1.Optimization of Quality of TCM Medicinal Materials:Comprehensive Application of GAP,HACCP and ISO Systems
Shihong FENG ; Xiao YE ; Wenji ZHAO
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):30-34
The global use of TCM has been steadily increasing,yet Chinese TCM products still face significant challenges in entering international markets,including cultural differences between East and West,inadequate quality standards for TCM,regulatory barriers against herbal medicines,and the substandard quality of medicinal materials.The 2022 edition of Chinese Herbal Medicine Production Quality Management Code introduced the concept of Hazard Analysis and Critical Control Points(HACCP)to control the harmful factors in the production of Chinese herbal medicine;at the same time,the international standard of TCM was established after the establishment of ISO/TC249 to control the quality of TCM from the source by carrying out GAP and ISO double certification,which is the fundamental way for Chinese TCM to expand its international market share.This study conducted a comparative analysis of the application status of three key systems—GAP(Good Agricultural Practices),HACCP and ISO(International Organization for Standardization)—in the quality control of TCM.Based on this analysis,this article proposed that China's TCM production standards should draw upon the strengths of these international quality management systems to reduce production risks and costs while enhancing the practicality and implementation of GAP guidelines.
2.Analysis of ACTH level heterogeneity and the diagnostic value of serum dehydroepiandrosterone sulfate in patients with subclinical Cushing′s syndrome
Wenji ZHAO ; Jiawei YANG ; Yuxing LOU ; Wei ZHANG ; Shiman LI ; Ziwei ZHANG ; Fan YANG ; Ping LI
Chinese Journal of Endocrinology and Metabolism 2025;41(10):830-836
Objective:To investigate the clinical characteristics and hormonal changes in patients with adrenocorticotropic hormone(ACTH)-suppressed and non-suppressed subclinical Cushing′s syndrome(SCS), to evaluate the influencing factors of ACTH suppression, and to assess the diagnostic efficiency of serum dehydroepiandrosterone sulfate(DHEAS) levels in distinguishing these two groups of SCS patients.Methods:Clinical data of patients diagnosed with SCS in the Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical College, between June 2014 and October 2023 were retrospectively collected. A total of 194 cases were included. According to morning(8: 00 AM) plasma ACTH levels, patients were divided into an ACTH-suppressed group(ACTH<2.2 pmol/L) and a non-suppressed group(ACTH≥2.2 pmol/L). Additionally, 194 gender-, age-, and BMI-matched patients with non-functional adrenal tumors(NFA) were enrolled as controls. Clinical characteristics and hormone levels were compared between groups. Logistic regression analysis was performed to identify factors influencing ACTH suppression in SCS patients. Furthermore, receiver operating characteristic(ROC) curve analysis was conducted to evaluate the diagnostic performance of serum DHEAS levels in distinguishing ACTH-suppressed and non-suppressed SCS patients. Results:There were no significant differences in the prevalence of overweight/obesity, hypertension, abnormal glucose metabolism, or bone metabolism disorders between the ACTH-suppressed and non-suppressed groups. The serum cortisol level after the 1 mg-dexamethasone suppression test(DST) was significantly lower in the ACTH non-suppressed group than that in the suppressed group, while the serum DHEAS level was significantly higher in the non-suppressed group(both P<0.01). The area under the curve(AUCs) of serum DHEAS for diagnosing ACTH non-suppressed SCS patients and ACTH-suppressed SCS patients was 0.779(95% CI 0.721-0.837) and 0.874(95% CI 0.831-0.918), respectively. Using a serum DHEAS cutoff of 60.0 μg/dL, the sensitivity and specificity for diagnosing ACTH non-suppressed SCS patients were 66.7% and 76.1%, respectively, while for ACTH-suppressed SCS patients, the sensitivity and specificity were 84.9% and 75.5%, respectively. Conclusion:There were no significant differences in metabolic characteristics between ACTH-suppressed and non-suppressed SCS patients. Serum cortisol level after 1 mg-DST is an independent influencing factor for ACTH suppression status. Low serum DHEAS level serves as a sensitive diagnostic marker for SCS and also demonstrates diagnostic value in ACTH non-suppressed SCS patients.
3.Advance of circRNA in the research on orthopedic diseases
Shugang LYU ; Tong ZHAO ; Guoliang CHEN ; Xin DU ; Wenji WANG
Basic & Clinical Medicine 2025;45(3):399-403
Circular RNAs(circRNAs)are a class of closed-loop non-coding RNAs(ncRNAs)formed by head-to-tail covalent bonds.CircRNAs participate in the development of osteoarthritis by regulating extracellular matrix degrada-tion,inflammatory response and homeostasis of chondrocytes;It regulates the osteogenic differentiation of bone mar-row mesenchymal stem cells,the activity of bone microvascular endothelial cells and angiogenesis to affect femoral head necrosis;It regulates the differentiation of bone marrow stem cells,osteoblasts and osteoclasts to cause osteo-porosis and it affects the invasion,metastasis and drug resistance of osteosarcoma through different pathogenesis.CircRNAs are expected to become a new clinical diagnostic marker in the future.
4.Based on the LDA topic model and linear regression method,the analysis and mining of the character-istics of the scientific popularization content on the"PSM medicine shield public welfare"official ac-count were conducted
Qiongtong FANG ; Xinrong WU ; Yishen CHEN ; Jiabi LIANG ; Huibin ZHAO ; Wenji LUO ; Meirong ZHANG
Modern Hospital 2025;25(9):1428-1432,1437
Objective Text mining of content characteristics of original science popularization articles on the WeChat public account"PSM Medicine Shield Public Welfare"based on LDA model and Linear Regression.Methods Through web crawling techniques,we collected 4,292 original pharmaceutical science popularization articles and associated comment data from the"PSM Drug Shield Public Welfare"WeChat Official Account to analyze the content distribution patterns and characteristics of pharmaceutical science communication.Employing Latent Dirichlet Allocation(LDA)modeling,we systematically categorized and mined article themes to identify public demand for science literacy and explore strategic directions for precision-targeted phar-maceutical science dissemination.Results The analysis of 4 292 original science popularization articles from the"PSM Medi-cine Shield Public Welfare"account showed an average readership of 1 815.73±4 385.31.Articles in headline positions,pub-lished on weekends,or using exclamatory titles achieved higher readership.Most articles(1 000-2 000 words)used direct-open-ing title strategies.Traditional Chinese medicines had the highest readership among drug categories.Top content categories in-cluded drug monographs,medicinal diets,disease medication guidance,myth clarification,and disease science.Linear regres-sion analysis identified headline placement,word count,title phrasing,title strategy,target audience,drug category,and content type as potential factors influencing readership.The LDA model with 9 s revealed key themes:management of drug adverse reac-tions,dermatological medication dosing,anti-infection effects of medicinal diets,and pediatric vaccination/health monitoring.Conclusion The"PSM Medicine Shield Public Welfare"WeChat account primarily disseminates pharmaceutical science content focusing on adverse drug reactions,pediatric medication safety,TCM-based health preservation,disease treatment protocols,symptom recognition guidelines,dosage optimization,and toxicity management.Pharmaceutical professionals should prioritize content length control,evidence-based title strategies,and thematic alignment with public health priorities during science commu-nication content creation.
5.Based on the LDA topic model and linear regression method,the analysis and mining of the character-istics of the scientific popularization content on the"PSM medicine shield public welfare"official ac-count were conducted
Qiongtong FANG ; Xinrong WU ; Yishen CHEN ; Jiabi LIANG ; Huibin ZHAO ; Wenji LUO ; Meirong ZHANG
Modern Hospital 2025;25(9):1428-1432,1437
Objective Text mining of content characteristics of original science popularization articles on the WeChat public account"PSM Medicine Shield Public Welfare"based on LDA model and Linear Regression.Methods Through web crawling techniques,we collected 4,292 original pharmaceutical science popularization articles and associated comment data from the"PSM Drug Shield Public Welfare"WeChat Official Account to analyze the content distribution patterns and characteristics of pharmaceutical science communication.Employing Latent Dirichlet Allocation(LDA)modeling,we systematically categorized and mined article themes to identify public demand for science literacy and explore strategic directions for precision-targeted phar-maceutical science dissemination.Results The analysis of 4 292 original science popularization articles from the"PSM Medi-cine Shield Public Welfare"account showed an average readership of 1 815.73±4 385.31.Articles in headline positions,pub-lished on weekends,or using exclamatory titles achieved higher readership.Most articles(1 000-2 000 words)used direct-open-ing title strategies.Traditional Chinese medicines had the highest readership among drug categories.Top content categories in-cluded drug monographs,medicinal diets,disease medication guidance,myth clarification,and disease science.Linear regres-sion analysis identified headline placement,word count,title phrasing,title strategy,target audience,drug category,and content type as potential factors influencing readership.The LDA model with 9 s revealed key themes:management of drug adverse reac-tions,dermatological medication dosing,anti-infection effects of medicinal diets,and pediatric vaccination/health monitoring.Conclusion The"PSM Medicine Shield Public Welfare"WeChat account primarily disseminates pharmaceutical science content focusing on adverse drug reactions,pediatric medication safety,TCM-based health preservation,disease treatment protocols,symptom recognition guidelines,dosage optimization,and toxicity management.Pharmaceutical professionals should prioritize content length control,evidence-based title strategies,and thematic alignment with public health priorities during science commu-nication content creation.
6.Optimization of Quality of TCM Medicinal Materials:Comprehensive Application of GAP,HACCP and ISO Systems
Shihong FENG ; Xiao YE ; Wenji ZHAO
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):30-34
The global use of TCM has been steadily increasing,yet Chinese TCM products still face significant challenges in entering international markets,including cultural differences between East and West,inadequate quality standards for TCM,regulatory barriers against herbal medicines,and the substandard quality of medicinal materials.The 2022 edition of Chinese Herbal Medicine Production Quality Management Code introduced the concept of Hazard Analysis and Critical Control Points(HACCP)to control the harmful factors in the production of Chinese herbal medicine;at the same time,the international standard of TCM was established after the establishment of ISO/TC249 to control the quality of TCM from the source by carrying out GAP and ISO double certification,which is the fundamental way for Chinese TCM to expand its international market share.This study conducted a comparative analysis of the application status of three key systems—GAP(Good Agricultural Practices),HACCP and ISO(International Organization for Standardization)—in the quality control of TCM.Based on this analysis,this article proposed that China's TCM production standards should draw upon the strengths of these international quality management systems to reduce production risks and costs while enhancing the practicality and implementation of GAP guidelines.
7.Analysis of ACTH level heterogeneity and the diagnostic value of serum dehydroepiandrosterone sulfate in patients with subclinical Cushing′s syndrome
Wenji ZHAO ; Jiawei YANG ; Yuxing LOU ; Wei ZHANG ; Shiman LI ; Ziwei ZHANG ; Fan YANG ; Ping LI
Chinese Journal of Endocrinology and Metabolism 2025;41(10):830-836
Objective:To investigate the clinical characteristics and hormonal changes in patients with adrenocorticotropic hormone(ACTH)-suppressed and non-suppressed subclinical Cushing′s syndrome(SCS), to evaluate the influencing factors of ACTH suppression, and to assess the diagnostic efficiency of serum dehydroepiandrosterone sulfate(DHEAS) levels in distinguishing these two groups of SCS patients.Methods:Clinical data of patients diagnosed with SCS in the Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical College, between June 2014 and October 2023 were retrospectively collected. A total of 194 cases were included. According to morning(8: 00 AM) plasma ACTH levels, patients were divided into an ACTH-suppressed group(ACTH<2.2 pmol/L) and a non-suppressed group(ACTH≥2.2 pmol/L). Additionally, 194 gender-, age-, and BMI-matched patients with non-functional adrenal tumors(NFA) were enrolled as controls. Clinical characteristics and hormone levels were compared between groups. Logistic regression analysis was performed to identify factors influencing ACTH suppression in SCS patients. Furthermore, receiver operating characteristic(ROC) curve analysis was conducted to evaluate the diagnostic performance of serum DHEAS levels in distinguishing ACTH-suppressed and non-suppressed SCS patients. Results:There were no significant differences in the prevalence of overweight/obesity, hypertension, abnormal glucose metabolism, or bone metabolism disorders between the ACTH-suppressed and non-suppressed groups. The serum cortisol level after the 1 mg-dexamethasone suppression test(DST) was significantly lower in the ACTH non-suppressed group than that in the suppressed group, while the serum DHEAS level was significantly higher in the non-suppressed group(both P<0.01). The area under the curve(AUCs) of serum DHEAS for diagnosing ACTH non-suppressed SCS patients and ACTH-suppressed SCS patients was 0.779(95% CI 0.721-0.837) and 0.874(95% CI 0.831-0.918), respectively. Using a serum DHEAS cutoff of 60.0 μg/dL, the sensitivity and specificity for diagnosing ACTH non-suppressed SCS patients were 66.7% and 76.1%, respectively, while for ACTH-suppressed SCS patients, the sensitivity and specificity were 84.9% and 75.5%, respectively. Conclusion:There were no significant differences in metabolic characteristics between ACTH-suppressed and non-suppressed SCS patients. Serum cortisol level after 1 mg-DST is an independent influencing factor for ACTH suppression status. Low serum DHEAS level serves as a sensitive diagnostic marker for SCS and also demonstrates diagnostic value in ACTH non-suppressed SCS patients.
8.Long-term hypomethylating agents in patients with myelodysplastic syndromes: a multi-center retrospective study
Xiaozhen LIU ; Shujuan ZHOU ; Jian HUANG ; Caifang ZHAO ; Lingxu JIANG ; Yudi ZHANG ; Chen MEI ; Liya MA ; Xinping ZHOU ; Yanping SHAO ; Gongqiang WU ; Xibin XIAO ; Rongxin YAO ; Xiaohong DU ; Tonglin HU ; Shenxian QIAN ; Yuan LI ; Xuefen YAN ; Li HUANG ; Manling WANG ; Jiaping FU ; Lihong SHOU ; Wenhua JIANG ; Weimei JIN ; Linjie LI ; Jing LE ; Wenji LUO ; Yun ZHANG ; Xiujie ZHOU ; Hao ZHANG ; Xianghua LANG ; Mei ZHOU ; Jie JIN ; Huifang JIANG ; Jin ZHANG ; Guifang OUYANG ; Hongyan TONG
Chinese Journal of Hematology 2024;45(8):738-747
Objective:To evaluate the efficacy and safety of hypomethylating agents (HMA) in patients with myelodysplastic syndromes (MDS) .Methods:A total of 409 MDS patients from 45 hospitals in Zhejiang province who received at least four consecutive cycles of HMA monotherapy as initial therapy were enrolled to evaluate the efficacy and safety of HMA. Mann-Whitney U or Chi-square tests were used to compare the differences in the clinical data. Logistic regression and Cox regression were used to analyze the factors affecting efficacy and survival. Kaplan-Meier was used for survival analysis. Results:Patients received HMA treatment for a median of 6 cycles (range, 4-25 cycles) . The complete remission (CR) rate was 33.98% and the overall response rate (ORR) was 77.02%. Multivariate analysis revealed that complex karyotype ( P=0.02, OR=0.39, 95% CI 0.18-0.84) was an independent favorable factor for CR rate. TP53 mutation ( P=0.02, OR=0.22, 95% CI 0.06-0.77) was a predictive factor for a higher ORR. The median OS for the HMA-treated patients was 25.67 (95% CI 21.14-30.19) months. HMA response ( P=0.036, HR=0.47, 95% CI 0.23-0.95) was an independent favorable prognostic factor, whereas complex karyotype ( P=0.024, HR=2.14, 95% CI 1.10-4.15) , leukemia transformation ( P<0.001, HR=2.839, 95% CI 1.64-4.92) , and TP53 mutation ( P=0.012, HR=2.19, 95% CI 1.19-4.07) were independent adverse prognostic factors. There was no significant difference in efficacy and survival between the reduced and standard doses of HMA. The CR rate and ORR of MDS patients treated with decitabine and azacitidine were not significantly different. The median OS of patients treated with decitabine was longer compared with that of patients treated with azacitidine (29.53 months vs 20.17 months, P=0.007) . The incidence of bone marrow suppression and pneumonia in the decitabine group was higher compared with that in the azacitidine group. Conclusion:Continuous and regular use of appropriate doses of hypomethylating agents may benefit MDS patients to the greatest extent if it is tolerated.
9.Increasing the thermostability of glutamate decarboxylase from Lactobacillus brevis by introducing proline.
Hui FANG ; Changjiang LÜ ; Yujiao HUA ; Sheng HU ; Weirui ZHAO ; Wenji FANG ; Kui SONG ; Jun HUANG ; Lehe MEI
Chinese Journal of Biotechnology 2019;35(4):636-646
Glutamate decarboxylase, a unique pyridoxal 5'-phosphate-dependent enzyme, catalyzes α-decarboxylation of L-glutamate to γ-aminobutyrate. However, glutamate decarboxylase from different sources has the common problem of poor thermostability that affects its application in industry. In this study, proline was introduced at 13 different positions in glutamate decarboxylase by using the design strategy of homologous sequence alignment between Thermococcus kodakarensis and Lactobacillus brevis CGMCC No.1306. A mutant enzyme G364P with higher thermostability was obtained. Compared to the wild type, thermostability of the mutant G364P was significantly improved, the half-life time (t1/2) at 55 °C and the semi-inactivation temperature (T₅₀ ¹⁵) of the mutant G364P increased 19.4 min and 5.3 °C, respectively, while kcat/Km of the mutant enzyme remained nearly unchanged. Further analysis of their thermostability by molecular dynamics simulations were performed. The root mean square deviation of G364P and root mean square fluctuation in the loop region including G364 were lower than the wild type at 313 K for 10 ns, and G364P increased one hydrophobic interaction in the loop region. It proves that mutation of flexible 364-Gly to rigid proline endows glutamate decarboxylase with enhanced thermostability.
Glutamate Decarboxylase
;
Glutamic Acid
;
Lactobacillus brevis
;
Molecular Dynamics Simulation
;
Proline
10.Clinical Observation of Alteplase Combined with Butylphthalide in the Treatment of Acute Ischemic Stroke
Jing ZHAO ; Hui ZHAO ; Wenji KONG ; Yanguo ZHANG
China Pharmacy 2016;27(35):4962-4964,4965
OBJECTIVE:To discuss clinical efficacy and safety of alteplase combined with butylphthalide to the patients with acute ischemic stroke. METHODS:98 patients with acute ischemic stroke in our hospital were selected and divided into ob-servation group and control group according to random number table,with 49 patients in each group. Control group was addition-ally given Butylphthalide and sodium chloride injection 100 ml,ivgtt,bid,on the basis of routine treatment as controlling blood glucose,blood pressure,etc.;observation group additionally received Alteplase for injection 5 mg added into NS 10 ml,iv+Al-teplase for injection 45 mg added into NS 100 ml,ivgtt,qd,on the basis of control group. Both groups were treated for 2 weeks. Clinical efficacies of 2 groups were compared as well as cerebral infarction area,NIHSS score,ability score of daily liv-ing,the levels of IL-6,IL-8,IL-10,CRP,24 h urine protein,Scr and creatinine clearance rate before and after treatment. The occurrence of ADR was also recorded. RESULTS:1 patient of observation group and 2 patients of control group withdrew from the study due to severe hemorrhage. Total effective rate of observation group(95.83%)was significantly higher than that of con-trol group(80.85%),with statistical significance(P<0.05). Before treatment,there was no statistical significance in above in-dexes between 2 groups (P>0.05). The cerebral infarction area and NIHSS score were reduced significantly in observation group after treatment,ability score of daily living were increased significantly in observation group after treatment,and the im-provement of observation group was significantly better than control group,with statistical significance (P<0.05). 24 h urine protein and Scr of observation group was significantly lower than those of control group,with statistical significance(P<0.05). the level of IL-6 in observation group 1 week after treatment and the levels of IL-6,IL-8,IL-10 and CRP 2 weeks after treat-ment were significantly lower than in control group,with statistical significance(P<0.05). There was no statistical significance in the incidence of ADR between 2 groups (P>0.05). CONCLUSIONS:Alteplase combined with butylphthalide show signifi-cant therapeutic efficacy,can effectively reduce the level of serum inflammatory factors,control brain tissue ischemia and cere-bral infarction area,and improve neurologic function and pro-tect renal function in patients with acute ischemic stroke.

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