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.Clinical observation of levosimendan in the treatment of septic shock combined with myocardial depression
Fang XIONG ; Chao LIU ; Kexiang ZHANG ; Qilong ZHOU ; Hua LU ; Jianguo CHEN ; Xi YUE ; Jianxin ZHAO ; Pengfei PAN
China Pharmacy 2024;35(20):2517-2521
OBJECTIVE To explore the effects of levosimendan on cardiac function, hemodynamics and prognosis of patients with septic shock complicated with myocardial depression, and evaluate the safety of levosimendan. METHODS Patients with septic shock complicated with myocardial depression who were admitted to the Department of Critical Care Medicine of Chongqing University Three Gorges Hospital from April 2021 to August 2023, underwent adequate fluid resuscitation, had a mean arterial pressure (MAP) ≥65 mmHg, and received pulse indicator continuous cardiac output (PiCCO) monitoring were enrolled. The patients were randomly divided into dobutamine group and levosimendan group according to a random number table, with 20 patients in each group. Both groups received intravenous infusion of Norepinephrine bitartrate injection at a dose of 0.1-2.0 μg/(kg·min). On this basis, the dobutamine group additionally received intravenous infusion of Dobutamine hydrochloride injection at a dose of 5- 10 μg/(kg·min) for 3 to 7 days, while the levosimendan group additionally received intravenous infusion of Levosimendan injection at a dose of 0.1-0.2 μg/(kg·min) for 24 hours. Heart rate (HR) and hemodynamic parameters [systolic blood pressure, diastolic blood pressure, MAP, central venous pressure (CVP)], PiCCO monitoring parameters [cardiac function index (CFI), cardiac index (CI), stroke volume index (SVI), extravascular lung water index, global end-diastolic volume index, pulmonary vascular permeability index (PVPI), global ejection fraction (GEF), systemic vascular resistance index, left ventricular contractility index], and prognosis indicators [death within 3 days after administration, mechanical ventilation time,intensive care unit (ICU) stay time, 28-day mortality rate] were compared between the two groups before treatment and at 24 and 72 hours after treatment. Adverse reactions were E-mail:recorded for both groups. RESULTS Compared with before treatment in the same group, CFI, CI and GEF at 24 hours after treatment, CI and GEF at 72 hours after treatment in the dobutamine group, as well as SVI at 24 hours after treatment and SVI and GEF at 72 hours after treatment in the levosimendan group were significantly increased; PVPI at 72 hours after treatment in the dobutamine group was significantly decreased (P<0.05). Compared with the dobutamine group during the same period, patients in the levosimendan group had significantly lower HR and significantly higher CVP at 24 hours after treatment (P<0.05). Within 3 days after administration, there were no deaths in either group; there were no statistically significant differences in mechanical ventilation time, ICU stay time, 28-day mortality rate, or the incidence of adverse reactions between the two groups (P>0.05). CONCLUSIONS For patients with septic shock complicated with myocardial depression who have undergone adequate fluid resuscitation and have a MAP of ≥65 mmHg, levosimendan is comparable to dobutamine in improving cardiac function and hemodynamic parameters, without affecting patients’ prognosis or increasing the risk of adverse reactions such as hypotension.
3. Morphometry of the ureteric bud branching in the developing mouse kidney
Ling GU ; Ke-Xin SONG ; Hong-Yu CHEN ; Jie ZHANG ; Xiao-Yue ZHAI ; Ping ZHANG ; Na LI ; Jing CONG
Acta Anatomica Sinica 2023;54(5):593-598
[Abstract] Objective To investigate the branching pattern of the ureteric bud and the number of the nephron induced by each ureteric bud tip, through the three-dimensional tracing of the ureteric tree, combined with the morphological analysis and measurement of the ureteric tree. Methods The kidneys were obtained from three mice at various developing time points and prepared for paraffin and epoxy sections. Then the microscopic images were digitized and aligned from these sections. Based on the computer-assisted tracing and visualization of ureteric tree, the number of branches and the nephron induced by each ureteric bud tip were obtained by counting. In addition, paraffin sections were stained with HE staining for morphological observation of nephrogenic zone and ureteric bud, while in order to reflect the density of the ureteric bud tips at nephrogenic zone, the distance between two neighboring ureteric bud tips was measured aided with the Claudin-7 immunohistochemical staining. Results The ureteric bud branching tree revealed that the initial bifid iterative branching formed the framework of renal medulla, the branching became complicated and dense in cortex and nephrogenic zone, while the distance between ureteric bud tips were also decreasing. The number of the nephron induced by each ureteric bud tip increased from one (E14. 5) to two (E17. 5), and occasionally to three. Conclusion Threedimeasional Visualization of ureteric bud branching tree reveals regional complication, suggesting molecules in different regions drive different branching patterns; While the density of the ureteric bud tips at nephrogenic zone increases corresponding to decreasing of thickness of the nephrogenic zone, and the disappearance of the ureteric bud tips after birth is also consistent with the gradual consumption of nephron progenitor cells.
4. Six body indexes and typing characteristics of Xibe adults
Guo-Chang XU ; Zhi-Guo CHEN ; Guo-Chang XU ; Zhi-Guo CHEN ; Ke-Lei GUO ; You-Feng WEN ; Dong JIANG
Acta Anatomica Sinica 2023;54(4):477-483
[Abstract] Objective To explore the body index and typing characteristics of Xibe nationality. Methods According to Anthropomatric Methods, height, chest circumference, sitting height, shoulder width, pelvic width and body mass morphological indexes were collected from 588 Xibe people in Yili area and 420 Xibe people over 18 years old in Shenyang area. After data collation, body index and typing were calculated and analyzed statistically. Results Except for Xibe male stature-shoulder breadth index and Caup’ s index in Yili area and female stature-shoulder breadth index in Shenyang area, there were differences among age groups in other indexes (P < 0. 05). Except for male stature-chest circumference index, stature-crista iliaca index, female stature-chest circumference index, stature-sitting height index, Manouvrier’s skelic index, there were differences among regions (P<0. 05). The adult body shape of Xibe nationality was mainly of wide chest, wide shoulder, long trunk, wide pelvis, medium leg and sub-long leg (male), sub-short leg and medium leg (female), and overweight. Conclusion There are regional and age differences in the body index and typing of Xibe adults. Compared with other ethnic minorities, Xibe nationality’s stature-chest circumference index, stature-shoulder breadth index, stature-crista iliaca index, Caup’s index are at a higher level. The proportion of legs and body of Xibe nationality is in the middle level, while the proportion of trunk is slightly shorter for men and slightly longer for women.
5. Ginsenoside Rg1 regulating BV2 microglia polarization in lipopolysaccharide-induced inflammatory response via peroxisome proliferator activated receptor γ
Ting-Yu LI ; Xing-Hang WANG ; Xiao-Chen CHI ; Kun-Fang LI ; Cui-Fen BAO
Acta Anatomica Sinica 2023;54(3):269-275
[Abstract] Objective To establish an inflammation model by stimulating BV2 microglia by lipopolysaccharide, and to explore the regulation effect of ginsenoside Rg1 on inflammation by activating peroxisome proliferator activated receptor γ(PPARγ) receptor protein. Methods BV2 microglia were randomly divided into control group, model group, ginsenoside Rg1 group, rosiglitazone group and GW9662 group. The control group did not do any treatment, the model group was treated with 1 mg/ L lipopolysaccharide, and the other groups were treated with lipopolysaccharide added with 0. 4 mmol/ L ginsenoside Rg1, 10 μmol/ L rosiglitazone or 10 μmol/ L respectively. GW9662. The proliferation of BV2 microglia in each group was detected by CCK-8 method; PPAR-γ, phospho-NF-κB p65 (p-NF-κB p65), induced expression of inducible nitric oxide synthase(iNOS) and human arginase 1(ARG-1) proteins. ELISA was used to detect the inflammatory factors interleukin-1β(IL-1β), interleukin-6(IL-6), interleukin-8(IL-8) and the content of tumor necrosis factor-α (TNF-α). Results Compared with the control group, the cell proliferation rate in the model group was significantly increased, and the contents of IL-1β, IL-6, IL-8 and TNF-α increased significantly. The result of immunofluorescence and Western blotting showed that iNOS and p-NF-κB p65 increased significantly, and the positive expressions of PPARγ and ARG-1 decreased significantly(both P<0. 01). The expression level of TNF-α decreased, the positive expressions of iNOS and p-NF-κB p65 decreased significantly, and the positive expressions of PPARγ and ARG-1 increased significantly(all P<0. 01). Conclusion Ginsenoside Rg1 inhibits the inflammatory response of BV2 microglia after lipopolysaccharide stimulation, and its mechanism may be related to the regulation of PPARγ/ NF-κB pathway to promote the M2-type polarization of microglia.
6. Three-dimensional visualization on the relationship between tubules after macula densa and afferent arterioles in mouse kidney
Si-Qi DENG ; Ling GU ; Kai-Yue WANG ; Yu-Jie LIU ; Jie ZHANG ; Xiao-Yue ZHAI ; Hong-Yu CHEN ; Yu-Jie LIU
Acta Anatomica Sinica 2023;54(1):87-91
Objective To establish the spatial course of distal tubule and afferent arterioles after macula densa, and to locate and detect the proteins in the adjacent parts by using three-dimensional visualization technology of microstructure. Methods C57 BL/6J mice were fixed by perfusion and embedded in epon 812. Tissue blocks were cut perpendicular to the longitudinal axis of the kidney. And a total of 720, 2. 5 μm-thick consecutive sections were obtained from the renal capsule to the outer stripe of the renal outer medulla. After aligning the digital microscopic images through computer registration procedures, the tubules and vessels were traced by 3D reconstruction program edited by C Language. Selecting the tissue sections of the contact site and applying the improved immunoperoxidase staining method to detect H
7.Thoughts on Digital Inheritance of Experiences of Famous and Veteran Physicians of Traditional Chinese Medicine
Jingnian NI ; Tianyu CAO ; Yajing CHEN ; Ting LI ; Mingqing WEI ; Jing SHI ; Jinzhou TIAN
Journal of Traditional Chinese Medicine 2023;64(17):1754-1758
The experience of famous and veteran physicians in traditional Chinese medicine (TCM) is a supplement to the cognition of industry groups and a high-quality learning resource. Digital inheritance of the experience of famous and veteran TCM physicians refers to the use of digital technology to record, organize, protect, spread, share and innovate the knowledge, skills and experiences of famous and veteran TCM physicians, which helps to overcome the inefficiency of traditional experience inheritance and realize the inheritance and development of TCM culture. Digital inheritance has certain advantages in accessibility, loss resistance, accuracy, innovation ability and effectiveness, which can assist the digital preservation, analysis and excavation of the experience of famous and veteran TCM physicians, and is an important supplement to the traditional way of learning from teachers. Digital inheritance is usually divided into the following steps: building a database of TCM knowledge, building a database of experienced medical records of famous and veteran TCM physicians, discovering laws by data mining, and assisting clinical decision-making with machine learning. The digital inheritance of famous and veteran TCM physicians is not only the use of experience information, but also the process of innovation and productization based on experience, which may become a new service model of TCM diagnosis and treatment.
8.Scutellaria Baicalensis Polysaccharides Alleviates the Inflammation of DSS-induced UC Model Mice by Regulating JAK2/STAT3 Pathway and IL-23/IL-17 Inflammatory Axis
Jie MA ; Yun-zhi CHEN ; Lei TIAN
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(3):423-429
ObjectiveTo investigate the effect and mechanism of Scutellaria Baicalensis polysaccharides on intestinal immunity in mice with ulcerative colitis (UC). MethodsC57BL/6 mice were randomly assigned to blank group, model group, mesalazine group and Scutellaria Baicalensis polysaccharides low-dose, medium-dose and high-dose groups (n=10 mice/group). The daily status of mice was observed and the disease activity index (DAI) score was recorded. The expression of cytokines including IL-6, IL-17 and IL-23 in serum was detected by ELISA. After the mice were sacrificed, HE was used to observe the intestinal mucosal damage in mice, and the colonic tissue damage index (TDI) score was recorded. Western blot and immunohistochemistry were used to detect the expression levels of Janus kinase 2 (JAK2), signal transducer and activator of transcription (STAT3), p-JAK2 and p-STAT3 proteins. ResultsCompared with the blank group, the DAI score of the model group was significantly increased, the contents of IL-6, IL-17 and IL-23 in serum were significantly increased, the ratio of p-JAK2/JAK2 and p-STAT3/STAT3 in colon tissue was significantly increased, and the expression levels of p-JAK2 and p-STAT3 were significantly increased. Compared with the model group, the DAI score of mice in each administration group was significantly decreased. The contents of IL-6, IL-17 and IL-23 in serum were decreased, the TDI score was decreased, the ratio of p-JAK2/JAK2 and p-STAT3/STAT3 in colon tissue was decreased, and the expression of p-JAK2 and p-STAT3 was decreased. ConclusionScutellaria Baicalensis polysaccharides may improve the inflammatory effect of UC mice through JAK2/STAT3 pathway and IL-23/IL-17 inflammatory axis.
9.Production and characterization of a novel aminopeptidase A from Lactococcus lactis.
Xin TIAN ; Jinzhou LIU ; Zhonghui HE ; Linfang CHEN ; Mengyuan LIU
Chinese Journal of Biotechnology 2023;39(8):3494-3507
Aminopeptidase A (Pep A) is a metal-dependent enzyme that specifically hydrolyze peptides with the N-terminal amino acids glutamic acid (Glu) and aspartic acid (Asp). A possible application of PepA is the hydrolysis of Glu/Asp-rich food proteins such as wheat gluten and casein, increasing the flavor and solubility of food protein. In the present study, the gene encoding a Pep A from Lactococcus lactis ssp. lactis IL1403 was synthesized and introduced into Pichia pastoris GS115 (His4). Lc-Pep A was successfully expressed and secreted to the culture medium, followed by identification and purification to homogeneity. Characteristics study demonstrated that Lc-Pep A could specifically hydrolyze the substrates Glu-pNA and Asp-pNA with similar catalytic activity, and this was further confirmed by the kinetics parameters measured. Additionally, Lc-Pep A showed a broad thermostability and pH stability with an optimum temperature of 60 ℃ and an optimum pH of 8.0. The enzyme activity of Lc-Pep A was activated by metal ions Co2+, Mn2+, and Zn2+ but was strongly inhibited by Ni2+and Cu2+. The routine proteinase inhibitor had no effect on the activity of Lc-Pep A. However, Lc-Pep A was strongly inhibited by the metallopeptidase inhibitor, EDTA, and disulfide bond-reducing agents. The study may facilitate production and application of Lc-Pep A.
Glutamyl Aminopeptidase
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Lactococcus lactis/genetics*
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Biological Transport
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Culture Media
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Glutamic Acid
10.Study on post-marketing safety of Compound porcine cerebroside and ganglioside injection in the treatment of ischemic stroke
Guanying HAN ; Bingjie MA ; Yu WANG ; Chao CHEN ; Shurong JIN ; Aijun CANG
China Pharmacy 2023;34(16):1995-1998
OBJECTIVE To evaluate the post-marketing safety of Compound porcine cerebroside and ganglioside injection in patients with ischemic stroke. METHODS A drug-induced, prospective, non-controlled clinical study design was conducted. Using the patients with ischemic stroke who received Compound porcine cerebroside and ganglioside injection at least once in 46 secondary class A and above medical institutions across the country from April 2020 to May 2021 as the monitoring objects, and their basic data, medication information and the occurrence of adverse drug reactions were analyzed. RESULTS Among 13 514 patients with ischemic stroke, the incidence of adverse events was 10.01%, and the incidence of adverse reactions related to Compound porcine cerebroside and ganglioside injection was 0.33%. Drug-related adverse drug reactions were mild or moderate, concentrated in the gastrointestinal system (18 cases), skin and subcutaneous tissue (10 cases), nervous system (7 cases) and other systems/organs, mainly including constipation, abdominal pain, diarrhea, rash, pruritus, dizziness and other symptoms. Most of the patients (91.03%) recovered or improved after treatment, and 2 patients died. Among the 45 patients with adverse drug reactions, 84.44% were cured or improved after drug withdrawal or symptomatic treatment, and 15.56% had no significant change. The incidence of adverse drug reactions in tertiary hospitals was significantly higher than that in secondary hospitals, and the incidence of adverse drug reactions in patients with allergic history was significantly higher than that in patients without allergic history (P<0.05). Irrational drug use was found in 2.76% of patients, and the incidence of adverse drug reactions(2.95%) was significantly higher than that in patients without irrational drug use(0.26%,P<0.05). CONCLUSIONS The adverse drug reaction symptoms of ischemic stroke patients treated with Compound porcine cerebroside and ganglioside injection are relatively common, the incidence rate is generally low, and it is related to the patients’ physique and whether the drug use is standardized.


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