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.Diagnosis and treatment of 15 cases with hepatic cystic echinococcosis
Yanxi MU ; Yalong YAO ; Jinzhou LI ; Wenjie WANG ; Kang CHEN ; Peng DONG ; Xiao CHEN
Chinese Journal of Infectious Diseases 2023;41(1):84-88
Objective:To provide reference for clinical diagnosis and treatment of hepatic cystic echinococcosis by analyzing the clinical characteristics of these patients.Methods:Clinical data of 15 patients with hepatic cystic echinococcosis hospitalized in the Second Hospital of Lanzhou University from April 22, 2019 to March 5, 2022 were collected. The general data, clinical manifestations, abdominal imaging results, treatment and outcome of the included patients were retrospectively analyzed.Results:The age of 15 patients with hepatic cystic echinococcosis ranged from 39 to 78 years, with a median age of 51 years. Among the 15 patients, 12 were farmers, two were freelance workers, and one was unknown. Eleven patients presented with abdominal pain and fatigue, one patient presented with obstructive jaundice, and three patients whom were found by physical examination did not complain of obvious discomfort. Echinococcoid cysts were located at the right lobe of the liver in eight patients, at the left lobe of the liver in five patients, and with multiple lesions in the left and right lobes of the liver in two patients. Two patients received conservative therapy. All the 13 patients who received surgical treatment recovered without complications, such as biliary fistula and subphrenic infection. The clinical symptoms including abdominal pain and fatigue were relieved significantly after surgery. The hospital stay were four to 23 days. All patients were administrated with albendazole (400 mg once daily).Conclusions:Hepatic cystic echinococcosis is more common in the right lobe of the liver, with atypical clinical symptoms. Preoperative imaging diagnosis and postoperative pathological examination are necessary for diagnosis. Surgery is the most effective treatment at present, and albendazole should be taken regularly in all patients.
4.Analysis of risk factors for multiple myeloma combined with radiation-based sarcopenia
Jie REN ; Lei QI ; Xingchen YAO ; Jinzhou WANG ; Xiangjun SHI ; Wenming CHEN ; Xinru DU
Chinese Journal of Orthopaedics 2023;43(9):567-573
Objective:To analyze the risk factors of radiation-based sarcopenia in patients with multiple myeloma (MM).Methods:A total of 185 clinical and imaging data of patients with MM admitted to Beijing Chaoyang Hospital from September 2009 to October 2019 were retrospectively analyzed. The area of the erector spinae muscle and the area of fatty infiltration (FI) in the fascial compartment were measured by Image-pro Ρlus software, and the area of the fat-free erector spinae muscle and the fat infiltration rate (FI%) were calculated. Sarcopenia was defined as an erector spinae area of less than 3 197 mm 2 in males and 2 895 mm 2 in females. The differences in gender, age, body mass index, disease duration, hemoglobin, leukocytes, platelets, albumin, serum calcium, lactate dehydrogenase, serum creatinine, alkaline phosphatase, M-protein, serum β 2-microglobulin, bortezomib chemotherapy, receipt of stem cell transplantation, osteopathy, stage, recurrence and progression of MM between the sarcopenia group and the normal muscle group were compared. Binary logistic regression was used to analyze the independent risk factors of sarcopenia in MM patients. Kaplan-Meier curves were drawn to compare the survival rates between the two groups. Results:53.0% (98/185) of MM patients were complicated with sarcopenia: there were 30 males, whose fat-free erector spinae area was 25.0±6.0 cm 2, the FI of erector spinae was 12.0±4.8 cm 2, and the FI% was 31.5%±12.0%, while there were 68 females, whose fat-free erector spinae area was 22.7±4.2 cm 2, the FI of erector spinae was 10.7±4.1 cm 2, and the FI% was 30.2%±9.8%. 47.0% (87/185) of MM patients had normal muscle mass: there were 62 males, whose fat-free erector spinae area was 40.6±6.5 cm 2, the FI of erector spinae was 9.3±4.8 cm 2, and the FI% was 17.9%±7.4%, while there were 25 females, whose fat-free erector spinae area was 33.6±5.1 cm 2, the FI of erector spinae was 9.9±3.0 cm 2, and the FI% was 21.9%±5.7%. There were statistically significant differences in the gender composition ratio (χ 2=30.47, P<0.001), hemoglobin ( t=-2.73, P=0.007), serum creatinine ( Z=-2.26, P=0.024), receipt of stem cell transplantation (χ 2=4.32, P=0.038), and MM recurrence and progression (χ 2=3.85, P=0.050) between the two groups. However, there were no significant differences in age, body mass index, course of disease, leukocytes, platelets, albumin, alkaline phosphatase, lactate dehydrogenase, serum calcium, M-protein, serum β 2-microglobulin, bortezomib chemotherapy, osteopathy or MM stage ( P>0.05). Binary logistic regression analysis showed that female was an independent risk factor for sarcopenia in MM patients. The survival rates at 2, 3, 4, and 5 years were 87.9%, 71.8%, 64.4%, and 53.7% in the sarcopenia group, and 92.1%, 75.8%, 66.8%, and 66.8% in the normal muscle group, respectively, with no statistically significant differences ( HR=0.71, P=0.364). Conclusion:The incidence of radiation-based sarcopenia in MM patients is 53.0%. Low hemoglobin and blood creatinine levels, not receiving stem cell transplantation, and recurrence or progression of MM are associated with sarcopenia in MM patients, and female is an independent risk factor for sarcopenia in MM patients.
5.Mechanism study of Qingre huashi decoction in the treatment of gastric cancer by up-regulating miRNA-155 and inhibiting Wnt/β-catenin signaling pathway
Shuoxin YIN ; Xianwei AO ; Bo LI ; Tao ZHANG ; Yuanneng CHEN
China Pharmacy 2023;34(19):2339-2343
OBJECTIVE To study the mechanism of Qingre huashi decoction in the treatment of gastric cancer by intervening in miRNA-155 and inhibiting Wnt/β-catenin signaling pathway. METHODS Thirty nude mice were randomly divided into model group, control group (0.004 g/kg cisplatin+0.02 g/kg fluorouracil), overexpression group, Qingre huashi prescription low-dose, medium-dose and high-dose groups (2.71, 5.43, 10.86 g/kg), with 5 mice in each group. The overexpression group was inoculated with miRNA-155 AGS cell line, and the other groups were inoculated with AGS cells to induce tumor-bearing gastric cancer model. The control group was given relevant medicine intraperitoneally, and other groups were given relevant medicine or normal saline intragastrically, once a day, for 3 consecutive weeks. The weight of tumor tissue in nude mice was determined; the pathological morphology of tumor tissue was observed; the miRNA-155 expression, mRNA and protein expressions of Wnt7, β-catenin and T- cell factor-4(TCF-4) in tumor tissue were detected. RESULTS Compared with the model group, the tumor weights of nude mice in the control group, the overexpression group and Qingre huashi decoction high-dose group were significantly reduced (P<0.05); mRNA and protein expressions of Wnt7, β -catenin and TCF-4 were significantly decreased (P<0.05), while miRNA-155 expression was increased significantly (P<0.05). Tumor cells exhibited varying degrees of loose arrangement, shallow nuclear staining, and necrotic foci. CONCLUSIONS Qingre huashi decoction can inhibit the protein and mRNA expressions of Wnt7, β-catenin and TCF-4 in Wnt/β-catenin signaling pathway by up-regulating miRNA-155, thus inhibiting the tumor growth of tumor-bearing nude mice.
6. 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.
7. 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.
8. 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.
9. 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
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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