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.Early clinical efficacy study on the efficacy of a three-stage conservative Chinese medicine external treatment for a-cute lateral ankle ligament injuries
Qing-Xin HAN ; Lei ZHANG ; Jun-Ying WU ; Xiao-Hua LIU ; Yan LI ; Tian-Xin CHEN ; Yu YI ; Mei-Qi YU
China Journal of Orthopaedics and Traumatology 2024;37(10):997-1002
Objective To evaluate the clinical effect of a new three-phase Chinese medicine(CM)external treatment for acute lateral ankle ligament injuries.Methods From July to December 2023,64 patients with acute lateral ankle ligament in-juries were randomly assigned to receive either the new three-phase CM external treatment combined with the POLICE(pro-tect,optimal loading,ice,compression,elevation)treatment(observation group)or the POLICE treatment(control group),with 32 cases in each group.The observation group consisted of 17 males and 15 females,with an average age of(30.59±3.10)years old ranging from 25 to 36 years old,while the control group included 14 males and 18 females,with an average age of(30.03±3.19)years old ranging from 24 to 37 years old.Visual analogue scale(VAS)evaluation and Figure of 8 measurement were used to evaluate the degree of ankle joint pain and swelling of the subjects at the initial enrollment and after 1 week and sixth weeks of treatment.At the same time,the American Orthopaedic Foot and Ankle Society(AOFAS)and Karlsson Ankle Function Score System were used to evaluate the improvement of ankle joint function in patients at all stages.MRI imaging was employed to observe the degree of biological healing of the anterior talofibular ligament,with the signal to noise ratio(SNR)in-dicating the level of healing.A lower SNR suggests better ligament healing,as it represents lower water content in the ligament.Results All patients completed a 6-week follow-up.There was no significant difference in VAS,AOFAS score and Karlsson score between the two groups before treatment(P>0.05).After 1 week and 6 weeks of treatment,the VAS,AOFAS score and Karlsson score of the two groups were significantly improved(P<0.05).After 1 week of treatment,the VAS score of the obser-vation group(3.21±0.87)was lower than that of the control group(4.21±1.50),and the difference was statistically significant(P<0.05).After 1 weeks of treatment,the AOFAS and Karlsson scores[(50.84±4.70)points,(49.97±4.00)points]of the ob-servation group were higher than those[(46.91±5.56)points,(46.66±5.36)points]of the control group(P<0.05).MRI images showed that after 6 weeks of treatment,the SNR value of the observation group was significantly lower than that of the control group,and the difference was statistically significant(SNR of the observation group was 75.25±16.59,the contral gruop was 85.81±15.55),(P<0.05).Conclusion Compared with the control group,the new three-phase CM external treatment is signifi-cantly effective in reducing pain and swelling,enhancing ligament repair quality,and promoting functional recovery of the an-kle joint in patients with acute lateral malleolar ligament injuries.
3.Changing resistance profiles of Staphylococcus isolates in hospitals across China:results from the CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Yuling XIAO ; Mei KANG ; Yi XIE ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Ping JI ; Fengbo ZHANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WEN ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2024;24(5):570-580
Objective To investigate the changing distribution and antibiotic resistance profiles of clinical isolates of Staphylococcus in hospitals across China from 2015 to 2021.Methods Antimicrobial susceptibility testing was conducted for the clinical isolates of Staphylococcus according to the unified protocol of CHINET(China Antimicrobial Surveillance Network)using disk diffusion method and commercial automated systems.The CHINET antimicrobial resistance surveillance data from 2015 to 2021 were interpreted according to the 2021 CLSI breakpoints and analyzed using WHONET 5.6.Results During the period from 2015 to 2021,a total of 204,771 nonduplicate strains of Staphylococcus were isolated,including 136,731(66.8%)strains of Staphylococcus aureus and 68,040(33.2%)strains of coagulase-negative Staphylococcus(CNS).The proportions of S.aureus isolates and CNS isolates did not show significant change.S.aureus strains were mainly isolated from respiratory specimens(38.9±5.1)%,wound,pus and secretions(33.6±4.2)%,and blood(11.9±1.5)%.The CNS strains were predominantly isolated from blood(73.6±4.2)%,cerebrospinal fluid(12.1±2.5)%,and pleural effusion and ascites(8.4±2.1)%.S.aureus strains were mainly isolated from the patients in ICU(17.0±7.3)%,outpatient and emergency(11.6±1.7)%,and department of surgery(11.2±0.9)%,whereas CNS strains were primarily isolated from the patients in ICU(32.2±9.7)%,outpatient and emergency(12.8±4.7)%,and department of internal medicine(11.2±1.9)%.The prevalence of methicillin-resistant strains was 32.9%in S.aureus(MRSA)and 74.1%in CNS(MRCNS).Over the 7-year period,the prevalence of MRSA decreased from 42.1%to 29.2%,and the prevalence of MRCNS decreased from 82.1%to 68.2%.MRSA showed higher resistance rates to all the antimicrobial agents tested except trimethoprim-sulfamethoxazole than methicillin-susceptible S.aureus(MSSA).Over the 7-year period,MRSA strains showed decreasing resistance rates to gentamicin,rifampicin,and levofloxacin,MRCNS showed decreasing resistance rates to gentamicin,erythromycin,rifampicin,and trimethoprim-sulfamethoxazole,but increasing resistance rate to levofloxacin.No vancomycin-resistant strains were detected.The prevalence of linezolid-resistant MRCNS increased from 0.2%to 2.3%over the 7-year period.Conclusions Staphylococcus remains the major pathogen among gram-positive bacteria.MRSA and MRCNS were still the principal antibiotic-resistant gram-positive bacteria.No S.aureus isolates were found resistant to vancomycin or linezolid,but linezolid-resistant strains have been detected in MRCNS isolates,which is an issue of concern.
4.Effects of climate change on scrub typhus in Xiamen
Xue-Mei KE ; Jiao-Na CHEN ; Shan-Shan MA ; Si-Han WU ; Chun-Xiang CAI ; Xiao-Yan WANG ; Shi-Jie HUANG
Chinese Journal of Zoonoses 2024;40(10):965-970
This study was aimed at examining the influence of meteorological factors on scrub typhus in Xiamen.Scrub ty-phus monitoring data and meteorological factors were collected in Xiamen from 2005 to 2023.Spearman correlation analysis and nonlinear regression were used to analyze the correlation between scrub typhus incidence and meteorological factors.The inci-dence of scrub typhus first increased and subsequently decreased in Xiamen from 2005 to 2023.The highest incidence was be-tween 2014 and 2016,and the peak incidence was from June to October.The monthly incidence of scrub typhus positively cor-related with daily minimum temperature(r=0.637,P<0.001,daily average temperature(r=0.627,P<0.001),daily maxi-mum temperature(r=0.612,P<0.001),sunshine duration(r=0.405,P<0.001),average relative humidity(r=0.346,P<0.001),and daily rainfall(r=0.207,P=0.002),and negatively correlated with average atmospheric pressure(r=-0.549,P<0.001),whereas no correlation was observed with the average wind speed in Xiamen.The regression equation of scrub ty-phus monthly incidence and meteorological parameters was y=-433.869-11.503x1+0.381x1 2+9.150x2-0.197x2 2+3.936 x3-0.132x3 2+0.881x4+0.035x4 2-1.048x5+0.009x5 2+0.186x6-0.023x6 2+0.421x7+6.210×10-5x8-1.051 × 10-10x8 2 in Xiamen,and the R2 was 0.473,thus indicating good model fit.Scrub typhus incidence correlated with the daily minimum av-erage temperature,average temperature,daily maximum tem-perature,sunshine duration,daily rainfall,relative humidity,and average atmospheric pressure in Xiamen.Various meteoro-logical factors had differing effects on scrub typhus.
5.Effects of canthaxanthin in increasing reproductive hormone secretion through re-ducing ovarian oxidative stress injury on egg production rate of Huaixiang chickens
Zhuo SUN ; Tingting XIE ; Zhuangzhi ZHAO ; Junwen ZHAO ; Anting ZHANG ; Jiang WU ; Mei XIAO ; Lilong AN
Chinese Journal of Veterinary Science 2024;44(10):2266-2276
A total of 360 healthy 26 week old Huaixiang hens were randomly divided into 10 groups,of which,five groups were reared at normal temperature(NC,NT1,NT2,NT3,NT4)and other five groups were reared at high temperature(HC,HT1,HT2,HT3,HT4),all chickens were feed with 0,4,6,8,10 mg/kg canthaxanthin(CX)respectively.The pre-test period was 2 weeks and the main test period was 9 weeks.The results showed that high temperature reduced the egg pro-duction rate(P<0.05),led to damage and hemorrhage in the ovaries,decreased the activity of su-peroxide dismutase(SOD),glutathione peroxidase(GSH-Px)in the serum and the ovaries(P<0.05),decreased the levels of FSH,LH,P4,and E2(P<0.05),decreased the expression of FSHR,LHR,ER,and PR(P<0.05),and increased the levels of malonaldehyde(MDA)(P<0.05)in the ovaries.Addition of CX increased the egg production rate(P<0.05),increased the activity of serum and ovarian SOD and GSH-Px enzymes(P<0.05),decreased the content of serum and ovarian MDA(P<0.05)),increased the ovarian levels of FSH,LH,P4,E2(P<0.05),and increased the o-varian expression of FSHR,LHR,ER,and PR(P<0.05)in Huaixiang chickens at normal and high temperature environmental conditions,respectively.Among them,the highest egg production rate,the strongest antioxidant capacity of serum and ovarian tissues,the best integrity of ovarian tis-sues,ovarian reproductive hormone secretion and expression of reproductive hormone receptors were observed in Huaixiang chickens when 6 mg/kg of CX was added to the diet under normal temperature and when 8 mg/kg CX was added to the diet under high temperature conditions.The results showed that under normal and high temperature conditions,adding CX to the diet signifi-cantly increased the antioxidant capacity of serum and ovaries,alleviated the damage of ovary,pro-moted the secretion of reproductive hormone and the expression of reproductive hormone recep-tors,and increased egg production rate.Dietary supplemented with CX could not restore the dam-age and repair of ovarian tissue,the secretion of reproductive hormone and receptor to normal tem-perature level.The effects of CX on egg production rate,ovarian tissue structure,reproductive hor-mone and receptor expression in chickens were affected by the environmental temperature.When the egg production rate,antioxidant capacity of ovarian tissues,reproductive hormone levels and receptor expression of Huaixiang chickens were optimal,the amount of CX in high temperature en-vironment was more than that of the dose in normal temperature environment.
6.Analysis of Plasma Metabolic Profile in Children with Transfusion-Dependent Thalassemia
Xiao-Lan LIU ; Wen-Zhong LI ; Qian ZHANG ; Xue-Mei WANG ; Yu-Ru ZHOU ; Cheng-Gao WU ; Si-Min XIONG ; Ai-Ping LE ; Zhang-Lin ZHANG
Journal of Experimental Hematology 2024;32(2):525-531
Objective:To explore the plasma metabolomic characteristics of children with transfusion-dependent thalassemia(TDT),and reveal the changes of metabolic pattern in children with TDT.Methods:23 children with TDT who received regular blood transfusion in Ganzhou Women and Children's Health Care Hospital in 2021 were selected,and 11 healthy children who underwent physical examination during the same period were selected as the control group.The routine indexes between children with TDT and the control group were compared,and then the metabolic composition of plasma samples from children with TDT and the control group was detected by liquid chromatography-mass spectrometry.An OPLS-DA model was established to perform differential analysis on the detected metabolites,and the differential metabolic pathways between the two groups were analyzed based on the differential metabolites.Results:The results of routine testing showed that the indexes of ferritin,bilirubin,total bile acid,glucose and triglycerides in children with TDT were significantly higher than those in healthy controls,while hemoglobin and total cholesterol were significantly lower(all P<0.05).However there was no significant difference in lactate dehydrogenase between the two groups(P>0.05).Compared with the control group,190 differential metabolites(VIP>1)were identified in TDT children.Among them,168 compounds such as arginine,proline and glycocholic acid were significantly increased,while the other 22 compounds such as myristic acid,eleostearic acid,palmitic acid and linoleic acid were significantly decreased.The metabolic pathway analysis showed that the metabolic impact of TDT on children mainly focused on the upregulation of amino acid metabolism and downregulation of lipid metabolism.Conclusion:The amino acid and lipid metabolism in children with TDT were significantly changed compared with the healthy control group.This finding is helpful to optimize the treatment choice for children with TDT,and provides a new idea for clinical treatment.
7.Long-term hypomethylating agents in patients with myelodysplastic syndromes: a multi-center retrospective study
Xiaozhen LIU ; Shujuan ZHOU ; Jian HUANG ; Caifang ZHAO ; Lingxu JIANG ; Yudi ZHANG ; Chen MEI ; Liya MA ; Xinping ZHOU ; Yanping SHAO ; Gongqiang WU ; Xibin XIAO ; Rongxin YAO ; Xiaohong DU ; Tonglin HU ; Shenxian QIAN ; Yuan LI ; Xuefen YAN ; Li HUANG ; Manling WANG ; Jiaping FU ; Lihong SHOU ; Wenhua JIANG ; Weimei JIN ; Linjie LI ; Jing LE ; Wenji LUO ; Yun ZHANG ; Xiujie ZHOU ; Hao ZHANG ; Xianghua LANG ; Mei ZHOU ; Jie JIN ; Huifang JIANG ; Jin ZHANG ; Guifang OUYANG ; Hongyan TONG
Chinese Journal of Hematology 2024;45(8):738-747
Objective:To evaluate the efficacy and safety of hypomethylating agents (HMA) in patients with myelodysplastic syndromes (MDS) .Methods:A total of 409 MDS patients from 45 hospitals in Zhejiang province who received at least four consecutive cycles of HMA monotherapy as initial therapy were enrolled to evaluate the efficacy and safety of HMA. Mann-Whitney U or Chi-square tests were used to compare the differences in the clinical data. Logistic regression and Cox regression were used to analyze the factors affecting efficacy and survival. Kaplan-Meier was used for survival analysis. Results:Patients received HMA treatment for a median of 6 cycles (range, 4-25 cycles) . The complete remission (CR) rate was 33.98% and the overall response rate (ORR) was 77.02%. Multivariate analysis revealed that complex karyotype ( P=0.02, OR=0.39, 95% CI 0.18-0.84) was an independent favorable factor for CR rate. TP53 mutation ( P=0.02, OR=0.22, 95% CI 0.06-0.77) was a predictive factor for a higher ORR. The median OS for the HMA-treated patients was 25.67 (95% CI 21.14-30.19) months. HMA response ( P=0.036, HR=0.47, 95% CI 0.23-0.95) was an independent favorable prognostic factor, whereas complex karyotype ( P=0.024, HR=2.14, 95% CI 1.10-4.15) , leukemia transformation ( P<0.001, HR=2.839, 95% CI 1.64-4.92) , and TP53 mutation ( P=0.012, HR=2.19, 95% CI 1.19-4.07) were independent adverse prognostic factors. There was no significant difference in efficacy and survival between the reduced and standard doses of HMA. The CR rate and ORR of MDS patients treated with decitabine and azacitidine were not significantly different. The median OS of patients treated with decitabine was longer compared with that of patients treated with azacitidine (29.53 months vs 20.17 months, P=0.007) . The incidence of bone marrow suppression and pneumonia in the decitabine group was higher compared with that in the azacitidine group. Conclusion:Continuous and regular use of appropriate doses of hypomethylating agents may benefit MDS patients to the greatest extent if it is tolerated.
8.Design of automatic urine volume detection and collection device
Yan CHEN ; De-Zhao ZHAI ; Xiao-Quan ZHANG ; Fu-Long LIU ; Xiao-Tao ZHANG ; Yong-Mei ZHANG ; Wei CEHN ; Fang ZHANG ; Guo-Hui WU ; Jun DENG ; Dan LI
Chinese Medical Equipment Journal 2024;45(4):66-69
Objective To develop an automatic urine volume detection and collection device to solve the problems of routine urine test.Methods An automatic urine volume detection and collection device was developed with the components of a main control system,a detection system,a prompting system and a grasping and moving system.The main control system consisted of two STM32 microcontrollers and a reset switch;the detection system was made up of a weighing module,an infrared module and indicator lights,which had its urine volume automatic detection algorithm developed based on the Keil5 platform;the prompting system realized voice broadcasting through the voice module fixed on the back panel of the box;the grasping and moving system was composed of a rail drive motor(86CM stepper motor),a photoelectric switch and a motorized gripper.Results The device developed tested urine samples with an accuracy of 99.44%,and could collect qualified samples automatically and quickly.Conclusion The device developed detects urine volume and collects samples automatically,and enhances the accuracy and efficiency of urine examination.[Chinese Medical Equipment Journal,2024,45(4):66-69]
9.Clinical characteristics and nutritional status of children with Crohn's disease and risk factors for malnutrition
Dong-Dan LI ; Xiao-Lin YE ; Mei-Chen WANG ; Hong-Mei HUANG ; Jie YAN ; Tian-Zhuo ZHANG ; Fei-Hong YU ; De-Xiu GUAN ; Wen-Li YANG ; Lu-Lu XIA ; Jie WU
Chinese Journal of Contemporary Pediatrics 2024;26(11):1194-1201
Objective To investigate the nutritional status of children with Crohn's Disease (CD) at diagnosis and its association with clinical characteristics. Methods A retrospective analysis was performed for the clinical data and nutritional status of 118 children with CD who were admitted to Beijing Children's Hospital,Capital Medical University,from January 2016 to January 2024. A multivariate logistic regression analysis was used to investigate the risk factors for malnutrition. Results A total of 118 children with CD were included,among whom there were 68 boys (57.6%) and 50 girls (42.4%),with a mean age of (11±4) years. Clinical symptoms mainly included recurrent abdominal pain (73.7%,87/118),diarrhea (37.3%,44/118),and hematochezia (32.2%,38/118),and 63.6% (75/118) of the children had weight loss at diagnosis. The incidence rate of malnutrition was 63.6% (75/118),and the children with moderate or severe malnutrition accounted for 67% (50/75). There were 50 children (42.4%) with emaciation,8 (6.8%) with growth retardation,and 9 (7.6%) with overweight or obesity. Measurement of nutritional indices showed a reduction in serum albumin in 83 children (70.3%),anemia in 74 children (62.7%),and a reduction in 25 hydroxyvitamin D in 15 children (60%,15/25). The children with malnutrition had significantly higher disease activity,proportion of children with intestinal stenosis,and erythrocyte sedimentation rate and a significant reduction in serum albumin (P<0.05). The multivariate logistic regression analysis showed that intestinal stenosis was an independent risk factor for malnutrition in children with CD (OR=4.416,P<0.05). Conclusions There is a high incidence rate of malnutrition in children with CD at diagnosis,which is associated with disease activity and disease behavior. The nutritional status of children with CD should be closely monitored.
10.Based on the interaction between supramolecules of traditional Chinese medicine and enterobacteria to explore the material basis of combination of Rhei Radix et Rhizoma - Coptidis Rhizoma
Xiao-yu LIN ; Ji-hui LU ; Yao-zhi ZHANG ; Wen-min PI ; Zhi-jia WANG ; Lin-ying WU ; Xue-mei HUANG ; Peng-long WANG
Acta Pharmaceutica Sinica 2024;59(2):464-475
Based on the interaction between supramolecule of traditional Chinese medicine and enterobacteria, the material basis of


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