1.Plasma ctDNA TP53 Mutation and Breast Cancer Prognosis:A Systematic Review and Meta-Analysis
Hao FAN ; Annan LIANG ; Wei ZOU ; Guangxi GAO ; Lijin LIU ; Fei LIU ; Lina ZHAO ; Zhihong WU
Medical Journal of Peking Union Medical College Hospital 2025;16(4):874-885
Objective To analyze the association between plasma circulating tumor DNA(ctDNA)TP53 mutation status and survival outcomes in breast cancer patients.Methods PubMed,Embase,and the Cochrane Library were searched for relevant literature published between 2000 and 2025,examining the impact of plasma ctDNA TP53 mutations on survival outcomes in breast cancer patients,including overall survival(OS),progression-free survival(PFS),or disease-free survival(DFS).Two researchers independently screened the literature according to predefined inclusion and exclusion criteria and extracted relevant data.The Newcastle-Ottawa scale and Cochrane Risk of Bias Assessment Tool were used to evaluate study quality.Meta-analysis,publication bias assessment,and sensitivity analysis were performed using Review Manager 5.3 and STATA 18.0 software.Results A total of 14 studies(13 cohort studies and 1 randomized controlled trial)in-volving 3521 breast cancer patients were included,among whom 921 had TP53 mutations.All studies were as-sessed as high-quality or low-risk.The random-effects model demonstrated that TP53 mutations were significantly associated with poorer OS(I2=77%,HR=1.82,95%CI:1.15-2.88,P=0.010),PFS(I2=63%,HR=1.68,95%CI:1.30-2.17,P<0.001),and DFS(I2=85%,HR=1.98,95%CI:1.05-3.75,P=0.040).Funnel plots indicated no significant publication bias,and sensitivity analysis confirmed the stabil-ity and reliability of the results.Subgroup analyses based on study design,breast cancer stage and molecular subtype revealed that TP53 mutations were associated with worse prognosis in prospective studies(OS:HR=2.32,95%CI:1.84-2.92,P<0.001;PFS:HR=1.83,95%CI:1.47-2.27,P<0.001),metastatic/ad-vanced breast cancer(OS:HR=2.03,95%CI:1.44-2.87,P<0.001;PFS:HR=1.90,95%CI:1.57-2.31,P<0.001),and hormone receptor-positive and human epidermal growth factor receptor 2-negative(HR+HER2-)patients(OS:HR=2.11,95%CI:1.56-2.85,P<0.001;PFS:HR=1.94,95%CI:1.62-2.33,P<0.001).Among different treatment regimens,patients with TP53 mutations receiving trastuzumab combined with paclitaxel exhibited relatively better prognosis(PFS:HR=0.08,95%CI:0.02-0.30,P<0.001).Conclusion Plasma ctDNA TP53 mutations are closely associated with survival outcomes in breast cancer patients and may serve as a potential predictor of poor prognosis,providing support for clinical manage-ment and prognostic assessment.
2.Requirements and Technical Aspects of Real world Data Governance in China's Medical Standards and Specifications
Xinmiao GUAN ; Yanzi ZHU ; Hao LIU ; Minjing LUO ; Changhao LIANG ; Feng CAO ; Zhihan LIU ; Jianguo ZHOU ; Dong ZHANG ; Yutong FEI
Medical Journal of Peking Union Medical College Hospital 2025;16(4):1008-1017
Objective To investigate the governance requirements for real world data(RWD)in China's medical standards and specifications,summarize key technical aspects of data governance,and provide refer-ences for RWD governance-related research.Methods Computerized searches were conducted in CNKI,Wan-fang Data,VIP,and SinoMed,as well as the official websites of 29 national medical societies and the National Standard Information Public Service Platform,covering all records from inception to December 12,2023.A data extraction form was developed,and the included standards and specifications were categorized according to the first six RWD governance processes outlined in the Guidelines for Real World Data Used to Generate Real-World Evidence(Trial)issued by the National Medical Products Administration:data security,data extraction,data cleaning,data transformation,data transmission and storage,and quality control.Relevant content on data governance was systematically summarized and comparatively analyzed.Results A total of 32 standards and specifications were included,comprising 15 foundational medical data standards and 17 data gov-ernance technical specifications.Among these,6 addressed data security,6 covered data extraction,5 focused on data cleaning,5 involved data transformation,6 pertained to data transmission and storage,and 4 discussed quality control.Foundational medical data standards included data description elements,terminology,and format standards,broadly covering essential data elements and meeting basic standardization needs.Data gov-ernance technical specifications primarily provided general guidelines for medical data governance,emphasizing requirements and recommendations.While requirements for data security and extraction were relatively well-de-fined,technical guidance on data transformation and quality control remained limited,and implementation pathways for data cleaning,transmission,and storage were insufficiently detailed.Conclusions As real-world evidence plays an increasingly critical role in healthcare decision-making,China's medical standards and speci-fications have established a preliminary governance framework for RWD.However,technical details and practi-cal implementation of RWD governance still require further refinement.
3.Analysis of Cardiac Involvement in Patients With Fabry Disease in Anhui Region
Zhiquan LIU ; Qi WANG ; Kui MAO ; Xueping WEI ; Guohong WU ; Jia LIU ; Wei WEN ; Fei YU ; Hao SU ; Ji YAN ; Dongmei YANG ; Kangyu CHEN
Chinese Circulation Journal 2025;40(6):597-604
Objectives:To analyze the cardiac involvement of patients with Fabry disease(FD)in Anhui region.Methods:This retrospective analysis included 48 previously and currently diagnosed FD patients(25 males)in Anhui region,overall patient and gender specific cardiac involvement was analyzed.Results:The median age of FD patients is 28.0(19.0,46.0)years.The cardiac manifestations of patients with FD were most commonly characterized by palpitations/arrhythmias(13/42 cases)and exertional dyspnea(11/42 cases),electrocardiographic changes were most commonly characterized by T-wave inversion(22/42 cases),ST-segment depression(16/42 cases),and left ventricular hypervoltage(18/42 cases),cardiac structural and functional changes were most common in papillary muscle hypertrophy(29/36 cases),bilateral sign(22/37 cases)and left ventricular hypertrophy(21/46 cases),as well as reduced left ventricular global longitudinal strain(26/39 cases).Neuropathic pain(28/43 cases)was the most common extracardiac manifestation of FD patients.FD patients of different gender differed in age at diagnosis(P=0.018),alpha galactosidase A activity(P<0.001),globotriaosylsphingosine(lyso-GL3)levels(P<0.001),enzyme replacement therapy rate(P=0.043),dyshidrosis(P<0.01),and the incidence of angiokeratoma(P=0.004).Correlation analysis showed that genotype was not correlated with enzyme activity or Lyso-GL-3 levels,whereas the Sokolow-Lyon index was positively correlated with Lyso-GL-3 levels(ρ=0.423,P=0.008),and the Sokolow-Lyon indices(septal thickness:ρ=0.562,P<0.001;left ventricle posterior wall thickness:ρ=0.569,P<0.001)and QRS duration(septal thickness:ρ=0.543,P<0.001;left ventricle posterior wall thickness:ρ=0.557,P<0.001)were positively correlated with left ventricular wall thickness.Conclusions:Cardiac involvement in patients with FD in the Anhui region is characterised by palpitations or arrhythmias,accompanied by nonspecific electrocardiographic changes.Echocardiography frequently reveals papillary muscle hypertrophy.The manifestation of cardiac involvement in patients of different genders is similar.
4.Occupational Hazard Factors and the Trajectory of Fasting Blood Glucose Changes in Chinese Male Steelworkers Based on Environmental Risk Scores: A Prospective Cohort Study.
Ming Xia ZOU ; Wei DU ; Qin KANG ; Yu Hao XIA ; Nuo Yun ZHANG ; Liu FENG ; Fei Yue LI ; Tian Cheng MA ; Ya Jing BAO ; Hong Min FAN
Biomedical and Environmental Sciences 2025;38(6):666-677
OBJECTIVE:
We aimed to investigate the patterns of fasting blood glucose (FBG) trajectories and analyze the relationship between various occupational hazard factors and FBG trajectories in male steelworkers.
METHODS:
The study cohort included 3,728 workers who met the selection criteria for the Tanggang Occupational Cohort (TGOC) between 2017 and 2022. A group-based trajectory model was used to identify the FBG trajectories. Environmental risk scores (ERS) were constructed using regression coefficients from the occupational hazard model as weights. Univariate and multivariate logistic regression analyses were performed to explore the effects of occupational hazard factors using the ERS on FBG trajectories.
RESULTS:
FBG trajectories were categorized into three groups. An association was observed between high temperature, noise exposure, and FBG trajectory ( P < 0.05). Using the first quartile group of ERS1 as a reference, the fourth quartile group of ERS1 had an increased risk of medium and high FBG by 1.90 and 2.21 times, respectively (odds ratio [ OR] = 1.90, 95% confidence interval [ CI]: 1.17-3.10; OR = 2.21, 95% CI: 1.09-4.45).
CONCLUSION
An association was observed between occupational hazards based on ERS and FBG trajectories. The risk of FBG trajectory levels increase with an increase in ERS.
Humans
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Male
;
Adult
;
Blood Glucose/analysis*
;
China
;
Prospective Studies
;
Occupational Exposure/adverse effects*
;
Risk Factors
;
Middle Aged
;
Steel
;
Fasting/blood*
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Metal Workers
;
East Asian People
5.Associations of Genetic Risk and Physical Activity with Incident Chronic Obstructive Pulmonary Disease: A Large Prospective Cohort Study.
Jin YANG ; Xiao Lin WANG ; Wen Fang ZHONG ; Jian GAO ; Huan CHEN ; Pei Liang CHEN ; Qing Mei HUANG ; Yi Xin ZHANG ; Fang Fei YOU ; Chuan LI ; Wei Qi SONG ; Dong SHEN ; Jiao Jiao REN ; Dan LIU ; Zhi Hao LI ; Chen MAO
Biomedical and Environmental Sciences 2025;38(10):1194-1204
OBJECTIVE:
To investigate the relationship between physical activity and genetic risk and their combined effects on the risk of developing chronic obstructive pulmonary disease.
METHODS:
This prospective cohort study included 318,085 biobank participants from the UK. Physical activity was assessed using the short form of the International Physical Activity Questionnaire. The participants were stratified into low-, intermediate-, and high-genetic-risk groups based on their polygenic risk scores. Multivariate Cox regression models and multiplicative interaction analyses were used.
RESULTS:
During a median follow-up period of 13 years, 9,209 participants were diagnosed with chronic obstructive pulmonary disease. For low genetic risk, compared to low physical activity, the hazard ratios ( HRs) for moderate and high physical activity were 0.853 (95% confidence interval [ CI]: 0.748-0.972) and 0.831 (95% CI: 0.727-0.950), respectively. For intermediate genetic risk, the HRs were 0.829 (95% CI: 0.758-0.905) and 0.835 (95% CI: 0.764-0.914), respectively. For participants with high genetic risk, the HRs were 0.809 (95% CI: 0.746-0.877) and 0.818 (95% CI: 0.754-0.888), respectively. A significant interaction was observed between genetic risk and physical activity.
CONCLUSION
Moderate or high levels of physical activity were associated with a lower risk of developing chronic obstructive pulmonary disease across all genetic risk groups, highlighting the need to tailor activity interventions for genetically susceptible individuals.
Humans
;
Pulmonary Disease, Chronic Obstructive/epidemiology*
;
Exercise
;
Male
;
Female
;
Middle Aged
;
Prospective Studies
;
Aged
;
Genetic Predisposition to Disease
;
Risk Factors
;
United Kingdom/epidemiology*
;
Incidence
;
Adult
6.Chemical composition and efficacy of warming lung and resolving fluid retention of Asarum forbesii grown under different shading conditions.
Lu LIAO ; Li-Xian LU ; Hong-Zhuan SHI ; Qiao-Sheng GUO ; Cheng-Hao FEI ; Kun ZHAO ; Yuan-Yuan XING ; Yong SU ; Chang LIU ; Xin-Yue YUAN
China Journal of Chinese Materia Medica 2025;50(2):384-394
Asarum forbesii is a perennial herb born in a shaded and humid environment, which is warm in nature. With the efficacy of warming lung, resolving fluid retention, and relieving coughs, it can be used to treat the syndrome of cold fluid accumulating in lung. To investigate the effects of different shading conditions on the composition and efficacy of A. forbesii, this study planted A. forbesii under 20% natural light(NL20), 40% natural light(NL40), 60% natural light(NL60), and 80% natural light(NL80) and utilized ultra performance liquid chromatography(UPLC) and micro broth 2-fold dilution method to detect the volatile chemical compounds and the minimum inhibitory concentration. At the same time, the study investigated the effects of A. forbesii grown under different shading conditions on the signs, pathological changes of lung tissues, serum cytokine levels, activities of mitochondrial respiratory chain complexes Ⅰ-Ⅴ in lung tissues, and relative expression of related genes of mice with syndrome of cold fluid accumulating in lung. The results indicated that with the increase of shading, the content of kakuol, methyl eugenol, and asarinin in A. forbesii and the antibacterial effect showed a tendency of increasing first and then decreasing, and the NL40 group was significantly better than the other groups. Under the conditions of NL20 and NL40, A. forbesii significantly alleviated the pathological damage to lung tissues, restored the homeostasis of the lung, and enhanced the energy metabolism level of mice with syndrome of cold fluid accumulating in lung. In addition, A. forbesii planted under the two conditions reduced the content of interleukin-8(IL-8), interleukin-13(IL-13), tumor necrosis factor-α(TNF-α), and mucin 5AC(MUC5AC), increased the levels of interleukin-10(IL-10) and aquaporin 1(AQP1), lowered the expression of MMP9, VEGF, TGF-β, and MAPK3. In conclusion, the therapeutic effect of A. forbesii on the syndrome of cold fluid accumulating in lung was positively correlated with the degree of shading, and the chemical composition and efficacy of warming lung and resolving fluid retention were optimal under the conditions of NL20-NL40. This study can provide reference for the pharmacological research and cultivation of A. forbesii.
Animals
;
Mice
;
Lung/pathology*
;
Drugs, Chinese Herbal/administration & dosage*
;
Male
;
Light
;
Cytokines/genetics*
;
Humans
7.External dose to caregivers and the public during 177Lu-PRRT for neuroblastoma
Yingying SUN ; Di ZUO ; Fei ZHENG ; Han WANG ; Hao YANG ; Yuxuan LIU ; Xiaorong SUN
Chinese Journal of Radiological Medicine and Protection 2025;45(3):216-222
Objective:To estimate the radiation dose to caregivers and the public from 177Lu- peptide receptor radionuclide therapy (PRRT) for pediatric neuroblastoma patients and determine the duration of contact restrictions, in order to provide a reference for relevant radiation protection measures. Methods:A retrospective study was conducted by collecting data from 18 pediatric neuroblastoma patients, aged between 3 and 13 (6.72±2.72), who received 177Lu-1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid-D-Phe1-Tyr3-Thr8-octreotide (DOTATATE) treatment at the Nuclear Medicine Department of Shandong Cancer Hospital from June 2023 to July 2023. Absorbed dose rate in air at 0, 0.1, 0.5, 1 and 2 m from the patients was measured using a radiation-survey at 1, 4, 24, 48 and 96 h after administration. The whole-body region of interest was delined using HERMES software. Subsequently, curve regression fitting was performed using a biexponential function model. By incorporating hypothesized social contact durations, the effective doses received by family members and the public in contact with patients were estimated. Additionally, MIM software was used to outline the whole-body VOI to obtain the total volume of lesions, and the Pearson or Spearman correlation coefficient was employed to analyze the relationship between the absorbed dose rate in air and clinical indicators as well as the total volume of lesions. Results:The 177Lu-DOTATATE administration dose was (4 353.42±1 451.51) MBq. All patients were discharged from hospital 24 h after 177Lu-DOTATATE administration. At the time of discharge, patients had excreted (76.70±3.99)% of the administered activity, and the absorbed dose rate in air at 0.1, 1 and 2 m from the patients were (32.74±6.98), 3.68(3.01, 4.70) and (1.22±0.51) μSv/h, respectively. After being discharged, the radiation doses to caregivers from children aged 2-5 years and 5-13 years were (2.47±1.80) mSv and (0.88±0.47) mSv, respectively. The contact restriction duration was 2 d for nighttime sleeping with family members and 1 d for contact with other children. On the day of discharge, patients should limit their time on public transportation within 4 h and do not need to restrict private transportation. Conclusions:To ensure the effective dose kept within the safety limits stipulated by current regulations, it is necessary to implement contact restrictions for patients’ family members and the public. After implementing preventive measures, 177Lu-DOTATATE treatment is a safe radionuclide therapeutic option.
8.Predictive value of changes in serum VIP and 5-HT levels for the outcome of spinal cord electrical stimulation in patients with postherpetic neuralgia
Yongqiang YE ; Shenghua LIU ; Bizheng TIAN ; Jianqiang HAO ; Jianwei LYU ; Fei XIE ; Hongbin LIU
International Journal of Laboratory Medicine 2025;46(9):1041-1045,1050
Objective To investigate the predictive value of serum vasoactive intestinal peptide(VIP)and 5-hydroxytryptamine(5-HT)levels on the outcome of spinal cord electrical stimulation(SCS)in patients with postherpetic neuralgia(PHN).Methods A total of 96 PHN patients who received SCS treatment in Ziy-ang Central Hospital from January 2022 to December 2023 were selected.According to the disease outcomes of all PHN patients after 6 months of treatment,a good group(n=71)and a poor group(n=25)were set up.The clinical data of the two groups were collected and the serum VIP and 5-HT levels were detected in all pa-tients before treatment.The predictive value of serum VIP and 5-HT on disease outcome after SCS treatment in PHN patients was evaluated by receiver operating characteristic(ROC)curve,and the influencing factors of disease outcome after SCS treatment in PHN patients was explored by multivariate Logistic steppe gression a-nalysis.Results The levels of serum VIP and 5-HT in poor group were higher than those in good group(P<0.05).The area under the curve(AUC)of serum VIP and 5-HT for predicting the disease outcome of PHN patients after SCS treatment were 0.829(95%CI:0.779-0.874)and 0.743(95%CI:0.693-0.793),respec-tively,and the AUC of combined prediction was 0.941(0.891-0.986).There were no significant differences in age,gender,body moss index,education,location of onset,hypertension and drinking history between the two groups(P>0.05).The time of initial hospital admission in the poor group was longer than that in the good group,skin rash area in the poor group was larger than that in the good group,and diabetes mellitus and smoking history in the poor group were higher than those in the good group(P<0.05).The time of admis-sion for initial treatment>3 d(OR=2.188,95%CI:1.383-3.461),skin rash area>10 cm2(OR=2.018,95%CI:1.283-3.173),diabetes mellitus(OR=2.264,95%CI:1.379-3.717),serum VIP level ≥41.78 ng/L(OR=3.022,95%CI:1.685-5.420),serum 5-HT level ≥99.27 ng/mL(OR=3.579,95%CI:1.885-6.793)were the influencing factors of disease outcome after SCS treatment in PHN patients(P<0.05).Con-clusion The elevated levels of serum VIP and 5-HT before treatment are associated with poor outcomes after SCS in patients with PHN,and could be used as potential markers to predict the outcomes of SCS in patients with PHN.
9.Correlation between serum DcR3,RAGE,MIP-1α levels and transfusion-related acute lung injury and prognosis in patients with acute massive hemorrhage
Fei WANG ; Meng LI ; Hao LIU ; Quanlun LI
International Journal of Laboratory Medicine 2025;46(17):2125-2130
Objective To investigate the correlation between the levels of serum decoy receptor 3(DcR3),receptor for advanced glycation end products(RAGE),and macrophage inflammatory protein-1α(MIP-1α)in patients with acute massive hemorrhage and the occurrence and prognosis of transfusion-related acute lung in-jury(TRALI).Methods A total of 122 patients with acute massive hemorrhage who were admitted to Taihe Hospital of Shiyan from September 2019 to September 2023,underwent blood transfusion treatment and had TRALI were selected as the TRALI group,and another 122 patients with acute massive hemorrhage who un-derwent blood transfusion treatment and did not experience TRALI during the same period were selected as the control group.Enzyme linked immunosorbent assay(ELISA)was applied to measure the levels of serum DcR3,RAGE,and MIP-1α.Multivariate Logistic regression analysis was applied to explore the factors that af-fected the prognosis of TRALI patients.Receiver operating characteristic(ROC)curve was applied to analyze the diagnostic value serum DcR3,RAGE,and MIP-1α for TRALI patients and the predictive value for the prognosis.Results Compared with the control group,the levels of serum DcR3,RAGE,and MIP-1α in the TRALI group were increased(P<0.05).The combination of serum DcR3,RAGE,and MIP-1α had the lar-gest area under the curve(AUC)for the diagnosis of TRALI,which was superior to those of individual diag-noses(Zcombination-DcR3=5.630,P<0.001,Zcombination-RAGE=4.173,P<0.001,Zcombination-MIP-1α=4.664,P<0.001).The levels of serum DcR3,RAGE,and MIP-1α in the death group were higher than those in the survival group(P<0.05).Multivariate Logistic regression analysis results showed that serum DcR3,RAGE,and MIP-1α were risk factors affecting the prognosis of TRALI patients(P<0.05).The combination of serum DcR3,RAGE,and MIP-1α had the largest AUC for predicting the prognosis of TRALI,which was superior to those of individual predictions(Zcombination-DcR3=2.768,P=0.006,Zcombination-RAGE=1.988,P=0.047,Zcombination-MIP-1α=2.730,P=0.006).Conclusion The levels of serum DcR3,RAGE,and MIP-1α are elevated in TRALI pa-tients,and their combination could better diagnose the occurrence of TRALI and predict the prognosis of TRALI patients.
10.Efficacy analysis of a novel inguinal tourniquet for compression hemostasis
Peng-Fei LIU ; Hao SUN ; Meng-Jie DOU ; Ya-Hua LIU ; Shao-Bin CHAI ; Si-Yu CHEN ; Fa-Qin LYU ; Wei CHEN
Medical Journal of Chinese People's Liberation Army 2025;50(6):688-694
Objective To assess the efficacy of a novel inguinal tourniquet in healthy individuals and to investigate the relationship between localized inguinal compression and femoral artery blood flow occlusion.Methods A self-controlled study was conducted.From November 9 to November 30,2024,11 volunteers were recruited at the Third Medical Center of Chinese PLA General Hospital.Three compression methods--finger pressure,a novel groin tourniquet,and a SAM junction tourniquet(SJT)—were applied bilaterally to the inguinal region until distal blood flow signals disappeared.Each compression method was tested in 22 trials with a 5-minute interval between operations.Differences in hemostatic efficacy between bilateral inguinal regions and across compression methods were compared.Subsequently,the novel tourniquet was incrementally pressurized in 120 mmHg multiples using an integrated pressure device to analyze trends in popliteal artery blood flow velocity.Observational indicators included the internal pressure of the tourniquet pressurization device,peak systolic velocity(PSV)of popliteal artery,inguinal surface pressure magnitude,inguinal surface pressure distribution,and pain scores(assessed using a single-dimensional numerical rating scale).Results No statistically significant difference was observed in the minimum pressure required to occlude femoral artery blood flow bilaterally(P>0.05).The success rates of femoral artery blood flow occlusion at the inguinal region were 100%for the novel inguinal tourniquet,SJT,and finger pressure.The novel inguinal tourniquet induced the highest pain scores,ranging from 5 to 8.A significant reduction in PSV of popliteal artery was noted when the intra-tourniquet pressure reached 360 mmHg and 480 mmHg(P<0.05),with a 95%hemostasis efficacy observed within the range of 360-600 mmHg.No significant association was observed between the recovery of popliteal artery blood flow after limb movement and inguinal pressure distribution(P>0.05).The PSV of popliteal artery exhibited the strongest negative correlation with the average pressure within the inguinal compression area(r=-0.79,P<0.001),with a linear regression fitting line of y=69.69-0.13x(P<0.001,R2=0.58).Conclusions The novel inguinal tourniquet effectively occludes femoral artery blood flow within a pressure range of 360-600 mmHg,accompanied by moderate-to-severe pain.Its hemostatic mechanism mainly relies on increasing the mean pressure within the inguinal compression area.

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