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.The characteristics of " not just right experiences" in patients with obsessive-compulsive disorder with different levels of obsessive beliefs and their relationship with obsessive-compulsive symptoms
Lijuan YANG ; Xiangyun YANG ; Daning CHEN ; Zhanjiang LI
Chinese Journal of Behavioral Medicine and Brain Science 2024;33(9):819-825
Objective:To evaluate the characteristics of not just right experiences (NJREs) with high and low obsessive-compulsive beliefs in obsessive-compulsive disorder (OCD) patients, and to analyze their relationship with OCD symptoms.Methods:A total of 142 patients with OCD and 51 patients with anxiety disorders were included in the outpatient department of Beijing Anding Hospital.The Yale-Brown obsessive-compulsive scale (Y-BOCS), obsessive belief questionnaire (OBQ-44), revised version of the not just right experience questionnaire (NJRE-Q-R), Beck depression inventory (BDI), and Beck anxiety inventory (BAI) were used to evaluate clinical symptoms in patients with OCD and anxiety disorders. Cluster analysis was used to divide OCD into high obsessive beliefs group (OCD-H, n=77) and low obsessive beliefs group (OCD-L, n=65).The SPSS 23.0 software was used for data analysis.Chi-square test and one-way analysis of variance were used to compare the demographic and clinical data of OCD-H, OCD-L, and anxiety groups. Multivariate Logistic regression analysis was used to analyze the risk factors for OCD, and multiple linear regression analysis was used to analyze the influencing factors of obsessive compulsive symptoms in the OCD-H and OCD-L groups, respectively. Results:There were significant differences in the scores of Y-BOCS((23.14±6.60), (17.77±6.48), (8.70±6.80)), OBQ-44((162.69±33.15), (86.54±19.09), (103.12±45.67)), NJRE-Q-R checklist scale((4.58±2.61), (2.92±2.15), (2.86±1.72)), NJRE-Q-R severity scale((32.86±8.97), (24.75±9.71), (18.86±8.51)) among OCD-H, OCD-L, and anxiety groups( F=68.87, 102.29, 11.06, 32.01, all P<0.001).Multivariate Logistic regression analysis showed the NJRE-Q-R severity score was a risk factor for OCD( B=0.124, OR=1.132, 95% CI=1.071-1.197, P<0.001).For the OCD-H group, Y-BOCS scores were influenced by disease duration, BDI scores, OBQ-44 factor 1 and factor 3 scores( B=0.020, 0.201, 0.133, 0.126, all P<0.05). For the OCD-L group, the Y-BOCS scores were influenced by the scores of BDI and the checklist and severity score of NJRE-Q-R( B=0.265, 0.852, 0.191, all P<0.05). Conclusions:NJREs are prevalent in OCD patients regardless of the level of OCD beliefs, with higher degrees than anxiety disorders. NJREs are a risk factor for OCD, especially for patients with low obsessive compulsive beliefs.NJREs may be a potential cause and intervention target for OCD patients especially with low OCD beliefs.
3.Characteristics of "not just right experiences" in patients with obsessive-compulsive disorder and the correlation with obsessive-compulsive symptoms
Daning CHEN ; Xiangyun YANG ; Lijuan YANG ; Zhanjiang LI
Chinese Journal of Psychiatry 2024;57(3):155-163
Objective:To explore the clinical manifestation and characteristics of not just right experiences (NJREs) in Chinese patients with obsessive-compulsive disorder (OCD), and the correlation with obsessive symptoms. The effect of clinical treatment on NJREs was studied.Methods:Clinical data were collected from 91 OCD patients in outpatient care at Beijing Anding Hospital, Capital Medical University, from March 2021 to March 2022. Patients were categorized into an untreated OCD group (40 cases, 24 males and 16 females, aged 29.3±8.1 years) and a treated OCD group (51 cases, 23 males and 28 females, aged 30.5±8.5 years) based on whether they received treatment in the month prior to admission. An age-matched healthy control group ( n=50, 25 males and 25 females, aged 30.8±8.9 years) was recruited simultaneously. The Not Just Right Experiences-Questionnaire-Revised (NJRE-Q-R) was used to evaluate the characteristics and severity of NJREs. The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Yale-Brown Obsessive Compulsive Scale Symptoms Checklist (Y-BOCS-SC), Obsessive Belief Questionnaire (OBQ-44), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) were used to evaluate the severity and types of obsessive-compulsive symptoms, obsessive-compulsive beliefs, anxiety, and depressive emotions. Analysis of variance was used to compare differences in NJREs among the untreated OCD group, treated OCD group and the healthy controls. Pearson correlation analysis was performed to explore the correlation between NJREs and clinical symptoms in OCD patients, and an intermediate effect model was used to analyze the mediation role of NJREs in the course of OCD. A treatment follow-up was conducted for 36 untreated OCD patients over 8 weeks, reassessing the severity of obsessive-compulsive symptoms and NJREs, as well as anxiety and depressive emotions to analyze the impact of treatment on NJREs. Results:The detection rates of NJREs in the untreated OCD group (87.5%) and the treated OCD group (96.8%) were higher than that those in the healthy control group (60%) with the difference statistically significant( χ 2=22.82, P<0.01). However, there was no statistically significant difference in the detection rate of NJREs between the untreated and treated OCD groups (χ 2=2.32, P=0.127). Regarding the severity of obsessive-compulsive symptoms and NJREs, the untreated and treated OCD groups showed statistically significant differences compared to the healthy control group (obsessive-compulsive symptom severity: 21.6±7.2 vs 20.9±7.1 vs 0.24±0.65; NJRE severity: 27.9±12.9 vs 27.7±11.8 vs 11.9±5.5; F=214.14, 37.05, both P<0.01). NJREs severity was positively correlated with the severity of obsessive-compulsive symptoms( r=0.522, P<0.05). Further mediation analysis revealed that NJRE severity significantly positively influenced Y-BOCS, BAI and BDI( β=0.398, 0.371, 0.312, all P<0.01); BDI significantly positively affected Y-BOCS( β=0.313, P<0.01); BAI had no significant impact on Y-BOCS ( β=0.071, P>0.01). After treatment, the severity of NJREs and obsessive-compulsive symptoms significantly reduced compared to the pre-treatment levels ( t=4.87, 2.01, both P<0.05). Changes in Y-BOCS total score were correlated with changes in NJRE-Q-R total score and NJRE-Q-R severity scores ( r=0.727, 0.555, both P<0.001). Conclusion:The detection rate and severity of NJREs in OCD patients are significantly higher than those in healthy controls. NJREs are correlated with obsessive-compulsive symptoms and NJREs can directly induce the development of obsessive-compulsive symptoms. Depressive emotions have a certain positive impact on the relationship between NJREs and obsessive-compulsive symptoms.
4.Characteristics of "not just right experiences" in patients with obsessive-compulsive disorder and the correlation with obsessive-compulsive symptoms
Daning CHEN ; Xiangyun YANG ; Lijuan YANG ; Zhanjiang LI
Chinese Journal of Psychiatry 2024;57(3):155-163
Objective:To explore the clinical manifestation and characteristics of not just right experiences (NJREs) in Chinese patients with obsessive-compulsive disorder (OCD), and the correlation with obsessive symptoms. The effect of clinical treatment on NJREs was studied.Methods:Clinical data were collected from 91 OCD patients in outpatient care at Beijing Anding Hospital, Capital Medical University, from March 2021 to March 2022. Patients were categorized into an untreated OCD group (40 cases, 24 males and 16 females, aged 29.3±8.1 years) and a treated OCD group (51 cases, 23 males and 28 females, aged 30.5±8.5 years) based on whether they received treatment in the month prior to admission. An age-matched healthy control group ( n=50, 25 males and 25 females, aged 30.8±8.9 years) was recruited simultaneously. The Not Just Right Experiences-Questionnaire-Revised (NJRE-Q-R) was used to evaluate the characteristics and severity of NJREs. The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Yale-Brown Obsessive Compulsive Scale Symptoms Checklist (Y-BOCS-SC), Obsessive Belief Questionnaire (OBQ-44), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) were used to evaluate the severity and types of obsessive-compulsive symptoms, obsessive-compulsive beliefs, anxiety, and depressive emotions. Analysis of variance was used to compare differences in NJREs among the untreated OCD group, treated OCD group and the healthy controls. Pearson correlation analysis was performed to explore the correlation between NJREs and clinical symptoms in OCD patients, and an intermediate effect model was used to analyze the mediation role of NJREs in the course of OCD. A treatment follow-up was conducted for 36 untreated OCD patients over 8 weeks, reassessing the severity of obsessive-compulsive symptoms and NJREs, as well as anxiety and depressive emotions to analyze the impact of treatment on NJREs. Results:The detection rates of NJREs in the untreated OCD group (87.5%) and the treated OCD group (96.8%) were higher than that those in the healthy control group (60%) with the difference statistically significant( χ 2=22.82, P<0.01). However, there was no statistically significant difference in the detection rate of NJREs between the untreated and treated OCD groups (χ 2=2.32, P=0.127). Regarding the severity of obsessive-compulsive symptoms and NJREs, the untreated and treated OCD groups showed statistically significant differences compared to the healthy control group (obsessive-compulsive symptom severity: 21.6±7.2 vs 20.9±7.1 vs 0.24±0.65; NJRE severity: 27.9±12.9 vs 27.7±11.8 vs 11.9±5.5; F=214.14, 37.05, both P<0.01). NJREs severity was positively correlated with the severity of obsessive-compulsive symptoms( r=0.522, P<0.05). Further mediation analysis revealed that NJRE severity significantly positively influenced Y-BOCS, BAI and BDI( β=0.398, 0.371, 0.312, all P<0.01); BDI significantly positively affected Y-BOCS( β=0.313, P<0.01); BAI had no significant impact on Y-BOCS ( β=0.071, P>0.01). After treatment, the severity of NJREs and obsessive-compulsive symptoms significantly reduced compared to the pre-treatment levels ( t=4.87, 2.01, both P<0.05). Changes in Y-BOCS total score were correlated with changes in NJRE-Q-R total score and NJRE-Q-R severity scores ( r=0.727, 0.555, both P<0.001). Conclusion:The detection rate and severity of NJREs in OCD patients are significantly higher than those in healthy controls. NJREs are correlated with obsessive-compulsive symptoms and NJREs can directly induce the development of obsessive-compulsive symptoms. Depressive emotions have a certain positive impact on the relationship between NJREs and obsessive-compulsive symptoms.
5.Prognostic prediction of the femoral head using osteonecrosis and contralateral regions based on CT images
Wenzhe ZHAO ; Shouye HU ; Yitong ZHAO ; Yinan LIU ; Yao LI ; Daning LI ; Dingxing HUANG ; Jian SUN
Journal of Xi'an Jiaotong University(Medical Sciences) 2022;43(5):732-736
【Objective】 To develop a prognosis model based on CT images using radiomics method for patients with osteonecrosis of the femoral head (ONFH) and to investigate the additional prediction value of the imaging features of the contralateral normal femoral head regions for the prognosis prediction. 【Methods】 A total of 51 patients were included in this retrospective study. All the patients had preoperative CT images. For each patient, two regions of interest (ROIs) were involved, including the osteonecrosis region and the contralateral normal femoral head region. A total of 968 radiomics features were extracted for each patient. We made both the univariate and multivariable analyses. Three models were developed based on the features of osteonecrosis region, contralateral normal femoral head region, and both regions. The 10 times of repeated random experiments were used for model construction and validation. The average performance of the 10 times of experiments was reported as the results. 【Results】 For the features of osteonecrosis region, 37 features showed significant predictive value, with the mean AUC value of 0.708 2±0.029 9. The AUC of the constructed prediction model was 0.911 0±0.029 4 and 0.688 6±0.089 3 for the training set and validation set, respectively. For the features of contralateral normal femoral head region, 14 features showed significant predictive value, with the mean AUC value of 0.703 6±0.006 9. The AUC value of the constructed model for the training set and validation set was 0.867 2±0.039 5 and 0.669 0±0.072 6, respectively. For the models developed based on combined features, the AUC value was higher than that of the models developed based on osteonecrosis region features (training set: 0.935 8±0.016 6 vs. validation set: 0.737 9±0.090 8). 【Conclusion】 We developed a novel CT images-based radiomics method to predict postoperative prognosis in patients with ONFH. Furthermore, the features of contralateral normal femoral head region has additional prediction value. Combining the imaging features of osteonecrosis region and contralateral normal femoral head region can obtain more accurate prediction of prognosis in patients with ONFH.
6.Current progress of not just right experiences in obsessive-compulsive disorder
Daning CHEN ; Xiangyun YANG ; Zhanjiang LI
Chinese Journal of Psychiatry 2021;54(6):428-433
Obsessive-compulsive disorder (OCD) is highly heterogeneous.Researchers increasingly recognize that the potential core motivation of OCD is not limited to “harm avoidance”. They have proposed that subjective experiences such as “not just right experiences”(NJREs) and incompleteness(INC) are also one of the core motivations of obsessive-compulsive disorder and have been included in the latest diagnostic criteria of OCD. This review focuses on the concept, clinical evaluation methods and mechanisms of NJREs and the impact of NJREs in the treatment of OCD. It discusses possible research directions in the future.
7.Current progress of not just right experiences in obsessive-compulsive disorder
Daning CHEN ; Xiangyun YANG ; Zhanjiang LI
Chinese Journal of Psychiatry 2021;54(6):428-433
Obsessive-compulsive disorder (OCD) is highly heterogeneous.Researchers increasingly recognize that the potential core motivation of OCD is not limited to “harm avoidance”. They have proposed that subjective experiences such as “not just right experiences”(NJREs) and incompleteness(INC) are also one of the core motivations of obsessive-compulsive disorder and have been included in the latest diagnostic criteria of OCD. This review focuses on the concept, clinical evaluation methods and mechanisms of NJREs and the impact of NJREs in the treatment of OCD. It discusses possible research directions in the future.
8.Effects of T-2 toxin on expression of fibroblast growth factor 8 and fibroblast growth factor receptor 3 in articular cartilage and bone marrow of rats under low selenium condition
Min SHI ; Qian FANG ; Yawen SHI ; Ge MI ; Daning LI ; Hui WANG ; Mengying WANG ; Meng ZHANG ; Tianyou MA ; Jinghong CHEN
Chinese Journal of Endemiology 2020;39(2):79-85
Objective:To study the effects of T-2 toxin on expression of fibroblast growth factor 8 (FGF8) and fibroblast growth factor receptor 3 (FGFR3) in articular cartilage and subchondral marrow of rats under low selenium condition, and to explore the mechanism of deep cartilage injury and secondary complications in Kaschin-Beck disease (KBD).Methods:Twenty-four healthy male SD rats weighted 60 - 80 g were selected, they were divided into conventional feed group (selenium content of 101.5 μg/kg) and low-selenium feed group (selenium content of 1.1 μg/kg) by random number table method, with 12 rats in each group. After 30 days of feeding, the conventional feed group was further divided into control group and T-2 toxin group (100 μg·kg -1·d -1), and the low-selenium feed group was further divided into low-selenium group and low-selenium+ T-2 toxin group, with 6 rats in each group. After 30 days of feeding, the rats were sacrificed and the knee cartilage with cancellous bone was taken. Pathological changes of knee cartilage were observed by HE staining. Immunohistochemical method was used to detect the expression of FGF8 and FGFR3 in cartilage and subchondral marrow of knee joint, positive expression rates of FGF8 and FGFR3 in articular cartilage were calculated, and the integrated optical density (IOD) values of FGF8 and FGFR3 positive expression in subchondral marrow were analyzed by Image-Pro Plus 6.0 software. Results:Under light microscope, chondrocytes in low-selenium+ T-2 toxin group were sparse, and empty chondrocytes in the deep and middle layers of articular cartilage increased, and chondrocytes died and became red cell shadows. The extracellular matrix dissolved and was slightly stained in deep region, turning into necrotic and unstructurized areas. Proliferating granulation tissue was visible nearby. The positive expression rate of FGF8 in articular cartilage of rats in low-selenium+ T-2 toxin group [(88.61 ± 10.97)%] was higher than that in control, low-selenium and T-2 toxin groups [(10.35 ± 2.48)%, (19.26 ± 3.08)%, (58.89 ± 9.29)%, P < 0.05]; IOD value of FGF8 positive expression in subchondral marrow [(16.73 ± 1.72) × 10 6] was higher than that in control, low-selenium and T-2 toxin groups [(1.20 ± 0.41) × 10 6, (4.33 ± 0.97) × 10 6, (12.80 ± 1.12) × 10 6, P < 0.05]. The positive expression rate of FGFR3 in articular cartilage of rats in low-selenium+ T-2 toxin group [(89.76 ± 8.59)%] was higher than that in control, low-selenium and T-2 toxin groups [(13.18 ± 2.25)%, (21.15 ± 2.33)%, (32.55 ± 6.72)%, P < 0.05]; IOD value of FGFR3 positive expression in subchondral marrow [(16.50 ± 5.36) × 10 6] was higher than that in control, low-selenium and T-2 toxin groups [(7.58 ± 1.02) × 10 6, (10.73 ± 7.13) × 10 6, (9.83 ± 5.63) × 10 6, P < 0.05]. Conclusion:Under low selenium condition, T-2 toxin changes expression of FGF8 and FGFR3 in deep chondrocytes of articular cartilage and subchondral marrow in rats, elevated expression of FGF8 and FGFR3 may be involved in the occurrence and development of secondary changes in KBD.
9. Establishment and evaluation of a triple-color human papillomavirus pseudovirion neutralization assay
Shuangping WEI ; Fei FAN ; Jie CHEN ; Xinlin LIU ; Yurou YANG ; Zhiping WANG ; Shuo SONG ; Zhihai LI ; Minxi WEI ; Daning WANG ; Shaowei LI ; Ningshao XIA
Chinese Journal of Preventive Medicine 2018;52(10):1039-1044
Objective:
To establish a triple-color pseudovirion-based neutralization assay (PBNA) and evaluate its capability of detecting immunogenicity of the sera generated by the immunization of HPV 9-valent vaccine.
Methods:
HPV pseudovirus (PsVs) 6/11/16/18/31/33/45/52/58 with the encapsidated fluorescence expressing red fluorescent plasmid N31-MCHREEY, green fluorescent N31-EGFP or blue fluorescent N31-mTagBFP were generated. The concentration of HPV PsVs and the infection titers of HPV PsVs were detected by double-antibody sandwich ELISA and TCID50, respectively. The single- and triple color HPV 16/33/45 PsVs were used to detect the neutralization titers of mice sera immunized with HPV 9-valent vaccine and confirmed the accuracy and specificity of the triple-color PBNAs. Then, the single- and triple color HPV 6/11/18/31/33/45/52/58 PsVs were employed to detect the neutralization titers of cynomolgus macaques sera immunized with HPV 9-valent vaccine and determined whether the triple-color PBNAs could be applied to evaluate the immunogenicity of the sera generated by the immunization of HPV9-valent vaccine.
Results:
The concentration of HPV16 PsVs encapsulating green, red or blue fluorescent plasmid was 5.0 to 6.0 μg/ml and HPV6/11/18/31/33/45/52/59 triple-color HPV PsVs was about 1.0 to 3.0 μg/ml. 9 types HPV PsVs containing EGFP, Mcherry or mTagBFP reporter plasmid were obtained and the concentration can meet the need of neutralization detection. 9 types single-color fluorescent HPV PsVs had similar infectivity against 293FT cells with the infection titer values between 1×104 and 1×105. The results of PBNAs showed that there was no significant difference in the anti-HPV neutralization titers of mice sera induced by HPV 9-valent vaccine between single-color and triple-color HPV16/33/45 PsVs (
10.Review for progress and current status of human papillomavirus prophylactic vaccine
Yunbing LI ; Shuo SONG ; Daning WANG ; Zhihai LI ; Ningshao XIA ; Shaowei LI
Chinese Journal of Biochemical Pharmaceutics 2016;36(6):33-37
Persistant infection of high-risk human papillomavirus (HPV) is the primary cause leading to cervical cancer, which is ranked as second cancer threatening the health of women following breast cancer.Development of HPV vaccine is very important because there is no effective therapeutics for cervical cancer.Three currently licensed HPV vaccines based on major capsid protein L1 in the foreign market confered good safety and efficacy in clinical trials, but the current price is expensive due to high cost, which limits the wide application in developing countries.So far, the vaccines have not been launced in China market.Here, we review the progress and the current status of the HPV vaccine, which will attract the readers’ interest on the forthcoming emergence of HPV vaccine in China.


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