1.Key Quality Control Items and Testing Points of Sheet for Oral Solid Preparation in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Xiaohui YU ; Wei XIONG ; Bin LIU ; Yiwei ZHAO ; Lei CHEN ; Kai XU
Herald of Medicine 2025;44(7):1065-1069
To promote the understanding of the requirements of sheet for oral solid preparation in the Pharmacopoeia of the People's Republic of China(2025 edition)and improve the quality control level of related parties in production and use,the key quality control items specified in Pharmacopoeia of the People's Republic of China and the testing points were analyzed and discussed combined with the current situation of sheet for oral solid preparation industry and relevant standards at home and abroad.Suggestion was given that quality control should be carried out according to product characteristics,application,production process,and risk assessment,and reasonable limits should be set.
2.Analysis of characteristics of hospitalized patients with acute myocardial infarction in a certain hospital from 2014 to 2023
Wen ZHANG ; Xinxin ZHANG ; Xiaoying NIE ; Ying XU ; Wenjia LI ; Yiwei GUO ; Beilei ZHANG ; Binchong WANG
Modern Hospital 2025;25(1):72-75
Objective To analyze the basic characteristics of patients with acute myocardial infarction in a tertiary hospi-tal from 2014 to 2023,and provide references for the prevention,treatment,management,and quality control of this disease.Methods Based on the data from the medical records of patients with acute myocardial infarction admitted to a tertiary hospital from January 1,2014,to December 31,2023,the basic characteristics of hospitalized patients and trends in hospitalization costs were analyzed to summarize the development patterns.Results Over the past decade,the number of hospitalized patients with a-cute myocardial infarction has been increasing,while the average length of hospital stay,average cost per hospitalization,and mortality rate have been decreasing.Among the 19 937 patients,there were 16 037 male patients(80.44%)and 3 900 female patients(19.56%),with a male-to-female ratio of 4.11∶1.The median age for male patients was 60 years,while for female patients it was 68 years,indicating that males tend to develop the disease approximately 10 years earlier than females.Among pa-tients aged 60 and above,the mortality rate is positively correlated with age,while among patients below 60,the mortality rate is negatively correlated with age.The decision to undergo surgery has a significant impact on hospitalization costs.From the per-spective of cost structure,the proportion of consumables has decreased from 69.81%to 54.60%in the past decade but remains relatively high.Conclusion With the advancement of hospital management and medical insurance policies,the diagnosis,treat-ment,and quality of care for acute myocardial infarction have significantly improved.However,consumables management remains a key focus.Men and individuals aged 50 and above should be given special attention.During the diagnosis and treatment process,greater attention should also be given to younger or older patients and female patients to reduce the mortality rate.
3.Correlation between GST gene polymorphism and concentration of azathioprine active metabolite 6-TGN in patients with inflammatory bowel disease
Jiashan DONG ; Jiarui CHEN ; Dayong ZENG ; Yiwei LIU ; Jianwen XU ; Rongfang LIN
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(10):1383-1390
AIM:To investigate the effects of glutathione-S-transferase(GST)gene polymorphism on the concentration of 6-thioguanine nucleotides(6-TGN),an active metabolite of azathioprine(AZA),in patients with inflammatory bowel disease(IBD),in order to provide reference for the optimization of AZA treatment in patients.METHODS:The clini-cal data of patients with IBD treated by AZA were collected prospectively,the genotypes of GST-A1,GST-M1,GST-P1 and GST-T1 were detected by tar-geted sequencing of multiplex PCR combined with high-throughput sequencing technology before ad-ministration,and the steady-state trough concen-trations of 6-TGN in patients' red blood cells were determined by HPLC.Statistical analysis was carried out by SPSS 26.0 software.RESULTS:A total of 90 patients were included in this study.The alleles fre-quencies of GST-A1,GST-M1,GST-P1 and GST-T1 were consistent with Hardy-Weinberg equilibrium law.Logistic regression analysis showed that carry-ing GST-A1 mutant gene was an independent risk factor for the increase of trough concentration of 6-TGN(low concentration OR=17.50,P=0.030;high concentration OR=3.60,P=0.033),while the gene polymorphism of GST-M1,GST-P1,GST-T1 had no significant correlation with the concentration of 6-TGN(P>0.05).CONCLUSION:The gene polymor-phism of GST-A1 may affect the concentration of 6-TGN,an active metabolite of AZA,and detection of GST-A1 genotype before AZA treatment will contrib-ute to clinical individualized medication.
4.Correlation between GST gene polymorphism and concentration of azathioprine active metabolite 6-TGN in patients with inflammatory bowel disease
Jiashan DONG ; Jiarui CHEN ; Dayong ZENG ; Yiwei LIU ; Jianwen XU ; Rongfang LIN
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(10):1383-1390
AIM:To investigate the effects of glutathione-S-transferase(GST)gene polymorphism on the concentration of 6-thioguanine nucleotides(6-TGN),an active metabolite of azathioprine(AZA),in patients with inflammatory bowel disease(IBD),in order to provide reference for the optimization of AZA treatment in patients.METHODS:The clini-cal data of patients with IBD treated by AZA were collected prospectively,the genotypes of GST-A1,GST-M1,GST-P1 and GST-T1 were detected by tar-geted sequencing of multiplex PCR combined with high-throughput sequencing technology before ad-ministration,and the steady-state trough concen-trations of 6-TGN in patients' red blood cells were determined by HPLC.Statistical analysis was carried out by SPSS 26.0 software.RESULTS:A total of 90 patients were included in this study.The alleles fre-quencies of GST-A1,GST-M1,GST-P1 and GST-T1 were consistent with Hardy-Weinberg equilibrium law.Logistic regression analysis showed that carry-ing GST-A1 mutant gene was an independent risk factor for the increase of trough concentration of 6-TGN(low concentration OR=17.50,P=0.030;high concentration OR=3.60,P=0.033),while the gene polymorphism of GST-M1,GST-P1,GST-T1 had no significant correlation with the concentration of 6-TGN(P>0.05).CONCLUSION:The gene polymor-phism of GST-A1 may affect the concentration of 6-TGN,an active metabolite of AZA,and detection of GST-A1 genotype before AZA treatment will contrib-ute to clinical individualized medication.
5.Key Quality Control Items and Testing Points of Sheet for Oral Solid Preparation in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Xiaohui YU ; Wei XIONG ; Bin LIU ; Yiwei ZHAO ; Lei CHEN ; Kai XU
Herald of Medicine 2025;44(7):1065-1069
To promote the understanding of the requirements of sheet for oral solid preparation in the Pharmacopoeia of the People's Republic of China(2025 edition)and improve the quality control level of related parties in production and use,the key quality control items specified in Pharmacopoeia of the People's Republic of China and the testing points were analyzed and discussed combined with the current situation of sheet for oral solid preparation industry and relevant standards at home and abroad.Suggestion was given that quality control should be carried out according to product characteristics,application,production process,and risk assessment,and reasonable limits should be set.
6.Discussion on the Pathogenesis and Treatment of Knee Osteoarthritis from the Theory of"Deficient Qi Stagnation"Based on Mitophagy
Zifeng YE ; Gaoyan KUANG ; Yiwei YUAN ; Liguo QIU ; Xiaotong XU ; Zhi WEN ; Min LU
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(8):14-18
Mitophagy,a critical regulator of knee joint homeostasis,its dysfunction can lead to pathological changes such as reactive oxygen species overproduction,calcium ion overload,and extracellular matrix degradation,inducing cartilage degeneration and serving as a key pathological mechanism of knee osteoarthritis(KOA)."Deficient qi stagnation"represents the core pathogenesis of KOA.Mitochondria,analogous in function to qi and serving as its microscopic manifestation,exhibit a high degree of congruence between mitophagy and the defensive functions of qi.Based on the pathogenic characteristics of"deficient qi stagnation"of KOA,and integrating modern medical explanations of mitophagy,this article believed that the deficiency of liver,spleen and kidney qi is the fundamental reason for the imbalance of mitochondrial autophagy in KOA,and the retention of pathogenic toxins is the key factor in the imbalance of mitochondrial autophagy.The basic treatment method of tonifying qi and strengthening the body,promoting blood circulation and promoting stagnation can provide clinical formula ideas for the TCM prevention and treatment of KOA.
7.Analysis of quality control and radiation protection testing data of selected medical electron linear accelerators in Shandong Province, China
Bao TAO ; Hui SHANG ; Lihei DE ; Ying GUO ; Tao XU ; Yiwei ZHANG
Chinese Journal of Radiological Health 2025;34(6):824-829
Objective To investigate the status of quality control of medical electron linear accelerators and radiation protection of machine rooms housing these accelerators in Shandong Province. Methods A total of 52 medical electron linear accelerators in 40 hospitals across Shandong Province were selected as the study subjects. A series of indicators were tested according to relevant quality control testing specifications and radiation protection testing standards. Statistical analysis was performed using SPSS 25.0. Results The five performance indicators of the 52 medical electron linear accelerators, including offset of the radiation beam axis relative to the equal center point (hereinafter referred to as the equal center point offset), dose deviation, output dose repeatability, output dose linearity, and uniformity of the square X-ray radiation field (10 cm × 10 cm), all had a qualified rate of 100%. The dose deviation of accelerators in secondary hospitals was superior to that in tertiary hospitals. The output dose linearity and uniformity of the square X-ray radiation field of accelerators in tertiary hospitals were superior to those in secondary hospitals. All machine rooms housing the investigated medical electron linear accelerators were qualified in radiation protection testing. Conclusion The performance indicators of the medical electron linear accelerators investigated in this study and the radiation protection of machine rooms all complied with national standards. Relevant hospitals should continue to strictly implement radiation protection standards and strengthen the supervision of the equipment sites.
8.Epidemiological Analysis of Pathogens in Acute Respiratory Infections During the 2023-2024 Autumn-Winter Season in Beijing:A Case Series of 5556 Patients at Peking Union Medical College Hospital
Yan CAO ; Yu CHEN ; Jie YI ; Lingjun KONG ; Ziyi WANG ; Rui ZHANG ; Qi YU ; Yiwei LIU ; Maimaiti MULATIJIANG ; Chenglin YANG ; Yujie SUN ; Yingchun XU ; Qiwen YANG ; Juan DU
Medical Journal of Peking Union Medical College Hospital 2025;16(3):680-686
Objective To analyze the epidemiological characteristics of acute respiratory infections(ARIs)during the autumn-winter season in Beijing,providing evidence for the prevention,control,diagnosis,and treatment of ARIs.Methods A convenience sampling method was employed,enrolling patients who visited Peking Union Medical College Hospital(PUMCH)between September 2023 and February 2024 due to ARIs.Na-sopharyngeal swabs were collected,and real-time fluorescence quantitative PCR was used to detect six common respiratory pathogens[influenza A virus(FluA),influenza B virus(FluB),human rhinovirus(HRV),Myco-plasma pneumoniae(MP),respiratory syncytial virus(RSV),and adenovirus(ADV)],as well as SARS-CoV-2 infection.The distribution patterns of pathogen infections were analyzed.Results A total of 5556 eligible patients were included.The overall positivity rate for the six common respiratory pathogens was 63.7%,with sin-gle-pathogen positivity at 54.0%,dual-pathogen positivity at 8.9%,and triple or more pathogen positivity at 0.7%.The predominant pathogens detected were FluA(16.1%)and RSV(15.7%),followed by ADV(11.1%),MP(11.1%),HRV(10.0%),and FluB(10.0%).No significant difference in overall pathogen positivity was observed between genders.However,significant differences were found between autumn and winter(x2=34.617,P<0.001)and among pediatric,young/middle-aged,and elderly patients(x2=422.38,P<0.001).Specifically,MP(x2=8.647,P=0.003),FluA(x2=131.932,P<0.001),and HRV(x2=174.199,P<0.001)exhibited significantly higher positivity rates in autumn than in winter,whereas FluB was more prevalent in winter(x2=287.894,P<0.001).In pediatric patients,MP,RSV,HRV,and ADV positivity rates were significantly higher than in young/middle-aged and elderly patients(all P<0.001),whereas FluB was more common in young/middle-aged patients(both P<0.001).The positivity rates of the six common respiratory pathogens significantly declined during the SARS-CoV-2 epidemic period,exhibiting an asynchronous seasonal pattern.Conclusions The prevalence of respiratory pathogens in Beijing is associated with age and season.Tar-geted preventive measures should be implemented in different seasons and for key populations.
9.Unlocking the role of wound microbiome in diabetic, burn, and germ-free wound repair treated by natural and synthetic scaffolds.
Zeyu XU ; Lixiang ZHANG ; Qinghan TANG ; Chenxi YANG ; Xiaotong DING ; Ziyu WANG ; Rizhong HUANG ; Ruihan JIANG ; Joannake MAITZ ; Huaikai SHI ; Xin YAN ; Mei DONG ; Jun CHEN ; Yiwei WANG
Acta Pharmaceutica Sinica B 2025;15(1):611-626
In current clinical practice, various dermal templates and skin substitutes are used to enhance wound healing. However, the role of wound commensal microbiome in regulating scaffold performance and the healing process remains unclear. In this study, we investigated the influence of both natural and synthetic scaffolds on the wound commensal microbiome and wound repair in three distinct models including diabetic wounds, burn injuries, and germ-free (GF) wounds. Remarkably, synthetic electrospun polycaprolactone (PCL) scaffolds were observed to positively promote microbiome diversity, leading to enhanced diabetic wound healing compared to the natural scaffolds Integra® (INT) and MatriDerm® (MAD). In contrast, both natural and synthetic scaffolds exhibited comparable effects on the diversity of the microbiome and the healing of burn injuries. In GF wounds with no detectable microorganisms, a reversed healing rate was noted showing natural scaffold (MAD) accelerated wound repair compared to the open or the synthetic scaffold (PCL) treatment. Furthermore, the response of the wound commensal microbiome to PCL scaffolds appears pivotal in promoting anti-inflammatory factors during diabetic wound healing. Our results emphasize that the wound commensal microbiome, mediated by different scaffolds plays an important role in the wound healing process.
10.Caffeic acid-vanadium nanozymes treat skin flap ischemia-reperfusion injury through macrophage reprogramming and the upregulation of X-linked inhibitors of apoptotic proteins.
Xinyu ZHAO ; Jie SHAN ; Hanying QIAN ; Xu JIN ; Yiwei SUN ; Jianghao XING ; Qingrong LI ; Xu-Lin CHEN ; Xianwen WANG
Acta Pharmaceutica Sinica B 2025;15(1):592-610
Ischemia-reperfusion (I/R) injury following skin flap transplantation is a critical factor leading to flap necrosis and transplant failure. Antagonizing inflammatory responses and oxidative stress are regarded as crucial targets for mitigating reperfusion injury and enhancing flap survival. In this study, caffeic acid-vanadium metal polyphenol nanoparticles (CA-V NPs) were prepared for the treatment of skin flap ischemia and reperfusion. This study was conducted using a one-step method to prepare new types of CA-V NPs with uniform sizes and stable structures. In vitro, the CA-V NPs exhibited CAT-like and SOD-like activities and could effectively scavenge ROS, generate oxygen, and alleviate oxidative stress. In the H2O2-induced cellular oxidative stress model, CA-V NPs effectively reduced ROS levels and inhibited apoptosis through the XIAP/Caspase-3 pathway. In the cellular inflammation model induced by LPS combined with IFN-γ, CA-V NPs reprogrammed macrophage polarization toward the M2 phenotype and reduced inflammatory responses by reducing the expression of the chemokines CCL4 and CXCL2. In addition, animal experiments have shown that CA-V NPs can alleviate oxidative stress in skin flap tissues, inhibit apoptosis, promote angiogenesis, and ultimately improve the survival rate of skin flaps. CA-V NPs provide a new target and strategy for the treatment of flap I/R injury.

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