1.Analysis on Clinical Trial Registration Status of TCM for the Treatment of Diabetic Nephropathy
Jiawei ZHANG ; Zhifen ZHAO ; Xiangge REN ; Peidong ZHAO ; Shoudao LI ; Tengfei SONG ; Wensheng ZHAI
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(10):73-79
Objective To analyze the current status of clinical trial registration in the TCM treatment of diabetic nephropathy(DN);To provide references for the registration and implementation of relevant clinical trials.Methods Clinical trials about TCM treatment for DN registered in the Chinese Clinical Trial Registry(ChiCTR)and the U.S.Clinical Trial Registry(ClinicalTrials.gov)from their inception to August 18,2024 were retrieved.The following information was analyzed:registration year,geographical distribution,funding sources,TCM syndrome patterns of participants,number of research centers,sample size,study type,study design,randomization method,blinding method,intervention measures,outcome indicators and safety indicators.Results A total of 88 clinical trials were included,comprising 79 interventional studies and 9 observational studies.The number of registrations has increased annually.The domestic registered trials were distributed across 17 provincial-level administrative regions in China,with Beijing and Shanghai having the highest number of registrations.The primary sources of funding were local and national government funds.The most common TCM syndrome pattern among participants was qi-yin deficiency with blood stasis.Most trials were single-center studies,with the majority having a sample size between 31 and 60.The predominant study type was interventional,mostly randomized controlled trials(RCTs),with simple randomization being the most frequently used method.31 trials reported blinding methods,with double-blinding being the most common.The intervention measures were mostly oral Chinese patent medicines or TCM compounds,and the outcome indicators were mainly efficacy indicators,with less safety indicators.Conclusion The number of registered clinical trials on TCM treatment for DN has increased annually;however,the overall number remains limited.There is uneven regional distribution and incomplete registration information for various factors such as randomization methods,blinding methods,number of research centers,intervention measures,and outcome indicators.
2.Differentiating bronchiolar adenoma from minimally invasive adenocarcinoma based on high-resolution CT features
Ziqian ZHAO ; Dan HAN ; Haiyan YANG ; Tengfei KE ; Wenyan WEI ; Yan WU ; Ying TAO ; Xinhui YANG ; Fengyi LI ; Wen ZHAO
Journal of Practical Radiology 2025;41(10):1633-1638
Objective To explore the pathological features of bronchiolar adenoma(BA)and its specific high-resolution computed tomography(HRCT)signs,and to differentiate BA from minimally invasive adenocarcinoma(MIA)using a non-invasive preoperative method.Methods A total of 80 patients with BA and 130 patients with MIA were retrospectively selected,and the clinical information and HRCT features were compared.All cases were divided into development set and test set at a 7︰3 ratio.Logistic regression analysis was used to screen the independent predictors of MIA and construct a model.Results There were significant differences in age,lobe distribution,density,vacuole sign,tumor-related vessels number(TVN),and distance to pleura(DTP)between BA and MIA patients(P<0.05).Age,density,TVN,DTP and long diameter were identified as independent predictors of MIA.A model was constructed,with area under the curve(AUC)of 0.887 and 0.884 in the development and test sets,respectively.Conclusion The model based on HRCT morphological features of BA and MIA demonstrates superior diagnostic performance compared to individual CT morphological features.
3.Analysis on Clinical Trial Registration Status of TCM for the Treatment of Diabetic Nephropathy
Jiawei ZHANG ; Zhifen ZHAO ; Xiangge REN ; Peidong ZHAO ; Shoudao LI ; Tengfei SONG ; Wensheng ZHAI
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(10):73-79
Objective To analyze the current status of clinical trial registration in the TCM treatment of diabetic nephropathy(DN);To provide references for the registration and implementation of relevant clinical trials.Methods Clinical trials about TCM treatment for DN registered in the Chinese Clinical Trial Registry(ChiCTR)and the U.S.Clinical Trial Registry(ClinicalTrials.gov)from their inception to August 18,2024 were retrieved.The following information was analyzed:registration year,geographical distribution,funding sources,TCM syndrome patterns of participants,number of research centers,sample size,study type,study design,randomization method,blinding method,intervention measures,outcome indicators and safety indicators.Results A total of 88 clinical trials were included,comprising 79 interventional studies and 9 observational studies.The number of registrations has increased annually.The domestic registered trials were distributed across 17 provincial-level administrative regions in China,with Beijing and Shanghai having the highest number of registrations.The primary sources of funding were local and national government funds.The most common TCM syndrome pattern among participants was qi-yin deficiency with blood stasis.Most trials were single-center studies,with the majority having a sample size between 31 and 60.The predominant study type was interventional,mostly randomized controlled trials(RCTs),with simple randomization being the most frequently used method.31 trials reported blinding methods,with double-blinding being the most common.The intervention measures were mostly oral Chinese patent medicines or TCM compounds,and the outcome indicators were mainly efficacy indicators,with less safety indicators.Conclusion The number of registered clinical trials on TCM treatment for DN has increased annually;however,the overall number remains limited.There is uneven regional distribution and incomplete registration information for various factors such as randomization methods,blinding methods,number of research centers,intervention measures,and outcome indicators.
4.Evaluation of the accuracy of three-dimensional data acquisition from liquid-inter-ference surfaces assisted by a scanner head with a compressed airflow system
Xinkai XU ; Jianjiang ZHAO ; Sukun TIAN ; Zhongning LIU ; Xiaoyi ZHAO ; Xiaobo ZHAO ; Tengfei JIANG ; Xiaojun CHEN ; Chao MA ; Yuchun SUN
Journal of Peking University(Health Sciences) 2025;57(1):121-127
Objective:To quantitatively evaluate the accuracy of data obtained from liquid-interference surfaces using an intraoral 3D scanner(IOS)integrated with a compressed airflow system,so as to pro-vide clinical proof of accuracy for the application of the compressed airflow system-based scanning head in improving data quality on liquid-interference surfaces.Methods:The study selected a standard model as the scanning object,adhering to the"YY/T 1818-2022 Dental Science Intraoral Digital Impression Scanner"guidelines,a standard that defined parameters for intraoral scanning.To establish a baseline for accuracy,the ATOS Q 12M scanner,known for its high precision,was used to generate true reference values.These true values served as the benchmark for evaluating the IOS performance.Building on the design of an existing scanner,a new scanning head was developed to integrate with a compressed airflow system.This new design aimed to help the IOS capture high-precision data on sur-faces where liquid-interference,such as saliva,might otherwise degrade scanning accuracy.The tradi-tional scanning method,without airflow assistance,was employed as a control group for comparison.The study included five groups in total,one control group and four experimental groups,to investigate the effects of scanning lens obstruction,airflow presence,liquid media,and the use of the new scan-ning head on scanning process and accuracy.Each group underwent 15 scans,generating ample data for a robust statistical comparison.By evaluating trueness and precision in each group,the study as-sessed the impact of the compressed airflow system on the accuracy of IOS data collected from liquid-interference surfaces.Additionally,we selected Elite and Primescan scanners as references for numeri-cal accuracy values.Results:The scanning accuracy on liquid-interference surfaces was significantly reduced in terms of both trueness and precision[Trueness:18.5(6.5)vs.38.0(6.7),P<0.05;Preci-sion:19.1(8.5)vs.31.7(15.0),P<0.05].The use of the new scanning head assisted by the com-pressed airflow system significantly improved the scanning accuracy[Trueness:22.3(7.6)vs.38.0(6.7),P<0.05;Precision:25.8(9.6)vs.31.7(15.0),P<0.05].Conclusion:The scanning head based on the compressed airflow system can assist in improving the accuracy of data obtained from liquid-inter-ference surfaces by the IOS.
5.Ultrasonic manifestations of local recurrence of breast cancer after surgery
Na ZHAO ; Shuai ZHENG ; Zhiguang CHEN ; Kai DU ; Liqian WANG ; Lijuan DU ; Tengfei YU ; Wei ZHANG
Chinese Journal of Medical Imaging Technology 2025;41(2):258-262
Objective To observe the ultrasonic manifestations of local recurrence(LR)of breast cancer after surgery.Methods Totally 82 female breast cancer patients with local hypoechoic in surgical area who underwent ultrasound follow-up were enrolled and divided into LR group(n=18)and non LR group(n=64)according to the local hypoechoic was LR or not.Clinical data and ultrasonic manifestations of primary lesion before operation and postoperative local hypoechoic were observed and compared between groups.Results Significant differences of surgical resection type,molecular subtype,status of smooth muscle actin,Calponin status,Ki-67 status,clinical staging,the maximum diameter and posterior echo of the primary lesion,as well as of involved tissue layer,location,long axis parallel to the skin or not,edge,internal echo,posterior echo,skin change and Adler blood flow grading of local hypoechoic in resection area were found between groups(all P<0.05).Conclusion Ultrasonic manifestations of LR of breast cancer after surgery had certain characteristics.
6.Ultrasonic manifestations of local recurrence of breast cancer after surgery
Na ZHAO ; Shuai ZHENG ; Zhiguang CHEN ; Kai DU ; Liqian WANG ; Lijuan DU ; Tengfei YU ; Wei ZHANG
Chinese Journal of Medical Imaging Technology 2025;41(2):258-262
Objective To observe the ultrasonic manifestations of local recurrence(LR)of breast cancer after surgery.Methods Totally 82 female breast cancer patients with local hypoechoic in surgical area who underwent ultrasound follow-up were enrolled and divided into LR group(n=18)and non LR group(n=64)according to the local hypoechoic was LR or not.Clinical data and ultrasonic manifestations of primary lesion before operation and postoperative local hypoechoic were observed and compared between groups.Results Significant differences of surgical resection type,molecular subtype,status of smooth muscle actin,Calponin status,Ki-67 status,clinical staging,the maximum diameter and posterior echo of the primary lesion,as well as of involved tissue layer,location,long axis parallel to the skin or not,edge,internal echo,posterior echo,skin change and Adler blood flow grading of local hypoechoic in resection area were found between groups(all P<0.05).Conclusion Ultrasonic manifestations of LR of breast cancer after surgery had certain characteristics.
7.Differentiating bronchiolar adenoma from minimally invasive adenocarcinoma based on high-resolution CT features
Ziqian ZHAO ; Dan HAN ; Haiyan YANG ; Tengfei KE ; Wenyan WEI ; Yan WU ; Ying TAO ; Xinhui YANG ; Fengyi LI ; Wen ZHAO
Journal of Practical Radiology 2025;41(10):1633-1638
Objective To explore the pathological features of bronchiolar adenoma(BA)and its specific high-resolution computed tomography(HRCT)signs,and to differentiate BA from minimally invasive adenocarcinoma(MIA)using a non-invasive preoperative method.Methods A total of 80 patients with BA and 130 patients with MIA were retrospectively selected,and the clinical information and HRCT features were compared.All cases were divided into development set and test set at a 7︰3 ratio.Logistic regression analysis was used to screen the independent predictors of MIA and construct a model.Results There were significant differences in age,lobe distribution,density,vacuole sign,tumor-related vessels number(TVN),and distance to pleura(DTP)between BA and MIA patients(P<0.05).Age,density,TVN,DTP and long diameter were identified as independent predictors of MIA.A model was constructed,with area under the curve(AUC)of 0.887 and 0.884 in the development and test sets,respectively.Conclusion The model based on HRCT morphological features of BA and MIA demonstrates superior diagnostic performance compared to individual CT morphological features.
8.Application value of 18F-D3FSP PET/CT in patients with cognitive impairment of varying degrees
Sihao LIANG ; Anqi LI ; Ruiyue ZHAO ; Jingwen LI ; Peng HOU ; Shuang XIONG ; Zhuohua WU ; Xiang CHEN ; Yuying HUANG ; Tengfei GUO ; Xinlu WANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2024;44(5):260-265
Objective:To explore the effectiveness of 18F-deuterated-Florbetapir (D3FSP) PET/CT imaging in detecting β-amyloid (Aβ) deposition in the brain and its correlation with plasma biomarkers. Methods:A retrospective analysis was conducted on 79 patients (32 males, 47 females; age(66±7)years) who underwent 18F-D3FSP PET/CT imaging from June 2022 to November 2023 at the First Affiliated Hospital, Guangzhou Medical University, as a part of the Greater Bay Area Healthy Aging Brain Longitudinal Cohort Study (GHABS). Based on the Alzheimer′s Disease Neuroimaging Initiative cohort standard protocol, patients were categorized into cognitively unimpaired (CU) group, mild cognitive impairment (MCI) group, and Alzheimer′s disease (AD) group. Brain regions were segmented using the AW workstation and the SUV ratio (SUVR) was calculated with the cerebellum as the reference region. One-way analysis of variance, Bonferroni correction and Pearson correlation analysis were used to analyze data. The ROC curve analysis was used to analyze the cut-off value and the diagnostic efficacy of SUVR. Results:There were 48, 15 and 16 cases in CU, MCI and AD groups respectively. During the transition from CU to MCI and then to AD, there was a rising trend in SUVR ( F values: 11.15-22.38, all P<0.001) across the whole brain and various brain regions (bilateral frontal lobes, bilateral anterior cingulate gyrus, bilateral precuneus, bilateral parietal lobes, bilateral lateral temporal lobes, and bilateral occipital lobes). SUVRs of the right anterior cingulate gyrus and bilateral precuneus were different between the CU and MCI groups (all P<0.017), and those of bilateral frontal lobes, right precuneus, bilateral parietal lobes, bilateral lateral temporal lobes, and bilateral occipital lobes were different between the MCI and AD groups (all P<0.017). SUVRs of brain regions were negatively correlated with cognitive scale scores ( r values: from -0.57 to -0.37, all P<0.001), and were positively correlated with plasma phosphorylated tau181 (p-tau181, r values: 0.50-0.61, all P<0.001). The ROC curve analysis suggested that the cut-off value of SUVR in the precuneus for distinguishing CU from AD was 1.20, with the AUC, sensitivity, specificity and accuracy of 0.85, 12/16, 91.7%(44/48)and 87.5%(56/64), respectively. Conclusion:18F-D3FSP PET/CT imaging has good clinical application value in assessing the deposition sites and the extent of Aβ in the brain, which is related to clinical cognition and plasma p-tau181 level.
9.New intraoral digital impression with pneumatic gingival retraction used in the restoration of crown for posterior teeth: a case report
Xinkai XU ; Meizi ZHANG ; Zhongning LIU ; Yuchun SUN ; Hu CHEN ; Weiwei LI ; Xiaoyi ZHAO ; Yongjie JIA ; Shujuan XIAO ; Chao MA ; Xiaojun CHEN ; Tengfei JIANG ; Xiaobo ZHAO ; Sukun TIAN
Chinese Journal of Stomatology 2024;59(10):1044-1048
In fixed prosthodontics, clear exposure of the preparation margin is the prerequisite for obtaining accurate digital impressions and improving the marginal fit of restorations. To resolve the issues associated with the cord retraction technique, such as pain, acute injury, and prolonged procedural time, this study proposes a new technology for intraoral digital impression taking with pneumatic gingival retraction. The new scanning head blows a high-speed airflow that instantaneously separates the free gingiva, locally exposing the subgingival preparation margin. Combined with the farthest point preservation stitching algorithm based on the distance from the normal vector and high-speed laser scanning photography, it achieves global preparation edge data and gingival reconstruction, realizing painless, non-invasive, and efficient precise acquisition of the preparation margin. Using this new technique, a patient with a full porcelain crown restoration on a posterior tooth was treated. The digital impression revealed a clear margin of the preparation, and the crown made from this data has a good marginal fit.
10.Progress in methodological research on bridging the efficacy-effectiveness gap of clinical interventions (1): to improve the validity of real-world evidence
Zuoxiang LIU ; Zilin LONG ; Zhirong YANG ; Shuyuan SHI ; Xinran XU ; Houyu ZHAO ; Zuyao YANG ; Zhu FU ; Haibo SONG ; Tengfei LIN ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2024;45(2):286-293
Objective:Differences between randomized controlled trial (RCT) results and real world study (RWS) results may not represent a true efficacy-effectiveness gap because efficacy-effectiveness gap estimates may be biased when RWS and RCT differ significantly in study design or when there is bias in RWS result estimation. Secondly, when there is an efficacy- effectiveness gap, it should not treat every patient the same way but assess the real-world factors influencing the intervention's effectiveness and identify the subgroup likely to achieve the desired effect.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:Ten articles were included to discuss how to use the RCT research protocol as a template to develop the corresponding RWS research protocol. Moreover, based on correctly estimating the efficacy-effectiveness gap, evaluate the intervention effect in the patient subgroup to confirm the subgroup that can achieve the expected benefit-risk ratio to bridge the efficacy-effectiveness gap.Conclusion:Using real-world data to simulate key features of randomized controlled clinical trial study design can improve the authenticity and effectiveness of study results and bridge the efficacy-effectiveness gap.

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