OBJECTIVE To establish a core competency evaluation system for drug clinical trial quality management personnel in China and validate its application. METHODS Based on the scope of work， responsibilities， and role positioning of quality management personnel in drug clinical trials， a preliminary draft of the core competency evaluation system was constructed through literature analysis and expert consultation. The draft was refined through a Delphi method involving 17 experts who provided feedback and revisions， ultimately forming a complete evaluation system. The developed system was applied to conduct electronic surveys from March to May 2024 among 110 quality management personnel from 38 drug clinical trial institutions， comparing their scores on indicator importance and self-assessed capabilities. RESULTS The response rate of both rounds of questionnaire survey was 100%， with Kendall’s W coefficients of 0.256 and 0.277 （P＜0.001 for both）， and an expert authority coefficient of 0.946. The finalized evaluation system for core competencies of clinical trial quality management personnel comprised 9 primary indicators， covering individual professional competence， communication skills， implementation condition verification， informed consent process review， clinical trial execution monitoring， adverse event disposal， reporting and documentation， trial record examination， trial report auditing， and inspection of other tasks， and 107 secondary indicators. Empirical research revealed significant discrepancies between importance scores and self-assessed competency scores across 70 indicators among 110 respondents （P＜0.05）. Indicators with relatively notable gaps between importance scores and self-assessed competency scores included in-depth understanding of Good Clinical Practice （GCP） requirements （0.34-point gap）， familiarity with national and institutional clinical trial inspection priorities （0.24-point gap），etc. CONCLUSIONS The indicator system constructed in this study has good scientificity and reliability. Clinical trial quality management personnel demonstrate deficiencies in multiple critical competencies， highlighting the urgent need for targeted training programs to enhance their overall professional capabilities.

Objective:To investigate the effect of mast cell-derived chemokine C-C motif ligand 5 (CCL5) on the migration of CD8 + T cells from vitiligo patients under oxidative stress conditions. Methods:From January 2017 to January 2023, 10 patients with progressive segmental vitiligo, 10 patients with non-segmental vitiligo, and 10 healthy individuals were collected from the Department of Dermatology, Xijing Hospital. Skin tissue samples were obtained from the lesions of vitiligo patients and from the normal skin of healthy individuals, with sampling sites including the face, neck, and upper extremities, and toluidine blue staining was performed to analyze the characteristics of mast cells infiltrating the skin lesions. The effect of H 2O 2 treatment on mast cells was investigated in Transwell chambers. Peripheral blood mononuclear cells (PBMCs) from vitiligo patients were added to the upper chamber, while the human mast cell line LAD2 was added to the lower chamber and divided into 4 groups to receive different treatments: untreated group receiving no special treatment, H 2O 2 group pretreated with H 2O 2, H 2O 2 + neutralization antibody group pretreated with H 2O 2 followed by the treatment with CCL5/RANTES-neutralizing antibodies, and H 2O 2 + PF group pretreated with H 2O 2 followed by the treatment with a Janus kinase 3/non-receptor protein tyrosine kinase selective inhibitor PF-06651600. After 6 hours of co-incubation, cell suspensions were collected from the lower chamber. The number of CD8 + T cells was counted using flow cytometry, and the CCL5 level in the cell culture supernatant was detected using enzyme-linked immunosorbent assay. One-way analysis of variance was used to analyze differences among groups, and least significant difference- t test was used for multiple comparisons. Pearson correlation analysis was performed for correlation analysis. Results:In the 200 × magnification field, the numbers of infiltrating mast cells significantly differed among segmental vitiligo lesions, non-segmental vitiligo lesions, and normal skin tissues (15.7 ± 3.3, 20.9 ± 3.9, 7.2 ± 2.9, respectively; F = 8.07, P = 0.002) ; additionally, the number of infiltrating mast cells was significantly higher in the segmental or non-segmental vitiligo lesions than in the normal skin tissues (LSD- t = 3.50, 5.70, P = 0.047, 0.001, respectively), but there was no significant difference between the segmental and non-segmental vitiligo lesions (LSD- t = 2.20, P = 0.293). A significant positive correlation was observed between the number of infiltrating mast cells and that of CD8 + T cells in the vitiligo lesions ( r = 0.82, P = 0.004). The numbers of CD8 + T cells and CCL5 levels significantly differed among the untreated group, H 2O 2 group, H 2O 2 + neutralization antibody group, and H 2O 2 + PF group (CD8 + T cells: 197.0 ± 45.9, 580.4 ± 62.6, 296.0 ± 43.2, 398.6 ± 62.8, respectively; CCL5: 2.2 ± 0.6 pg/ml, 9.9 ± 1.3 pg/ml, 3.4 ± 0.4 pg/ml, 6.33 ± 0.7 pg/ml, respectively; F = 11.03, 17.77, respectively, both P < 0.001) ; additionally, the H 2O 2 group showed significantly increased numbers of CD8 + T cells and CCL5 levels compared with the untreated group, H 2O 2 + neutralization antibody group, and H 2O 2 + PF group (all P < 0.05) . Conclusion:Mast cells may be involved in the pathogenesis of vitiligo under oxidative stress, and mast cell-derived CCL5 appears to contribute to the occurrence and development of vitiligo by affecting CD8 + T cell migration.

Uterine arteriovenous fistula (UAVF), a relatively rare vascular anomaly, may lead to life-threatening hemorrhage and poses diagnostic and management challenges for primary hospitals during initial encounters. This article reports four cases of UAVF treated with Drospirenone and ethinyl estradiol tablets at Department of Gynaecology, Zhuji Maternal and Child Health Hospital between 2023 and 2024. Combined with literature review, we systematically analyzed the etiological mechanisms, clinical characteristics, and diagnostic-therapeutic strategies of this condition, with particular focus on evaluating the efficacy and safety of conservative pharmacological management. By summarizing case features and individualized treatment protocols, this study aims to provide clinical references for early identification, accurate diagnosis, and rational intervention of UAVF, thereby reducing risks of massive hemorrhage and long-term complications while improving patient prognosis.

Uterine arteriovenous fistula (UAVF), a relatively rare vascular anomaly, may lead to life-threatening hemorrhage and poses diagnostic and management challenges for primary hospitals during initial encounters. This article reports four cases of UAVF treated with Drospirenone and ethinyl estradiol tablets at Department of Gynaecology, Zhuji Maternal and Child Health Hospital between 2023 and 2024. Combined with literature review, we systematically analyzed the etiological mechanisms, clinical characteristics, and diagnostic-therapeutic strategies of this condition, with particular focus on evaluating the efficacy and safety of conservative pharmacological management. By summarizing case features and individualized treatment protocols, this study aims to provide clinical references for early identification, accurate diagnosis, and rational intervention of UAVF, thereby reducing risks of massive hemorrhage and long-term complications while improving patient prognosis.

Objective:To investigate the effect of mast cell-derived chemokine C-C motif ligand 5 (CCL5) on the migration of CD8 + T cells from vitiligo patients under oxidative stress conditions. Methods:From January 2017 to January 2023, 10 patients with progressive segmental vitiligo, 10 patients with non-segmental vitiligo, and 10 healthy individuals were collected from the Department of Dermatology, Xijing Hospital. Skin tissue samples were obtained from the lesions of vitiligo patients and from the normal skin of healthy individuals, with sampling sites including the face, neck, and upper extremities, and toluidine blue staining was performed to analyze the characteristics of mast cells infiltrating the skin lesions. The effect of H 2O 2 treatment on mast cells was investigated in Transwell chambers. Peripheral blood mononuclear cells (PBMCs) from vitiligo patients were added to the upper chamber, while the human mast cell line LAD2 was added to the lower chamber and divided into 4 groups to receive different treatments: untreated group receiving no special treatment, H 2O 2 group pretreated with H 2O 2, H 2O 2 + neutralization antibody group pretreated with H 2O 2 followed by the treatment with CCL5/RANTES-neutralizing antibodies, and H 2O 2 + PF group pretreated with H 2O 2 followed by the treatment with a Janus kinase 3/non-receptor protein tyrosine kinase selective inhibitor PF-06651600. After 6 hours of co-incubation, cell suspensions were collected from the lower chamber. The number of CD8 + T cells was counted using flow cytometry, and the CCL5 level in the cell culture supernatant was detected using enzyme-linked immunosorbent assay. One-way analysis of variance was used to analyze differences among groups, and least significant difference- t test was used for multiple comparisons. Pearson correlation analysis was performed for correlation analysis. Results:In the 200 × magnification field, the numbers of infiltrating mast cells significantly differed among segmental vitiligo lesions, non-segmental vitiligo lesions, and normal skin tissues (15.7 ± 3.3, 20.9 ± 3.9, 7.2 ± 2.9, respectively; F = 8.07, P = 0.002) ; additionally, the number of infiltrating mast cells was significantly higher in the segmental or non-segmental vitiligo lesions than in the normal skin tissues (LSD- t = 3.50, 5.70, P = 0.047, 0.001, respectively), but there was no significant difference between the segmental and non-segmental vitiligo lesions (LSD- t = 2.20, P = 0.293). A significant positive correlation was observed between the number of infiltrating mast cells and that of CD8 + T cells in the vitiligo lesions ( r = 0.82, P = 0.004). The numbers of CD8 + T cells and CCL5 levels significantly differed among the untreated group, H 2O 2 group, H 2O 2 + neutralization antibody group, and H 2O 2 + PF group (CD8 + T cells: 197.0 ± 45.9, 580.4 ± 62.6, 296.0 ± 43.2, 398.6 ± 62.8, respectively; CCL5: 2.2 ± 0.6 pg/ml, 9.9 ± 1.3 pg/ml, 3.4 ± 0.4 pg/ml, 6.33 ± 0.7 pg/ml, respectively; F = 11.03, 17.77, respectively, both P < 0.001) ; additionally, the H 2O 2 group showed significantly increased numbers of CD8 + T cells and CCL5 levels compared with the untreated group, H 2O 2 + neutralization antibody group, and H 2O 2 + PF group (all P < 0.05) . Conclusion:Mast cells may be involved in the pathogenesis of vitiligo under oxidative stress, and mast cell-derived CCL5 appears to contribute to the occurrence and development of vitiligo by affecting CD8 + T cell migration.

The adulteration and counterfeiting of herbal ingredients in medicinal and food homology (MFH) have a serious impact on the quality of herbal materials, thereby endangering human health. Compared to pharmaceutical drugs, health products derived from traditional Chinese medicine (TCM) are more easily accessible and closely integrated into consumers' daily life. However, the authentication of the authenticity of TCM ingredients in MFH has not received sufficient attention. The lack of clear standards emphasizes the necessity of conducting systematic research in this area. This study utilized DNA barcoding technology, combining ITS2, psbA-trnH, matK as universal barcode sequences, and DX, HH, JYH as specific barcode sequences, to identify the authenticity of commercial medicinal and food homology scented herbal teas. The aim was to investigate the authenticity of scented herbal tea products circulating in the market. The research results revealed that among 180 scented herbal tea samples, DNA barcodes were successfully obtained from 164 samples, while the remaining samples either lacked the target components or suffered severe DNA degradation, resulting in failed amplification. Combined with morphological identification studies, it was found that out of the 180 samples, 141 were authentic, accounting for 78.33% of the total samples, while 31 samples showed adulteration and 8 samples lacked the target components, accounting for 21.67% of the total samples. Additionally, water testing revealed that 5 samples of Carthamus tinctorius herbal tea exhibited the phenomenon of weight adulteration. This study exposed the presence of adulteration and weight adulteration in scented herbal tea products, highlighting the need for regulatory authorities to expedite the establishment of quality standards in scented herbal tea industry. These findings provide valuable insights for the rapid development of the scented herbal tea industry.

Jiming Powder is a traditional ancient prescription with good therapeutic effect in the treatment of heart failure, but its mechanism lacks further exploration. In this study, a mouse model of coronary artery ligation was used to evaluate the effect and mechanism of Jiming Powder on myocardial fibrosis in mice with myocardial infarction. The study constructed a mouse model of heart failure after myocardial infarction using the method of left anterior descending coronary artery ligation. The efficacy of Jiming Powder was evaluated from multiple angles, including ultrasound imaging, hematoxylin-eosin(HE) staining, Masson staining, Sirius Red staining, and serum myocardial enzyme spectrum detection. Western blot analysis was performed to detect key proteins involved in ventricular remodeling, including transforming growth factor-β1(TGF-β1), α-smooth muscle actin(α-SMA), wingless-type MMTV integration site family member 3a(Wnt3a), β-catenin, matrix metallopeptidase 2(MMP2), matrix metallopeptidase 3(MMP3), TIMP metallopeptidase inhibitor 1(TIMP1), and TIMP metallopeptidase inhibitor 2(TIMP2). The results showed that compared with the model group, the high and low-dose Jiming Powder significantly reduced the left ventricular internal diameter in systole(LVID;s) and diastole(LVID;d), increased the left ventricular ejection fraction(LVEF) and left ventricular fractional shortening(LVFS), effectively improved cardiac function in mice after myocardial infarction, and effectively reduced the levels of myocardial injury markers such as creatine kinase(CK), creatine kinase isoenzyme(CK-MB), and lactic dehydrogenase(LDH), thus protecting ischemic myocardium. HE staining showed that Jiming Powder could attenuate myocardial inflammatory cell infiltration after myocardial infarction. Masson and Sirius Red staining demonstrated that Jiming Powder effectively inhibited myocardial fibrosis, reduced the collagen Ⅰ/Ⅲ ratio in myocardial tissues, and improved collagen remodeling after myocardial infarction. Western blot results showed that Jiming Powder reduced the expression of TGF-β1, α-SMA, Wnt3a, and β-catenin, decreased the levels of MMP2, MMP3, and TIMP2, and increased the level of TIMP1, suggesting its role in inhibiting cardiac fibroblast transformation, reducing extracellular matrix metabolism in myocardial cells, and lowering collagen Ⅰ and α-SMA content, thus exerting an anti-myocardial fibrosis effect after myocardial infarction. This study revealed the role of Jiming Powder in improving ventricular remodeling and treating myocardial infarction, laying the foundation for further research on the pharmacological effect of Jiming Powder.
Mice ; Animals ; Transforming Growth Factor beta1/metabolism* ; Matrix Metalloproteinase 2/metabolism* ; beta Catenin/metabolism* ; Matrix Metalloproteinase 3/therapeutic use* ; Powders ; Ventricular Remodeling ; Stroke Volume ; Ventricular Function, Left ; Myocardial Infarction/drug therapy* ; Myocardium/pathology* ; Heart Failure/metabolism* ; Collagen/metabolism* ; Creatine Kinase ; Fibrosis

Objective:To investigate the protective effect of racanisodamine on lung injury in mice exposed to irradiation.Methods:C57BL/6 mice were randomly divided into control group, racanisodamine group, 18 Gy irradiation group (model group) and racanisodamine combined with 18 Gy irradiation group (treatment group), with 5 mice in each group. The mice in the treatment group received racanisodamine (5 mg/kg) intraperitoneally 3 d before irradiation and contained the whole experiments. Then, single chest irradiation of 18 Gy X-rays was performed both in the model and treatment groups. The racanisodamine group and treatment group received racanisodamine intraperitoneally once a day until 6 weeks after irradiation. The mice were killed at 6 weeks after irradiation. The lung histopathology was observed by HE staining. Serum and bronchial alveolar lavage fluid (BALF) inflammatory cytokines such as TNF-α, IL-1β and IL-6 were determined by ELISA method. Cell senescence was detected by SA-β-Gal staining. The expressions of Nrf2, p-Nrf2 and p62 in lung tissue were performed by immunehistochemistry and Western blot assays.Results:Compared with the model group, the scores of HE staining were decreased ( t=8.66, P<0.01), the number of infiltrated inflammatory cells in BALF were decreased ( t=10.70, P<0.01), and protein concentration in BALF had lower levels ( t=6.75, P<0.01), the serum TNF-α, IL-1β and IL-6 were decreased significantly ( t=8.17, 4.58, 6.54, P<0.01), the activity of SA-β-gal was decreased, and the expressions of Nrf2, p-Nrf2 were enhanced ( t=6.42, 7.30, P<0.01), while the expression of p62 was reduced ( t=4.62, P<0.01) in the treatment group. Conclusions:Racanisodamine plays the protective effect of radiation-induced lung injury by alleviating inflammation associating with the activating of Nrf2-related pathway, which reversed radiation-induced cell senescence.

As the disease with high morbidity and mortality in the world, heart failure affects the development of human society. Due to its complicated pathology and limited treatment options, it is urgent to discover new disease targets and develop new treatment strategies. As innate immune cells accompanied by the evolution of heart failure, macrophages play an important role in cardiac homeostasis and stress. In recent years, the role of macrophages in the heart has attracted more and more attention as a potential target for heart failure intervention, and the research on cardiac macrophages has made important progress. Traditional Chinese medicine(TCM) has significant effects on regulating inflammatory response, treating heart failure, and maintaining homeostasis. In this article, researches on the functions of cardiac macrophages and application of TCM were reviewed from the source and classification of cardiac macrophages and the relationship of macrophages and cardiac inflammation, myocardial fibrosis, cardiac angiogenesis, and cardiac electrical conduction, which provided a basis for further basic research and clinical applications.
Humans ; Medicine, Chinese Traditional ; Heart Failure/drug therapy* ; Macrophages ; Drugs, Chinese Herbal/therapeutic use*