1.Chinese expert consensus on the evaluation of allergen-specific immunotherapy outcomes(Wuhan, 2025).
Yuqin DENG ; Xi LUO ; Zhuofu LIU ; Shuguang SUN ; Jing YE ; Tiansheng WANG ; Jianjun CHEN ; Meiping LU ; Yin YAO ; Ying WANG ; Wei ZHOU ; Bei LIU ; Qingxiang ZENG ; Yuanteng XU ; Qintai YANG ; Yucheng YANG ; Feng LIU ; Chengli XU ; Yanan SUN ; Haiyu HONG ; Haibo YE ; Liqiang ZHANG ; Fenghong CHEN ; Huabin LI ; Hongtian WANG ; Yuncheng LI ; Wenlong LIU ; Yu XU ; Hongfei LOU
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(11):1075-1085
Allergen-specific immunotherapy(AIT) remains the only therapeutic approach with the potential to modify the natural course of allergic rhinitis(AR). Nevertheless, considerable inter-individual variability exists in patients'responses to AIT. To facilitate more reliable assessment of treatment efficacy, the China Rhinopathy Research Cooperation Group(CRRCG) convened young and middle-aged nasal experts in China to formulate the present consensus. The recommended subjective outcome measures for AIT comprise symptom scores, medication scores, combined symptom and medication scores, quality-of-life assessments, evaluation of disease control, and assessment of comorbidities. Objective indicators may supplement these measures. Currently available objective approaches include skin prick testing, nasal provocation testing, and allergen exposure chambers. However, these methods remain constrained by practical limitations and are not yet appropriate for routine implementation in clinical efficacy evaluation. In addition, several biomarkers, including sIgE and the sIgE/tIgE ratio, sIgG4, serum IgE-blocking activity, IgA, cytokines and chemokines, as well as immune cell surface molecules and their functional activity, have been shown to have associations with AIT outcomes. While these biomarkers may complement subjective assessments, they are subject to significant limitations. Consequently, large-scale multicenter trials and real-world evidence are required to strengthen the evidence base. The present consensus underscores the necessity of integrating patients'subjective experiences with objective testing throughout the treatment process, thereby providing a more comprehensive and accurate framework for efficacy evaluation. Looking forward, future investigations should prioritize the incorporation of multi-omics data and artificial intelligence methodologies, which hold promise for overcoming current limitations in assessment strategies and for advancing both the standardization and personalization of AIT.
Humans
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Allergens/immunology*
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China
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Consensus
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Desensitization, Immunologic
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Immunoglobulin E
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Quality of Life
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Rhinitis, Allergic/therapy*
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Treatment Outcome
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East Asian People
2.Assessments of ki-67 expression in hepatocellular carcinoma using enhanced MRI intratumoral and peritu-moral radiomics and clinical imaging features
Huiliang CAI ; Qianying ZHANG ; Ying HUANG ; Weisheng PENG ; Chengli WANG ; Cuiting YANG ; Na DENG ; Sizhu ZHANG ; Nina XU ; Xiaobing HAN
The Journal of Practical Medicine 2025;41(15):2311-2319
Objective To construct a model for predicting ki-67 expression in hepatocellular carcinoma using the intratumoral and peritumoral radiomic features of contrast enhanced magnetic resonance imaging(CEMRI)in the arterial phase as well as clinical imaging features.Methods A total of 120 patients pathologically diagnosed with hepatocellular carcinoma(HCC)from January 2016 to December 2024 in No.910 Hospital of the Joint Logis-tics Support Force of the Chinese People's Liberation Army were retrospectively enrolled and randomly divided into a training set(84 cases)and a test set(36 cases)in a ratio of 7∶3.ITK-SNAP software was used to delineate the global region of interest(ROI)of HCC on the arterial phase MR images.The ROIs of all patients were automatically expanded outward by 2 mm,and then the intratumoral ROI areas were eliminated to obtain the peritumoral ROI.With the help of PyRadiomics software,1 198 intratumoral and peritumoral radiomic features were extracted.Spearman correlation analysis,maximum relevance-minimum redundancy(mRMR),and least absolute shrinkage and selection operator(LASSO)regression were used to reduce the data dimension and select the best features.Then,a radiomics model of the logistic regression(LR)machine learning algorithm was constructed.A combined model including clinical imaging features and radiomics features was established.The area under the curve(AUC),accuracy,sensitivity,specificity,positive predictive value(PPV),negative predictive value(NPV),calibration curve and decision curve analysis(DCA)were used to evaluate the efficacy of the intratumoral and peritumoral radiomics features combined with clinical imaging features model in predicting ki-67 expression in hepatocellular car-cinoma.Results The intratumor model exhibited an efficacy in predicting the expression of ki-67 in hepatocellular carcinoma with AUC values of 0.817 and 0.787 in the training set and test set,respectively.The peritumoral model showed an efficacy with AUC values of 0.805 and 0.633 in the training set and test set,respectively.The intratumoral and peritumoral model demonstrated AUC values of 0.874 and 0.836 in the training set and test set,respectively.The combined model constructed by integrating the intratumoral and peritumoral model with clinical imaging features yielded AUC values of 0.877 and 0.849 in the training set and test set,respectively,indicating clinical imaging features improved the performance of the model.DCA showed that the combined models all had good clinical benefits,with the intratumoral and peritumoral model performing the best.Conclusion The intratumoral and peritumoral radiomics model based on CEMRI arterial phase combined with clinical imaging data can accurately predict the expression of ki-67 in hepatocellular carcinoma.This combined model yields the best clinical benefit.
3.Comparison of the therapeutic effects of antimicrobial photodynamic therapy combined with subgingival scaling and root planing in the treatment of chronic periodontitis
Pengfei YANG ; Chengli XIONG ; Chengrong LIU
Chongqing Medicine 2025;54(10):2366-2370
Objective To evaluate the therapeutic effect of antimicrobial photodynamic therapy(aPDT)combined with subgingival scaling and root planing(SRP)on chronic periodontitis.Methods A total of 198 patients with chronic periodontitis who were diagnosed and treated in the Department of Stomatology of the hospital from August 2023 to April 2024 were selected as the study subjects.A randomized block design was used to divide the patients into a control group(n=98)and an experimental group(n=98).The control group received oral education and SRP treatment,while the experimental group received oral education and aPDT+SRP treatment.The depth of periodontal pocket probing(PD),positive rate of bleeding probing(BOP),bleeding index(BI),and plaque index(PLI)were compared of patients before and after 6 weeks of treatment,and the levels of tumor necrosis factor-α(TNF-α)and IL-6 in gingival crevicular fluid were meas-ured.Results After treatment,the proportion of patients with PLI grade 0 and 1 in the experimental group was higher than the control group(x2=30.640,P<0.001).The PD of the experimental group was lower than that of the control group(t=9.420,P<0.001).The AL of the experimental group was lower than that of the control group(t=4.495,P<0.001).The proportion of patients with grade 0 and grade 1 of BI index in the experimental group was higher(x2=48.839,P<0.001).The average levels of IL-6 and TNF-α in the ex-perimental group were lower than those in the control group(P<0.001).Conclusion SRP+aPDT therapy not only effectively improves periodontal clinical indicators in patients with chronic periodontitis,but also sig-nificantly reduces the levels of local inflammatory factors,which is worthy of promotion and application.
4.Study on the relationship between serum S100A4,S100A12 and the infection types and prognosis of neonatal infectious pneumonia
Shuxia ZHANG ; Chengli ZOU ; Xiaolong WANG ; Yongqiang WANG ; Yulin YANG ; Zhongjie HE
International Journal of Laboratory Medicine 2025;46(14):1676-1681,1688
Objective To explore the relationship between serum S100 calcium-binding protein(S100)A4,S100A12 and the infection type and prognosis of neonatal infectious pneumonia(NIP).Methods A total of 300 children with NIP admitted to the Neijiang Second People's Hospital from January 2021 to March 2024 were selected and divided into the bacterial infection group(214 cases)and the non-bacterial infection group(86 cases)according to the types of pathogenic bacteria.Another 150 healthy newborns in the same hospital during the same period were selected as the control group.The levels of serum S100A4 and S100A12 were de-tected by enzyme-linked immunosorbent assay.Pearson correlation analysis was conducted to examine the cor-relations between serum S100A4,S100A12 and procalcitonin(PCT),white blood cell count(WBC),albumin(Alb),and platelet count(PLT).The receiver operating characteristic(ROC)curve was used to evaluate the differential value of serum S100A4,S100A12,PCT,WBC,Alb,and PLT alone and in combination for NIP bac-terial infection.According to the prognosis,children with NIP were divided into the poor prognosis group(63 cases)and the good prognosis group(237 cases).Multivariate Logistic regression model was used to analyze the influencing factors of poor prognosis in children with NIP,and ROC curve was used to analyze the value of each factor in predicting poor prognosis in children with NIP.Results The levels of serum S100A4,S100A12,PCT,WBC,and PLT in the bacterial infection group were higher than those in the non-bacterial infection group and the control group,while Alb was lower than that in the non-bacterial infection group and the control group,the differences were statistically significant(P<0.05).Pearson correlation analysis showed that serum S100A4 and S100A12 in children with NIP were positively correlated with PCT,WBC and PLT(P<0.05),and negatively correlated with Alb(P<0.05).The results of ROC curve analysis showed that the area under the curve(AUC)of serum S100A4 and S100A12 in differentiating NIP infection types was slightly lower than that of PCT,WBC,Alb,and PLT in differentiating NIP infection types.The results of multivariate Logistic re-gression analysis showed that elevated S100A4,elevated S100A12,elevated PCT,bacterial infection,and lung consolidation were independent risk factors for poor prognosis in children with NIP(P<0.05).The AUC of bacterial infection,lung consolidation,PCT,S100A4,and S100A12 for predicting the poor prognosis of chil-dren with NIP was 0.903.It was greater than the AUC predicted separately by bacterial infection,lung consol-idation,PCT,S100A4,and S100A12 levels(Z=9.989,9.460,5.514,4.084,4.376,P<0.001).Conclusion The combination of serum S100A4 and S100A12 with traditional markers has certain discrimina-tory value for the infection types of NIP,and the levels of serum S100A4 and S100A12 are related to the prog-nosis of NIP.
5.Efficacy of transarterial chemoembolization combined with targeted therapy and immunotherapy in treating advanced hepatocellular carcinoma
Jun YANG ; Luyang LI ; Haoming LI ; Tian XIA ; Tao ZHANG ; Meng PU ; Yingbo MA ; Shuhan ZHANG ; Chengli LIU
Journal of Interventional Radiology 2025;34(4):398-402
Objective To discuss the efficacy of transcatheter arterial chemoembolization(TACE)in combination with targeted therapy and immune checkpoint inhibitors for advanced hepatocellular carcinoma(HCC),and to identify the influencing factors.Methods A total of 60 patients with advanced HCC,who were admitted to the Air Force Medical Center of China from January 2016 to December 2022,were enrolled in this study.Thirty patients received TACE combined with targeted therapy and immune checkpoint inhibitors(TACE-L-P group),and the other 30 patients received TACE combined with targeted therapy(TACE-L group).The progression-free survival(PFS),overall survival(OS),disease control rate(DCR),and objective response rate(ORR)were compared between the two groups.Results In the TACE-L group and TACE-L-P group,the median PFS(mPFS)was 7 months and 10 months respectively(P=0.011),the median OS(mOS)was 15.5 months and 29 months respectively(P=0.014).Child-Pugh class B(HR=3.89,95%CI:1.27-11.94,P=0.018)and Barcelona Clinic Liver Cancer(BCLC)stage C(HR=2.83,95%CI:1.32-6.03,P=0.007)were the independent risk factors for OS,while micro wave ablation(HR=0.21,95%CI:0.07-0.63,P=0.005)and TACE-L-P(HR=0.09,95%CI:0.03-0.3,P=0.001)were the independent protection factors for OS.Besides,elevated bilirubin level(HR=1.03,95%CI:1-1.06,P=0.032)and elevated gamma-glutamyl transferase(GGT)level(HR=1.01,95%CI:1-1.01,P=0.002)were the independent risk factors for disease progression,and TACE-L-P(HR=0.27,95%CI:0.09-0.79,P=0.017)was the independent protection factor for disease progression.The ORR and DCR in TACE-L-P group were remarkably higher than those in TACE-L group,which were 43.4%vs 13.3%and 63.4%vs 23.3%respectively,the differences between the two groups were statistically significant(both P<0.05).Conclusion In treating advanced HCC,TACE combined with targeted therapy and immune checkpoint inhibitors is superior to TACE combined with targeted therapy in therapeutic efficacy.
6.A column chart prediction model for preoperative lymph node metastasis diagnosis in gastric adenocarcinoma based on enhanced CT image radiomics features and parameters
Weisheng PENG ; Yi YANG ; Cuiting YANG ; Chengli WANG ; Guifeng HE ; YuQiang ZHENG ; Ying HUANG
Journal of Clinical Surgery 2025;33(4):405-409
Objective To explore its application value of LNM in patients with gastric adenocarcinoma based on the construction of a radiomic nomogram prediction model for preoperative lymph node metastasis in gastric adenocarcinoma using enhanced CT imaging features and parameters.Methods 131 patients with gastric adenocarcinoma who underwent radical gastric cancer surgery(Billroth Ⅱ)+lymph node dissection in our hospital from August 2019 to October 2023 were retrospectively analysed,and the preoperative enhancement CT extracted lesions,histological features of lymph node images,and pathological examination of LNM were recorded respectively,and the statistically significant Enhanced CT image histological features and parameters,multifactorial logistic regression to analyse the independent risk factors of gastric adenocarcinoma LNM(+)and construct a column-line diagram,and evaluate its performance.The performance and clinical value of the prediction model were evaluated using subject work characteristic(ROC)curves,and the column-line diagram was internally validated.Results The results of univariate analysis showed that the maximum diameter of the tumour,the lymph node status,the short-axis length and volume of the largest lymph node in the lymph node group and the sum of the short-axis lengths of all the lymph nodes were associated with the occurrence of LNM,and the difference was statistically significant(P<0.05);multifactorial logistic regression analysis suggested that the maximum diameter of the tumour was ≥15 mm and the lymph node status was positive in the enhanced CT imaging examination,maximum lymph node short-axis length ≥ 7 mm in the lymph node group,the sum of short-axis lengths of all lymph nodes ≥ 11 mm,and the maximum lymph node short-axis volume ≥ 300 mm3 in the lymph node group were the independent risk factors for gastric adenocarcinoma patients with LNM(+)(P<0.05);the area under the curve of the model was plotted using a ROC curve with an AUC=0.816(95% CI 0.810-0.939),with the sensitivity of 0.91 and the specificity of 0.86.Model validation was performed using the BOOTSTRAP method containing 500 resamples,and the results suggested that the differences between the fitted curves and the ideal curves of the constructed column-line graphical model were not significant,and the validity and reliability were good.Conclusion The radiomic nomogram prediction model based on enhanced CT imaging features and parameters can effectively predict preoperative lymph node metastasis in gastric adenocarcinoma,providing strong support for clinical decision-making in gastric adenocarcinoma patients.
7.A study on the correlation between HPV DNA and IHC P16 expression in cervical lesions
Haochen WANG ; Liqing JIA ; Yu YANG ; Qian WANG ; Chengli YU ; Tian TIAN ; Rui BI ; Xiaoyu TU ; Qianming BAI ; Xiaoli ZHU ; Xiaoyan ZHOU ; Min REN
China Oncology 2025;35(3):298-308
Background and purpose:Human papilloma virus(HPV)infection status is crucial for diagnosing cervical precancerous lesions and classifying cervical cancer.High-risk(HR)HPV is often linked to P16 protein overexpression,so P16 detection via immunohistochemistry(IHC)is commonly used to assess HPV infection.However,the differences between HPV status and P16 expression remains unclear.An in-depth study of the correlation between HPV and P16 is essential for clinical guidance.Methods:We retrospectively collected clinical and pathological data of cervical lesions from 618 patients diagnosed at the Department of Pathology,Fudan University Shanghai Cancer Center from January 2020 to December 2023(Ethical number:050432-4-2307E).Polymerase chain reaction(PCR)reverse dot hybridization was used to detect HPV including HR and low-risk(LR)subtypes,and immunohistochemistry was used to detect P16 for comparative analysis.Based on different clinical and pathological diagnoses,the sensitivity and specificity of P16 expression in evaluating HPV infection were evaluated.Among the 618 cases of cervical lesions,there were 92 cases of cervical squamous cell carcinoma,257 cases of cervical adenocarcinoma,79 cases of high-grade squamous intraepithelial lesions(HSIL),105 cases of low-grade squamous intraepithelial lesions(LSIL),and 85 cases of chronic cervical inflammation.Results:According to clinical diagnosis,the HR-HPV positive rate in cervical squamous cell carcinoma was 88.0%(81/92),the P16 positive rate was 91.3%(84/92),and the overall consistency rate between P16 and HPV detection was 90.2%(88/92);for HR-HPV infection,the sensitivity and specificity of P16 were 96.3%and 45.5%.The positive rate of HR-HPV in adenocarcinoma was 54.5%(140/257),the positive rate of P16 was 58.8%(151/257),and the overall consistency rate between P16 and HPV detection was 82.5%(212/257);for HR-HPV infection,the sensitivity and specificity of P16 were 87.9%and 76.1%.In HSIL,the HR-HPV positive rate was 75.9%(60/79),the positive rate of P16 was 70.9%(56/79),and the overall consistency rate between P16 and HR-HPV detection was 82.2%(65/79);for HR-HPV infection,the sensitivity and specificity of P16 were 85.0%and 73.7%.In LSIL,the HR-HPV positive rate was 73.3%(77/105),the positive rate of P16 was 8.5%(9/105),and the overall consistency rate between P16 and HR-HPV detection was 33.3%(35/105);for HR-HPV infection,the sensitivity and specificity of P16 were 10.4%and 96.4%.In chronic cervical inflammation,the HR-HPV positive rate was 20%(17/85),the positive rate of P16 was 0.0%(0/85);for HR-HPV infection,the sensitivity and specificity of P16 were 0.0%and 100.0%.There was a significant positive correlation between P16 positivity and HPV16/18 in cervical squamous cell carcinoma,adenocarcinoma,and HSIL(P=0.000),while there was no significant correlation in LSIL and chronic cervical inflammation(P>0.05).Conclusion:In cervical squamous cell carcinoma and adenocarcinoma,the consistency of P16 expression and HPV DNA positivity are high,especially in HPV16/18 subtype.There is a good concordance between HR-HPV positivity and P16 protein overexpression.The positive expression of P16 in HSIL may initially reflect HPV infection status.However,in LSIL and chronic cervicitis,P16 expression may not accurately correlate with HPV infection.The inconsistency between P16 and HPV DNA testing could be influenced by multiple factors,including HPV subtypes,histopathological categories,specimen quality,and technical limitations.In clinical practice,it is recommended to conduct comprehensive analysis or employ multiple diagnostic methods to confirm HPV infection status for precise evaluation.
8.Assessments of ki-67 expression in hepatocellular carcinoma using enhanced MRI intratumoral and peritu-moral radiomics and clinical imaging features
Huiliang CAI ; Qianying ZHANG ; Ying HUANG ; Weisheng PENG ; Chengli WANG ; Cuiting YANG ; Na DENG ; Sizhu ZHANG ; Nina XU ; Xiaobing HAN
The Journal of Practical Medicine 2025;41(15):2311-2319
Objective To construct a model for predicting ki-67 expression in hepatocellular carcinoma using the intratumoral and peritumoral radiomic features of contrast enhanced magnetic resonance imaging(CEMRI)in the arterial phase as well as clinical imaging features.Methods A total of 120 patients pathologically diagnosed with hepatocellular carcinoma(HCC)from January 2016 to December 2024 in No.910 Hospital of the Joint Logis-tics Support Force of the Chinese People's Liberation Army were retrospectively enrolled and randomly divided into a training set(84 cases)and a test set(36 cases)in a ratio of 7∶3.ITK-SNAP software was used to delineate the global region of interest(ROI)of HCC on the arterial phase MR images.The ROIs of all patients were automatically expanded outward by 2 mm,and then the intratumoral ROI areas were eliminated to obtain the peritumoral ROI.With the help of PyRadiomics software,1 198 intratumoral and peritumoral radiomic features were extracted.Spearman correlation analysis,maximum relevance-minimum redundancy(mRMR),and least absolute shrinkage and selection operator(LASSO)regression were used to reduce the data dimension and select the best features.Then,a radiomics model of the logistic regression(LR)machine learning algorithm was constructed.A combined model including clinical imaging features and radiomics features was established.The area under the curve(AUC),accuracy,sensitivity,specificity,positive predictive value(PPV),negative predictive value(NPV),calibration curve and decision curve analysis(DCA)were used to evaluate the efficacy of the intratumoral and peritumoral radiomics features combined with clinical imaging features model in predicting ki-67 expression in hepatocellular car-cinoma.Results The intratumor model exhibited an efficacy in predicting the expression of ki-67 in hepatocellular carcinoma with AUC values of 0.817 and 0.787 in the training set and test set,respectively.The peritumoral model showed an efficacy with AUC values of 0.805 and 0.633 in the training set and test set,respectively.The intratumoral and peritumoral model demonstrated AUC values of 0.874 and 0.836 in the training set and test set,respectively.The combined model constructed by integrating the intratumoral and peritumoral model with clinical imaging features yielded AUC values of 0.877 and 0.849 in the training set and test set,respectively,indicating clinical imaging features improved the performance of the model.DCA showed that the combined models all had good clinical benefits,with the intratumoral and peritumoral model performing the best.Conclusion The intratumoral and peritumoral radiomics model based on CEMRI arterial phase combined with clinical imaging data can accurately predict the expression of ki-67 in hepatocellular carcinoma.This combined model yields the best clinical benefit.
9.A column chart prediction model for preoperative lymph node metastasis diagnosis in gastric adenocarcinoma based on enhanced CT image radiomics features and parameters
Weisheng PENG ; Yi YANG ; Cuiting YANG ; Chengli WANG ; Guifeng HE ; YuQiang ZHENG ; Ying HUANG
Journal of Clinical Surgery 2025;33(4):405-409
Objective To explore its application value of LNM in patients with gastric adenocarcinoma based on the construction of a radiomic nomogram prediction model for preoperative lymph node metastasis in gastric adenocarcinoma using enhanced CT imaging features and parameters.Methods 131 patients with gastric adenocarcinoma who underwent radical gastric cancer surgery(Billroth Ⅱ)+lymph node dissection in our hospital from August 2019 to October 2023 were retrospectively analysed,and the preoperative enhancement CT extracted lesions,histological features of lymph node images,and pathological examination of LNM were recorded respectively,and the statistically significant Enhanced CT image histological features and parameters,multifactorial logistic regression to analyse the independent risk factors of gastric adenocarcinoma LNM(+)and construct a column-line diagram,and evaluate its performance.The performance and clinical value of the prediction model were evaluated using subject work characteristic(ROC)curves,and the column-line diagram was internally validated.Results The results of univariate analysis showed that the maximum diameter of the tumour,the lymph node status,the short-axis length and volume of the largest lymph node in the lymph node group and the sum of the short-axis lengths of all the lymph nodes were associated with the occurrence of LNM,and the difference was statistically significant(P<0.05);multifactorial logistic regression analysis suggested that the maximum diameter of the tumour was ≥15 mm and the lymph node status was positive in the enhanced CT imaging examination,maximum lymph node short-axis length ≥ 7 mm in the lymph node group,the sum of short-axis lengths of all lymph nodes ≥ 11 mm,and the maximum lymph node short-axis volume ≥ 300 mm3 in the lymph node group were the independent risk factors for gastric adenocarcinoma patients with LNM(+)(P<0.05);the area under the curve of the model was plotted using a ROC curve with an AUC=0.816(95% CI 0.810-0.939),with the sensitivity of 0.91 and the specificity of 0.86.Model validation was performed using the BOOTSTRAP method containing 500 resamples,and the results suggested that the differences between the fitted curves and the ideal curves of the constructed column-line graphical model were not significant,and the validity and reliability were good.Conclusion The radiomic nomogram prediction model based on enhanced CT imaging features and parameters can effectively predict preoperative lymph node metastasis in gastric adenocarcinoma,providing strong support for clinical decision-making in gastric adenocarcinoma patients.
10.A study on the correlation between HPV DNA and IHC P16 expression in cervical lesions
Haochen WANG ; Liqing JIA ; Yu YANG ; Qian WANG ; Chengli YU ; Tian TIAN ; Rui BI ; Xiaoyu TU ; Qianming BAI ; Xiaoli ZHU ; Xiaoyan ZHOU ; Min REN
China Oncology 2025;35(3):298-308
Background and purpose:Human papilloma virus(HPV)infection status is crucial for diagnosing cervical precancerous lesions and classifying cervical cancer.High-risk(HR)HPV is often linked to P16 protein overexpression,so P16 detection via immunohistochemistry(IHC)is commonly used to assess HPV infection.However,the differences between HPV status and P16 expression remains unclear.An in-depth study of the correlation between HPV and P16 is essential for clinical guidance.Methods:We retrospectively collected clinical and pathological data of cervical lesions from 618 patients diagnosed at the Department of Pathology,Fudan University Shanghai Cancer Center from January 2020 to December 2023(Ethical number:050432-4-2307E).Polymerase chain reaction(PCR)reverse dot hybridization was used to detect HPV including HR and low-risk(LR)subtypes,and immunohistochemistry was used to detect P16 for comparative analysis.Based on different clinical and pathological diagnoses,the sensitivity and specificity of P16 expression in evaluating HPV infection were evaluated.Among the 618 cases of cervical lesions,there were 92 cases of cervical squamous cell carcinoma,257 cases of cervical adenocarcinoma,79 cases of high-grade squamous intraepithelial lesions(HSIL),105 cases of low-grade squamous intraepithelial lesions(LSIL),and 85 cases of chronic cervical inflammation.Results:According to clinical diagnosis,the HR-HPV positive rate in cervical squamous cell carcinoma was 88.0%(81/92),the P16 positive rate was 91.3%(84/92),and the overall consistency rate between P16 and HPV detection was 90.2%(88/92);for HR-HPV infection,the sensitivity and specificity of P16 were 96.3%and 45.5%.The positive rate of HR-HPV in adenocarcinoma was 54.5%(140/257),the positive rate of P16 was 58.8%(151/257),and the overall consistency rate between P16 and HPV detection was 82.5%(212/257);for HR-HPV infection,the sensitivity and specificity of P16 were 87.9%and 76.1%.In HSIL,the HR-HPV positive rate was 75.9%(60/79),the positive rate of P16 was 70.9%(56/79),and the overall consistency rate between P16 and HR-HPV detection was 82.2%(65/79);for HR-HPV infection,the sensitivity and specificity of P16 were 85.0%and 73.7%.In LSIL,the HR-HPV positive rate was 73.3%(77/105),the positive rate of P16 was 8.5%(9/105),and the overall consistency rate between P16 and HR-HPV detection was 33.3%(35/105);for HR-HPV infection,the sensitivity and specificity of P16 were 10.4%and 96.4%.In chronic cervical inflammation,the HR-HPV positive rate was 20%(17/85),the positive rate of P16 was 0.0%(0/85);for HR-HPV infection,the sensitivity and specificity of P16 were 0.0%and 100.0%.There was a significant positive correlation between P16 positivity and HPV16/18 in cervical squamous cell carcinoma,adenocarcinoma,and HSIL(P=0.000),while there was no significant correlation in LSIL and chronic cervical inflammation(P>0.05).Conclusion:In cervical squamous cell carcinoma and adenocarcinoma,the consistency of P16 expression and HPV DNA positivity are high,especially in HPV16/18 subtype.There is a good concordance between HR-HPV positivity and P16 protein overexpression.The positive expression of P16 in HSIL may initially reflect HPV infection status.However,in LSIL and chronic cervicitis,P16 expression may not accurately correlate with HPV infection.The inconsistency between P16 and HPV DNA testing could be influenced by multiple factors,including HPV subtypes,histopathological categories,specimen quality,and technical limitations.In clinical practice,it is recommended to conduct comprehensive analysis or employ multiple diagnostic methods to confirm HPV infection status for precise evaluation.

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