The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.

Objective To investigate the effects of inclined axial compressive force and flexion moment on the anterior and posterior shear stiffness of the lumbosacral segment.Methods Six fresh-frozen human cadaveric L5-S1 segments were tested under intact and two progressively impaired structural conditions:intact,a 4-mm bilateral facet joint gap,and anterior discectomy with nucleus pulposus removal plus circumferential release of the inner annular fibers(disc injury).A 300 N axial compressive force was applied either vertically downward or with a 10° or 20° anterior inclination through the disc's shear center.Anterior(0 N to 250 N)and posterior(-50 N to 0 N)shear tests were conducted using a material testing machine.These tests were repeated under a 5 N-m flexion moment.The relative motion between L5 and Si was measured using a three-dimensional motion capture system.Results In the intact state,the inclination of the axial compressive force did not significantly alter anterior or posterior shear stiffness.However,the application of a flexion moment increased anterior shear stiffness by 49.3％.Progressive structural damage resulted in incremental increases in anteroposterior shear translation and corresponding reductions in stiffness.Notably,under combined loading with axial compression and flexion moment,anterior stiffness decreased from 939 N/mm(intact)to 224 N/mm(disc injury),while posterior stiffness decreased from 572 N/mm to 217 N/mm.Within the low-load range,no significant differences in shear stiffness were observed across any structural conditions,regardless of axial force inclination or combined with a flexion moment.Conclusions This study supports the clinical view that retro-inclination of the pelvis serves as a compensatory mechanism to enhance segmental shear stability.However,this compensatory capacity gradually diminishes and ultimately fails as spinal degeneration progresses.

This study aims to investigate the relationship between serum vitamin A(VA)and mar-bling grade and the effect of different levels of serum VA on slaughter performance and fatty acid composition and related gene expression in the longissimus dorsi muscle of Woking black cattle and Angus cattle.Thirty Woking black cattle and seventeen Angus cattle aged 30 months were ran-domly selected and analyzed for the linear relationship between serum VA and marbling grade af-ter slaughter.The cattle were divided into three groups:the low VA group,medium VA group and high VA group,ranked in order of VA value in both Woking black cattle and Angus cattle.Statisti-cal analysis of the effects of different types and levels of VA on marbling grade,slaughter performance,fatty acid composition,and the effects of different levels of VA on the expression of genes related to intramuscular fat deposition and other genes in Woking black cattle or Angus cat-tle were also analyzed.The results showed that the marbling grade of Woking black cattle increased numerically with increasing serum VA at slaughter(P=0.203),whereas Angus cattle showed a numerical decrease(P=0.139).Analyses of subsequent subgroups showed that Woking black cat-tle had significantly higher marbling grade and oleic acid,monounsaturated/saturated fatty acids ratio in the longissimus dorsi muscle compared to Angus cattle(P＜0.05).As serum VA levels in-creased,DHA was significantly higher and n-6/n-3 fatty acid ratio significantly lower in the longis-simus dorsi muscle of Woking black cattle(P＜0.05).Whereas VA was elevated in Angus cattle,a significant decrease in DHA and a significant increase in n-6/n-3 fatty acids(P＜0.05)were found.Furthermore,a notable up-or down-regulation(P＜0.05)of LPL,FABP4,PPARγ,C APZA2 and Villin 2 was observed in Woking black or Angus cattle,respectively,as VA levels increased.Based on these results,it was suggested that Woking black cattle require an appropriate increase in dieta-ry VA during the late fattening stage,which was found to produce a higher marbling grade and a higher percentage of beneficial fatty acids for human health when serum VA reached 80.7 IU/dL.Whereas Angus cattle still need to be restricted in ration VA content in the late fattening stage,when serum VA is elevated to 73.6 IU/dL,they produce beef that not only has a lower marbling grade but also has a corresponding reduction in fatty acids beneficial to human health.

Objective:Special clinical types of lung cancer nodules with " small tumors and big metastases" are seriously harmful to human health, but their clinical characteristics are rarely reported. The aim of this study is to analyse the clinical characteristics of these lung cancer nodules.Methods:From Jan. 2019 to Nov. 2024, patients with stage T1 solid lung cancer who were pathologically confirmed in the First Affiliated Hospital of Chongqing Medical University were prospectively collected and divided into lung cancer nodule with metastasis group (study group) and stage Ia lung cancer group (control group). The differences in clinical, imaging, pathological and molecular features between the two groups were compared, and the differences in the distribution of metastases in the study group and in patients with or without bone metastasis were analyzed.Results:A total of 827 patients with an average age of 62.65±11.01 years were included, including 425 in the study group and 402 in the control group. The proportion of males, number of smokers, nodule size and EGFR mutation rate in the study group were significantly higher than those in the control group (all P<0.05). Stage IV patients accounted for 63.76% in the study group, among which bone metastasis patients accounted for the highest proportion (51.66%), and alkaline phosphatase, calcium and phosphorus were significantly increased. Conclusions:Patients with smoking, male and solid lung cancer nodules are more likely to have " small tumor and large metastasis", and bone metastasis is the most common distant metastatic site. The increase of alkaline phosphatase, calcium and phosphorus is helpful for early identification of bone metastases.

Objective To investigate the effects of inclined axial compressive force and flexion moment on the anterior and posterior shear stiffness of the lumbosacral segment.Methods Six fresh-frozen human cadaveric L5-S1 segments were tested under intact and two progressively impaired structural conditions:intact,a 4-mm bilateral facet joint gap,and anterior discectomy with nucleus pulposus removal plus circumferential release of the inner annular fibers(disc injury).A 300 N axial compressive force was applied either vertically downward or with a 10° or 20° anterior inclination through the disc's shear center.Anterior(0 N to 250 N)and posterior(-50 N to 0 N)shear tests were conducted using a material testing machine.These tests were repeated under a 5 N-m flexion moment.The relative motion between L5 and Si was measured using a three-dimensional motion capture system.Results In the intact state,the inclination of the axial compressive force did not significantly alter anterior or posterior shear stiffness.However,the application of a flexion moment increased anterior shear stiffness by 49.3％.Progressive structural damage resulted in incremental increases in anteroposterior shear translation and corresponding reductions in stiffness.Notably,under combined loading with axial compression and flexion moment,anterior stiffness decreased from 939 N/mm(intact)to 224 N/mm(disc injury),while posterior stiffness decreased from 572 N/mm to 217 N/mm.Within the low-load range,no significant differences in shear stiffness were observed across any structural conditions,regardless of axial force inclination or combined with a flexion moment.Conclusions This study supports the clinical view that retro-inclination of the pelvis serves as a compensatory mechanism to enhance segmental shear stability.However,this compensatory capacity gradually diminishes and ultimately fails as spinal degeneration progresses.

Liquid-liquid phase separation is an important process in which intracellular biomolecules condense to form membraneless organelles,playing a significant role in cell signaling and gene expression regulation.Studies have shown that liquid-liquid phase separation may be involved in the occurrence and development of atherosclerosis and has po-tential applications in the diagnosis and treatment of the disease.This article introduces the concept and mechanism of liquid-liquid phase separation,delves into the relationship between liquid-liquid phase separation and atherosclerosis,sum-marizes the progress of liquid-liquid phase separation in atherosclerosis research,and looks forward to its application pros-pects.

Objective:The aim of this study is to analyse the clinical characteristics of Special clinical types of lung cancer nodules with "small tumors and big metastases" .Methods:From Jan. 2019 to Nov. 2024, patients with stage T1 solid lung cancer who were pathologically confirmed in the First Affiliated Hospital of Chongqing Medical University were prospectively collected and divided into lung cancer nodule with metastasis group (study group) and stage Ia lung cancer group (control group). The differences in clinical, imaging, pathological and molecular features between the two groups were compared, and the differences in the distribution of metastases in the study group and in patients with or without bone metastasis were analyzed.Results:A total of 827 patients with an average age of 62.65±11.01 years were included, including 425 in the study group and 402 in the control group. The proportion of males, number of smokers, nodule size and EGFR mutation rate in the study group were significantly higher than those in the control group (all P<0.05). Stage IV patients accounted for 63.76% in the study group, among which bone metastasis patients accounted for the highest proportion (51.66%), and alkaline phosphatase, calcium and phosphorus were significantly increased. Conclusions:Patients with smoking, male and solid lung cancer nodules are more likely to have "small tumor and large metastasis", and bone metastasis is the most common distant metastatic site. The increase of alkaline phosphatase, calcium and phosphorus is helpful for early identification of bone metastases.

The diagnosis,treatment,and prognosis evaluation of cervical spondylosis are challenging in clinic.Machine learning(ML)models can improve the accuracy and efficiency of cervical spondylosis diagnosis by processing complex clinical data,assist in selecting more precise treatment plans,and evaluate prognosis.Through the domestic and foreign literature review on the application of ML models in cervical spondylosis in recent years,the study classifies and summarizes the relevant models applied in the diagnosis,treatment,and prognosis evaluation of cervical spondylosis,introduces classic algorithms such as random forest,as well as new algorithms such as convolutional neural networks,deep neural networks and long short-term memory networks,aiming to provide reference ML solutions for various stages of cervical spondylosis diagnosis and treatment.

BACKGROUND: Neoadjuvant chemoradiotherapy followed by radical surgery has been a common practice for patients with locally advanced rectal cancer, but the response rate varies among patients. This study aimed to develop a ResNet-Vision Transformer based magnetic resonance imaging (MRI)-endoscopy fusion model to precisely predict treatment response and provide personalized treatment. METHODS: In this multicenter study, 366 eligible patients who had undergone neoadjuvant chemoradiotherapy followed by radical surgery at eight Chinese tertiary hospitals between January 2017 and June 2024 were recruited, with 2928 pretreatment colonic endoscopic images and 366 pelvic MRI images. An MRI-endoscopy fusion model was constructed based on the ResNet backbone and Transformer network using pretreatment MRI and endoscopic images. Treatment response was defined as good response or non-good response based on the tumor regression grade. The Delong test and the Hanley-McNeil test were utilized to compare prediction performance among different models and different subgroups, respectively. The predictive performance of the MRI-endoscopy fusion model was comprehensively validated in the test sets and was further compared to that of the single-modal MRI model and single-modal endoscopy model. RESULTS: The MRI-endoscopy fusion model demonstrated favorable prediction performance. In the internal validation set, the area under the curve (AUC) and accuracy were 0.852 (95% confidence interval [CI]: 0.744-0.940) and 0.737 (95% CI: 0.712-0.844), respectively. Moreover, the AUC and accuracy reached 0.769 (95% CI: 0.678-0.861) and 0.729 (95% CI: 0.628-0.821), respectively, in the external test set. In addition, the MRI-endoscopy fusion model outperformed the single-modal MRI model (AUC: 0.692 [95% CI: 0.609-0.783], accuracy: 0.659 [95% CI: 0.565-0.775]) and the single-modal endoscopy model (AUC: 0.720 [95% CI: 0.617-0.823], accuracy: 0.713 [95% CI: 0.612-0.809]) in the external test set. CONCLUSION The MRI-endoscopy fusion model based on ResNet-Vision Transformer achieved favorable performance in predicting treatment response to neoadjuvant chemoradiotherapy and holds tremendous potential for enabling personalized treatment regimens for locally advanced rectal cancer patients.
Humans ; Rectal Neoplasms/diagnostic imaging* ; Magnetic Resonance Imaging/methods* ; Male ; Female ; Middle Aged ; Neoadjuvant Therapy/methods* ; Aged ; Adult ; Chemoradiotherapy/methods* ; Endoscopy/methods* ; Treatment Outcome