1.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.
2.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
3.Analysis of the genotype distribution and changes in norovirus in Asia and Russia in GenBank from 1995 to 2023
Hui-min JIANG ; Yan CHEN ; Li-li LI ; Xiao-man SUN ; Chui-zhao XUE ; Jin-song LI ; Yin-hui PEI ; Zhao-jun DUAN
Chinese Journal of Zoonoses 2025;41(5):515-521
An analysis of 24 144 norovirus sequences from Asia and Russia deposited in GenBank between 1995 and 2023 was conducted,to understand the temporal and spatial variations in norovirus genotypes in these regions.Norovirus sequences from Asia and Russia were downloaded in FASTA format from GenBank for the years 1995-2023,and analyzed in Excel,R language,and GraphPad Prism for data visualization.The number of norovirus sequences submitted to GenBank increased annually from 2004 and peaked in 2015.Notably,China and Japan contributed 62.3%of all submitted norovirus sequences.These sequences encompassed 31 capsid genotypes(C-type),with GⅠ accounting for 9%and GⅡ accounting for 90%.Additionally,49 polymerase types(P-type)were identified,along with 68 combinations of CP types;among the analyzed recombinant sequences(4 460 entries in total),approxi-mately 41%belonged to three predominant recombinant strains:GⅡ.2[P16],GⅡ.4[P31],and GⅡ.4[P16].This analysis provides valuable insights into the distribution characteristics of norovirus genotypes across Asia and Russia over time,thereby supporting vac-cine design and evaluation efforts.
4.Expert consensus on holistic integrative management of oropharyngeal squamous cell carcinoma
Moyi SUN ; Zongxuan HE ; Qianwei NI ; Xiaoying LI ; Lin KONG ; Qing XI ; Wei GUO ; Zhangui TANG ; Guoxin REN ; Zhijun SUN ; Jian MENG ; Jie ZHANG ; Jichen LI ; Yue HE ; Chunjie LI ; Lizheng QIN ; Kai YANG ; Bing HAN ; Yan SUN ; Haijun LU ; Xiaohong ZHAN ; Dapeng HAO ; Kai SONG ; Haoyue XU ; Lingxue BU ; Jieying LI ; Man HU ; Mingjin XU ; Yun LI ; Wei SHANG
Journal of Practical Stomatology 2025;41(3):293-304
Oropharyngeal squamous cell carcinoma(OPSCC)is a malignant tumor originating from the squamous epithelium of the oro-pharyngeal mucosa,accounting for more than 90%of oropharyngeal malignancies.In recent years,human papillomavirus(HPV)infec-tion has become one of the primary etiological factors of oropharyngeal squamous carcinoma.The incidence of HPV-associated oropharyn-geal squamous carcinoma has been rising annually,with a noticeable trend toward younger populations,posing a significant threat to hu-man health.Due to the distinct biological behavior and clinical characteristics of HPV-associated oropharyngeal squamous carcinoma com-pared to its non-HPV-related counterpart,the diagnostic and treatment strategies for oropharyngeal squamous carcinoma have undergone substantial changes.Prevention and screening for oropharyngeal squamous carcinoma are of critical importance.The diagnostic and treat-ment process involves multi-disciplinary collaboration,including oral and maxillofacial surgery,otolaryngology,head and neck surgery,oncology,radiology and pathology.Based on evidence from clinical practice,a comprehensive,integrated diagnostic and therapeutic ap-proach has been established,centered around the concept of"prevention,screening,diagnosis,treatment,and rehabilitation",covering the entire patient lifecycle and providing a valuable reference for clinical practice.
5.Advances and future research prospects in regulatory policies for clin-ical trials of artificial intelligence medical devices
Hao LIANG ; Shun WANG ; Cheng CUI ; Ling SONG ; Ailin SUN ; Man LI ; Jie QIAO ; Chun-li SONG ; Haiyan LI ; Yangguang ZHAO ; Haiyan LI ; Chenguang ZHANG ; Dongyang LIU
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(3):427-431
Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.
6.Bibliometric analysis of research trends and hotspots in medication literacy researches
Chaoyue SUN-LI ; Chunxia MAN ; Suying YAN ; Hua LIU ; Guanchun WANG ; Qing XIE
Adverse Drug Reactions Journal 2025;27(7):422-427
Objective:To analyze the current situation and hotspots of medication literacy research at home and abroad, and provide references for medication literacy research in China.Methods:The literature related to medication literacy in the Web of Science Core Collection Database, Scopus and China National Knowledge Infrastructure Database were retrieved (up to May 31, 2024). The CiteSpace software was used to analyze the number of published papers, countries, institutions, journals, authors and keywords, etc.Results:A total of 604 literature were included (361 in Chinese and 243 in English). The literature related to medication literacy were first seen in 2000, and the number grew slowly, which showed rapid growth after 2016, and reached a peak in 2023. The country with the largest number of published English literature was China (69 articles), followed by the United States (66 articles). The literature from the United States were cited 3 623 times, and those from China were cited 2 523 times. Central South University and the Third Xiangya Hospital of Central South University were tied for the first place in terms of the number of published articles as institutions (both 15 articles). The top 5 institutions in terms of the number of Chinese publications were Xiangya Third Hospital of Central South University, Central South University, Yanbian University, Affiliated Hospital of Yanbian University, and Tianjin Chest Hospital. The discipline with the largest number of published English literature was pharmacology/pharmacy (107 articles), followed by public environmental occupational health (88 articles) and general internal medicine (39 articles); the discipline with the largest number of Chinese published articles was clinical medicine (124 articles), followed by research on medical and health policies and regulations (56 articles), and medical education and marginal medical disciplines (34 articles). Keyword cluster analysis showed that the top 3 keywords in the English literature were medication errors, health education, and community pharmacy, while those in the Chinese literature were health literacy, self-management, and health education.Conclusions:Research on medication literacy has rapidly developed in recent years. China and the United States are the main countries for research related to medication literacy. Health education and medication errors are the mainstream of the research. Future research can focus on personalized assessment and intervention measures of medication literacy, so as to develop high-quality assessment tools for medication literacy.
7.Expert consensus on holistic integrative management of oral squamous cell carcinoma
Moyi SUN ; Zongxuan HE ; Haoyue XU ; Xiaoying LI ; Jie ZHANG ; Haijun LU ; Xiaohong ZHAN ; Dapeng HAO ; Shizhu BAI ; Wei GUO ; Zhangui TANG ; Guoxin REN ; Jian MENG ; Zhijun SUN ; Jichen LI ; Yue HE ; Chunjie LI ; Lizheng QIN ; Kai YANG ; Qing XI ; Lin KONG ; Bing HAN ; Lingxue BU ; Yuanyong FENG ; Kai SONG ; Hongyu HAN ; Jieying LI ; Qianwei NI ; Yun LI ; Juan CHAI ; Xiaochen YANG ; Man HU ; Mingjin XU ; Wei SHANG
Journal of Practical Stomatology 2025;41(4):437-449
Oral squamous cell carcinoma(OSCC)is a malignant lesion originating from the oral mucosal squamous epithelium,account-ing for over 80%of oral and maxillofacial malignancies.Key etiological factors include tobacco,alcohol abuse,and betel quid chewing.In China,its incidence has shown an overall upward trend,posing a significant threat to public health.OSCC exhibits high local invasive-ness,making early diagnosis critical for improving prognosis.Its clinical management requires close multidisciplinary collaboration among oral and maxillofacial surgery,head and neck surgery,radiation oncology,medical oncology,reconstructive surgery,radiology,patholo-gy,and nutritional support teams.Given the increasing disease burden of OSCC and rapid development of multidisciplinary collaborative models,an expert panel has formulated this integrated management consensus based on evidence-based medicine and extensive deliber-ation.Centered on the'Prevention-Screening-Diagnosis-Treatment-Rehabilitation'framework,the consensus provides comprehensive guidance for the entire disease course of OSCC patients,aiming to standardize clinical practice.
8.Complete genomic sequence analysis of the G6P1bovine rotavirus BLL strain
Jin-hua ZHANG ; Xia-fei LIU ; Jun-jie YU ; Jia-xin FAN ; Ming-yue WANG ; Guang-ping XIONG ; Yi-peng WANG ; Dan-di LI ; Xiao-man SUN ; Li-li PANG ; Zhao-jun DUAN
Chinese Journal of Zoonoses 2025;41(1):8-14
Bovine rotavirus(BRV)is an important pathogen causing diarrhea in calves.To understand the genomic charac-teristics and genetic variations in bovine rotavirus,and to further enrich data on the biological characteristics of rotavirus,we aimed to amplify 11 gene segments of the isolated and cultured G6P[1]bovine rotavirus BLL strain,perform whole genome se-quencing,and analyze the molecular characteristics.MEGA7.0 and DNAMAN software were used for homology and typing a-nalysis,and the whole genome phylogenetic tree was constructed to analyze genetic evolution relationships.The complete geno-type of the BLL strain was G6-P[1]-I2-R2-C2-M2-A3-N2-T6-E2-H3.Phylogenetic analysis of the VP7 and VP4 genes of the BLL strain showed that the VP7 gene had the highest homology with RVA/Cow-wt/HB01/China/2021,and the VP4 gene of the BLL strain was in the same branch as RVA/Human-tc/ISR/Ro8059/1995.From the sequence alignment of VP8*amino acids,the sialic acid domain of the BLL strain was found to be similar to that in other P[1]strains,but different from those in other types of strains,except for residue 189,which was the same as that in Ro8059 but different from that in other strains.The results suggested that the BLL strain might potentially infect humans.Therefore,continued monitoring and study of the biological characteristics of this strain are necessary to provide more information and evidence supporting further research on the cross-species transmission of group A rotavirus in China.
9.Protective effect of achyranthes bidentata against doxorubicin-induced spermatogenic disorder in mice:An investigation based on the glycolytic metabolic pathway
Man-yu WANG ; Yang FU ; Pei-pei YUAN ; Li-rui ZHAO ; Yan ZHANG ; Qing-yun MA ; Yan-jun SUN ; Wei-sheng FENG ; Xiao-ke ZHENG
National Journal of Andrology 2025;31(2):99-107
Objective:To investigate the protective effect of achyranthes bidentata(AB)on sperm quality in mice with sper-matogenic disorder through the glycolytic metabolic pathway and its action mechanism.Methods:We equally randomized 40 Kun-ming mice into a normal control,a model control,a low-dose AB(3.5 g/kg)and a high-dose AB group(7.0 g/kg),and established the model of spermatogenic disorder in the latter three groups of mice by intraperitoneal injection of doxorubicin(30 mg/kg).Two days after modeling,we collected the testis and kidney tissues and blood samples from the mice for observation of the pathological changes in the testis tissue by HE staining,detection of perm motility with the sperm quality analyzer,examination of the apoptosis of testis cells by flow cytometry,measurement of the levels of testosterone(T),malondialdehyde(MDA),superoxide dismutase(SOD)and cata-lase(CAT)in the serum and testis tissue by ELISA,and determination of expressions of the key enzymes of glycolysis hexokinase Ⅱ(HK2),pyruvate kinase M2(PKM2),platelet phosphofructokinase(PFKP),lactate dehydrogenase A(LDHA)and the meiosis pro-teins REC8 and SCP3 by Western blot,and the mRNA expressions of glycolytic phosphofructokinase 1(PFK1),phosphoglycerate ki-nase 1(PGK1),tumor necrosis factor-α(TNF-α)and interleukin-1 β(IL-1β)by fluorescence quantitative PCR(FQ-PCR).Results:Compared with the model controls,the mice in the AB groups showed significant increases in the testis coefficient,kidney in-dex,sperm concentration,sperm motility,spermatogonia,primary spermatocytes,spermatids,sperm count and the serum T level(P<0.05 orP<0.01),but dramatic decreases in the apoptosis of testis cells and percentage of morphologically abnormal sperm(P<0.01).Achyranthes bidentata also significantly elevated the levels of SOD and CAT,and down-regulated the mRNA expressions of MDA,TNF-α and IL-1β(P<0.05 or P<0.01),and up-regulated the protein expressions of HK2,PKM2,PFKP,LDHA,REC8 and SCP3,and expressions of the glycolysis key genes Pfk1 and Pgk1(P<0.05 orP<0.01).Conclusion:Achyranthes bidentata ameliorates doxorubicin-induced spermatogenic disorder in mice by regulating the glycolytic pathway and reducing oxidative stress and the expressions of inflammatory factors.
10.Variability of remnant cholesterol inflammation index exhibits a dose-response relationship with stroke risk:Evidence from the Chinese Kailuan cohort
Liuliu CAO ; Man LI ; Zhaohui WU ; Maolin ZHAO ; Baohua WANG ; Li ZHANG ; Peng LI ; Yongna YANG ; Weiguo ZHENG ; Haiyan ZHAO ; Shuohua CHEN ; Shouling WU ; Lixia SUN
Journal of Army Medical University 2025;47(22):2847-2857
Objective To investigate the association between the variability of remnant cholesterol inflammatory index(RCII),a novel composite biomarker,and the risk of stroke,in order to provide a theoretical basis for stroke prevention.Methods A prospective cohort study was conducted on 38 659 Kailuan individuals who took annual physical examinations in 2006,2008,and 2010.These subjects were grouped based on the quartiles of RCII variability,which was represented by standard deviation(SD)and average real variability(ARV),and were followed up every 2 years,with the occurrence of stroke(including ischemic and hemorrhagic strokes),death,or the end of follow-up on December 31,2022 as the endpoints.Kaplan-Meier method was used to calculate the cumulative incidence rate of endpoint events across different groups,and log-rank test was used to compare the difference of cumulative incidence of endpoint events in each group.Multivariate Cox proportional hazards regression model was adopted to analyze the association between RCII variability and risk of stroke.Results Among the 38 659 participants,a total of 2 539 strokes occurred during a mean follow-up period of 11.22±2.26 years.After adjusting confounding factors,when the participants were grouped by the quartiles of RCII-SD,the hazard ratio(HR)for stroke was 1.034(95%CI:0.917~1.167,P=0.584),1.146(95%CI:1.018~1.290,P=0.025),and 1.209(95%CI:1.066~1.370,P=0.003),respectively in the Q2,Q3,and Q4 groups,when compared with the Q1 group(Ptrend<0.05).When they were grouped by the quartiles of RCII-ARV,the HR for stroke was 1.008(95%CI:0.894~1.136,P=0.901),1.109(95%CI:0.986~1.248,P=0.085),and 1.152(95%CI:1.018~1.303,P=0.025),respectively,in the Q2,Q3,and Q4 groups,when compared with the Q1 group.Furthermore,both sensitivity and stratified analyses yielded similar results.Conclusion RCII variability is significantly associated with stroke,and the risk of stroke is gradually increasing with increment of the variability.Countermeasures Relevant authorities can focus on reducing RCII variability as a central objective by establishing regular monitoring mechanism,strengthening lifestyle interventions,and standardizing dietary,exercise,and weight management in order to suppress the index fluctuations.The principle of stable lipid-lowering in medication and optimization of therapeutic regimens with stable efficacy should be emphasized to prevent the risk of additional vascular damage.

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