1.Evaluation of CARIFS Score and Negative Antigen Conversion Rate of Qingxuan Daozhi Formula in Treatment of Influenza in Children (Heat Accumulation in Lung and Stomach Syndrome):A Multi-center Randomized Controlled Clinical Study
Jing WANG ; Liqun WU ; Tiegang LIU ; Yongning CAO ; Jing QIU ; Jing LI ; Huaqing TAN ; Ying ZHANG ; Xulei GOU ; Jia WANG ; Jing LI ; Haipeng CHEN ; Xueying QIN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Lin JIANG ; Yingqi XU ; Jianping LIU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):188-196
ObjectiveThis paper aims to observe the syndrome improvement and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome). MethodsThrough a multi-center randomized controlled methodology design,confirmed influenza cases were collected from October 2022 to April 2023 in the pediatrics department of eight hospitals,such as Dongfang Hospital of Beijing University of Chinese Medicine. A total of 180 children with influenza and heat accumulation in the lung and stomach syndrome conforming to the standard were recruited through the clinic. The sick children meeting the inclusion criteria were randomly divided into groups by a block-randomized method. The children in the experimental group were treated with Qingxuan Daozhi formula for five days,and those in the control group were treated with Oseltamivir Phosphate Granules for five days. The primary efficacy indicator was the negative conversion rate of influenza antigen detection. Secondary efficacy indicators were the Canadian acute respiratory illness and flu scale (CARIFS) and the incidence of complications,severe cases, and critical cases. Follow-up observation was conducted on the day of enrollment,48 hours after medication,72 hours after medication, and (6+1) d after medication. ResultsOne hundred and eighty participants were randomly assigned to the experimental group (90 cases) or the control group (90 cases). All participants were followed up during the study. Comparison of influenza antigen detection results in the primary efficacy indicators showed that the average time of negative influenza antigen conversion in the experimental group was (5.29±1.25) d,and that in the control group was (5.40±1.68) d,without a statistically significant difference. After five days of intervention,52 cases in the experimental group and 51 cases in the control group converted to negative,without a statistically significant difference. CARIFS score results in the secondary efficacy indicators showed that during 72 hours after intervention,there were statistically significant differences between the experimental group and the control group in three dimensions, including headache,muscle soreness, and the need for extra care (P<0.05). On the (6+1) days after the intervention,the differences in both the experimental group and the control group were statistically significant in 10 dimensions, including sore throat,bad sleep,uncomfortable feeling,poor spirit and fatigue,crying more than usual,the need for extra care,symptom,function,influence on parents,and total score (P<0.05). The comparison results within the group in the dimensional scores of symptom, function, and influence on parents,as well as the CARIFS total score showed that with the delay of follow-up time,scores of both groups decreased significantly,with a statistically significant difference (P<0.01). Inter-group comparison results showed that the mean score of the experimental group was higher than that of the control group at the time of enrollment. With the progress of intervention,the score of the experimental group was significantly decreased compared with that of the control group. At the end of follow-up,the mean score of the experimental group was lower than that of the control group,with no statistically significant difference. In terms of the incidence of complications,severe cases, and critical cases, there were no complications,severe cases, and critical cases in the two groups,without a statistically significant difference. ConclusionThe symptom improvement effect and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome) are not inferior to Oseltamivir Phosphate granules, and children's acceptance is better. It can be more widely used in clinical treatment of influenza in children (heat accumulation in the lung and stomach syndrome).
2.Shuhe Granules (舒和颗粒) in Treating Rheumatoid Arthritis Comorbid with Insomnia with Kidney-Heart Deficiency and Qi-Blood Disharmony Syndrome:An Exploratory Single-Arm Clinical Trial
Yonghao PAN ; Yuxi LI ; Yu GAO ; Xiangbin CHEN ; Kaixin GAO ; Runyue HUANG ; Fei TAN ; Jiamin YUAN ; Biyun XU ; Zhimin YANG
Journal of Traditional Chinese Medicine 2026;67(16):1743-1751
ObjectiveTo investigate the clinical effects and safety of Shuhe Granules (舒和颗粒) in patients with rheumatoid arthritis (RA) comorbid with insomnia. MethodsA single-arm prospective exploratory design was adopted. Thirty RA patients comorbid with insomnia and diagnosed with the traditional Chinese medicine (TCM) syndrome of kidney-heart deficiency and qi-blood disharmony were enrolled. On the basis of maintaining their original RA treatment regimens, all patients received oral Shuhe Granules, one dose per day, for 12 consecutive weeks. The outcomes were assessed before treatment and at weeks 4, 8, and 12 after treatment. Sleep and related psychosomatic function were evaluated using the insomnia severity index (ISI), Pittsburgh sleep quality index (PSQI), fatigue severity scale (FSS), patient health questionnaire-9 (PHQ-9), generalized anxiety disorder-7 (GAD-7), and Montreal cognitive assessment (MoCA) scores. RA-related assessments included the 28-joint disease activity score based on C-reactive protein (DAS28-CRP), pain visual analog scale (VAS), tender joint count (TJC28), swollen joint count (SJC28), morning stiffness duration, and health assessment questionnaire (HAQ) score. Laboratory parameters included erythrocyte sedimentation rate (ESR), serum C-reactive protein (CRP), anti-cyclic citrullinated peptide antibody (anti-CCP), and rheumatoid factor (RF) levels. A literature-based historical control group was established through literature retrieval and meta-analysis. The ISI, PSQI, DAS28-CRP, and pain VAS scores were compared between the treatment group in the present study and the historical control group. Safety assessments were also performed. ResultsCompared with baseline before treatment, ISI and PSQI scores decreased at weeks 4, 8, and 12, while MoCA scores increased at weeks 4, 8, and 12. FSS scores decreased at weeks 4 and 12. At weeks 8 and 12, GAD-7 scores, DAS28-CRP scores, duration of morning stiffness, TJC28, and SJC28 were reduced. At week 12, PHQ-9, pain VAS, and HAQ scores significantly decreased (P<0.05). FSS and DAS28-CRP scores at week 12 were lower than those at week 4, and CRP levels at week 8 were lower than those at week 4 (P<0.05). Compared with the historical control group, the treatment group showed superior improvement in ISI and PSQI scores (P<0.001); however, no statistically significant differences were observed between the two groups in DAS28-CRP or pain VAS scores (P>0.05). No serious adverse events occurred during the study, and the 4 reported mild adverse events were all considered unrelated to the study medication. ConclusionShuhe Granules significantly improve sleep quality, fatigue, emotional status, cognitive function, RA-related symptoms, and joint function in patients with RA comorbid insomnia, with good safety and tolerability.
3.Trend analysis of changes in blood donor populations in CSBT sentinel sites from 2021 to 2025
Xiaojie GUO ; Junhong YANG ; Wenqin ZHU ; Ruru HE ; Guoqiang FENG ; Ruiqing JU ; Fei TANG ; Zhujiang YE ; Mingliang YUAN ; Xin CHEN ; Zhenping LU ; Dongfu XIE ; Qing XU ; Xia HUANG ; Jia ZENG
Chinese Journal of Blood Transfusion 2026;39(8):1052-1060
Objective: To analyze the structural changes in whole blood and apheresis platelet donations in Chinese Society of Blood Transfusion (CSBT) sentinel units from 2021 to 2025, and to provide evidence for donor recruitment and blood service management. Methods: Aggregated data reported by sentinel sites were collected and stratified according to six indicators: age, sex, donation history, donation volume, donation site, and organization mode. Pearson χ
test, Cramer′V coefficient, Cochran-Armitage trend test and simple linear regression were adopted for analysis. Results: A total of 16 256 973 whole blood donations and 1 576 546 apheresis platelet donations were included. Among whole-blood donations, the proportion of donors aged 18-22 years decreased from 27.30% to 10.60%. The proportion of male donors increased from 58.81% to 63.13%; the proportion of people aged 30 and above increased from 58.40% to 75.30%; the proportion of fixed locations rose from 28.37% to 36.57%; the proportion of social groups increased from 21.69% to 39.69%. The 400-mL donations decreased from 62.12% to 53.46%, while individually initiated voluntary donations remained above 50%. Apheresis platelet donations were predominantly from males, individuals aged 30-39 years, and repeat donors; 2-treatment-unit apheresis platelet donations increased from 67.19% to 74.93%, and individually initiated donations accounted for 92.97%-96.02%. Statistically significant overall annual compositional differences were observed for all six indicators (all P<0.001), whereas linear trends for some sub-categories were not statistically significant. Conclusion: In the participating CSBT sentinel units, among whole blood donations, the proportions of donors aged 18-22 years, university-organized group donations, and donations at blood mobiles decreased, whereas the proportions of organizational group donations and donations at fixed venues increased. The apheresis platelet donation cohort is relatively mature and is evolving toward a high-efficiency donation model. Individual voluntary donation remains the primary organization mode for both donation types. Strategies such as youth donor recruitment, optimized layout of fixed donation sites, and retention of repeat donors should be strengthened to improve the resilience of blood supply.
4.Cost-utility analysis of influenza vaccination among primary and secondary school students in Anshun City
LI Jiao, XU Fei, ZENG Fei, ZHANG Dandan, YANG Li, LIU Lili, LI Jun, ZHENG Changning, LIU Ming
Chinese Journal of School Health 2026;47(7):1040-1044
Objective:
To evaluate the cost utility of different influenza vaccination strategies for primary and secondary school students in Anshun City, so as to provide healtheconomic evidence for influenza prevention and control in this population.
Methods:
Based on the demographic data of 380 700 students aged 5-14 in Anshun City in 2024, a decision tree model for different influenza vaccination strategies was constructed. The incremental cost utility ratio (ICUR) and net monetary benefit (NMB) were calculated, and sensitivity analysis was performed to assess the robustness of the model results.
Results:
For influenza vaccination among primary and secondary school students in Anshun City, compared with the selfpaid strategy (2% coverage), the free strategy (45% coverage) and the target strategy (70% coverage) both yielded an ICUR of -7 874.29 yuan per quality adjusted life year (QALY). When using 1 and 3 times the per capita Gross Domestic Product (GDP) as the willingness to pay thresholds, the per capita Net Monetary Benefit (NMB) was 1 000, 1 600 and 2 900, 4 500 RMB, respectively. The number of influenza infections or school absenteeism decreased by 25% and 40%, while saving a total cost of (46.779 5 and 73.976 8) million yuan, and increasing QALY by 5 940.79 and 9 394.73, respectively. Sensitivity analysis showed that within the reasonable fluctuation range of parameters, the ICUR remained consistently lower than the one and three times willingness to pay. Furthermore, 99% of the simulation results for both the free and target strategies fell below those thresholds, indicating high robustness of the model results.
Conclusion
Implementing free and target influenza vaccination strategies for primary and secondary school students in Anshun City offer distinct cost utility advantages, and the advantage enhances as the vaccination coverage rate increases.
5.Effects of emotion regulation ability on inhibitory control in patients with alcohol use disorder
Fei CHENG ; Tianzhen CHEN ; Xu YOU ; Baoshuang XUE ; Yunbin YANG ; Jiang DU
Journal of Shanghai Jiaotong University(Medical Science) 2025;45(7):883-891
Objective·To investigate the performance and psychological mechanisms of inhibitory control in patients with alcohol use disorder(AUD)under different emotional contexts,and to examine the influence of emotion regulation difficulties on inhibitory control.Methods·A total of 28 male AUD inpatients(AUD group)and 28 age-and education-matched healthy controls(HC group)were recruited.The emotional Go/Nogo task(angry/neutral facial expressions)was used to evaluate the subjects'behavioral inhibition,and the hierarchical drift-diffusion model(HDDM)was used to quantify the cognitive parameters(drift rate,decision threshold,and non-decision time).The Difficulties in Emotion Regulation Scale(DERS)and Alcohol Use Disorder Identification Test(AUDIT)were used for clinical evaluation.The moderated mediation effects were tested by bootstrap method.Results·The AUD group scored higher than the HC group on the DERS total score and all sub-dimensions(goal-directed behavior,impulse control,strategy access,and emotional clarity),and the difference was statistically significant(all P<0.05).At the behavioral level,compared with the HC group,the AUD group had elevated commission error rates[F(1,54)=8.62,P=0.005]and omission error rates[F(1,54)=4.28,P=0.043],and the reaction time of angry face stimuli was generally prolonged[F(1,54)=12.26,P=0.001].Cognitive modeling showed that the drift rate of the AUD group was significantly lower than that of the HC group[F(1,54)=15.56,P<0.001],indicating impaired information processing efficiency.The moderated mediation model showed that,under the condition of angry face stimuli,the drift rate partially mediated the relationship between group and commission error rate,and the total indirect effect value was 9.564(95%CI 3.874?16.387).Further analysis showed that the conditional indirect effect increased to 10.133(95%CI 3.963?17.927)at high levels of emotion regulation difficulty(one standard deviation above the mean),and to 9.011(95%CI 3.778?14.921)at low levels(one standard deviation below the mean).Conclusion·The deficits in information processing efficiency of AUD patients partly explains the impairment of inhibitory control,and this effect is associated with individual emotion regulation capacity.It is suggested that abnormal processing of social threat information may be an important factor affecting the impairment of inhibitory control in AUD patients,especially in individuals with weak emotion regulation ability.
6.Mechanism of QingRe HuoXuo Formula against NSCLC based on network pharmacology and molecular docking technology
Bin-bin LI ; Jing-tao ZHANG ; Xue LI ; Yi-yang JIANG ; Shuang SONG ; Xiang-dong XU ; Fei XU
Chinese Pharmacological Bulletin 2025;41(8):1542-1552
Aim To explore the material basis and un-derlying mechanism of Qingre Huoxue Formula(QRHXF)in the treatment of non-small cell lung cancer(NSCLC)by applying network pharmacology,molecular docking technology and bioinformatics com-bined with animal experiments.Methods TCMSP,ECTM,and BATMAN databases were used to obtain active components and corresponding targets of QRHXF;GEO and DisGeNENT databases were con-ducted to acquire NSCLC-associated differential expres-sion genes.By intersecting them,the common targets were obtained.It was chosen to construct a herb-com-ponent-disease network and protein-protein interaction(PPI)network.Furthermore,DAVID database was used to perform gene ontology(GO)function and Kyo-to encyclopedia of genes and genomes(KEGG)path-way enrichment analyses.The molecular docking was presented by adopting Autodock Vina program to verify key targets.RNA-seq datawere downloaded from TC-GA database to obtain differential gene expression.Ka-planMeier(KM)analysis was performed to analyze the relationship between gene expression and overall sur-vival.Mouse subcutaneous tumor model of LLC was established.The effects of QRHXF on body weight,tumor volume and weight were monitored for pharmaco-dynamic analysis.Tumor tissues slides were stained with hematoxylin and eosin(HE)for histopathological examination.Immunohistochemistry(IHC)staining was employed for detecting Ki67 and EP300.Western blot was performed to measure the protein expression of TP53,CDK1 and NTRK1.Results The results of net-work pharmacology showed that a total of seven com-mon targets were screened from NSCLC and QRHXF,and the effect of QRHXF on anti-NSCLC may occur via multiple signaling pathways,including cell cycle.The results of molecular docking indicated that the main ac-tive components of QRHXF had low binding energy and stable docking conformation with the molecular target for treating NSCLC.According to bioinformatic analy-sis,there were significant differences in BRCA1,CDK1 and NTRK1 mRNA expression between tumor tissues and normal tissues,which were also prognostic factors for overall survival.Animal experimental research showed QRHXF inhibited subcutaneous tumor growth(P<0.01)and improved the quality of life in mice with NSCLC.After QRHXF intervention,the density of tumor cells was significantly reduced,and necrotic are-as were increased.The expressions of Ki67 and EP300 were significantly decreased.Compared with the model group,Western blot showed up-regulation of TP53 and NTRKA(P<0.05),whereas CDK1 were down-regu-lated(P<0.05).Conclusion QRHXF exerted anti-NSCLC effects by regulating NTRK1,EP300,TP53,CDK1 and inducing cell cycle,cell cycle arrest and in-hibiting tumor growth,metastasis and angiogenesis.
7.Serum metabonomic study of patients with pancreatic cancer and chronic pancreatitis
Ming YANG ; Yisha GAO ; Diya LYU ; Fei FENG ; Can XU
Chinese Journal of Pancreatology 2025;25(2):97-103
Objective:To investigate the serum metabonomics of pancreatic cancer and chronic pancreatitis patients and screen the differential metabolites for differentiating pancreatic cancer from chronic pancreatis.Methods:From June 2021 to June 2022, the clinical data of 54 patients diagnosed with pancreatic ductal adenocarcinoma in the Department of Hepatobiliary, Pancreatic and Splenic Surgery of the First Affiliated Hospital of Naval Medical University were collected. A total of 54 patients with chronic pancreatitis who were admitted at the same time were selected as the control group. UHPLC/Q-TOF MS-based metabonomics techniques were applied to analyze the difference in serum metabolites in the two groups with multivariate and univariate statistical method, and the different metabolites were screened and identified in accordance with the molecular weight, metabolites databases and mass spectrometry (MS)/MS information. Two-thirds of the cases were randomly selected from patients with pancreatic cancer and chronic pancreatitis as the modeling population, and the remaining population was used as the validation population. In the modeled population, the receiver operating characteristic curve (ROC) of the screened differential metabolites was plotted and the area under the curve (AUC) was calculated. Differential metabolite variables with AUC ≥75%, a VIP value ≥1.5 were selected into the logistic multivariate regression analysis model, and the regression equation and the regression coefficients of each selected independent variable were obtained by stepwise regression by backward method. The final selected differential metabolites were evaluated by the formula P=1/{1+Exp[-(β0+β1X1+β1X1+…+βiXi)]} to establish a diagnostic model and predict the clinical application value of the model by evaluating it compared to the CA19-9 ROC curve. At the same time, the non-parametric Bootstrap method was used to verify the diagnostic performance of the model in the validation population. Results:There were 18 kinds of different serum metabolits in the final screening and identification in the two groups. The level of hypoxanthine, L-carnitine, acetylcarnitine, C16 sphinganine, linoleic acid, palmitoylcarnitine, linoleyl carnitine, uracil deoxynucleotide, glycocholic chenodeoxycholic acid in serum of pancreatic cancer patients were higher than that in the chronic pancreatitis patients; Uric acid, tryptophan, indoxylsulfuric acid, 1-palmitoyl lysophosphatidic acid, LPA(18∶2/0∶0), LysoPE (18∶1/0∶0), LysoPC (14∶0), LysoPC(15∶0), LysoPC(16∶1) in the serum were lower in patients with pancreatic cancer compared with that in chronic pancreatitis patients, and all the differences were statistically significant (all P value <0.05). In the modeled population, the ROC curve was established according to the peak intensity of 18 differential metabolites, and the metabolic differentiators with AUC of ≥75% and VIP value of ≥1.5 were selected for logistic multivariate analysis, and finally linoleoleic carnitine and LPA (18∶2/0∶0) were included in the logistic regression model. The prediction model of pancreatic cancer with two serum metabolites linoleyl carnitine and LPA (18∶2/0∶0) was established. The AUC value (95% CI) of the prediction model was 0.91 (0.85-0.97), which was higher than that of CA19-9 (0.85, 0.76-0.94), the sensitivity and specificity were 86.4% and 80.6%, respectively, and the sensitivity was higher than that of CA19-9 (77.3%), but the specificity was lower than that of CA19-9 (91.7%). Internal validation showed than the AUC value (95% CI) of the prediction model was 0.91 (0.79-0.94), which was higher than that of CA19-9 ( P<0.05). Conclusions:The serum metabolites linolein carnitine and LPA(18∶2/0∶0) may be potential diagnostic markers to distinguish pancreatic cancer from patients with chronic pancreatitis.
8.Novel Miniature Mobile Integrated Operating Cabin-Theatre: A Clinical Application
Jie ZHANG ; Ming LIANG ; Jingyang SUN ; Xiaozeng WANG ; Yang LI ; Chengfei PENG ; Zhenyang LIANG ; Quanmin JING ; Ning SUN ; Kai XU ; Fei LI ; Yaling HAN
Cardiology Discovery 2025;05(3):202-207
Objective::This study aimed to investigate the feasibility, efficacy, and safety of using a miniature mobile integrated cabin-theatre equipped with angiography and surgical operating room capabilities, and to explore its therapeutic scope, effectiveness, and operational mode.Methods::A miniature mobile integrated operating cabin-theatre was deployed across 15 hospitals in 15 cities or counties in China from April 2012 to November 2024. The interventions and outcomes of interventional and minimally invasive surgical procedures were prospectively observed and evaluated; perioperative complications were documented, and the stability, adaptability, and mobility of the integrated system were assessed.Results::A total of 133 procedures were successfully performed, 130 of which were interventional and 3 minimally invasive. The angiography machine showed good imaging performance without any equipment failures, loosening, or damage, with normal chamber unfolding. One patient experienced a fever the day after laparoscopy, while none of the other patients exhibited perioperative complications such as infection, surgical site bleeding/hematoma, or reperfusion arrhythmia. The instrument was easily manipulated, aligning with the needs of clinical intervention and surgery, and was perceived by patients as being a comfortable environment, with no psychological or other obvious discomfort.Conclusions::The miniature mobile integrated cabin-theatre, comprising an angiography machine and an operating room, allows interventional or minimally invasive surgical procedures to be performed smoothly and safely. It can also provide rapid and efficient on-site treatment of acute and critical illnesses across multiple body systems, including the cardiovascular, cerebrovascular, and gastrointestinal systems.
9.Correlation between deltoid muscle tone and postoperative prognosis of patients with rotator cuff tear
Tong BAO ; Jinyi WANG ; Yang CHEN ; Feng XU ; Fei LI
Chinese Journal of Orthopaedics 2025;45(6):361-367
Objective:To explore whether changes in the deltoid muscle tone of the affected side before and after arthroscopic rotator cuff repair (ARCR) are correlated with shoulder joint pain and shoulder joint function.Methods:A total of 55 patients (22 males and 33 females, aged 60.44±9.54 years with a range of 41 to 78 years, BMI 25.86±4.25 kg/m 2 with a range of 18.82 to 42.32 kg/m 2, symptom duration 5.94±7.27 months with a range of 0.3 to 36.0 months) diagnosed with rotator cuff tear and underwent ARCR at the First Affiliated Hospital of Tsinghua University between December 2019 and June 2023 were included. All the patients suffered from unilateral symptom (23 left side and 32 right side), the size of rotator cuff tear was 16.47±5.98 mm (range, 6.92-36.38 mm). Following the operation, postoperative rehabilitation exercises were arranged with a minimum follow-up duration of six months. The muscle tone of the deltoid was measured bilaterally using a muscle tone tester before the operation and at 1, 3, 6 months after operation. The area under curve (AUC) of the pressure-displacement curve was used to reflect the muscle tone, with larger AUC values represent less muscle tone. Visual analogue scale (VAS) and Constant-Murley score were evaluated and recorded at the same time points. Results:At 1, 3, and 6 months postoperatively, the VAS scores were all significantly reduced compared to preoperative values, with the Constant-Murley scores and the AUC values of the pressure-displacement of the affected-side deltoid significantly increased ( P<0.05). The postoperative AUC values of the pressure-displacement of the affected side deltoid muscle were significantly lower than those of the contralateral side ( P<0.05). There was no significant correlation between the changes in deltoid muscle pressure-displacement AUC and age, gender, disease duration, or BMI ( P>0.05), while a significant positive correlation was observed between the AUC and the size of the rotator cuff tear ( r=0.369, P=0.006). There was a positive correlation between the change in VAS and the change in deltoid muscle pressure-displacement AUC ( t=0.424, P<0.001), and the unary linear regression equation was: change in VAS=4.314+0.837×(change in deltoid muscle pressure-displacement AUC). There was a positive correlation between the changes in Constant-Murley shoulder score and the changes in deltoid AUC ( t=5.336, P<0.001), and the unary linear regression equation was: change in Constant-Murley score=24.838+6.097×(change in deltoid muscle pressure-displacement AUC). Conclusions:ARCR can reduce the affected side deltoid muscle tone, relieve shoulder pain and improve shoulder joint function. The changes in deltoid muscle tone are positively correlated with the degree of shoulder pain and function.
10.Assessment of Genotoxicity of Tissue Engineered Materials Based on Improved in vivo Hepatocyte Unscheduled DNA Synthesis(UDS)Assay
Luan-luan WANG ; Li HOU ; Xiang-yu CHU ; Zi-yi YANG ; Ling-xiao SUN ; Xiao-fei WANG ; Qiu-jin QU ; Jing XU ; Zeng-xiang LIU ; Xiao-xia SUN
Progress in Modern Biomedicine 2025;25(17):2740-2748
Objective:An in vivo mammalian hepatocyte Unscheduled DNA Synthesis(UDS)test was used to evaluate the genotoxicity of Cross-linked Sodium Hyaluronate Gel and Bone Repair Materials,providing experimental evidence for establishing a UDS testing method for medical devices and materials.Methods:0.9%sodium chloride injection and cottonseed oil were used as the solvent for test materials and negative control,respectively.N-dimethylnitrosamine(NDMA)was used as the positive control for the early sampling times,and 2-acetylaminofluorene(2-AAF)was used as the positive control for the late sampling times.SD rats were administered a single dose for toxic exposure,and liver tissues were collected at 4 h and 16 h,respectively.Hepatocytes were isolated using collagenase perfusion.After labeling with 5-ethynyl-2'-deoxyuridine(EdU),and the net average fluorescence intensity(NAFI)of cell nuclei and nucleoplasm was measured by fluorescence microscope.Data from 50 cells were used to analyze the DNA repair level.Results:Compared with the negative control groups,the positive control groups(NDMA and 2-AAF)showed highly statistically significant differences in NAFI(P<0.01),indicating successful induction of DNA damage.There was no statistically significant differences between the cross-linked sodium hyaluronate gel groups,bone repair material groups and the negative control group(P>0.05),suggesting that these materials did not significantly induce DNA damage under the experimental conditions.Conclusion:This study first applied EdU labeling technology to the in vivo hepatic UDS assay,achieving non-radioactive labeling through click chemistry reactions.Under the conditions of this study,cross-linked sodium hyaluronate gel and bone repair materials did not exhibit genotoxicity.In the follow-up,the sample range can be expanded and the observation period can be prolonged to further improve the genotoxicity evaluation system of medical devices.


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