1.The Association of Iodixanol With Renal and Cardiovascular Safety in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention:A Prospective Cohort Study
Zhaoping LIU ; Jian AN ; Aijie HOU ; Yanqin REN ; Lei QIN ; Xiaojie CHEN ; Guozhen HAO ; Xi SU ; Ping YANG ; Guidong SHEN ; Shenghuang WANG ; In-ho CHAE ; Yong HUO
Journal of Cardiovascular Intervention 2026;5(1):38-48
Background:
This study was performed to characterize the incidence, costs, and risk factors associated with renal and cardiovascular adverse outcomes following primary percutaneous coronary intervention (pPCI) in patients with ST-elevation myocardial infarction (STEMI).
Methods:
Patients with STEMI who underwent pPCI using iso-osmolar contrast were enrolled at 39 centers. The incidence of acute kidney injury (AKI) and major adverse renal and cardiovascular events (MARCE) was analyzed, as well as inpatient costs. Logistic regression analysis was performed to identify risk factors.
Results:
Among 2,293 patients, the incidence of AKI and MARCE within 72 hours post-pPCI was 4.14% (n = 95) and 4.40% (n = 101), respectively. AKI and/or MARCE were associated with systolic blood pressure (AKI: odds ratio [OR], 1.009; 95% confidence interval [CI], 1.000–1.018), hypertension (AKI: OR, 1.815; 95% CI, 1.133–2.906; MARCE: OR, 1.760;95% CI, 1.118–2.769), anterior wall infarction (AKI: OR, 1.895; 95% CI, 1.196–3.004; MARCE:OR, 1.939; 95% CI, 1.240–3.032), Killip class (AKI: OR, 1.465; 95% CI, 1.117–1.922; MARCE:OR, 1.467; 95% CI, 1.131–1.903), and serum creatinine (SCr; MARCE: OR, 1.006; 95% CI, 1.000–1.012). Hospitalization costs for patients with STEMI who developed AKI or MARCE were significantly higher than for those without AKI (9,595 ± 5,795 vs. 8,279 ± 3,872 USD, P = 0.003) or without MARCE (9,890 ± 5,616 vs. 8,255 ± 3,859 USD, P < 0.001).
Conclusions
In patients with STEMI undergoing pPCI with iso-osmolar contrast, the incidence of AKI and MARCE was associated with higher hospitalization costs. Systolic blood pressure, hypertension, anterior wall infarction, Killip class, and SCr were identified as risk factors for these outcomes.
2.Chinese expert consensus on salvage esophagectomy for esophageal cancer after definitive chemoradiotherapy
Zhaoxian LIN ; Yang HU ; Lei XIAN ; Yun LI ; Jinbo ZHAO ; Xiaobin HOU ; Shuangping ZHANG ; Sunkui KE ; Changying GUO ; Songping XIE ; Haitao WEI ; Yong LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(07):977-987
Definitive chemoradiotherapy (dCRT) has become a cornerstone in the treatment of locally advanced esophageal cancer; however, local control remains suboptimal, and persistent lesions or locoregional recurrences after treatment are not uncommon. For patients without distant metastases but with local failure, whether surgical intervention can still offer curative potential remains a major clinical dilemma. Salvage esophagectomy (SE) offers potential long-term survival for selected patients, but this procedure is performed in the context of severe fibrosis, impaired local blood supply, and obscured anatomical planes following chemoradiotherapy, resulting in significantly higher perioperative risk compared to primary esophagectomy. Consequently, controversies exist regarding patient selection, preoperative restaging, choice of surgical approach, extent of lymphadenectomy, gastrointestinal reconstruction, and perioperative management. In recent years, with the refinement of restaging modalities such as PET/CT, the accumulation of experience in high-volume centers, and emerging evidence from clinical studies, the clinical role of SE has gradually shifted from a "high-risk salvage measure" to a "selective curative strategy aimed at achieving long-term survival in carefully selected patients". Nevertheless, standardized guidelines for patient selection, technical approaches, and perioperative management are still lacking. Based on current evidence and clinical experience, experts organized by the Integrated Esophageal Cancer Committee of Chinese Anti-Cancer Association systematically reviewed key issues regarding SE, including its definition, indications, preoperative evaluation, choice of surgical approach, lymphadenectomy, gastrointestinal reconstruction, and perioperative management, and formulated a Chinese expert consensus. This consensus aims to provide guidance for standardized assessment, appropriate referral, individualized surgical decision-making, and optimized perioperative management of patients with locoregional failure after dCRT. Ultimately, this will increase the likelihood of R0 resection, reduce the risk of severe complications, and promote the safer, more judicious, and standardized implementation of SE in high-risk scenarios.
3.The Dual Role and Clinical Potential of Core Fucosylation in Liver Diseases
Zi-Han LEI ; Hui-Min XU ; De-Zhi ZHAO ; Yong-Hong GUO ; Hao-Qi DU
Progress in Biochemistry and Biophysics 2026;53(8):2161-2178
Core fucosylation, catalyzed exclusively by fucosyltransferase 8 (FUT8), is an evolutionarily conserved post-translational modification that has emerged as a central regulatory hub linking liver homeostasis, chronic disease progression, and malignant transformation. Liver diseases, particularly hepatocellular carcinoma, remain a leading global health burden characterized by late diagnosis, limited therapeutic options, and poor overall survival. While aberrant glycosylation is now recognized as a hallmark of cancer and inflammatory disorders, existing research on FUT8-mediated core fucosylation in liver diseases remains fragmented: the dynamic functional switch of FUT8 from a homeostatic regulator to a pathological driver across the full disease continuum has not been systematically delineated, and the integrated mechanisms by which core fucosylation modulates oncogenic signaling, metabolic reprogramming, and immune evasion remain poorly understood. This review synthesizes recent advances to establish a unified framework for understanding the dual role of core fucosylation in liver physiology and pathology, and evaluates its translational potential for precision medicine. At the molecular level, FUT8’s unique catalytic specificity makes core fucosylation an irreplaceable modification, as evidenced by the perinatal lethality and severe organ dysfunction in Fut8 knockout mice. In hepatocellular carcinoma, genomic amplification of guanosine 5'-diphosphate-fucose biosynthetic enzymes provides metabolic support for aberrant core fucosylation. FUT8 expression is tightly regulated by a multi-layered network: transcriptional activation via Wnt/β‑catenin and wild-type p53, epigenetic upregulation by lncRNAs, post-transcriptional repression by miR-122-5p and miR-34a, and virus-specific induction by hepatitis B virus/hepatitis C virus. Physiologically, core fucosylation maintains liver homeostasis through four core mechanisms: it acts as a molecular switch for epidermal growth factor receptor/hepatocyte growth factor receptor signaling to enable liver regeneration; directs polarized secretion of hepatocyte-derived glycoproteins into bile ducts; modulates cholesterol metabolism via the hepatocyte nuclear factor 1α-proprotein convertase subtilisin/kexin type 9-low density lipoprotein receptor axis; and regulates aging through insulin‑like growth factor 1 receptor signaling. Pathologically, core fucosylation exhibits context-dependent dual functions: in liver fibrosis, FUT8 upregulation in hepatic stellate cells forms a negative feedback loop that limits excessive fibrogenesis; in hepatocellular carcinoma, however, aberrant FUT8 overexpression drives cell-autonomous malignancy by constitutively activating epidermal growth factor/hepatocyte growth factor receptor, transforming growth factor‑β/Smad, and Wnt/β‑catenin pathways, while simultaneously establishing a multi-layered immune evasion network by stabilizing programmed cell death ligand 1 and cluster of differentiation 47, and impairing natural killer cell homeostasis via interleukin‑2 receptor β glycosylation. Clinically, stage-specific core fucosylation biomarkers enable non-invasive monitoring of liver disease progression: low molecular mass kringle-Fc fusion protein outperforms conventional markers for early fibrosis detection, while alpha-fetoprotein-L3 and novel glycopeptides (α‑2‑macroglobulin N‑linked glycosylation site 1424, lumican core fucosylated peptide) significantly improve early hepatocellular carcinoma diagnosis, especially in alpha-fetoprotein-negative patients. Next-generation detection technologies (chemoenzymatic labeling, site-specific mass spectrometry) overcome the specificity limitations of traditional lectin assays. Therapeutically, four promising strategies are emerging: small-molecule FUT8 inhibitors, afucosylated antibodies with enhanced antibody‑dependent cellular cytotoxicity, Fuc-modified targeted drug delivery systems, and core fucose-specific lectins for NASH treatment. The core challenge for clinical translation lies in FUT8’s inherent “double-edged sword” effect, as systemic inhibition disrupts its essential physiological functions beyond pathological roles. Long-term systemic FUT8 blockade not only impairs post-injury liver regeneration by abrogating epidermal growth factor/hepatocyte growth factor receptor signaling but also disrupts cholesterol homeostasis via the hepatocyte nuclear factor 1α-proprotein convertase subtilisin/kexin type 9-low density lipoprotein receptor axis, leading to dyslipidemia and altered bile secretion. Critically, it compromises immune surveillance by destabilizing interleukin‑2 receptor β on natural killer cells, reducing their cytotoxic activity against malignant and virally infected cells, and impairs IgG Fc-mediated effector functions, increasing susceptibility to infections. This fundamental trade-off between therapeutic efficacy and systemic toxicity necessitates a paradigm shift from non-specific global inhibition to precision modulation of pathological core fucosylation. By addressing these critical challenges, FUT8-mediated core fucosylation has the potential to transform liver disease management from late-stage intervention to early detection and precision therapy, ultimately improving patient outcomes and reducing the global burden of liver diseases.
4.Trends and global comparisons of non-rheumatic degenerative mitral valve disease burden in China from 1990 to 2023
Junning LIU ; Peidong LI ; Qilin LU ; Kanglin XU ; Ziao LU ; Yong LEI ; Guiying ZHU ; Haibo ZHANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(09):1439-1447
Objective To analyze the disease burden trend of non-rheumatic degenerative mitral valve disease (NR-DMVD) in China from 1990 to 2023 and compare it with global levels and those in the United States and India. Methods Based on the Global Burden of Disease (GBD) 2023 database, data on incidence, mortality, prevalence, and disability-adjusted life years (DALYs) for NR-DMVD were extracted. Joinpoint regression, decomposition analysis, and autoregressive integrated moving average model (ARIMA) were used to analyze trends, drivers, and project burden to 2040. Results In 2023, China's age-standardized DALY rate (2.56/100 000) and mortality rate (0.037/100 000) for NR-DMVD were significantly lower than those in the United States, India, and globally, while its age-standardized incidence rate (10.39/100 000) and prevalence rate (126.03/100 000) showed slow increases. From 1990 to 2023, the estimated annual percentage changes (EAPC) for China's age-standardized DALY rate and mortality rate were –2.11% [95%CI (–2.25%, –1.98%)] and –4.54% [95%CI (–4.92%, –4.16%)], respectively, while the incidence rate and prevalence rate continued to rise; India showed increasing trends in all burden indicators. Decomposition analysis indicated that population aging was the primary driver of the increase in DALYs and prevalence cases, while epidemiological improvement was the key factor that led to the reduction in the number of deaths. Joinpoint analysis showed that China's age-standardized DALY rate declined most rapidly between 2000 and 2013, while the age-standardized mortality rate decreased fastest between 2007 and 2013. ARIMA models projected that China's prevalence rate would continue to rise and mortality rate would continue to decline through 2040. Conclusion NR-DMVD in China exhibits a dual-track pattern of "declining mortality but rising prevalence", driven by population aging. A tiered prevention and control system focusing on the elderly and high-risk male groups is needed.
5.Exploring Mechanism of Luoshi Neiyi Prescription in Treating Endometriosis Based on Ferroptosis and Serum Metabolomics
Haixia PAN ; Yingqiao ZHONG ; Ting MAO ; Ziyi DENG ; Meilin WU ; Lei HUANG ; Siyang CHEN ; Yong GUO ; Ying ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):201-212
ObjectiveThis study aimed to investigate the mechanism by which Luoshi Neiyi prescription treats endometriosis (EMs) through regulating ferroptosis, and to screen key metabolites and analyze their association with ferroptosis. MethodsClinical samples of normal endometrium from patients without EMs and eutopic and ectopic endometrium from EMs patients (10 cases each) were collected and divided into control group, eutopic group, and EMs group. Hematoxylin-eosin (HE) staining was performed to observe ectopic lesions of EMs. Immunohistochemistry was used to detect the expression of solute carrier family 7 member 11 (SLC7A11) and glutathione peroxidase 4 (GPX4). Enzyme-linked immunosorbent assay (ELISA) was adopted to determine the levels of malondialdehyde (MDA), ferrous ion (Fe2+), GPX4 and glutathione (GSH) in endometrial tissues, as well as serum levels of Fe2+, GPX4 and GSH. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of SLC7A11, GPX4, transferrin receptor (TFR) and ferritin heavy chain 1 (FTH1). In the in vitro experiment, primary stromal cells were isolated from ectopic lesions of EMs patients. Cell counting kit-8 (CCK-8) was used to determine the optimal concentration of drug-containing serum for intervention. The level of reactive oxygen species (ROS) was measured, and Real-time PCR was applied to detect ferroptosis-related indicators. In the animal experiments, an EM rat model was established, and the rats were randomly assigned to the sham operation group, EMs group, low-dose Luoshi Neiyi Formula group (7.87 g·kg-1), high-dose Luoshi Neiyi prescription group (15.74 g·kg-1), and danazol group (42 mg·kg-1). Untargeted metabolomics detection and pathway enrichment analysis were conducted on serum samples from patients and rats. Spearman correlation analysis was performed to assess the relationship between differential metabolites and ferroptosis indicators. The correlations between differential metabolites in patient endometrium and serum and key ferroptosis indicators (GPX4, Fe2+, MDA, GSH) as well as ferroptosis-related mRNAs (GPX4, SLC7A11, FTH1) were analyzed, and correlation heatmaps were generated accordingly. ResultsCompared with normal eutopic endometrium, ectopic lesions in EMs patients showed glandular disorganization and stromal fibrosis. In ectopic endometrium, the contents of MDA, ROS, and Fe2+ decreased, while GPX4 level increased, and the mRNA expression of SLC7A11 and GPX4 was upregulated (P<0.05, P<0.01). In serum, the levels of GPX4 and Fe2+ were elevated, whereas the GSH level declined, suggesting abnormalities in ferroptosis-related pathways in ectopic lesions (P<0.05, P<0.01). After intervention with Luoshi Neiyi prescription-containing serum, the intracellular ROS level in ectopic endometrial stromal cells was elevated, the mRNA expression of SLC7A11 and GPX4 was downregulated, and TFR mRNA expression was upregulated (P<0.05, P<0.01). Metabolomics analysis revealed 1104 and 198 differential metabolites in EMs patients and EMs rats, respectively, compared with their corresponding control groups, and both low-dose and high-dose Luoshi Neiyi prescription were found to regulate this metabolic disturbance, with the core regulatory pathways mainly involving arginine and proline metabolism. Correlation analysis showed that the glycerophospholipids including PI(16∶0/17∶0) and PI[18∶2(9Z,12Z)] were negatively correlated with GPX4 and positively correlated with MDA, while 17α-hydroxyprogesterone was positively correlated with GPX4, SLC7A11, and FTH1 q<0.05). ConclusionLuoshi Neiyi prescription may systematically ameliorate disease-associated metabolic dysregulation via modulation of the serum arginine and proline metabolism pathway, and may regulate ferroptosis in ectopic lesions through a mechanism potentially linked to the serum glycerophospholipid and steroid metabolism pathways. Collectively, these findings provide experimental evidence for the clinical application of Luoshi Neiyi prescription.
6.Exploring Mechanism of Luoshi Neiyi Prescription in Treating Endometriosis Based on Ferroptosis and Serum Metabolomics
Haixia PAN ; Yingqiao ZHONG ; Ting MAO ; Ziyi DENG ; Meilin WU ; Lei HUANG ; Siyang CHEN ; Yong GUO ; Ying ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):201-212
ObjectiveThis study aimed to investigate the mechanism by which Luoshi Neiyi prescription treats endometriosis (EMs) through regulating ferroptosis, and to screen key metabolites and analyze their association with ferroptosis. MethodsClinical samples of normal endometrium from patients without EMs and eutopic and ectopic endometrium from EMs patients (10 cases each) were collected and divided into control group, eutopic group, and EMs group. Hematoxylin-eosin (HE) staining was performed to observe ectopic lesions of EMs. Immunohistochemistry was used to detect the expression of solute carrier family 7 member 11 (SLC7A11) and glutathione peroxidase 4 (GPX4). Enzyme-linked immunosorbent assay (ELISA) was adopted to determine the levels of malondialdehyde (MDA), ferrous ion (Fe2+), GPX4 and glutathione (GSH) in endometrial tissues, as well as serum levels of Fe2+, GPX4 and GSH. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of SLC7A11, GPX4, transferrin receptor (TFR) and ferritin heavy chain 1 (FTH1). In the in vitro experiment, primary stromal cells were isolated from ectopic lesions of EMs patients. Cell counting kit-8 (CCK-8) was used to determine the optimal concentration of drug-containing serum for intervention. The level of reactive oxygen species (ROS) was measured, and Real-time PCR was applied to detect ferroptosis-related indicators. In the animal experiments, an EM rat model was established, and the rats were randomly assigned to the sham operation group, EMs group, low-dose Luoshi Neiyi Formula group (7.87 g·kg-1), high-dose Luoshi Neiyi prescription group (15.74 g·kg-1), and danazol group (42 mg·kg-1). Untargeted metabolomics detection and pathway enrichment analysis were conducted on serum samples from patients and rats. Spearman correlation analysis was performed to assess the relationship between differential metabolites and ferroptosis indicators. The correlations between differential metabolites in patient endometrium and serum and key ferroptosis indicators (GPX4, Fe2+, MDA, GSH) as well as ferroptosis-related mRNAs (GPX4, SLC7A11, FTH1) were analyzed, and correlation heatmaps were generated accordingly. ResultsCompared with normal eutopic endometrium, ectopic lesions in EMs patients showed glandular disorganization and stromal fibrosis. In ectopic endometrium, the contents of MDA, ROS, and Fe2+ decreased, while GPX4 level increased, and the mRNA expression of SLC7A11 and GPX4 was upregulated (P<0.05, P<0.01). In serum, the levels of GPX4 and Fe2+ were elevated, whereas the GSH level declined, suggesting abnormalities in ferroptosis-related pathways in ectopic lesions (P<0.05, P<0.01). After intervention with Luoshi Neiyi prescription-containing serum, the intracellular ROS level in ectopic endometrial stromal cells was elevated, the mRNA expression of SLC7A11 and GPX4 was downregulated, and TFR mRNA expression was upregulated (P<0.05, P<0.01). Metabolomics analysis revealed 1104 and 198 differential metabolites in EMs patients and EMs rats, respectively, compared with their corresponding control groups, and both low-dose and high-dose Luoshi Neiyi prescription were found to regulate this metabolic disturbance, with the core regulatory pathways mainly involving arginine and proline metabolism. Correlation analysis showed that the glycerophospholipids including PI(16∶0/17∶0) and PI[18∶2(9Z,12Z)] were negatively correlated with GPX4 and positively correlated with MDA, while 17α-hydroxyprogesterone was positively correlated with GPX4, SLC7A11, and FTH1 q<0.05). ConclusionLuoshi Neiyi prescription may systematically ameliorate disease-associated metabolic dysregulation via modulation of the serum arginine and proline metabolism pathway, and may regulate ferroptosis in ectopic lesions through a mechanism potentially linked to the serum glycerophospholipid and steroid metabolism pathways. Collectively, these findings provide experimental evidence for the clinical application of Luoshi Neiyi prescription.
7.Effects of combined occupational exposure to benzene series, dust and noise on high-frequency hearing loss
Shujun LI ; Feng WANG ; Siqi CHEN ; Ying LUO ; Zhen PAN ; Lei NI ; Yong YAO
Journal of Public Health and Preventive Medicine 2026;37(5):56-59
Objective To investigate the effects of combined exposure to benzene series, dust and noise on occupational high-frequency hearing loss (HFHL) in the electronics manufacturing industry. Methods A total of 740 employees from an electronic manufacturing enterprise were selected as the study subjects. According to the detection of occupational hazard factors, they were divided into noise group, noise benzene group, and noise dust group, with 325, 167, and 248 people, respectively. Occupational health examinations were conducted on the study participants to analyze their HFHL detection status and influencing factors. Results Among all participants (n=740), 456 (61.62%) were male, 284 (38.38%) were female, and 123 (15.62%) were detected with HFHL. The detection rate of HFHL increased with age and length of service (P<0.01). According to the exposure factor grouping, the detection rates of HFHL in the noise group, noise benzene group, and noise dust group were 12.00%, 19.16%, and 20.97%, respectively (P<0.05). Multivariate logistic regression analysis showed that workers aged ≥ 40 years, with 10-20 years of work experience, ≥ 20 years of work experience, exposure to noise and benzene series, and exposure to noise and dust had an increased risk of developing HFHL to 1.734, 1.923, 3.071, 1.706, and 1.527, respectively (P<0.05). Conclusion Combined exposure to noise and benzene series, combined exposure to noise and dust, as well as age and extended length of service may increase the risk of HFHL among workers.
8.A Behavior and Event-Related Potentials Study on the of the Effects of Long-Term Emotional Disturbance and Liver Failing to Govern Conveyance and Dispersion on Prospective Memory in Middle-Aged and Elderly People in the Community
Zhongpeng QIN ; Xianghong ZHAN ; Yong LIU ; Junlin HOU ; Ning LI ; Ziwei ZHAO ; Huanghong ZHAO ; Lei HUO ; Yan ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(3):739-751
Objective To explore the neuroelectrophysiological mechanism of the decline of overall cognitive function and prospective memory,the syndrome manifestation of liver failing to govern conveyance and dispersion of the middle-aged and elderly people in the community with long-term emotional disturbance were evaluated.Methods Eysenck personality questionnaire(EPQ)and general condition questionnaire were used to screen the middle-aged and elderly people from 46 to 65 years old in the community who met the high and low neuroticism criteria,which were included in the long-term emotional disturbance group and the control group.According to the principle of matching sex,age(±2 years)and years of education(±2 years),60 subjects in each group were included.The scores of livers meridian syndrome,anxiety factor,depression factor and the total scores of three factors in the two groups were detected with the emotion rating scale for Ganzangxiang of traditional Chinese medicine.The overall cognitive function,the overall level of prospective memory and the dual-task paradigm of event-related memory were evaluated and event-related potential components were detected.Results Compared to the control group,the total scores of emotion rating scale for Ganzangxiang of traditional Chinese medicine and the scores of liver meridian syndrome factor,anxiety factor and depression factor all increased in the long-term emotional disturbance group significantly(P<0.05).The total scores of MoCA scale(after correction)and the level scores of visual space and executive function,attention and delayed recall decreased significantly(P<0.05),and the total scores of prospective memory questionnaire decreased significantly(P<0.05).The correct rates of ongoing tasks and prospective memory tasks in the event-based prospective memory dual task paradigm were decreased,and the reaction time was prolonged in the long-term emotional disorder group significantly(P<0.05).The amplitude of P200 of ongoing task and prospective memory task were increased in the long-term emotional disorder group(0.05
9.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.
10.Analysis of the Construction Approach of the Prefilled Syringe Standard System in Chinese Pharmacopoeia
Yong SHEN ; Xiaowen BO ; Xiaohui YU ; Hui YU ; Lei CHEN
Herald of Medicine 2025;44(4):523-527
Objective This study aims to comprehensively analyze the overall framework and key quality attributes of the proposed standard system for prefilled syringes through key clause analysis.Methods Based on a thorough understanding of market product conditions and the current status of domestic and international standards;the critical quality attributes of pre-filled syringe container systems were identified.Results A new standard system for prefilled syringes was constructed to meet the regulatory and industry development needs of China.Conclusions The proposed standard system for prefilled syringes is designed with both rigidity and flexibility,meeting regulatory needs and facilitating industry development.


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