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.Study on the mechanism of hyperoside regulating hepatic lipid synthesis to ameliorate non-alcoholic fatty liver disease in mice
Changrui LONG ; Shijian XIANG ; Zhenhua ZHANG ; Huixing WU ; Benjie ZHOU ; Chengyu LU
China Pharmacy 2025;36(6):668-673
OBJECTIVE To investigate the improvement mechanism of hyperoside (HYP) on non-alcoholic fatty liver disease (NAFLD). METHODS Male C57BL/6 mice were randomly divided into normal (NFD) group, model (HFD) group and HYP group, with 8 mice in each group. Except for NFD group, the mice in other groups were fed with HF60 high-fat diet to establish NAFLD model; HYP group was simultaneously given HYP 100 mg/kg intragastrically every day, for 16 consecutive weeks. The body weight and liver weight of mice in each group were recorded 16 h after the last medication; the histopathological changes and lipid accumulation in the liver were observed, and the contents of triglyceride (TAG) in liver tissue and serum contents of TAG, aspartate transaminase (AST) and alanine transaminase (ALT) were measured; LC-MS/MS method was adopted to detect lipid changes in the liver tissue of mice for lipidomics analysis, and protein expressions of lipid synthesis-associated proteins peroxisome proliferator-activated receptor α (PPARα) were also tested. Human hepatocellular carcinoma cell line HepG2 was divided into normal control group, model group, HYP low-concentration group (50 μmol/L), HYP high-concentration group (100 μmol/L), HYP low-concentration+GW6471 (PPARαinhibitor) group, and HYP high-concentration+GW6471 group. Except for normal control group, the remaining cells were induced with oleic acid and palmitic acid to establish a high-fat cell model. The accumulation of lipid droplets in each group of cells was observed, and the TAG content was detected. RESULTS Compared with HFD group, HYP group exhibited significant reductions in liver fat vacuoles, lipid accumulation, liver weight, and TAG content in liver tissue, as well as serum contents of ALT, AST and TAG (P<0.05). Additionally, the expression of PPARα protein in liver tissue was significantly increased (P<0.05), and the pathological morphological changes associated with NAFLD were alleviated. Lipidomic analysis revealed that HYP significantly reduced the levels of TAG, diacylglycerol and other lipids in the liver. Compared with model group, cellular lipid droplet accumulation and TAG content decreased significantly in HYP low- and high-concentration groups (P<0.05); GW6471 could significantly reverse the improvement effect of HYP on above indicators (P<0.05). CONCLUSIONS HYP can effectively ameliorate NAFLD induced by a high-fat diet in mice, and the mechanism may be related to the activation of PPARα to regulate hepatic lipid synthesis.
3.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.
4.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.
5.Ertugliflozin in the treatment of type 2 diabetes mellitus:a rapid health technology assessment
Fang QIN ; Kunrong WU ; Chengyu LIU ; Daihua LIU
Chinese Journal of Pharmacoepidemiology 2024;33(7):778-789
Objective To evaluate the efficacy,safety and cost-effectiveness of ertugliflozin in the treatment of type 2 diabetes mellitus by rapid health technology assessment to provide a basis for clinical decision-making.Methods PubMed,Embase,the Cochrane Library,CNKI,WanFang Data,VIP database and health technology assessment(HTA)related websites and databases were searched from the inception date to January 2024.Two researchers independently screened the literature,extracted the data,assessed the quality and carried out the qualitative analysis.Results A total of 27 articles were included,in which 2 HTA reports,24 systematic reviews/meta-analyses and 2 pharmacoeconomic studies.Compared with placebo,ertugliflozin could significantly lower hemoglobin Alc level,fasting plasma glucose,hospitalization for heart failure,body weight and blood pressure levels,but there were no significant difference in all-cause mortality,cardiovascular mortality and composite renal outcome.In terms of safety,there were no significant difference in the risk of urinary tract infections,fracture,amputation and symptomatic hypoglycemia between ertugliflozin and placebo or other hypoglycemic drugs.However,ertugliflozin increased the risk of ketoacidosis,genital mycotic infections and lowered of estimated glomerular filtration rate.Pharmacoeconomic studies showed that ertugliflozin had better cost-utility and cost-effectiveness in type 2 diabetes in China.Conclusion Ertugliflozin is effective and safety in treating type 2 diabetes mellitus,but it's necessary to carry out the head to head studies among efficacy,safety and economics research in China.
6.Clinical and pathological characteristics and prognostic analysis of large B-cell lymphoma with IRF4 rearrangement
Shi HE ; Chengyu WU ; Shuyi LU ; Longfeng KE ; Yating QIU ; Wenwen ZHANG ; Gang CHEN ; Yanping CHEN
Chinese Journal of Clinical and Experimental Pathology 2024;40(7):730-735
Purpose To explore the clinicopathological features,diagnosis and differential diagnosis of large B-cell lym-phoma with IRF4 rearrangement(LBCL-IRF4r).Methods Clinical data of 8 cases of LBCL-IRF4r were collect,hematoxy-lin-eosin and immunohistochemical of EnVision two-step stains,in situ hybridization and FISH was used to study the histology,immunotypes and molecular genetic characteristics.The rele-vant literatures were reviewed.Results Among 8 cases of LBCL-IRF4r,the male to female ratio was 1.67:1,with age range 10-53 years(mean 25.8 years).Five cases occurred in tonsils,2 cases in nasopharynx and 1 cases in inguinal lymph node.Microscopically,the tumors presented with a purely follic-ular,purely diffuse or a combined follicular and diffuse architec-ture.The tumor cells were typical centroblasts and less frequent-ly medium-sized blastic cells with smaller nucleoli,apoptosis and nuclear fragmentation were easily seen.Immunophenotypi-cally,the tumor cells of the eight cases of LBCL-IRF4r diffuse strongly expressed CD20(8/8),PAX5(2/2),CD79a(3/3),BCL6(8/8)and MUM-1(8/8),mostly expressed CD10(7/8),partially expressed BCL2(5/8)and CD5(4/8),and did not express Cyclin D1,CD23 and CD30.The percentage of Ki67 index ranged from 70%to 95%.EBER in situ hybridiza-tion was negative in all cases.IRF4 rearrangements were detec-ted in all cases(8/8).BCL6 rearrangements were detected in one case(1/2).MYC(0/4)and BCL2(0/3)rearrangements were not detected in all cases.Conclusion LBCL-IRF4r is more common in children and adolescents with characteristic IG::IRF4 rearrangement and a good prognosis,which needs to be differentiated from other types of large B-cell lymphoma.
7.Assessment of different bone marrow infiltration patterns with MR whole-body diffusion weighted imaging in multiple myeloma
Yawen WU ; Dongmei WANG ; Hongwei CAO ; Fengzhen CUI ; Chengyuan XU ; Jie LIU ; Chengyu JIN ; Boyi LI ; Yuqing LI
Journal of Practical Radiology 2024;40(6):952-956
Objective To evaluate the apparent diffusion coefficient(ADC)values of different bone marrow infiltration patterns in multiple myeloma(MM)patients with MR whole-body diffusion weighted imaging(WB-DWI)and to determine the ADC thresholds for different bone marrow infiltration patterns.Methods Nineteen MM patients diagnosed for the first time were selected.The lesions types of each site(cervical spine,ribs,sternum,humerus,scapula,sacral spine,ilium,femur,thoracic spine,and lumbar spine)after the WB-DWI images were visually evaluated,which were divided into focal group(including focal lesion in combined focal and diffuse infiltration)[region of interest(ROI)=141],pure diffuse infiltration group(ROI=150),diffuse lesion in combined focal and diffuse infiltration group(ROI=127),"salt-and-pepper"group(ROI=54),and normal appearance group(ROI=68).ADC values were measured and compared between each group and the receiver operating characteristic(ROC)curve was drawn to distinguish different patterns of bone marrow infiltration.Results There was no statistically significant difference in ADC values between the diffuse lesion in combined focal and diffuse infiltration group and the"salt-and-pepper"group(P>0.99),and there was statistically significant difference in ADC values between the other groups(P<0.05).The ROC curve showed that the area under the curve(AUC)for identifying focal group and the"salt-and-pepper"group was 0.889[95%confidence interval(CI)0.844-0.934],the AUC for identifying pure diffuse infiltration group and the normal appearance group was 0.968(95%CI 0.949-0.987).ADC values were able to accurately and visually differentiate between the different patterns of bone marrow infiltration.Conclusion The ADC values can be used as a quantitative tool to objectively distinguish different bone marrow infiltration patterns in MM patients.
8.Improvement on Quality Standard of Yuanhu Zhitong Oral Liquid
Lu FU ; Chengyu CHEN ; Jin GAO ; Dan WU ; Chun LI ; Zhiming CAO ; Jianli GUAN ; Ping WANG ; Haiyu XU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(9):125-131
ObjectiveTo improve the quality standard of Yuanhu Zhitong oral liquid in order to strengthen the quality control of this oral liquid. MethodThin layer chromatography(TLC) was used for the qualitative identification of Corydalis Rhizoma and Angelicae Dahuricae Radix in Yuanhu Zhitong oral liquid by taking tetrahydropalmatine, corydaline reference substances and Corydalis Rhizoma reference medicinal materials as reference, and cyclohexane-trichloromethane-methanol(5∶3∶0.5) as developing solvent, Corydalis Rhizoma was identified using GF254 glass thin layer plate under ultraviolet light(365 nm). And taking petroleum ether(60-90 ℃) -ether-formic acid(10∶10∶1) as developing solvent, Angelicae Dahuricae Radix was identified using a silica gel G TLC plate under ultraviolet light(305 nm). High performance liquid chromatography(HPLC) was performed on a Waters XSelect HSS T3 column(4.6 mm×250 mm, 5 μm) with acetonitrile(A)-0.1% glacial acetic acid solution(adjusted pH to 6.1 by triethylamine)(B) as the mobile phase for gradient elution(0-10 min, 20%-30%A; 10-25 min, 30%-40%A; 25-40 min, 40%-50%A; 40-60 min, 50%-60%A), the detection wavelength was set at 280 nm, then the fingerprint of Yuanhu Zhitong oral liquid was established, and the contents of tetrahydropalmatine and corydaline were determined. ResultIn the thin layer chromatograms, the corresponding spots of Yuanhu Zhitong oral liquid, the reference substances and reference medicinal materials were clear, with good separation and strong specificity. A total of 12 common peaks were identified in 10 batches of Yuanhu Zhitong oral liquid samples, and the peaks of berberine hydrochloride, dehydrocorydaline, glaucine, tetrahydropalmatine and corydaline. The similarities between the 10 batches of samples and the control fingerprint were all >0.90. The results of determination showed that the concentrations of corydaline and tetrahydropalmatine had good linearity with paek area in the range of 0.038 6-0.193 0, 0.034 0-0.170 0 g·L-1, respectively. The methodological investigation was qualified, and the contents of corydaline and tetrahydropalmatine in 10 batches of Yuanhu Zhitong oral liquid samples were 0.077 5-0.142 9、0.126 1-0.178 2 g·L-1, respectively. ConclusionThe established TLC, fingerprint and determination are simple, specific and reproducible, which can be used to improve the quality control standard of Yuanhu Zhitong oral liquid.
9.β-caryophyllene promotes white fat browning in obese mice through up-regulation of the PPARγ/PGC-1α/UCP1 pathway
Haoran JIANG ; Xiaofei TANG ; Jielin WU ; Jiaoling WANG ; Chengyu HUANG ; Shuguang ZHU ; Linquan ZANG
Acta Universitatis Medicinalis Anhui 2024;59(9):1591-1598
Objective To investigate the effects of β-caryophyllene(BCP)on the browning of white adipose tissue in obese mice and the related mechanisms.Methods An obese mouse model was established via intraperitoneal injection of a high-fat diet supplemented with propylthiouracil saline solution[14.4 mg/(kg·d)]in male Kun-ming mice.Obesity model mice were randomly divided into a model group(Model group)and a BCP administra-tion group(BCP-50 group);normal diet mice were set up as a control group(Control group),with 8 mice in each group.BCP administration was given by gavage at a dose of 50 mg/kg once in the morning and once in the evening in the BCP-administered group,while the rest of the group was administered by gavage with aqueous solution of Tween 80 for 4 weeks.The oral glucose tolerance test was performed at the end of 4-week administration,and mice were executed after overnight fasting at the end of the experiment,and blood samples and adipose tissues were rap-idly collected for subsequent experimental tests.The kit was used to detect serological-related indexes;hematoxy-lin-eosin staining was conducted to observe the morphology of adipose tissue;immunohistochemical staining was carried out to observe the expression of uncoupling protein 1(UCP1)in adipose tissue;Western blot was employed to detect expression of peroxisome proliferator-activated receptor γ coactivator1-α(PGC1α),peroxisome prolifera-tor-activated receptor γ(PPARγ),UCP1 and cannabinoid receptor 2(CNR2)proteins in epididymal white adi-pose(eWAT).Results Compared with the model group,the body mass of obese mice in the BCP-50 group was significantly reduced(P<0.05),food intake was decreased(P<0.01),insulin resistance was improved(P<0.000 1),and the serum content of low-density lipoprotein cholesterol(LDL-C)and nonesterified fatty acid(NE-FA)in the obese mice was significantly reduced(P<0.000 1 and P<0.01).Total cholesterol(TC),triglycer-ide(TG),and high-density lipoprotein cholesterol(HDL-C)contents did not change significantly.In addition,the adiposity coefficient and eWAT specific gravity of obese mice in the BCP-50 group were significantly decreased(P<0.05);the adipocytes in eWAT and BAT were reduced;and the expression of the UCP1 protein was signifi-cantly elevated(P<0.01 and P<0.05).In addition to UCP1,the expression levels of PGC1α,PPARγ,and CNR2 proteins in the eWAT of obese mice in the BCP-50 group were also significantly elevated(P<0.01,P<0.05,and P<0.001).Conclusion β-caryophyllene promotes white adipose tissue browning through up-regula-ting PPARγ/PGC-1α/UCP1 pathway expression,thus improving obesity.
10.A Brief Account of Professor Wu Kaopan's Academic Thoughts
Weiming REN ; Chengyu WU ; Chengyan WU
Journal of Nanjing University of Traditional Chinese Medicine 2024;40(10):1044-1049
Professor Wu Kaopan is a famous contemporary Chinese medicine scientist,Chinese medicine literature scientist,and Chinese medicine educator.This paper summarizes Professor Wu Kaopan's academic thoughts.Professor Wu Kaopan not only re-searched classics such as Basic Questions,The Spiritual Pivot,The Classic of Difficult Issues,Treatise on Cold Damage,and Essentials from the Golden Cabinet,but also proposed that we should rationally understand the role and value of the five elements theory;that the way to be a doctor should be familiar with the meridian theory;that we should know the constant and adapt to changes,and oppose the blind adherence to the five movements and six qi like looking for a noble steed to correspond with the one drawn;that the medicine should be effective and the method should be flexible.Professor Wu Kaopan has devoted his life to the inheritance and development of Chinese medicine,and has contributed his life to the fields of Chinese medicine teaching,scientific research,and clinical practice.


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