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.Meteorological factor-driven prediction of high-use days of budesonide: construction and comparison of ensemble learning models
Qitao CHEN ; Yue ZHOU ; Xiaojun ZHANG ; Jingwen NI ; Guoqiang SUN ; Fenfei GAO ; Lizhen XIA ; Zihao LI
China Pharmacy 2025;36(21):2723-2726
OBJECTIVE To construct ensemble learning models for predicting high-use days of budesonide based on meteorological factors, thereby providing reference for hospital pharmacy management. METHODS Meteorological data for 2024 and outpatient budesonide usage data from the jurisdiction of Sanming Hospital of Integrated Traditional Chinese and Western Medicine were collected. High-use days were defined as the 75th percentile of outpatient budesonide usage, and a corresponding dataset was established. The prediction task was formulated as a classification problem, and three ensemble learning models were developed: Random Forest, Extreme Gradient Boosting (XGBoost), and Histogram-based Gradient Boosting Classifier. Model performance was evaluated using accuracy, precision, recall, F1-score, and log-loss. Model interpretability was analyzed using Shapley Additive Explanations (SHAP). RESULTS The Histogram-based Gradient Boosting Classifier achieved the best performance (accuracy=0.75, F1-score=0.48), followed by XGBoost (accuracy=0.74, F1-score=0.43) and Random Forest (accuracy=0.72, F1-score=0.22). SHAP results suggested that the prediction results of the last two models have the highest correction. CONCLUSIONS Ensemble learning models can effectively predict high-use days of budesonide, with the Histogram- based Gradient Boosting Classifier demonstrating the best predictive performance. Low temperature, high humidity, and low atmospheric pressure show significant positive impacts on the prediction of daily budesonide usage.
3.Analysis of factors influencing premature birth in cases with placenta previa complicated by placenta ac-creta spectrum disorders
Jingyu WANG ; Yi HE ; Cuifang FAN ; Guoping XIONG ; Guoqiang SUN ; Shaoshuai WANG ; Suhua CHEN ; Jianli WU ; Dongrui DENG ; Ling FENG ; Haiyi LIU ; Xiaohe DANG ; Wanjiang ZENG
The Journal of Practical Medicine 2024;40(21):2982-2988
Objective To retrospectively analyze of factors influencing early preterm birth(EPB)and late preterm birth(LPB)in pregnancy women with placenta previa complicated by placenta accreta spectrum disorders(PAS),and assess maternal and infant outcomes.Methods We included 590 cases of pregnancy women with placenta previa complicated by PAS who underwent cesarean sections at five hospitals in Wuhan and Xianning cities between January 2018 and June 2021.These patients were divided into three groups based on delivery gesta-tional age:EPB,LPB,and term birth(TB).A multiple logistic regression model was employed to analyze the risk factors associated with EPB and LPB.Additionally,differences in early maternal and infant outcomes among these groups were examined.Results Among 590 pregnancy women with placenta previa complicated by PAS,the proportions of EPB and LPB were 9.7%and 54.4%.The use of uterine contraction inhibitors prior to cesarean section,vaginal bleeding,and previous cesarean sections history were identified as risk factors for both EPB and LPB.The proportion of severe postpartum hemorrhage was comparable between the EPB group and the LPB group;however,the incidence of neonatal asphyxia,low birth weight infants,and the rate of newborns transferred to the Neonatal Intensive Care Unit(NICU)within 24 hours after cesarean delivery were significantly higher in the EPB group compared to the LPB group.Conclusions Placenta previa complicated by PAS predominantly leads to LPB.The history of prior cesarean sections,uterine contractions,and vaginal bleeding prior to cesarean section,are sig-nificantly associated with both EPB and LPB.During the perinatal period,efforts should be made to extend gesta-tional weeks under close monitoring to minimize the incidence of premature births and thereby improve early mater-nal and infant outcomes.
4.A comparative study on the efficiency of three human-computer interaction modes for flight interaction tasks
Duanqin XIONG ; Naiming YAO ; Rong LIN ; Hanxiao GE ; Jian DU ; Yiwen HU ; Lin DING ; Xu WU ; Guoqiang SUN
Space Medicine & Medical Engineering 2024;35(3):156-161
Objective To compare the interaction efficiency of three human-machine interaction modes with hand-touch control,eye movement control and voice control,based on a multi-channel human-machine interaction system in flight mission scenarios.Methods 20 pilots took part in the study and completed the first level(relatively simple)and second level(relatively complex)interactive experimental tasks in three human-computer interaction modes based on specific flight mission scenarios.The interaction efficiency indicators included the system's interaction time,response time,fusion calculation time,and number of errors.After the experiment was completed,the pilots conducted a subjective evaluation,which included the suitability of the interaction mode to the task,consistency with expected usage,fault-tolerance,effective feedback,and the tendency of the interaction mode to be applied in future flight fields.Results There were generally significant differences in interaction efficiency between hand-touch control,voice control,and eye movement control in flight mission scenarios,but the differences differed in first-level and second-level interaction tasks.Based on the comprehensive interaction experimental tasks at all levels,the experimental results obtained included:(1)the interaction time of hand-touch control was the shortest,the interaction time of voice control was the longest,and the main effect of the interaction mode was significant(F=18.214,P<0.001,η2=0.565);(2)The response time of hand-touch control was the shortest,while the response time of eye movement control was the longest.The main effect of interaction mode was significant(F=153.085,P<0.001,η2=0.944);(3)The fusion calculation time for hand-touch control was the shortest,while the fusion calculation time for voice control was the longest.The main effect of the interaction mode was significant(F=41.702,P<0.001,η2=0.777);(4)The errors in voice control were the least,while those in eye movement control were the most.The main effect of interaction mode was significant(χ2=22.845,P<0.001,φ=1.097);(5)The subjective evaluation scores of pilots on voice control were higher than those on eye movement control,and all had statistical significance(P<0.001,P<0.01).Conclusions This study focuses on flight interaction tasks and compares the interaction efficiency of three interaction modes of hand-touch control,voice control,and eye movement control,through a combination of experiments and subjective evaluations.The differences in various interaction efficiency indicators among different interaction modes are found,and the interaction modes have a significant impact on interaction efficiency.Hand-touch control has a significant advantage in interaction time efficiency,voice control has an advantage in accuracy for simple tasks,while eye movement control has relatively weak time efficiency and accuracy;Compared to eye movement control,pilots exhibit higher evaluations and tendencies towards voice control.The research results can provide reference for the future design,evaluation,and application of multi-modal interaction systems.
5.Analysis of the whole genome sequence of a GⅡ.12P16 norovirus strain
Meijia LI ; Guoqiang WANG ; Mingxin GUO ; Xiaolin LIU ; Ti LIU ; Wenkui SUN ; Zhongyan FU ; Zengqiang KOU
Chinese Journal of Experimental and Clinical Virology 2024;38(2):144-149
Objective:To characterize the complete genome sequence and elucidate the structural features of norovirus (NoV) isolate SD20200267.Methods:The viral nucleic acid was extracted from patient samples, followed by amplification and sequencing for genotyping based on the nucleotide sequences. The metagenomic sequencing technology was utilized for whole genome sequencing, and subsequent analysis was performed on the acquired nucleotide sequences.Results:The complete genome sequence of the SD20200267 strain, spanning a total length of 7 465 nucleotides, was successfully obtained. The SD20200267 strain belongs to the GⅡ.12 and GⅡ.P16 genotypes in the VP1 and RdRp regions, respectively. The nucleotide sequence identity of SD20200267 strain with other GⅡ.12[P16] strains ranged from 96.0% to 97.3%, exhibiting 15 amino acid variations. The strain displayed evidence of recombination, with the recombination site located in the overlapping region of ORF1 and ORF2.Conclusions:SD20200267 is classified as a GⅡ.12[P16] strain, and recombination was observed in the overlapping region of ORF1 and ORF2.
6.Impacts of participation in surgical clinical trial on safety and survival outcomes in patients with right-sided colon cancer
Huaqing ZHANG ; Guoqiang WANG ; Bin WU ; Guole LIN ; Huizhong QIU ; Beizhan NIU ; Junyang LU ; Lai XU ; Xiyu SUN ; Guannan ZHANG ; Yi XIAO
Chinese Journal of Gastrointestinal Surgery 2024;27(9):928-937
Objective:To explore the impact on safety and prognosis in patients with right-sided colon cancer participating in surgical clinical research.Methods:This retrospective cohort study utilized data from a randomized controlled trial (RELARC study) conducted by the colorectal surgery group at Peking Union Medical College Hospital in which laparoscopic complete mesocolic excision (CME) was compared with D2 radical resection for the management of right-sided colon cancer. The eligibility criteria were age 18–75 years, biopsy-proven colon adenocarcinoma, tumor located between the cecum and right 1/3 of the transverse colon, enhanced chest, abdomen, and pelvic CT scans suggesting tumor stage T2–T4N0M0 or TanyN+ M0, and having undergone radical surgical treatment from January 2016 to December 2019. Exclusion factors included multiple primary colorectal cancers, preoperative stage T1N0 or enlarged central lymph nodes, tumor involving surrounding organs requiring their resection, definite distant metastasis or otherwise unable to undergo R0 resection, history of any other malignant tumors within previous 5 years, intestinal obstruction, perforation, or gastrointestinal bleeding requiring emergency surgery, and assessed as unsuitable for laparoscopic surgery. Patients who had participated in the RELARC study were included in the RELARC group, whereas those who met the inclusion criteria but refused to participate in the RELAEC study were included in the control group. The main indicators studied were the patient's baseline data, surgery and perioperative conditions, pathological characteristics, adjuvant treatment, and postoperative follow-up (including average frequency of follow-up within the first 3 years) and survival (including 3-year disease-free survival rate (DFS) and 3-year overall survival rate (OS). Differences in these indicators between the RELARC and control groups were compared.Results:The study cohort comprised 290 patients, 173 in the RELARC group (RELARC-CME group, 82; RELARC-D2 group, 91) and 117 in the control group (CME control group, 72; D2 control group, 45). There was a significantly higher proportion of overweight patients (BMI ≥24 kg/m 2) in the RELARC-CME than in the CME control group (67.1% [55/82] vs. 33.3% [24/72], χ 2=17.469, P<0.001). There were no other statistically significant differences in baseline characteristics (all P>0.05). No significant disparities were found between the CME and D2 groups in terms of operation duration, intraoperative blood loss, rate of conversion to open surgery, combined organ resection, intraoperative blood transfusion, or intraoperative complications (all P>0.05). There was a trend toward Clavien–Dindo grade II or higher postoperative complications in the RELARC-CME group (24.4% [20/82]) than in the CME control group (18.1% [13/72]); however, this difference was not statistically significant (χ 2=0.914, P=0.339). Similarly, the difference in this rate did not differ significantly between the RELARC-D2 group (25.3% [23/91]) and D2 control group (24.4% [11/45], χ 2=0.011, P=0.916). The median duration of postoperative follow-up was significantly shorter in the RELARC groups than in the corresponding control groups. Specifically, the median duration of follow-up was 4.5 (4.5, 4.5) months in the RELARC-CME and 7.2 (6.0, 9.0) months in the CME control group ( Z=-10.608, P<0.001). Similarly, the median duration of follow-up was 4.5 (4.5, 4.5) months in the RELARC-D2 group as opposed to 8.3 (6.6, 9.0) months in the D2 control group ( Z=-10.595, P<0.001). The 3-year DFS rate (91.5%) and OS rate (96.3%) tended to be higher in the RELARC-CME group than in the CME control group (84.7% and 90.3%, respectively). The 3-year DFS rate (87.9%) and OS rate (96.7%) tended to be higher in the RELARC-D2 group than in the D2 control group (81.8% and 88.6%, respectively); however, these differences were not statistically significant (all P>0.05). Subgroup analysis according to pathological stage revealed that patients in the RELARC-D2 group with pN0 stage achieved a significantly superior 3-year OS rate than did those in the D2 control group (100% vs. 88.9%, P=0.008). We identified no statistically significant differences in survival rates between the remaining subgroups (all P>0.05). Conclusions:A high-quality surgical clinical trial with close follow-up can achieve perioperative safety and a trend toward improved survival outcomes.
7.Clinical results of 100 cases of modified eversion carotid endarterectomy
Leng NI ; Wenzhuo LIAN ; Rong ZENG ; Xiao DI ; Xitao SONG ; Fangda LI ; Liqiang CUI ; Guoqiang SUN ; Yuehong ZHENG ; Changwei LIU
Chinese Journal of Surgery 2024;62(12):1143-1149
Objective:The primary goal of this study is to explore the safety and effectiveness of a new modified eversion carotid endarterectomy (MECEA).Methods:This is a retrospective case series study. One hundred patients were consecutively treated with MECEA by the same operator at Department of Vascular Surgery,Peking Union Medical College Hospital from January 2019 to December 2023. There were 77 males and 23 females. The age was (66.0±8.6)years (range: 39 to 85 years). Twenty-four (24.0%) patients were symptomatic with the degree of carotid stenosis over 50%,76 patients (76.0%) were asymptomatic with the degree of stenosis over 70%. All these patients meet the indication of carotid endarterectomy. The main difference between MECEA and traditional eversion carotid endarterectomy was the anterior,lateral,and posterior walls of the internal carotid artery were incised obliquely from the origin of the internal carotid artery toward the common carotid artery,leaving the wall of internal carotid artery intact at the bifurcation. The surgical process,cardiovascular and cerebrovascular complications and other surgical complications were recorded. The incidences of complications,restenosis of intraoperative target lesions and re-intervention were collected during follow-up.Results:All procedures were performed successfully under general anesthesia. The total operation time was (36.5±10.1)minutes (range: 22 to 65 minutes),and carotid clamping time was (15.0±6.3)minutes (range: 7 to 31 minutes). One patient (1.0%) occurred postoperative cerebrovascular accident,1 patient (1.0%) developed cerebral hyperperfusion syndrome (CHS),and another 1 patient (1.0%) suffered myocardial infarction. All these patients were recovered after medical treatment within a week. The follow-up time( M(IQR)) was 24 (28) months (range: 6 to 62 months). Two patients (2.0%) were reported to have hemodynamically significant restenosis within 2 years,with one patient requiring intervention. No patient suffered from ipsilateral ischemic stroke. Conclusions:MECEA is a safe and effective surgical method of treating carotid artery stenosis. This method can reduce carotid clamping time and lowers the risk of ischemic stroke. Meantime,it preserves the integrity of the adventitia at the bifurcation of carotid artery,reduces the chance of restenosis. Moreover,it might be helpful to prevent postoperative CHS due to reducing damage to the carotid body and carotid sinus nerve.
8.Impacts of participation in surgical clinical trial on safety and survival outcomes in patients with right-sided colon cancer
Huaqing ZHANG ; Guoqiang WANG ; Bin WU ; Guole LIN ; Huizhong QIU ; Beizhan NIU ; Junyang LU ; Lai XU ; Xiyu SUN ; Guannan ZHANG ; Yi XIAO
Chinese Journal of Gastrointestinal Surgery 2024;27(9):928-937
Objective:To explore the impact on safety and prognosis in patients with right-sided colon cancer participating in surgical clinical research.Methods:This retrospective cohort study utilized data from a randomized controlled trial (RELARC study) conducted by the colorectal surgery group at Peking Union Medical College Hospital in which laparoscopic complete mesocolic excision (CME) was compared with D2 radical resection for the management of right-sided colon cancer. The eligibility criteria were age 18–75 years, biopsy-proven colon adenocarcinoma, tumor located between the cecum and right 1/3 of the transverse colon, enhanced chest, abdomen, and pelvic CT scans suggesting tumor stage T2–T4N0M0 or TanyN+ M0, and having undergone radical surgical treatment from January 2016 to December 2019. Exclusion factors included multiple primary colorectal cancers, preoperative stage T1N0 or enlarged central lymph nodes, tumor involving surrounding organs requiring their resection, definite distant metastasis or otherwise unable to undergo R0 resection, history of any other malignant tumors within previous 5 years, intestinal obstruction, perforation, or gastrointestinal bleeding requiring emergency surgery, and assessed as unsuitable for laparoscopic surgery. Patients who had participated in the RELARC study were included in the RELARC group, whereas those who met the inclusion criteria but refused to participate in the RELAEC study were included in the control group. The main indicators studied were the patient's baseline data, surgery and perioperative conditions, pathological characteristics, adjuvant treatment, and postoperative follow-up (including average frequency of follow-up within the first 3 years) and survival (including 3-year disease-free survival rate (DFS) and 3-year overall survival rate (OS). Differences in these indicators between the RELARC and control groups were compared.Results:The study cohort comprised 290 patients, 173 in the RELARC group (RELARC-CME group, 82; RELARC-D2 group, 91) and 117 in the control group (CME control group, 72; D2 control group, 45). There was a significantly higher proportion of overweight patients (BMI ≥24 kg/m 2) in the RELARC-CME than in the CME control group (67.1% [55/82] vs. 33.3% [24/72], χ 2=17.469, P<0.001). There were no other statistically significant differences in baseline characteristics (all P>0.05). No significant disparities were found between the CME and D2 groups in terms of operation duration, intraoperative blood loss, rate of conversion to open surgery, combined organ resection, intraoperative blood transfusion, or intraoperative complications (all P>0.05). There was a trend toward Clavien–Dindo grade II or higher postoperative complications in the RELARC-CME group (24.4% [20/82]) than in the CME control group (18.1% [13/72]); however, this difference was not statistically significant (χ 2=0.914, P=0.339). Similarly, the difference in this rate did not differ significantly between the RELARC-D2 group (25.3% [23/91]) and D2 control group (24.4% [11/45], χ 2=0.011, P=0.916). The median duration of postoperative follow-up was significantly shorter in the RELARC groups than in the corresponding control groups. Specifically, the median duration of follow-up was 4.5 (4.5, 4.5) months in the RELARC-CME and 7.2 (6.0, 9.0) months in the CME control group ( Z=-10.608, P<0.001). Similarly, the median duration of follow-up was 4.5 (4.5, 4.5) months in the RELARC-D2 group as opposed to 8.3 (6.6, 9.0) months in the D2 control group ( Z=-10.595, P<0.001). The 3-year DFS rate (91.5%) and OS rate (96.3%) tended to be higher in the RELARC-CME group than in the CME control group (84.7% and 90.3%, respectively). The 3-year DFS rate (87.9%) and OS rate (96.7%) tended to be higher in the RELARC-D2 group than in the D2 control group (81.8% and 88.6%, respectively); however, these differences were not statistically significant (all P>0.05). Subgroup analysis according to pathological stage revealed that patients in the RELARC-D2 group with pN0 stage achieved a significantly superior 3-year OS rate than did those in the D2 control group (100% vs. 88.9%, P=0.008). We identified no statistically significant differences in survival rates between the remaining subgroups (all P>0.05). Conclusions:A high-quality surgical clinical trial with close follow-up can achieve perioperative safety and a trend toward improved survival outcomes.
9.Clinical results of 100 cases of modified eversion carotid endarterectomy
Leng NI ; Wenzhuo LIAN ; Rong ZENG ; Xiao DI ; Xitao SONG ; Fangda LI ; Liqiang CUI ; Guoqiang SUN ; Yuehong ZHENG ; Changwei LIU
Chinese Journal of Surgery 2024;62(12):1143-1149
Objective:The primary goal of this study is to explore the safety and effectiveness of a new modified eversion carotid endarterectomy (MECEA).Methods:This is a retrospective case series study. One hundred patients were consecutively treated with MECEA by the same operator at Department of Vascular Surgery,Peking Union Medical College Hospital from January 2019 to December 2023. There were 77 males and 23 females. The age was (66.0±8.6)years (range: 39 to 85 years). Twenty-four (24.0%) patients were symptomatic with the degree of carotid stenosis over 50%,76 patients (76.0%) were asymptomatic with the degree of stenosis over 70%. All these patients meet the indication of carotid endarterectomy. The main difference between MECEA and traditional eversion carotid endarterectomy was the anterior,lateral,and posterior walls of the internal carotid artery were incised obliquely from the origin of the internal carotid artery toward the common carotid artery,leaving the wall of internal carotid artery intact at the bifurcation. The surgical process,cardiovascular and cerebrovascular complications and other surgical complications were recorded. The incidences of complications,restenosis of intraoperative target lesions and re-intervention were collected during follow-up.Results:All procedures were performed successfully under general anesthesia. The total operation time was (36.5±10.1)minutes (range: 22 to 65 minutes),and carotid clamping time was (15.0±6.3)minutes (range: 7 to 31 minutes). One patient (1.0%) occurred postoperative cerebrovascular accident,1 patient (1.0%) developed cerebral hyperperfusion syndrome (CHS),and another 1 patient (1.0%) suffered myocardial infarction. All these patients were recovered after medical treatment within a week. The follow-up time( M(IQR)) was 24 (28) months (range: 6 to 62 months). Two patients (2.0%) were reported to have hemodynamically significant restenosis within 2 years,with one patient requiring intervention. No patient suffered from ipsilateral ischemic stroke. Conclusions:MECEA is a safe and effective surgical method of treating carotid artery stenosis. This method can reduce carotid clamping time and lowers the risk of ischemic stroke. Meantime,it preserves the integrity of the adventitia at the bifurcation of carotid artery,reduces the chance of restenosis. Moreover,it might be helpful to prevent postoperative CHS due to reducing damage to the carotid body and carotid sinus nerve.
10.Risk Analysis and Countermeasure Suggestions for Hospital Near-source Cyber-attacks
Xiaoyang MENG ; Wei YANG ; Nan ZHANG ; Guoqiang SUN
Journal of Medical Informatics 2024;45(9):87-90
Purpose/Significance To analyze the risks of near-source cyber-attacks faced by hospitals,and to propose counter-measures.Method/Process Combined with practical work experience,the risk analysis of hospital network architecture,on-site physi-cal environment,personnel behavior and other aspects is carried out from the perspective of near-source cyber-attacker.Then,from the perspective of defender and in combination with regulatory requirements and technical practices,countermeasures and suggestions are proposed.Result/Conclusion 5 main risks are identified,including wireless LAN cracking,exposed wired network sockets,improper configuration of self-service machines,poisoning & phishing,and sensitive information leakage.5 preventive suggestions are put for-ward,including strengthening Wi-Fi management,full coverage of network terminal access,multi-department collaboration in self-service device management,disabling mobile storage media on Intranet terminals,and updating cyber-security education.


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