1.Analysis of Quality Uniformity of Hengzhi Kechuan Capsules Based on HPLC-DAD-CAD
Qian MA ; An LIU ; Qingxia XU ; Cong GUO ; Jun ZHANG ; Maoqing WANG ; Xiaodi KOU ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):168-174
ObjectiveTo establish the fingerprints of 15 batches of Hengzhi Kechuan capsules, to quantitatively analyze 10 index components, and to evaluate the quality uniformity of samples from different batches. MethodsThe fingerprints and quantitative analysis of Hengzhi Kechuan capsules were established by a combination method of high performance liquid chromatography coupled with diode array detector and charged aerosol detector(HPLC-DAD-CAD), adenosine, guanosine, vanillic acid, safflomin A, agarotetrol, naringin, hesperidin, militarine, ginsenoside Rb1, and glycyrrhizic acid were selected as quality attribute indexes. A total of 15 batches of Hengzhi Kechuan capsules from 2022 to 2024(3 boxes per batch) were qualitatively and quantitatively analyzed, and the quality uniformity level of the manufacturers was characterized by parameters of intra-batch consistency(PA) and inter-batch consistency(PB). The homogeneity and difference of quality attribute indexes of samples from different years were analyzed by heatmap clustering analysis. ResultsHPLC fingerprints and quantitative method of Hengzhi Kechuan capsules were established, and the methods could be used for qualitative and quantitative analysis of this preparation, which was found to be stable and reliable by method validation. The similarity of fingerprints of 15 batches of samples was 0.887-0.975, a total of 13 common peaks were calibrated, and 10 common peaks were designated, all of which were quality attribute index components. The results of quantitative analysis showed that the contents of the above 10 ingredients in the samples were 0.038-0.078, 0.115-0.251, 0.007-0.018, 0.291-0.673, 0.122-0.257, 0.887-1.905, 1.841-3.364, 1.412-2.450, 2.207-3.112, 0.650-1.161, respectively. And the contents of ginsenoside Rb1 and glycyrrhizic acid met the limit requirements in the 2020 edition of Chinese Pharmacopoeia. For the samples from 15 batches, the PA values of the 10 index components were all <10%, indicating good intra-batch homogeneity, and the PB values ranged from 33.86% to 92.97%, suggesting that the inter-batch homogeneity was poor. Heatmap clustering analysis showed that the samples from different years were clustered into separate categories, and adenosine, guanosine, safflomin A, naringin, hesperidin and agarotetrol were the main differential components. ConclusionThe intra-annual quality uniformity of Hengzhi Kechuan capsules is good and the inter-annual quality uniformity is insufficient, which may be related to the quality difference of Pinellinae Rhizoma Praeparatum, Carthami Flos, Citri Sarcodactylis Fructus, Citri Reticulatae Pericarpium, Aquilariae Lignum Resinatum, Citri Fructus, etc. In this study, the fingerprint and multi-indicator determination method of Hengzhi Kechuan capsules was established, which can be used for more accurate and efficient quality control and standardization enhancement.
2.Traditional Chinese Medicine Treats Sepsis by Regulating PI3K/Akt Pathway: A Review
Zhu LIU ; Jiawei WANG ; Jing YAN ; Jinchan PENG ; Mingyao XU ; Liqun LI ; Sheng XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):314-322
Sepsis is a systemic inflammatory response syndrome caused by the invasion of pathogenic microorganisms such as bacteria. In addition to the manifestations of systemic inflammatory response syndrome and primary infection lesions, critical cases often have manifestations of organ hypoperfusion. The morbidity and mortality of sepsis have remained high in recent years, which seriously affect the quality of life of the patients. The pathogenesis of sepsis is complicated, in which uncontrollable inflammation is a key mechanism. The phosphatidylinositol 3-kinase/protein kinase B (PI3K/Akt) signaling pathway plays a key role in mediating inflammation in sepsis. The available therapies of sepsis mainly include resuscitation, anti-infection, vasoactive drugs, intensive insulin therapy, and organ support, which show limited effects of reducing the mortality. Therefore, finding new therapeutic drugs is a key problem to be solved in the clinical treatment of sepsis. In recent years, studies have shown that traditional Chinese medicine (TCM) can regulate the PI3K/Akt pathway via multiple pathways, multiple effects, and multiple targets to inhibit inflammation and curb the occurrence and development of sepsis, which has gradually become a hot spot in the prevention and treatment of sepsis. Moreover, studies have suggested that TCM has unique advantages in the treatment of sepsis. TCM can regulate the PI3K/Akt signaling pathway to inhibit inflammation, reduce oxidative stress, and control apoptosis in the prevention and treatment of sepsis. Despite the research progress, a systematic review remains to be performed regarding the TCM treatment of sepsis by regulating the PI3K/Akt signaling pathway. After reviewing relevant papers published in recent years, this study systematically summarizes the relationship between PI3K/Akt pathway and sepsis and the role of TCM in the treatment of sepsis, aiming to provide new ideas for the potential treatment of sepsis and the development of new drugs.
3.Epidemiological characteristics of sexually transmitted diseases in Yangzhou City from 2019 to 2023
XU Chun ; LI Jincheng ; YANG Wenbin ; JIANG Yan ; YANG Kejiao ; BU Chunhong
Journal of Preventive Medicine 2025;37(2):158-162
Objective:
o analyze the epidemic characteristics of five sexually transmitted diseases (STDs), including syphilis, gonorrhea, condyloma acuminatum, genital herpes and genital Chlamydia trachomatis infection in Yangzhou City, Jiangsu Province from 2019 to 2023, so as to provide the reference for the prevention and control strategies of STDs.
Methods:
Data of the onset time and diagnostic types of STDs cases in Yangzhou City from 2019 to 2023 were collected from the Infectious Disease Surveillance System of Chinese Disease Prevention and Control Information System. The temporal, regional and population characteristics of five types of STDs was analyzed using the descriptive epidemiological method.
Results:
A total of 10 895 cases of STDs were reported in Yangzhou City from 2019 to 2023, with an average annual reported incidence rate of 47.83/105. The average annual reported incidence rates of syphilis, gonorrhea, condyloma acuminatum, genital herpes and genital Chlamydia trachomatis infections were 41.11/105, 2.83/105, 2.59/105, 0.43/105 and 0.85/105, respectively. The reported incidence rate of STDs showed a decreasing trend from 2019 to 2023 (P<0.05), with an average annual growth rate of -3.44%. The reported incidence rates of syphilis and gonorrhea showed a decreasing trend (both P<0.05), with average annual growth rates of -4.26% and -6.47%, respectively. The reported incidence rate of genital Chlamydia trachomatis infection showed an increasing trend (P<0.05), with an average annual growth rate of 22.32%. Baoying County, Guangling District and Hanjiang District had the top three reported incidence rates of STDs, at 56.61/105, 55.61/105 and 46.50/105, respectively. The average annual reported incidence rate of STDs among males was higher than that among females (53.19/105 vs. 42.54/105, P<0.05). The STD cases were primarily people aged 50 years and above, with 6 641 cases accounting for 60.95%. The occupations of STD cases were mainly farmers, housekeepers and unemployed, with 4 670 and 3 273 cases accounting for 42.86% and 30.04%, respectively.
Conclusions
The overall reported incidence of STDs in Yangzhou City from 2019 to 2023 showed a downward trend, while the reported incidence of genital Chlamydia trachomatis infection showed an upward trend. The individuals aged 50 years and above, farmers, housekeepers and the unemployed were identified as high-risk groups for STDs.
4.Disease burden of chronic kidney disease attributable to high BMI in China and trend prediction in 1992-2021
Hong LIU ; Guimao YANG ; Yan SUI ; Xia ZHANG ; Xuebing CHENG ; Yaxing WU ; Xu GUO ; Yanfeng REN
Journal of Public Health and Preventive Medicine 2025;36(1):27-31
Objective To analyze the disease burden of chronic kidney diseases (CKD) attributed to high body mass index (BMI) in China from 1992 to 2021 and predict the disease burden for the next decade, and to provide evidence for the prevention and treatment of CKD. Methods Using the Global Burden of Disease (GBD) database and the Joinpoint model, the average annual percentage rate change (AAPC) of the mortality rate and disability-adjusted life year (DALY) rate was calculated to describe and analyze the CKD disease burden attributed to high BMI in China from 1992 to 2021. The ARIMA model was employed to predict and analyze the change trend of the CKD disease burden. Results From 1992 to 2021, the mortality rate and DALY rate attributed to high BMI-induced chronic kidney disease showed an upward trend. Compared to 1992, the attributed number of deaths increased by 324.38%, and DALYs increased by 268.56%; the mortality rate increased by 64.00%, and the DALY rate grew by 51.62%. From 1992 to 2021, the mortality rate and DALY rate for males were lower than those for females, but the growth rate for males exceeded that of females. From 1992 to 2021, the mortality rate and DALY rate of chronic kidney disease attributed to high BMI in China increased with age. The average annual change rate of chronic kidney disease attributed to high BMI in China from 1992 to 2021 (mortality rate: 1.40 per 100,000 (95% CI: 1.04–1.76), DALY rate: 1.43 per 100 000 (95% CI: 1.17–1.70)) was higher than thHuaiyin Normal University, Huai'anher social demographic index (SDI) regions. The ARIMA model predicted that the age-standardized mortality rate increased from 2.91 per 100 000 in 2022 to 3.05 per 100 000 in 2026, and the age-standardized DALY rate increased from 69.65 per 100 000 in 2022 to 73.58 per 100 000 in 2026. Conclusion Chronic kidney disease attributed to high BMI in China is on the rise, and it will continue to grow in the future. The focus of CKD prevention and control should be on males and the elderly, while active measures should be taken to reduce the occurrence and progression of chronic kidney disease.
5.Clinical and Mechanism of Modified Xiaoyaosan and Its Effective Components in Treatment of Thyroid Diseases: A Review
Shanshan LI ; Yu FU ; Dandan WEI ; Fei WANG ; Mengjiao XU ; Ting WANG ; Shuxun YAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):302-310
Thyroid diseases are common clinical endocrine disorders, and their pathogenesis is generally considered to be closely related to genetic predisposition factors, immune system disorders, hormone levels, etc. Xiaoyaosan is widely used in the treatment of various thyroid diseases with excellent effects. This study summarized the relevant literature on the treatment of thyroid diseases with modified Xiaoyaosan prescriptions and their active ingredients from aspects such as theoretical analysis, clinical research, and mechanism research. Theoretical analysis revealed that Xiaoyaosan could not only disperse stagnated liver qi but also replenish deficient spleen Qi, which was consistent with the etiology and pathogenesis of thyroid diseases. Clinical studies found that Xiaoyaosan and its modified prescriptions could be widely used in the treatment of multiple thyroid diseases, such as hyperthyroidism, Hashimoto's thyroiditis, and thyroid nodules. Both the use of modified Xiaoyaosan alone and in combination with medications such as methimazole, propylthiouracil, and euthyrox could effectively improve patients' clinical symptoms. In the mechanism research, this study discovered that the whole formula of Xiaoyaosan and its modified prescriptions could inhibit inflammatory reactions, regulate immune balance, and delay liver damage during the treatment of thyroid diseases. The research on Xiaoyaosan for treating thyroid diseases mainly focused on thyroid cancer, autoimmune thyroiditis, hyperthyroidism, and hypothyroidism. The mechanisms of action mainly involved promoting cell apoptosis, inhibiting cell proliferation and migration, arresting the cell cycle, and regulating thyroid hormone levels. In conclusion, this study systematically combs and summarizes the research status of Xiaoyaosan in treating thyroid diseases through literature retrieval, aiming to provide new perspectives and new ideas for the prevention and treatment of thyroid diseases with traditional Chinese medicine.
6.Research progress on ANXA3 gene and protein
Tingting FENG ; Jingxiang ZHANG ; Yan WANG ; Weiheng XU ; Junping ZHANG
Journal of Pharmaceutical Practice and Service 2025;43(2):47-50
Annexin A3(ANXA3)is a member of the membrane associated protein family. It has two subtypes of 36 kDa and 33 kDa. Its gene is located on the fourth chromosome of human. ANXA3, widely expressed in human bone marrow, lung, placenta, prostate and thyroid, is closely related to several biological processes such as exoplasmosis, vascular production, fat cell maturity, and white blood cell migration. Studies have found that ANXA3 is abnormally expressed in various diseases including cancer, cardiovascular disease and inflammation. It can regulate multiple signaling pathways such as JNK, NF-κB, PI3K/AKT, and may become a potential drug target for treatment of related diseases. The structure, functions, the link with diseases and related mechanisms of ANXA3 were summarized in this paper, which could provide reference for ANXA3 related research.
7.Determination method of plasma concentrations of 7 anti-tumor drugs and its application
Jinxiu LYU ; Nan YAN ; Wenjun XU ; Jing ZHAO ; Hua ZHU ; Pengzhou HANG
China Pharmacy 2025;36(4):475-481
OBJECTIVE To establish a method for simultaneous determination of 7 anti-tumor drugs (irinotecan, capecitabine, paclitaxel, docetaxel, tamoxifen, letrozole and methotrexate) in human plasma and apply it to the clinic. METHODS After precipitating with a methanol-acetonitrile mixture (1∶ 1, V/V) containing 0.1% formic acid, liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to determine the plasma concentration, using deuterium isotopes of each analyte as internal standards. The chromatography was performed on the Agilent Eclipse Plus C18 column with a gradient elution of water (containing 0.1% formic acid+0.04% 5 mmol/L ammonium formate) as mobile phase A and acetonitrile (containing 0.1% formic acid) as mobile phase B. The flow rate was 0.6 mL/min, and the column temperature was set at 40 ℃ . The sample size was 10 μL, and the analysis lasted for 5.5 min. Electrospray ionization was used in positive and negative ion mode, and multiple reaction monitoring mode was used. The ion pairs used for quantitative analysis were m/z 587.1→167.1 (irinotecan), m/z 360.1→244.1 (capecitabine), m/z 876.4→308.0 (paclitaxel), m/z 830.3→304.2 (docetaxel), m/z 372.1→129.1 (tamoxifen), m/z 284.1→242.1 (letrozole), and m/z 455.0→ 308.0 (methotrexate). A total of 97 patients with malignant tumors in our hospital were selected to measure the plasma concentrations of 7 anti-tumor drugs using the above method. RESULTS The linear ranges of irinotecan, capecitabine, paclitaxel, docetaxel, tamoxifen, letrozole and methotrexate were 2-1 000 ng/mL (r=0.994 3), 20-10 000 ng/mL (r=0.997 5), 2-1 000 ng/mL (r=0.997 9), 1-500 ng/mL (r=0.995 8), 1-500 ng/mL (r=0.995 2), 1-500 ng/mL (r=0.996 4), 10-5 000 (r=0.997 7), respectively. The quantitative lower limits were 2, 20, 2, 1, 1, 1 and 10 ng/mL; RSDs of intra-assay precision were 0.08%-14.86% (n=6). RSDs of inter-batch precision were 1.51%-11.55% (n=3), and the accuracies were 89.17%-114.93% (n=6). The matrix effects ranged from 89.89%-119.74% (n=6). RSDs of the stability tests were 1.98%-14.88% (n=6). The results of E-mail:hangpengzhou@163.com clinical application showed, the average plasma concentrations of irinotecan, capecitabine, paclitaxel and docetaxel were 704.09, 909.40, 36.45, 150.43 ng/mL, respectively. The values of the coefficient of variation were 25.24%, 62.65%, 122.69%, and 92.27%. CONCLUSIONS The established LC-MS/MS method is simple and rapid, and can be used for the simultaneous determination of 7 commonly used anti-tumor drugs in the plasma of patients with malignancy.
8.Survey on the perception and current status of drug risk management in medical institutions
Xuelin SUN ; Mingqing XING ; Zixuan ZHANG ; Wenjing ZHAO ; Dongfang QIAN ; Yan LIANG ; Li XU ; Pengfei JIN ; Yatong ZHANG
China Pharmacy 2025;36(1):7-12
OBJECTIVE To know about the perception and current status of drug risk management among pharmacists in Chinese medical institutions, providing insights and recommendations for enhancing the drug risk management system in medical institutions. METHODS A questionnaire survey was conducted across 28 provinces, cities, and autonomous regions; stratified radom sampling was employed to study the population of medical workers and pharmaceutical professionals in medical institutions nationwide. The survey included information on the survey population, the current status of drug risk management implementation in medical institutions, the cognition, definition and process of drug risk management related concepts, and the content and mode of drug risk management work in medical institutions. Finally, suggestions were collected from various medical institutions on the system construction of drug risk management. Descriptive statistical analysis was adopted to summarize the obtained data. RESULTS A total of 446 questionnaires were collected in this survey, including 420 valid questionnaires and 26 invalid questionnaires. The questionnaire collection rate was 100%,and the effective rate was 94.17%. 51.19% of the respondents No.2020YFC2009001)。 based their understanding of drug risk management on Management Measures for Adverse Drug Reaction Reports and Monitoring, while 87.38% recognized the need for drug risk management throughout the drug use process. 63.33% of the participants stated that their medical institutions had dedicated positions related to drug risk management, with the highest proportion (72.17%) was in third-grade class A medical institutions. 66.43% reported implementing risk management across all drug use stages. Suggestions for the development of drug risk management systems in medical institutions by the research participants focused on enhancing guiding documents, clarifying concepts, establishing information-sharing mechanisms. CONCLUSIONS The overall awareness of drug risk management in China’s medical institutions is high, with practices in place across various stages in multiple forms. However, there remains a need to strengthen institutional documents, management regulations, system development, and information-sharing mechanisms to improve collaborative governance, improve drug management levels, and ensure patient safety.
9.Practical exploration of ethical review in decentralized drug clinical trials
Xu ZUO ; Yingshuo HUANG ; Yue LI ; Lihan XING ; Chunxiu YANG ; Yan CUI
Chinese Medical Ethics 2025;38(1):40-45
ObjectiveTo explore the process and guidelines for ethical review in decentralized drug clinical trials, promote clinical trial progress, and ensure drug development progress. MethodsThe key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials, analyzing the advantages and challenges of decentralized drug clinical trials, and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials. ResultsRelevant laws and regulations were the basis for the ethical review, and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures. The ethics committee should focus on the feasibility, applicability, and rationality, the adequacy of informed consent, the protection of rights and interests and privacy of subjects, as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials. ConclusionDecentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations. Ethical review is also constantly being refined through exploration. It is necessary to supervise the implementation of responsibilities by all parties, pay attention to the rights and interests of subjects, and gradually promote the implementation of decentralized drug clinical trials.
10.Influencing factors for delay in healthcare-seeking, definitive diagnosis, identification in patients with pulmonary tuberculosis in Minhang District
MA Qiongjin ; YAN Huiqin ; WU Yunhua ; GUO Xu ; YANG Lijia ; TANG Lihong ; YANG Shengyuan
Journal of Preventive Medicine 2025;37(1):59-64
Objective:
To investigate the influencing factors for delay in healthcare-seeking, definitive diagnosis and identification in patients with pulmonary tuberculosis (PTB) in Minhang District, Shanghai Municipality, so as to provide the basis for effectively reducing delay in PTB patients.
Methods:
Data of PTB patients in Minhang District from 2017 to 2022 were collected from the Infectious Disease Reporting Information System of Chinese Disease Prevention and Control Information System. The prevalence rates of delay in healthcare-seeking, definitive diagnosis and identification were analyzed, and factors affecting delay in healthcare-seeking, definitive diagnosis and identification were identified using multivariable logistic regression models.
Results:
A total of 4 214 PTB patients were reported in Minhang District from 2017 to 2022, including 2 802 males and 1 412 females, with a male-to-female ratio of 1.98∶1. The majority of patients were aged 25 to <45 years (1 664 cases, 39.49%). The prevalence rates of delay in healthcare-seeking, definitive diagnosis and identification were 36.81%, 30.21% and 38.09%, respectively. Delay in healthcare-seeking was associated with the year (2018, OR=0.708; 2019, OR=0.549; 2020, OR=0.670; 2021, OR=0.682), gender (female, OR=1.199), occupation (worker, OR=1.379; housekeeping service/housework/unemployed, OR=1.481), case identification route (symptom-based consultation, OR=11.159), and level of the first-diagnosed hospital (city-level, OR=1.528). Delay in definitive diagnosis was associated with age (45 to <65 years, OR=1.476), occupation (commercial service, OR=0.687; housekeeping service/housework/unemployed, OR=0.672), household registration (non-local, OR=0.820), case identification route (symptom-based consultation, OR=0.616), pathogen test result (negative/not tested, OR=1.903), and the level of the first-diagnosed hospital (city-level, OR=0.311). Delay in identification was associated with the year (2018, OR=0.785; 2019, OR=0.647; 2020, OR=0.790; 2021, OR=0.710), occupation (commercial service, OR=0.687), household registration (non-local, OR=0.848) and level of the first-diagnosed hospital (city-level, OR=0.560)
Conclusions
Year, gender, occupation, case identification route and level of the first-diagnosed hospital are influencing factors for delay in healthcare-seeking in PTB patients. Age, occupation, household registration, case identification route, pathogen test result and level of the first-diagnosed hospital are influencing factors for delay in definitive diagnosis. Year, occupation, household registration and level of the first-diagnosed hospital are influencing factors for delay in identification.


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