1.Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine
Jiaqi LAI ; Qian HUANG ; Xueyin CHEN ; Shaonan LIU ; Lihong YANG ; MIMAZHUOGA ; DAWA ; Zhijian LI ; Tuerxun WUFUER ; Xinfeng GUO
Journal of Traditional Chinese Medicine 2026;67(13):1461-1464
Current formulation of objective performance criteria (OPC) in traditional Chinese medicine (TCM) faces methodological challenges, including poor reporting quality, insufficient standardization of methods, limited comparability of study populations, and inadequate consideration of the genetic and environment particularities of ethnic minority populations. In response to these issues, this paper proposes optimization strategies for setting OPC in TCM, with particular attention to ethnic minority medicine. These include improving methodological techniques and statistical descriptions, ensuring transparency in meta-analyses and data sources; standardizing the estimation of point estimates and confidence intervals, and incorporating multidisciplinary expert consensus for value determination; introducing local real-world data from the same period, especially cohort study evidence, to compensate for the lack of high-quality randomized controlled trial data. Through process transparency and dynamic updating mechanisms, the credibility of OPC method can be enhanced, thereby providing methodological support for strengthening evidence-based research capacity in this field.
2.Epidemiological characteristics of human brucellosis in Jiande City from 2005 to 2024
YANG Xianqing ; FANG Lihong ; FANG Lian ; ZHONG Rongwan ; WANG Fei ; LIANG Jie ; HUANG Yanyin ; XU Xiaoping
Journal of Preventive Medicine 2025;37(3):304-307,311
Objective:
To investigate the epidemiological characteristics of human brucellosis in Jiande City, Zhejiang Province from 2005 to 2024, so as to provide the evidence for strengthening the prevention and control of brucellosis.
Methods:
Data on brucellosis cases and surveillance in Jiande City from 2005 to 2024 were collected through the Chinese Disease Prevention and Control Information System, the annual brucellosis surveillance reports from the Jiande Center for Disease Control and Prevention, and the annual summaries of brucellosis prevention and control efforts. The epidemiological characteristics of human brucellosis were analyzed using a descriptive epidemiological method.
Results:
A total of 1 125 individuals were monitored in Jiande City from 2005 to 2024, with 18 seropositive cases identified and the seropositivity rate of 1.60%. The average annual seropositivity rate from 2015 to 2024 was 3.35%, which was significantly higher than that of 0.57% from 2005 to 2014 (P<0.05). There were 10 confirmed brucellosis cases and 8 asymptomatic infections, with no reported deaths. The peak incidence occurred between March and August. Among the 16 towns (streets) in Jiande City, 8 reported brucellosis cases. Of the brucellosis cases, 14 were male and 4 were female, with a male-to-female ratio of 3.5∶1. The majority of cases (13 cases) were aged between 40 and 60 years. Occupational exposure was identified in 16 cases, all of whom were infected through direct hand contact with the excreta, secretions, or animal products of infected sheep or cattle. The primary source of infection was sheep, followed by cattle. Five strains of Brucella were isolated and cultured, all identified as Brucella melitensis biovar 3.
Conclusions
The brucellosis epidemic in Jiande City remained at a sporadic and low prevalence level from 2005 to 2024, with an increasing trend observed from 2015 to 2024. Male occupational groups aged 40 to 60 years were the key population for brucellosis prevention and control, and sheep were the primary source of infection.
3.Central nervous system invasive fungal disease in patients with B-cell malignancies treated with zanubrutinib: 3 cases report and literature review
Zhenshuo JIN ; Yuehua HUANG ; Fan YU ; Yi GUO ; Sheng DONG ; Lihong LI ; Yanying WANG
Chinese Journal of Hematology 2025;46(6):575-578
The advent of bruton tyrosine kinase inhibitors (BTKi) has offered more therapeutic choices for patients with B-cell malignancies. However, with its widespread application in recent years, the use of BTKi increases the risk of severe infections in patients. Here, we report three cases of B-cell malignancies, including one case of chronic lymphocytic leukemia and two cases of diffuse large B-cell lymphoma. During treatment with BTKi zanubrutinib, different degrees of invasive fungal disease (IFD) of the central nervous system occurred in these patients. All patients fully recovered following antifungal therapy. With a median follow-up of 35 months, all patients remained in a continuous remission state, and none of them had a recurrence of IFD.
4.Respiratory syncytial virus vaccine based on bacterial outer membrane vesicle
Xiaocao MENG ; Yiman HUANG ; Aijun CHEN ; Lihong YAO ; Chao WANG ; Shiyuan ZHENG ; Enrui GUAN ; Jiayang HE ; Lishu ZHENG
Chinese Journal of Microbiology and Immunology 2025;45(6):498-506
Objective:To analyze the protective effect of a respiratory syncytial virus (RSV) vaccine based on bacterial outer membrane vesicle (OMV) in mice.Methods:The pre-fusion protein (preF) of RSV was linked to the surface of OMV through the transmembrane protein cytolysin A (ClyA) to form the nanovaccine OMV-preF. The morphological characteristics of OMV and OMV-preF were observed under a transmission electron microscope. OMV-preF was intramuscularly injected into BALB/c mice and the elicited humoral and cellular immune responses were evaluated. The protective effect of OMV-preF was assessed by challenging the immunized mice with RSV Long strain. One-way analysis of variance and Tukey test were used for statistical analysis.Results:The results showed that preF was stably expressed in OMV, and both OMV-preF and OMV exhibited a double-layer vesicle structures under the microscope. OMV-preF could significantly activate the cellular and humoral immune responses in mice, causing a significant increase in CD8 + T cells and CD19 + B cells as well as a significant increase in the serum level of specific IgG. The neutralizing antibodies produced in the immunized mice could significantly inhibit the replication of RSV Long strain in vivo. Conclusions:The nanovaccine OMV-preF can induce high-level humoral and cellular immune responses, and the antibodies produced following immunization can effectively inhibit viral replication. This study provides a new strategy for RSV subunit vaccines.
5.Development of Core Outcome Set for Clinical Research on Vitiligo Treated with Uyghur Medicine
Qian HUANG ; Xinfeng GUO ; Lihong YANG ; Genghang CHEN ; Wufuer TUERSON ; Yiming Maimaiti TURSUNTAI ; Abuduwayiti JULAITI ; Zhijian LI ; Shaonan LIU
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(10):2595-2602
Objective To develop a core outcome set(COS)for treatment of progressive vitiligo in Uyghur medicine,and to standardize the selection and reporting of outcome measures in relevant studies.Methods Based on the existing core outcome domain set of randomized controlled trials for vitiligo,additional outcome indicators reflecting the advantages and characteristics of Uyghur medical treatment were developed.Specific indicators for Uyghur medical treatment of progressive vitiligo were collected through literature review and semi-structured questionnaire surveys,and then a list of indicators were formed.The Delphi survey and consensus meetings were used to select core indicators.Results A total of 54 studies were included,and 86 questionnaires were collected.Through literature review and questionnaire surveys,a list of 28 indicators were obtained.After two rounds of Delphi survey and one consensus meeting,12 outcome indicators in 7 domains were finally determined,including vitiligo lesion area,repigmentation,disease control time,maintenance of repigmentation,recurrence rate,immune indicators,psychological health,patients' quality of life,adverse events,adverse reaction incidence,liver and kidney function monitoring,and Uyghur medicine syndrome differentiation of mucus.Additionally,some measurement tools for certain indicators were recommended.Conclusion The development of the COS for vitiligo treatment in Uyghur medicine helps to comprehensively evaluate the efficacy of Uyghur medicine,and will provide a model for establishing efficacy evaluation methods that conform to the characteristics of ethnic minority medicine.
6.Exploring the Effect of Indigo on Lipopolysaccharide-Induced HaCaT Cells Through the AhR/NLRP3 Signaling Pathway
Haiqing LEI ; Yu LIN ; Muchen XU ; Jiyuan ZHENG ; Weile HUANG ; Lihong YANG ; Ling HAN ; Jing LIU
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(11):2831-2839
Objective To investigate the effect of indigo on inflammatory factors and the aryl hydrocarbon receptor(AhR)/NOD-like receptor thermal protein domain associated protein 3(NLRP3)signaling pathway in lipopolysaccharide(LPS)-induced keratinocytes(HaCaT cells).Methods An LPS-induced HaCaT cell model was established,and experimental groups were set as follows:blank group,model group,indigo group,AhR agonist(2,3,7,8-tetrachlorodibenzo-p-dioxin,TCDD)group,AhR inhibitor(CH-223191)group,and indigo+AhR inhibitor group.The Cell Counting Kit-8(CCK-8)assay was used to detect the effects of different concentrations of indigo,TCDD,and CH-223191 on HaCaT cell viability after 24 hours of intervention.Quantitative real-time PCR(qPCR)was employed to measure the mRNA expression levels of interleukin-1β(IL-1β),nuclear factor kappa B(NF-κB),tumor necrosis factor-α(TNF-α),AhR,cytochrome P450 family 1 subfamily A member 1(CYP1A1),NLRP3,Caspase-1,and apoptosis-associated speck-like protein(ASC)in each group.Western Blot analysis was used to assess changes in the cellular localization of AhR protein expression.Results(1)The IC50 of indigo intervention in HaCaT cells was 118.7 μmol·L-1.Treatment with different concentrations of CH-223191 and TCDD for 24 hours had no significant effect on HaCaT cell viability.(2)Compared with the model group,the indigo group showed decreased mRNA expression levels of IL-1β,NF-κB,NLRP3,and Caspase-1(P<0.05 or P<0.000 1),while the mRNA expression levels of AhR and CYP1A1 were significantly increased(P<0.05 or P<0.000 1).(3)Compared with the blank group,the indigo group reduced cytoplasmic AhR protein expression and increased nuclear AhR protein expression(P<0.001 or P<0.000 1).(4)Compared with the model group,both the indigo group and the AhR agonist group significantly increased AhR mRNA expression levels(P<0.05),while the AhR inhibitor group decreased AhR and CYP1A1 mRNA expression levels(P<0.05)and increased IL-1β and NLRP3 mRNA expression levels(P<0.05).(5)Compared with the AhR inhibitor group,the indigo+AhR inhibitor group showed increased mRNA expression levels of AhR and CYP1A1(P<0.05)and decreased mRNA expression levels of NLRP3,Caspase-1,and IL-1β(P<0.05).Conclusion Indigo reduces inflammatory factors in LPS-induced HaCaT cells and participates in inhibiting the occurrence and development of psoriasis by activating AhR to negatively regulate the NLRP3 inflammasome.
7.Phosphatidylethanolamine promotes macrophage senescence and liver injury by activating endoplasmic reticulum stress
Longchuan HAN ; Yue LI ; Zhihui ZOU ; Jing LUO ; Ruoyi LI ; Yingting ZHANG ; Xinxin TANG ; Lihong TIAN ; Yuheng LU ; Ying HUANG ; Ming HE ; Yinkun FU
Journal of Shanghai Jiaotong University(Medical Science) 2025;45(6):693-704
Objective·To investigate the effects and molecular mechanisms of phosphatidylethanolamine(PE)on macrophage senescence and its senescence-associated secretory phenotype(SASP),as well as its pathophysiological role in liver injury.Methods·A macrophage senescence model was established using doxorubicin(DOX),followed by PE treatment.A mouse liver injury model was generated via intraperitoneal co-administration of PE and lipopolysaccharide(LPS)to investigate the effects of PE on liver injury.Senescence markers and SASP factors,including senescence-associated β-galactosidase(SA-β-gal),cell cycle inhibitor p21,tumor necrosis factor-α(TNF-α),and interleukin-6(IL-6),were evaluated using SA-β-gal staining,quantitative real-time PCR,and Western blotting.RNA sequencing(RNA-seq)was performed,followed by Gene Ontology(GO)cellular component enrichment analysis,Kyoto Encyclopedia of Genes and Genomes(KEGG)enrichment analysis,Gene Set Variation Analysis(GSVA),and Gene Set Enrichment Analysis(GSEA),to explore the molecular mechanisms and signaling pathways by which PE promotes macrophage senescence.The expression of endoplasmic reticulum(ER)stress-related proteins,including inositol-requiring enzyme 1 α(IRE1α),spliced X-box binding protein 1(XBP1s),activating transcription factor 6(ATF6),ATF4,and C/EBP homologous protein(CHOP),was analyzed through in vivo and in vitro experiments.Results·PE significantly promoted the expression of senescence markers SA-β-gal,p21,p16 and SASP factors.RNA-seq analysis revealed that ER stress was involved in PE-induced promotion of SASP.Further experiments demonstrated that PE activated the ER stress signaling pathway,promoting macrophage senescence and the expression of SASP factors.In vivo experiments further confirmed that PE exacerbated LPS-induced liver injury in mice through ER stress.Conclusion·PE promotes macrophage senescence and the expression of SASP factors by activating ER stress signaling pathway,thereby aggravating LPS-induced liver injury.
8.Expression levels and clinical significance of Galectin-3,IL-1β and IL-9 in peripheral blood of children with refractory mycoplasma pneumoniae pneumonia
Qianqian HE ; Han HUANG ; Lihong LIANG ; Linlin WU ; Dongge LIANG
Tianjin Medical Journal 2025;53(4):393-397
Objective To investigate the expression levels and clinical significance of Galectin-3,interleukin(IL)-1β and IL-9 in peripheral blood of children with refractory mycoplasma pneumoniae pneumonia(RMPP).Methods A total of 132 hospitalized children diagnosed with RMPP were selected as the RMPP group,and another 128 children with general MPP(GMPP)in the same period were selected as the GMPP group.The clinical data of C-reactive protein(CRP),tumor necrosis factor-α(TNF-α)and procalcitonin(PCT)in pediatric patients were collected.The expression levels of Galectin-3,IL-1β and IL-9 were detected by enzyme-linked immunosorbent assay(ELISA).The correlation between Galectin-3,IL-1β and IL-9 levels in peripheral blood of RMPP children and clinical factors were analyzed by Pearson or Spearman methods.Multivariate Logistic regression analysis was used to analyze risk factors of GMPP progression to RMPP.The predictive value of peripheral blood Galectin-3,IL-1β and IL-9 levels to RMPP was analyzed by receiver operating characteristic(ROC)curve.Results The heat course,CRP,TNF-α,PCT,Galectin-3,IL-1β,IL-9 and the proportion of extrapulmonary complications were higher in the RMPP group than those in the GMPP group(P<0.01).The correlation analysis results showed that Galectin-3,IL-1β and IL-9 levels were positively correlated with heat course,extrapulmonary complications,CRP,TNF-α and PCT(P<0.01).Logistic regression analysis showed that the increased levels of Galectin-3,IL-1β and IL-9 were independent risk factors for GMPP progression to RMPP(P<0.05).The area under the curve(AUC)of peripheral blood Galectin-3,IL-1β,IL-9 and their combined prediction of GMPP progression to RMPP were 0.852,0.813,0.812 and 0.949,respectively,and the combined prediction showed the highest efficacy(P<0.01).Conclusion The levels of Galectin-3,IL-1β and IL-9 in the peripheral blood of children with RMPP are abnormally elevated,and their combined detection can be used as an important indicator for evaluating the progression of GMPP to RMPP.
9.Current status analysis of anti-infection research by using the Bayesian method
Yiling LIU ; Jinglin LIU ; Zhenzhen LU ; Yingying WANG ; Qijing JIANG ; Bingzhe LI ; Luyan DAI ; Fanrong YAN ; Lihong HUANG
Chinese Journal of Pharmacoepidemiology 2025;34(1):69-77
Objective To analyze the application characteristics,trends,and special advantages of anti-infection research using the Bayesian method,and to provide methodological reference for the development of anti-infection research.Methods PubMed,CNKI and WanFang Data were electronically searched for the studies on anti-infection using Bayesian method published from January 1,2015 to November 21,2023.The relevant information of publication time,anti-infection type,sample size,Bayesian characteristics and Bayesian application pattern were analyzed descriptively and reviewed.Results A total of 86 studies were included,of which 41.9%were observational studies,only 7.0%were enterprise-initiated studies,and 48.8%were mentioning prior information studies.There was no domestic intervention study.The application characteristics and advantages of Bayesian method in intervention study,observational study and pharmacokinetic study are different.In intervention researches and observational researches,the application of Bayesian design decision and the application of Bayesian analysis and estimation accounts for 69.2%and 52.8%at most,respectively.Conclusions The Bayesian method is flexible,can be used for small sample sizes and complex model research,and can deal with uncertainty.In intervention studies in the field of anti-infection in China,the Bayesian method has not been applied widely.Only a handful of studies applying Bayesian method have been initiated by companies.In the future,it is still necessary to promote the advantages and application scenarios of Bayesian methods in the field of anti-infection research and strengthen the standardization of the application of Bayesian method.
10.The causal relationship between time spent outdoors in summer and myopia:based on Mendelian randomization
Lihong HUANG ; Dazheng ZHANG ; Ming LIU
Recent Advances in Ophthalmology 2025;45(1):50-54
Objective To study the causal relationship between time spent outdoors in summer and myopia by using a two-sample Mendel randomization analysis.Methods In this study,a two-sample Mendelian randomization(MR)a-nalysis was conducted,and the data from the Genome-Wide Association Studies(GWAS)were analyzed to identify whether time spent outdoors in summer could exert a causal effect on myopia.The data of exposure events and outcome events were collected based on European descent,with the significant whole genome(P<0.5 × 10-8)and independent(r2<0.001)single nucleotide polymorphism(SNP)as instrumental variables.The data on time spent outdoors in summer in-cluded 419 314 samples,and the data on myopia included 367906 samples.The OR values were used to evaluate the causal effect of time spent outdoors in summer on myopia risk.Meanwhile,the robustness and pleiotropy of the effect estimates of the heterogeneity and sensitivity analysis were also analyzed.Results The results of inverse variance weighted(IVW)random effects after the analysis based on 33 SNPs were:OR=0.604 952 2;95%CI:0.527-0.693;P=4.959 237 × 10-13.It was found that there was a causal relationship between time spent outdoors in summer and myopia.At the same time,there was some heterogeneity(I2=0.42)and no significant pleiotropy(intercept=-0.0066,SE=0.004 82,P=0.182)in the effect estimation.The IVW analysis results showed that shorter time spent outdoors in summer could increase the risk of myopia.Meanwhile,the analysis results based on the weighted median(WM)method and MR-Egger regression also re-sulted in similar results.The sensitivity analysis showed that genetic pleiotropy did not induce bias in the results.In sum-mary,for every one standard deviation decrease in the time spent outdoors in summer after the logarithmic transformation,the risk of myopia increased by 39%.Conclusion There may be a negative causal relationship between time spent out-doors in summer and myopia.


Result Analysis
Print
Save
E-mail