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 observe the feelings of listening to music and the importance of music in the daily life of post-lingual deaf adults with cochlear implants, and to explore the relevant influencing factors.Methods:This was a cross-sectional survey study. From January 2021 to August 2021,the Music-Related Quality of Life Scale was used to evaluate the music needs and music experiences of 63 post-lingual deaf adults who met the inclusion criteria, including 27 males and 36 females, aged (40.7±12.3) years, at the time of surgery (36.8±13.1) years, and with a preoperative hearing aid ineffective time of (3.9±5.8) years. Indicators analyzed included age, duration of ineffective preoperative hearing aid wear, preoperative music preference, duration of postoperative cochlear implant use, current hearing aid modality, and auditory rehabilitation outcomes. Whether the six factors mentioned above constituted an influence on the subjects′ music listening was investigated using SPSS 25.0 statistical software.Results:All of the observations in the scale were correlated with a single factor. The two sub-dimensions of music experience section were related to the effect of auditory rehabilitation. In the importance section, the effect of auditory rehabilitation was the influential factor of the dimension of "participation importance", and the preoperative enjoyment of music was the relevant influential factor of the dimension of "perceived importance". There was a significant difference between the groups when they were grouped by the above factors ( P value<0.05), while there was no statistically significance between the groups when they were grouped by other factors ( P value>0.05). Conclusions:Post-lingual deaf adults show the need and attempt to listen to music after cochlear implantation. The effectiveness of auditory rehabilitation and the degree of music preference preoperatively are two important factors that influence music listening in implant recipients. Once the level of auditory communication has been restored to a certain degree, it is important to pay more attention to the needs of music for implant recipients and train them in time, especially for those with music preferences preoperatively.

Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic interstitial lung disease with an unclear etiology, characterized clinically by worsening dyspnea and dry cough. Its typical pathological features include excessive activation of fibroblasts and deposition of abundant extracellular matrix. Early diagnosis of IPF is challenging, treatment options are limited with significant constraints, and patients have a poor prognosis. SPECT and PET, as advanced representatives of molecular imaging, can reflect cellular functional abnormalities before anatomical structural abnormalities appear, thereby facilitating early diagnosis of IPF and optimization of treatment strategies, leading to improved prognosis. This review summarizes the research progress on molecular imaging targets and corresponding SPECT and PET probes in IPF.

Objective To explore the effectiveness of high-definition diffusion weighted imaging(DWI)sequence combined with T1 WI-fat suppression(FS)dynamic contrast enhancement(DCE)sequence for preoperative T-stage of rectal cancer by using 3.0T MRI standardized scanning.Methods A retrospective analysis was conducted on MRI images of 57 patients with rectal cancer confirmed by pathology.Before surgery,the patients underwent 3.0T MRI standardized rectal cancer scan methods,including routine sequence,high-definition DWI sequence,and T1 WI-FS DCE sequence,etc.Then two experienced physicians evaluated the T-stage of preoperative rectal cancer through high-definition DWI(transverse and sagittal sections)and T1 WI-FS DCE sequences in the double-blind method.Using the postoperative pathological results of rectal cancer as the"gold standard",two sequences were combined to evaluate the accuracy,sensitivity,and specificity of rectal cancer T-stage.Results Among the 57 cases,there were 9 cases of upper rectal cancer,39 cases of middle rectal cancer,and 9 cases of lower rectal cancer.The accuracy rates of preoperative T-stage diagnosis for rectal cancer by two evaluator were both 85.7％(6/7)in T1 stage,88.2％(15/17)and 94.1％(16/17)in T2 stage,96.9％(31/32)and 93.8％(30/32)in T3 stage,and both 100.0％(1/1)in T4 stage.For evaluator 1,the sensitivity and specificity of the rectal cancer T-stage diagnosis were 96.1％and 83.3％,and for evaluator 2 were 94.1％and 83.3％,respectively.For rectal cancer MRI diagnosis,the accuracy rates and sensitivity were higher when combining the high-definition DWI sequence and T1 WI-FS DCE sequence,compared with a single high-definition DWI sequence or T1 WI-FS DCE sequence,and the difference was statistically significant.The average preoperative apparent diffusion coefficient(ADC)value of rectal cancer was compared between the corresponding postoperative pathological T1 to T4 stage groups,and the difference was statistically significant.Conclusion The combination of high-definition DWI sequence and T1 WI-FS DCE sequence improves the accuracy of rectal cancer T-stage,providing assistance for personalized clinical treatment.

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.