1.A qualitative study on digital-intelligent equipment empowering"generalized"development of traditional Chinese medicine inspection
Chen ZHAO ; Aomeng ZHANG ; Zehui YE ; Jiaying LUO ; Qiang SHI ; Ying YU ; Xiaoyu ZHANG ; Yin JIANG ; Zhicong ZENG ; Fengxia LIN ; Yinghui JIN ; Xue XU ; Xiaowei ZHANG ; Liangzhen YOU ; Yipin FAN ; Dameng YU ; Shaoyang MEN ; Jian DU ; Rui XU ; Ruijin QIU ; Yingjie ZHI ; Zhineng CHEN ; Xuan ZHANG ; Hongcai SHANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(8):1052-1061
Objective This study investigated feasible cases and their significance in promoting the"generalized"development of inspection through digital-intelligent equipment.Methods A qualitative research approach was used,involving interviews conducted between February 2025 and March 2025 with experts in traditional Chinese medicine diagnostics,clinical research methodology,medical engineering integration,and related disciplines,using both online and offline methods.In accordance with the Consolidated Criteria for Reporting Qualitative Research,feasible cases involving the specific application of digital equipment in various parts of observation were collected through item enrichment.The significance of extending observation capabilities via these cases was analyzed,along with the overall implications of integrating digital technologies with traditional inspection method.Results Interviews were completed with 11 experts from domestic universities and research institutes in the fields of traditional Chinese medicine diagnosis,medical engineering integration,and related disciplines.A total of 78 feasible cases of digital-intelligent inspection were identified,along with 69 insights regarding the significance of enhancing the inspection capabilities.These insights were synthesized into two dimensions and 23 holistic meanings.The first dimension is to expand the scope of inspection,including obtaining internal environmental characteristics,observing external environmental characteristics,expanding thermodynamic characteristic data,and crossing time and space.The second dimension is to improve the quality of observation and diagnosis information collection and analysis,including 19 specific meanings,such as standardized collection environment,objective quantification,and refined observation.Conclusion Digital-intelligent equipment plays a significant role in expanding the scope of inspection content and achieving high-quality acquisition and analysis of extensive inspection information.These advancements extend and enrich the capabilities of traditional inspection method in traditional Chinese medicine.
2.A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
Lai WEI ; Jia SHANG ; Xuan AN ; Guoqiang ZHANG ; Yujuan GUAN ; Hongxin PIAO ; Jinglan JIN ; Lang BAI ; Xingxiang YANG ; Daokun YANG ; Xinhua LUO ; Shufang YUAN ; Yingren ZHAO ; Yingjie MA ; Guangming LI ; Feng LIN ; Xiaoping WU ; Jiawei GENG ; Guizhou ZOU ; Jiabao CHANG ; Zuojiong GONG ; Xiaorong MAO ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2025;33(6):560-569
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
3.A qualitative study on digital-intelligent equipment empowering"generalized"development of traditional Chinese medicine inspection
Chen ZHAO ; Aomeng ZHANG ; Zehui YE ; Jiaying LUO ; Qiang SHI ; Ying YU ; Xiaoyu ZHANG ; Yin JIANG ; Zhicong ZENG ; Fengxia LIN ; Yinghui JIN ; Xue XU ; Xiaowei ZHANG ; Liangzhen YOU ; Yipin FAN ; Dameng YU ; Shaoyang MEN ; Jian DU ; Rui XU ; Ruijin QIU ; Yingjie ZHI ; Zhineng CHEN ; Xuan ZHANG ; Hongcai SHANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(8):1052-1061
Objective This study investigated feasible cases and their significance in promoting the"generalized"development of inspection through digital-intelligent equipment.Methods A qualitative research approach was used,involving interviews conducted between February 2025 and March 2025 with experts in traditional Chinese medicine diagnostics,clinical research methodology,medical engineering integration,and related disciplines,using both online and offline methods.In accordance with the Consolidated Criteria for Reporting Qualitative Research,feasible cases involving the specific application of digital equipment in various parts of observation were collected through item enrichment.The significance of extending observation capabilities via these cases was analyzed,along with the overall implications of integrating digital technologies with traditional inspection method.Results Interviews were completed with 11 experts from domestic universities and research institutes in the fields of traditional Chinese medicine diagnosis,medical engineering integration,and related disciplines.A total of 78 feasible cases of digital-intelligent inspection were identified,along with 69 insights regarding the significance of enhancing the inspection capabilities.These insights were synthesized into two dimensions and 23 holistic meanings.The first dimension is to expand the scope of inspection,including obtaining internal environmental characteristics,observing external environmental characteristics,expanding thermodynamic characteristic data,and crossing time and space.The second dimension is to improve the quality of observation and diagnosis information collection and analysis,including 19 specific meanings,such as standardized collection environment,objective quantification,and refined observation.Conclusion Digital-intelligent equipment plays a significant role in expanding the scope of inspection content and achieving high-quality acquisition and analysis of extensive inspection information.These advancements extend and enrich the capabilities of traditional inspection method in traditional Chinese medicine.
4.A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
Lai WEI ; Jia SHANG ; Xuan AN ; Guoqiang ZHANG ; Yujuan GUAN ; Hongxin PIAO ; Jinglan JIN ; Lang BAI ; Xingxiang YANG ; Daokun YANG ; Xinhua LUO ; Shufang YUAN ; Yingren ZHAO ; Yingjie MA ; Guangming LI ; Feng LIN ; Xiaoping WU ; Jiawei GENG ; Guizhou ZOU ; Jiabao CHANG ; Zuojiong GONG ; Xiaorong MAO ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2025;33(6):560-569
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
5.The value of a nomogram for predicting the outcome of intracerebral hemorrhage based on clinical characteristics and diffusion-weighted imaging of hyperintense lesions
Ailing ZHANG ; Long TIAN ; Na DING ; Ling CUI ; Hao HU ; Mengyang REN ; Peihong QI ; Yingjie SHANG
Chinese Journal of Internal Medicine 2023;62(10):1187-1193
Objective:To investigate the value of a nomogram predicting the outcome of intracerebral hemorrhage (ICH) based on clinical characteristics and diffusion-weighted imaging (DWI) of hyperintense lesions.Methods:A case-control study. Consecutive patients, aged 30-88(59±13) years old, with ICH were recruited at the Stroke Center of Zhengzhou People′s Hospital from January 2018 to August 2021. Patients were divided into a group with DWI lesions and a group without DWI lesions depending on whether there were DWI hyperintense lesions distant from the hematoma. Prognosis was evaluated at 90 days via the modified Rankin Scale (mRS). Univariate and multivariable logistic regression models were used to identify independent predictors of a poor ICH outcome (mRS score≥4), and a nomogram model was developed. The performance of the nomogram was validated via the area under the receiver operating characteristic curve (AUC) and a calibration chart.Results:Of the 303 patients included in the study, 24.8% presented with DWI lesions; 17.5% with asymptomatic DWI lesions and 7.3% with symptomatic DWI lesions. Poor outcomes were significantly more frequent in the group with DWI lesions than in the group without DWI lesions ( χ2=21.32, P<0.001). In multivariable regression analysis, age [odds ratio ( OR)=1.032, 95% confidence interval ( CI) 1.002-1.063, P=0.035], hematoma volume ( OR=1.050, 95% CI 1.011-1.090, P=0.012), hematoma location ( OR=3.839, 95% CI 1.248-11.805, P=0.019), DWI lesions ( OR=3.955, 95% CI 1.906-8.206, P<0.001), and baseline NIHSS scores ( OR=1.102, 95% CI 1.038-1.170, P=0.001) were independent predictors of a poor outcome. In subgroup analysis patients with asymptomatic DWI lesions had a 3-fold greater risk of a poor outcome compared to those without DWI lesions ( OR=3.135, 95% CI 1.382-7.112, P=0.006), and patients with symptomatic DWI lesions had a 7-fold greater risk of a poor outcome compared to those without DWI lesions ( OR=7.126, 95% CI 2.279-22.277, P=0.001). A nomogram model was established based on the independent predictors for a poor outcome. The AUC of the nomogram was 0.846 (95% CI 0.795-0.898), and a calibration chart indicated good consistency between values predicted by the nomogram and actual observed values. Conclusions:DWI lesions are an independent risk factor for a poor outcome in patients with ICH-particularly symptomatic DWI lesions. A nomogram model based on clinical characteristics and DWI lesions exhibited good efficacy when predicting the outcome of ICH.
6.Association between small diffusion-weighted imaging hyperintensities lesions and total cerebral small vessel disease burden and the influence on prognosis in patients with acute intracerebral hemorrhage
Ailing ZHANG ; Mengyang REN ; Long TIAN ; Weiping ZANG ; Zhijun ZHANG ; Zhuoya HAN ; Bin ZHANG ; Hao HU ; Peihong QI ; Yingjie SHANG
Chinese Journal of Neurology 2022;55(8):842-853
Objective:To investigate the associations between small diffusion-weighted imaging (DWI) hyperintensities lesions and total cerebral small vessel disease (cSVD) burden and the influence on prognosis in patients with acute intracerebral hemorrhage (ICH).Methods:Consecutive patients with acute spontaneous ICH from January 2018 to June 2021 were recruited in the Stroke Center of Zhengzhou People′s Hospital. Magnetic resonance imaging was performed to quantify DWI hyperintensities lesions and cSVD imaging markers, including white matter hyperintensities, enlarged perivascular spaces, lacunes and cerebral microbleeds, which were calculated for the total cSVD burden (0-4 points). The prognosis was assessed with the modified Rankin Scale (mRS) at discharge and 90-day. Multivariable Logistic regression models were adopted to explore the associations between DWI lesions and total cSVD burden and clinical outcome.Results:Of 283 included patients, 59 (20.8%) had small DWI lesions, 32 (11.3%) had multiple lesions. They were mostly punctate, mainly located in the cortical and subcortical regions, and scattered in multiple vascular territories. With the increase of cSVD burden, the number of DWI lesions gradually increased. Spearman correlation analysis showed that the total cSVD burden was positively correlated with the number of DWI lesions ( r=0.21, P<0.001). In multivariable regression analyses, the total cSVD burden was independently associated with DWI lesions ( OR=1.63, 95% CI 1.23-2.15, P=0.001). The 90-day poor outcome (mRS scores≥4) in patients with DWI lesions was significantly higher than those without DWI lesions (39.3% vs 16.3%, χ 2=14.38, P<0.001), while there was no statistically significant difference in the poor outcome of discharge between the two groups (26.5% vs 17.7%, χ 2=3.06, P=0.080). With the increase in the number of DWI lesions, the 90-day poor outcome increased significantly (trend chi-squared test χ 2=11.50, P=0.001). Multivariable analyses showed that DWI lesions ( OR=4.39, 95% CI 1.92-10.03, P<0.001) and their number ( OR=1.42, 95% CI 1.06-1.90, P=0.018) were independently associated with the 90-day poor outcome. Conclusions:Higher total cSVD burden is an independent risk factor for small DWI lesions in patients with ICH. Small DWI lesions were independently associated with the 90-day poor outcome, but not with the discharge outcome.
7. Evaluation of clinical efficacy and safety of single-channel intracavitary applicator for uterine cervical cancer: early results of a prospective randomized phase Ⅱ clinical trial
Dan LI ; En WEN ; Shen LIN ; Yingjie ZHANG ; Lijia HE ; Peirong REN ; Changling SHANG ; Li XIANG ; Hongru YANG ; Jianwen ZHANG ; Juan FAN ; Qinglian WEN ; Jingbo WU
Chinese Journal of Radiation Oncology 2018;27(8):753-758
Objective:
To evaluate whether the self-designed single-channel intracavitary applicator yields equivalent clinical efficacy and safety to the standard Fletcher-type three-channel applicator in the high-dose-rate (HDR) brachytherapy for uterine cervical cancer.
Methods:
From December 2011 to April 2017, patients initially diagnosed with cervical cancer were randomly assigned into the external beam radiotherapy (EBRT)+ single-channel intracavitary applicator group (the patent single-channel group) and EBRT+ the Fletcher applicator group. Whole pelvis irradiation was delivered with 6-MV photons via a four-field box variant or anterior and posterior parallel fields. Five to six fractions of intracavitary brachytherapy were performed at a dose of 7 Gy at point A once a week after 30 Gy (BED at point A: 80-90 Gy). Chemotherapy was given with intravenous injection of cisplatin at a dose of 40 mg/m2 once weekly during EBRT.Clinical efficacy and safety were evaluated after the treatment.
Results:
In total, 150 eligible cases were assigned into the Fletcher applicator group and 149 cases into the patent single-channel group. The short-term clinical efficacy and acute toxicity did not significantly differ between two groups. The response rate was 94.0% in the Fletcher group, and 94.7% in the patent single-channel group. In the Fletcher applicator group, 76(50.7%) patients developed ≥ grade 3 hematologic toxicity and 61(40.9%) in the patent group (
8.CT appearances of abdominal primary malignant fibrous histiocytoma
Peihong QI ; Dapeng SHI ; Hongwei ZHENG ; Yingjie SHANG ; Peng XUE ; Yong CHEN
Journal of Practical Radiology 2016;32(7):1056-1058,1062
Objective To investigate CT appearances of abdominal primary malignant fibrous histiocytoma(MFH).Methods The CT characteristics,clinical features and pathological data of 1 7 patients with MFH proved pathologically were analyzed retrospectively. Results The lesions located in retroperitoneum were 6,in liver were 5,in kidney were 2,in superior mesentery was 1,in greater omentum was 1,in stomach was 1,in ileum was 1.The lesions are oval shape,lobulated,nodule shape,and the size of these lesions were large. 2 cases of MFH located in gastrointestinal tract were slightly low density,and the remaining were uneven high density due to necro-sis.In CT contrast enhanced scan,the solid portion and internal divisions showed progressive or continuous enhancement,and the nec-rosis were not enhanced in MFH located in the retroperitoneum,the greater omentum,the superior mesentery and the liver.MFH in kidney was poorly circumscribed and showed mild progressive enhancement lower than normal renal parenchyma.The stomach and ileum lesions showed uniform and continuous enhancement with normal gastrointestinal mucosa in corresponding parts.Conclusion Imaging features of retroperitoneal MFH were the same as those of interstitial tumors,and most tumors showed features of progres-sive and persistent enhancement,but have different imaging appearances with the malignant lesions in corresponding parts.
9.Variations of spatial position and overlap ratio for GTV50 and IGTV of primary thoracic esophageal cancer during radiotherapy:a study based on 4DCT scans
Jinzhi WANG ; Jianbin LI ; Wei WANG ; Yingjie ZHANG ; Yun DING ; Tonghai LIU ; Dongping SHANG
Chinese Journal of Radiation Oncology 2014;23(6):491-494
Objective To investigate the variations of the spatial position and overlap ratio for gross tumor volume (respiratory phase 50%) (GTV50) and internal gross tumor volume (IGTV) of primary thoracic esophageal cancer during conventional fractionated radiotherapy based on repeated four-dimensional computed tomography (4DCT) scans.Methods Thirty-three patients with thoracic esophageal cancer underwent contrast-enhanced 4DCT scans before radiotherapy and at the 10th and 20th fractions of radiotherapy.Scans were registered to the baseline 4DCT scan using bony landmarks.The GTV50 was delineated by the same radiotherapist on each 4DCT imaging data set,and the IGTV was constructed accordingly.The target volume,degree of inclusion (DI),and matching index (MI) were compared in different phases.Results The volumes of GTV50 and IGTV decreased along with treatment course.No significant changes in the centroid position were observed for the GTV50 and IGTV.The median DIs of the target volumes at the 10th and 20th fractions in the original target volume were 0.75 and 0.63(P =0.000) for GTV50 and were 0.79 and 0.66(P=0.000) for IGTV,while the median MIs were 0.61 and 0.56(P=0.002) for GTV50 and were 0.68 and 0.58 (P =0.005) for IGTV.A positive correlation between the variation of volume ratio and the variation of DI was found for GTV50 and IGTV (r =0.632,r =0.783),and the variation of volume ratio was also positively correlated with the variation of MI (r =0.387,r =0.483) ;the 3D vector was negatively correlated with the MI (r =-0.455,r =-0.438).Conclusions During conventional fractionated radiotherapy,the variation of spatial position is less than 0.8 cm for GTV50 and IGTV of primary thoracic esophageal cancer,and the decline of the target leads to varying degrees of decreases in DI and the MI.
10.Variations of the spatial position and overlap ratio for primary thoracic esophageal cancer target during radiotherapy based on four-dimensional CT scans
Jinzhi WANG ; Jianbin LI ; Wei WANG ; Yingjie ZHANG ; Yun DING ; Tonghai LIU ; Dongping SHANG
Chinese Journal of Radiological Medicine and Protection 2014;34(8):592-596
Objective To investigate the variations of the spatial position and overlap ratio of the internal target volume (ITV) and planning target volume (PTV) of primary thoracic esophagus carcinoma using repeated four-dimensional computed tomography (4D-CT) scanning during conventional fractionated radiotherapy.Methods Thirty patients with thoracic esophageal carcinoma were included whose 4D-CT scans were conducted before radiotherapy and between every ten fractions.The gross tumor volumes (GTVs) were delineated by the same radiation oncologist on each 4D-CT image phase,and the ITV and PTV were constructed afterwards.Results No significant difference of the isocenters was observed for the ITV and PTV during the treatment course,yet both the volumes of the ITV and PTV decreased.The median DI (the degree of inclusion) of the target acquired subsequently in the original target were 0.85,0.77 (Z=-3.10,P <0.05) for ITV and 0.86、0.82(Z =-2.49,P <0.05)for PTV respectively during entire treatment.The variation of volume ratio correlated strongly with the variation of DI (the DI of the target acquired subsequent in the original target) (rITV =0.71,rPTV =0.77,P <0.05).The variation of volume ratio and the variation of the matching index (MI) were positively correlated (rITV =0.47,rPTV =0.59,P < 0.05).The 3D vectors of ITV and PTV motions were negatively correlated with the corresponding MI (rITV =--0.52,rPTV =-0.36,P < 0.05).If the initial PTV was used for treatment planning,8.80% and 6.37% of the target volume would be missed at the tenth and twentieth fraction (Z =-0.55,P > 0.05),respectively.In the meanwhile,11.45% and 18.49% of the normal tissues would be wrongly irradiated at the corresponding time points (Z =-2.49,P < 0.05).Conclusions The variations of the spatial position of all targets were all less than 0.6 cm.The DI and the MI of the target decrease by various degrees during the treatment course,which lead to target mispositioning and normal tissue irradiation at different levels.

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