1.Comparison of Domestic and International Standards for Prefilled Syringes
Xiaowen BO ; Guangyu SUN ; Aijuan LIU ; Yong SHEN ; Min ZHANG ; Lei CHEN
Herald of Medicine 2025;44(4):527-531
Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system.Methods A thorough review of the framework,scope,and quality control key points of the 2015 national pharmaceutical packaging material standards(abbreviated as YBB standards),the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted.Comparative analysis was employed to reveal the similarities and differences among the three,thereby uncovering the unique characteristics of each.Results The YBB standards emphasize quality control for prefilled syringes,offering clear and operational guidelines that provide companies with precise directives for production and testing.However,the scope of these standards is relatively limited.ISO standards apply to a wide range of products,featuring comprehensive coverage and a degree of flexibility.They emphasize the universality of products and compatibility with other international standards,which facilitates global production and trade.USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach.Conclusion By thoroughly studying and drawing upon the quality control philosophies,standard frameworks,and key control points of prefilled syringes from both domestic and international standards,we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.
2.Comparison of Domestic and International Standards for Prefilled Syringes
Xiaowen BO ; Guangyu SUN ; Aijuan LIU ; Yong SHEN ; Min ZHANG ; Lei CHEN
Herald of Medicine 2025;44(4):527-531
Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system.Methods A thorough review of the framework,scope,and quality control key points of the 2015 national pharmaceutical packaging material standards(abbreviated as YBB standards),the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted.Comparative analysis was employed to reveal the similarities and differences among the three,thereby uncovering the unique characteristics of each.Results The YBB standards emphasize quality control for prefilled syringes,offering clear and operational guidelines that provide companies with precise directives for production and testing.However,the scope of these standards is relatively limited.ISO standards apply to a wide range of products,featuring comprehensive coverage and a degree of flexibility.They emphasize the universality of products and compatibility with other international standards,which facilitates global production and trade.USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach.Conclusion By thoroughly studying and drawing upon the quality control philosophies,standard frameworks,and key control points of prefilled syringes from both domestic and international standards,we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.
3.Epidemiological characteristics of occupational exposures in a stomatological hospital from 2020 to 2024
Fanglong LI ; Ting WANG ; Linlin CHENG ; Wendi XU ; Aijuan ZHANG ; Hongyan ZHANG
Chinese Journal of Nosocomiology 2025;35(22):3490-3494
OBJECTIVE To investigate the current status and characteristics of occupational exposure in a stomato-logical hospital and explore the influencing factors for occupational exposure among dentists so as to propose pre-ventive and control measures for occupational exposure in the stomatological hospital.METHODS A retrospective study was carried out to analyze 180 incidents of occupational exposures in Qingdao Stomatological Hospital Affili-ated to Qingdao University from 2020 to 2024,involving the departments,names,genders,age,average annual workload,average annual outpatient days,exposure links,instruments leading to exposures,exposure sources,occupational type and professional titles.The incidence of occupational exposure was compared among the subjects with different occupations,professional titles and department affiliations.Logistic regression analysis was per-formed for the influencing factors for the occupational exposures among the dentists.RESULTS The incidence of occupational exposures was 7.52%(180/2395)within the 5 years,and the sharp instrument injury(99.40%)was the predominant exposure approach.The department of oral and maxillofacial surgery,department of restorative dentisty and department of prosthodontics were the departments at high risk of occupational exposures.There was significant difference in the incidence of occupational exposures among the staff and the doctors with different pro-fessional titles(P<0.05).The subjects for whom the exposure source was positive or failed to be tracked accoun-ted for 56.11%.The professional title(OR=0.328)was a protective factor for the occupational exposure among the doctors,and the high-risk department(OR=4.912)was a risk factor for the occupational exposure(P<0.05).CONCLUSIONS The occupational exposures to the stomatology department staff are characterized by high prevalence,monotonous type,concentrated distribution of populations and uncontrollable occupational exposures.It is necessary to complete the preoperative screening of infectious diseases,strengthen the awareness of prevention,standardize the technical procedures and boost the innovation of auxiliary instruments so as to re-duce the incidence of occupational exposures.
4.Right heart contrast-enhanced echocardiographic diagnosis of a left superior vena cava aneurysm
Hui CHEN ; Aijuan FANG ; Ning ZHANG ; Guanjun GUO ; Lei LIU ; Jing YAO
Chinese Journal of Ultrasonography 2025;34(4):352-353
Permanent left superior vena cava aneurysm is a rare mediastinal venous lesion,the majority of the literature is in the form of case reports. In this article,a 50-year-old female with an incidental permanent left superior vena cava aneurysm discovered on echocardiography in Nanjing Gulou Hospital,and the right heart contrast-enhanced echocardiographic played an important role in the process of clear diagnosis. The patient was observed without intervention. No complications were attributable to the permanent left superior vena cava aneurysm during follow-up.
5.Erratum: Publisher erratum to "Fenofibrate-promoted hepatomegaly and liver regeneration are PPARα-dependent and partially related to the YAP pathway" Acta Pharmaceutica Sinica B 14 (2024) 2992-3008.
Shicheng FAN ; Yue GAO ; Pengfei ZHAO ; Guomin XIE ; Yanying ZHOU ; Xiao YANG ; Xuan LI ; Shuaishuai ZHANG ; Frank J GONZALEZ ; Aijuan QU ; Min HUANG ; Huichang BI
Acta Pharmaceutica Sinica B 2025;15(6):3354-3354
[This corrects the article DOI: 10.1016/j.apsb.2024.03.030.].
6.Expression levels of PGC-1β,HIF-1α,and RETN in gouty arthritis and their correlation with the degree of joint damage
Aijuan SHEN ; Tie LIU ; Panpan DING ; Jingyu WANG ; Shuo ZHANG ; Weiwei LU
International Journal of Laboratory Medicine 2025;46(9):1071-1076
Objective To investigate the expression levels of peroxisome proliferator-activated receptor gamma coactivator-1β(PGC-1β),hypoxia-inducible factor-1α(HIF-1α),and resistin(RETN)in gouty arthri-tis(GA),and analyze their correlation with the degree of joint damage.Methods A total of 134 patients with GA in the hospital from January 2022 to October 2023 were selected as GA group,and 134 healthy people who underwent the physical examination in the same period were selected as control group.The serum expression levels of PGC-1β,HIF-1α and Retn were compared between the two groups.The expression levels of PGC-1β,HIF-1α and Retn in serum and synovial fluid of patients with different clinical characteristics in GA group were compared,the degree of joint destruction was graded according to the subjective pain grading method(VAS)and the patients were divided into a severe GA subgroup of 78 cases and a mild GA subgroup of 56 ca-ses.The expression levels of PGC-1β,HIF-1α,RETN,bone destruction factors[β-cross linked degradation products(β-CTX),tartrate resistant acid phosphatase-5b(TRACP5b),receptor activator of nuclear factor kappa B ligand(RANKL)]and inflammatory factors[tumor necrosis factor-α(TNF-α),interleukin-1β(IL-1β)]were compared among different degrees of joint destruction,and the correlation between serum and syno-vial fluid PGC-1β,HIF-1α,RETN and the degree of joint destruction,bone destruction factors,and inflamma-tory factors was analyzed.Results The expression level of PGC-1β in serum of GA group was lower than that of the control group,while the expression levels of HIF-1α and RETN in serum were higher than those of the control group(P<0.05).There were statistically significant differences in serum and synovial fluid PGC-1β,HIF-1α,and RETN levels among GA patients with different clinical stages,affected joints,disease duration,and annual seizure frequency(P<0.05).The expression levels of PGC-1β in the serum and synovial fluid of the severe GA subgroup were lower than those of the mild GA subgroup(P<0.05),while the expression lev-els of HIF-1α and RETN were higher than those of the mild GA subgroup(P<0.05).The expression levels ofβ-CTX and TRACP5b in the severe GA subgroup were higher than those in the mild GA subgroup(P<0.05),while the expression level of RANKL was lower than that in the mild GA subgroup(P<0.05).PGC-1βin serum and synovial fluid was negatively correlated with the degree of joint destruction,β-CTX,TRACP5b,TNF-α,and IL-1β,and positively correlated with RANKL.HIF-1α and RETN were positively correlated with the degree of joint destruction,β-CTX,TRACP5b,TNF-α,and IL-1β,and negatively correlated with RANKL.Conclusion PGC-1β,HIF-1α,and RETN are abnormally expressed in patients with GA,and are closely associ-ated with the degree of joint destruction,bone destruction factors,and inflammatory factors.They are expec-ted to become reliable indicators for evaluating the occurrence and progression of GA.
7.Epidemiological characteristics of occupational exposures in a stomatological hospital from 2020 to 2024
Fanglong LI ; Ting WANG ; Linlin CHENG ; Wendi XU ; Aijuan ZHANG ; Hongyan ZHANG
Chinese Journal of Nosocomiology 2025;35(22):3490-3494
OBJECTIVE To investigate the current status and characteristics of occupational exposure in a stomato-logical hospital and explore the influencing factors for occupational exposure among dentists so as to propose pre-ventive and control measures for occupational exposure in the stomatological hospital.METHODS A retrospective study was carried out to analyze 180 incidents of occupational exposures in Qingdao Stomatological Hospital Affili-ated to Qingdao University from 2020 to 2024,involving the departments,names,genders,age,average annual workload,average annual outpatient days,exposure links,instruments leading to exposures,exposure sources,occupational type and professional titles.The incidence of occupational exposure was compared among the subjects with different occupations,professional titles and department affiliations.Logistic regression analysis was per-formed for the influencing factors for the occupational exposures among the dentists.RESULTS The incidence of occupational exposures was 7.52%(180/2395)within the 5 years,and the sharp instrument injury(99.40%)was the predominant exposure approach.The department of oral and maxillofacial surgery,department of restorative dentisty and department of prosthodontics were the departments at high risk of occupational exposures.There was significant difference in the incidence of occupational exposures among the staff and the doctors with different pro-fessional titles(P<0.05).The subjects for whom the exposure source was positive or failed to be tracked accoun-ted for 56.11%.The professional title(OR=0.328)was a protective factor for the occupational exposure among the doctors,and the high-risk department(OR=4.912)was a risk factor for the occupational exposure(P<0.05).CONCLUSIONS The occupational exposures to the stomatology department staff are characterized by high prevalence,monotonous type,concentrated distribution of populations and uncontrollable occupational exposures.It is necessary to complete the preoperative screening of infectious diseases,strengthen the awareness of prevention,standardize the technical procedures and boost the innovation of auxiliary instruments so as to re-duce the incidence of occupational exposures.
8.Right heart contrast-enhanced echocardiographic diagnosis of a left superior vena cava aneurysm
Hui CHEN ; Aijuan FANG ; Ning ZHANG ; Guanjun GUO ; Lei LIU ; Jing YAO
Chinese Journal of Ultrasonography 2025;34(4):352-353
Permanent left superior vena cava aneurysm is a rare mediastinal venous lesion,the majority of the literature is in the form of case reports. In this article,a 50-year-old female with an incidental permanent left superior vena cava aneurysm discovered on echocardiography in Nanjing Gulou Hospital,and the right heart contrast-enhanced echocardiographic played an important role in the process of clear diagnosis. The patient was observed without intervention. No complications were attributable to the permanent left superior vena cava aneurysm during follow-up.
9.LGR5 Modulates Differentiated Phenotypes of Chondrocytes Through PI3K/AKT Signaling Pathway
Xu WU ; Yaoyao FU ; Jing MA ; Chenlong LI ; Aijuan HE ; Tianyu ZHANG
Tissue Engineering and Regenerative Medicine 2024;21(5):791-807
BACKGROUND:
Tissue engineering is increasingly viewed as a promising avenue for functional cartilage reconstruction.However, chondrocyte dedifferentiation during in vitro culture remains an obstacle for clinical translation of tissue engineered cartilage. Re-differentiated induction have been employed to induce dedifferentiated chondrocytes back to their original phenotype. Regrettably, these strategies have been proven to be only moderately effective.
METHODS:
To explore underlying mechanism, RNA transcriptome sequencing was conducted on primary chondrocytes (P0), dedifferentiated chondrocytes (P5), and redifferentiated chondrocytes (redifferentiation-induction of P5, P5.R). Based on multiple bioinformatics analysis, LGR5 was identified as a target gene. Subsequently, stable cell lines with LGR5 knocking-down and overexpression were established using P0 chondrocytes. The phenotypic changes in P1 and P5 chondrocytes with either LGR5 knockdown or overexpression were assessed to ascertain the potential influence of LGR5 dysregulation on chondrocyte phenotypes. Regulatory mechanism was then investigated using bioinformatic analysis, protein–protein docking, immunofluorescence co-localization and immunoprecipitation.
RESULTS:
The current study found that dysregulation of LGR5 can significantly impact the dedifferentiated phenotypes of chondrocytes (P5). Upregulation of LGR5 appears to activate the PI3K/AKT signal via increasing the phosphorylation levels of AKT (p-AKT1). Moreover, the increase of p-AKT1 may stabilize b-catenin and enhance the intensity of Wnt/b-catenin signal, and help to restore the dedifferentated phenotype of chondrocytes.
CONCLUSION
LGR5 can modulate the phenotypes of chondrocytes in P5 passage through PI3K/AKT signaling pathway.
10.Exploration and construction of an evaluation indicator framework for clinical research benefits in China
Aiyi ZHANG ; Hu CHEN ; Aijuan SHENG ; Nan BAI ; Yanfen CHEN ; Zhongguang YU
Chinese Medical Ethics 2024;37(4):448-452
Objective:The aim is to construct an evaluation framework for clinical research benefits,and provide a reference for the formulate of evaluation standards for clinical research benefits.Methods:The Delphi method was used to carry out expert consultation,and the mean,score of importance,coefficient of variation and coordination,etc.of evaluation indicators were summarized and calculated,to screen evaluation indicators for clinical research benefits.Results:Twenty-three experts in this field were selected for correspondence,and their enthusiasm was 100%in both rounds,the authority coefficients were≥0.90,and Kendall's coefficients of concordance were<0.25(P<0.001).By referring to the mean and coefficient of variation of the indicators,as well as combining them with expert suggestions,an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators,5 secondary indicators,and 8 tertiary indicators.Conclusion:The evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits,as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.

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