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*

Objective:To explore the clinical efficacy of coiling dragon needling plus chin tuck against resistance(CTAR)training for post-stroke deglutition disorders and its impact on surface electromyography.Methods:A total of 100 patients with post-stroke deglutition disorders were randomly divided into two groups,with 50 cases in each group.Both groups received the same CTAR training,and the observation group was treated with additional coiling dragon needling.Both groups were treated for 2 weeks.The clinical efficacy,swallowing function,average value of the maximum amplitude of surface electromyography,quality of life,and the difference in adverse reactions were compared between the two groups.Results:The total effective rate of the observation group was higher than that of the control group(P<0.05).After treatment,the standardized swallowing assessment(SSA),aspiration score,and deglutition disorders score of the videofluoroscopic swallowing study(VFSS)in both groups were significantly lower than those before treatment(P<0.05).The average value of the maximum amplitude of surface electromyography in the relaxed state,dry swallowing state,and the state of swallowing water,and the swallowing quality of life questionnaire(SWAL-QOL)score were all significantly higher than those before treatment in the two groups(P<0.05).After treatment,the SSA score,VFSS aspiration score,and VFSS deglutition disorders score in the observation group were lower than those in the control group(P<0.05),and the average value of the maximum amplitude of surface electromyography in the relaxed state,dry swallowing state,and the state of swallowing water,and the SWAL-QOL score in the observation group were higher than those in the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:Compared to CTAR treatment alone,coiling dragon needling plus CTAR treatment can enhance the clinical efficacy in treating patients with post-stroke deglutition disorders,enhancing the contraction ability of swallowing muscles and improving their swallowing function and quality of life.

As an independent first-level discipline,an appropriate classification of nursing science is significant.In China,each nursing degree-granting institution has developed its own secondary-level discipline directions based on its research characteristics and strengths,with varying names and research scopes.Furthermore,there is no unified global classification system.This paper,based on the characteristics of nursing as a discipline and combined with China's discipline classification principles,used literature analysis,comprehensive classification,philosophical reflection,logical reasoning,and expert consultation methods to explore the connotation of nursing,its unique research objects and scope,and to construct a secondary-level discipline classification system for nursing science that is suitable for China's national conditions.The paper also discussed the challenges faced by the nursing discipline and its future development directions,providing theoretical and practical guidance for the development of the nursing discipline.

With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.

Diterpenoid ferruginol is a key intermediate in biosynthesis of active ingredients such as tanshinone and carnosic acid.However, the traditional process of obtaining ferruginol from plants is often cumbersome and inefficient. In recent years, the increasingly developing gene editing technology has been gradually applied to the heterologous production of natural products, but the production of ferruginol in microbe is still very low, which has become an obstacle to the efficient biosynthesis of downstream chemicals, such as tanshinone. In this study, miltiradiene was produced by integrating the shortened diterpene synthase fusion protein,and the key genes in the MVA pathway were overexpressed to improve the yield of miltiradiene. Under the shake flask fermentation condition, the yield of miltiradiene reached about(113. 12±17. 4)mg·L~(-1). Subsequently, this study integrated the ferruginol synthase Sm CYP76AH1 and Sm CPR1 to reconstruct the ferruginol pathway and thereby realized the heterologous synthesis of ferruginol in Saccharomyces cerevisiae. The study selected the best ferruginol synthase(Il CYP76AH46) from different plants and optimized the expression of pathway genes through redox partner engineering to increase the yield of ferruginol. By increasing the copy number of diterpene synthase, CYP450, and CPR, the yield of ferruginol reached(370. 39± 21. 65) mg·L~(-1) in the shake flask, which was increased by 21. 57-fold compared with that when the initial ferruginol strain JMLT05 was used. Finally, 1 083. 51 mg·L~(-1) ferruginol was obtained by fed-batch fermentation, which is the highest yield of ferruginol from biosynthesis so far. This study provides not only research ideas for other metabolic engineering but also a platform for the construction of cell factories for downstream products.
Saccharomyces cerevisiae/genetics* ; Diterpenes/metabolism* ; Metabolic Engineering ; Fermentation ; Abietanes

Objective:To observe the clinical value of neutrophil to lymphocyte ratio(NLR),platelet to lymphocyte ratio(PLR),C-reactive protein(CRP)to albumin(ALB)ratio(CAR)dynamic monitoring in the acute phase of Kawasaki disease(KD).Methods:This study was a single-center prospective study,146 in the acute phase of KD patients who were admitted to The Third Affiliated Hospital of Guangdong Medical University from June 2022 to September 2024 were selected as the study subjects(KD group).Hospitalized patients with fever ≥ 3 days received during the same period(fever control group,n=146)and healthy children underwent physical examination(healthy control group,n=146)were seleted.According to the differences in response to intravenous immunoglobulin treatment,KD patients were divided into two subgroups:immunoglobulin insensitive group(n=21)and immunoglobulin sensitive group(n=125).According to the presence or absence of coronary artery injury(CAL),KD patients were divided into two subgroups:non CAL group(n=97)and CAL group(n=49).According to alanine aminotransferase(ALT)expression level,KD patients were divided into two subgroups:non liver injury group(ALT value＜80 U/L,n=110)and liver injury group(ALT value ≥ 80 U/L,n=36).NLR,PLR,and CAR of KD group,fever control group,and healthy control group were compared.NLR,PLR,and CAR were compared at admission,before and 3 d after immunoglobulin infusion between the immunoglobulin sensitive group and immunoglobulin insensitive group,liver injury group and non liver injury group,CAL group and non CAL group.Receiver operating characteristic(ROC)curve was used to evaluate diagnostic efficacy.Result:NLR,PLR,and CAR of the KD group and fever control group were higher than those of the healthy control group,and the KD group were higher than those of the fever control group(P＜0.05).NLR,PLR,and CAR of the immunoglobulin insensitive group were higher than those of the immunoglobulin sensitive group at admission,before and 3 d after immunoglobulin infusion(P＜0.05).NLR,PLR,and CAR of the liver injury group were higher than those of non liver injury group at admission,before and 3 d after immunoglobulin infusion(P＜0.05).NLR,PLR,and CAR of the CAL group were higher than those of the non CAL group at admission,before and 3 days after immunoglobulin infusion(P＜0.05).When NLR,PLR,and CAR were used alone or in combination at admission,the area under curve(AUC)(95％CI)of ROC values were 0.798(0.715～0.869),0.802(0.717～0.871),0.833(0.752～0.896),and 0.935(0.873～0.973),respectively,among them,the combination had the highest diagnostic efficacy.Conclusion:NLR,PLR,and CAR are all abnormally elevated in KD patients,and which are associated with patient immunoglobulin sensitivity,liver injury and CAL.The combination detection of the above three indicators has better diagnostic efficacy for KD.

Objective To characterize the expression patterns of serum microRNA-497(miR-497)in patients with colorectal cancer(CRC)and to investigate its associations with clinicopathological characteristics,diagnostic performance,and long-term prognostic outcomes.Methods This study retrospectively analyzed data from 122 patients with CRC admitted to the hospital between March 2020 and March 2022(CRC group),and enrolled 100 healthy individuals undergoing routine physical examinations(healthy control group)for comparison.Serum samples were collected from all participants prior to any surgical intervention,and the expression levels of miR-497 in serum were quantified using real-time quantitative polymerase chain reaction(qRT-PCR).Simulta-neously,the levels of carcinoembryonic antigen(CEA)and carbohydrate antigen 199(CA199)were measured.To investigate the association between miR-497 expression and clinicopathological characteristics,we evaluated its diagnostic performance using receiver operating characteristic(ROC)curve analysis.Furthermore,Kaplan-Meier survival analysis and Cox proportional hazards regression models were employed to assess its impact on patient prognosis.Results Compared to healthy individuals,CRC patients exhibited significantly lower serum miR-497 expression levels(P<0.001).Notably,miR-497 expression was strongly correlated with TNM stage progression and lymph node metastasis(P<0.001),but showed no significant association with tumor location,patient sex,or age.Diagnostic evaluation using ROC curves demonstrated that miR-497 achieved an AUC of 0.845 for CRC detection,outperforming CEA(AUC=0.748)and CA19-9(AUC=0.702),with DeLong's test confirming the statistically significant differences(P<0.05).Kaplan-Meier survival analysis revealed a significantly higher 3-year DFS rate among patients with high miR-497 expression(84.06%)compared to those with low expression(64.58%),with median DFS not reached in the high-expression group versus 36 months in the low-expression group(P=0.015).Multivariate Cox regression analysis confirmed that reduced miR-497 expression(HR=1.923,95%CI:1.184～3.125),advanced TNM stage(HR=2.511,95%CI:1.421～4.437),and lymph node metastasis(HR=1.753,95%CI:1.151～2.664)were independently associated with poorer disease-free survival outcomes.Conclusions Serum miR-497 is downregulated in patients with CRC and is significantly associated with tumor progression and poor prognosis.It demonstrates high diagnostic accuracy and strong potential for prognostic evalua-tion,highlighting its promise as a biomarker for auxiliary diagnosis and outcome prediction in CRC.

With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.

Objective:To observe the clinical value of neutrophil to lymphocyte ratio(NLR),platelet to lymphocyte ratio(PLR),C-reactive protein(CRP)to albumin(ALB)ratio(CAR)dynamic monitoring in the acute phase of Kawasaki disease(KD).Methods:This study was a single-center prospective study,146 in the acute phase of KD patients who were admitted to The Third Affiliated Hospital of Guangdong Medical University from June 2022 to September 2024 were selected as the study subjects(KD group).Hospitalized patients with fever ≥ 3 days received during the same period(fever control group,n=146)and healthy children underwent physical examination(healthy control group,n=146)were seleted.According to the differences in response to intravenous immunoglobulin treatment,KD patients were divided into two subgroups:immunoglobulin insensitive group(n=21)and immunoglobulin sensitive group(n=125).According to the presence or absence of coronary artery injury(CAL),KD patients were divided into two subgroups:non CAL group(n=97)and CAL group(n=49).According to alanine aminotransferase(ALT)expression level,KD patients were divided into two subgroups:non liver injury group(ALT value＜80 U/L,n=110)and liver injury group(ALT value ≥ 80 U/L,n=36).NLR,PLR,and CAR of KD group,fever control group,and healthy control group were compared.NLR,PLR,and CAR were compared at admission,before and 3 d after immunoglobulin infusion between the immunoglobulin sensitive group and immunoglobulin insensitive group,liver injury group and non liver injury group,CAL group and non CAL group.Receiver operating characteristic(ROC)curve was used to evaluate diagnostic efficacy.Result:NLR,PLR,and CAR of the KD group and fever control group were higher than those of the healthy control group,and the KD group were higher than those of the fever control group(P＜0.05).NLR,PLR,and CAR of the immunoglobulin insensitive group were higher than those of the immunoglobulin sensitive group at admission,before and 3 d after immunoglobulin infusion(P＜0.05).NLR,PLR,and CAR of the liver injury group were higher than those of non liver injury group at admission,before and 3 d after immunoglobulin infusion(P＜0.05).NLR,PLR,and CAR of the CAL group were higher than those of the non CAL group at admission,before and 3 days after immunoglobulin infusion(P＜0.05).When NLR,PLR,and CAR were used alone or in combination at admission,the area under curve(AUC)(95％CI)of ROC values were 0.798(0.715～0.869),0.802(0.717～0.871),0.833(0.752～0.896),and 0.935(0.873～0.973),respectively,among them,the combination had the highest diagnostic efficacy.Conclusion:NLR,PLR,and CAR are all abnormally elevated in KD patients,and which are associated with patient immunoglobulin sensitivity,liver injury and CAL.The combination detection of the above three indicators has better diagnostic efficacy for KD.

Objective To characterize the expression patterns of serum microRNA-497(miR-497)in patients with colorectal cancer(CRC)and to investigate its associations with clinicopathological characteristics,diagnostic performance,and long-term prognostic outcomes.Methods This study retrospectively analyzed data from 122 patients with CRC admitted to the hospital between March 2020 and March 2022(CRC group),and enrolled 100 healthy individuals undergoing routine physical examinations(healthy control group)for comparison.Serum samples were collected from all participants prior to any surgical intervention,and the expression levels of miR-497 in serum were quantified using real-time quantitative polymerase chain reaction(qRT-PCR).Simulta-neously,the levels of carcinoembryonic antigen(CEA)and carbohydrate antigen 199(CA199)were measured.To investigate the association between miR-497 expression and clinicopathological characteristics,we evaluated its diagnostic performance using receiver operating characteristic(ROC)curve analysis.Furthermore,Kaplan-Meier survival analysis and Cox proportional hazards regression models were employed to assess its impact on patient prognosis.Results Compared to healthy individuals,CRC patients exhibited significantly lower serum miR-497 expression levels(P<0.001).Notably,miR-497 expression was strongly correlated with TNM stage progression and lymph node metastasis(P<0.001),but showed no significant association with tumor location,patient sex,or age.Diagnostic evaluation using ROC curves demonstrated that miR-497 achieved an AUC of 0.845 for CRC detection,outperforming CEA(AUC=0.748)and CA19-9(AUC=0.702),with DeLong's test confirming the statistically significant differences(P<0.05).Kaplan-Meier survival analysis revealed a significantly higher 3-year DFS rate among patients with high miR-497 expression(84.06%)compared to those with low expression(64.58%),with median DFS not reached in the high-expression group versus 36 months in the low-expression group(P=0.015).Multivariate Cox regression analysis confirmed that reduced miR-497 expression(HR=1.923,95%CI:1.184～3.125),advanced TNM stage(HR=2.511,95%CI:1.421～4.437),and lymph node metastasis(HR=1.753,95%CI:1.151～2.664)were independently associated with poorer disease-free survival outcomes.Conclusions Serum miR-497 is downregulated in patients with CRC and is significantly associated with tumor progression and poor prognosis.It demonstrates high diagnostic accuracy and strong potential for prognostic evalua-tion,highlighting its promise as a biomarker for auxiliary diagnosis and outcome prediction in CRC.