At present, the cause of traditional Chinese medicine(TCM) in China has entered a new period of high-quality development. How to strengthen the foundation for the TCM industry from the source is an important issue that deserves the attention of the authorities, industry, and academia. This study systematically analyzed the regulatory system of TCM raw materials and preparations. The study took the TCM industry chain and the product life cycle as a clue and focused on the dimensions of TCM resource protection and plant cultivation(farming), production and quality supervision of TCM raw materials and preparations, and their market access and distribution. It analyzed the current situation of the regulation of TCM raw materials and preparations under the regulatory system of drugs, discussed the main problems, and put forward corresponding suggestions. The results can provide an important reference value for the subsequent improvement of the regulatory system of drugs and the construction of a prominent regulatory system of drugs in accordance with TCM characteristics.
Drugs, Chinese Herbal/economics* ; Medicine, Chinese Traditional/standards* ; China ; Quality Control ; Humans ; Plants, Medicinal/chemistry*

Objective To investigate the causal relationship between hyperthyroidism and systemic lu-pus erythematosus(SLE).Methods According to the current summary data of genome-wide association studies(GWAS),the screened single nucleotide polymorphism(SNP)was selected as the instrumental varia-bles,hyperthyroidism served as the exposure factor and SLE as the outcome variable,and the Mendelian ran-domization analysis(MR)analysis method was used for conducting the study.Among them,the inverse vari-ance weighting(IVW)was the main MR analysis method,the MR-Egger regression method was used to the test for horizontal pleiotropy,and the sensitivity adopted the leave-one-method test,and the MR results con-ducted the visualized analysis by scatter plot,forest plot and funnel plot.Results Ten valid SNP were screened.In the MR analysis,IVW supported a causal relationship between hyperthyroidism and SLE(OR=1.838,95%CI:1.302-2.593,P<0.001);the MR-egger regression method supported the relationship be-tween hyperthyroidism and SLE(OR=4.070,95%CI:1.961-8.449,P=0.003);in addition,the weighted median method also supported the relationship between hyperthyroidism and SLE(OR=1.685,95%CI:1.238-2.294,P<0.001).Conclusion There appears to be a causal relationship between hyperthyroidism and SLE.

Objective To explore the risk factors of early hypocalcemia after endoscopic thyroidectomy by breast approach(ETBA)and establish a predictive model to evaluate its occurrence risk.Methods A total of 155 patients with thyroid nodules who underwent ETBA were selected.Patients were divided into the low calcium group(＜2 mmol/L,n=41)and the normal group(≥2 mmol/L,n=114)according to the serum calcium level 24 hours after the operation.Before the operation,thyroid function and parathyroid hormone(PTH)were detected,and ultrasound was performed to evaluate cervical lymph node enlargement.Meanwhile,nodule location,maximum tumor diameter,nodule adhesion to the capsule,calcification and the edge of the nodule were also detected.The surgical conditions such as gland resection(unilateral or bilateral),operation time and misresection of parathyroid glands were recorded.PTH and serum calcium were detected 24 hours after the operation.Pathological assessment was used to evaluate benign and malignant conditions,Hashimoto's thyroiditis,multifocal lesions,thyroid capsule invasion and lymph node metastasis.Results Compared with the normal group,the cervical lymph node metastasis,malignant nodules,multifocal lesions,cervical lymph node enlargement,bilateral gland resection,parathyroid gland resection by mistake,combined Hashimoto's thyroiditis,maximum tumor diameter and operation time were increased in the hypocalcemia group,but PTH at 24 hours after the operation was decreased(P＜0.05).Multivariate Logistic regression analysis showed that cervical lymph node metastasis,long operation time,parathyroid resection by mistake,combined Hashimoto's thyroiditis and maximum tumor diameter were independent risk factors for early hypocalcemia in ETBA.Based on this,a visual nomogram model was constructed,with excellent discrimination[the area under the receiver operating characteristic(ROC)curve was 0.920(95%CI:0.834-0.971)],and the calibration curve showed that the predicted values were highly consistent with the measured values(Hosmer-Lemeshow χ2=0.007,P=0.087).Conclusion The nomogram model constructed based on multivariate Logistic regression can effectively predict the risk of early hypocalcemia after ETBA.

Objective To explore the risk factors of early hypocalcemia after endoscopic thyroidectomy by breast approach(ETBA)and establish a predictive model to evaluate its occurrence risk.Methods A total of 155 patients with thyroid nodules who underwent ETBA were selected.Patients were divided into the low calcium group(＜2 mmol/L,n=41)and the normal group(≥2 mmol/L,n=114)according to the serum calcium level 24 hours after the operation.Before the operation,thyroid function and parathyroid hormone(PTH)were detected,and ultrasound was performed to evaluate cervical lymph node enlargement.Meanwhile,nodule location,maximum tumor diameter,nodule adhesion to the capsule,calcification and the edge of the nodule were also detected.The surgical conditions such as gland resection(unilateral or bilateral),operation time and misresection of parathyroid glands were recorded.PTH and serum calcium were detected 24 hours after the operation.Pathological assessment was used to evaluate benign and malignant conditions,Hashimoto's thyroiditis,multifocal lesions,thyroid capsule invasion and lymph node metastasis.Results Compared with the normal group,the cervical lymph node metastasis,malignant nodules,multifocal lesions,cervical lymph node enlargement,bilateral gland resection,parathyroid gland resection by mistake,combined Hashimoto's thyroiditis,maximum tumor diameter and operation time were increased in the hypocalcemia group,but PTH at 24 hours after the operation was decreased(P＜0.05).Multivariate Logistic regression analysis showed that cervical lymph node metastasis,long operation time,parathyroid resection by mistake,combined Hashimoto's thyroiditis and maximum tumor diameter were independent risk factors for early hypocalcemia in ETBA.Based on this,a visual nomogram model was constructed,with excellent discrimination[the area under the receiver operating characteristic(ROC)curve was 0.920(95%CI:0.834-0.971)],and the calibration curve showed that the predicted values were highly consistent with the measured values(Hosmer-Lemeshow χ2=0.007,P=0.087).Conclusion The nomogram model constructed based on multivariate Logistic regression can effectively predict the risk of early hypocalcemia after ETBA.

OBJECTIVE To evaluate the clinical value of anlotinib in third-line treatment for patients with advanced non-small cell lung cancer(NSCLC)through real-world data.METHODS Clinical data of patients with advanced NSCLC who received treatment at the First Affiliated Hospital of Anhui University of Chinese Medicine from February 2021 to December 2024 were retrospectively collected.They were divided into anlotinib group(27 cases,receiving anlotinib therapy)and immunotherapy group(22 cases,receiving immunotherapy agents alone or in combination with chemotherapy drugs)according to treatment regimens.The progression-free survival(PFS)and overall survival(OS)of patients were compared between the two groups,and the occurrence of adverse drug reactions during the treatment period was recorded.Using a partitioned survival model,an economic evaluation of the two treatment regimens was conducted with a cost-utility analysis approach from the perspective of the healthcare system.RESULTS The median PFS and OS of patients in the anlotinib group were 5.93 months and 11.27 months,respectively;the median PFS and OS of patients in the immunotherapy group were 5.33 months and 9.77 months,respectively;the difference was not statistically significant(P＞0.05).There was no statistical difference in the total incidence of adverse drug reactions and grade 3-4 serious adverse drug reactions between the two groups(P＞0.05).Compared with the immunotherapy group,the incremental cost-effectiveness ratio of the anlotinib group was 1 806 724.60 yuan/quality-adjusted life year(QALY),which was significantly higher than three times China's per capita gross domestic product in 2024(287 247 yuan/QALY).CONCLUSIONS For third-line treatment of advanced NSCLC patients,the efficacy of anlotinib is no worse than that of immunotherapy alone or in combination with chemotherapy drugs,and the safety of the two groups is comparable.However,anlotinib is not cost-effective.

OBJECTIVE To explore the effect and potential mechanism of the compatibility of Astragali Radix-Puerariae Lobatae Radix on ferroptosis of liver cells in type 2 diabetes mellitus (T2DM) insulin resistance (IR) rats.METHODS Sixty male SD rats were randomly divided into control group (12 rats) and modeling group (48 rats).The modeling group was fed with a high-fat diet for 4 consecutive weeks and then given a one-time tail vein injection of 1％ streptozotocin to establish T2DM IR model.The model rats were randomly divided into model group,the compatibility of Astragali Radix-Puerariae Lobatae Radix group[QG group,4.05 g/(kg·d),intragastric administration],ferroptosis inhibitor ferrostatin-1 group[Fer-1 group,5 mg/kg by intraperitoneal injection,once every other day],the compatibility of Astragali Radix-Puerariae Lobatae Radix+ferroptosis inducer erastin group[QG+erastin group,4.05 g/(kg·d) by intragastric administration+erastin 10 mg/(kg·d),intraperitoneal injection].After 4 weeks of intervention,serum fasting blood glucose (FBG) and fasting insulin (FINS) were measured in each group of rats,and homeostasis model assessment of insulin resistance (HOMA-IR) and the natural logarithm of insulin action index(IAI) were calculated;the serum levels of total cholesterol (TC),triglyceride (TG),low-density lipoprotein cholesterol (LDL-C),high-density lipoprotein cholesterol (HDL-C),aspartate transaminase (AST) and alanine transaminase (ALT),Fe2+and Fe content,glutathione (GSH),malondialdehyde (MDA) and superoxide dismutase (SOD) levels,NADP+/NADPH ratio and reactive oxygen species (ROS) were determined.The pathological morphology of its liver tissue was observed;the protein expressions of glutathione peroxidase 4 (GPX4),ferritin heavy chain 1 (FTH1),long-chain acyl-CoA synthetase 3 (ACSL3),ACSL4,ferritin mitochondrial (FTMT),and cystine/glutamate anti-porter (xCT) in the liver tissue of rats were detected.RESULTS Compared with control group,the liver cells in the model group of rats showed disordered arrangement,swelling,deepened nuclear staining,and more infiltration of inflammatory cells,as well as a large number of hepatocyte vacuoles and steatosis;FBG (after medication),the levels of TC,TG,LDL-C,AST,ALT,FINS,MDA and ROS,HOMA-IR,Fe2+and Fe content,NADP+/NADPH ratio and protein expression of ACSL4 were significantly increased or up-regulated,while the levels of HDL-C,GSH and SOD,IAI,protein expressions of GPX4,FTH1,ACSL3,FTMT and xCT were significantly reduced or down-regulated (P<0.01).Compared with the model group,both QG group and Fer-1 group showed varying degrees of improvement in pathological damage of liver tissue and the levels of the above indicators,the differences in the changes of most indicators were statistically significant (P<0.01 or P<0.05).Compared with QG group,the improvement of the above indexes of QG+erastin group had been reversed significantly (P<0.01).CONCLUSIONS The compatibility decoction of Astragali Radix-Puerariae Lobatae Radix can reduce the level of FBG in T2DM IR rats,and alleviate IR degree,ion overload and pathological damage of liver tissue.The above effects are related to the inhibition of ferroptosis.

ObjectiveTo investigate the molecular mechanism by which Si Junzitang in intervening in the development of hepatocellular carcinoma （HCC） by regulating the O-linked β-N-acetylglucosamine modification （O-GlcNAcylation） of nuclear factor kappa-B （NF-κB） p65 in the paracancerous tissues. MethodThe orthotopic liver cancer mouse model was established. Twenty-four C57BL/6 mice were randomly divided into four groups： Normal group， model group， Si Junzitang low-dose group （10 g·kg^-1）， and Si Junzitang high-dose group （25 g·kg^-1）， with 6 mice in each group. The O-GlcNAcylation level and phosphorylation modification level of p65 in the paracancerous tissues were detected using Western blot. The O-GlcNAcylation of p65 was assessed using immunoprecipitation （IP）. The mRNA expression of interleukin-6 （IL-6）， tumor necrosis factor-α （TNF-α）， transforming growth factor-β₁ （TGF-β₁）， vascular endothelial growth factor A （VEGFA）， matrix metalloproteinase-2 （MMP-2）， matrix metalloproteinase-9 （MMP-9） in the paracancerous tissues was detected using real-time quantitative polymerase chain reaction （Real-time PCR）. The tumor number， liver weight， locomotor activity， grip strength， and Qi status of the mice were observed and analyzed. ResultCompared with the normal group， the model group showed a significant decrease in O-GlcNAcylation in the paracancerous tissues （P<0.01）， a significant decrease in p65 O-GlcNAcylation （P<0.01）， a significant increase in p65 phosphorylation （P<0.01）， significantly elevated mRNA levels of cytokines IL-6， TNF-α， TGF-β₁， VEGFA， MMP-2， and MMP-9 （P<0.01）， significantly increased liver weight （P<0.01）， significantly declined grip strength， number of grid crossings， and number of vertical stand-ups （P<0.01）， and significantly dwindled Qi status （P<0.01）. Compared with model group， the Si Junzitang low-dose and high-dose groups showed significantly increased levels of O-GlcNAcylation in the paracancerous tissues （P<0.05， P<0.01）， significantly upregulated p65 O-GlcNAcylation levels （P<0.05， P<0.01）， and significantly decreased p65 phosphorylation levels （P<0.01）. In the Si Junzitang low-dose group， the mRNA levels of IL-6， TGF-β₁， and VEGFA significantly decreased （P<0.05， P<0.01）. In the Si Junzitang high-dose group， the mRNA levels of IL-6， TNF-α， TGF-β₁， VEGFA， MMP-2， and MMP-9 significantly decreased （P<0.01）， the number of tumors larger than 3 mm in diameter significantly decreased （P<0.01）， and liver weight significantly decreased （P<0.05）. Additionally， grip strength， number of grid crossings， and number of vertical stand-ups significantly increased （P<0.05， P<0.01）， along with a significant increase in qi status （P<0.01）. ConclusionSi Junzitang can inhibit the progression of orthotopic HCC in mice， which may be achieved by increasing the O-GlcNAcylation level in the paracancerous tissues， enhancing the O-GlcNAcylation of p65， inhibiting the phosphorylation modification of p65， and ultimately suppressing the expression of downstream IL-6， TNF-α， TGF-β₁， VEGFA， MMP-2， and MMP-9.

Objective:To explore the immunological characteristics of peripheral blood and genetic variations of 11 immunodeficiency virus(HIV)-negative children with Talaromyces marneffei(TM) infection, thus enhancing the diagnostic and therapeutic levels of TM infection in children. Methods:Clinical data of 11 HIV-negative children with TM infection who presented to Guangzhou Women and Children′s Medical Center, Guangzhou Medical University from January 2010 to December 2022 were retrospectively analyzed, including clinical characteristics, peripheral immune profile and genetic test results.Results:A total of 11 HIV-negative children with TM infections were recruited, involving 9 males and 2 females with a median age of 19 months.The main clinical manifestations were fever (10/11, 90.91%), cough (10/11, 90.91%) and hepatomegaly (7/11, 63.64%). Common severe complications included acute respiratory distress syndrome (7/11, 63.64%) and septic shock (5/11, 45.45%). Finally, 2 children died.Transient neutropenia occurred in 6 cases (6/11, 54.55%), and lymphocytopenia combined with serum immunoglobulin (Ig) G decrease was observed in 4 cases (4/11, 36.36%). IgA decrease, IgM decrease, IgE decrease, IgM increase and IgE increase were observed in 6 cases, 3 cases, 5 cases, 3 cases, and 2 cases, respectively.Both T-lymphocyte and B-lymphocyte counts decreases was observed in 1 case.Genetic testing was performed in all recruited children, and genetic variations were detected in all of them.Inborn errors of immunity (IEIs) were diagnosed in 8 cases, including 4 diagnosed as CD 40 ligand deficiency with CD40LG variation, 1 of severe combined immunodeficiency with IL2RG variation, 1 of Signal transduction and activator of transcription 3(STAT3)-hyper-IgE syndrome with STAT3 variation and 1 of familial candidiasis type 2 with CARD9 compound heterozygous mutations.In the other 3 cases, 2 carried genetic variations that were likely pathogenic, and 1 case was considered uncertain. Conclusions:The clinical manifestations of HIV-negative children with TM infection are atypical, which is characterized as serious complications and high mortality.Early identification and gene testing to detect potential IEIs can improve the prognosis of TM infection.

Objective To screen differentially-expressed circRNA in plasma exosomes of patients with non-small cell lung cancer(NSCLC)and verify its diagnostic value for NSCLC.Methods The plasma exosomes of six patients with NSCLC and six healthy people were analyzed by circRNA sequencing.The expression of hsa_circ_0052513 in plasma exosomes of 60 NSCLC patients and 60 healthy controls was detected by qRT-PCR.The expression level of hsa_circ_0052513 in plasma exosomes of NSCLC patients before and after surgery was detected by qRT-PCR.The correlation between the expression of plasma exosomal hsa_circ_0052513 and clinical data of patients with NSCLC was statistically analyzed.Results Sequencing results showed that the expression of hsa_circ_0052513 in the plasma exosomes of NSCLC patients was higher than that of healthy controls,and the results were confirmed by qRT-PCR.Hsa_circ_0052513 was decreased in patients with NSCLC after tumor resection(P<0.05).The high expression of plasma exosomal hsa_circ_0052513 in patients with NSCLC was correlated with tumor size,distant metastasis,and TNM stage of NSCLC(all P<0.05).The area under the curve of plasma exosomal hsa_circ_0052513 in the diagnosis of patients with NSCLC was 0.7904(P<0.0001).Conclusion Hsa_circ_0052513 is highly expressed in the plasma exosomes of patients with NSCLC and is related to tumor size,metastasis,and TNM stage.Hence,Hsa_circ_0052513 could be a new diagnostic marker for NSCLC.

Objective:To determine the content of the released nickel ion through the 7 extraction media to extract the Ni-Ti wires and to plot the curve of the released nickel ion so as to identify a leaching medium that can be substituted for blood for in vitro Ni release evaluation. Methods:The release of Ni through microwave digestion/inductively coupled plasma mass spectrometry (ICP-MS) in the goat serum was determined. Because of the high content of Ni release, it could be determined by diluting the extraction medium, and other extraction media could be determined directly. Ni release standard curves were plotted by the release amount and different time point variables. Though the different extraction media Ni release curves confirm the specificity of extraction media instead of blood.Results:By analyzing the Ni release curves of seven leaching media, it was found that none of these seven extraction media was suitable for the evaluation of Ni release in in vitro leaching media. Considering the safety of the leaching medium and the simplicity of preparation, hydrochloric acid solution was chosen as the leaching medium, but the concentration needed to be diluted accordingly. Finally, a hydrochloric acid solution was created as an alternative to blood for the in vitro study of Ni release from Ni-Ti alloy cardiovascular products, with a volume fraction of 0.005%. Conclusions:The in vitro leaching medium that can replace blood was found to be hydrochloric acid for the time being, but its concentration was too high, resulting in too much Ni release as well, which deviated from the actual situation. Therefore, the hydrochloric acid solution was diluted step by step, and the Ni release curve was examined until it was close to the clinical release level, and the actual concentration was determined, thus laying a solid foundation for the subsequent evaluation of the safety and risk.