1.The Problems and Solutions in the Design and Record of TCM Clinical Research Case Report Form
Fang HAN ; Kegang CAO ; Ying GAO ; Baoli LIU ; Tiantian ZHOU ; Jing HU
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(2):533-538
Case report form(CRF)is an important tool to obtain clinical research data.Scientifically designed and properly recorded CRF is of great significance to improve the quality of clinical research.The author summarized the common problems existing in the design and recording of CRF in traditional Chinese medicine(TCM)clinical studies,including:①Delayed design time point.②Unstandardized CRF design,recording and modification.③Imperfect records of combined medication/therapy.④Insufficient quantification of syndrome efficacy indicators and objectification of tongue and pulse.⑤ Insufficient protection of subjects' privacy.⑥ Unstandardized records of adverse events.Accordingly,this paper discusses some solutions to provide reference for other TCM researchers,including:①Advance CRF design time.②Standardize CRF design,recording and modification.③Design drug combinations/therapies according to Clinical Data Acquisition Standards Harmonization(CDASH).④Standardization of syndrome and tongue and pulse.⑤Use of subject identification codes to protect privacy.⑥AE records should vary from study to study.
2.Relationship between CALLY index,serum autotaxin,PRSS2 and postoperative recurrence and metastasis in gastric cancer patients
Renjie LUAN ; Baoli XU ; Ge GAO ; Wenhao TENG ; Guang LI
Immunological Journal 2025;41(9):632-638
Objective To investigate the relationship of C-reactive protein-albumin-lymphocyte(CALLY)index,serum autotaxin and serine protease 2(PRSS2)with postoperative recurrence and metastasis in gastric cancer patients.Methods A total of 188 patients who underwent radical gastrectomy for gastric cancer from December 2019 to December 2021 were selected as the research subjects.According to the postoperative situation,they were divided into the recurrence and metastasis group(n=72)and the non-recurrence and metastasis group(n=116).C reactive protein(CRP)was detected by immunoturbidimetry,albumin was detected by bromocresol green method,lymphocyte count was detected by blood routine analyzer,and CALLY index was calculated.Enzyme-linked immunosorbent assay was used to detect serum levels of autotaxin and PRSS2,and Spearman/Pearson correlation analysis was used to analyze the correlation between CALLY index,serum autotaxin,PRSS2 levels and clinical data.Multivariate logistic regression was used to analyze the influencing factors of recurrence and metastasis in patients with gastric cancer after radical resection,and receiver operating characteristic(ROC)curve was used to analyze the predictive value of CALLY index,serum autotaxin and PRSS2 levels for recurrence and metastasis in patients with gastric cancer after radical resection.Kaplan-Meier method was used to analyze the relationship between CALLY index,serum autotaxin,PRSS2 levels and postoperative recurrence and metastasis.Results Compared with the non-recurrence and metastasis group,the recurrence and metastasis group had a higher proportion of patients with TNM stage Ⅲ,Borrmann type Ⅲ-Ⅳ,lymphovascular invasion,neoadjuvant therapy and postoperative chemotherapy,higher serum levels of autotaxin and PRSS2,and lower CALLY index(P<0.01).TNM stage,Borrmann type,lymphovascular invasion,neoadjuvant therapy and postoperative chemotherapy were negatively correlated with CALLY index,and positively correlated with serum autotaxin and PRSS2 levels,while serum autotaxin and PRSS2 levels were negatively correlated with CALLY index(P<0.01).TNM stage,Borrmann type,lymphovascular invasion,CALLY index,autotaxin and PRSS2 were the influencing factors of recurrence and metastasis in patients with gastric cancer after radical resection(P<0.05,P<0.01).The area under the curve(AUC)of CALLY index,autotaxin and PRSS2 for predicting recurrence and metastasis was 0.962,which was significantly larger than that of CALLY index,autotaxin and PRSS alone(P<0.01).The 3-year recurrence and metastasis rate of patients with low CALLY index expression[56.52%(52/92)]was higher than that of patients with high CALLY index expression[20.83%(20/96)](P<0.01).The 3-year recurrence and metastasis rate of patients with high expression of autotaxin[49.47%(47/95)]was higher than that of patients with low expression[26.88%(25/93)](P<0.01).The 3-year recurrence and metastasis rate of patients with high PRSS2 expression[47.87%(45/94)]was higher than that of patients with low PRSS2 expression[28.72%(27/94)](P<0.01).Conclusion The CALLY index decreases,and serum autotaxin and PRSS2 increase in patients with postoperative recurrence and metastasis of gastric cancer.The combined prediction of the three factors demonstrates higher predictive performance for postoperative recurrence and metastasis.
3.Relationship between CALLY index,serum autotaxin,PRSS2 and postoperative recurrence and metastasis in gastric cancer patients
Renjie LUAN ; Baoli XU ; Ge GAO ; Wenhao TENG ; Guang LI
Immunological Journal 2025;41(9):632-638
Objective To investigate the relationship of C-reactive protein-albumin-lymphocyte(CALLY)index,serum autotaxin and serine protease 2(PRSS2)with postoperative recurrence and metastasis in gastric cancer patients.Methods A total of 188 patients who underwent radical gastrectomy for gastric cancer from December 2019 to December 2021 were selected as the research subjects.According to the postoperative situation,they were divided into the recurrence and metastasis group(n=72)and the non-recurrence and metastasis group(n=116).C reactive protein(CRP)was detected by immunoturbidimetry,albumin was detected by bromocresol green method,lymphocyte count was detected by blood routine analyzer,and CALLY index was calculated.Enzyme-linked immunosorbent assay was used to detect serum levels of autotaxin and PRSS2,and Spearman/Pearson correlation analysis was used to analyze the correlation between CALLY index,serum autotaxin,PRSS2 levels and clinical data.Multivariate logistic regression was used to analyze the influencing factors of recurrence and metastasis in patients with gastric cancer after radical resection,and receiver operating characteristic(ROC)curve was used to analyze the predictive value of CALLY index,serum autotaxin and PRSS2 levels for recurrence and metastasis in patients with gastric cancer after radical resection.Kaplan-Meier method was used to analyze the relationship between CALLY index,serum autotaxin,PRSS2 levels and postoperative recurrence and metastasis.Results Compared with the non-recurrence and metastasis group,the recurrence and metastasis group had a higher proportion of patients with TNM stage Ⅲ,Borrmann type Ⅲ-Ⅳ,lymphovascular invasion,neoadjuvant therapy and postoperative chemotherapy,higher serum levels of autotaxin and PRSS2,and lower CALLY index(P<0.01).TNM stage,Borrmann type,lymphovascular invasion,neoadjuvant therapy and postoperative chemotherapy were negatively correlated with CALLY index,and positively correlated with serum autotaxin and PRSS2 levels,while serum autotaxin and PRSS2 levels were negatively correlated with CALLY index(P<0.01).TNM stage,Borrmann type,lymphovascular invasion,CALLY index,autotaxin and PRSS2 were the influencing factors of recurrence and metastasis in patients with gastric cancer after radical resection(P<0.05,P<0.01).The area under the curve(AUC)of CALLY index,autotaxin and PRSS2 for predicting recurrence and metastasis was 0.962,which was significantly larger than that of CALLY index,autotaxin and PRSS alone(P<0.01).The 3-year recurrence and metastasis rate of patients with low CALLY index expression[56.52%(52/92)]was higher than that of patients with high CALLY index expression[20.83%(20/96)](P<0.01).The 3-year recurrence and metastasis rate of patients with high expression of autotaxin[49.47%(47/95)]was higher than that of patients with low expression[26.88%(25/93)](P<0.01).The 3-year recurrence and metastasis rate of patients with high PRSS2 expression[47.87%(45/94)]was higher than that of patients with low PRSS2 expression[28.72%(27/94)](P<0.01).Conclusion The CALLY index decreases,and serum autotaxin and PRSS2 increase in patients with postoperative recurrence and metastasis of gastric cancer.The combined prediction of the three factors demonstrates higher predictive performance for postoperative recurrence and metastasis.
4.The Problems and Solutions in the Design and Record of TCM Clinical Research Case Report Form
Fang HAN ; Kegang CAO ; Ying GAO ; Baoli LIU ; Tiantian ZHOU ; Jing HU
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(2):533-538
Case report form(CRF)is an important tool to obtain clinical research data.Scientifically designed and properly recorded CRF is of great significance to improve the quality of clinical research.The author summarized the common problems existing in the design and recording of CRF in traditional Chinese medicine(TCM)clinical studies,including:①Delayed design time point.②Unstandardized CRF design,recording and modification.③Imperfect records of combined medication/therapy.④Insufficient quantification of syndrome efficacy indicators and objectification of tongue and pulse.⑤ Insufficient protection of subjects' privacy.⑥ Unstandardized records of adverse events.Accordingly,this paper discusses some solutions to provide reference for other TCM researchers,including:①Advance CRF design time.②Standardize CRF design,recording and modification.③Design drug combinations/therapies according to Clinical Data Acquisition Standards Harmonization(CDASH).④Standardization of syndrome and tongue and pulse.⑤Use of subject identification codes to protect privacy.⑥AE records should vary from study to study.
5.The characteristics of gut microbiota in patients with type 2 diabetes mellitus and concurrent nonalcoholic fatty liver disease
Yuting GAO ; Tianyi ZHAO ; Shixuan LIU ; Na LV ; Tao YUAN ; Junxiang GAO ; Baoli ZHU ; Weigang ZHAO
Chinese Journal of Clinical Nutrition 2024;32(2):80-89
Objective:To investigate the characteristics of gut microbiota in patients with type 2 diabetes (T2DM) complicated by nonalcoholic fatty liver disease (NAFLD).Methods:A total of 74 patients first diagnosed with T2DM at the Endocrinology Department of Peking Union Medical College Hospital from April 2021 to October 2023 were included. Among them, 28 patients had concurrent NAFLD while 46 patients did not. Additionally, 51 healthy controls were matched (HC group). Clinical laboratory parameters were collected, and 16S rRNA sequencing with fecal samples was conducted to compare the differences in gut microbiota across the groups.Results:Compared to the group with T2DM, patients with concurrent T2DM and NAFLD were younger, had higher level of insulin resistance as assessed by the homeostatic model assessment of insulin resistance, higher body mass index (BMI), and higher triglyceride levels. There was no difference in α-diversity across the three groups ( P>0.05), while there was a significant difference in β-diversity ( P=0.03). The Eubacterium coprostanoligenes, Fusicatenibacter, Parasutterella and Tyzzerella 3 were enriched in the group with concurrent T2DM and NAFLD as shown by the relative abundance, while the relative abundance of Flavonifractor was decreased in this group. Tyzzerella 3 abundance was positively correlated with triglyceride and albumin levels and negatively correlated with high-density lipoprotein cholesterol (HDL-C) levels. Conclusion:Patients with T2DM complicated by NAFLD exhibit dysbiosis in gut microbiota composition and specific genera abundance, with Flavonifractor identified as a potential protective factor for T2DM complicated by NAFLD.
6.Chinese expert consensus on diagnosis, treatment and prevention of venous thrombus embolism associated with chest trauma (2022 version)
Kaibin LIU ; Yi YANG ; Hui LI ; Yonten TSRING ; Zhiming CHEN ; Hao CHEN ; Xinglong FAN ; Congrong GAO ; Chundong GU ; Yutong GU ; Guangwei GUO ; Zhanlin GUO ; Jian HU ; Ping HU ; Hai HUANG ; Lijun HUANG ; Weiwei HE ; Longyu JIN ; Baoli JING ; Zhigang LIANG ; Feng LIN ; Wenpan LIU ; Danqing LI ; Xiaoliang LI ; Zhenyu LI ; Haitao MA ; Guibin QIAO ; Zheng RUAN ; Gang SUI ; Dongbin WANG ; Mingsong WANG ; Lei XUE ; Fei XIA ; Enwu XU ; Quan XU ; Jun YI ; Yunfeng YI ; Jianguo ZHANG ; Dongsheng ZHANG ; Qiang ZHANG ; Zhiming ZHOU ; Zhiqiang ZOU
Chinese Journal of Trauma 2022;38(7):581-591
Chest trauma is one of the most common injuries. Venous thromboembolism (VTE) as a common complication of chest trauma seriously affects the quality of patients′ life and even leads to death. Although there are some consensus and guidelines on the prevention and treatment of VTE at home and abroad, the current literatures lack specificity considering the diagnosis, treatment and prevention of VTE in patients with chest trauma have their own characteristics, especially for those with blunt trauma. Accordingly, China Chest Injury Research Society and editorial board of Chinese Journal of Traumatology organized relevant domestic experts to jointly formulate the Chinese expert consensus on the diagnosis, treatment and prevention of chest trauma venous thromboembolism associated with chest trauma (2022 version). This consensus provides expert recommendations of different levels as academic guidance in terms of the characteristics, clinical manifestations, risk assessment, diagnosis, treatment, and prevention of chest trauma-related VTE, so as to offer a reference for clinical application.
7.Design and Implementation of Quality and Safety Traceability System for Reusable Medical Devices Disinfection Based on RFID Technology.
Baoli GAO ; Ran GE ; Dongchen ZHANG ; Xifeng LIU ; Xudong MA
Chinese Journal of Medical Instrumentation 2021;45(2):167-171
Focusing on the requirements of visual traceability for reprocessing of reused medical devices under the background of deep integration of intelligent medical treatment, a quality and safety traceability system for disinfection of reused medical devices is developed. The multi-dimensional data of the reprocessing chain of reusable medical devices are acquired in real time by the RFID mobile terminal handset and stored temporarily. The data package is formatted based on LoRa protocol and uploaded to the management and control platform in multi-threaded transmission mode for in-depth analysis and traceability. The corresponding prototype system is developed. The first-line operation and maintenance test results show that the prototype system has strong cooperation, strong operation robustness, and obvious advantages in the identification rate and other layers of sterile equipment package.
Disinfection
;
Radio Frequency Identification Device
;
Technology
8.Comparison of network report and actual detection of suspected occupational diseases among lead exposed workers in Jiangsu Province from 2016 to 2018
Qianqian GAO ; Baoli ZHU ; Hengdong ZHANG ; Wenjing ZHU ; Lei HAN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(9):667-670
Objective:To analyze and compare the detection level and actual detection of suspected occupational diseases of lead exposed workers in the network report of occupational disease and occupational health information monitoring system, so as to provide a basis for formulating and improving relevant laws and regulations on occupational disease monitoring in the future.Methods:From January 2016 to December 2018, the network report occupational health examination data of lead exposed workers in Jiangsu Province were selected, the network report detection rate of suspected occupational diseases of lead exposed workers was counted and compared with the actual detection rate judged in the early stage, and the distribution characteristics of the network report detection rate of different years, regions and occupational health examination institutions and the reasons for the difference with the actual detection rate were analyzed.Results:Network report detection rate of suspected occupational disease in Jiangsu Province from 2016 to 2018 (0.042%, 30/71810) was significantly lower than the actual detection rate of 1.12% (805/71810) , and the difference was statistically significant (χ 2=723.518, P<0.01) . The network report detection rates of suspected occupational chronic lead poisoning showed an increasing trend year by year, and the difference were statistically significant (χ 2trend=7.627, P<0.01) . All the 30 network report cases were male, and 28 cases (93.33%) were from small and medium-sized enterprises. Among the 805 cases of suspected occupational chronic lead poisoning, 689 cases (85.59%) came from small and medium-sized enterprises. The three cities with more cases were Huai'an 222 cases (27.58%) , Suzhou 208 cases (25.84%) and Changzhou 138 cases (17.14%) . Compared with the actual detection, the number of network reports in Yangzhou accounted for 85.29% (29/34) of the actual detection from 2016 to 2018, that in Suqian accounted for 10.00% (1/10) , and that in other prefecture level cities was 0. From 2016 to 2018, 46.22% (33191/71810) of the occupational health examinations of lead exposed workers were undertaken by Centers for Disease Control and prevention at all levels (referred to as "CDC") . The 30 suspected cases of occupational chronic lead poisoning reported network came from CDC, accounting for 4.89% (30/614) of the actual detection, and the rest were 0. Conclusion:There are great differences between the network report and the actual detection rate of suspected occupational chronic lead poisoning among lead exposed workers, mainly due to the differences in the judgment level of suspected occupational diseases in different regions, the nature of institutions and the level of professional technicians.
9.Discussion on the evaluation of occupational disease diagnostic criteria
Lei HAN ; Qianqian GAO ; Lang ZHOU ; Hengdong ZHANG ; Baoli ZHU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(11):877-880
Occupational disease diagnosis standards are an important basis for occupational disease diagnosis, occupational health surveillance, occupational health supervision, occupational disease treatment, occupational disease disability assessment, and handling of occupational disease diagnosis disputes in conjunction with the "Occupational Disease Prevention and Control Law of the People's Republic of China". With the successive promulgation of the "Standardization Law of the People's Republic of China" and the "Administrative Measures on Health Standards", the establishment of a mandatory standard implementation evaluation mechanism has gradually been paid attention to. However, there is still a lack of systematic research on the evaluation of diagnostic criteria for occupational diseases. Therefore, this article combines the current status of the diagnostic standards for occupational diseases in China, and proposes reasonable suggestions on how to carry out the evaluation of the implementation of this type of standard in terms of evaluation methods and content.
10.Comparison of network report and actual detection of suspected occupational diseases among lead exposed workers in Jiangsu Province from 2016 to 2018
Qianqian GAO ; Baoli ZHU ; Hengdong ZHANG ; Wenjing ZHU ; Lei HAN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(9):667-670
Objective:To analyze and compare the detection level and actual detection of suspected occupational diseases of lead exposed workers in the network report of occupational disease and occupational health information monitoring system, so as to provide a basis for formulating and improving relevant laws and regulations on occupational disease monitoring in the future.Methods:From January 2016 to December 2018, the network report occupational health examination data of lead exposed workers in Jiangsu Province were selected, the network report detection rate of suspected occupational diseases of lead exposed workers was counted and compared with the actual detection rate judged in the early stage, and the distribution characteristics of the network report detection rate of different years, regions and occupational health examination institutions and the reasons for the difference with the actual detection rate were analyzed.Results:Network report detection rate of suspected occupational disease in Jiangsu Province from 2016 to 2018 (0.042%, 30/71810) was significantly lower than the actual detection rate of 1.12% (805/71810) , and the difference was statistically significant (χ 2=723.518, P<0.01) . The network report detection rates of suspected occupational chronic lead poisoning showed an increasing trend year by year, and the difference were statistically significant (χ 2trend=7.627, P<0.01) . All the 30 network report cases were male, and 28 cases (93.33%) were from small and medium-sized enterprises. Among the 805 cases of suspected occupational chronic lead poisoning, 689 cases (85.59%) came from small and medium-sized enterprises. The three cities with more cases were Huai'an 222 cases (27.58%) , Suzhou 208 cases (25.84%) and Changzhou 138 cases (17.14%) . Compared with the actual detection, the number of network reports in Yangzhou accounted for 85.29% (29/34) of the actual detection from 2016 to 2018, that in Suqian accounted for 10.00% (1/10) , and that in other prefecture level cities was 0. From 2016 to 2018, 46.22% (33191/71810) of the occupational health examinations of lead exposed workers were undertaken by Centers for Disease Control and prevention at all levels (referred to as "CDC") . The 30 suspected cases of occupational chronic lead poisoning reported network came from CDC, accounting for 4.89% (30/614) of the actual detection, and the rest were 0. Conclusion:There are great differences between the network report and the actual detection rate of suspected occupational chronic lead poisoning among lead exposed workers, mainly due to the differences in the judgment level of suspected occupational diseases in different regions, the nature of institutions and the level of professional technicians.

Result Analysis
Print
Save
E-mail