1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.Mechanism study of PF-CA@AS-IV hydrogel in promoting skin ulcer healing in diabetic rats
Chengyu LI ; Qinxia LI ; Bo YUAN ; Jianda ZHOU ; Zheng YANG ; Hongyu HUANG ; Fengcheng YE ; Keqian LIU ; Wu XIONG ; Jinhui HU
Journal of Chinese Physician 2025;27(11):1626-1632
Objective:To construct a temperature-sensitive hydrogel (PF-CA@AS-IV hydrogel) composed of Pluronic F-127 (PF-127)/calcium alginate (CA) loaded with astragaloside IV (AS-IV), and to explore its repair effect and potential mechanism on diabetic skin ulcers (DSU).Methods:The PF-CA@AS-IV hydrogel loaded with AS-IV and gelling at 37 ℃ was prepared. Its temperature sensitivity, rheological properties, and morphology were characterized. A rat model of DSU was established, and the rats were randomly divided into blank control group, model group, AS-IV spray group, PF-CA hydrogel group, and PF-CA@AS-IV hydrogel group ( n=5 each). After 21 days of intervention, the wound healing rate of each group was evaluated. Hematoxylin-eosin (HE) staining was used to observe the pathological changes of granulation tissue, and immunohistochemistry was applied to detect the expression level of CD34, a marker of new blood vessels. Results:Rheological analysis showed that the storage modulus (G′) of PF-CA@AS-IV hydrogel began to exceed the loss modulus (G″) at 33 ℃, and a stable three-dimensional network structure was formed at 37 ℃. Scanning electron microscopy confirmed its loose and porous microstructure. Animal experiment results indicated that compared with the blank control group, the model group had a significantly lower wound healing rate, massive infiltration of inflammatory cells, and fewer new capillaries and CD34 expression (all P<0.05). Compared with the model group, each treatment group can promote wound healing, reduce inflammatory infiltration and increase the positive expression of CD34 to varying degrees (all P<0.05), and the curative effect of PF-CA@AS-IV hydrogel group is the most significant, which is better than that of AS-IV spray group and PF-CA hydrogel group (all P<0.05). Conclusions:PF-CA@AS-IV hydrogel can effectively regulate inflammatory response and promote angiogenesis through sustained release of AS-IV, thereby accelerating DSU healing, and has good translational potential in the field of chronic wound repair.
3.Analysis of risk factors and development of a nomogram model for early recurrence following curative resection of resectable pancreatic cancer
Chengyu HU ; Jianyu YANG ; Yannan XU ; Yifan YIN ; Minwei YANG ; Xueliang FU ; Dejun LIU ; Yanmiao HUO ; Wei LIU ; Junfeng ZHANG ; Yongwei SUN ; Rong HUA
Chinese Journal of Pancreatology 2025;25(2):104-111
Objective:To identify independent risk factors for early recurrence following curative resection of resectable pancreatic cancer and establish a nomogram prediction model.Methods:Clinical data from 405 patients with resectable pancreatic cancer treated at Renji Hospital, Shanghai Jiao Tong University School of Medicine from February 2010 to December 2020 were retrospectively reviewed. Patients were stratified into a training cohort (265 patients form February 2010 to December 2018) and a validation cohort (140 patients from January 2019 to December 2020) based on surgery dates. Optimal cutoff values for clinical variables were determined using X-tile software. Independent risk factors were identified through univariate and multivariate Cox proportional hazards regression analyses. Kaplan-Meier curves for recurrence-free survival (RFS) were generated across subgroups, and a nomogram was developed to predict early recurrence (within 1 year post-surgery). Time-dependent receiver operating characteristic (tROC) curves was drawn and area under the curve (AUC) metrics were utilized to evaluate predictive accuracy, while model reliability was assessed by calibration curves. Individualized risk scores derived from the nomogram were stratified into high- and low-risk groups using X-tile-derived cutoff values. Survival differences between groups were analyzed via log-rank tests. The clinical application value was judged by decision curve analysis (DCA) compared to TNM staging. Results:In the training cohort, 139 patients (52.45%) experienced early recurrence, with a median RFS of 11.1 months [interquartile range ( IQR): 6.0-26.0]. The validation cohort reported 70 early recurrences (50.00%) and a median RFS of 11.8 months ( IQR: 4.9-21.4). Univariate analysis revealed significant associations between early recurrence and tumor diameter, carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 125 (CA125), systemic immune-inflammation index (SⅡ), and prognostic nutritional index (PNI). Multivariate analysis identified tumor diameter ≥3.75 cm ( HR=1.718, 95% CI 1.223-2.412, P=0.002), CA19-9≥218 U/ml ( HR=1.567, 95% CI 1.107-2.220, P=0.011), CA125≥20.98 U/ml ( HR=2.501, 95% CI 1.768-3.539, P<0.001), SⅡ≥388.28 ( HR=1.708, 95% CI 1.096-2.662, P=0.018), and PNI<53.18 ( HR=0.596, 95% CI 0.404-0.879, P=0.009) as independent risk factors for early recurrence. The nomogram achieved AUC values of 0.771 and 0.708 in the training and validation cohorts, respectively. Calibration curves demonstrated strong agreement between predicted and observed survival probabilities. Kaplan-Meier analysis revealed significantly lower 1-year RFS rates in high-risk versus low-risk groups for both cohorts (training: HR=3.65, 95% CI 2.45-5.44, P<0.001; validation: HR=2.37, 95% CI 1.39-4.06, P=0.001). DCA indicated superior net benefit of the nomogram over TNM staging across threshold probabilities of 0.2-0.9. Conclusions:The proposed nomogram effectively integrates clinical and serological biomarkers to preoperatively assess early recurrence risk in resectable pancreatic cancer patients, offering enhanced precision for clinical decision-making.
4.Analysis of risk factors and development of a nomogram model for early recurrence following curative resection of resectable pancreatic cancer
Chengyu HU ; Jianyu YANG ; Yannan XU ; Yifan YIN ; Minwei YANG ; Xueliang FU ; Dejun LIU ; Yanmiao HUO ; Wei LIU ; Junfeng ZHANG ; Yongwei SUN ; Rong HUA
Chinese Journal of Pancreatology 2025;25(2):104-111
Objective:To identify independent risk factors for early recurrence following curative resection of resectable pancreatic cancer and establish a nomogram prediction model.Methods:Clinical data from 405 patients with resectable pancreatic cancer treated at Renji Hospital, Shanghai Jiao Tong University School of Medicine from February 2010 to December 2020 were retrospectively reviewed. Patients were stratified into a training cohort (265 patients form February 2010 to December 2018) and a validation cohort (140 patients from January 2019 to December 2020) based on surgery dates. Optimal cutoff values for clinical variables were determined using X-tile software. Independent risk factors were identified through univariate and multivariate Cox proportional hazards regression analyses. Kaplan-Meier curves for recurrence-free survival (RFS) were generated across subgroups, and a nomogram was developed to predict early recurrence (within 1 year post-surgery). Time-dependent receiver operating characteristic (tROC) curves was drawn and area under the curve (AUC) metrics were utilized to evaluate predictive accuracy, while model reliability was assessed by calibration curves. Individualized risk scores derived from the nomogram were stratified into high- and low-risk groups using X-tile-derived cutoff values. Survival differences between groups were analyzed via log-rank tests. The clinical application value was judged by decision curve analysis (DCA) compared to TNM staging. Results:In the training cohort, 139 patients (52.45%) experienced early recurrence, with a median RFS of 11.1 months [interquartile range ( IQR): 6.0-26.0]. The validation cohort reported 70 early recurrences (50.00%) and a median RFS of 11.8 months ( IQR: 4.9-21.4). Univariate analysis revealed significant associations between early recurrence and tumor diameter, carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 125 (CA125), systemic immune-inflammation index (SⅡ), and prognostic nutritional index (PNI). Multivariate analysis identified tumor diameter ≥3.75 cm ( HR=1.718, 95% CI 1.223-2.412, P=0.002), CA19-9≥218 U/ml ( HR=1.567, 95% CI 1.107-2.220, P=0.011), CA125≥20.98 U/ml ( HR=2.501, 95% CI 1.768-3.539, P<0.001), SⅡ≥388.28 ( HR=1.708, 95% CI 1.096-2.662, P=0.018), and PNI<53.18 ( HR=0.596, 95% CI 0.404-0.879, P=0.009) as independent risk factors for early recurrence. The nomogram achieved AUC values of 0.771 and 0.708 in the training and validation cohorts, respectively. Calibration curves demonstrated strong agreement between predicted and observed survival probabilities. Kaplan-Meier analysis revealed significantly lower 1-year RFS rates in high-risk versus low-risk groups for both cohorts (training: HR=3.65, 95% CI 2.45-5.44, P<0.001; validation: HR=2.37, 95% CI 1.39-4.06, P=0.001). DCA indicated superior net benefit of the nomogram over TNM staging across threshold probabilities of 0.2-0.9. Conclusions:The proposed nomogram effectively integrates clinical and serological biomarkers to preoperatively assess early recurrence risk in resectable pancreatic cancer patients, offering enhanced precision for clinical decision-making.
5.Mechanism study of PF-CA@AS-IV hydrogel in promoting skin ulcer healing in diabetic rats
Chengyu LI ; Qinxia LI ; Bo YUAN ; Jianda ZHOU ; Zheng YANG ; Hongyu HUANG ; Fengcheng YE ; Keqian LIU ; Wu XIONG ; Jinhui HU
Journal of Chinese Physician 2025;27(11):1626-1632
Objective:To construct a temperature-sensitive hydrogel (PF-CA@AS-IV hydrogel) composed of Pluronic F-127 (PF-127)/calcium alginate (CA) loaded with astragaloside IV (AS-IV), and to explore its repair effect and potential mechanism on diabetic skin ulcers (DSU).Methods:The PF-CA@AS-IV hydrogel loaded with AS-IV and gelling at 37 ℃ was prepared. Its temperature sensitivity, rheological properties, and morphology were characterized. A rat model of DSU was established, and the rats were randomly divided into blank control group, model group, AS-IV spray group, PF-CA hydrogel group, and PF-CA@AS-IV hydrogel group ( n=5 each). After 21 days of intervention, the wound healing rate of each group was evaluated. Hematoxylin-eosin (HE) staining was used to observe the pathological changes of granulation tissue, and immunohistochemistry was applied to detect the expression level of CD34, a marker of new blood vessels. Results:Rheological analysis showed that the storage modulus (G′) of PF-CA@AS-IV hydrogel began to exceed the loss modulus (G″) at 33 ℃, and a stable three-dimensional network structure was formed at 37 ℃. Scanning electron microscopy confirmed its loose and porous microstructure. Animal experiment results indicated that compared with the blank control group, the model group had a significantly lower wound healing rate, massive infiltration of inflammatory cells, and fewer new capillaries and CD34 expression (all P<0.05). Compared with the model group, each treatment group can promote wound healing, reduce inflammatory infiltration and increase the positive expression of CD34 to varying degrees (all P<0.05), and the curative effect of PF-CA@AS-IV hydrogel group is the most significant, which is better than that of AS-IV spray group and PF-CA hydrogel group (all P<0.05). Conclusions:PF-CA@AS-IV hydrogel can effectively regulate inflammatory response and promote angiogenesis through sustained release of AS-IV, thereby accelerating DSU healing, and has good translational potential in the field of chronic wound repair.
6.Status of screening myopia among primary and middle school students in Linfen Community of Shanghai from 2019 to 2023
GU Yuerong, CHEN Ruiyang, WAN Qiuping, ZHU Chengyu, WANG Limeng, HU Hong
Chinese Journal of School Health 2024;45(7):941-944
Objective:
To analyze the prevalence and trend of screening myopia among primary and middle school students in Linfen Community of Shanghai from 2019 to 2023, so as to provide a reference for the prevention and control of myopia from the perspective of the community.
Methods:
From 2019 to 2023, all primary(5) and middle(2) school students aged 6-15 years in Linfen Community of Shanghai were screened. Statistical analysis was performed using the Chi square test and trend Chi square test. The curve fitting model was used to fit the model of the increase rate of screening myopia among primary and middle school students in 2019, 2021 and 2023.
Results:
The overall rate of screening myopia among primary and middle school students in Linfen community from 2019 to 2023 was 55.17%. The prevalence rate of screening myopia was 79.43% in boys and 81.92% in girls in middle school, and the difference was statistically significant ( χ 2=5.71, P =0.02). In 2019, 2021, and 2023, the peak age of screening myopia among primary and middle school students in Linfen Community gradually occurred earlier, at the age of 7(12.13%), 6( 12.28 %), and 6(14.99%) years old, respectively. The growth rate of screening myopia in students aged 8-12 years in 2023 was lower than that in 2019 and 2021.
Conclusions
The screening myopia rate of primary and middle school students aged 6-15 years in Linfen Community is relatively high, with primary school girls higher than boys, and growth spurt accelerates. It is suggested that prevention and control of myopia in the community should focus on preschool children and adolescent girls.
7.Association between cancer-associated fibroblasts and liver cancer
Xiao HU ; Dewen MAO ; Chengyu YA
Journal of Clinical Hepatology 2021;37(2):444-447
Liver cancer has always been a threat to national health since liver disease has a high incidence rate in China. At present, methods for the prevention and treatment of liver cancer have unsatisfactory effects in clinical practice, and with in-depth studies, scholars have changed their focus to cancer-associated fibroblasts (CAFs) in tumor microenvironment. More and more evidence has shown that CAFs may provide a new target for the prevention and treatment of liver cancer. This article summarizes the role of CAFs in the development and progression of liver cancer and the potential of CAFs in the treatment of liver cancer.
8.Effects of laryngeal mask airway combined with lung-protective ventilation on postoperative pulmonary complications in patients undergoing open abdominal surgery with general anesthesia
Li ZHANG ; Chengyu LUO ; Yu HU ; Junmei HU ; Yu LIANG ; Qin LI ; Wei WU
Chinese Journal of Anesthesiology 2018;38(5):529-532
Objective To investigate the effects of laryngeal mask airway combined with lung-protective ventilation on postoperative pulmonary complications in patients undergoing open abdominal surgery with general anesthesia.Methods Eighty-seven patients of both sexes,aged 18-64 yr,of American Society of Anesthesiologists physical status Ⅱ or Ⅲ,scheduled for elective open abdominal surgery under general anesthesia,were randomly divided into 2 groups:endotracheal intubation plus routine ventilation group (group IC,n =43) and laryngeal mask airway plus protective ventilation group (group LP,n =44).In group IC,single lumen endotracheal tube was inserted and the patients were mechanically ventilated,with inhaled pure oxygen 2 L/min,tidal volume 8-10 ml/kg,respiratory rate 8-12 breaths/min,inspiratory/expiratory ratio 1 ∶ 2.In group LP,the ProSeal laryngeal mask airway was inserted and lung-protective ventilation was performed,with inhaled pure oxygen 2 L/min,tidal volume 6-8 ml/kg,respiratory rate 12-16 breaths/min,inspiratory/expiratory ratio 1 ∶ 2,positive end-expiratory pressure 5 cm H2O,and recruitment maneuvers was performed manually every 30 min during operation.End-tidal pressure of carbon dioxide was maintained at 35-45 mmHg.The development of pulmonary complications such as pneumonia,pleural effusion,pulmonary atelectasis,pneumothorax,bronchospasm and acute respiratory failure was recorded within 7 days after surgery.Results Pulmonary atelectasis,pneumothorax or acute respiratory failure was not found in the two groups.Compared with group IC,no significant change was found in the incidence of pneumonia,pleural effusion and bronchospasm after operation (P>0.05),and the total incidence of postoperative pulmonary complications was significantly decreased in group LP (P<0.05).Conclusion Compared with endotracheal intubation and conventional ventilation,laryngeal mask airway combined with lung-protective ventilation can reduce postoperative pulmonary complications in the patients undergoing open abdominal surgery with general anesthesia.
9.The Clinical Study of Wenxin Keli in the Treatment of Atrial Fibrillation: a Systematic Review
Min LI ; Ruijin QIU ; Yang SUN ; Xiaoyu ZHANG ; Rui ZHENG ; Jiayuan HU ; Chengyu LI ; Shiqi CHEN ; Yin JIANG ; Xinyu YANG ; Zhaofeng SHI ; Songjie HAN ; Tianmai HE ; Ya HUANG ; Hongcai SHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(10):1761-1771
Objective: To conduct a comprehensive and systematic review of the efficacy and safety of Wenxin Keli (WXKL) in the treatment of atrial fibrillation (AF) . Methods: Seven databases (PubMed, The Cochrane Library, Web ofScience, CNKI, Wanfang Database, VIP and SinoMed) were searched to identify relevant randomized controlled trials (RCTs) from inceptions to 1 October, 2018. Two review authors independently assessed the methodological quality andanalyzed data by Cochrane handbook and the Rev Man 5.3 software. Begg.s test was conducted to assess publication biasvia Stata 14 software. Results: Twenty-four RCTs with 2246 patients were included in this review. Compared with blankcontrol, placebo or western medicine alone, WXKL alone or combined with western medicine could effectively reducerapid ventricular rate (MD=-7.14, 95%CI:-8.42——5.87), the frequency and duration of AF. It could also shorten thesinus rhythm conversion time (MD=-3.04, 95%CI:-3.47——2.61), increase the sinus rhythm conversion rate (RR=1.19, 95% CI: 1.09~1.29) and decrease recurrence rate of AF (RR=0.28, 95% CI: 0.13-0.59) . Besides, WXKL alone orcombined with western medicine was beneficial for improving the left ventricular ejection fraction (LVEF) (MD=3.44, 95% CI: 0.87-6.01), left ventricular end diastolic diameter (LVEDD) (MD=-2.47, 95% CI:-2.86——2.08), left atrialdiameter (LAd) (MD=-0.91, 95%CI:-1.58——0.25) and P wave dispersion (Pd) (MD=-4.04, 95%CI:-4.15——3.93) .WXKL combined with low-dose amiodarone was superior to conventional-dose amiodarone alone in improving themaximum P wave (Pmax) (MD=-8.25, 95% CI:-10.33——6.17), and WXKL combined with conventional-doseamiodarone is more effective (MD=-13.10, 95%CI:-13.65——12.55) . Compared with the control group, the treatmentgroup had fewer adverse reactions, and the Begg.s test did not find any publication bias. Conclusion: WXKL alone orcombined with western medicine exhibited better therapeutic effects in the treatment of AF, but these results still needhigh-quality evidence to verify.
10.Status Quo and Reflections of Development of Integrative Coronary Heart Disease Clinical Practice Guidelines
Chengyu LI ; Yaolong CHEN ; Jiayuan HU ; Hongcai SHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(12):2101-2108
Objective: Through analyzing development statue of integrative coronary heart disease clinical practice guidelines, we aim to provide a reference baseline for the future study. Methods: Databases including CBM, CNKI, WanFang, VIP were searched for published integrative coronary heart disease clinical practices. The website medlive.cn was also used as supplementary. The reporting tool for clinical practice guidelines RIGHT statement was used to evaluate the reporting quality. Results: A total of nine relevant clinical practice guidelines or experts consensuses were included, covering five integrative treatment therapy guidelines of PCI or CABG perioperative period, three myocardial infarction guidelines and one atherosclerosis guideline. Experts consensus methods were adopted in seven guidelines, the remining two guidelines used the evidence-based guidelines development methods. The evaluation of RIGHT statements showed that most guidelines reported complete information in"Basic information"and"Background"domain, however, they usually failed to provide enough description in"Evidence", "Recommendations", "Review and quality assurance", "Funding and declaration and management of interests"and"Other information"parts. Conclusion: Although some achievements have been reached in the development of integrative coronary heart disease clinical practice guidelines, the development methods and quality of reporting still needs further improvements. Researchers should explore more specific Chinese medicine guideline development methods and tools in the future.


Result Analysis
Print
Save
E-mail