Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

AIM: To compare and analyze the efficacy of femtosecond laser-assisted in situ keratomileusis(FS-LASIK)with small incision lenticule extraction(SMILE)in the treatment of moderate myopia.METHODS:Retrospective study. A total of 100 patients(100 eyes)with moderate myopia admitted to our hospital from August 2022 to October 2024 were selected(all the data of the right eye were taken for study). The 52 cases in FS-LASIK group received FS-LASIK, while the 48 cases in SMILE group received SMILE. The patients were followed up for 6 mo, the visual recovery, spherical equivalent, corneal curvature, corneal Q value, central corneal thickness, corneal volume, high-order aberrations, corneal biomechanical parameters and incidence of complications were compared between the two groups.RESULTS: At 3 and 6 mo after surgery, the uncorrected visual acuity(UCVA)and spherical equivalent of both groups increased compared to before surgery(all P<0.05). At 6 mo after surgery, both groups showed a decrease in corneal curvature, central corneal thickness, and corneal volume, with the FS-LASIK group having a lower corneal volume; both groups showed a great increase in Q values, with the FS-LASIK group having a higher Q value(all P<0.001); the total high-order aberration, spherical aberration, and trefoil aberration all increased in both groups, with higher values observed in the FS-LASIK group(all P<0.001); the integrated radius(IR), inverse concave radius(ICR)and deformation amplitude ratio 2(DAR2)were all increased, while the stiffness parameter at first applanation(SP-A1), the highest concavity radius(HC-Radius)and the ambrosio's relational thickness to the horizontal profile(ARTh)were all decreased in both groups(all P<0.001). There was no statistical difference in the incidence of complications between two groups(P>0.05).CONCLUSION: Both FS-LASIK and SMILE can help improve the visual quality of patients with moderate myopia, and their early postoperative corneal morphological changes have their own characteristics. In addition, patients who receive FS-LASIK have larger corneal Q value and high-order aberrations after surgery.

Objective To analyze the death rate and life loss of injuries in Jinshan District of Shanghai from 1990 to 2023, and to provide a scientific basis for the formulation of injury prevention and control measures. Methods Excel 2010 was used to establish a database for injury death reports in Jinshan District from 1990 to 2023, and the crude mortality rate, standardized mortality rate, age-specific mortality rate, potential years of life lost (PYLL), rate of potential years of life lost (PYLLR) and standardized rate of potential years of life lost (SPYLLR) were calculated. Results From 1990 to 2023, the crude mortality rate due to injuries in Jinshan District was 52.25/100 000, while the standardized mortality rate was 36.95/100 000. Based on the standardized mortality rate, the top four causes of injury-related deaths were traffic accidents, falls, drowning, and suicide. Traffic accidents ranked first as the leading cause of death for both males (19.30/100 000) and females (8.41/100 000). The top cause of death for the 0-14 years old group was drowning, the 15-64 years old group was traffic accidents, and the 65 years old and above was falls. Over the 34-year period, according to SPYLLR, the top four causes of death for both genders were consistently traffic accidents, drowning, suicide, and falls. Conclusion From 1990 to 2023, traffic accidents, falls, drowning, and suicide have been the primary causes of injury-related deaths in Jinshan District, Shanghai. It is essential to develop targeted prevention and control strategies based on the specific characteristics of these injury-related fatalities.

Bone repair remains an important target in tissue engineering, making the development of bioactive scaffolds for effective bone defect repair a critical objective. In this study, β-tricalcium phosphate (β-TCP) scaffolds incorporated with processed pyritum decoction (PPD) were fabricated using three-dimensional (3D) printing-assisted freeze-casting. The produced composite scaffolds were evaluated for their mechanical strength, physicochemical properties, biocompatibility, in vitro pro-angiogenic activity, and in vivo efficacy in repairing rabbit femoral defects. They not only demonstrated excellent physicochemical properties, enhanced mechanical strength, and good biosafety but also significantly promoted the proliferation, migration, and aggregation of pro-angiogenic human umbilical vein endothelial cells (HUVECs). In vivo studies revealed that all scaffold groups facilitated osteogenesis at the bone defect site, with the β-TCP scaffolds loaded with PPD markedly enhancing the expression of neurogenic locus Notch homolog protein 1 (Notch1), vascular endothelial growth factor (VEGF), bone morphogenetic protein-2 (BMP-2), and osteopontin (OPN). Overall, the scaffolds developed in this study exhibited strong angiogenic and osteogenic capabilities both in vitro and in vivo. The incorporation of PPD notably promoted the angiogenic-osteogenic coupling, thereby accelerating bone repair, which suggests that PPD is a promising material for bone repair and that the PPD/β-TCP scaffolds hold great potential as a bone graft alternative.
Calcium Phosphates/chemistry* ; Animals ; Bone Regeneration ; Rabbits ; Tissue Scaffolds ; Printing, Three-Dimensional ; Humans ; Human Umbilical Vein Endothelial Cells ; Neovascularization, Physiologic ; Osteogenesis ; Tissue Engineering/methods* ; Biomimetic Materials ; Cell Proliferation ; Angiogenesis

Total laryngectomy is a crucial surgical intervention for patients with advanced malignant tumors of the larynx and nasopharynx. Despite its effectiveness, this procedure permanently severs the connection between the nasal cavity and the lower respiratory tract, leading to the cessation of nasal airflow. This disruption significantly impairs the patient's sense of smell and adversely affects their quality of life. Although olfactory loss is common in these patients, the assessment and rehabilitation of their olfactory function are often overlooked. This article reviews relevant literature on evaluating olfactory function and rehabilitation methods following total laryngectomy, with the aim of providing a theoretical foundation to enhance olfactory rehabilitation and overall quality of life for these patients.
Humans ; Laryngectomy/rehabilitation* ; Quality of Life ; Smell ; Laryngeal Neoplasms/surgery* ; Olfaction Disorders/etiology*

ADC189 is a novel drug of cap-dependent endonuclease inhibitor. In our study, its antiviral efficacy was evaluated in vitro and in vivo, and compared with baloxavir marboxil and oseltamivir. A first-in-human phase I study in healthy volunteers included single ascending dose (SAD) and food effect (FE) parts. In the preclinical study, ADC189 showed potent antiviral activity against various types of influenza viruses, including H1N1, H3N2, influenza B virus, and highly pathogenic avian influenza, comparable to baloxavir marboxil. Additionally, ADC189 exhibited much better antiviral efficacy than oseltamivir in H1N1 infected mice. In the phase I study, ADC189 was rapidly metabolized to ADC189-I07, and its exposure increased proportionally with the dose. The terminal elimination half-life (T_1/2) ranged from 76.69 to 98.28 hours. Of note, food had no effect on the concentration, clearance, and exposure of ADC189. It was well tolerated, with few treatment-emergent adverse events (TEAEs) reported and no serious adverse events (SAEs). ADC189 demonstrated excellent antiviral efficacy both in vitro and in vivo. It was safe, well-tolerated, and had favorable pharmacokinetic characteristics in healthy volunteers, supporting its potential for single oral dosing in clinical practice.
Humans ; Antiviral Agents/therapeutic use* ; Animals ; Male ; Adult ; Mice ; Female ; Endonucleases/antagonists & inhibitors* ; Influenza, Human/drug therapy* ; Young Adult ; Dibenzothiepins/pharmacology* ; Oseltamivir/pharmacology* ; Middle Aged ; Triazines/pharmacology* ; Thiepins/pharmacology* ; Influenza B virus/drug effects* ; Influenza A Virus, H1N1 Subtype/drug effects* ; Pyridines/pharmacology* ; Morpholines ; Pyridones

Objective To investigate the changes and clinical significance of serum 25-hydroxyvitamin D3[25(OH)D3],blood calcium and bone metabolism indexes in menopausal women with benign paroxysmal positional vertigo(BPPV).Methods A total of 103 menopausal BPPV patients from Hangzhou Ninth People's Hospital from August 2020 to August 2021 were enrolled into BPPV group.According to the one-year recurrence situation,they were divided into recurrence group(n=18)and non-recurrence group(n=85).A total of 50 healthy menopausal women during the same period were enrolled as control group.The clinical data,serum 25(OH)D3,calcium and bone metabolism indexes[procollagen typeⅠN-terminal propeptide(PINP),N-terminal midfragment of osteocalcin(N-MID),β-isomerised C-terminal telopeptide of collagen typeⅠ(β-CTX),bone alkaline phosphatase(BALP)]were collected.Logistic regression model was constructed to analyze the risk factors of BPPV in menopausal women.The predictive value of related indexes for BPPV recurrence was analyzed by receiver operating characteristic curves.Results The serum 25(OH)D3 level in BPPV group was significantly lower than that in control group(P<0.05),and the proportion of long-term irregular diet,PINP,N-MID and BALP levels were significantly higher than those in control group(P<0.05).Multivariate Logistic regression analysis showed that low 25(OH)D3,high PINP,high N-MID and high BALP were all risk factors for BPPV in menopausal women(P<0.05).The 25(OH)D3 level in recurrence group was significantly lower than that in non-recurrence group(P<0.05),and the PINP,N-MID and BALP levels were significantly higher than those in non-recurrence group(P<0.05).The area under the curve(AUC)of 25(OH)D3,PINP,N-MID,BALP and the four combined predictions for BPPV recurrence were 0.833,0.654,0.697,0.782 and 0.910,respectively,and the AUC of the four combined predictions was the largest.The sensitivity and specificity were 98.97%and 70.62%,respectively.Conclusion There is no significant change in level of serum calcium in menopausal women with BPPV.Decreased serum 25(OH)D3 and increased PINP,N-MID and BALP are risk factors of BPPV,which can be applied to predict BPPV recurrence.

Objective: To investigate the achievement of the target for blood glucose control among community patients with type 2 diabetes mellitus (T2DM) and its influencing factors, so as to provide insights into developing blood glucose management strategies and intervention measures. Methods: Basic information, lifestyle, medication use, disease history, and HbA1c test results of T2DM patients aged 18 years and older and living in Jinshan District, Shanghai Municipality for more than 6 months were collected through Jinshan District Chronic Disease Follow up Management System and district-level information platform. The proportion of blood glucose achieving the control target (HbA1c<7%) was analyzed. Factors affecting the achievement of the target for blood glucose control were identified using a multivariable logistic regression model. Results: A total of 16 758 T2DM patients were included, with 7 844 males (46.81%) and 8 914 females (53.19%), and a median age of 69.00 (interquartile range, 12.00) years. There were 8 095 patients achieving the blood glucose control target, accounting for 48.31%. Multivariable logistic regression analysis showed that age (60-69 years, OR=0.749, 95%CI: 0.675-0.832; 70-79 years, OR=0.892, 95%CI: 0.801-0.993; ≥80 years, OR=1.238, 95%CI: 1.086-1.411), body mass index (overweight, OR=0.926, 95%CI: 0.863-0.993; obesity, OR=0.800, 95%CI: 0.718-0.891), disease course (6-10 years, OR=0.728, 95%CI: 0.673-0.787; ≥11 years, OR=0.534, 95%CI: 489-0.583), smoking (daily, OR=0.792, 95%CI: 0.730-0.860), drinking (daily, OR=0.788, 95%CI: 0.642-0.967), medication adherence (intermittent, OR=0.293, 95%CI: 0.271-0.317; self discontinuation, OR=0.074, 95%CI: 0.064-0.087), hypertension (OR=0.643, 95%CI: 0.588-0.703) and cardiovascular and cerebrovascular diseases (OR=0.671, 95%CI: 0.563-0.800) were the influencing factors for the achievement of the target for blood glucose control among T2DM patients. Conclusion The blood glucose control among T2DM patients is mainly affected by age, body mass index, disease course, smoking, drinking, medication adherence and comorbidities.

Objective To observe the effects of Daizong Prescription on glycogen metabolism in adipose tissue of obese mice;To explore its regulatory mechanism in activating browning in the white adipose tissue.Methods A obesity model was established by feeding high-fat diet to C57BL/6J mice.The obese mice were divided into model group,metformin group(0.15 g/kg),and Daizong Prescription low-(0.20 g/kg)and high-dosage(0.40 g/kg)groups.Mice fed a standard diet were set as the normal group,with 12 mice in each group.Each medication group was given corresponding drugs by gavage for 6 consecutive weeks.Body mass and fasting blood glucose were monitored,serum triglycerides(TG),total cholesterol(TC),high-density lipoprotein cholesterol(HDL-C),and low-density lipoprotein cholesterol(LDL-C)contents were measured.Brown adipose tissue from the interscapular region and white adipose tissue from the inguinal,perirenal and epididymal region were collected,the adipose tissue mass was measured,and the body fat coefficient was calculated.HE staining was performed to observe morphological changes in adipose tissue,PAS staining was used to observe glycogen distribution in adipose tissue,immunohistochemistry staining was performed to detect the expressions of Gys2,Ppp1r3c,and GSK-3β in inguinal white adipose tissue.Results Compared with the normal group,the body mass and fasting blood glucose in different time points of the model group significant increase(P<0.05,P<0.01),and serum TC and HDL-C contents significantly increased(P<0.01);the mass and body fat coefficient of white adipose tissue in inguinal,perirenal,and epididymis significantly increased(P<0.01),the cells in white adipose tissue in inguinal were hypertrophic and appeared as large vacuoles,with less glycogen accumulation,the expressions of Gys2 and Ppp1r3c significantly decreased(P<0.01).Compared with the model group,the mice in Daizong Prescription high-dosage group showed a significant decrease in body mass and fasting blood glucose at 4 and 6 weeks of administration(P<0.05,P<0.01),and the contents of serum TG,TC,HDL-C,and LDL-C were significantly decreased(P<0.01);the mass and body fat coefficient in white adipose tissue of perirenal and epididymal significantly decreased(P<0.05,P<0.01),and the mass of inguinal white adipose tissue significantly decreased(P<0.05),multiple irregularly shaped small vacuoles could be seen in inguinal white adipose tissue,accompanied by nuclear aggregation and increased glycogen accumulation,the expressions of Gys2 and Ppp1r3c significantly increased(P<0.01).There was no significant difference in the expression of GSK-3β inguinal white adipose tissue of mice among the groups.Conclusion Daizong Prescription can increase the activity of Gys2 by upregulating the expression of Ppp1r3c,promote glycogen synthesis,induce browning of adipose tissue,increase fat heat production,and improve obesity and related disorders of glycolipid metabolism.

Objective:To analyze the differentially expressed genes of human respiratory syncytial virus (RSV) subtype A genotype ON1, a predominant genotype in Beijing, after infecting A549 cells using transcriptomic sequencing, and provide potential targets for RSV prevention and treatment.Methods:A local strain (61397-ON1) identified by whole-genome sequencing as ON1 genotype of RSV subtype A was selected to infect A549 cells. Total mRNA was extracted, and the differentially expressed genes in infected and uninfected A549 cells were screened by transcriptomic sequencing. GO analysis and KEGG pathway analysis were performed. Besides, six genes with differential expression ratio greater than two times were randomly selected for qRT-PCR verification.Results:There were 1 632 differentially expressed genes between infected and uninfected A549 cells, of which 807 genes were up-regulated and 825 genes were down-regulated. The differentially expressed genes were mainly involved in immune response-related biological processes such as cytokine response and positive regulation of MAPK cascades, and were enriched in MAPK signaling pathway, NOD-like receptor signaling pathway, p53 signaling pathway, TNF signaling pathway, IL-17 signaling pathway and NF-κB signaling pathway. The results of qRT-PCR for six differentially expressed genes were consistent with the trend of transcriptome data.Conclusions:The differentially expressed genes of RSV A subtype ON1 genotype after infecting A549 cells are mainly involved in cytokine response and immune-related signaling pathways. This study provides basic data for further study of the molecular mechanism of RSV infection and the development of prevention and treatment strategies.