1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
2.Obesity-driven oleoylcarnitine accumulation in tumor microenvironment promotes breast cancer metastasis-like phenotype.
Chao CHEN ; Hongxia ZHANG ; Lingling QI ; Haoqi LEI ; Xuefei FENG ; Yingjie CHEN ; Yuanyuan CHENG ; Defeng PANG ; Jufeng WAN ; Haiying XU ; Shifeng CAO ; Baofeng YANG ; Yan ZHANG ; Xin ZHAO
Acta Pharmaceutica Sinica B 2025;15(4):1974-1990
Obesity is a significant risk factor for cancer and is associated with breast cancer metastasis. Nevertheless, the mechanism by which alterations in systemic metabolism affect tumor microenvironment (TME) and consequently influence tumor metastasis remains inadequately understood. Herein, we found that perturbations in circulating metabolites induced by obesity promote metastasis-like phenotypes in breast cancer. Oleoylcarnitine (OLCarn) concentrations were elevated in the serum of obese mice and humans. Administration of exogenous OLCarn induces metastasis-like characteristics in breast cancer cells. Mechanistically, OLCarn directly interacts with the Arg176 site of adenylate cyclase 10 (ADCY10), leading to the activation of ADCY10 and enhancement of cAMP production. Mutations at Arg176 prevent OLCarn from binding to ADCY10, disrupting the ADCY10-mediated activation of cyclic adenosine monophosphate (cAMP) signaling pathway. This activation promotes transcription factor 4 (TCF4)-dependent kinesin family member C1 (KIFC1) transcription, thereby driving breast cancer metastasis. Conversely, the neutralization of both ADCY10 and KIFC1 through knockdown or pharmacological inhibition abrogates the oncogenic effects mediated by OLCarn. Hence, obesity-induced systemic environmental changes lead to the aberrant accumulation of OLCarn within the TME, making it a potential therapeutic target and biomarker for breast cancer.
3.Prognostic analysis of postoperative adjuvant therapy for hepatocellular carcinoma after con-version therapy of combined targeted therapy and immunotherapy followed by sequential hepatectomy: a multicenter study
Kongying LIN ; Jia LIN ; Zisen LAI ; Yongping LAI ; Kui WANG ; Jinhong CHEN ; Zhibo ZHANG ; Jingdong LI ; Sheng TAI ; Shifeng WANG ; Siming ZHENG ; Jianxi ZHANG ; Lu ZHENG ; Kai WANG ; Jiacheng ZHANG ; Jiahui LYU ; Liming HUANG ; Yongyi ZENG
Chinese Journal of Digestive Surgery 2025;24(1):103-112
Objective:To investigate the prognosis of postoperative adjuvant therapy for hepatocellular carcinoma after conversion therapy of combined targeted therapy and immunotherapy followed by sequential hepatectomy.Methods:The retrospective cohort study was conducted. The clinicopathological data of 103 patients with initially unresectable hepatocellular carcinoma (HCC) who were admitted to 11 medical centers in China, including Mengchao Hepatobiliary Hospital of Fujian Medical University et al, from November 2019 to May 2023 were collected. There were 83 males and 20 females, aged (54±12)years. All 103 patients underwent conversion therapy of tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) successfully followed by sequential hepatectomy, of which 72 patients undergoing postoperative adjuvant therapy were divided into the adjuvant therapy group, and 31 patients undergoing postoperative follow-up monitoring were divided into the follow-up monitoring group. Observation indicators: (1) follow-up and postoperative condi-tions; (2) analysis of factors influencing recurrence-free survival time of patients; (3) stratified ana-lysis. Comparison of count data between group was conducted using the chi-square test or Fisher exact probability. The R software was used to draw survival curves, and the Log-rank test was used for survival analysis. Univariate and multivariate analyses were conducted using the Cox proportional hazard model. Results:(1) Follow-up and postoperative conditions. All 103 patients were followed up for 21.0(range, 1.9?47.2)months, with the median recurrence-free survival time of 28.7 months and the 1-, 2-, 3-year recurrence-free survival rates of 68.6%, 55.6%, 41.2%. The median overall survival time of 103 patients was unreached, and the 1-, 2-, 3-year overall survival rates were 90.9%, 82.1%, 69.6%, respectively. The median recurrence-free survival time was 33.1 months in patients of the adjuvant therapy group, with the 1-, 2-year recurrence-free survival rates as 77.2%, 61.5%. The median recurrence-free survival time was 11.1 months in patients of the follow-up monitoring group, with the 1-, 2-year recurrence-free survival rates as 46.6%, 40.8%. There was a significant difference in recurrence-free survival between the two groups of patients ( χ2=5.492, P<0.05). (2) Analysis of factors influencing recurrence-free survival time of patients. Results of multivariate analy-sis showed that pathologic complete response and postoperative adjuvant therapy were independent factors influencing recurrence-free survival time of HCC patients undergoing conversion therapy of combined targeted therapy and immunotherapy followed by sequential hepatectomy ( hazard ratio=0.297, 0.492, 95% confidence interval as 0.137?0.647, 0.268?0.903, P<0.05). (3) Stratified analysis. Of the 71 patients with non-pathologic complete response, the median recurrence-free survival time of 48 patients in the adjuvant therapy group was 24.0 months, with the 1-, 2-year recurrence-free survival rates as 67.4%, 48.8%. The median recurrence-free survival time of 23 patients with non-pathological complete response in the follow-up monitoring group was 7.4 months, with the 1-, 2-year recurrence-free survival rates as 35.0%, 26.3%. There was a significant difference in recurrence-free survival between the 48 patients with non-pathologic complete response in the adjuvant therapy group and the 23 patients with non-pathologic complete response in the follow-up monitoring group ( χ2=5.241, P<0.05). Conclusion:For HCC patients with conversion therapy of TKIs and ICIs followed by sequential hepatectomy, postoperative adjuvant therapy, compared to postoperative follow-up monitoring, can prolong the recurrence-free survival time of patients, of whom cases with non-pathologic complete response can benefit from adjuvant therapy.
4.Comparison of the efficacy of posterior "S" shape incision versus medial small incision with suture anchor for treating avulsion fractures of the tibial insertion of the posterior cruciate ligament
Tiangang CHEN ; Heng ZHANG ; Shuai SONG ; Lei ZHANG ; Shifeng DAI ; Kunnan XIE
Clinical Medicine of China 2025;41(2):133-139
Objective:To compare and analyze the clinical efficacy of using a posterior "S" shape incision versus a medial small incision with suture anchors in the treatment of avulsion fractures at the tibial insertion of the posterior cruciate ligament (PCL).Methods:A retrospective study was conducted on clinical data from patients with PCL tibial avulsion fractures who met surgical criteria and were treated at Department of Joint 2, Tangshan Second Hospital from March 2021 to May 2023. Among those patients, there were 25 cases classified as Meyers-McKeever type Ⅱ and 41 cases as type Ⅲ. 32 patients who underwent surgery through the posterior "S" shape incision served as the control group; based on matched baseline characteristics, 34 patients who underwent surgery through the medial small incision were selected as the observation group. Both groups received fixation of the avulsion fracture with suture anchors. Surgical indicators, as well as Lysholm scores, International Knee Documentation Committee (IKDC) scores, visual analogue scale (VAS) scores, range of motion (ROM) of the injured knee, the difference in posterior tibial translation between both sides (calculated by measuring the posterior translation on both sides), and the incidence of postoperative complications were collected at 1, 3, and 6 months post-surgery. Comparative analyses were conducted to evaluate postoperative functional recovery. Chi-square tests were used for categorical data comparison, and t-tests were employed for normally distributed continuous data.Results:The observation group had shorter incision lengths ((5.71±1.85) cm), less intraoperative blood loss ((74.87±20.74) mL), and shorter operation times ((48.76±6.46) min) compared to the control group ((12.45±1.52) cm, (120.29±31.12) mL, (61.14±10.23) min), and the differences were statistically significant ( t values were 16.21, 7.02, 5.92, respectively; all P<0.001). At 3 and 6 months post-surgery, the Lysholm ((79.67±3.08), (91.16±2.23) points) and IKDC scores ((84.67±5.08), (93.16±3.23) points) in the observation group were significantly higher than those ((65.29±3.84), (79.52±2.98), (79.29±4.84), (85.32±3.98) points) in the control group, and the differences were statistically significant ( t values were 16.72, 18.04, 4.40, 8.81, respectively; all P<0.001). At 3 and 6 months, the VAS scores ((2.83±0.38), (2.12±0.34) points) in the control group were significantly higher than those ((2.41±0.25), (1.73±0.49) points) in the observation group ( t values were 5.34 and 3.73 respectively, both P<0.001). At 6 months post-surgery, all fractures had healed, in the observation group and control group the ROM ((130.56±5.96)° and (121.45±7.32)°) of the injured knee had increased, and the difference in posterior tibial translation ((1.17±0.61) and (1.94±0.57) mm) had decreased. However, the ROM in the observation group was significantly greater than that in the control group, and the difference in posterior tibial translation was significantly lower in the observation group, with statistically significant differences ( t values were 5.56 and 5.29 respectively; both P<0.001). Conclusions:Compared to the posterior "S" shape incision approach, the medial small incision approach with suture anchors for treating PCL tibial avulsion fractures offers advantages such as reduced trauma, shorter operation time, and less intraoperative blood loss, which is more beneficial for knee joint functional recovery.
5.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
Jun ZHANG ; Baoming NING ; Shifeng WEI ; Haoyu SHEN ; Yue SHANG ; Ran ZHU ; Xinyi XU ; Lei CHEN ; Tingting LIU ; Shuangcheng MA
Drug Standards of China 2025;26(1):34-44
To introduce the general thinking,guidelines,work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition,and to summarize and figure out the main characteristics on dosage forms,physico-chemical testing,microbial and biological testing,ref-erence standards and guidelines.The newly revised general chapters of pharmacopoeia give full play to the norma-tive and guiding role of the Chinese Pharmacopoeia standard,track the frontier dynamics of international drug regu-latory science and the elaboration of monographs,expand the application of state-of-the-art technologies,and stead-ily promote the harmonization and unification with the ICH guidelines;further enhance the overall capacity of TCM quality control,actively implement the 3 R principles on animal experiments,and practice the concept of environ-mental-friendly;replace and/orreduce the use of toxic and hazardousreagents,strengthen the requirementsofdrug safety control.This paper aims to provide a full-view perspective for the comprehensive,correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
6.The value of coronary CT angiography-based traditional features and radiomics in identification of culprit plaques to cause acute myocardial infarction
Pei NIE ; Shuo ZHANG ; Yan DENG ; Shifeng YANG ; Xinxin YU ; Kaiyue ZHI ; He ZHU ; Peng LI ; Jingjing CUI ; Wenjing CHEN ; Yanmei WANG ; Yuchao XU ; Dapeng HAO ; Ximing WANG
Chinese Journal of Radiology 2025;59(9):1017-1028
Objective:To investigate the value of coronary CTA (CCTA)-based traditional features and radiomics of plaque in the identification of culprit lesions that caused acute myocardial infarction (AMI).Methods:This was a retrospective multicenter study. From July 2016 to November 2023, a total of 344 patients from the Affiliated Hospital of Qingdao University (training cohort, n=184), Shandong Provincial Hospital Affiliated to Shandong First Medical University (validation cohort, n=88) and Qilu Hospital of Shandong University (test cohort, n=72) who received percutaneous coronary intervention (PCI) due to AMI and underwent CCTA within 48 hours of AMI were enrolled. The culprit plaques and non-culprit plaques were identified using a combination of electrocardiogram, CCTA, and angiographic findings. The vessel, plaque location, plaque type, Coronary Artery Disease-Reporting and Data System (CAD-RADS) score, high-risk plaque characteristics, plaque length, plaque volume, and burden were analyzed, and 1 904 radiomics features were extracted for each plaque. The traditional imaging model, the radiomics model, and the combined model were established by using multivariate Logistic regression analysis. The area under the receiver operating characteristic curve (AUC) was used to evaluate the performance of each model in identifying culprit lesions. The DeLong test was used for the comparison of AUC between every two models. The net reclassification index (NRI) was used to evaluate the incremental value of the combined model to the traditional imaging model and the radiomics model. The decision curve analysis (DCA) was used to assess the clinical net benefit of these models. A correlation heatmap was used to evaluate the correlation between the radiomics score and traditional CCTA factors. The interpretable analysis of the decision process of the combined model was performed by the Shapley Additive exPlanations (SHAP). Results:In the validation cohort and the test cohort, the AUC of the traditional imaging model developed by the vessel, plaque type, positive remodeling and CAD-RADS score was 0.898 (95% CI 0.869-0.922) and 0.881 (95% CI 0.848-0.910), respectively. The radiomics model developed by six radiomics features was 0.863 (95% CI 0.831-0.891) and 0.863 (95% CI 0.827-0.864), respectively. The AUC of the combined model was 0.930 (95% CI 0.905-0.950)and 0.919 (95% CI 0.889-0.942), respectively. In the validation cohort and the test cohort, the AUC of the combined model was higher than that of the traditional imaging model ( Z=4.013, 4.272, P<0.001) and that of the radiomics model ( Z=4.819, 3.784, P<0.001), respectively. In the validation cohort, the combined model yielded an NRI of 20.43% (95% CI 10.43%-30.44%, P<0.001) and 20.21% (95% CI 9.62%-30.80%, P<0.001) for identifying culprit lesions compared with the traditional imaging model and the radiomics model, respectively. In the test cohort, the combined model yielded an NRI of 28.05% (95% CI 16.72%-39.38%, P<0.001) and 23.57% (95% CI 13.58%-33.56%, P<0.001) for identifying culprit lesions compared with the traditional imaging model and the radiomics model, respectively. DCA showed the combined model had the highest clinical net benefit. The correlation heatmap showed the radiomics score was not correlated or only weakly correlated with traditional CCTA factors. SHAP indicated the radiomics and CAD-RADS score contributed significantly to the model. Conclusion:The CCTA-based traditional features and radiomics of plaque have favorable performance for the identification of culprit plaques in patients with AMI.
7.Comparison of the efficacy of posterior "S" shape incision versus medial small incision with suture anchor for treating avulsion fractures of the tibial insertion of the posterior cruciate ligament
Tiangang CHEN ; Heng ZHANG ; Shuai SONG ; Lei ZHANG ; Shifeng DAI ; Kunnan XIE
Clinical Medicine of China 2025;41(2):133-139
Objective:To compare and analyze the clinical efficacy of using a posterior "S" shape incision versus a medial small incision with suture anchors in the treatment of avulsion fractures at the tibial insertion of the posterior cruciate ligament (PCL).Methods:A retrospective study was conducted on clinical data from patients with PCL tibial avulsion fractures who met surgical criteria and were treated at Department of Joint 2, Tangshan Second Hospital from March 2021 to May 2023. Among those patients, there were 25 cases classified as Meyers-McKeever type Ⅱ and 41 cases as type Ⅲ. 32 patients who underwent surgery through the posterior "S" shape incision served as the control group; based on matched baseline characteristics, 34 patients who underwent surgery through the medial small incision were selected as the observation group. Both groups received fixation of the avulsion fracture with suture anchors. Surgical indicators, as well as Lysholm scores, International Knee Documentation Committee (IKDC) scores, visual analogue scale (VAS) scores, range of motion (ROM) of the injured knee, the difference in posterior tibial translation between both sides (calculated by measuring the posterior translation on both sides), and the incidence of postoperative complications were collected at 1, 3, and 6 months post-surgery. Comparative analyses were conducted to evaluate postoperative functional recovery. Chi-square tests were used for categorical data comparison, and t-tests were employed for normally distributed continuous data.Results:The observation group had shorter incision lengths ((5.71±1.85) cm), less intraoperative blood loss ((74.87±20.74) mL), and shorter operation times ((48.76±6.46) min) compared to the control group ((12.45±1.52) cm, (120.29±31.12) mL, (61.14±10.23) min), and the differences were statistically significant ( t values were 16.21, 7.02, 5.92, respectively; all P<0.001). At 3 and 6 months post-surgery, the Lysholm ((79.67±3.08), (91.16±2.23) points) and IKDC scores ((84.67±5.08), (93.16±3.23) points) in the observation group were significantly higher than those ((65.29±3.84), (79.52±2.98), (79.29±4.84), (85.32±3.98) points) in the control group, and the differences were statistically significant ( t values were 16.72, 18.04, 4.40, 8.81, respectively; all P<0.001). At 3 and 6 months, the VAS scores ((2.83±0.38), (2.12±0.34) points) in the control group were significantly higher than those ((2.41±0.25), (1.73±0.49) points) in the observation group ( t values were 5.34 and 3.73 respectively, both P<0.001). At 6 months post-surgery, all fractures had healed, in the observation group and control group the ROM ((130.56±5.96)° and (121.45±7.32)°) of the injured knee had increased, and the difference in posterior tibial translation ((1.17±0.61) and (1.94±0.57) mm) had decreased. However, the ROM in the observation group was significantly greater than that in the control group, and the difference in posterior tibial translation was significantly lower in the observation group, with statistically significant differences ( t values were 5.56 and 5.29 respectively; both P<0.001). Conclusions:Compared to the posterior "S" shape incision approach, the medial small incision approach with suture anchors for treating PCL tibial avulsion fractures offers advantages such as reduced trauma, shorter operation time, and less intraoperative blood loss, which is more beneficial for knee joint functional recovery.
8.Prognostic analysis of postoperative adjuvant therapy for hepatocellular carcinoma after con-version therapy of combined targeted therapy and immunotherapy followed by sequential hepatectomy: a multicenter study
Kongying LIN ; Jia LIN ; Zisen LAI ; Yongping LAI ; Kui WANG ; Jinhong CHEN ; Zhibo ZHANG ; Jingdong LI ; Sheng TAI ; Shifeng WANG ; Siming ZHENG ; Jianxi ZHANG ; Lu ZHENG ; Kai WANG ; Jiacheng ZHANG ; Jiahui LYU ; Liming HUANG ; Yongyi ZENG
Chinese Journal of Digestive Surgery 2025;24(1):103-112
Objective:To investigate the prognosis of postoperative adjuvant therapy for hepatocellular carcinoma after conversion therapy of combined targeted therapy and immunotherapy followed by sequential hepatectomy.Methods:The retrospective cohort study was conducted. The clinicopathological data of 103 patients with initially unresectable hepatocellular carcinoma (HCC) who were admitted to 11 medical centers in China, including Mengchao Hepatobiliary Hospital of Fujian Medical University et al, from November 2019 to May 2023 were collected. There were 83 males and 20 females, aged (54±12)years. All 103 patients underwent conversion therapy of tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) successfully followed by sequential hepatectomy, of which 72 patients undergoing postoperative adjuvant therapy were divided into the adjuvant therapy group, and 31 patients undergoing postoperative follow-up monitoring were divided into the follow-up monitoring group. Observation indicators: (1) follow-up and postoperative condi-tions; (2) analysis of factors influencing recurrence-free survival time of patients; (3) stratified ana-lysis. Comparison of count data between group was conducted using the chi-square test or Fisher exact probability. The R software was used to draw survival curves, and the Log-rank test was used for survival analysis. Univariate and multivariate analyses were conducted using the Cox proportional hazard model. Results:(1) Follow-up and postoperative conditions. All 103 patients were followed up for 21.0(range, 1.9?47.2)months, with the median recurrence-free survival time of 28.7 months and the 1-, 2-, 3-year recurrence-free survival rates of 68.6%, 55.6%, 41.2%. The median overall survival time of 103 patients was unreached, and the 1-, 2-, 3-year overall survival rates were 90.9%, 82.1%, 69.6%, respectively. The median recurrence-free survival time was 33.1 months in patients of the adjuvant therapy group, with the 1-, 2-year recurrence-free survival rates as 77.2%, 61.5%. The median recurrence-free survival time was 11.1 months in patients of the follow-up monitoring group, with the 1-, 2-year recurrence-free survival rates as 46.6%, 40.8%. There was a significant difference in recurrence-free survival between the two groups of patients ( χ2=5.492, P<0.05). (2) Analysis of factors influencing recurrence-free survival time of patients. Results of multivariate analy-sis showed that pathologic complete response and postoperative adjuvant therapy were independent factors influencing recurrence-free survival time of HCC patients undergoing conversion therapy of combined targeted therapy and immunotherapy followed by sequential hepatectomy ( hazard ratio=0.297, 0.492, 95% confidence interval as 0.137?0.647, 0.268?0.903, P<0.05). (3) Stratified analysis. Of the 71 patients with non-pathologic complete response, the median recurrence-free survival time of 48 patients in the adjuvant therapy group was 24.0 months, with the 1-, 2-year recurrence-free survival rates as 67.4%, 48.8%. The median recurrence-free survival time of 23 patients with non-pathological complete response in the follow-up monitoring group was 7.4 months, with the 1-, 2-year recurrence-free survival rates as 35.0%, 26.3%. There was a significant difference in recurrence-free survival between the 48 patients with non-pathologic complete response in the adjuvant therapy group and the 23 patients with non-pathologic complete response in the follow-up monitoring group ( χ2=5.241, P<0.05). Conclusion:For HCC patients with conversion therapy of TKIs and ICIs followed by sequential hepatectomy, postoperative adjuvant therapy, compared to postoperative follow-up monitoring, can prolong the recurrence-free survival time of patients, of whom cases with non-pathologic complete response can benefit from adjuvant therapy.
9.The value of coronary CT angiography-based traditional features and radiomics in identification of culprit plaques to cause acute myocardial infarction
Pei NIE ; Shuo ZHANG ; Yan DENG ; Shifeng YANG ; Xinxin YU ; Kaiyue ZHI ; He ZHU ; Peng LI ; Jingjing CUI ; Wenjing CHEN ; Yanmei WANG ; Yuchao XU ; Dapeng HAO ; Ximing WANG
Chinese Journal of Radiology 2025;59(9):1017-1028
Objective:To investigate the value of coronary CTA (CCTA)-based traditional features and radiomics of plaque in the identification of culprit lesions that caused acute myocardial infarction (AMI).Methods:This was a retrospective multicenter study. From July 2016 to November 2023, a total of 344 patients from the Affiliated Hospital of Qingdao University (training cohort, n=184), Shandong Provincial Hospital Affiliated to Shandong First Medical University (validation cohort, n=88) and Qilu Hospital of Shandong University (test cohort, n=72) who received percutaneous coronary intervention (PCI) due to AMI and underwent CCTA within 48 hours of AMI were enrolled. The culprit plaques and non-culprit plaques were identified using a combination of electrocardiogram, CCTA, and angiographic findings. The vessel, plaque location, plaque type, Coronary Artery Disease-Reporting and Data System (CAD-RADS) score, high-risk plaque characteristics, plaque length, plaque volume, and burden were analyzed, and 1 904 radiomics features were extracted for each plaque. The traditional imaging model, the radiomics model, and the combined model were established by using multivariate Logistic regression analysis. The area under the receiver operating characteristic curve (AUC) was used to evaluate the performance of each model in identifying culprit lesions. The DeLong test was used for the comparison of AUC between every two models. The net reclassification index (NRI) was used to evaluate the incremental value of the combined model to the traditional imaging model and the radiomics model. The decision curve analysis (DCA) was used to assess the clinical net benefit of these models. A correlation heatmap was used to evaluate the correlation between the radiomics score and traditional CCTA factors. The interpretable analysis of the decision process of the combined model was performed by the Shapley Additive exPlanations (SHAP). Results:In the validation cohort and the test cohort, the AUC of the traditional imaging model developed by the vessel, plaque type, positive remodeling and CAD-RADS score was 0.898 (95% CI 0.869-0.922) and 0.881 (95% CI 0.848-0.910), respectively. The radiomics model developed by six radiomics features was 0.863 (95% CI 0.831-0.891) and 0.863 (95% CI 0.827-0.864), respectively. The AUC of the combined model was 0.930 (95% CI 0.905-0.950)and 0.919 (95% CI 0.889-0.942), respectively. In the validation cohort and the test cohort, the AUC of the combined model was higher than that of the traditional imaging model ( Z=4.013, 4.272, P<0.001) and that of the radiomics model ( Z=4.819, 3.784, P<0.001), respectively. In the validation cohort, the combined model yielded an NRI of 20.43% (95% CI 10.43%-30.44%, P<0.001) and 20.21% (95% CI 9.62%-30.80%, P<0.001) for identifying culprit lesions compared with the traditional imaging model and the radiomics model, respectively. In the test cohort, the combined model yielded an NRI of 28.05% (95% CI 16.72%-39.38%, P<0.001) and 23.57% (95% CI 13.58%-33.56%, P<0.001) for identifying culprit lesions compared with the traditional imaging model and the radiomics model, respectively. DCA showed the combined model had the highest clinical net benefit. The correlation heatmap showed the radiomics score was not correlated or only weakly correlated with traditional CCTA factors. SHAP indicated the radiomics and CAD-RADS score contributed significantly to the model. Conclusion:The CCTA-based traditional features and radiomics of plaque have favorable performance for the identification of culprit plaques in patients with AMI.
10.Quantitative analysis of the distance between articular disc and condyle in patients with temporomandibular disorders
Lei SUN ; Shifeng DAI ; Yuhua CHEN ; Xinyi XU ; Kele JIANG ; Xiaowen LI ; Chengjing LI ; Tingting WU
Journal of Shanghai Jiaotong University(Medical Science) 2025;45(6):684-692
Objective·To evaluate the relationships between disc-condyle distance and anterior disc displacement,as well as between disc-condyle distance and disc morphology,in patients with temporomandibular disorders(TMD)using magnetic resonance imaging(MRI)of the temporomandibular joint(TMJ).Methods·From September 2023 to March 2024,90 patients(180 TMJs)who visited the TMJ clinic of Department of Stomatology,The Second Affiliated Hospital of Anhui Medical University,with clinical symptoms of TMD and were diagnosed via MRI with either anterior disc displacement or no significant displacement,were included.Clinical data were collected,and MRI images were used to measure the angle of disc displacement,disc-condyle distance,disc length,and thickness.The degree of disc deformation was assessed.The relationships between clinical symptoms and anterior disc displacement,between anterior disc displacement and both disc morphology and disc-condyle distance,and between disc-condyle distance and disc morphology were analyzed.Results·Among the 90 patients,there were 16 males and 74 females,with a mean age of(28.1±14.5)years.Among the 180 TMJs,175 had clinical symptoms and 5 were asymptomatic.There were 40 joints with no displacement,78 with reducible anterior disc displacement,and 62 with irreducible anterior disc displacement.In the joints with irreducible anterior disc displacement,the proportion of those with two or more symptoms was slightly higher at 62.9%,but the difference was not statistically significant compared with the joints with no displacement or reducible anterior disc displacement.MRI assessment revealed that in the joints with irreducible anterior disc displacement,the proportion of disc deformation type Ⅲ or higher was significantly higher compared with the non-displaced joints(P<0.001).The disc length was significantly shorter(P<0.001),and the intermediate zone thickness was significantly greater(P<0.001)compared with the non-displaced joints.The disc displacement angles at centric closure and maximum opening were also significantly larger(P<0.001).The disc-condyle distance was 3.10(2.70,3.70)mm for non-displaced joints,3.40(3.00,4.00)mm for joints with reducible anterior disc displacement,and 6.60(4.78,7.90)mm for joints with irreducible anterior disc displacement,with significant differences(P<0.001).The disc-condyle distance was 3.10(2.80,3.60)mm for type Ⅰ discs,3.70(3.10,4.60)mm for type Ⅱ discs,5.10(4.00,7.30)mm for type Ⅲ discs,and 6.80(4.98,8.20)mm for type Ⅳ/Ⅴ discs,with significant differences(P<0.001).The disc-condyle distance was negatively correlated with disc length(rs=-0.469,P<0.001),positively correlated with intermediate zone thickness(rs=0.319,P<0.001),and positively correlated with disc displacement angle at centric closure(rs=0.626,P<0.001).Conclusion·With increasing severity of disc deformation,intermediate zone thickness,and disc displacement angle at centric closure,as well as decreasing disc length,the disc-condyle distance increases.The disc-condyle distance is an important indicator for MRI assessment of pathological changes in TMD.

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