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.Analysis of risk factors and development of a prediction model for acute kidney injury complicated by acute non-variceal upper gastrointestinal bleeding
Lu LIU ; Caihua DUAN ; Guosheng XIA ; Juan LIU
Chongqing Medicine 2025;54(11):2594-2599,2604
Objective To analyze the risk factors for acute kidney injury(AKI)in patients with acute non-variceal upper gastrointestinal bleeding(ANVUGIB)and establish a prediction model.Methods A total of 286 ANVUGIB patients admitted to our hospital from August 2021 to August 2024 were enrolled.Patients were divided into an observation group(with AKI,n=43)and a control group(without AKI,n=243).The influencing factors for AKI in ANVUGIB patients were analyzed,and a nomogram prediction model was con-structed to evaluate its predictive efficacy.Results Among 286 ANVUGIB patients,43 cases(15.03%)de-veloped AKI.Logistic regression analysis showed that platelet count had no significant effect on AKI compli-cation in ANVUGIB(P>0.05).Hemoglobin,albumin,and sodium were independent protective factors for AKI complication(P<0.05),while comorbid coronary heart disease,bleeding volume,blood transfusion,and risk grade were independent risk factors(P<0.05).The nomogram prediction model for AKI complication in ANVUGIB demonstrated good fit in the Hosmer-Lemeshow test.ROC curve analysis revealed an AUC of 0.908(95%CI:0.868 to 0.939),with a sensitivity of 83.72%and specificity of 84.77%.The calibration curve showed a Brier score of 0.075 and calibration slope of 0.808,indicating good calibration.Conclusion Comorbid coro-nary heart disease,bleeding volume,blood transfusion,risk grade,hemoglobin,albumin,and sodium are signif-icant influencing factors for AKI complication in ANVUGIB.The nomogram model based on these factors shows favorable predictive performance and serves as a reliable tool for AKI risk stratification in ANVUGIB patients,supporting early clinical intervention decisions.
3.Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(10):an overview and case study of quality assessment tools
Qingyong ZHENG ; Caihua XU ; Yongjia ZHOU ; Xiao TANG ; Mengjun ZHANG ; Jinzhi QI ; Ming LIU ; Ya GAO ; Feng SUN ; Jinhui TIAN
Chinese Journal of Pharmacoepidemiology 2025;34(10):1113-1126
Methodological quality assessment is a pivotal link between primary studies and reliable evidence-based practice,and an essential pathway for operationalizing the core principles of the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition).A prevalent challenge in practice,however,is the conflation of appraising methodological robustness(risk of bias assessment)with verifying reporting transparency(adherence to reporting guidelines).This paper systematically addresses this fundamental challenge,beginning with a clear distinction between the essence and boundaries of these two concepts.On this basis,the article provides a comprehensive review of mainstream quality assessment tools,covering the methodological features and evolutionary trajectory of numerous instruments for interventional(e.g.,RoB 2,ROBINS-I),observational(e.g.,NOS,the JBI/SIGN/NIH series),secondary(e.g.,AMSTAR 2),and other specific types of studies such as health economic evaluations.Furthermore,a complete case study is used to illustrate the practical application of the ROBINS-I tool.The paper's central thesis advocates for an"appraisal-informed design"philosophy,urging a conceptual shift from the retrospective critique of existing literature to the prospective quality control of new research by internalizing appraisal standards as design principles,while also exploring the emerging paradigm of artificial intelligence in assisting assessment.This paper provides a comprehensive methodological reference for researchers and practitioners to prudently select appropriate assessment tools and to conduct rigorous critical appraisals of pharmacoepidemiological evidence.
4.Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(10):an overview and case study of quality assessment tools
Qingyong ZHENG ; Caihua XU ; Yongjia ZHOU ; Xiao TANG ; Mengjun ZHANG ; Jinzhi QI ; Ming LIU ; Ya GAO ; Feng SUN ; Jinhui TIAN
Chinese Journal of Pharmacoepidemiology 2025;34(10):1113-1126
Methodological quality assessment is a pivotal link between primary studies and reliable evidence-based practice,and an essential pathway for operationalizing the core principles of the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition).A prevalent challenge in practice,however,is the conflation of appraising methodological robustness(risk of bias assessment)with verifying reporting transparency(adherence to reporting guidelines).This paper systematically addresses this fundamental challenge,beginning with a clear distinction between the essence and boundaries of these two concepts.On this basis,the article provides a comprehensive review of mainstream quality assessment tools,covering the methodological features and evolutionary trajectory of numerous instruments for interventional(e.g.,RoB 2,ROBINS-I),observational(e.g.,NOS,the JBI/SIGN/NIH series),secondary(e.g.,AMSTAR 2),and other specific types of studies such as health economic evaluations.Furthermore,a complete case study is used to illustrate the practical application of the ROBINS-I tool.The paper's central thesis advocates for an"appraisal-informed design"philosophy,urging a conceptual shift from the retrospective critique of existing literature to the prospective quality control of new research by internalizing appraisal standards as design principles,while also exploring the emerging paradigm of artificial intelligence in assisting assessment.This paper provides a comprehensive methodological reference for researchers and practitioners to prudently select appropriate assessment tools and to conduct rigorous critical appraisals of pharmacoepidemiological evidence.
5.Single-cell transcriptomics reveals cell atlas and identifies cycling tumor cells responsible for recurrence in ameloblastoma
Xiong GAN ; Xie NAN ; Nie MIN ; Ling RONGSONG ; Yun BOKAI ; Xie JIAXIANG ; Ren LINLIN ; Huang YAQI ; Wang WENJIN ; Yi CHEN ; Zhang MING ; Xu XIUYUN ; Zhang CAIHUA ; Zou BIN ; Zhang LEITAO ; Liu XIQIANG ; Huang HONGZHANG ; Chen DEMENG ; Cao WEI ; Wang CHENG
International Journal of Oral Science 2024;16(2):251-264
Ameloblastoma is a benign tumor characterized by locally invasive phenotypes,leading to facial bone destruction and a high recurrence rate.However,the mechanisms governing tumor initiation and recurrence are poorly understood.Here,we uncovered cellular landscapes and mechanisms that underlie tumor recurrence in ameloblastoma at single-cell resolution.Our results revealed that ameloblastoma exhibits five tumor subpopulations varying with respect to immune response(IR),bone remodeling(BR),tooth development(TD),epithelial development(ED),and cell cycle(CC)signatures.Of note,we found that CC ameloblastoma cells were endowed with stemness and contributed to tumor recurrence,which was dominated by the EZH2-mediated program.Targeting EZH2 effectively eliminated CC ameloblastoma cells and inhibited tumor growth in ameloblastoma patient-derived organoids.These data described the tumor subpopulation and clarified the identity,function,and regulatory mechanism of CC ameloblastoma cells,providing a potential therapeutic target for ameloblastoma.
6.Research progress in association between Helicobacter pylori and metabolic syndrome and its effect on occurrence and development of metabolic syndrome
Yanbin ZHANG ; Guangye GUO ; Caihua ZHENG ; Xinyan LIU
Journal of Jilin University(Medicine Edition) 2024;50(6):1757-1762
Metabolic syndrome(MS)is a complex syndrome based on metabolic disorders in the human body,and is a risk factor for cardiovascular diseases and even certain tumors,with a complicated etiology and unclear pathogenesis.Helicobacter pylori(Hp)is one of the most common pathogenic bacteria,closely associated with the occurrence and development of various diseases.Currently,there are numerous studies both domestically and internationally on the relationship between Hp and MS and its components.Most studies suggest that there is an association between Hp and MS and Hp influences the occurrence and development of MS through multiple pathways.Eradicating Hp may become a new option for treating MS.Based on recent studies from both domestic and international sources,this paper discusses the association between Hp and MS,analyzes the effects of Hp on obesity,blood glucose,blood lipids,and blood pressure,and aims to provide new ideas for the prevention and treatment of MS.
7.Analysis of the correlation between the clinical features of 1 865 children and adolescents with supernumerary teeth and the selection of anesthesia methods
ZHANG Yaqiu ; FENG Caihua ; LIANG Lirong ; LIU Fei ; WU Long ; WANG Peijuan ; GAO Zhenzhen ; LIU Bing
Journal of Prevention and Treatment for Stomatological Diseases 2024;32(12):954-962
Objective:
To retrospectively analyze the epidemiological characteristics of supernumerary teeth in patients aged 4-18 years old and the influencing factors on the selection of anesthesia methods, and to provide a reference for the selection of anesthesia plans for children and adolescents with supernumerary teeth.
Methods:
This study is a retrospective study approved by the Institutional Ethics Committee. Based on clinical electronic medical record system and cone beam CT (CBCT) data, a retrospective analysis was conducted on 2 210 patients 4-18 years of age who underwent supernumerary tooth extraction at the School of Stomatology, Fourth Military Medical University from August 2019 to July 2021. Inclusion criteria: ① Age 4-18 years old; and ② The American Society of Anesthesiologists (ASA) classifies anesthesia into grades I-II; and ③ Have complete oral and anesthesia case records and relevant imaging data. Exclusion criteria: ① Incomplete medical records or unclear imaging data; and ② Patients with ASA grade II or above. Patients’ gender and age, the number of supernumerary teeth, arch, location, orientation, eruption status, reason for appointment, anxiety level, degree of cooperation, anesthesia method, and other relevant information were collected and statistically analyzed.
Results:
A total of 1 865 eligible patients were included, with an average age of (8.9±3.2) years old. There were more male patients (71.37%, 1 331 cases) than female patients (28.63%, 534 cases) (P < 0.001), with a gender ratio of 2.49:1. The majority of supernumerary teeth were single (75.97%, 1 417/1 865), primarily located in the maxilla (97.2%, 1 812/1 865) and the anterior dental region (94.2%, 1 757/1 865), and in a centric position (77.3%, 1 442/1 865). The majority of patients with erupted supernumerary teeth were active in seeking treatment (97.67%, 335/343). Patients with supernumerary teeth located in the maxilla and mandible bones, as well as in the nasal floor, were mainly referred to the department for diagnosis, accounting for 94.38%(1 361/1 442) and 90.00% (72/80) (χ2=1 363.24, P < 0.001), respectively. Regarding anesthesia methods, the largest proportion of patients received nitrous oxide sedation-assisted local anesthesia or nerve block anesthesia, accounting for 38.07% (710/1 865), followed by local anesthesia, accounting for 35.23% (657/1 865). The proportion of patients receiving midazolam intravenous sedation with local anesthesia or nerve block anesthesia and general anesthesia was relatively small, accounting for 20.86% (389/1 865) and 5.84% (109/1 865). Patients 13-18 years of age with supernumerary teeth in the mandibular and posterior regions and without anxiety had the highest proportion of local anesthesia use (P < 0.001). In contrast, patients who had supernumerary teeth located at the base of the nose (50%), severe anxiety (94.12%), and poor cooperation (98.18%) had the highest proportion of general anesthesia use (P < 0.001). There was no significant difference (P = 0.35) in the incidence of intraoperative and postoperative complications after the extraction of supernumerary teeth. However, the proportion of anesthesia-related complications, such as dizziness, coughing, and respiratory depression, occurring in patients who received general anesthesia was higher than local anesthesia, accounting for 3.81% (P = 0.006).
Conclusion
There is a gender difference in the incidence of supernumerary teeth in patients 4-18 years of age, with a higher prevalence in males. The majority of supernumerary teeth are single and located in the maxillary anterior region, predominantly in a centric position. Patients whose teeth had erupted were more likely to seek medical treatment voluntarily, while patients with supernumerary teeth located in the maxilla and mandible bones, as well as in the nasal floor were more likely to be referred to the department. Patients with high levels of anxiety, poor cooperation, young age, multiple teeth, and high surgical difficulty were more inclined to choose general anesthesia.
8.Oral anti-coagulants use in Chinese hospitalized patients with atrial fibrillation
Jing LIN ; Deyong LONG ; Chenxi JIANG ; Caihua SANG ; Ribo TANG ; Songnan LI ; Wei WANG ; Xueyuan GUO ; Man NING ; Zhaoqing SUN ; Na YANG ; Yongchen HAO ; Jun LIU ; Jing LIU ; Xin DU ; Louise MORGAN ; C. Gregg FONAROW ; C. Sidney SMITH ; Y.H. Gregory LIP ; Dong ZHAO ; Jianzeng DONG ; Changsheng MA
Chinese Medical Journal 2024;137(2):172-180
Background::Oral anti-coagulants (OAC) are the intervention for the prevention of stroke, which consistently improve clinical outcomes and survival among patients with atrial fibrillation (AF). The main purpose of this study is to identify problems in OAC utilization among hospitalized patients with AF in China.Methods::Using data from the Improving Care for Cardiovascular Disease in China-Atrial Fibrillation (CCC-AF) registry, guideline-recommended OAC use in eligible patients was assessed.Results::A total of 52,530 patients with non-valvular AF were enrolled from February 2015 to December 2019, of whom 38,203 were at a high risk of stroke, 9717 were at a moderate risk, and 4610 were at a low risk. On admission, only 20.0% (6075/30,420) of patients with a diagnosed AF and a high risk of stroke were taking OAC. The use of pre-hospital OAC on admission was associated with a lower risk of new-onset ischemic stroke/transient ischemic attack among the diagnosed AF population (adjusted odds ratio: 0.54, 95% confidence interval: 0.43–0.68; P <0.001). At discharge, the prescription rate of OAC was 45.2% (16,757/37,087) in eligible patients with high stroke risk and 60.7% (2778/4578) in eligible patients with low stroke risk. OAC utilization in patients with high stroke risk on admission or at discharge both increased largely over time (all P <0.001). Multivariate analysis showed that OAC utilization at discharge was positively associated with in-hospital rhythm control strategies, including catheter ablation (adjusted odds ratio [OR] 11.63, 95% confidence interval [CI] 10.04–13.47; P <0.001), electronic cardioversion (adjusted OR 2.41, 95% CI 1.65–3.51; P <0.001), and anti-arrhythmic drug use (adjusted OR 1.45, 95% CI 1.38–1.53; P <0.001). Conclusions::In hospitals participated in the CCC-AF project, >70% of AF patients were at a high risk of stroke. Although poor performance on guideline-recommended OAC use was found in this study, over time the CCC-AF project has made progress in stroke prevention in the Chinese AF population.Registration::ClinicalTrials.gov, NCT02309398.
9.Early experience with mechanical hemodynamic support for catheter ablation of malignant ventricular tachycardia
Mengmeng LI ; Yang YANG ; Deyong LONG ; Chenxi JIANG ; Ribo TANG ; Caihua SANG ; Wei WANG ; Xin ZHAO ; Xueyuan GUO ; Songnan LI ; Changyi LI ; Man NING ; Changqi JIA ; Li FENG ; Dan WEN ; Hui ZHU ; Yuexin JIANG ; Fang LIU ; Tong LIU ; Jianzeng DONG ; Changsheng MA
Chinese Journal of Cardiology 2024;52(7):768-776
Objective:To explore the role of mechanical hemodynamic support (MHS) in mapping and catheter ablation of patients with hemodynamically unstable ventricular tachycardia (VT), report single-center experience in a cohort of consecutive patients receiving VT ablation during MHS therapy, and provide evidence-based medical evidence for clinical practice.Methods:This was a retrospective cohort study. Patients with hemodynamically unstable VT who underwent catheter ablation with MHS at Beijing Anzhen Hospital, Capital Medical University between August 2021 and December 2023 were included. Patients were divided into rescue group and preventive group according to the purpose of treatment. Their demographic data, periprocedural details, and clinical outcomes were collected and analyzed.Results:A total of 15 patients with hemodynamically unstable VT were included (8 patients in the rescue group and 7 patients in the preventive group). The acute procedure was successful in all patients. One patient in the rescue group had surgical left ventricular assist device (LVAD) implantation, remaining 14 patients received extracorporeal membrane oxygenation (ECMO) for circulation support. ECMO decannulation was performed in 12 patients due to clinical and hemodynamic stability, of which 6 patients were decannulation immediately after surgery and the remaining patients were decannulation at 2.0 (2.5) d after surgery. Two patients in the rescue group died during the index admission due to refractory heart failure and cerebral hemorrhage. During a median follow-up of 30 d (1 d to 12 months), one patient with LVAD had one episode of ventricular fibrillation at 6 months after discharge, and no further episodes of ventricular fibrillation and/or VT occurred after treatment with antiarrhythmic drugs. No malignant ventricular arrhythmia occurred in the remaining 12 patients who were followed up.Conclusions:MHS contributes to the successful completion of mapping and catheter ablation in patients with hemodynamically unstable VT, providing desirable hemodynamic status for emergency and elective conditions.
10.Efficacy and safety of Shugan Jieyu capsule combined with mosapride in the treatment of functional dyspepsia: a multicenter, randomized, double-blind, placebo-controlled trial
Ping XU ; Biyu WU ; Bin ZHAO ; Weiwu SHI ; Xuefeng ZHANG ; Shujun LIU ; Lina MENG ; Caihua WANG ; Rongyuan QIU ; Jie WU ; Xuanping XIA ; Xiujuan YAN ; Shengliang CHEN
Chinese Journal of Digestion 2024;44(10):671-678
Objective:To evaluate the efficacy and safety of mosapride citrate dispersible tablet (MP) combined with Shugan Jieyu capsule (SGJY) in the treatment of functional dyspepsia (FD).Methods:From April 2018 to January 2019, FD patients from 10 hospitals including Renji Hospital, Shanghai Jiaotong University School of Medicine, Luohe Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Handan Hospital of Traditional Chinese Medicine and Nanshi Hospital of Nanyang were selected for a randomized, double-blind, placebo-controlled trial. The patient health questionnaire-9 (PHQ-9) and generalized anxiety disorder-7 (GAD-7) were used to assess depression and anxiety in FD patients, respectively. According to the random number table method, 200 FD patients who met the inclusion criteria were randomly divided into SGJY+ MP group and placebo+ MP group, with 100 patients in each group, and all the patients were given oral MP. The patients of the SGJY+ MP group and the placebo+ MP group were given oral SGJY or placebo on the basis of MP, respectively. The patients of both groups were treated continuously for 6 weeks. Total FD symptom scores, PHQ-9 and GAD-7 scores, as well as efficiency and safety were evaluated after treatment. Independent samples t-test and chi-square test were used for statistical analysis. Results:A total of 193 patients were included into the full analysis set with 94 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group. A total of 183 patients completed the 6-week trial, including 89 cases in the SGJY+ MP group and 94 cases in the placebo+ MP group. A total of 198 patients were included in the safety analysis set, including 99 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group.After treatment, the total FD symptom scores of the SGJY+ MP group and the placebo+ MP group were both lower than those of baseline before treatment (3.71±3.06 vs. 11.79±5.18 and 4.17±3.69 vs. 11.19±5.05), and the differences were both statistically significant ( t=-24.87 and -23.27, both P<0.001). The efficacy of the SGJY+ MP group was higher than that of the placebo+ MP group (86.5%, 77/89 vs. 74.5%, 70/94), and the difference was statistically significant ( χ2=4.69, P=0.030). The efficacy of patients with moderate-to-severe anxiety and depression in the SGJY+ MP group was both higher than that of patients in the placebo+ MP group (10/10 vs. 3/7, 85.0%, 17/20 vs. 8/14), and the differences were statistically significant ( χ2=5.66 and 5.33, P=0.017 and 0.010). The efficacy of patients with postprandial distress syndrome (PDS) subtype in the SGJY+ MP group was higher than that of patients in the placebo+ MP group (93.0%, 53/57 vs. 76.5%, 39/51), and the difference was statistically significant (χ 2=5.82, P=0.016). The PHQ-9 scores of patients with depression in both SGJY+ MP and placebo+ MP groups were lower than those at baseline before treatment (3.63±2.76 vs. 7.87±2.24 and 3.35±2.51 vs. 7.63±2.25), and the differences were statistically significant ( t=-14.88 and -15.87, both P<0.001). There was no significant difference in proportion of depressed patients with a ≥50% reduction in PHQ-9 scores from baseline value between the SGJY+ MP group and the placebo+ MP group (60.2%, 50/83 vs. 62.8%, 54/86; χ2=0.05, P=0.825). The GAD-7 scores of anxious patients both the SGJY+ MP group and the placebo+ MP group were lower than the baseline value before treatment (3.27±2.57 vs. 7.09±2.08 and 3.86±2.49 vs. 6.84±1.66), and the differences were statistically significant ( t=-13.30 and -11.47, both P<0.001). The proportion of anxious patients with a ≥50% reduction in GAD-7 scores from baseline in the SGJY+ MP group was higher than that of the placebo+ MP group (54.4%, 43/79 vs. 36.5%, 27/74), and the difference was statistically significant ( χ2=4.53, P=0.033). There were no serious adverse events in both the SGJY+ MP group and the placebo+ MP group during the treatment. There were no significant differences in the incidence of adverse events and adverse reactions during the treatment between the SGJY+ MP group and the placebo+ MP group (7.1%, 7/99 vs. 5.1%, 5/99, and 3.0%, 3/99 vs. 3.0%, 3/99, respectively; both P>0.05). Conclusion:SGTY can safely and effectively improve the efficacy of the prokinetic drugs in the treatment of FD symptoms, especially in FD patients with PDS subtype or with moderate-to-severe anxiety and with depression.


Result Analysis
Print
Save
E-mail