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 Role of Cerebral-Placenta-Uterine Ratio in Predicting Late-Onset Fetal Growth Restriction
Yongyan CHU ; Haiyan TANG ; Jiayi ZHANG ; Chuqin XIONG ; Haoyue HUANG ; Runhe LIANG ; Cuiying LEI ; Ting ZENG ; Yanyan LI ; Li HE ; Minping CHEN ; Libei DU ; Shengmou LIN
Journal of Practical Obstetrics and Gynecology 2024;40(1):36-41
		                        		
		                        			
		                        			Objective:To evaluate the efficacy of cerebral-placental-uterine ratio(CPUR)in predicting late-on-set fetal growth restriction(FGR).Methods:From May 2020 to May 2021,1255 women with singleton pregnancy who underwent prenatal examinations at the University of Hong Kong Shenzhen Hospital were selected for fetal growth and Doppler measurements at 35-37 +6 weeks of gestation.Pregnant women with birth weight of newbo-rns<the 10th percentile were the FGR group.The pulsatility index(PI)of uterine artery(UtA),umbilical artery(UA)and fetal middle cerebral artery(MCA)were analyzed separately and in combination.ROC curve was used to analyze the cerebral-placental-uterine ratio(CPUR),cerebral-placental ratio(CPR),cerebral-uterine ratio(C-UtA)for predicting late-onset FGR;and to evaluate the sensitivity,positive and negative predictive value and of CPUR in the prediction of late-onset FGR.Results:The area under the curve(AUC)of CPUR,CPR,C-UtA and mean UtA-PI for FGR grope were 0.88,0.86,0.84 and 0.72.Under certain cut-off values and 87% specificity,the specificity of CPUR,CPR,C-UtA and mean UtA-Pifor predicting FGR group was 43.2%,46.6%,39.8% and 23.9%,respectively.The positive predictive values of CPUR,CPR,C-UtA and mean UtA-PI,UA-PI for predicting FGR group were 90.5%,71.9%,83.3%,63.6%and 5.2%,respectively.Conclusions:CPUR is more effective in predicting late onset FGR than CPR,C-UtA and mean UtA-PI.It can effectively increase the detection rate of fetal growth restrictionand reduce the FGR risk.
		                        		
		                        		
		                        		
		                        	
3.Establishment and clinical application of imipenem measurement method in patients with severe infection
Yongyan CHEN ; Didi SUN ; Wenchao HAN ; Qian WANG ; Hanjuan ZHANG
China Pharmacy 2024;35(16):2023-2026
		                        		
		                        			
		                        			OBJECTIVE To establish two-dimensional liquid chromatography method for the determination of imipenem blood concentration and apply it in clinical practice. METHODS The method for the determination of imipenem blood concentration was established based on automatic two-dimensional liquid chromatography. The targets were extracted by 1-dimensional column Aston SNCB (50 mm ×4.6 mm, 5 μm) and further separated and determined by 2-dimensional column Aston SCB (250 mm×4.6 mm, 5 μm). The 1-dimensional mobile phase was imipenem-1D mobile phase [acetonitrile-methanol-water (15∶10∶75, V/V/V)] with a flow rate of 1.0 mL/min; 2-dimensional mobile phase was 72%OPI-1 organic mobile phase (chromatographic grade methanol)-20% BPI-1 alkaline mobile phase [water (containing 20.0 mmol/L ammonium phosphate, pH adjusted to 7.2 with triethylamine)]-8%API-1 acidic mobile phase [water (containing 20.0 mmol/L ammonium phosphate, pH adjusted to 3.0 with phosphoric acid)] with a flow rate of 1.0 mL/min; the column temperature was 40 ℃, UV detection wavelength was 310 nm and injection volume was 100 μL. Elution procedure: 1-dimensional column consisted of imipenem-1D mobile phase with eluting for 0-3.40 min; 2-dimensional column consisted of 72% OPI-1 organic mobile phase-20%BPI-1 alkaline mobile phase-8%API-1 acidic mobile phase with eluting for 3.40-11.00 min. RESULTS The linear range of imipenem was 0.171-18.570 μg/mL (R 2=0.999 9) with the lower limit of quantification for 0.171 μg/mL; the recovery rate ranged from 93.47% to 106.16%( n=5) and the RSDs of both intra-day and inter- day precision were below 15% (n=5). The minimum concentration of imipenem in 51 patients ranged from 0 to 19.57 μg/mL. CONCLUSIONS The established method is simple and fast with the large scale of sample, and can be used for the imipenem blood concentration monitoring in patients with severe infection.
		                        		
		                        		
		                        		
		                        	
4.Comparison of clinically relevant factors in bipolar disorder patients with different age of onset
Yan MA ; Xiaoyi TIAN ; Yueqin HUANG ; Zhaorui LIU ; Yongyan DENG ; Liang ZHOU ; Yan LIU ; Bo LIU ; Jie ZHANG ; Yuandong GONG ; Xiang FU ; Qiongxian ZHAO ; Jin LU ; Wannian SHA ; Hao HE ; Zonglin SHEN ; Tingting ZHANG ; Wenming CHEN
Chinese Mental Health Journal 2024;38(1):42-49
		                        		
		                        			
		                        			Objective:To compare clinical characteristics,treatment patterns and physiological indicators in bipolar disorder(BD)patients with different age of onset.Methods:Totally 380 patients with DSM-5 BD were se-lected in this study.Psychiatrists diagnosed the patients using the Mini International Neuropsychiatric Interview.The clinical information questionnaire and the Global Assessment of Functioning scale were utilized to collected clinical characteristics,treatment status,and physiological indicators.The onset age of BD was divided into 21 and 35 years as cut-off points.Multivariate logistic regression and linear regression were used to analyze related factors.Results:Among the 380 patients with BD,199 cases were early-onset group(52.4%),121 cases were middle-onset group(31.8%),and 60 cases were late-onset group(15.8%).There were 26.6%of patients in the early-onset group in-itially diagnosed as depression,23.1%in the middle-onset group,and 11.7%in the late-onset group.Multivariate analysis revealed that compared to the early-onset group of BD,the middle-onset(OR=2.22)and late-onset(OR=4.99)groups had more risk to experience depressive episodes,and the late-onset group(OR=6.74)had 6.74 times of risk to suffer from bipolar Ⅱ disorder.Additionally,patients in the middle-onset(β=-1.52)and late-on-set(β=-4.29)groups had shorter durations of delayed treatment,and those in the middle-onset(β=-1.62)and late-onset(β=-3.14)groups had fewer hospitalizations.Uric acid levels were lower in both the middle-onset(β=-28.39)and late-onset(β=-31.47)groups,and total cholesterol level was lower in the middle-onset group(β=-0.23).Conclusion:Patients with BD in different age of onset show significant differences in clinical charac-teristics,treatment conditions and physiological indicators.
		                        		
		                        		
		                        		
		                        	
5.Effects of transdermal meridian-targeted drug delivery of Pelvic Inflammation No.1 formula on IL-10,IL-6,MMP-9 and immune function in patients with chronic pelvic inflammatory disease
Qiang FENG ; Hongmei CHEN ; Ruilian TANG ; Yuqing WU ; Yongyan YU ; Jiping YE
Chinese Journal of Immunology 2024;40(8):1735-1739
		                        		
		                        			
		                        			Objective:To investigate the application value of Pelvic Inflammation No.1 formula of transdermal meridian point-targeted drug delivery therapy in the treatment of patients with chronic pelvic inflammatory disease(damp-heat stasis type).Methods:All patients with chronic pelvic inflammatory disease(damp-heat stasis type)visited Danzhou Hospital of Traditional Chinese Medi-cine from August 2017 to March 2021 and were randomly grouped,57 patients in the control group were treated with simple Western medicine,and 57 patients in the observation group were combined with Pelvic Inflammation No.1 formula transdermal meridian target-ed transdermal medication,and the therapeutic efficacies were compared after 3 months of treatment.Results:After treatment,serum matrix metalloproteinase-9(MMP-9),D dimer(D-D),IL-6 and other indexes in the observation group were lower than those in the control group,and IL-10 was higher than that in the control group,the difference was statistically significant(P<0.05).After treat-ment,the carbohydrate antigen CA125 in the observation group was lower than that in the control group,and the CD4+/CD8+and CD4+cells in the observation group were higher than those in the control group(P<0.05).After treatment,the score of summary of health status surveys(SF-36)in the observation group was higher than that in the control group,and the total score of TCM symptoms was lower than that in the control group(P<0.05).The total effective rate in the observation group was 96.49%(55/57),which was higher than 82.46%(46/57)in the control group(P<0.05).Conclusion:For patients with chronic pelvic inflammatory disease(damp-heat stagnation type),combined with Pelvic Inflammation No.1 formula transdermal via acupoints targeted drug therapy can help to regu-late inflammatory factors,regulate immune function,and improve clinical efficacy.
		                        		
		                        		
		                        		
		                        	
6.Current status of research on diagnosis,prevention and control of Surra
Yongyan CHEN ; Cheng DU ; Xiaojun WANG
Chinese Journal of Veterinary Science 2024;44(7):1571-1578
		                        		
		                        			
		                        			Surra is a bloodborne protozoan disease caused by Trypanosoma evansi(T.evansi)that infects most mammals and is widely distributed worldwide.The Ministry of Agriculture of China classifies Surra as a category Ⅲ animal disease,it can lead to anemia,wasting,and even death in e-quine animals,camels,buffaloes,etc.,causing huge economic losses to the stock raising industry.In addition,T.evansi may also have zoonotic potential,making its accurate diagnosis crucial.Howev-er,the close affinity between the subgenus of trypanosomes,as well as the presence of antigenic variation and immune escape,make the accurate diagnosis of T.evansi difficult.In this paper,we review the pathogens,immune mechanism,diagnosis,prevention and control of Surra,aiming to provide scientific references for the accurate diagnosis and prevention of this disease.
		                        		
		                        		
		                        		
		                        	
7.Estimation model for the exposure of mycophenolic acid in early renal transplant recipients
Hanjuan ZHANG ; Jianqiang DING ; Wenchao HAN ; Yongyan CHEN ; Gaobiao WANG ; Rui DING ; Dongdong YUAN
China Pharmacy 2023;34(20):2530-2534
		                        		
		                        			
		                        			OBJECTIVE To establish the estimation model for the exposure of mycophenolic acid (MPA) in early renal transplant recipients [calculated by the area under the plasma concentration-time curve with 12 h (AUC0-12 h)]. METHODS Twenty kidney transplant recipients, who received triple immunosuppressive therapy of mycophenolate mofetil (MMF)+tacrolimus+ methylprednisolone, were selected and given MMF dispersible tablets (750 mg, q12 h) on the 15th day after the operation; the blood samples were collected from the patients before and 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 hours after the administration, respectively. The blood concentration of MPA was determined, and the pharmacokinetic parameters of MPA were calculated. The multivariate linear stepwise regression analysis method was used to fit an estimation formula for the finite sampling method suitable for MPA-AUC0-12 h of the recipients. Bland-Altman analysis was used to evaluate the agreement between the estimation formula and the classical pharmacokinetic method. RESULTS The main pharmacokinetic parameters of MPA in 20 renal transplant recipients: c0 was (1.53±0.84) μg/mL, cmax was (12.07±5.97) μg/mL, t1/2 was (5.41±3.67) h, tmax was (1.58±0.75) h, and the average AUC0-12 h calculated by the classical pharmacokinetic method was (33.95±13.40) μg·h/mL. MPA-AUC0-12 h was estimated with sampling points of “4.0, 8.0, 12.0 h”; the simplified calculation formula was AUC0-12 h=12.058+2.819c4.0+7.045c8.0+ 3.879c12.0 (R 2=0.934). The predicted value had a good correlation and consistency with the measured value, and 95.0% of predicted values did not exceed the x±1.96SD (standard deviation) range. CONCLUSIONS The estimation model is established successfully for the exposure of MPA in early renal transplant recipients; the model has better prediction accuracy and fewer sampling points.
		                        		
		                        		
		                        		
		                        	
8.Advances in Chemical Constituents and Pharmacological Action of Tinosporae Radix
Jingjing WANG ; Ruwei YANG ; Yongyan XIE ; Ziwei XU ; Shuaikang WANG ; Liping CHEN ; Daoyuan LAN ; Qiujin GUO ; Liping HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(24):273-282
		                        		
		                        			
		                        			Tinosporae Radix, as a traditional Chinese medicinal herb, is the dried root tuber of Tinospora sagittata or T. capillipes. It was first recorded in the Compendium of Materia Medica Supplement in the Qing Dynasty and included in the previous edition of the Chinese Pharmacopoeia. Tinosporae Radix is excavated in autumn and winter and used after removing fibrous roots, washing, and drying. It is indicated for sore throat, carbuncle boils poison, waist and abdominal pain, and various heat syndromes and is commonly used to treat chronic inflammation. Its efficacy is significantly known as “broad-spectrum antibiotics in Zhuang medicine”. Tinosporae Radix is a traditional Chinese medicinal herb often taken by Zhuang and Yao nationalities in Guangxi province and has a wide range of application and development values and research significance. Modern studies have shown that Tinosporae Radix contains diterpenoids, alkaloids, sterols, anthraquinones, glycosides, fatty acids, volatile oils, and other compounds, which have many pharmacological activities such as anti-inflammatory and analgesic, antibacterial and antibacterial, antioxidant, anti-diabetic, and anti-tumor and anti-cancer effects, and it has achieved good efficacy in inhibiting inflammation and treating sore throat and other diseases. In recent years, there have been many research reports on the status, chemical constituents, pharmacological action, clinical application, and quality evaluation of Tinosporae Radix resources, but there is no systematic review and introduction at present. By consulting the literature and combining it with modern research, this paper systematically summarizes and collates Tinosporae Radix resources to provide guidance for the comprehensive development and utilization of Tinosporae Radix resources and subsequent in-depth study. 
		                        		
		                        		
		                        		
		                        	
9.Clinical types and fungal pathogens of children′s tinea capitis analysis of 542 cases in a tertiary first-class hospital of Wuhan
CHEN Zunyi ; YU Huiyuan ; CHEN Yao ; CAO Yongyan ; DONG Bilin ; ZENG Zhiliang ; YANG jing
China Tropical Medicine 2023;23(8):811-
		                        		
		                        			
		                        			Abstract: Objective To investigate the clinical types of children's tinea capitis and the distribution of fungal pathogens in Wuhan from 2011 to 2020, and to provide scientific basis for the prevention, diagnosis and treatment of children's tinea capitis. Methods Laboratory data of children with tinea capitis in outpatient and inpatient department of dermatology in Wuhan No.1 Hospital from January 2011 to December 2020 were collected. A total of 542 cases of pediatric tinea capitis were included, with 239 male cases and 303 female cases. Microscopic examination of fungi and culture identification were performed on the affected skin lesions of the children. Chi-square test was used to analyze the differences in pathogen spectrum of children with different age groups and clinical type. Results Among the pediatric tinea capitis patients, the age group with the highest prevalence was preschool children(3 to <7 years old), accounting for 48.52%(263/542). The top three pathogenic fungi were Trichophytes violaceum(49.26%, 267/542), Microsporum canis(31.55%, 171/542) and Trichophyton mentagrophytes (9.96%, 54/542). Trichophyton violaceum was the main pathogen in all ages, followed by Microsporum canis. The infection rate of Microsporum canis in children over 7 years old was lower than that in children under 7 years old, and the infection rate of Trichophyton rubrum in infants was higher than that in other ages. The distribution of Trichophytes violaceum, Trichophyton mentagrophytes, Nannizzia gypseum and Microsporum ferrugineum was uniform in all age groups. Trichophytes violaceum and Trichophyton tousurans mainly caused black-dot ringworm, Microsporum canis mainly caused tinea alba, Trichophyton mentagrophytes,Nannizzia gypseum and Trichophytonrubrum mainly caused kerion. Except for Microsporum ferrugineum, the composition ratios of other fungi species showed statistically significant differences among different clinical types of tinea capitis(P<0.05). Conclusions Preschool children are the most commonly affected age group by pediatric tinea capitis, and black-dot ringworm caused by Trichophytes violaceum is the main clinical type. Analysis of the high-riskage group, pathogenic fungi and clinical types of tinea capitis in children can enhance the understanding of its epidemiological characteristics, which is helpful for early diagnosis and targeted standardized treatment of pediatric tinea capitis.
		                        		
		                        		
		                        		
		                        	
10.Construction and clinical application of An analytical method for rapidly detecting sulfamethoxazole plasma concentration in heart transplant patients
WANG Gaobiao ; ZHANG Hanjuan ; CHEN Yongyan ; HAN Wenchao ; DING Rui ; YUAN Dongdong
Chinese Journal of Modern Applied Pharmacy 2023;40(13):1853-1857
		                        		
		                        			
		                        			OBJECTIVE To explore and establish an analysis method for sulfamethoxazole blood concentration in patients with heart transplantation to guide clinical rational drug use. METHODS A new two-dimensional liquid chromatograph (2D-LC-UV) based on column switching technology was used. The on-line solid-phase extraction of sulfamethoxazole in serum was performed using a one-dimensional column Aston SC2(3.5 mm×25 mm, 5 μm), then it was intercepted and retained through the middle column Aston SBR(3.5 mm×10 mm, 5 μm), and the target analytes were completely separated and detected by transfer to the second-dimension column Aston SNX4(4.6 mm×130 mm, 5 μm). The chromatographic conditions were obtained by optimization. The one-dimensional mobile phase was acetonitrile-methanol-H2O(10:10:70), the flow rate was 0.8 mL·min-1; the two-dimensional mobile phase ratio was BPI-1 basic mobile phase-API-3 acidic mobile phase-methanol(20:40:40) the flow rate was 1.2 mL·min-1. The UV detection wavelength was 240 nm. RESULTS The correlation coefficient between the concentration of sulfamethoxazole and peak area was in the range of 9.96‒200.04 μg·mL-1 with R2=0.999 6, it showed a good linear relationship. The intra-day and inter-day precisions(RSD) at low, medium and high concentrations were <15%, and the relative recoveries were between 85%‒115%. The blood concentration of 56 patients in the hospital was measured, and only 30 patients(53.57%) had the blood sample sulfamethoxazole concentration of 100‒150 μg·mL-1, and the rest were not comfortable about the concentration treatment window; there were 0 cases of grade III-IV adverse reactions in the urinary system/blood system/liver, etc. CONCLUSION This method has a simple pre-treatment, high automation, can be sampled in large volumes, and has high accuracy and sensitivity. It can meet the requirements of clinical applications. The research results can provide a methodological reference for clinical therapeutic drug monitoring..
		                        		
		                        		
		                        		
		                        	
            

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