Drug quality problems seriously threaten the life and health of patients,drug quality problems handling is an important part of pharmaceutical management in medical institutions,and strengthening the management of drug quality problems in medical institutions can provide a strong guarantee for drug safety of patients.This standard was compiled by the Pharmaceutical Affairs Commission of the Chinese Hospital Association,and the process included problems identification,framework development,manuscript writing,opinions gathering,expert argumentation and deliberation,and standards development.The standard regulates the basic requirements,coping strategies,quality control and continuous improvement of drug quality problems handling in medical institutions.This article elaborates on the methods and contents of formulating standards for drug quality problems handling,to pro-vide reference and inspiration for medical institutions to carry out drug quality problems handling.

Drug quality problems seriously threaten the life and health of patients,drug quality problems handling is an important part of pharmaceutical management in medical institutions,and strengthening the management of drug quality problems in medical institutions can provide a strong guarantee for drug safety of patients.This standard was compiled by the Pharmaceutical Affairs Commission of the Chinese Hospital Association,and the process included problems identification,framework development,manuscript writing,opinions gathering,expert argumentation and deliberation,and standards development.The standard regulates the basic requirements,coping strategies,quality control and continuous improvement of drug quality problems handling in medical institutions.This article elaborates on the methods and contents of formulating standards for drug quality problems handling,to pro-vide reference and inspiration for medical institutions to carry out drug quality problems handling.

Objective:To evaluate the relationship between transverse sinus stenosis (TSS) and cerebral blood flow in normal adults based on four-dimensional flow (4D Flow) MRI.Methods:The study was a cross-sectional study. Totally 81 normal volunteers who underwent magnetic resonance venography (MRV) and 4D Flow MRI were prospectively enrolled at Beijing Friendship Hospital, Capital Medical University from January 2020 to December 2022. Based on MRV evaluation of transverse sinus dysplasia, the volunteers were divided into a dysplasia group (26 cases) and a non-dysplasia group (55 cases); The area of the stenosis and the normal transverse sinus at the distal end were measured. The degree of TSS and the bilateral average transverse sinus stenosis (BA-TSS) were calculated. TSS was determined using TSS levels of 1/3, 1/2, and 2/3 as thresholds, and was divided into three groups: no TSS group, unilateral TSS group, and bilateral TSS group, with 28, 39, and 14 cases, 37, 37, and 7 cases, and 43, 36, and 2 cases, respectively. Based on 4D Flow MRI, the blood flow of the internal carotid artery, vertebral artery, superior sagittal sinus, straight sinus, and transverse sinus distal and proximal ends were measured. The cerebral blood flow (bilateral internal carotid artery blood flow+bilateral vertebral artery blood flow), venous sinus return blood flow 1 (superior sagittal sinus blood flow+straight sinus blood flow), return blood flow 2 (sum of bilateral transverse sinus distal end blood flow), return blood flow 3 (sum of bilateral transverse sinus proximal end blood flow), and the ratio of return blood flow to cerebral blood flow were calculated. Independent sample t-test was used to compare the differences between the group with and without transverse sinus dysplasia; Single factor analysis of variance was used to compare the differences between the TSS free group, unilateral TSS group, and bilateral TSS group. Based on single factor linear regression, the relationships between BA-TSS and blood flow parameters were analyzed.Results:There was no statistically significant difference in various blood flow parameters between the group with and without transverse sinus dysplasia (all P>0.05). When using 1/3, 1/2, and 2/3 as thresholds, there was no statistically significant difference in various blood flow parameters between the non TSS group, unilateral TSS group, and bilateral TSS group (all P>0.05). BA-TSS was linearly positively correlated with cerebral blood flow (β=0.986, 95% CI 0.108-1.865, P=0.028), but not linearly correlated with return blood flow 1, 2, and 3 (all P>0.05). The degree of BA-TSS was linearly negatively correlated with return blood flow 1/cerebral blood flow (β=-0.001, 95% CI -0.002-0, P=0.009) and return blood flow 2/cerebral blood flow (β=-0.001, 95% CI -0.002-0, P=0.018), but not with return blood flow 3/cerebral blood flow ( P=0.076). Conclusion:The BA-TSS degree in normal adults is positively correlated with cerebral blood inflow and negatively correlated with the proportion of venous sinus outflow.

Objective : To investigate the prevalence of negative emotions in hospitalized youth patients with type 2 diabetes(T2DM) and its correlation with coping strategies and psychological resilience. Methods : 141 youth T2DM patients who met the research standards were selected. Blood glucose related indicators, blood pressure, body mass index(BMI), diabetes chronic complications screening results and other data were collected. The basic information and disease related information questionnaire, self-rating depression scale(SDS), self-rating anxiety scale(SAS), diabetes distress scale(DDS), medical coping modes questionnaire(MCMQ) and Connor-Davidson resilience scale(CD-RISC) were completed. Results: Among 141 hospitalized youth T2DM patients, 37.6% were combined with depression, 32.6% were combined with anxiety, and 35.5% were combined with diabetic distress(DD). Univariate analysis showed that systolic blood pressure(P<0.01), educational level, and the form of hospitalization expenses(P<0.05) were significantly correlated with depression. Marital status(P<0.01), family residence, blood glucose monitoring methods, and the last fasting blood glucose(P<0.05) were significantly correlated with anxiety. BMI, whether it was first diagnosed or treated(P<0.01), gender, occupation, disease course, weekly blood glucose monitoring frequency, and the presence of chronic complications(P<0.05) were significantly correlated with DD. In multivariate analysis, systolic blood pressure(P<0.01), educational level, and the form of hospitalization expenses were significantly correlated with depression, marital status(P<0.05) was significantly correlated with anxiety; BMI and weekly blood glucose monitoring frequency(P<0.01) were significantly correlated with DD. SDS, SAS, total scores and dimensions of DDS were negatively correlated with the total score and dimensions of CD-RISC(rs=-0.182--0.467, P<0.05 or 0.01), and positively correlated with the yielding coping strategies(rs=0.177-0.271,P<0.05 or 0.01). SAS,total scores and dimensions of DDS were positively correlated with avoiding coping strategies(rs=0.237-0.419,P<0.05 or 0.01). The total and dimensions of CD-RISC were positively correlated with facing coping strategies(rs=0.215-0.349,P<0.05 or 0.01),and negatively correlated with yielding coping strategies(rs=-0.234--0.325,P<0.01). Conclusion More than 30% of hospitalized youth T2DM may experience negative emotions such as depression,anxiety,and DD. The occurrence of negative emotions in such patients may be related to disease management or socio-economic issues such as systolic blood pressure,educational level,hospitalization expenses,marital status,BMI,and frequency of blood glucose monitoring,as well as decreased psychological resilience and negative coping strategies.

Objective:To investigate the electron microscopic evaluation results of pre-transplant biopsies of deceased donor kidneys and the corresponding recovery of graft function in recipients after kidney transplantation.Methods:A retrospective analysis was conducted on the clinical data and donor kidney electron microscopy (EM) reports of 196 kidney transplant recipients who underwent pre-implantation kidney biopsies at Renmin Hospital of Wuhan University between October 2020 and June 2023. The ultrastructural pathological features assessed in the pre-transplant kidney biopsy included: the number of glomeruli, the presence of leukocytes and endothelial cells within the glomeruli, the arrangement of capillary loops, abnormalities in podocytes, mesangial cells, mesangial matrix and glomerular basement membrane (GBM), and multilayering of the peritubular capillary basement membrane. Referring to the Mayo Clinic/Renal Pathology Society Consensus Report on the pathological classification, diagnosis, and reporting of glomerulonephritis, the expert consensus on renal biopsy pathology reporting models, and the content of the 2019 Banff Transplant Pathology Meeting, a scoring system was established for ultrastructural pathology of donor kidneys. According to the scores, the recipients were divided into three groups: Group A (total score ≥ 8 points, 94 cases), Group B (total score between 6 and 8 points, 85 cases), and Group C (total score < 6 points, 17 cases). The serum creatinine, estimated glomerular filtration rate (eGFR), and proteinuria at postoperative day 1, day 7, month 1, month 3, month 6, and year 1 were compared among the three groups.Results:Among the 196 donor kidneys, EM examination before transplantation showed the following findings: 19 cases (9.7%) had prominent leukocyte infiltration within the glomeruli, 8 cases (4.1%) had mild leukocyte infiltration, and the remaining 169 cases (86.2%) showed no obvious increase in glomerular leukocytes. Glomerular capillary loop collapse or narrowing was seen in 19 cases (9.7%). Endothelial cell proliferation was observed in 32 cases (16.3%). Homogeneous thickening of the GBM (400-900 nm) was present in 82 cases (41.8%). Foot process effacement ranged from partial to diffuse. Podocyte vacuolar degeneration was seen in 62 cases (32.1%), and podocyte swelling in 10 cases (5.1%). Electron-dense deposits in the mesangial area were observed in 9 cases (4.6%). Mild tubular epithelial swelling was present in 6 cases (3.1%). Only 22 cases (11.2%) showed no multilayering of the peritubular capillary basement membrane, while 174 cases (88.8%) showed 2 to 5 layers of multilayering. All donor glomeruli showed irregular capillary loop arrangement, and the renal interstitium showed scattered inflammatory infiltration and varying degrees of collagen fiber deposition. Group C had significantly higher qualitative proteinuria levels at day 7 and month 1 post-transplantation compared with Groups A and B ( P=0.036, 0.004). There were no statistically significant differences in other renal function indicators among the groups (all P>0.05). Conclusions:Pre-transplant electron microscopy of donor kidneys helps in accurately assessing donor kidney quality and identifying subtle pre-existing pathological changes. It can serve as a reference tool for predicting post-transplant functional recovery. Mild ultrastructural abnormalities in donor kidneys have a relatively controllable impact on long-term graft outcomes.

OBJECTIVE: To explore the molecular mechanism of Shenmai Injection (SMI) against doxorubicin (DOX) induced cardiomyocyte apoptosis. METHODS: A total of 40 specific pathogen-free (SPF) male Sprague Dawley (SD) male rats were divided into 5 groups based on the random number table, including the control group, the model group, miR-30a agomir group, SMI low-dose (SMI-L) group, and SMI high-dose (SMI-H) group, with 8 rats in each group. Except for the control group, the rats were injected weekly with DOX (2 mg/kg) in the tail vein for 4 weeks to induce myocardial injury, and were given different regimens of continuous intervention for 2 weeks. Cardiac function was detected by echocardiography and myocardial pathological changes were observed by Van Gieson (VG) staining. Myocardial injury serum markers, including creatine kinase (CK), lactate dehydrogenase (LDH), troponin T (cTnT), N-terminal pro-brain natriuretic peptide (NT-proBNP), soluble ST2 (sST2), and growth differentiation factor-15 (GDF-15) were detected by enzyme linked immunosorbent assay (ELISA). Cardiomyocyte apoptosis was observed by terminal deoxynucleotidyl transferase-mediated biotinylated dUTP triphosphate nick end labeling (TUNEL) and transmission electron microscopy, and the expressions of target proteins and mRNA were detected by Western blot and quantitative real time polymerase chain reaction (qRT-RCR), respectively. RESULTS: The treatment with different doses of SMI reduced rat heart mass index and left ventricular mass index (P<0.05), significantly improved the left ventricular ejection fraction (P<0.05), decreased the levels of serum CK, LDH, cTnT, and NT-proBNP (P<0.05 or P<0.01), reduced the levels of serum sST2 and GDF-15 (P<0.05 or P<0.01), decreased the collagen volume fraction, reduced the expressions of rat myocardial type I and type III collagen (P<0.05 or P<0.01), and effectively alleviated myocardial fibrosis. And the study found that SMI promoted the expression levels of miR-30a and Bcl-2 in myocardium, and down-regulated the expression of Bax, which inhibited the activation of Caspase-3 and Caspase-9 (P<0.05 or P<0.01), and improved myocardial cell apoptosis. CONCLUSIONS SMI can alleviate myocardial injury and apoptosis caused by DOX, and its mechanism possibly by promoting the targeted expression of myocardial Bcl-2 protein through miR-30a.
Animals ; Myocytes, Cardiac/metabolism* ; Apoptosis/drug effects* ; MicroRNAs/genetics* ; Rats, Sprague-Dawley ; Male ; Drugs, Chinese Herbal/administration & dosage* ; Doxorubicin/pharmacology* ; Proto-Oncogene Proteins c-bcl-2/genetics* ; Drug Combinations ; Injections ; Rats

Objective:To evaluate the relationship between transverse sinus stenosis (TSS) and cerebral blood flow in normal adults based on four-dimensional flow (4D Flow) MRI.Methods:The study was a cross-sectional study. Totally 81 normal volunteers who underwent magnetic resonance venography (MRV) and 4D Flow MRI were prospectively enrolled at Beijing Friendship Hospital, Capital Medical University from January 2020 to December 2022. Based on MRV evaluation of transverse sinus dysplasia, the volunteers were divided into a dysplasia group (26 cases) and a non-dysplasia group (55 cases); The area of the stenosis and the normal transverse sinus at the distal end were measured. The degree of TSS and the bilateral average transverse sinus stenosis (BA-TSS) were calculated. TSS was determined using TSS levels of 1/3, 1/2, and 2/3 as thresholds, and was divided into three groups: no TSS group, unilateral TSS group, and bilateral TSS group, with 28, 39, and 14 cases, 37, 37, and 7 cases, and 43, 36, and 2 cases, respectively. Based on 4D Flow MRI, the blood flow of the internal carotid artery, vertebral artery, superior sagittal sinus, straight sinus, and transverse sinus distal and proximal ends were measured. The cerebral blood flow (bilateral internal carotid artery blood flow+bilateral vertebral artery blood flow), venous sinus return blood flow 1 (superior sagittal sinus blood flow+straight sinus blood flow), return blood flow 2 (sum of bilateral transverse sinus distal end blood flow), return blood flow 3 (sum of bilateral transverse sinus proximal end blood flow), and the ratio of return blood flow to cerebral blood flow were calculated. Independent sample t-test was used to compare the differences between the group with and without transverse sinus dysplasia; Single factor analysis of variance was used to compare the differences between the TSS free group, unilateral TSS group, and bilateral TSS group. Based on single factor linear regression, the relationships between BA-TSS and blood flow parameters were analyzed.Results:There was no statistically significant difference in various blood flow parameters between the group with and without transverse sinus dysplasia (all P>0.05). When using 1/3, 1/2, and 2/3 as thresholds, there was no statistically significant difference in various blood flow parameters between the non TSS group, unilateral TSS group, and bilateral TSS group (all P>0.05). BA-TSS was linearly positively correlated with cerebral blood flow (β=0.986, 95% CI 0.108-1.865, P=0.028), but not linearly correlated with return blood flow 1, 2, and 3 (all P>0.05). The degree of BA-TSS was linearly negatively correlated with return blood flow 1/cerebral blood flow (β=-0.001, 95% CI -0.002-0, P=0.009) and return blood flow 2/cerebral blood flow (β=-0.001, 95% CI -0.002-0, P=0.018), but not with return blood flow 3/cerebral blood flow ( P=0.076). Conclusion:The BA-TSS degree in normal adults is positively correlated with cerebral blood inflow and negatively correlated with the proportion of venous sinus outflow.

Objective:To investigate the electron microscopic evaluation results of pre-transplant biopsies of deceased donor kidneys and the corresponding recovery of graft function in recipients after kidney transplantation.Methods:A retrospective analysis was conducted on the clinical data and donor kidney electron microscopy (EM) reports of 196 kidney transplant recipients who underwent pre-implantation kidney biopsies at Renmin Hospital of Wuhan University between October 2020 and June 2023. The ultrastructural pathological features assessed in the pre-transplant kidney biopsy included: the number of glomeruli, the presence of leukocytes and endothelial cells within the glomeruli, the arrangement of capillary loops, abnormalities in podocytes, mesangial cells, mesangial matrix and glomerular basement membrane (GBM), and multilayering of the peritubular capillary basement membrane. Referring to the Mayo Clinic/Renal Pathology Society Consensus Report on the pathological classification, diagnosis, and reporting of glomerulonephritis, the expert consensus on renal biopsy pathology reporting models, and the content of the 2019 Banff Transplant Pathology Meeting, a scoring system was established for ultrastructural pathology of donor kidneys. According to the scores, the recipients were divided into three groups: Group A (total score ≥ 8 points, 94 cases), Group B (total score between 6 and 8 points, 85 cases), and Group C (total score < 6 points, 17 cases). The serum creatinine, estimated glomerular filtration rate (eGFR), and proteinuria at postoperative day 1, day 7, month 1, month 3, month 6, and year 1 were compared among the three groups.Results:Among the 196 donor kidneys, EM examination before transplantation showed the following findings: 19 cases (9.7%) had prominent leukocyte infiltration within the glomeruli, 8 cases (4.1%) had mild leukocyte infiltration, and the remaining 169 cases (86.2%) showed no obvious increase in glomerular leukocytes. Glomerular capillary loop collapse or narrowing was seen in 19 cases (9.7%). Endothelial cell proliferation was observed in 32 cases (16.3%). Homogeneous thickening of the GBM (400-900 nm) was present in 82 cases (41.8%). Foot process effacement ranged from partial to diffuse. Podocyte vacuolar degeneration was seen in 62 cases (32.1%), and podocyte swelling in 10 cases (5.1%). Electron-dense deposits in the mesangial area were observed in 9 cases (4.6%). Mild tubular epithelial swelling was present in 6 cases (3.1%). Only 22 cases (11.2%) showed no multilayering of the peritubular capillary basement membrane, while 174 cases (88.8%) showed 2 to 5 layers of multilayering. All donor glomeruli showed irregular capillary loop arrangement, and the renal interstitium showed scattered inflammatory infiltration and varying degrees of collagen fiber deposition. Group C had significantly higher qualitative proteinuria levels at day 7 and month 1 post-transplantation compared with Groups A and B ( P=0.036, 0.004). There were no statistically significant differences in other renal function indicators among the groups (all P>0.05). Conclusions:Pre-transplant electron microscopy of donor kidneys helps in accurately assessing donor kidney quality and identifying subtle pre-existing pathological changes. It can serve as a reference tool for predicting post-transplant functional recovery. Mild ultrastructural abnormalities in donor kidneys have a relatively controllable impact on long-term graft outcomes.

Nowadays,with the continuous deepening and development of vocational education teaching reform,medical higher vocational education always takes moral education as the fundamental task.As an independent type of education,vocational education should always deepen the integration of industry and education and the integration of science and education.Through the teaching research of"problem chain+course ideological and political case",this study innovates the coordinated education team of drug nursing curriculum,the collaborative education method and the collaborative education evaluation,and improves the teaching effect.