)states were lower in the PD group than in the ET group(P<0.05).There were statistically significant differences in the tremor rhythm patterns between the two groups in the resting and weight-bearing states(P<0.05),with the PD group dominated by alternating contraction patterns and the ET group by synchronous contraction pat-terns.Multivariate Logistic regression analysis revealed that the tremor peak frequency in the weight-bearing state,the tremor rhythm pattern in the resting state,and the frequency of tremor spectrum were independent influencing factors of PD(P<0.05).The ROC curves showed that the AUCs of the tremor peak frequency in the weight-bearing state,the tremor rhythm pattern in the resting state,and the frequency of tremor spectrum for diagnosing PD were 0.886,0.750,and 0.779,respec-tively.The combination of these three indicators yielded the highest AUC(0.936)for diagnosing PD,with a sensitivity of 81.54%and a specificity of 94.87%.Conclusion The tremor peak fre-quency in the weight-bearing state,the tremor rhythm pattern in the resting state,and the frequency of tremor spectrum provided by EMG tremor analysis can serve as clinical indicators for early diagno-sis of PD,and their combined use offers higher diagnostic value,which can be used to differentiate PD from ET.

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