In recent years, the reform of the registration, evaluation, and approval system for traditional Chinese medicine(TCM) has been promoted at the national level, with establishment of an evaluation evidence system for TCM registration that combines TCM theory, human use experience, and clinical trials(known as the "three-combined" evaluation evidence system). This system, which aligns with the characteristics of TCM clinical practice and the laws of TCM research and development, recognizes the unique value of human use experience in medicine and returns to the essence of medicine as an applied science, thus receiving widespread recognition from both academia and industry. However, it meanwhile poses new and higher challenges. This article delves into the value and challenges faced by the "three-combined" evaluation evidence system from three perspectives: registration management, medical institutions, and the TCM industry. Furthermore, it discusses how the China Association of Chinese Medicine, leveraging its academic platform advantages and leading roles, has made exploratory and practical efforts to facilitate the research and development of new TCM drugs and the implementation of the "three-combined" evaluation evidence system.
Drugs, Chinese Herbal/standards* ; Humans ; Medicine, Chinese Traditional/standards* ; China ; Drug Development

Objective To identify key proteins associated with sudden cardiac death(SCD)caused by lethal arrhythmia and to explore their potential molecular mechanisms through integrated proteomic analysis,data mining,and bioinformatics.Methods A lethal arrhythmia model was established in 8-week-old male Sprague-Dawley rats,which were divided into an arrhythmia group and a control group.Proteomic techniques were applied to identify and quantify proteins in left ventricular myocardial tissue,and differentially expressed proteins related to arrhythmia were screened.Key proteins were further identified through comparison with target proteins in databases combined with joint analyses.Bioinformatics methods were then used to investigate potential molecular mechanisms.Results A total of 356 differentially expressed proteins were identified,including 189 upregulated and 167 downregulated.Association analysis with target gene proteins identified 71 key proteins,and a protein-protein interaction network was constructed.GO enrichment and KEGG pathway analyses indicated that these key proteins were primarily involved in ion channel dysfunction,enhanced oxidative stress,and autonomic nervous system imbalance.Conclusion This study,through the integration of proteomics,data mining,and bioinformatics,revealed critical molecular mechanisms underlying SCD associated with lethal arrhythmia.These findings provide new perspectives and potential biomarkers for forensic identification and research on the mechanisms of death.

Objective To identify key proteins associated with sudden cardiac death(SCD)caused by lethal arrhythmia and to explore their potential molecular mechanisms through integrated proteomic analysis,data mining,and bioinformatics.Methods A lethal arrhythmia model was established in 8-week-old male Sprague-Dawley rats,which were divided into an arrhythmia group and a control group.Proteomic techniques were applied to identify and quantify proteins in left ventricular myocardial tissue,and differentially expressed proteins related to arrhythmia were screened.Key proteins were further identified through comparison with target proteins in databases combined with joint analyses.Bioinformatics methods were then used to investigate potential molecular mechanisms.Results A total of 356 differentially expressed proteins were identified,including 189 upregulated and 167 downregulated.Association analysis with target gene proteins identified 71 key proteins,and a protein-protein interaction network was constructed.GO enrichment and KEGG pathway analyses indicated that these key proteins were primarily involved in ion channel dysfunction,enhanced oxidative stress,and autonomic nervous system imbalance.Conclusion This study,through the integration of proteomics,data mining,and bioinformatics,revealed critical molecular mechanisms underlying SCD associated with lethal arrhythmia.These findings provide new perspectives and potential biomarkers for forensic identification and research on the mechanisms of death.

Cough variant asthma （CVA） is a chronic respiratory disease with cough as its main symptom. The occurrence of CVA is closely related to non-specific airway inflammation， and its pathogenesis involves environmental， genetic， immune， and other factors. In recent years， the advantages of traditional Chinese medicine （TCM） in the treatment of CVA have attracted the attention of experts and scholars in China and abroad， especially its prominent role in regulating immune balance， relieving cough symptoms in CVA patients， and reducing recurrence. T Helper cells 1 （Th1）， T helper cells 2 （Th2）， T helper cells 17 （Th17）， and regulatory T cells （Treg） are derived from CD4⁺ T cells. Immune imbalance of Th1/Th2 and Th17/Treg is a new hotspot in the pathogenesis of CVA and a potential key target in the treatment of CVA by TCM. Th cell subsets are in dynamic balance under physiological conditions， maintaining respiratory immune homeostasis in which pro-inflammatory cytokines and anti-inflammatory cytokines are balanced. Immature helper T cells （Th0） can be differentiated into Th1， Th2， Th17， Treg， and other cell subsets due to cytokine types in the microenvironment in the stage of CVA maturation. The proliferation of Th2 cells leads to eosinophilic airway inflammation. Excessive differentiation of Th17 cells induces neutrophil airway inflammation. Th1/Th2 and Th17/Treg cells are mutually restricted in number and function， and the immune imbalance of Th1/Th2 and Th17/Treg is easy to aggravate the generation of inflammatory response. Restoring immune balance is particularly important for the airway anti-inflammatory therapy of CVA. In this paper， the imbalance of Th1/Th2 and Th17/Treg and the pathogenesis of CVA were systematically expounded. Meanwhile， the latest research on the regulation of immune imbalance by TCM compound， single TCM， and its effective ingredients in the treatment of CVA was reviewed. It provides ideas and references for revealing the scientific connotation of TCM regulating immune balance therapy of CVA， as well as the development of clinical treatment and basic research of CVA.

Objective To explore the effect on management of high value dental implantable consumables based on SPD model(supply-processing-distribution),therefore to establish a new management model for clinical pratice.Methods Hstorical non-concurrent controlled pretest-posttest design method was used in the study.The conventional management mode was applied in the control group for high-value dental implantable medical consumables between June and August 2022,and the SPD mode was employed in the trial group for high-value dental implantable medical consumables between October and December 2022.Before and after the implementation of SPD mode,the time of storage for high-value dental implant consumables,the time of daily postoperative register of consumables,the time of monthly consumables usage summary and the accuracy of charging items for primary bone implanted high-value dental consumables in the two groups were collected.Results A comparison of the management time of various consumables between the two groups showed statistically significant difference(P<0.001).Also,the storage time of high-value consumables in the trial group,the time of daily postoperative register of consumables and the time of monthly consumables usage summary were all less than those in the control group.The accuracy of the two groups was compared and the trial group was,higher than that of the control group(P<0.01),with statistically significant difference.Conclusion Management of high value medical consumables for dental implants based on SPD can ensure the safety in high value dental consumables and improve the working efficiency.

ObjectiveTo systematically review the clinical experience of four sessions of Masters of Traditional Chinese Medicine and two sessions of National Famous Chinese Medicine Practitioners in treating ulcerative colitis （UC）. Data mining and analysis were conducted to clarify the diagnosis and treatment ideas and characteristics of prescription used by these famous doctors in treating UC. MethodsRelevant literature on the treatment of UC by renowned doctors was retrieved from the establishment of the database until March 31， 2023. The literature was collected from databases such as China National Knowledge Infrastructure （CNKI）， Wanfang Data Knowledge Service Platform， Chinese Science and Technology Periodicals Database， and China Biomedical Literature Database. The data mining techniques including frequency analysis， association rules， and cluster analysis were conducted using the Ancient and Modern Medical Case Cloud Platform V2.3.5. ResultsA total of 157 literatures were included in this study， including 115 clinical case data. The study found that UC can be categorized into 14 types of syndrome patterns for treatment， including large intestine dampness-heat syndrome （75，65.22%）， syndrome of dampness stagnancy due to spleen deficiency （23， 20.00%）， spleen-kidney yang deficiency syndrome （21， 18.26%）. The main affected organs were the spleen （85， 73.91%） and large intestine （75， 65.22%）， and they were closely related to liver （24， 20.87%） and the kidney （21， 18.26%）. The predominant pathogenic factors were dampness （83， 72.17%） ， heat （80， 69.57%） and qi deficiency （65， 56.52%）. The treatment involved 30 kinds of treatment methods， including heat-clearing and dampness-draining method （75， 65.22%）， pleen-tonifying and qi-boosting method （25，21.74%） and spleen-invigorating and dampness-transforming method （23， 20.00%）. The medication involved 187 ingredients， with the most commonly used being heat-clearing herbs （37， 19.79%） and tonifying herbs （27， 14.44%）. The tastes of the herbs were mostly sweet （85， 45.45%） ， bitter （80， 42.78%） ， and pungent （71， 37.97%）. The association rules revealed 16 high-frequency combinations mainly composed of Huanglian （黄连）， Baishao （白芍） and Gancao （甘草） along with Baizhu （白术）， Fuling （茯苓）， Muxiang （木香） and Danggui （当归）. ConclusionFamous doctors are skilled in diagnosing and treating UC based on the differentiation of the zang-fu organs and qi-blood. The key pathological mechanism is “spleen deficiency as the root， and large intestine damp-heat as the manifestation”. The core treatment approach is “heat-clearing， spleen-tonifying， and dampness-draining”， with the inclusion of “regulating qi and blood， and balancing cold and heat”.

Traditional Chinese medicine （TCM） and western medicine have their respective advantages and limitations in the diagnosis and treatment of common otorhinolaryngology head and neck diseases. Although the integrated TCM and western medicine exhibits definite curative effects， there is no consensus on the otorhinolaryngology head and neck diseases responding specifically to TCM or integrated TCM and western medicine， as well as the diagnosis and treatment schemes. The China Association of Chinese Medicine （CACM） thus organized the otorhinolaryngology head and neck specialists of both TCM and western medicine to discuss the etiology， pathogenesis， and clinical diagnosis and treatment methods of common otorhinolaryngology head and neck diseases with the results of multiple clinical trials taken into account. The acute pharyngitis， chronic pharyngolaryngitis， paraesthesia pharyngis， hysterical aphasia， allergic rhinitis， subjective tinnitus， and otogenic vertigo were confirmed to respond specifically to TCM or integrated TCM and western medicine. Then a mutually agreed diagnosis and treatment scheme and recommendation with integrated TCM and western medicine was formulated as a reference for clinical practice， thus benefiting more patients.

Infertility with diminished ovarian reserve(DOR) is a major problem in the field of reproductive health and it has attracted great attention worldwidely.Function deficiency of the kidney is one of the fundamental pathogenesis for DOR.Traditional Chinese medicines(TCMs) have a long history with rich experience for the treatment of infertility.Some TCMs are very effective in the treatment of kidney deficiency for infertility with DOR.The integrated TCMs and western medicine,and combination of disease differentiation and syndrome differentiation may help for diagnosis and treatment of infertility with DOR.We adopt the concept of unified treatment for special disease,and the methods and principle of treatment can be used.Therefore,we adopt the TCM concept of kidney-tonifying,blood-nourishing,liver-dispersing and spleen-invigorating.The TCMs kidney-tonifying formulae are added and subtracted.TCMs can regulate the reproductive function via multiple systems for simultaneous conditioning of follicular development and ovulation.At the same time,a hypothesis of " simultaneous conditioning of follicular development and ovulation" was proposed.Two-stage therapy with integrated TCMs and western medicine has been used,mainly for increasing the number of eggs,and improving follicle quality.The goal is to achieve simultaneous conditioning of follicular development and ovulation and ultimately for effective treatment of infertility with DOR.

It is still an important and hard work to diagnose anaphylactic shock in forensic practice. However, no breakthrough progresses in the diagnosis of anaphylactic shock and relevant research have been made so far due to the problems we used to meet in actual postmortem examination ,which are short of specific pathological changes in autopsy, the condition progress of patients who occur anaphylactic shock and history of allergy. Furthermore, patients suffer from diseases such as coronary heart disease, pneumonia, asthma, skin irritation, etc, and blood serum allergy biomarkers degrade after hemolysis on account of a long time from death to autopsy ,which are also the difficulties we have to cope with. The aim of this review is to focus on present situation and diagnostic index of anaphylactic shock including the pathological changes and some experimental methods such as special stain, immunohistochemical and serological test to provide reference for diagnosis and study of anaphylactic shock.

Objective To observe the expression changes in apoptosis-related microRNA(miRNA) in cerebral cortex after cardiac arrest-cardiopulmonary resuscitation(CA-CPR)in rats and explore the factors that may affect the mechanism of CPR. Methods 24 clean male Sprague-Dawley(SD)rats were randomly divided into three groups,the normal control group,sham operation group and CA-CPR group(each n=8). The animal model of CA induced by asphyxia was established and CPR was performed. In the normal control group,no special management was performed. In the sham operation group,only abdominal cavity anesthesia,tracheotomy,vascular puncture and electrocardiogram(ECG)were performed without clamping the trachea and resuscitating. Normal feeding in normal control group and 24 hours after tracheotomy in sham operation group,at 24 hours after recovery of spontaneous circulation(ROSC)in CA-CPR group,cerebral cortex specimens were obtained for detection of the expression of miRNA by using real time fluorescence quantitative reverse transcription - polymerase chain reaction(RT-PCR). Flow cytometry(FCM)was used to detect the neurocyte apoptotic rate. Results Compared between normal control and sham operation groups,there were no significant differences in the expression of apoptosis-related miRNA and neurocyte apoptosis rate of cerebral cortex(both P>0.05). Compared with sham operation group,in CA-CPR group, 16 miRNA expressions were up-regulated,including Let-7c,miR-15a,miR-21,miR-24,miR-29,miR-29b, miR-34a, miR-103, miR-200a, miR-200b, miR-200c, miR-210, miR-326, miR-338-3p, miR-494 and miR-497,and there were 22 down-regulated,being Let-7a,Let-7b,Let-7d,Let-7e,miR-19a,miR-19b-1, miR-20a,miR-20b,miR-23a,miR-23b,miR-25,miR-98,miR-107,miR-122a,miR-125a,miR-125b, miR-145,miR-181a,miR-181c,miR-335,miR-384-5p and miR-422a. Eight miRNA had significant changes at 24 hours after ROSC,in which miR-15a,miR-21,miR-34a,miR-497 were up-regulated respectively for 6.831±2.625,8.122±3.442,5.349±2.010,6.590±3.689 times,and miR-125b,miR-145,Let-7a,Let-7e were down-regulated respectively for 0.122±0.039,0.199±0.096,0.191±0.069,0.160±0.082 times. The apoptosis rate of cerebral cortex was increased significantly in CA-CPR group〔(32.23±5.31)%〕compared with that in normal control group〔(3.66±1.34)%〕and sham operation group〔(4.98±1.84)%,both P<0.01〕. Conclusions In early period after CA-CPR,obvious neurocyte apoptosis may be found in brain tissue of rats,and in the mean time, changes in apoptosis-related miRNA expression in cerebral cortex occur. The various types of miRNA with significant changes possibly play important roles in cerebral protection after CA-CPR in rats.
down-regulated respectively for 0.122±0.039,0.199±0.096,0.191±0.069,0.160±0.082 times. The apoptosis rate of cerebral cortex was increased significantly in CA-CPR group〔(32.23±5.31)%〕compared with that in normal control group〔(3.66±1.34)%〕and sham operation group〔(4.98±1.84)%,both P<0.01〕. Conclusions In early period after CA-CPR,obvious neurocyte apoptosis may be found in brain tissue of rats,and in the mean time, changes in apoptosis-related miRNA expression in cerebral cortex occur. The various types of miRNA with significant changes possibly play important roles in cerebral protection after CA-CPR in rats.