1.Clinical research design and challenges of multi-conjugate vaccine and polyvalent vaccine
Hongyan LIU ; Weiwei HAN ; Mingzhi GAN ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2025;46(7):1304-1310
Multi-conjugate vaccine and polyvalent vaccine can reduce the number of vaccinations, improve vaccination efficiency, and provide wider protection against diseases, and can not only brings convenience to recipients but also reduce healthcare costs, making it a key focus in modern vaccine development. However, even if the components of the vaccine are derived from already approved monovalent vaccines, it must still be considered as a new vaccine and undergo randomized controlled clinical trials to evaluate their safety and efficacy in humans. Due to the inclusion of multiple antigens, clinical evaluation must consider the potential interactions between or among the components, as well as the impacts of adjuvants, preservatives, and other ingredients on the vaccines' safety and efficacy. These factors introduce certain specific challenges in the clinical evaluation of multi-conjugate vaccine and polyvalent vaccine. This article summarizes the key elements and methods of clinical study design for multi-conjugate vaccine and polyvalent vaccine in terms of safety, immunogenicity, and protective efficacy, and discuss the problems and challenges exisitng in vaccine clinical evaluation to provide reference for the standardization of clinical study design of multi-conjugate vaccine and polyvalent vaccine.
2.Bibliometric analysis of literature published in the Chinese Journal of Psychiatry (1996-2024)
Chinese Journal of Psychiatry 2025;58(6):419-426
Objective:To investigate the dynamics of articles published in the Chinese Journal of Psychiatry since 1996 through bibliometrics and visual analysis.Methods:The studies published in the Chinese Journal of Psychiatry between 1996 and 2024 were retrieved from the Wanfang Database. Bibliometric analysis was used to statistically examine the publication year distribution, geographic regions, institutions, authorship, keywords, and citation frequencies. VOSviewer software was utilized for network visualization analysis.Results:A total of 2 843 articles were included for analysis.Publications originated from 22 provinces, 4 municipalities, 4 autonomous regions, and the Hong Kong Special Administrative Region. First authors were affiliated with 672 institutions, encompassing medical centers, universities, research institutes, academic societies, administrative agencies, and pharmaceutical companies. A total of 13 356 authorship instances, including 1 879 first authors, were identified. The overall collaboration index was 4.70, with a collaboration rate of 88.39%. Keyword co-occurrence analysis revealed nine major research hotspots in psychiatry.Conclusion:The Chinese Journal of Psychiatry has steadily enhanced its academic reputation and influence over the past three decades, attracting a cohort of influential core researchers. The journal′s publications cover a wide range of topics, reflecting the major research hotspots in psychiatry.
3.Clinical research design and challenges of multi-conjugate vaccine and polyvalent vaccine
Hongyan LIU ; Weiwei HAN ; Mingzhi GAN ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2025;46(7):1304-1310
Multi-conjugate vaccine and polyvalent vaccine can reduce the number of vaccinations, improve vaccination efficiency, and provide wider protection against diseases, and can not only brings convenience to recipients but also reduce healthcare costs, making it a key focus in modern vaccine development. However, even if the components of the vaccine are derived from already approved monovalent vaccines, it must still be considered as a new vaccine and undergo randomized controlled clinical trials to evaluate their safety and efficacy in humans. Due to the inclusion of multiple antigens, clinical evaluation must consider the potential interactions between or among the components, as well as the impacts of adjuvants, preservatives, and other ingredients on the vaccines' safety and efficacy. These factors introduce certain specific challenges in the clinical evaluation of multi-conjugate vaccine and polyvalent vaccine. This article summarizes the key elements and methods of clinical study design for multi-conjugate vaccine and polyvalent vaccine in terms of safety, immunogenicity, and protective efficacy, and discuss the problems and challenges exisitng in vaccine clinical evaluation to provide reference for the standardization of clinical study design of multi-conjugate vaccine and polyvalent vaccine.
4.Bibliometric analysis of literature published in the Chinese Journal of Psychiatry (1996-2024)
Chinese Journal of Psychiatry 2025;58(6):419-426
Objective:To investigate the dynamics of articles published in the Chinese Journal of Psychiatry since 1996 through bibliometrics and visual analysis.Methods:The studies published in the Chinese Journal of Psychiatry between 1996 and 2024 were retrieved from the Wanfang Database. Bibliometric analysis was used to statistically examine the publication year distribution, geographic regions, institutions, authorship, keywords, and citation frequencies. VOSviewer software was utilized for network visualization analysis.Results:A total of 2 843 articles were included for analysis.Publications originated from 22 provinces, 4 municipalities, 4 autonomous regions, and the Hong Kong Special Administrative Region. First authors were affiliated with 672 institutions, encompassing medical centers, universities, research institutes, academic societies, administrative agencies, and pharmaceutical companies. A total of 13 356 authorship instances, including 1 879 first authors, were identified. The overall collaboration index was 4.70, with a collaboration rate of 88.39%. Keyword co-occurrence analysis revealed nine major research hotspots in psychiatry.Conclusion:The Chinese Journal of Psychiatry has steadily enhanced its academic reputation and influence over the past three decades, attracting a cohort of influential core researchers. The journal′s publications cover a wide range of topics, reflecting the major research hotspots in psychiatry.
5.The biologically and ecologically important natural products from the Chinese sea hare Bursatella leachii:structures,stereochemistry and beyond
Xinyuan ZHANG ; Mingzhi SU ; Mingxin ZHU ; Sha CHEN ; Zhen GAO ; Yuewei GUO ; Xuwen LI
Chinese Journal of Natural Medicines (English Ed.) 2024;22(11):1030-1039
A novel amide alkaloid,bursatamide A(1),featuring an unprecedented propyl-hexahydronaphthalene carbon frame-work,was isolated from the infrequently studied sea hare Bursatella leachi,alongside a new 3-phenoxypropanenitrile alkaloid,bursatellin B(2),and twelve known compounds.The structures of 1 and 2 were elucidated through comprehensive spectroscopic data analyses,while their relative and absolute configurations(ACs)were established through total synthesis and a series of quantum chem-ical calculations,including calculated electronic circular dichroism(ECD)spectra,optical rotatory dispersion(ORD)methods,and DP4+probability analyses.Bursatamide A(1)demonstrated inhibitory effects against the human pathogenic bacteria Listeria monocyt-ogenes and Vibrio cholerae.Erythro-bursatellin B(21),a diastereoisomer of 2,exhibited notable antibacterial activity against the fish pathogenic bacterium Streptococcus parauberis FP KSP28,with an MIC90 value of 0.0472 μg·mL-1.
6.Recent advance in anti-neurexin-3α antibody-associated encephalitis
Jiajie CHEN ; Hongyan ZHU ; Lingchun LIU ; Hao FU ; Da LIU ; Shunyu YANG ; Ruihan YANG ; Mingzhi ZHANG ; Qiang MENG
Chinese Journal of Neuromedicine 2023;22(1):84-88
Neurexin-3α, discovered in 2016, is a new type of autoimmune encephalitis antibody. Anti-neurexin-3α antibody-associated encephalitis is generally associated with prodromal symptoms or mood changes, having main clinical manifestations as seizures, memory disorders, confusion or loss of consciousness, central ventilation insufficiency, abnormal behavior, and speech disorders. This paper reviews the relevant research progress at home and abroad about pathogenesis, diagnosis and differential diagnosis, treatment and prognosis of anti-neurexin-3α antibody-associated encephalitis, so as to expand the understanding of clinicians for this disease.
7. Model informed precision dosing of warfarin: China expert consensus report (2022 version)
Jinhua ZHANG ; Maobai LIU ; Mingzhi CAI ; Yingli ZHENG ; Haiyan LAO ; Qian XIANG ; Liping DU ; Zhu ZHU ; Jing DONG ; Xiaocong ZUO ; Xingang LI ; Dewei SHANG ; Bing CHEN ; Yanrong YE ; Yuzhu WANG ; Jianjun GAO ; Jian ZHANG ; Wansheng CHEN ; Haitang XIE ; Zheng JIAO
Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(11):1201-1212
Model informed precision dosing for warfarin is to provide individualized dosing by integrating information related to patient characteristics, disease status and pharmacokinetics /pharmacodynamics of warfarin, through mathematical modeling and simulation techniques based on the quantitative pharmacology. Compared with empirical dosing, it can improve the safety, effectiveness, economy, and adherence of pharmacotherapy of warfarin. This consensus report describes the commonly used modeling and simulation techniques for warfarin, their application in developing and adjusting dosing regimens, medication adherence and economy. Moreover, this consensus also elaborates the detailed procedures for the implementation in the warfarin pharmacy service pathway to facilitate the development and application of model informed precision dosing for warfarin.
8.Detection and analysis of EBV DNA integration in NK/T cell lymphoma genome
Xin WANG ; Xudong ZHANG ; Qingjiang CHEN ; Guannan WANG ; Junxia HU ; Shaoxuan WU ; Mijing MA ; Meifeng YIN ; Wanqiu YANG ; Meng DONG ; Mengjie DING ; Mingzhi ZHANG ; Linan ZHU
Chinese Journal of Clinical Oncology 2018;45(23):1194-1200
To investigate the presence of integrated Epstein-Barr virus (EBV) DNA in the NK/T cell lymphoma (NKTCL) ge-nome and analyze the integration information in the genome of NKTCL cell lines. Methods: PCR and in situ hybridization were used to detect EBV infection in five EBV (+) NK/T samples and four EBV (-) NK/T samples provided by the biobanks of the First Affiliated Hospi-tal of Zhengzhou University. Whole-genome DNA of the samples was sequenced and subjected to bioinformatics analysis. Whole-ge-nome sequence alignment was used to identify the EBV integration sequence. BLAST analysis was used to compare EBV fasta files of the samples and EBV fasta library. CREST software was used to extract softclip reads, filter all paired reads, and enumerate their distri-bution on chromosomes. The integrated genomics viewer (IGV) was used to compare the distribution of reads in partial regions of chromosome. PCR was used to amplify the high-frequency integration region of the EBV DNA. The amplified fragments were sanger se-quenced. Results: EBV DNA and EBER expression were detected in five EBV (+) NK/T samples but not in the four EBV (-) NK/T samples. Sequencing depth, coverage depth, proportion of coverage, and proportion of alignment all met the requirements for subsequent re-search. Sequence alignment revealed that the captured sequences were viral sequences. Filtered reads were most numerous in EBV (+) NKTCL cell line SNK, YTS, and EBV (+) nasal NKTCL tissue. The reads were non-randomly enriched in chromosome 2. EBV DNA inte-gration in the 400 bp region of chr2:30234084-30234483 caused insertion or deletion in the chr2p23.1 site. Conclusions: EBV DNA is highly integrated in the chr2p23.1 site of EBV (+) NKTCL cells and may affect the expression of related genes.
9.Expression and clinical significance of PD-1/PD-Ls in EBV-positive T/NK lymphoprolif-erative disorders
Junxia HU ; Qingjiang CHEN ; Xudong ZHANG ; Wencai LI ; Guannan WANG ; Xin WANG ; Meng DONG ; Shaoxuan WU ; Mijing MA ; Meifeng YIN ; Wanqiu YANG ; Mengjie DING ; Mingzhi ZHANG ; Linan ZHU
Chinese Journal of Clinical Oncology 2018;45(24):1248-1253
Objective: To investigate the expression and clinical significance of programmed death-ligand 1 (PD-L1), programmed death-ligand 2 (PD-L2), and their receptor programmed cell death protein 1 (PD-1) in EBV-positive T/NK lymphoproliferative disease [Epstein-Barr virus-positive T/natural killer (NK)-cell lymphoproliferative disease, EBV(+)-T/NK-LPD]. Methods: The pathological paraffin-embedded tissues of 17 patients with EBV(+)-T/NK-LPD from the First Affiliated Hospital of Zhengzhou University from January 2013 to December 2017 were collected. These patients include 12 males and 5 females, aged 10-82 years old, the average age being 29 years, 4 people in gradeⅠ, 7 in gradeⅡ, 3 in gradeⅢ, and 3 people with hydroa vacciniforme-like lymphoproliferative disorders. Immunohistochemical SP method was used to detect the expression of PD-1, PD-L1, and PD-L2 in human EBV(+)-T/NK-LPD tissues. The relationship between PD-1, PD-L1, PD-L2 expression, and clinicopathological parameters, pathological grades and prognosis were analyzed by Fisher's exact probabilities and Spearman rank correlation. Result: After statistical analysis, the results showed that in 17 cases of tissue samples, there were 12 cases with positive PD-1 expression, 6 cases with positive PD-L1 expression and 5 cases with positive PD-L2 expression. There was no significant correlation between PD-1 and PD-L2 expression and prognosis (P>0.05). PD-L1 expression showed a positive correlation with prognosis (P<0.05). There was no significant correlation between the expression of PD-L1 and PD-L2 with age, sex, as well as LDH and Ki-67 levels (P>0.05). Moreover, there was no significant correlation of PD-1 and PD-L2 expression with pathological grade (r=0.141, r=-0.149, both P>0.05). However, there was a negative correlation between the PD-L1 expression and pathological grade (r=-0.563), and the correlation between the PD-L1 ex-pression and pathological grade was statistically significant (P<0.05). Conclusions: PD-1, PD-L1, and PD-L2 are abnormally expressed in the pathological tissues of EBV(+)-T/NK-LPD. Although there was no significant correlation between the expression of PD-1 and prognosis or pathological grade, it was significantly higher in EBV+T/NK-LPD. PD-1/PD-Ls associated signaling pathway is expected to be a potential new target for EBV(+)-T/NK-LPD immunotherapy.
10.Correlation between peripheral inflammatory cytokines and anxiety symptoms in patients with the first-episode generalized anxiety disorder
Gang YE ; Zhen TANG ; Xin LI ; Mingzhi PAN ; Feng ZHU ; Jialin FU ; Tian FU ; Qichun LIU ; Zhenyong GAO ; Xinyun CHEN
Chinese Journal of Behavioral Medicine and Brain Science 2016;25(8):709-712
Objective To investigate the relationship between peripheral inflammatory cytokines and anxiety symptoms in patients with the first?episode generalized anxiety disorder. Methods 48 patients diagnosed with the first?episode generalized anxiety disorder according to ICD?10 criteria and 48 healthy sub?jects were recruited. Peripheral levels of IL?1, IL?2, IL?4, IL?5, IL?6, IL?8, IL?10, IL?12p70, GM?CSF and IFN?γ of both groups were evaluated by enzyme?linked immunosorbent assay ( ELISA) ,and CRP was evalua?ted by immunoturbidimetric method. Generalized Anxiety Disorder Scale( GAD?7) and State?Trait Anxiety Inventory ( STAI ) were used to assess the levels of overall anxiety, state anxiety and trait anxiety. Results The levels of CRP ( ( 1. 19 ± 0. 80 ) mg/L vs ( 0. 68 ± 0. 70 ) mg/L, t=3. 31 ) , IL?1α( ( 70. 34 ± 3.60)pg/ml vs (16.94±3.42)pg/ml, t=74.50),IL?2((7.25±3.42)pg/ml vs (4.95±2.31)pg/ml, t=3.85), IL?4((102.02±73.14)pg/ml vs (75.55±32.78)pg/ml, t=2.29),IL?6((12.55±2.37)pg/ml vs (2.71±1.35) pg/ml, t=14.79),IL?8((44.64±16.21)pg/ml vs (35.69±11.70)pg/ml, t=3.10),IL?12((18.16±24.17) pg/ml vs (10.82±4.72)pg/ml, t=2.06),IFN?γ((23.32±15.52)pg/ml vs (16.48±6.80)pg/ml, t=2.79), GM?CSF((19.07±11.12)pg/ml vs (13.40±8.54)pg/ml, t=2.80) in patients with the first?episode general?ized anxiety disorder were significantly higher than normal controls(P<0.05) . Both SAI and TAI had signifi? cantly positive correlation with the levels of IL?1α, IL?2, IL?6, IL?8, IL?12, IFN?γ and GM?CSF ( r=0.24?0.76, P<0.05) . Conclusion The levels of some peripheral inflammatory cytokines in patients with the first?episode generalized anxiety disorder are significantly increased,and they have positive correlation with gener?al anxiety,state anxiety and trait anxiety,which may suggest some immune system defects in the patients.

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