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

Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards* ; Humans ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Surveys and Questionnaires

Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans ; China ; Drugs, Chinese Herbal/standards* ; History, 20th Century ; History, 21st Century ; Medicine, Chinese Traditional/trends*

In this study, lipopolysaccharide(LPS), ovalbumin(OVA), and compound 48/80(C48/80) were administered to establish non-infectious pneumonia models under simulated clinical conditions, and the correlation between their pathological characteristics and traditional Chinese medicine(TCM) syndromes was compared, providing the basis for the selection of appropriate animal models for TCM efficacy evaluation. An acute pneumonia model was established by nasal instillation of LPS combined with intraperitoneal injection for intensive stimulation. Three doses of OVA mixed with aluminum hydroxide adjuvant were injected intraperitoneally on days one, three, and five and OVA was administered via endotracheal drip for excitation on days 14-18 to establish an OVA-induced allergic pneumonia model. A single intravenous injection of three doses of C48/80 was adopted to establish a C48/80-induced pneumonia model. By detecting the changes in peripheral blood leukocyte classification, lung tissue and plasma cytokines, immunoglobulins(Ig), histamine levels, and arachidonic acid metabolites, the multi-dimensional analysis was carried out based on pathological evaluation. The results showed that the three models could cause pulmonary edema, increased wet weight in the lung, and obvious exudative inflammation in lung tissue pathology, especially for LPS. A number of pyrogenic cytokines, inclading interleukin(IL)-6, interferon(IFN)-γ, IL-1β, and IL-4 were significantly elevated in the LPS pneumonia model. Significantly increased levels of prostacyclin analogs such as prostaglandin E2(PGE2) and PGD2, which cause increased vascular permeability, and neutrophils in peripheral blood were significantly elevated. The model could partly reflect the clinical characteristics of phlegm heat accumulating in the lung or dampness toxin obstructing the lung. The OVA model showed that the sensitization mediators IgE and leukotriene E4(LTE4) were increased, and the anti-inflammatory prostacyclin 6-keto-PGF2α was decreased. Immune cells(lymphocytes and monocytes) were decreased, and inflammatory cells(neutrophils and basophils) were increased, reflecting the characteristics of "deficiency", "phlegm", or "dampness". Lymphocytes, monocytes, and basophils were significantly increased in the C48/80 model. The phenotype of the model was that the content of histamine, a large number of prostacyclins(6-keto-PGE1, PGF2α, 15-keto-PGF2α, 6-keto-PGF1α, 13,14-D-15-keto-PGE2, PGD2, PGE2, and PGH2), LTE4, and 5-hydroxyeicosatetraenoic acid(5S-HETE) was significantly increased, and these indicators were associated with vascular expansion and increased vascular permeability. The pyrogenic inflammatory cytokines were not increased. The C48/80 model reflected the characteristics of cold and damp accumulation. In the study, three non-infectious pneumonia models were constructed. The LPS model exhibited neutrophil infiltration and elevated inflammatory factors, which was suitable for the efficacy study of TCM for clearing heat, detoxifying, removing dampness, and eliminating phlegm. The OVA model, which took allergic inflammation as an index, was suitable for the efficacy study of Yiqi Gubiao formulas. The C48/80 model exhibited increased vasoactive substances(histamine, PGs, and LTE4), which was suitable for the efficacy study and evaluation of TCM for warming the lung, dispersing cold, drying dampness, and resolving phlegm. The study provides a theoretical basis for model selection for the efficacy evaluation of TCM in the treatment of pneumonia.
Animals ; Disease Models, Animal ; Mice ; Pneumonia/genetics* ; Medicine, Chinese Traditional ; Male ; Humans ; Cytokines/immunology* ; Female ; Lipopolysaccharides/adverse effects* ; Lung/drug effects* ; Drugs, Chinese Herbal ; Ovalbumin ; Mice, Inbred BALB C

Objective:To formulate a community teacher standard for the training of general practitioner program (direction in hospice care).Methods:This was a qualitative study. Twenty-nine experts in general practice and hospice care from various teaching hospitals and community health service centers were invited to participate in two rounds of Delphi consultation from April to August 2022. Based on the results of the consultation, a standard for community faculty training in comprehensive care and end-of-life care for general practitioners was formulated, and the weight coefficients of the indicators were calculated.Results:Of the 29 experts, 11 (37.9%) were male, their age was (52.9±8.9) years, and their working life was (17.0±7.2) years. In the two rounds of expert consultation, the expert positive coefficient was 100.0% (29/29) and 96.6% (28/29), the expert authority coefficient was 0.789 and 0.851, and the expert opinion coordination coefficient W of the importance of all indicators was 0.124 and 0.131, respectively ( χ2=123.01, 131.71, P<0.05). Finally, a set of community-based teacher standard for general practitioner specialty training (direction in hospice care) was established, which consisted of 4 first-level indicators and 30 second-level indicators. The four first-level indicators were basic literacy, clinical qualification and ability, teaching qualification and ability, and scientific research ability, all with the weight coefficients of 0.254, 0.254, 0.252 and 0.240, respectively. Conclusion:The standard of teachers in the community base of general practitioner specialty training (direction in hospice care) established in this study is more scientific, which is conducive to the comprehensive evaluation of teachers in the community training base.

Objective:To develop accreditation standards for clinical faculty in general practitioner specialized training of hospice care.Methods:This was a qualitative study. Twenty nine experts in fields of general practice and hospice care were invited for two rounds of Delphi consultation from April 2022 to August 2022. Based on the consultation results, the accreditation standards for clinical faculty in general practitioner training bases of hospice care specialty was preliminarily developed.Results:The mean age of the consulting experts was (52.9±8.9) years with a mean working year of (17.0±7.2), and 69.0% (20/29) of them held senior professional titles. In the two rounds of consultation, the expert positive coefficient was 100.0% (29/29) and 96.6% (28/29), the expert authority coefficient was 0.765 and 0.813, and the expert opinion coordination coefficient W for the importance of all indicators was 0.112 and 0.196, respectively. The expert opinions tended to be consistent. Finally, a set of clinical base faculty standards for general specialty training was developed, which consisted of 4 first-level indicators and 24 second-level indicators. The 4 first-level indicators were basic literacy, clinical qualification and ability, teaching qualification and ability, scientific research ability, with the weight coefficients of 0.253, 0.255, 0.254 and 0.241, respectively. Conclusion:The standards for clinical teaching faculty in general practitioner specialty training base of hospice care has been established in this study, which is conducive to the comprehensive quality evaluation for training faculty.

Objective:The greater tuberosity angle(GTA)and critical shoulder angle(CSA)are commonly referred to as radiographic markers which were used to described morphology of the greater tu-berosity and acromion respectively.At present,most international studies focus on the correlation be-tween the above two parameters and rotator cuff tears(RCTs),and their diagnostic value and risk assess-ment.This study attempts to find out the trend of GTA and CSA changes and risk threshold of RCTs,as well as the protective factors and risk factors.Methods:In this study,130 individuals from May 2019 to December 2020 were recruited.According to Southern California Orthopedic Institute(SCOI)classifica-tion,the individuals were divided into four groups retrospectively:Group A,negative control group;Group B,partial tears(articular side);Group C,partial tears(bursal side);Group D,full-thickness tears.GTA and CSA were measured respectively on true anteroposterior position X-ray of shoulder with arm in neutral rotation and performed by the same trained technician team in single-blind.The correla-tions between RCTs and relevant factors were analyzed.Results:According to the area under the receiver operating characteristic curve(AUC),GTA and CSA of RCTs(Groups B,C and D)were 0.736 and 0.673 with 95％confidence interval(CI),the cut-off value of GTA and CSA of RCTs were 70.5° and 39.5° respectively.Comparing with the control group,RCTs groups had significant statistical differences in age and body mass index(BMI)(P＜0.05),especially the full-thickness RCTs(Group D),which was older than Groups A,B and C(P＜0.05,cut-off value:56.5 years old)and shorter than Groups A and B(P＜0.05,cut-off value:1.58 m).Analyzed from scatter plot and regression analysis,there was no linear correlation between GTA and CSA.There were no significant differences in gender,dominant shoulders and smoking between the RCTs groups and the control group(P＞0.05).Conclusion:Larger GTA(＞70.5°)and CSA(＞39.5°)would be highly predictive in diagnosing RCTs without linear cor-relation,and GTA has a higher diagnostic value in contrast.Subacromial impingement and shoulder de-generation occurred before RCTs.Patients with age＞56.5 years and height＜1.58 m were more likely to develop disease of full-thickness RCTs and no statistic differences in weight and BMI.Gender,domi-nant shoulder and smoking were neither risk factors nor protective factors.

Aim To explore the mechanism of the syn-ergistic effect of the ferroptosis inducer erastin com-bined with shikonin in promoting ferroptosis in human hypertrophic scar fibroblasts(HSFBs).Methods Hypertrophic scar tissues provided by the General Hos-pital of Ningxia Medical University were collected,and HSFBs were extracted.HSFBs were identified by HE staining and immunofluorescence.The inhibitory rates of Era and SHK on HSFBs at different concentrations were detected by CCK-8 assay,and the IC50 value was calculated.CompuSyn software was used to calculate the co-use index(CI).Control group,Erastin(Era)group,shikonin(SHK)group and Era+SHK group were set up,and the number and morphological chan-ges of cells were observed after 24 hours of interven-tion.The ability of cell migration and invasion was de-tected by scratch test and Transwell test.The changes of malondialdehyde(MDA),total iron ion and reactive oxygen species(ROS)were detected by corresponding biochemical kits.The expressions of collagen I,α-SMA and GOT1,SLC7A11,GPX4 and FTH1 were detected by Western blot.Results The IC50 value of Era and SHK of primary HSFBs was 2.22 μmol·L-1 and 3.94μmol·L-1 respectively,which was used as the single drug concentration for subsequent experiments.The CompuSyn software was employed to calculate the CI value when the two drugs were used in combination,and the concentrations corresponding to CI=0.39597(Era:1.2 μmol·L-1+SHK:1.5 μmol·L-1)were selected as subsequent combination concentrations(Because when CI was equal to 0.395 97,the concen-tration of each drug was lower than the concentration of single drug,and the inhibition rate of combined drug was greater than 50％).Compared with the monother-apy group,the number of HSFBs in the SHK+Era group was significantly reduced,cell membrane showed breakage and vesiculation,cell wrinkling became smal-ler,and cytoplasm was concentrated.The migration and invasion ability of HSFBs in the SHK+Era group were obviously weakened(P＜0.05),and the expres-sion of fibrosis-related proteins collagen Ⅰ and α-SMA was reduced(P＜0.05);the contents of MDA,total i-ron ions,and ROS in HSFBs of the SHK+Era group increased(P＜0.05),and the protein expression lev-els of SLC7A11,GOT1,GPX4,and FTH1 further de-creased(P＜0.05).Conclusions Erastin in combi-nation with shikonin can synergistically inhibit the pro-liferation,migration and fibrosis levels of HSFBs.The mechanism may be that erastin enhances the inhibition of shikotin on GOT1,increases the levels of cellular i-ron ions,ROS,and lipid peroxides,thereby promoting ferroptosis in HSFBs.

Objective:To observe the effect of Ba Duan Jin combined with Du Mai fumigation on improving sleep quality and negative emotions in perimenopausal insomnia patients.Methods:This study was a single-center prospective randomized controlled trial,80 perimenopausal insomnia patients who were admitted to Zhuzhou Maternal and Child Health Hospital from December 2023 to August 2024 were selected.Patients were randomly divided into control group(treated with Du Mai fumigation)and study group(treated with Ba Duan Jin combined with Du Mai fumigation)used random number table method,with 40 cases in each group.The clinical efficacy,sleep quality[Pittsburgh Sleep Quality Index(PSQI)],negative emotions[Self Rating Anxiety Scale(SAS),Self Rating Depression Scale(SDS)],clinical symptoms(Kupperman score),improvement in quality of life[the short form-36 health survey(SF-36)Score],and incidence of adverse reactions between two groups were compared before and after treatment.Results:The clinical total efficiency rate in the study group was higher than that in the control group(P＜0.05).2 weeks and 4 weeks after treatment,PSQI,SAS,SDS and Kupperman scores in the study group were lower than those in the control group,and SF-36 score was higher than that in the control group(P＜0.05).Neither group showed significant adverse reactions.Conclusion:Ba Duan Jin combined with Du Mai fumigation on improving sleep quality and negative emotions in perimenopausal insomnia patients,can effectively improve sleep quality,alleviate negative emotions,and enhance quality of life,without any significant adverse reactions.