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.Prenatal Screening and Genetic Analysis of Fetal Aberrant Right Subclavian Ar-tery
Mengjie ZHU ; Haiyan TANG ; Yanyan LI ; Yongyan CHU ; Lilu NONG ; Libing LUO ; Ting ZENG ; Xiaoying DAI ; Shengmou LIN
Journal of Practical Obstetrics and Gynecology 2025;41(6):508-513
Objective:To investigate the clinical significance of prenatal screening and genetic analysis in the diagnosis of fetal aberrant right subclavian artery(ARSA).Methods:The ultrasonographic features of ARSA fetu-ses detected by prenatal ultrasound at the University of Hong Kong-Shenzhen Hospital from October 2017 to March 2022 were retrospectively analyzed.The fetuses were divided into isolated ARSA group and complicated ARSA group.Their genetic analysis results and pregnancy outcome were analyzed.Results:Among 30,260 preg-nant women,185 fetuses were diagnosed with ARSA by prenatal ultrasound screening,with an incidence of 0.6%;5 fetuses(2.6%)were diagnosed by ultrasound in the first trimester,and the remaining were diagnosed by fetal grade Ⅲ structural ultrasound examination at 20~24 weeks' gestation.Among them,158 fetuses(85.4%)had isolated ARSA,and 27(14.6%)had complicated ARSA.Among fetuses with ARSA and other structural abnormal-ities,cardiovascular system accounted for the highest proportion(44.4%),followed by nervous system(22.2%)and urinary system(22.2%).Through genetic analysis,8.3%(4/48)fetuses with isolated ARSA and 40.0%(4/10)fetuses with complicated ARSA were found to have chromosomal numerical or structural abnormalities,with statis-tically significant difference between the two groups(P=0.024).Genetic analysis was completed in 48 isolated ARSA,and the positive rate of pathogenic copy number variants(CNV)was 4.2%(2/48),which was not signifi-cantly different from the pathogenic CNV incidence rate of 0.4%(1/239)in elderly pregnant cases during the same period(P=0.074).The Down syndrome positive likelihood ratio(LR+)for isolated ARSA was 2.5 and the Down syndrome LR+for complicated ARSA was 49.6.Conclusions:Complicated ARSA is often associated with cardiovascular abnormalities and is more likely to develop Down syndrome than isolated ARSA.Although the inci-dence of pCNV in isolated ARSA is slightly higher than the natural incidence,the correlation between pCNV and i-solated ARSA has not been clearly determined by the current sample size.
3.The Discipline Development of Traditional Chinese Medicine in the Context of Mutual Understanding of Civilizations
Yongyan WANG ; Yipin FAN ; Qiang LI ; Xinyu JI
Journal of Traditional Chinese Medicine 2025;66(1):2-5
The mutual learning between Chinese and Western civilizations today provides a broad perspective and new opportunity for the development of traditional Chinese medicine (TCM), fostering the interdisciplinary integration, fusion, and innovation of the discipline. The premise of mutual understanding of civilizations is uphold the principles of Chinese traditional scholarship and original thinking, overcome academic barriers and cognitive differences, and achieve the organic integration of knowledge systems and research methods. The development of TCM as a discipline should first be based on literature as a carrier to convey ideas and ensure the continuity of the academic tradition. Secondly, the discipline development should be guided by the unique, original thinking of TCM, accurately identifying the bottlenecks in its development, focusing on the key links for improvement, continuously exploring innovative academic paths, and striving to build a leading research platform. Finally, the cultivation of talents in the field of TCM discipline should focus on leading ones with international academic discourse power and influence, and establish an academic team with clinical thinking and interdisciplinary knowledge structure.
4.Evaluation Value of miR-127-3P and miR-129-5P in IgA Nephropathy with Micro-Blood Stasis Syndrome Based on Pathological Indices and Laboratory Parameters
Yongyan ZHANG ; Shaojie ZHANG ; Yayu LI
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(10):2387-2392
Objective To investigate the potential roles of miR-127-3p and miR-129-5p in guiding micro-blood stasis syndrome differentiation,predicting renal pathological outcomes,assessing disease activity,and evaluating prognosis in IgA nephropathy(IgAN)patients.Methods Thirty IgAN patients meeting the diagnostic criteria of"micro-blood stasis syndrome"were enrolled from Hangzhou Hospital of Traditional Chinese Medicine between September 2020 and December 2021.Plasma levels of miR-127-3p and miR-129-5p were measured,and their correlations with renal pathological indices(including activity index and chronicity index)and laboratory parameters(including liver function indicators,renal function indicators,coagulation function indicators,urinary markers,and lipid profiles)were analyzed.Results(1)Activity index:No significant correlation was observed between miR-127-3p expression and any activity indices(P>0.05).miR-129-5p expression showed a positive correlation with mesangial hypercellularity index(MsHI)(r=0.470,P=0.009)but had no significant correlations with endocapillary hypercellularity index(endoI),glomerular capillary loop destruction activity index(dGAI),or mesangial matrix expansion index(MsMT)(P>0.05).(2)Chronicity index:Neither miR-127-3p nor miR-129-5p expression correlated significantly with glomerular chronicity index(GCI),tubular chronicity index(TCI)(P>0.05).(3)Liver function:miR-127-3p showed no significant correlation with alanine aminotransferase(ALT),aspartate aminotransferase(AST),or albumin(ALB)(P>0.05).miR-129-5p expression was negatively correlated with ALB(r=-0.388,P=0.034)and positively correlated with AST(r=0.448,P=0.013),but was not correlated with ALT(P>0.05).(4)Renal function:No significant correlations were found between miR-127-3p/miR-129-5p and blood urea nitrogen(BUN),serum creatinine(Scr),uric acid(UA),creatinine clearance rate(CCr),or cystatin C(Cys-C)(P>0.05).(5)Coagulation function:Neither miR-127-3p/miR-129-5p was correlated with prothrombin time(PT),activated partial thromboplastin time(APTT),thrombin time(TT),fibrinogen(FIB),or D-dimer(D-D)(P>0.05).(6)Urinary markers:No significant correlations were observed with 24-hour urinary protein quantification(24hUPQ)or urinary N-acetyl-β-D-glucosaminidase-to-creatinine ratio(UNAG/UCr)(P>0.05).(7)Lipid profiles:NeithermiR-127-3p/miR-129-5p showed significant correlations with triglycerides(TG),total cholesterol(TC),or low-density lipoprotein cholesterol(LDL-C)(P>0.05).Conclusion In IgAN patients with micro-blood stasis syndrome,miR-129-5p demonstrates potential in reflecting renal pathological damage and shows prospects for evaluating disease activity and prognosis.These findings suggest its potential value in guiding integrated Chinese and western medicine diagnosis and treatment of IgAN.
5.Characteristics of coagulation function and immune function in children with severe adenovirus pneumonia and their clinical significance
Jia LIU ; Yabin YU ; Lan WANG ; Ying LI ; Xin YU ; Yongyan CAI ; Na MA ; Zhixin YAN
Journal of Clinical Medicine in Practice 2025;29(5):122-126
Objective To explore the characteristics of coagulation and immune function and their clinical significance in children with severe adenovirus pneumonia(SAP).Methods A total of 122 children with SAP and 120 children with non-severe adenovirus pneumonia(NSAP)were enrolled and assigned to severe group and non-severe group.The severe group was further subdivided into good prognosis subgroup(n=105)and poor prognosis subgroup(n=17)according to prognosis.Addition-ally,120 healthy children undergoing physical examination during the same period were included as control group.Coagulation function indicators,including prothrombin time(PT),activated partial thromboplastin time(APTT),fibrinogen(FIB),and thrombin time(TT)were measured.Levels of immunoglobulin A(IgA),immunoglobulin G(IgG),and immunoglobulin M(IgM)were determined using the nephelometric immunoassay.Multivariate Cox regression analysis was conducted to explore the influencing factors of poor prognosis.Results Compared with the control group,children in both the non-severe and severe groups exhibited increased levels of white blood cells(WBC),neutrophils(N),C-reactive protein(CRP),erythrocyte sedimentation rate(ESR),interleukin-6(IL-6),procalci-tonin(PCT),FIB,and IgG,as well as decreased levels of B lymphocytes,natural killer(NK)cells,PT,APTT,IgA,and IgM(P<0.05).Compared with the non-severe group,children in the severe group showed increased levels of WBC,N,CRP,ESR,IL-6,PCT,FIB,and IgG,as well as decreased levels of B lymphocytes,NK cells,PT,APTT,IgA,and IgM(P<0.05).Compared with the good prognosis subgroup,the poor prognosis subgroup exhibited increased levels of CRP,IL-6,PCT,and IgG,as well as decreased levels of APTT,IgM,and IgA(P<0.05).The results of multivariate Cox regression analysis showed that PCT,APTT,and IgM were influencing factors of poor prognosis in children with SAP(P<0.05).Conclusion Children with SAP have decreased levels of PT,APTT,IgA,and IgM,as well as increased levels of FIB and IgG.Coagulation and im-mune function indicators are correlated with the prognosis of SAP.
6.Prenatal Screening and Genetic Analysis of Fetal Aberrant Right Subclavian Ar-tery
Mengjie ZHU ; Haiyan TANG ; Yanyan LI ; Yongyan CHU ; Lilu NONG ; Libing LUO ; Ting ZENG ; Xiaoying DAI ; Shengmou LIN
Journal of Practical Obstetrics and Gynecology 2025;41(6):508-513
Objective:To investigate the clinical significance of prenatal screening and genetic analysis in the diagnosis of fetal aberrant right subclavian artery(ARSA).Methods:The ultrasonographic features of ARSA fetu-ses detected by prenatal ultrasound at the University of Hong Kong-Shenzhen Hospital from October 2017 to March 2022 were retrospectively analyzed.The fetuses were divided into isolated ARSA group and complicated ARSA group.Their genetic analysis results and pregnancy outcome were analyzed.Results:Among 30,260 preg-nant women,185 fetuses were diagnosed with ARSA by prenatal ultrasound screening,with an incidence of 0.6%;5 fetuses(2.6%)were diagnosed by ultrasound in the first trimester,and the remaining were diagnosed by fetal grade Ⅲ structural ultrasound examination at 20~24 weeks' gestation.Among them,158 fetuses(85.4%)had isolated ARSA,and 27(14.6%)had complicated ARSA.Among fetuses with ARSA and other structural abnormal-ities,cardiovascular system accounted for the highest proportion(44.4%),followed by nervous system(22.2%)and urinary system(22.2%).Through genetic analysis,8.3%(4/48)fetuses with isolated ARSA and 40.0%(4/10)fetuses with complicated ARSA were found to have chromosomal numerical or structural abnormalities,with statis-tically significant difference between the two groups(P=0.024).Genetic analysis was completed in 48 isolated ARSA,and the positive rate of pathogenic copy number variants(CNV)was 4.2%(2/48),which was not signifi-cantly different from the pathogenic CNV incidence rate of 0.4%(1/239)in elderly pregnant cases during the same period(P=0.074).The Down syndrome positive likelihood ratio(LR+)for isolated ARSA was 2.5 and the Down syndrome LR+for complicated ARSA was 49.6.Conclusions:Complicated ARSA is often associated with cardiovascular abnormalities and is more likely to develop Down syndrome than isolated ARSA.Although the inci-dence of pCNV in isolated ARSA is slightly higher than the natural incidence,the correlation between pCNV and i-solated ARSA has not been clearly determined by the current sample size.
7.The clinical significance and value manifestation of the doctor-patient narrative community
Zixu WANG ; Yipin LIU ; Jie LI ; Jingjing ZHAO ; Yongyan WANG
Chinese Medical Ethics 2025;38(8):1009-1015
This paper explored the significance and value of building a doctor-patient narrative community in clinical practice.It was clarified that clinical practice guided by evidence-based medicine thinking is essentially a"narrative"process:patients narrate their illness stories,and doctors,through a series of humanistic narrative practices,strengthen trust and empathy between patients and doctors on an emotional and ethical level,while bridging cognitive gaps,enhancing diagnostic and treatment outcomes,and ultimately fostering a harmonious and efficient doctor-patient narrative community relationship.The realization of a doctor-patient narrative community not only optimizes the treatment process but also enhances patients'self-efficacy and doctors'professional satisfaction,which is conducive to saving medical costs,optimizing public health governance,and highlighting a harmonious social atmosphere.
8.Clinical study of intracranial hypotension targeted body posture combined with pharmacotherapy in the treatment of chronic subdural hematoma
Jiayu CHEN ; Zhe WANG ; Di ZANG ; Ruizhe ZHENG ; Xiangru YE ; Zengxin QI ; Zeyu XU ; Zhiqiang LI ; Chengfeng SUN ; Liangjun SHEN ; Luoping SHENG ; Fulin XU ; Ruyong YE ; Kaiyu ZHOU ; Weijun TANG ; Yueqing HU ; Dapeng SHI ; Yuquan WANG ; Xizhen WU ; Ying WANG ; Qilin ZHANG ; Feili LIU ; Guo YU ; Yiping LU ; Yirui SUN ; Ning ZHANG ; Feng HUANG ; Xialong GU ; Han ZHANG ; Jian DING ; Yongyan BI ; Haolan DU ; Jing ZHANG ; Hailong JI ; Ding DING ; Wei ZHANG ; Xuehai WU
Chinese Journal of Surgery 2025;63(3):212-218
Objective:To compare the efficacy of body posture combined with pharmacotherapy and pharmacotherapy alone in the treatment of chronic subdural hematoma(CSDH).Methods:Firstly, retrospective case series study was conducted. Thirty cases of CSDH that had received body posture combined with pharmacotherapy at Department of Neurosurgery, Huashan Hospital Affiliated to Fudan University from December 2016 to October 2020 were studied retrospectively. Twenty-seven patients were male, and 3 patients were female. The age of patients ( M(IQR)) was 66(16) years (range:28 to 84). Nineteen patients had unilateral hematoma, and 11 patients had bilateral hematoma. All patients received pharmacotherapy and body posture therapy that was to raise their lower limbs 20 to 30 cm with leg lift pad and get abdominal compressed with customized abdominal belt in supine position. Patients were required to maintain the body posture as much as possible, with the maximum to 16 to 18 hours per day. Patients with unilateral hematoma should tilt the head to the affected side and avoid tilting it to the opposite side. For patients with bilateral hematoma, there was no need for head lateralization. Patient were treated with oral dexamethasone and atorvastatin simultaneously. The preliminary efficacy of body posture combined with pharmacotherapy was determined by hematoma improvement rate which was analyzed by Clopper-Pearson method. Then, the multi-center, prospective, randomized controlled trial had carried out in 9 medical centers from August 2020 to November 2021. The stratified block randomization method was adopted. Patients were randomized in a ratio of 1∶1 to either receive pharmacotherapy alone(the control group) or body posture combined with pharmacotherapy(the experiment group) for 3 months and followed up for 6 months. Effective treatment was defined as complete absorption of hematoma, or the hematoma volume decreased by more than 10 ml and Markwalder grading scale score had improved by more than 1 point compared to the baseline. The efficacy rate and surgery conversion rate at 3 months and recurrence at 6 months were observed. Comparison between groups was performed with paired sample t test, Mann-Whitney U test, χ2 test, corrected χ2 test, or Fisher exact probability method. Logistic regression was used to compare the effective rate and operation rate between the two groups. Results:In the respective study, 30 patients completed follow-up 13 to 353 days after treatment. At the last follow-up, the incidence of almost complete absorption or significantly absorption of hematoma (hematoma volume was significantly reduced accompanied by symptom improvement) was 93.3%. The 95% CI for the incidence that analyzed by the Clopper-Pearson method was 77.9% to 99.2%. One hundred and six patients were enrolled in the multicenter study. Fifty-five patients underwent body posture combined with pharmacotherapy. The age was 74(17) years (range:26 to 92). Thirty-nine patients were males and 16 were females. Fifty-one patients underwent pharmacotherapy alone. The age was 69(12) years (range:48 to 84). Thirty-seven patients were males and 14 were females. The length of body posture recorded in diary card was (15.7±2.3) hours(range:7.6 to 19.3 hours). The efficacy rate in the body posture combined with pharmacotherapy group and pharmacotherapy alone group were 83.6% (46/55) and 56.9% (29/51), respectively at 3 months. The result of the logistic regression analysis showed that the efficacy of body posture combined with pharmacotherapy group was better than that of pharmacotherapy alone group ( OR=3.88,95% CI:1.57 to 9.58, P=0.003). Surgery rate in the body posture combined with pharmacotherapy group and pharmacotherapy alone group were 5.5% (3/55) and 21.6% (11/51) respectively. The result of Logistic regression showed that the pharmacotherapy alone group was more likely to be converted to surgery ( OR=0.21,95% CI:0.05 to 0.80, P=0.023). At the 6 months, no recurrence of cases was found in the body posture combined with pharmacotherapy group. However, the recurrence rate of pharmacotherapy alone group was 6.3% (3/48), there was no significant difference between the two groups ( P>0.05). Conclusion:The effect of body posture combined with pharmacotherapy for chronic subdural hematoma is better than that of pharmacotherapy alone.
9.Optimization of Molding Process and Determination of Volatile Components Assay in Compound Shexiang Huangqi Dropping Pills by A Central Composite Design-Response Surface Method
Mengdi SHAO ; Shuyan ZHANG ; Qi ZHENG ; Chunhui CHANG ; Jiahao LI ; Yunke ZHANG ; Yongyan JIA
Herald of Medicine 2025;44(1):88-95
Objective The molding process of compound Shexiang Huangqi dropping pills was optimized by central composite design and response surface method,the determination of volatile components in the compound by gas chromatography was established in order to improve the quality standard of the compound.Methods Single factor method was used to select the optimum range of matrix type,the ratio of matrix to liquid,and drop distance of compound Shexiang Huangqi dropping pills;Appearance traits,a difference of pill weight,and dissolution time were used as evaluation indexes,the optimum forming process conditions of compound Shexiang Huangqi dropping pills were optimized by central composite design and response surface method;Three batches of compound Shexiang Huangqi dropping pills were taken as test samples and determined by gas chromatography;The gas chromatographic column was HP-5 sillica capillary column,the inlet temperature was 260 ℃,the temperature was programmed,and the detector temperature was 300 ℃,the split ratio was 10∶1,nitrogen was selected as the carrier gas with a flow rate of 1.0 mL·min-1.Results The optimum forming process conditions of compound Shexiang Huangqi dropping pills were selected by central composite design and response surface method as a matrix:matrix=0.99,drug:matrix=0.55,drop distance=6.00,and the comprehensive score were 0.845 2.Under these conditions,the quality of the prepared dropping pills was the best;The chromatographic peaks of borneol,muscone,and ligustilide reached the baseline separation;the linear ranges of the three components were 0.327-1.962,0.140-0.840,0.710 5-4.263 μg(all r>0.999);The average recoveries were 92.30%(RSD=1.65%,n=6),101.28%(RSD=0.81%,n=6)and 98.99%(RSD=0.65%,n=6);The average contents of the three components were 0.201 7,0.084 7 and 1.382 9 mg·g-1,respectively.Conclusions The forming process is stable and feasible,which can provide a reference for the development and application of compound Shexiang Huangqi dropping pills;The gas chromatography method established can simultaneously determine the contents of borneol,muscone,and ligustilide in compound Shexiang Huangqi dropping pills,which can be used for quality control of compound Shexiang Huangqi dropping pills.
10.Optimization of Molding Process and Determination of Volatile Components Assay in Compound Shexiang Huangqi Dropping Pills by A Central Composite Design-Response Surface Method
Mengdi SHAO ; Shuyan ZHANG ; Qi ZHENG ; Chunhui CHANG ; Jiahao LI ; Yunke ZHANG ; Yongyan JIA
Herald of Medicine 2025;44(1):88-95
Objective The molding process of compound Shexiang Huangqi dropping pills was optimized by central composite design and response surface method,the determination of volatile components in the compound by gas chromatography was established in order to improve the quality standard of the compound.Methods Single factor method was used to select the optimum range of matrix type,the ratio of matrix to liquid,and drop distance of compound Shexiang Huangqi dropping pills;Appearance traits,a difference of pill weight,and dissolution time were used as evaluation indexes,the optimum forming process conditions of compound Shexiang Huangqi dropping pills were optimized by central composite design and response surface method;Three batches of compound Shexiang Huangqi dropping pills were taken as test samples and determined by gas chromatography;The gas chromatographic column was HP-5 sillica capillary column,the inlet temperature was 260 ℃,the temperature was programmed,and the detector temperature was 300 ℃,the split ratio was 10∶1,nitrogen was selected as the carrier gas with a flow rate of 1.0 mL·min-1.Results The optimum forming process conditions of compound Shexiang Huangqi dropping pills were selected by central composite design and response surface method as a matrix:matrix=0.99,drug:matrix=0.55,drop distance=6.00,and the comprehensive score were 0.845 2.Under these conditions,the quality of the prepared dropping pills was the best;The chromatographic peaks of borneol,muscone,and ligustilide reached the baseline separation;the linear ranges of the three components were 0.327-1.962,0.140-0.840,0.710 5-4.263 μg(all r>0.999);The average recoveries were 92.30%(RSD=1.65%,n=6),101.28%(RSD=0.81%,n=6)and 98.99%(RSD=0.65%,n=6);The average contents of the three components were 0.201 7,0.084 7 and 1.382 9 mg·g-1,respectively.Conclusions The forming process is stable and feasible,which can provide a reference for the development and application of compound Shexiang Huangqi dropping pills;The gas chromatography method established can simultaneously determine the contents of borneol,muscone,and ligustilide in compound Shexiang Huangqi dropping pills,which can be used for quality control of compound Shexiang Huangqi dropping pills.


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