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 explore the clinical outcomes and recent follow-up results of the Modified Diamond Protocol in patients with low ejection fraction heart failure (HF) during the perioperative period of cardiac surgery.Methods:Retrospectively collected clinical data of 62 patients who underwent open heart surgery in the cardiac surgery department of Nanjing Drum Tower Hospital from August 2022 to January 2024, including 48 males and 14 females with mean age of (63.3±11.5)years old. All patients were diagnosed with low ejection fraction heart failure preoperatively, with left ventricular ejection fraction (LVEF) ≤0.35. Based on the indications of postoperative heart failure medication, 21 patients who received the Modified Diamond Protocol treatment were included in the Modified group, and 41 patients who received the standard treatment plan were included in the Control group. The baseline clinical characteristics and data of the two groups were compared. The left ventricular end-diastolic diameter (LVDd), pulmonary artery pressure (PH), LVEF, postoperative heart failure improvement, mortality, and readmission rates at preoperative, postoperative, and final discharge follow-up times of the two groups were analyzed.Results:There was no statistical difference in baseline data between the control group and the modified diamond regimen group ( P>0.05). There were no perioperative deaths in either group of patients. Compared to preoperative levels, there were significant decrease in PH, a significant reduction in LVDd, and significant increase in LVEF within each group ( P<0.05). Compared to control group, the Modified group demonstrated a greater reduction in PH (-17 mmHg vs. -12 mmHg, 1 mmHg=0.133 kPa), a greater reduction in LVDd (-0.59 mm vs. -0.57 mm), and a greater increase in LVEF (0.08 vs. 0.03), indicating an overall better improvement in cardiac function in the Modified group. However, there were no statistically significant differences between two groups ( P>0.05). All patients were followed up for 3-12 months. The overall mortality rate within 1 year was 12.9%(8/62). During the final follow-up for cardiac function, when comparing within each group, both groups showed a decrease in PH, a reduction in LVDd, and an increase in LVEF, all of which were improvements compared to preoperative levels, with statistically significant differences( P<0.05). Compared to control group, the Modified group showed a greater decrease in pulmonary hypertension (PH) (-17 mmHg vs. -12 mmHg), a greater reduction in LVDd(-0.58 mm vs. -0.57 mm), and a greater increase in left ventricular ejection fraction (LVEF) (0.06 vs. 0.07). The overall improvement in cardiac function was similar between the two groups, with no statistically significant differences( P>0.05). The readmission rate in the Modified group was significantly lower than in the Control group (9.5% vs. 36.6%, P=0.02), and the mortality rate was relatively lower (4.8% vs. 19.5%, P=0.11). Conclusion:The Modified Diamond Protocol is an effective approach to enhance postoperative cardiac function in patients with low ejection fraction undergoing cardiac surgery, contributing to early recovery and reduced readmission rates, but the long-term trend in mortality rates remain to be observed.

Peritoneal fibrosis(PF)is an important reason that restricts long-term treatment of peritoneal dialysis(PD).Based on the theory of collateral disease,PF is considered to be an abdominal collateral disease,with dampness as the main pathogenic factor,and collateral qi deficiency and stagnation,toxicity and blood stasis as the core pathogenesis.The peritoneum is chronically exposed to an inflammatory microenvironment induced by non-biocompatible peritoneal dialysis fluid,reflecting the pathogenic mechanism of dampness-induced pathology.The resultant pathological processes,including damage of peritoneal mesothelial cells,accumulation of inflammatory mediators and metabolic products,and angiogenesis—elucidate the scientific connotation of dampness impairing collaterals and inducing deficiency,toxicity,and stasis.On this basis,the treatment principles of invigorating qi,detoxifying,resolving stasis and unblocking collaterals were proposed,and the Qixue Huazheng prescription was formed with Astragalus as the main ingredient and Centella asiatica and Ligusticum wallichii as the compatibility,which provides a reference for the prevention and treatment of PD-relat-ed PF by traditional Chinese medicine.

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.

Peritoneal fibrosis(PF)is an important reason that restricts long-term treatment of peritoneal dialysis(PD).Based on the theory of collateral disease,PF is considered to be an abdominal collateral disease,with dampness as the main pathogenic factor,and collateral qi deficiency and stagnation,toxicity and blood stasis as the core pathogenesis.The peritoneum is chronically exposed to an inflammatory microenvironment induced by non-biocompatible peritoneal dialysis fluid,reflecting the pathogenic mechanism of dampness-induced pathology.The resultant pathological processes,including damage of peritoneal mesothelial cells,accumulation of inflammatory mediators and metabolic products,and angiogenesis—elucidate the scientific connotation of dampness impairing collaterals and inducing deficiency,toxicity,and stasis.On this basis,the treatment principles of invigorating qi,detoxifying,resolving stasis and unblocking collaterals were proposed,and the Qixue Huazheng prescription was formed with Astragalus as the main ingredient and Centella asiatica and Ligusticum wallichii as the compatibility,which provides a reference for the prevention and treatment of PD-relat-ed PF by traditional Chinese medicine.

Objective:To explore the clinical outcomes and recent follow-up results of the Modified Diamond Protocol in patients with low ejection fraction heart failure (HF) during the perioperative period of cardiac surgery.Methods:Retrospectively collected clinical data of 62 patients who underwent open heart surgery in the cardiac surgery department of Nanjing Drum Tower Hospital from August 2022 to January 2024, including 48 males and 14 females with mean age of (63.3±11.5)years old. All patients were diagnosed with low ejection fraction heart failure preoperatively, with left ventricular ejection fraction (LVEF) ≤0.35. Based on the indications of postoperative heart failure medication, 21 patients who received the Modified Diamond Protocol treatment were included in the Modified group, and 41 patients who received the standard treatment plan were included in the Control group. The baseline clinical characteristics and data of the two groups were compared. The left ventricular end-diastolic diameter (LVDd), pulmonary artery pressure (PH), LVEF, postoperative heart failure improvement, mortality, and readmission rates at preoperative, postoperative, and final discharge follow-up times of the two groups were analyzed.Results:There was no statistical difference in baseline data between the control group and the modified diamond regimen group ( P>0.05). There were no perioperative deaths in either group of patients. Compared to preoperative levels, there were significant decrease in PH, a significant reduction in LVDd, and significant increase in LVEF within each group ( P<0.05). Compared to control group, the Modified group demonstrated a greater reduction in PH (-17 mmHg vs. -12 mmHg, 1 mmHg=0.133 kPa), a greater reduction in LVDd (-0.59 mm vs. -0.57 mm), and a greater increase in LVEF (0.08 vs. 0.03), indicating an overall better improvement in cardiac function in the Modified group. However, there were no statistically significant differences between two groups ( P>0.05). All patients were followed up for 3-12 months. The overall mortality rate within 1 year was 12.9%(8/62). During the final follow-up for cardiac function, when comparing within each group, both groups showed a decrease in PH, a reduction in LVDd, and an increase in LVEF, all of which were improvements compared to preoperative levels, with statistically significant differences( P<0.05). Compared to control group, the Modified group showed a greater decrease in pulmonary hypertension (PH) (-17 mmHg vs. -12 mmHg), a greater reduction in LVDd(-0.58 mm vs. -0.57 mm), and a greater increase in left ventricular ejection fraction (LVEF) (0.06 vs. 0.07). The overall improvement in cardiac function was similar between the two groups, with no statistically significant differences( P>0.05). The readmission rate in the Modified group was significantly lower than in the Control group (9.5% vs. 36.6%, P=0.02), and the mortality rate was relatively lower (4.8% vs. 19.5%, P=0.11). Conclusion:The Modified Diamond Protocol is an effective approach to enhance postoperative cardiac function in patients with low ejection fraction undergoing cardiac surgery, contributing to early recovery and reduced readmission rates, but the long-term trend in mortality rates remain to be observed.

Replantation of traumatic amputation in children has its own characteristics. This consensus primarily focuses on the issues related to the treatment of traumatically amputated limb injuries in children. Organised along a timeline, the consensus summarises domestic and international clinical experiences in emergency care and injury assessment of traumatic limb amputation limbs, indications and contraindications for replantation surgery, principles and procedures of replantation surgery, postoperative medication and management, as well as rehabilitation in children. The aim of this consensus is to propose standardise the treatment protocols for limb replantation for children therefore to serve as a reference for clinical practitioners in medical practices, and further improve the treatment and care for the traumatic limb amputations in children.

Background: Diabetes mellitus (DM) is a chronic metabolic disease that poses serious threats to human physical and mental health worldwide. The PDZ domain-containing 8 (PDZD8) protein mediates mitochondria-associated endoplasmic reticulum (ER) membrane (MAM) formation in mammals. We explored the role of PDZD8 in DM and investigated its potential mechanism of action. Methods: High-fat diet (HFD)- and streptozotocin-induced mouse DM and palmitic acid (PA)-induced insulin 1 (INS-1) cell models were constructed. PDZD8 expression was detected using immunohistochemistry, quantitative real-time polymerase chain reaction (qRT-PCR), and Western blotting. MAM formation, interactions between voltage-dependent anion-selective channel 1 (VDAC1) and inositol 1,4,5-triphosphate receptor type 1 (IP3R1), pancreatic β-cell apoptosis and proliferation were detected using transmission electron microscopy (TEM), proximity ligation assay (PLA), terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay, immunofluorescence staining, and Western blotting. The mitochondrial membrane potential, cell apoptosis, cytotoxicity, and subcellular Ca2+ localization in INS-1 cells were detected using a JC-1 probe, flow cytometry, and an lactate dehydrogenase kit. Results: PDZD8 expression was up-regulated in the islets of HFD mice and PA-treated pancreatic β-cells. PDZD8 knockdown markedly shortened MAM perimeter, suppressed the expression of MAM-related proteins IP3R1, glucose-regulated protein 75 (GRP75), and VDAC1, inhibited the interaction between VDAC1 and IP3R1, alleviated mitochondrial dysfunction and ER stress, reduced the expression of ER stress-related proteins, and decreased apoptosis while increased proliferation of pancreatic β-cells. Additionally, PDZD8 knockdown alleviated Ca2+ flow into the mitochondria and decreased cyclophilin D (Cypd) expression. Cypd overexpression alleviated the promoting effect of PDZD8 knockdown on the apoptosis of β-cells. Conclusion PDZD8 knockdown inhibited pancreatic β-cell death in DM by alleviated ER-mitochondria contact and the flow of Ca2+ into the mitochondria.

Background: Diabetes mellitus (DM) is a chronic metabolic disease that poses serious threats to human physical and mental health worldwide. The PDZ domain-containing 8 (PDZD8) protein mediates mitochondria-associated endoplasmic reticulum (ER) membrane (MAM) formation in mammals. We explored the role of PDZD8 in DM and investigated its potential mechanism of action. Methods: High-fat diet (HFD)- and streptozotocin-induced mouse DM and palmitic acid (PA)-induced insulin 1 (INS-1) cell models were constructed. PDZD8 expression was detected using immunohistochemistry, quantitative real-time polymerase chain reaction (qRT-PCR), and Western blotting. MAM formation, interactions between voltage-dependent anion-selective channel 1 (VDAC1) and inositol 1,4,5-triphosphate receptor type 1 (IP3R1), pancreatic β-cell apoptosis and proliferation were detected using transmission electron microscopy (TEM), proximity ligation assay (PLA), terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay, immunofluorescence staining, and Western blotting. The mitochondrial membrane potential, cell apoptosis, cytotoxicity, and subcellular Ca2+ localization in INS-1 cells were detected using a JC-1 probe, flow cytometry, and an lactate dehydrogenase kit. Results: PDZD8 expression was up-regulated in the islets of HFD mice and PA-treated pancreatic β-cells. PDZD8 knockdown markedly shortened MAM perimeter, suppressed the expression of MAM-related proteins IP3R1, glucose-regulated protein 75 (GRP75), and VDAC1, inhibited the interaction between VDAC1 and IP3R1, alleviated mitochondrial dysfunction and ER stress, reduced the expression of ER stress-related proteins, and decreased apoptosis while increased proliferation of pancreatic β-cells. Additionally, PDZD8 knockdown alleviated Ca2+ flow into the mitochondria and decreased cyclophilin D (Cypd) expression. Cypd overexpression alleviated the promoting effect of PDZD8 knockdown on the apoptosis of β-cells. Conclusion PDZD8 knockdown inhibited pancreatic β-cell death in DM by alleviated ER-mitochondria contact and the flow of Ca2+ into the mitochondria.

Background: Diabetes mellitus (DM) is a chronic metabolic disease that poses serious threats to human physical and mental health worldwide. The PDZ domain-containing 8 (PDZD8) protein mediates mitochondria-associated endoplasmic reticulum (ER) membrane (MAM) formation in mammals. We explored the role of PDZD8 in DM and investigated its potential mechanism of action. Methods: High-fat diet (HFD)- and streptozotocin-induced mouse DM and palmitic acid (PA)-induced insulin 1 (INS-1) cell models were constructed. PDZD8 expression was detected using immunohistochemistry, quantitative real-time polymerase chain reaction (qRT-PCR), and Western blotting. MAM formation, interactions between voltage-dependent anion-selective channel 1 (VDAC1) and inositol 1,4,5-triphosphate receptor type 1 (IP3R1), pancreatic β-cell apoptosis and proliferation were detected using transmission electron microscopy (TEM), proximity ligation assay (PLA), terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay, immunofluorescence staining, and Western blotting. The mitochondrial membrane potential, cell apoptosis, cytotoxicity, and subcellular Ca2+ localization in INS-1 cells were detected using a JC-1 probe, flow cytometry, and an lactate dehydrogenase kit. Results: PDZD8 expression was up-regulated in the islets of HFD mice and PA-treated pancreatic β-cells. PDZD8 knockdown markedly shortened MAM perimeter, suppressed the expression of MAM-related proteins IP3R1, glucose-regulated protein 75 (GRP75), and VDAC1, inhibited the interaction between VDAC1 and IP3R1, alleviated mitochondrial dysfunction and ER stress, reduced the expression of ER stress-related proteins, and decreased apoptosis while increased proliferation of pancreatic β-cells. Additionally, PDZD8 knockdown alleviated Ca2+ flow into the mitochondria and decreased cyclophilin D (Cypd) expression. Cypd overexpression alleviated the promoting effect of PDZD8 knockdown on the apoptosis of β-cells. Conclusion PDZD8 knockdown inhibited pancreatic β-cell death in DM by alleviated ER-mitochondria contact and the flow of Ca2+ into the mitochondria.