1.Analysis on the Current Status of Clinical Trial Registries of TCM in Prevention and Treatment of Osteoporosis
Chongyang ZHANG ; Bo LIU ; Jian HUANG ; Wenping LIN
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(11):56-62
Objective To explore the research status and development direction by analyzing the registered clinical trials of TCM prevention and treatment of osteoporosis.Methods The clinical trials of TCM in the prevention and treatment of osteoporosis were retrieved from Chinese Clinical Trial Registry(ChiCTR)and the ClinicalTrials.gov from the establishment of databases to September 2024.Excel 2024 was used to input the screening data,and the registration number,research topic,registration time,region,institution,funding source,research disease,research type,stage and design scheme,randomized method and blind method,intervention measures,participation center,sample size and outcome index of the included trials were analyzed.Results A total of 101 clinical trials of TCM in the prevention and treatment of osteoporosis were included in the study,involving 4 countries.China's registered projects involved 58 research institutions in 21 provincial administrative regions,of which Beijing,Shanghai and Guangzhou had a large number of registered projects;the studies were dominated by single-center,interventional,and randomized controlled trials,with the most application of simple randomization methods;blinding was applied to 20 trials;postmenopausal osteoporosis was the dominant disease under study,and Chinese patent medicines were the main interventions;the main outcome indicators were bone mineral density,biochemical indicators of bone metabolism and visual analog score.Conclusion The number of clinical trials of TCM in the prevention and treatment of osteoporosis has been increasing rapidly,and researchers have been paying more attention to the studies.However,there are some problems,such as unbalanced research area,less preventive and observational research,insufficient use of blind method,unclear outcome indicators,and low attention paid to some treatment methods.
2.Experimental study on the efficacy evaluation of targeted three-dimensional contrast-enhanced ultrasound in combination with thermal ablation and molecular targeted drug therapy for renal cell carcinoma
Cuixian LI ; Beijian HUANG ; Yunjie JIN ; Beilei LU ; Cong LI ; Jingjing WANG ; Wenping WANG
Chinese Journal of Ultrasonography 2025;34(4):340-347
Objective:To investigate the value of targeted three-dimensional contrast-enhanced ultrasound(3D-tCEUS)in efficacy evaluation of non-surgical treatments for renal cell carcinoma(RCC).Methods:Forty nude mice with subcutaneous xenograft tumor model of human RCC(786-O cells)were divided into four groups based on different treatment methods:control,thermal ablation(TA),sunitinib(Suni),and TA+Suni. 3D-tCEUS were performed on days 1,3,7,and 14 post-treatment using self-developed vascular endothelial growth factor receptor 2(VEGFR2)targeted microbubbles. Tumor overall volume(V T)and non-enhanced volume(V N)were measured,from which the volume of the active(enhanced)region was calculated as V A = V T - V N. The tumor total and active area volume was standardized as V T st and V A st(standardized tumor volume = tumor volume after treatment / tumor volume at the beginning of treatment). Tumor growth curves were plotted and tumor inhibition rates calculated for V T and V A respectively. Quantitative parameters,including the area under the curve(AUC)and the difference in peak intensity before and after burst(dTE),were obtained from the viable tumor enhanced region,and the standardized targeted quantitative parameters were derived by calculating the ratios of parameters at various time points post-treatment to those pre-treatment. The differences in V T st,V A st,AUC and dTE between different treatment groups at different time points were compared. At the end of the experiment,tumor tissues were obtained for immunohistochemical staining to observe the expression of VEGFR2 and CD31 antigens. Results:During the treatment period,no statistically significant differences in weight changes were observed among groups(all P > 0.05). When V T was taken as the research object,V T st increased across all groups during the treatment period,with the TA group showing the most significant growth,while the TA + Suni group exhibited the smoothest increase in growth curve. When analyzing the tumor enhanced region,tumor growth trend of V A st was different with V T st for all groups;the Suni group showed a slow upward trend,whereas the TA + Suni group showed a continuous decline. Significant differences in tumor inhibition rate originated from V T and V A were noted within the same experimental group( P < 0.05 for all experimental groups). One day post-treatment,the AUC and dTE of the TA group were higher than that of the Control group,while the dTE of the TA + Suni group was lower than that of the Control group(all P < 0.05). By day 3,statistically significant differences in AUC and dTE were observed between each experimental group and Control groups(all P < 0.05). At day 14,the TA group showed increased AUC and dTE compared with those before treatment,while all other groups,particularly Suni group and TA + Suni group,demonstrated significant reductions(all P < 0.05). Immunohistochemical results revealed the highest VEGFR2 and CD31 positivity in the TA group,followed by the Control group,while the Suni and TA + Suni groups exhibited lower rates. Conclusions:The combination of TA and targeted therapy effectively induces RCC cells death,demonstrating superior efficacy compared to monotherapy. 3D-tCEUS serves as a accurate and reliable tool for early evaluating the efficacy of non-surgical RCC treatments.
3.The predictive value of serum β2M level for prognosis in exacerbated COPD and the results of when it is compared with other inflammatory markers
Wenping MAO ; Qian HAN ; Fengwei JIAO ; Jing WANG ; Kewu HUANG
Journal of Capital Medical University 2025;46(4):718-723
Objective To investigate the prognostic role of serum beta 2-microglobulin(β2M)as a systemic inflammatory biomarker in hospitalized patients with exacerbation of COPD,compared with other inflammatory biomarkers.Methods We retrospectively analyzed hospitalized patients with exacerbated COPD as the first diagnosis at Beijing Chao-Yang hospital,P.R.China,from December 31,2012 to December 28,2017.Serum β2M levels,laboratory and clinical indexes were measured or collected on admission,and all patients were followed up for 90 days.The prognostic performance of β2M was compared with the neutrophils-lymphocytes ratio(NLR),C-reactive protein values(CRP)and white blood cell(WBC)using MedCalc.Results For 30-day mortality,β2M,NLR,and CRP showed significant predictive value(all P<0.001)and were better than WBC(P=0.044,0.003 and 0.030,respectively)in hospitalized patients with exacerbated COPD,while WBC had no predictive significance.For 90-day mortality,β2M,NLR,CRP,and WBC were all statistically significant,but only NLR outperformed WBC(P=0.004).No significant differences were observed among β2M,NLR,and CRP.Conclusion As a systemic inflammatory biomarker,serum β2M was a useful prognostic biomarker for short-term death in hospitalized patients with COPD exacerbations.It performed slightly better than NLR and CRP for 30-day mortality prediction and slightly superior to CRP and slightly inferior to NLR for 90-day mortality prediction.
4.The predictive value of serum β2M level for prognosis in exacerbated COPD and the results of when it is compared with other inflammatory markers
Wenping MAO ; Qian HAN ; Fengwei JIAO ; Jing WANG ; Kewu HUANG
Journal of Capital Medical University 2025;46(4):718-723
Objective To investigate the prognostic role of serum beta 2-microglobulin(β2M)as a systemic inflammatory biomarker in hospitalized patients with exacerbation of COPD,compared with other inflammatory biomarkers.Methods We retrospectively analyzed hospitalized patients with exacerbated COPD as the first diagnosis at Beijing Chao-Yang hospital,P.R.China,from December 31,2012 to December 28,2017.Serum β2M levels,laboratory and clinical indexes were measured or collected on admission,and all patients were followed up for 90 days.The prognostic performance of β2M was compared with the neutrophils-lymphocytes ratio(NLR),C-reactive protein values(CRP)and white blood cell(WBC)using MedCalc.Results For 30-day mortality,β2M,NLR,and CRP showed significant predictive value(all P<0.001)and were better than WBC(P=0.044,0.003 and 0.030,respectively)in hospitalized patients with exacerbated COPD,while WBC had no predictive significance.For 90-day mortality,β2M,NLR,CRP,and WBC were all statistically significant,but only NLR outperformed WBC(P=0.004).No significant differences were observed among β2M,NLR,and CRP.Conclusion As a systemic inflammatory biomarker,serum β2M was a useful prognostic biomarker for short-term death in hospitalized patients with COPD exacerbations.It performed slightly better than NLR and CRP for 30-day mortality prediction and slightly superior to CRP and slightly inferior to NLR for 90-day mortality prediction.
5.Early differentiation of Kawasaki disease shock syndrome and septic shock in children
Haiyan GE ; Shuang LIU ; Jing CHEN ; Wenping GAO ; Siyuan HUANG ; Fang LI ; Fang LYU ; Dong QU
Chinese Journal of Pediatrics 2025;63(11):1229-1233
Objective:To explore the differences in early clinical features between Kawasaki disease shock syndrome (KDSS) and septic shock (SS).Methods:A retrospective case-control study was conducted. Clinical data was collected from 64 children who were diagnosed with KDSS or SS and admitted to the Department of Critical Care Medicine of Capital Center for Children′s Health, Capital Medical University from January 2018 to February 2025. Mann-Whitney U test, χ2 test, or Fisher′s exact test were used to compare the differences in clinical features, treatment, and outcomes between children with KDSS and SS. Lasso regression was applied to screen predictive variables, and multivariable logistic regression analysis was performed to identify factors associated with KDSS. Receiver operating characteristic (ROC) curve was used to evaluate the predictive value of parameters for KDSS. Results:Among the 64 children (30 males and 34 females), the age was 3.6 (1.2, 6.5) years. There were 51 cases in the SS group and 13 cases in the KDSS group. Compared to children with SS, children with KDSS had a longer pre-shock fever duration, lower lactate levels and serum albumin levels, and higher soluble interleukin-2 receptor (sIL-2R) levels (all P<0.05). Additionally, they exhibited a higher incidence of coronary involvement, pericardial effusion, and ascites, a higher utilization rate of intravenous immunoglobulin, and a lower utilization rate of invasive mechanical ventilation (all P<0.05). There was no significant difference in in-hospital mortality between KDSS and SS ( P=0.574). Multivariate logistic regression analysis identified pre-shock fever duration and sIL-2R as independent factors associated with KDSS ( OR=1.52 and 1.54 per 1 000 U increase, 95% CI 1.12-2.05 and 1.06-2.24, respectively; both P<0.05). ROC curve analysis showed that the areas under the curve for pre-shock fever duration and sIL-2R in identifying KDSS were 0.83 (95% CI 0.73-0.94, P=0.001) and 0.70 (95% CI 0.53-0.87, P=0.042), respectively. The optimal cutoff values were 3.5 d and 3.8×10 6 U/L, with sensitivities of 0.91 and 0.82, and specificities of 0.71 and 0.62, respectively. Conclusions:Children with KDSS have higher incidences of coronary involvement, pericardial effusion, and ascites compared to those with SS. Pre-shock fever duration and sIL-2R may serve as potential early indicators for distinguishing KDSS from SS.
6.Experimental study on the efficacy evaluation of targeted three-dimensional contrast-enhanced ultrasound in combination with thermal ablation and molecular targeted drug therapy for renal cell carcinoma
Cuixian LI ; Beijian HUANG ; Yunjie JIN ; Beilei LU ; Cong LI ; Jingjing WANG ; Wenping WANG
Chinese Journal of Ultrasonography 2025;34(4):340-347
Objective:To investigate the value of targeted three-dimensional contrast-enhanced ultrasound(3D-tCEUS)in efficacy evaluation of non-surgical treatments for renal cell carcinoma(RCC).Methods:Forty nude mice with subcutaneous xenograft tumor model of human RCC(786-O cells)were divided into four groups based on different treatment methods:control,thermal ablation(TA),sunitinib(Suni),and TA+Suni. 3D-tCEUS were performed on days 1,3,7,and 14 post-treatment using self-developed vascular endothelial growth factor receptor 2(VEGFR2)targeted microbubbles. Tumor overall volume(V T)and non-enhanced volume(V N)were measured,from which the volume of the active(enhanced)region was calculated as V A = V T - V N. The tumor total and active area volume was standardized as V T st and V A st(standardized tumor volume = tumor volume after treatment / tumor volume at the beginning of treatment). Tumor growth curves were plotted and tumor inhibition rates calculated for V T and V A respectively. Quantitative parameters,including the area under the curve(AUC)and the difference in peak intensity before and after burst(dTE),were obtained from the viable tumor enhanced region,and the standardized targeted quantitative parameters were derived by calculating the ratios of parameters at various time points post-treatment to those pre-treatment. The differences in V T st,V A st,AUC and dTE between different treatment groups at different time points were compared. At the end of the experiment,tumor tissues were obtained for immunohistochemical staining to observe the expression of VEGFR2 and CD31 antigens. Results:During the treatment period,no statistically significant differences in weight changes were observed among groups(all P > 0.05). When V T was taken as the research object,V T st increased across all groups during the treatment period,with the TA group showing the most significant growth,while the TA + Suni group exhibited the smoothest increase in growth curve. When analyzing the tumor enhanced region,tumor growth trend of V A st was different with V T st for all groups;the Suni group showed a slow upward trend,whereas the TA + Suni group showed a continuous decline. Significant differences in tumor inhibition rate originated from V T and V A were noted within the same experimental group( P < 0.05 for all experimental groups). One day post-treatment,the AUC and dTE of the TA group were higher than that of the Control group,while the dTE of the TA + Suni group was lower than that of the Control group(all P < 0.05). By day 3,statistically significant differences in AUC and dTE were observed between each experimental group and Control groups(all P < 0.05). At day 14,the TA group showed increased AUC and dTE compared with those before treatment,while all other groups,particularly Suni group and TA + Suni group,demonstrated significant reductions(all P < 0.05). Immunohistochemical results revealed the highest VEGFR2 and CD31 positivity in the TA group,followed by the Control group,while the Suni and TA + Suni groups exhibited lower rates. Conclusions:The combination of TA and targeted therapy effectively induces RCC cells death,demonstrating superior efficacy compared to monotherapy. 3D-tCEUS serves as a accurate and reliable tool for early evaluating the efficacy of non-surgical RCC treatments.
7.Analysis on the Current Status of Clinical Trial Registries of TCM in Prevention and Treatment of Osteoporosis
Chongyang ZHANG ; Bo LIU ; Jian HUANG ; Wenping LIN
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(11):56-62
Objective To explore the research status and development direction by analyzing the registered clinical trials of TCM prevention and treatment of osteoporosis.Methods The clinical trials of TCM in the prevention and treatment of osteoporosis were retrieved from Chinese Clinical Trial Registry(ChiCTR)and the ClinicalTrials.gov from the establishment of databases to September 2024.Excel 2024 was used to input the screening data,and the registration number,research topic,registration time,region,institution,funding source,research disease,research type,stage and design scheme,randomized method and blind method,intervention measures,participation center,sample size and outcome index of the included trials were analyzed.Results A total of 101 clinical trials of TCM in the prevention and treatment of osteoporosis were included in the study,involving 4 countries.China's registered projects involved 58 research institutions in 21 provincial administrative regions,of which Beijing,Shanghai and Guangzhou had a large number of registered projects;the studies were dominated by single-center,interventional,and randomized controlled trials,with the most application of simple randomization methods;blinding was applied to 20 trials;postmenopausal osteoporosis was the dominant disease under study,and Chinese patent medicines were the main interventions;the main outcome indicators were bone mineral density,biochemical indicators of bone metabolism and visual analog score.Conclusion The number of clinical trials of TCM in the prevention and treatment of osteoporosis has been increasing rapidly,and researchers have been paying more attention to the studies.However,there are some problems,such as unbalanced research area,less preventive and observational research,insufficient use of blind method,unclear outcome indicators,and low attention paid to some treatment methods.
8.Early differentiation of Kawasaki disease shock syndrome and septic shock in children
Haiyan GE ; Shuang LIU ; Jing CHEN ; Wenping GAO ; Siyuan HUANG ; Fang LI ; Fang LYU ; Dong QU
Chinese Journal of Pediatrics 2025;63(11):1229-1233
Objective:To explore the differences in early clinical features between Kawasaki disease shock syndrome (KDSS) and septic shock (SS).Methods:A retrospective case-control study was conducted. Clinical data was collected from 64 children who were diagnosed with KDSS or SS and admitted to the Department of Critical Care Medicine of Capital Center for Children′s Health, Capital Medical University from January 2018 to February 2025. Mann-Whitney U test, χ2 test, or Fisher′s exact test were used to compare the differences in clinical features, treatment, and outcomes between children with KDSS and SS. Lasso regression was applied to screen predictive variables, and multivariable logistic regression analysis was performed to identify factors associated with KDSS. Receiver operating characteristic (ROC) curve was used to evaluate the predictive value of parameters for KDSS. Results:Among the 64 children (30 males and 34 females), the age was 3.6 (1.2, 6.5) years. There were 51 cases in the SS group and 13 cases in the KDSS group. Compared to children with SS, children with KDSS had a longer pre-shock fever duration, lower lactate levels and serum albumin levels, and higher soluble interleukin-2 receptor (sIL-2R) levels (all P<0.05). Additionally, they exhibited a higher incidence of coronary involvement, pericardial effusion, and ascites, a higher utilization rate of intravenous immunoglobulin, and a lower utilization rate of invasive mechanical ventilation (all P<0.05). There was no significant difference in in-hospital mortality between KDSS and SS ( P=0.574). Multivariate logistic regression analysis identified pre-shock fever duration and sIL-2R as independent factors associated with KDSS ( OR=1.52 and 1.54 per 1 000 U increase, 95% CI 1.12-2.05 and 1.06-2.24, respectively; both P<0.05). ROC curve analysis showed that the areas under the curve for pre-shock fever duration and sIL-2R in identifying KDSS were 0.83 (95% CI 0.73-0.94, P=0.001) and 0.70 (95% CI 0.53-0.87, P=0.042), respectively. The optimal cutoff values were 3.5 d and 3.8×10 6 U/L, with sensitivities of 0.91 and 0.82, and specificities of 0.71 and 0.62, respectively. Conclusions:Children with KDSS have higher incidences of coronary involvement, pericardial effusion, and ascites compared to those with SS. Pre-shock fever duration and sIL-2R may serve as potential early indicators for distinguishing KDSS from SS.
9.Minimally invasive robot-assisted treatment of tibial plateau fractures of Schatzker types Ⅱ and Ⅲ that can be indirectly reduced
Fei XIAO ; Wenping HE ; Junwen WANG ; Jing JIAO ; Ming CHEN ; Yucheng HUANG ; Keke CHENG ; Tianrun LEI
Chinese Journal of Orthopaedic Trauma 2024;26(7):604-610
Objective:To explore the advantages of minimally invasive internal fixation assisted by an orthopedic robot in the treatment of tibial plateau fractures of Schatzker types Ⅱ and Ⅲ that can be indirectly reduced.Methods:A retrospective study was conducted of the 18 patients who had been treated for tibial plateau fractures of Schatzker types Ⅱ and Ⅲ at Department of Orthopaedics, The Fourth Hospital of Wuhan from December 2019 to December 2021. They were 12 males and 6 females with an age of (45.2±9.6) years. All fractures were closed. Of them, 6 were complicated with an avulsion fracture at the insertion point of the anterior cruciate ligament, 1 with tear of the medial collateral ligament, and 8 with tear of the lateral meniscus. All patients were treated with minimally invasive internal fixation using the "fence" screw technique after indirect reduction assisted by an orthopedic surgical robot. Those combined with avulsion fracture of the anterior cruciate ligament and meniscus tear underwent one-stage arthroscopic surgery, while those combined with tear of the medial collateral ligament underwent one-stage open repair. The fracture reduction was evaluated according to the Rasmussen radiological scoring system, and the knee joint function evaluated using the American Hospital for Special Surgery (HSS) scoring system.Results:All the 18 patients were fully followed up for (10.6±1.9) months. The X-ray films immediately after surgery showed good fracture reduction. The fractures healed after (11.3±1.2) weeks. At 6 months after surgery, the Rasmussen knee score was (16.8±1.0) points, giving 5 excellent and 13 good cases; the HSS score was (93.2±3.0) points, giving 17 excellent and 1 good cases. By the last follow-up, no serious complications occurred, such as common peroneal nerve injury, popliteal vascular injury, postoperative infection, or internal fixation failure.Conclusion:Since minimally invasive internal fixation assisted by an orthopedic robot can lead to fine clinical efficacy for tibial plateau fractures of Schatzker types Ⅱ and Ⅲ, this technique can be widely applied in clinical practice.
10.Application of remote fundus image reading training in improving the diagnostic ability of ophthalmologists in Xinjiang Uygur Autonomous Region
Xufeng ZHAO ; Xiuyan MA ; Xuejing LI ; Li QIN ; Lina SUO ; Wenping MA ; Shihao LI ; Jiaxing CHEN ; Yaxin YANG ; Xinxia LI ; Tao XIE ; Juan LI ; Yuanshan XIONG ; Zhiyong WU ; Zhihuai CHANG ; Mowen FANG ; Ting WANG ; Hong LIU ; Pengju MA ; Pengpeng LIU ; Jing RAN ; Di YANG ; Changle XUE ; Zhen XIE ; Zhao FAN ; Yang WANG ; Peng LEI ; Qingjiang HUANG ; Bing LI ; Shi FENG ; Zhangwanyu WEI ; Yishuang MAO ; Weihong YU ; Linjun ZHANG
Chinese Journal of Ocular Fundus Diseases 2024;40(12):941-946
Objective:To explore the feasibility and effect of remote medical education model using online film reading training to improve the ability of ophthalmologists in the Xinjiang Uygur Autonomous Region (hereinafter referred to as "Xinjiang Region" ) in diagnosing fundus diseases.Methods:The three-level film reading training system of Xinjiang Production and Construction Corps system division hospital-Corps Hospital-Peking Union Medical College Hospital was established. From June 2022 to January 2023, 4 159 posterior color fundus images were continuously collected from Department of Ophthalmology of Xinjiang Corps Hospital and 4 divisional hospitals in the Corps medical system. Among them, hypertensive retinopathy, diabetic retinopathy, exudative age-related macular degeneration (AMD), atrophic AMD and retinal vein occlusion were 3 073, 651, 43, 186 and 206 cases, respectively. The images were divided into 3 rounds (first, second and last) according to the proportion of diseases. The doctors who participated in the training (hereinafter referred to as the "training") were 15 ophthalmologists from the Corps Hospital of Xinjiang Region and the division hospital of the Corps system. There were 7 male and 8 female. Age was (38.1±4.0) years. The titles of senior, deputy senior, intermediate and junior are 1, 6, 5 and 3 respectively; Bachelor's degree and master's degree are 13 and 2 respectively. The working time of fundus disease specialty was (9.6±3.3) years. The film reading system training was conducted before the first round of labeling, and after each round of film reading, the doctors of Peking Union Medical College Hospital gave feedback and explanation on the film reading results. The diagnostic consistency, sensitivity and specificity were compared by paired sample t test. Spearman or Pearson correlation analysis was conducted between the improvement of diagnostic level and professional title, education, age and working hours of ocular fundus disease. Results:All the participating doctors completed the first, second and last reading. After each round of film reading, the film reading summary was carried out for 2 hours. The average diagnostic agreement rates of participating physicians were 53.0%, 67.0% and 75.0%, respectively. The sensitivity and specificity were 0.38, 0.69, 054 and 0.66, 0.85, 0.96, respectively. There was significant difference between the first and last examination ( P<0.001). The sensitivity of the second reading was significantly higher than that of the first reading, and the sensitivity of the last reading was significantly lower than that of the second reading, with statistical significance ( P<0.05). The specificity of the second reading was significantly higher than that of the first reading, and the last reading was significantly higher than that of the second reading, with statistical significance ( P<0.05). There was no significant correlation ( P>0.05) between the improvement of diagnostic level of participating physicians and educational background ( Rho=0.07), professional title ( Rho=0.13), age ( r=0.20), and working time of ophthalmofundus disease specialty ( r=0.26). Conclusions:Relying on the three-level online telemedicine training, it can improve the ability of ophthalmologists in Xinjiang region to diagnose fundus diseases. The preliminary telemedicine education model has demonstrated potential for feasibility and effectiveness in remote areas with inadequate medical resources.

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