To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Aim To establish and evaluate an alternative meth-od for detecting skin sensitization of cosmetics based on local lymph node assay using bromodeoxyuridine(BrdU)with flow cytometry(FCM).Methods(1)25％hexyl cinnamic alde-hyde(HCA)was chosen as a positive control with an acetone:olive oil(4∶1,V/V,AOO)mixture as a vehicle control for the experiment.The dorsal sides of both ears of mice were treated with test solutions on day 1,day 2,and day 3.Brdu solution was injected inter-peritoneally on day 5.On day 6,the bilateral ears and mandibular lymph nodes were excised,and the number of Brdu positive cells was measured by flow cytometry.The stim-ulation index(SI)was calculated to identify whether it was ≥3,in order to establish the method of LLNA:Brdu-FCM.(2)BrdU-FCM test was conducted using a blind method with the fif-teen reference substances listed in OECD TG429 whose skin sensitization potentials were known.The test substances were dissolved in AOO,N,N-dimethylformamide(DMF)or dimeth-yl sulfoxide(DMSO)at three different concentrations.Tests were performed the same as above.SI and EC2.7 were calculat-ed to evaluate whether the test substance was categorized as a skin sensitizer.The reliability and accuracy of the method were validated by comparing the classification of test substances with that in OECD TG429.Results The SI for 25％HCA was 3.9,showing positive in the skin sensitization test.It demonstrated that the LLNA:Brdu-FCM test method was properly implemen-ted.Nine test substances(2,4-dinitrochlorobenzene,4-pheny-lenediamine,cobalt chloride,2-mercaptobenzothiazole,hexyl-cinnamaldehyde,eugenol,phenyl benzoate,cinnamic alcohol,imidazolidinyl urea)were positive,and six test substances(methyl methacrylate,chlorobenzene,isopropanol,lactic acid,methyl salicylate,salicylic acid)were negative.The method was evaluated with sensitivity of 90％,specificity of 100％,positive prediction rate of 100％,negative prediction rate of 83％,false positive rate of 0％,false negative rate of 17％and accuracy of 93％.The LLNA:BrdU-FCM assay could correctly categorize the test substances that were skin sensitizers or non-sensitizers.Conclusion The LLNA:BrdU-FCM assay appears to be a relia-ble predictor of skin sensitization protential of chemicals,and it is expected to an alternative method for identifying skin sensitization as a supplementary in safety evaluation of cosmetic ingredient.

BACKGROUND:Compensatory changes in sagittal parameters of the cervicothoracic spine after orthopedic surgery in patients with lumbar degenerative scoliosis and their intrinsic relationship,as well as the impact of these changes on quality of life,are still lacking.OBJECTIVE:To evaluate the compensatory alignment of cervical and thoracic vertebrae after correction of lumbar degenerative scoliosis.METHODS:103 patients who underwent surgical correction of lumbar degenerative scoliosis were included in this study.Patients'demographic characteristics and spinal sagittal parameters were assessed,and prediction equations between changes in cervical sagittal parameters and lumbar deformity correction were attempted.Simultaneously,the SRS-22 scale was used to assess the quality of life of patients and to explore the relationship between the compensatory changes of the cervical and thoracic spine after correction and the patients'health-related quality of life.RESULTS AND CONCLUSION:(1)At 3 months and 2 years after surgery,all indicators of the cervical spine and thoracic spine were significantly improved compared with those before surgery(P＜0.05),but there was no significant change at 3 months after surgery compared with 2 years after surgery(P＞0.05).At 3 months and 2 years after surgery,the lumbar spine parameters including lumbar lordosis,C7-S1 sagittal vertical axis,and pelvic incident-lumbar lordosis had significant changes compared with those before surgery(P＜0.05),but the change was not significant at 3 months after surgery compared with 2 years after surgery(P＞0.05).(2)Correlation analysis showed that the lumbar lordosis was highly correlated with the C3-C7 cervical lordosis,C1-C7 cervical lordosis,C2-7 sagittal vertical axis,thoracic inlet angle,and C7-S1 sagittal vertical axis(|r|≥ 0.5,P＜0.000 1).The lumbar lordosis was correlated with the thoracic kyphosis(r=-0.280).(3)Two prediction formulas were established for compensatory changes in cervical spine:cervical lordosis=0.524x,lumbar lordosis=-6.612,C2-7 sagittal vertical axis=-0.263x,and lumbar lordosis=-5.436(P＜0.05,R2＞0.6).(4)When postoperative C2-7 sagittal vertical axis was between 14.4 and 26.8 mm;cervical lordosis was between 9° and 41°,lumbar lordosis was between 42.7° and 68.7°,and sagittal vertical axis was between-40 and 40 mm,patients had better quality of life recovery.(5)It is indicated that significant compensatory changes in the sagittal plane of the cervical spine can be observed after correction of lumbar degenerative scoliosis.We found that each 1° increase in lumbar lordosis was associated with a corresponding increase of about 0.5° in cervical lordosis and a corresponding decrease of about 0.3 mm in the vertical axis of the C2-7 sagittal plane.Patient satisfaction was higher if compensatory changes were closer to normal sagittal plane.

Objective:To evaluate the impact of Diagnosis-Intervention Packet(DIP)payment reform on medical service costs and efficiency for inpatients in public hospitals,and to compare differences between surgical and medical groups.Methods:A quasi-experimental design was employed,using 605 636 discharged patients from a tertiary hospital in Hebei Province between January 2020 and March 2025 as the sample.The difference-in-differences(DID)model was used to analyze the changes in key indicators between the DIP settlement group(intervention group)and the non-DIP settlement group(control group).Results:Total hospitalization costs,out-of-pocket expenses,and medication costs were significantly reduced in the DIP settlement group(P<0.05),while costs for examinations,nursing,laboratory tests,and treatments increased significantly(P<0.05).Material costs increased by 30.7%in the surgical group(P<0.1)and decreased by 19.8%in the medical group(P<0.01).In terms of efficiency,the average length of stay,time,and cost consumption index all decreased(P<0.01),while the proportion of medical services increased(P<0.01).The case mix index(CMI)showed no significant changes.Conclusion:The DIP reform effectively controlled costs and improved efficiency,but it also resulted in cost shifting and departmental disparities.Therefore,it is necessary to optimize cost control and departmental management policies.

Objective To explore the current situation,hot spots and trends of clinical research on the treatment of carotid atherosclerosis(CAS)with traditional Chinese medicine.Methods Search CNKI,Wanfang,VIP,Web of Science core collection database related literature,using Python 3.9.6 cleaning data,using CiteSpace and VOSviewer for visual analysis of authors,institutions,keywords,etc.Results 910 Chinese literatures and 5 English literatures were included.The most published authors were Wang Changyin and Yin Chunping,and the institution was Handan Hospital of Traditional Chinese Medicine,Hebei Province.The cooperation between institutions was independent and regional.Research focus on:phlegm stasis interjunction,dyslipidemia,inflammatory factors,vascular endothelial function,nerve function defect,Banxia Baizhu Tianma decoction,coronary heart disease and so on;The treatment of CAS from"interjunction of phlegm and blood stasis"will continue to become a research hotspot in this field.Conclusion The clinical research of traditional Chinese medicine in the treatment of CAS should be closely combined with the observation of curative effect and the revelation of mechanism,and the law of traditional Chinese medicine in the treatment of CAS should be explored.In the future,the treatment of CAS should focus on the treatment of"phlegm and blood stasis",and the pathogenesis principle of"phlegm and blood stasis",the efficacy and mechanism of resolving phlegm and removing blood stasis in the treatment of CAS should be systematically and deeply explored.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

BACKGROUND:Compensatory changes in sagittal parameters of the cervicothoracic spine after orthopedic surgery in patients with lumbar degenerative scoliosis and their intrinsic relationship,as well as the impact of these changes on quality of life,are still lacking.OBJECTIVE:To evaluate the compensatory alignment of cervical and thoracic vertebrae after correction of lumbar degenerative scoliosis.METHODS:103 patients who underwent surgical correction of lumbar degenerative scoliosis were included in this study.Patients'demographic characteristics and spinal sagittal parameters were assessed,and prediction equations between changes in cervical sagittal parameters and lumbar deformity correction were attempted.Simultaneously,the SRS-22 scale was used to assess the quality of life of patients and to explore the relationship between the compensatory changes of the cervical and thoracic spine after correction and the patients'health-related quality of life.RESULTS AND CONCLUSION:(1)At 3 months and 2 years after surgery,all indicators of the cervical spine and thoracic spine were significantly improved compared with those before surgery(P＜0.05),but there was no significant change at 3 months after surgery compared with 2 years after surgery(P＞0.05).At 3 months and 2 years after surgery,the lumbar spine parameters including lumbar lordosis,C7-S1 sagittal vertical axis,and pelvic incident-lumbar lordosis had significant changes compared with those before surgery(P＜0.05),but the change was not significant at 3 months after surgery compared with 2 years after surgery(P＞0.05).(2)Correlation analysis showed that the lumbar lordosis was highly correlated with the C3-C7 cervical lordosis,C1-C7 cervical lordosis,C2-7 sagittal vertical axis,thoracic inlet angle,and C7-S1 sagittal vertical axis(|r|≥ 0.5,P＜0.000 1).The lumbar lordosis was correlated with the thoracic kyphosis(r=-0.280).(3)Two prediction formulas were established for compensatory changes in cervical spine:cervical lordosis=0.524x,lumbar lordosis=-6.612,C2-7 sagittal vertical axis=-0.263x,and lumbar lordosis=-5.436(P＜0.05,R2＞0.6).(4)When postoperative C2-7 sagittal vertical axis was between 14.4 and 26.8 mm;cervical lordosis was between 9° and 41°,lumbar lordosis was between 42.7° and 68.7°,and sagittal vertical axis was between-40 and 40 mm,patients had better quality of life recovery.(5)It is indicated that significant compensatory changes in the sagittal plane of the cervical spine can be observed after correction of lumbar degenerative scoliosis.We found that each 1° increase in lumbar lordosis was associated with a corresponding increase of about 0.5° in cervical lordosis and a corresponding decrease of about 0.3 mm in the vertical axis of the C2-7 sagittal plane.Patient satisfaction was higher if compensatory changes were closer to normal sagittal plane.

Aim To establish and evaluate an alternative meth-od for detecting skin sensitization of cosmetics based on local lymph node assay using bromodeoxyuridine(BrdU)with flow cytometry(FCM).Methods(1)25％hexyl cinnamic alde-hyde(HCA)was chosen as a positive control with an acetone:olive oil(4∶1,V/V,AOO)mixture as a vehicle control for the experiment.The dorsal sides of both ears of mice were treated with test solutions on day 1,day 2,and day 3.Brdu solution was injected inter-peritoneally on day 5.On day 6,the bilateral ears and mandibular lymph nodes were excised,and the number of Brdu positive cells was measured by flow cytometry.The stim-ulation index(SI)was calculated to identify whether it was ≥3,in order to establish the method of LLNA:Brdu-FCM.(2)BrdU-FCM test was conducted using a blind method with the fif-teen reference substances listed in OECD TG429 whose skin sensitization potentials were known.The test substances were dissolved in AOO,N,N-dimethylformamide(DMF)or dimeth-yl sulfoxide(DMSO)at three different concentrations.Tests were performed the same as above.SI and EC2.7 were calculat-ed to evaluate whether the test substance was categorized as a skin sensitizer.The reliability and accuracy of the method were validated by comparing the classification of test substances with that in OECD TG429.Results The SI for 25％HCA was 3.9,showing positive in the skin sensitization test.It demonstrated that the LLNA:Brdu-FCM test method was properly implemen-ted.Nine test substances(2,4-dinitrochlorobenzene,4-pheny-lenediamine,cobalt chloride,2-mercaptobenzothiazole,hexyl-cinnamaldehyde,eugenol,phenyl benzoate,cinnamic alcohol,imidazolidinyl urea)were positive,and six test substances(methyl methacrylate,chlorobenzene,isopropanol,lactic acid,methyl salicylate,salicylic acid)were negative.The method was evaluated with sensitivity of 90％,specificity of 100％,positive prediction rate of 100％,negative prediction rate of 83％,false positive rate of 0％,false negative rate of 17％and accuracy of 93％.The LLNA:BrdU-FCM assay could correctly categorize the test substances that were skin sensitizers or non-sensitizers.Conclusion The LLNA:BrdU-FCM assay appears to be a relia-ble predictor of skin sensitization protential of chemicals,and it is expected to an alternative method for identifying skin sensitization as a supplementary in safety evaluation of cosmetic ingredient.

Objective To explore the diagnosis,treatment and prognostic factors of urachal carcinoma(UrC),aiming to provide reference for the standardized diagnosis and treatment of this disease.Methods A retrospective analysis was conducted on the clinical data of 75 UrC patients confirmed with postoperative pathology treated in our hospital during Mar.2010 and Mar.2023.All patients underwent surgical treatment,and 35 received postoperative chemotherapy.Univariate and multivariate Cox regression analyses were performed to identify independent prognostic factors.Kaplan-Meier curves were adopted to calculate the cumulative survival rates and overall survival(OS).Results Among the 75 patients,the male to female ratio was 2.8∶1 and the mean age was(58.4±2.2)years.Median follow-up was 60 months and median OS was 48 months.The 3-year survival rate was 67.3％and the 5-year survival rate was 38.8％.There were 19 cases(25.3％)of CK7 positive,60 cases(80.0％)of Sheldon stage Ⅲ and above,and 26 cases(34.7％)of postoperative recurrence.CK7 positive(P=0.001),Sheldon staging Ⅲ+Ⅳ(P=0.005)and postoperative recurrence(P=0.003)were independent prognostic factors.Conclusion Urachal carcinoma is a rare malignant tumor in males with occult onset.CK7 positive,Sheldon staging and postoperative recurrence were independent prognostic factors of this disease.

Objective To explore different construction models and experiences of clinical laboratory centers under exist-ing Integrated county healthservices entity,analyze and discuss the characteristics of various construction models,and provide ref-erences for the development of county-level clinical laboratory centers.Methods Based on the five factors of"man,machine,material,method,and environment"in Total Quality Management theory,an interview outline and questionnaire were designed for county-level clinical laboratory centers.Eleven county-level clinical laboratory centers across the country were investigated to analyze their construction models,investment returns,and other aspects.Literature reviews and case studies were also conducted to summarize the construction models and characteristics of county-level clinical laboratory centers.Results The construction models of county-level clinical laboratory centers are mainly divided into five types,each with distinct features.Through an analy-sis of the investment returns of these models unde rIntegrated county healthservices entity,it was found that a profit distribution ratio of approximately 5∶5 between county-level clinical laboratory centers and township health centers for referred samples is more conducive to maintaining the stability of sample sources.The construction model of county-level clinical laboratory centers is closely related to the medical service capacity of both county and township levels.Conclusion Counties with stronger county hospital capabilities tend to establish relatively independent regional laboratory centers based on the county hospital's laboratory department.Regardless of the model,the primary goal of county-level clinical laboratory centers should be to provide high-quality testing services coverage across the entire county.The key to the success of county-level clinical laboratory centers lies in motiva-ting grassroots personnel.