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*

Aim To investigate the potential role and related mechanisms of protein phosphatase 2Cm(PP2Cm)overexpression in atorvastatin-induced insu-lin resistance.Methods Male C57BL/6J mice,fibro-blast growth factor 21 knockout(FGF21-KO)mice,and wildtype(WT)mice were raised for 12 weeks to construct models.Groups included atorvastatin,con-trol,atorvastatin+PP2Cm overexpression(OE),FGF21-KO+vehicle,FGF21-KO+PP2Cm OE,WT+vehicle,WT+PP2Cm OE.Body weight,fasting blood glucose levels,fasting insulin levels,and intraperitoneal glucose tolerance tests(IPGTT)were measured in 4,8 and 12 weeks.The concentrations of branched-chain a-mino acids(BCAA)in cells,tissues and serum,as well as the mRNA and protein expression of BCAA cat-abolic enzymes,were determined by qRT-PCR,Western blot and ELISA after atorvastatin treatment.Further-more,the effects of PP2Cm overexpression on these in-dicators were explored,and the FGF21 was verified in vivo and in vitro.Results Atorvastatin induced insu-lin resistance in mice,altered insulin,glucose tolerance and increased BCAA levels.PP2Cm overexpression mitigated these changes.In the Atorvastatin+PP2Cm OE group,FGF21 mRNA,protein and concentration were all significantly upregulated.Regardless of PP2Cm overexpression,the knockout of FGF21 signifi-cantly increased BCAA expression levels,both fasting insulin and blood glucose levels were significantly high-er than those in WT group.Conclusions FGF21 may be an important regulator of PP2Cm involved in atorv-astatin-induced insulin resistance.PP2Cm overexpres-sion alleviates the effects of atorvastatin-induced insulin resistance by regulating FGF21.

This article summarizes the rapid rehabilitation nursing experience for one pediatric pa-tient with pancreatic divisum who underwent en bloc pancreatoduodenectomy preserving the duodenum,common bile duct,and Oddi's sphincter(DCOPPHTR).The nursing care encompassed preoperative prehabilitation to enhance physical and psychological preparation,postoperative precise volume and dynamic blood glucose management,early mobilization to facilitate recovery,personalized nutritional support to improve nutritional status,psychological nursing to bolster confidence,and family involve-ment to enhance quality of life.The pediatric patient experienced rapid recovery and was discharged from the hospital.A six-month follow-up indicated a significant improvement in quality of life.

Objective:To investigate the association between serum IgG concentration and renal prognosis in patients with IgA nephropathy (IgAN).Methods:It was a multi-center retrospective cohort study, patients with biopsy proven primary IgAN who were recorded in the Chinese IgA Nephropathy Information Registration System between April 1996 and September 2018 were included. Exclusion criteria were: (1) age <18 years; (2) <8 glomeruli in biopsy specimens; (3) estimated glomerular filtration rate (eGFR) <15 ml·min -1·(1.73 m 2) -1 at biopsy; (4) missing baseline serum IgG values; (5) incomplete follow-up data; (6) follow-up duration <12 months. Enrolled patients were divided into 3 groups according to the baseline tertiles of serum IgG: ≤9.50 g/L (G1 group), 9.51-11.99 g/L (G2 group), and ≥12.00 g/L (G3 group). Clinical, and pathological parameters were compared across groups. The endpoint events were defined as doubled serum creatinine level from baseline, or end-stage renal disease (ESRD). Results:A total of 1 976 IgAN patients were included in this study, 631 were in G1 group, 664 in G2 group, and 681 in G3 group. The comparison of baseline clinical data showed that there were statistically significant differences among the three groups in terms of gender, age, microscopic hematuria, edema, body mass index, systolic blood pressure, diastolic blood pressure, hemoglobin, serum creatinine, eGFR, 24-hour urine protein quantity, blood uric acid, blood albumin, serum IgA, serum IgM, the proportion of using immunosuppressants, and the proportion of using glucocorticoids (all P<0.05). In terms of pathology, the higher the serum IgG concentration, the relatively less severe the overall renal pathological damage. The results of univariate Cox regression analysis showed that gender, systolic blood pressure, diastolic blood pressure, hemoglobin, serum creatinine, eGFR, 24-hour urine protein quantity, total protein, serum albumin, globulin, serum IgG, Oxford renal pathological classification, glomerular sclerosis ratio, and glomerular IgM deposition were all associated with the occurrence of renal endpoint events (all P<0.05). Based on clinical practice and previous studies, after adjusting for gender, age, systolic blood pressure, diastolic blood pressure, eGFR, 24-hour urine protein quantity, body mass index, Oxford renal pathological classification, glomerular sclerosis ratio, and the use of renin-angiotensin-aldosterone system inhibitors, glucocorticoids, and immunosuppressants, multivariate Cox regression analysis showed that as a continuous variable, the baseline serum IgG level ( HR=0.91, 95% CI 0.87-0.96) was independently associated with the risk of renal endpoint events in IgAN patients; as a categorical variable, with serum IgG ≤ 9.50 g/L as the reference, serum IgG 9.51-11.99 g/L and serum IgG ≥ 12.00 g/L were independent factors for the occurrence of renal endpoint events in IgAN patients ( HR=0.69, 95% CI 0.49-0.96, P=0.027; HR=0.50, 95% CI 0.34-0.74, P<0.001). During a median follow-up of 33(21, 53) months started from the date of renal biopsy and continued until December 31, 2019, the median follow-up duration was 33 (21, 53) months, and a total of 232 patients (11.74%) reached the composite endpoint. Kaplan-Meier survival analysis showed that the higher the serum IgG concentration in patients with IgAN, the higher their cumulative renal survival rate (Log-rank test, χ2=47.176, P<0.001). Conclusion:The higher level of serum IgG at diagnosis is associated with better clinicopathologic features and renal outcomes, and may portend better renal survival in IgAN patients.

Aim To investigate the potential role and related mechanisms of protein phosphatase 2Cm(PP2Cm)overexpression in atorvastatin-induced insu-lin resistance.Methods Male C57BL/6J mice,fibro-blast growth factor 21 knockout(FGF21-KO)mice,and wildtype(WT)mice were raised for 12 weeks to construct models.Groups included atorvastatin,con-trol,atorvastatin+PP2Cm overexpression(OE),FGF21-KO+vehicle,FGF21-KO+PP2Cm OE,WT+vehicle,WT+PP2Cm OE.Body weight,fasting blood glucose levels,fasting insulin levels,and intraperitoneal glucose tolerance tests(IPGTT)were measured in 4,8 and 12 weeks.The concentrations of branched-chain a-mino acids(BCAA)in cells,tissues and serum,as well as the mRNA and protein expression of BCAA cat-abolic enzymes,were determined by qRT-PCR,Western blot and ELISA after atorvastatin treatment.Further-more,the effects of PP2Cm overexpression on these in-dicators were explored,and the FGF21 was verified in vivo and in vitro.Results Atorvastatin induced insu-lin resistance in mice,altered insulin,glucose tolerance and increased BCAA levels.PP2Cm overexpression mitigated these changes.In the Atorvastatin+PP2Cm OE group,FGF21 mRNA,protein and concentration were all significantly upregulated.Regardless of PP2Cm overexpression,the knockout of FGF21 signifi-cantly increased BCAA expression levels,both fasting insulin and blood glucose levels were significantly high-er than those in WT group.Conclusions FGF21 may be an important regulator of PP2Cm involved in atorv-astatin-induced insulin resistance.PP2Cm overexpres-sion alleviates the effects of atorvastatin-induced insulin resistance by regulating FGF21.

Objective:To investigate the association between serum IgG concentration and renal prognosis in patients with IgA nephropathy (IgAN).Methods:It was a multi-center retrospective cohort study, patients with biopsy proven primary IgAN who were recorded in the Chinese IgA Nephropathy Information Registration System between April 1996 and September 2018 were included. Exclusion criteria were: (1) age <18 years; (2) <8 glomeruli in biopsy specimens; (3) estimated glomerular filtration rate (eGFR) <15 ml·min -1·(1.73 m 2) -1 at biopsy; (4) missing baseline serum IgG values; (5) incomplete follow-up data; (6) follow-up duration <12 months. Enrolled patients were divided into 3 groups according to the baseline tertiles of serum IgG: ≤9.50 g/L (G1 group), 9.51-11.99 g/L (G2 group), and ≥12.00 g/L (G3 group). Clinical, and pathological parameters were compared across groups. The endpoint events were defined as doubled serum creatinine level from baseline, or end-stage renal disease (ESRD). Results:A total of 1 976 IgAN patients were included in this study, 631 were in G1 group, 664 in G2 group, and 681 in G3 group. The comparison of baseline clinical data showed that there were statistically significant differences among the three groups in terms of gender, age, microscopic hematuria, edema, body mass index, systolic blood pressure, diastolic blood pressure, hemoglobin, serum creatinine, eGFR, 24-hour urine protein quantity, blood uric acid, blood albumin, serum IgA, serum IgM, the proportion of using immunosuppressants, and the proportion of using glucocorticoids (all P<0.05). In terms of pathology, the higher the serum IgG concentration, the relatively less severe the overall renal pathological damage. The results of univariate Cox regression analysis showed that gender, systolic blood pressure, diastolic blood pressure, hemoglobin, serum creatinine, eGFR, 24-hour urine protein quantity, total protein, serum albumin, globulin, serum IgG, Oxford renal pathological classification, glomerular sclerosis ratio, and glomerular IgM deposition were all associated with the occurrence of renal endpoint events (all P<0.05). Based on clinical practice and previous studies, after adjusting for gender, age, systolic blood pressure, diastolic blood pressure, eGFR, 24-hour urine protein quantity, body mass index, Oxford renal pathological classification, glomerular sclerosis ratio, and the use of renin-angiotensin-aldosterone system inhibitors, glucocorticoids, and immunosuppressants, multivariate Cox regression analysis showed that as a continuous variable, the baseline serum IgG level ( HR=0.91, 95% CI 0.87-0.96) was independently associated with the risk of renal endpoint events in IgAN patients; as a categorical variable, with serum IgG ≤ 9.50 g/L as the reference, serum IgG 9.51-11.99 g/L and serum IgG ≥ 12.00 g/L were independent factors for the occurrence of renal endpoint events in IgAN patients ( HR=0.69, 95% CI 0.49-0.96, P=0.027; HR=0.50, 95% CI 0.34-0.74, P<0.001). During a median follow-up of 33(21, 53) months started from the date of renal biopsy and continued until December 31, 2019, the median follow-up duration was 33 (21, 53) months, and a total of 232 patients (11.74%) reached the composite endpoint. Kaplan-Meier survival analysis showed that the higher the serum IgG concentration in patients with IgAN, the higher their cumulative renal survival rate (Log-rank test, χ2=47.176, P<0.001). Conclusion:The higher level of serum IgG at diagnosis is associated with better clinicopathologic features and renal outcomes, and may portend better renal survival in IgAN patients.

Objective To screen long non-coding RNA(lncRNA)associated with disulfidptosis and investigate the immune landscape between lncRNA and pancreatic cancer,for effective guidance in clinical practice.Methods The normal and pancreatic cancer tissue samples were obtained from The Cancer Genome Atlas database,and the lncRNA associated with disulfidptosis was identified based on the Cox and LASSO regression analyses.A risk prognosis model was constructed,and its predictive performance was verified using comprehensive methods.An accurate nomogram was construted to predict the prognosis of patients with pancreatic cancer.The biological differences were analyzed via Gene Ontology,Gene Set Enrichment Analysis,and an immunoassay.The immunotherapy response was estimated using the tumor mutational burden(TMB)score.Results A total of 251 disulfidptosis-related lncRNAs were successfully identified,and three groups of lncRNAs were selected as the reference for the risk model.Pathway analysis showed that immune-related pathways were associated with disulfidptosis-related lncRNA risk models.The risk score was significantly correlated with immune cell infiltration and the ESTIMATE score.Patients with higher risk scores had elevated TMB,indicating that high-risk patients exhibited a better immune checkpoint blockade response.Conclusion The findings of this study contribute to a deeper understanding of disulfidpto-sis-related lncRNA and provide a potential therapeutic strategy for pancreatic cancer.

Objective To verify the stability and accuracy of the made-in-China Quick TargSeq Fully Integrated Automated On-site Rapid DNA Detection Instrument(hereinafter referred to as Quick Targ-Seq DNA detection instrument)and evaluate its forensic application prospects.Methods A total of 74 blind samples provided by the expert group of Criminal Investigation Bureau of the Ministry of Public Security(4 individuals,20 samples)and five participating institutions(54 samples)were used to test on 5 Quick TargSeq DNA detection instruments and the accompanying microfluidic chip cartridges.The results were compared with the known genotypes to calculate the samples'detection rate and genotyping accuracy.Results The results of reproducibility obtained from 20 samples provided by the expert group on the 5 Quick TargSeq DNA detection instruments were all consistent with the known genotypes.The detection rate of the 74 samples was 100%,and the genotyping accuracy was 97.33%.Conclusion The Quick TargSeq DNA detection instrument has good stability and high genotyping accu-racy.

Female ; Humans ; Breast Neoplasms ; Testosterone ; Prolactin ; Estradiol ; Testosterone Congeners ; China

Objective This study aimed to investigate the potential relationship between urinary metals copper (Cu), arsenic (As), strontium (Sr), barium (Ba), iron (Fe), lead (Pb) and manganese (Mn) and grip strength. Methods We used linear regression models, quantile g-computation and Bayesian kernel machine regression (BKMR) to assess the relationship between metals and grip strength.Results In the multimetal linear regression, Cu (β=-2.119), As (β=-1.318), Sr (β=-2.480), Ba (β=0.781), Fe (β= 1.130) and Mn (β=-0.404) were significantly correlated with grip strength (P < 0.05). The results of the quantile g-computation showed that the risk of occurrence of grip strength reduction was -1.007 (95％ confidence interval:-1.362, -0.652; P < 0.001) when each quartile of the mixture of the seven metals was increased. Bayesian kernel function regression model analysis showed that mixtures of the seven metals had a negative overall effect on grip strength, with Cu, As and Sr being negatively associated with grip strength levels. In the total population, potential interactions were observed between As and Mn and between Cu and Mn (Pinteractions of 0.003 and 0.018, respectively).Conclusion In summary, this study suggests that combined exposure to metal mixtures is negatively associated with grip strength. Cu, Sr and As were negatively correlated with grip strength levels, and there were potential interactions between As and Mn and between Cu and Mn.