1.The introduction on the standards system of water for pharmaceutical purposes in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; WANG Lin ; ZHANG Gongchen ; MA Shihong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):077-082
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the standards system of Water for Pharmaceutical Purposes has been perfected. This article focuses on the Work Background, Overall Approach,Work Methodology,Standard Framework,Key Content and Significance on the standards system of Water for Pharmaceutical Purposes in the Chinese Pharmacopoeia 2025, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
2.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
FAN Yiling ; ZHU Ran ; YANG Yan ; JIANG Bo ; SONG Minghui ; WANG Jing ; LI Qiongqiong ; LI Gaomin ; WANG Shujuan ; SHAO Hong ; MA Shihong ; CAO Xiaoyun ; HU Changqin ; MA Shuangcheng, ; YANG Meicheng
Drug Standards of China 2025;26(1):093-098
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.
3.Mitochondrial Transfer Promotes Immune Escape in Osteosarcoma Cells: Mechanisms and Research Advances
Qishun QIN ; Xingsheng WANG ; Kai LI ; Pei PENG ; Shihong XU
Medical Journal of Peking Union Medical College Hospital 2025;16(5):1250-1259
Osteosarcoma is a highly aggressive malignant bone tumor whose immuno evasion mechanisms play a pivotal role in tumor progression and therapeutic resistance. Recent studies have identified mitochondrial transfer as a novel mode of intercellular communication that significantly influences metabolic reprogramming and immune evasion in osteosarcoma cells. This mechanism operates through three principal pathways: (1) enhancing energy metabolic efficiency in tumor cells; (2) mitigating intracellular oxidative stress; and (3) modulating immune checkpoint molecule expression. Collectively, these alterations impair host immune surveillance while promoting tumor proliferation, invasion, and distant metastasis through metabolic remodeling, immune tolerance induction, and tumor microenvironment reconstruction. This review systematically elucidates the molecular mechanisms by which mitochondrial transfer regulates immune evasion in osteosarcoma and its dynamic impact on the tumor microenvironment. Furthermore, we discuss the translational potential of targeting this pathway for precision therapy and outline future research directions in this emerging field.
4.Clinical course, causes of worsening, and outcomes of severe ischemic stroke: A prospective multicenter cohort study.
Simiao WU ; Yanan WANG ; Ruozhen YUAN ; Meng LIU ; Xing HUA ; Linrui HUANG ; Fuqiang GUO ; Dongdong YANG ; Zuoxiao LI ; Bihua WU ; Chun WANG ; Jingfeng DUAN ; Tianjin LING ; Hao ZHANG ; Shihong ZHANG ; Bo WU ; Cairong ZHU ; Craig S ANDERSON ; Ming LIU
Chinese Medical Journal 2025;138(13):1578-1586
BACKGROUND:
Severe stroke has high rates of mortality and morbidity. This study aimed to investigate the clinical course, causes of worsening, and outcomes of severe ischemic stroke.
METHODS:
This prospective, multicenter cohort study enrolled adult patients admitted ≤30 days after ischemic stroke from nine hospitals in China between September 2017 and December 2019. Severe stroke was defined as a score of ≥15 on the National Institutes of Health Stroke Scale (NIHSS). Clinical worsening was defined as an increase of 4 in the NIHSS score from baseline. Unfavorable functional outcome was defined as a modified Rankin scale score ≥3 at 3 months and 1 year after stroke onset, respectively. We performed Logistic regression to explore baseline features and reperfusion therapies associated with clinical worsening and functional outcomes.
RESULTS:
Among 4201 patients enrolled, 854 patients (20.33%) had severe stroke on admission. Of 3347 patients without severe stroke on admission, 142 (4.24%) patients developed severe stroke in hospital. Of 854 patients with severe stroke on admission, 33.95% (290/854) experienced clinical worsening (median time from stroke onset: 43 h, Q1-Q3: 20-88 h), with brain edema (54.83% [159/290]) as the leading cause; 24.59% (210/854) of these patients died by 30 days, and 81.47% (677/831) and 78.44% (633/807) had unfavorable functional outcomes at 3 months and 1 year respectively. Reperfusion reduced the risk of worsening (adjusted odds ratio [OR]: 0.24, 95% confidence interval [CI]: 0.12-0.49, P <0.01), 30-day death (adjusted OR: 0.22, 95% CI: 0.11-0.41, P <0.01), and unfavorable functional outcomes at 3 months (adjusted OR: 0.24, 95% CI: 0.08-0.68, P <0.01) and 1 year (adjusted OR: 0.17, 95% CI: 0.06-0.50, P <0.01).
CONCLUSIONS:
Approximately one-fifth of patients with ischemic stroke had severe neurological deficits on admission. Clinical worsening mainly occurred in the first 3 to 4 days after stroke onset, with brain edema as the leading cause of worsening. Reperfusion reduced the risk of clinical worsening and improved functional outcomes.
REGISTRATION
ClinicalTrials.gov , NCT03222024.
Humans
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Male
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Female
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Prospective Studies
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Ischemic Stroke/mortality*
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Aged
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Middle Aged
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Aged, 80 and over
;
Stroke
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Brain Ischemia
5.Research progress in the mechanism and treatment of post traumatic platelet dysfunction.
Kai LI ; Peixin WANG ; Kun WEI ; Jia LIU ; Xue BAI ; Tiantao ZHANG ; Chen ZHANG ; Shihong XU
Chinese Journal of Cellular and Molecular Immunology 2025;41(11):1041-1046
Trauma is the main cause of death and disability. Patients with severe trauma have hemorrhagic shock, traumatic coagulopathy and other diseases, which increase the risk of death. Platelets are important in the hemostatic response, but their function is rapidly dysregulated in trauma patients, leading to traumatic coagulopathy, blood loss, and early death. In addition to their role in hemostasis, platelets act as coordinators of the initial immune response, which can lead to immunothrombosis, organ dysfunction, and increased late mortality. At present, the treatment of post traumatic platelet dysfunction is mainly based on early hemostasis, and late prevention and treatment of thrombosis and organ dysfunction. In this review, the characteristics, underlying mechanisms, diagnosis and treatment strategies of platelet dysfunction in different periods are summarized, to provide ideas for studying the mechanism of platelet dysfunction after trauma and the treatment strategy for trauma patients.
Humans
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Wounds and Injuries/therapy*
;
Blood Platelets/metabolism*
;
Blood Platelet Disorders/etiology*
;
Animals
;
Hemostasis
6.2024 Expert Consensus on Hospital Acquired Infection Control Principles in the Department of Critical Care Medicine
Wenzhao CHAI ; Jingjing LIU ; Xiaoting WANG ; Xiaojun MA ; Bo TANG ; Qing ZHANG ; Bin WANG ; Xiaomeng WANG ; Shihong ZHU ; Wenjin CHEN ; Zujun CHEN ; Quanhui YANG ; Rongli YANG ; Xin DING ; Hua ZHAO ; Wei CHENG ; Jun DUNA ; Jingli GAO ; Dawei LIU
Medical Journal of Peking Union Medical College Hospital 2024;15(3):522-531
Critically ill patients are at high risk for hospital acquired infections, which can significantly increase the mortality rate and treatment costs for these patients. Therefore, in the process of treating the primary disease, strict prevention and control of new hospital infections is an essential component of the treatment for critically ill patients. The treatment of critically ill patients involves multiple steps and requires a concerted effort from various aspects such as theory, management, education, standards, and supervision to achieve effective prevention and control of hospital infections. However, there is currently a lack of unified understanding and standards for hospital infection prevention and control. To address this, in March 2024, a group of experts in critical care medicine, infectious diseases, and hospital infection from China discussed the current situation and issues of hospital infection control in the intensive care unit together. Based on a review of the latest evidence-based medical evidence from both domestic and international sources,
7.Serological Investigation into the Infected Genotypes of Patients with Japanese Encephalitis in the Coastal Provinces of China
Zhang WEIJIA ; Zhao JIERONG ; Yin QIKAI ; Liu SHENGHUI ; Wang RUICHEN ; Fu SHIHONG ; Li FAN ; He YING ; Nie KAI ; Liang GUODONG ; Xu SONGTAO ; Yang GUANG ; Wang HUANYU
Biomedical and Environmental Sciences 2024;37(7):716-725
Objective Genotypes(G)1,3,and 5 of the Japanese encephalitis virus(JEV)have been isolated in China,but the dominant genotype circulating in Chinese coastal areas remains unknown.We searched for G5 JEV-infected cases and attempted to elucidate which JEV genotype was most closely related to human Japanese encephalitis(JE)in the coastal provinces of China. Methods In this study,we collected serum specimens from patients with JE in three coastal provinces of China(Guangdong,Zhejiang,and Shandong)from 2018 to 2020 and conducted JEV cross-neutralization tests against G1,G3,and G5. Results Acute serum specimens from clinically reported JE cases were obtained for laboratory confirmation from hospitals in Shandong(92 patients),Zhejiang(192 patients),and Guangdong(77 patients),China,from 2018 to 2020.Seventy of the 361 serum specimens were laboratory-confirmed to be infected with JEV.Two cases were confirmed to be infected with G1 JEV,32 with G3 JEV,and two with G5 JEV. Conclusion G3 was the primary infection genotype among JE cases with a definite infection genotype,and the infection caused by G5 JEV was confirmed serologically in China.
8.5.0T MR susceptibility weighted imaging for displaying cerebral small veins and detecting cerebral microbleeds
Xiyin MIAO ; Zhang SHI ; Shihong HAN ; Rui WANG ; Caizhong CHEN ; Shengxiang RAO ; Jiang LIN ; Mengsu ZENG
Chinese Journal of Medical Imaging Technology 2024;40(5):657-660
Objective To observe the value of 5.0T MR susceptibility weighted imaging(SWI)for displaying cerebral small veins and detecting cerebral microbleeds(CMB).Methods Head MR examinations were prospectively performed using both 3.0T and 5.0T MR scanner in 30 stroke patients suspected caused by cerebral small vessel disease.The image quality,effect of displaying cerebral small veins and detecting CMB were compared between 3.0T and 5.0T SWI.Results The image quality scores,signal-to-noise ratios,contrast-to-noise ratios,scores of displaying deep cerebral veins and subcortical veins,the counts of detecting CMB and iron deposition on cortical surface of 5.0T SWI were all higher than those of 3.0T SWI(all P<0.05).High consistency of CMB positions was found between 3.0T and 5.0T SWI(Kappa=1.0).Conclusion The effect of 5.0T MR SWI for displaying cerebral small veins and detecting cerebral microbleeds were better than 3.0T MR SWI,which could be used to assess stroke caused by cerebral small vascular disease.
9.Comparison of growth characteristics of different genotypes of Japanese encephalitis virus in different cell lines
Weijia ZHANG ; Shenghui LIU ; Xiaohui YAO ; Yuke ZHENG ; Jiehui WU ; Ruichen WANG ; Shihong FU ; Qikai YIN ; Fan LI ; Kai NIE ; Qianqian CUI ; Songtao XU ; Huanyu WANG
Chinese Journal of Experimental and Clinical Virology 2024;38(1):15-20
Objective:To analyze the growth characteristics of different genotypes of Japanese encephalitis virus (JEV) in different cell lines, and to provide scientific basis for the selection of cell lines in the study of JEV.Methods:BHK-21, Vero, C6/36, PK-15, DF-1, N2a, SH-sy5y and MDCK cell lines were selected. The proliferation ability of genotype 1 (NX1889 strain), genotype 3 (P3 strain) and genotype 5 (XZ0934 strain) JEV in these cell lines was evaluated by plaque assay and RT-qPCR.Results:Significant cytopathogenic effects (CPE) were observed in BHK-21, Vero, C6/36, DF-1, N2a and PK-15 cell lines across all three JEV genotypes. However, no significant differences in CPE characteristics were observed within the same cell line. SH-sy5y and MDCK cell lines did not show significant CPE, but virus proliferation was detected in SH-sy5y cell line, while MDCK cell line were found to be insensitive to JEV. No significant difference was observed in the proliferation curves of G1, G3 and G5 JEV in BHK-21, Vero and SH-sy5y cell lines. In C6/36 and PK-15 cell lines, the titer of G1 JEV was higher than that of G3 and G5. In DF-1 cell line, G5 demonstrated a higher titer than the other two genotypes, whereas in N2a cell line, G5 showed a lower titer than the other two.Conclusions:There are differences in the proliferation of three different genotypes of JEV in different cell lines, which can provide reference for the study of JEV in different directions.
10.Predictive value of cognitive function trend for recurrence risk in patients after acute cerebral infarction
Zejing LIU ; Lingqun MAO ; Shihong CHEN ; Yi WANG ; Weizhen FENG ; Feng XU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2024;26(11):1334-1337
Objective To explore the predictive value of cognitive function trend after ACI for the recurrence risk of cerebral infarction.Methods A total of 256 ACI patients admitted to our hospi-tal from January 2021 to December 2023 were enrolled retrospectively.Based on their MoCA score at 3 months after onset,they were assigned into 96 cases of no PSCI,51 cases of improved PSCI,17 cases of delayed PSCI and 92 cases of persistent PSCI.According to the results of MoCA at 2 weeks after onset,they were divided into 133 cases of PSCI group and 123 cases of non-PSCI group.The clinical data of the ACI patients were compared between the two groups,and their cog-nitive function trends were analyzed.Results Advanced age,and larger proportions of female,du-al antiplatelet therapy and PSQI>5 were observed in the PSCI group than the non-PSCI group(P<0.05,P<0.01).There were significant differences in the incidences of recurrence and poor prognosis in the ACI patients with different cognitive function trends(P<0.01).The persistent PSCI was associated with the increased risk of recurrence of cerebral infarction and poor prognosis(P<0.05).The AUC value of persistent PSCI in predicting the recurrence and poor prognosis of cerebral infarction was 0.703(95%CI:0.631-0.767)and 0.595(95%CI:0.521-0.666),respec-tively.Conclusion Persistent PSCI can be used as a predictor of recurrence of cerebral infarction,and it also increases the risk of cognitive dysfunction in ACI patients.

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