1.Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system
Min JIANG ; Li LIN ; Chenxi GAN ; Wenxiong SUN ; Qingsong XU ; Xiuli ZHAO
China Pharmacy 2025;36(3):275-279
OBJECTIVE To investigate and analyze the current management of drug clinical trial institutions in Jiangxi Province and the situation of undertaking drug clinical trials after the implementation of the filing system. METHODS A survey was conducted on 38 new institutions (obtained qualifications during the implementation of the filing system) and old institutions (obtained qualifications during the implementation of the recognition system) that had completed drug clinical trial institution qualification filing for more than one year in Jiangxi Province. The survey focused on the basic information of the institutions, the number of registered principal investigator (PI), institutional hardware and information construction, personnel allocation and training, and drug registration clinical trials undertaken by the institutions. RESULTS Of 38 institutions surveyed, there were 22 general hospitals and 16 specialized hospitals; there were 24 old institutions and 14 new institutions. Whether in general hospitals or specialized hospitals, the old institutions were better than the new institutions in the number of approved beds, the number of outpatients, the number of inpatients, the number of specialties, and the number of PI; both old and new institutions had separate offices; all new institutions were set up with GCP pharmacy. The adoption of clinical trial management system in new institutions is significantly less than in old institutions. In the general hospital, both the number of full-time managers and the number of quality controllers in old institutions were significantly more than in the new institutions, while the opposite was true at the level of specialized hospitals. In terms of centralized training on GCP, new institutions were all better than the old ones. Whether in general hospitals or specialized hospitals, the number of drug registration clinical trial projects undertaken by new institutions was significantly less than that of old ones. CONCLUSIONS The new institutions are worse than the old institutions in comprehensive strength and information construction of hospitals, and the number of clinical trials undertaken by new institutions is also less than old institutions.
2.Prevalence of menopausal syndrome among postmenopausal women in Pan'an County
YING Huizhen ; JI Li ; KONG Wenjuan ; WANG Yuan ; CHEN Xiaoxia ; HU Caihong ; FU Haiying ; LU Yuanyuan ; CHE Xiuli
Journal of Preventive Medicine 2025;37(3):312-315
Objective:
To investigate the prevalence and influencing factors of menopausal syndrome among postmenopausal women in Pan'an County, Zhejiang Province, so as to provide the basis for guiding the health management of postmenopausal women.
Methods:
From May 2023 to April 2024, the postmenopausal women aged 40 to 69 years in Pan'an County were selected using the random cluster sampling method. Demographic information, lifestyle and prevalence of gynecological diseases were collected through questionnaire surveys. The prevalence of menopausal syndrome was assessed by modified Kupperman Score Scale. Factors affecting menopausal syndrome were analyzed by a multivariable logistic regression model.
Results:
A total of 816 postmenopausal women were surveyed, with an mean age of (57.63±2.92) years and a mean natural menopause age of (49.85±2.13) years. There were 574 cases with menopausal syndrome, with a prevalence of 70.34%. Flashes and sweating, insomnia and irritability were common symptoms, accounting for 62.87%, 47.43% and 41.18%, respectively. Multivariable logistic regression analysis showed that monthly personal income of ≤5 000 yuan (<3 000 yuan, OR=3.124, 95%CI: 1.829-5.335; 3 000-5 000 yuan, OR=2.399, 95%CI: 1.370-4.201) and having gynecological diseases (OR=1.970, 95%CI: 1.292-3.004) were associated with a higher risk of menopausal syndrome, while average (OR=0.141, 95%CI: 0.072-0.276) or sufficient sleep quality (OR=0.095, 95%CI: 0.049-0.185) were associated with a lower risk of menopausal syndrome.
Conclusion
The prevalence of menopausal syndrome among postmenopausal women in Pan'an County is relatively high, and is mainly influenced by personal economic status, sleep quality and the presence of gynecological diseases.
3.Effectiveness of clinical intervention among elderly female patients with stress urinary incontinence
ZHANG He ; PIAO Li ; YU Xiuli ; HUANG Jintao ; QU Xiaomei
Journal of Preventive Medicine 2025;37(8):852-857
Objective:
To evaluate the impact of comprehensive nursing based on the behavioral goal attainment model on the clinical intervention effect among elderly female patients with stress urinary incontinence (SUI), so as to provide a basis for optimizing the nursing strategies for patients with SUI and improving their quality of life.
Methods:
A total of 190 elderly female patients with SUI who were treated in the Department of Gynecology of the First Hospital of Jilin University from January 2023 to August 2024 were selected and randomly divided into the intervention group and the control group. The control group received routine nursing care, while the intervention group received comprehensive nursing based on the behavioral goal attainment model. The 1-hour pad test was used to assess urinary incontinence symptoms. The bio-electrical stimulation feedback instrument was employed to detect the electromyogram (EMG) values in the pre-resting stage and slow-muscle stage for evaluating pelvic floor function. The bladder function scale was utilized to evaluate bladder function. The Chinese version of urinary incontinence ego-efficacy rating scales and incontinence quality of life assessment scale (IQOL) were used to assess self-efficacy and quality of life. The data on intervention compliance and nursing satisfaction were collected by a questionnaire survey. The differences between the two groups before and after the intervention were compared using the analysis of variance for repeated-measures data to evaluate the intervention effect.
Results:
There were 95 cases in the control group and 95 cases in the intervention group, with median ages were 64.00 (interquartile range, 23.50) and 64.50 (interquartile range, 19.50) years, respectively. The proportion of patients with cesarean section as the last delivery method was 21.05% in the control group and 12.63% in the intervention group. The proportion of patients with moderate disease severity was 67.36% in the control group and 58.95% in the intervention group. There were no statistically significant differences in age, body mass index, number of pregnancies, number of deliveries, marital status, educational level, mode of last delivery and severity of the disease between the two groups of patients (all P>0.05). The analysis of variance of repeated-measures data showed that there were significant interactions between time and group for the urine leakage volume in the 1-hour pad test, the EMG values in the pre-resting stage, the EMG values in the slow-muscle stage, the scores of the bladder function, the self-efficacy scores, and the IQOL scores (all P<0.05). After 12 weeks of intervention, the EMG values in the slow-muscle stage, the scores of the bladder function, the self-efficacy scores, the IQOL scores in the intervention group were higher than those in the control group, while the urine leakage volume in the 1-hour pad test and the EMG values in the pre-resting stage in the intervention group were lower than those in the control group (all P<0.05). The good compliance rate of intervention and the satisfaction rate of nursing in the intervention group were higher than those in the control group (83.16% vs. 60.00%, 90.53% vs. 75.79%, both P<0.05).
Conclusion
Comprehensive nursing based on the behavioral goal attainment model can improve urinary incontinence symptoms, pelvic floor function, bladder function, self-efficacy, quality of life, and intervention compliance of elderly female patients with SUI.
4.FLT3 ligand regulates expansion of regulatory T-cells induced by regulatory dendritic cells isolated from gut-associated lymphoid tissues through the Notch pathway.
Na LI ; Jingwei MAO ; Haiying TANG ; Xiaoyan TAN ; Jian BI ; Hao WU ; Xiuli CHEN ; Yingde WANG
Chinese Medical Journal 2025;138(13):1595-1606
BACKGROUND:
Regulatory dendritic cell (DCreg) subset exhibits a unique capacity for inducing immune tolerance among the variety subsets of dendritic cells (DCs) within gut-associated lymphoid tissues (GALTs). Fms-like tyrosine kinase 3 ligand (FLT3L) is involved in the differentiation of DCregs and the subsequent expansion of regulatory T-cells (Tregs) mediated by DCregs, though the precise mechanism remains poorly understood. This study aimed to explore the expansion mechanism of Treg induced by DCreg and the role of FLT3L in this process.
METHODS:
DCregs were distinguished from other DC subsets isolated from GALTs of BALB/c mice through a mixed lymphocyte reaction assay. The functions and mechanisms by which FLT3L promoted Treg expansion via DCregs were investigated in vitro through co-culture experiments involving DCregs and either CD4 + CD25 - T-cells or CD4 + CD25 + T-cells. Additionally, an in vivo experiment was conducted using a dextran sulfate sodium (DSS)-induced colitis model in mice.
RESULTS:
CD103 + CD11b + DC exhibited DCreg-like functionality and was identified as DCreg for subsequent investigation. Analysis of Foxp3 + Treg percentages within a co-culture system of CD4 + CD25 - T-cells and DCregs, with or without FLT3L, demonstrated the involvement of the FLT3/FLT3L axis in driving the differentiation of precursor T-cells into Foxp3 + Tregs induced by DCregs. Cell migration and co-culture assays revealed that the FLT3/FLT3L axis enhanced DCreg migration toward Tregs via the Rho pathway. Additionally, it was observed that DCregs could promote Treg proliferation through the Notch pathway, as inhibition of Notch signaling by DAPT (N-[N-(3,5-difluorophenacetyl)-l-alanyl]-S-phenylglycine t-butyl ester) suppressed Treg expansion within the co-culture system of DCregs and CD4 + T-cells or CD4 + CD25 + T-cells. Furthermore, the FLT3/FLT3L axis influenced JAG1 expression in DCregs, indirectly modulating Treg expansion. In vivo experiments further established that FLT3L promoted DCreg expansion and restored Treg balance in DSS-induced colitis models, thereby ameliorating colitis symptoms in mice.
CONCLUSION
The FLT3/FLT3L axis is integral to the maintenance of DCreg function in Treg expansion.
Animals
;
T-Lymphocytes, Regulatory/immunology*
;
Dendritic Cells/immunology*
;
Mice
;
Mice, Inbred BALB C
;
Membrane Proteins/metabolism*
;
Receptors, Notch/metabolism*
;
Lymphoid Tissue/metabolism*
;
Signal Transduction/physiology*
;
Coculture Techniques
;
Flow Cytometry
5.The interval of rescue treatment does not affect the efficacy and safety of Helicobacter pylori eradication: A prospective multicenter observational study.
Minjuan LIN ; Junnan HU ; Jing LIU ; Juan WANG ; Zhongxue HAN ; Xiaohong WANG ; Zhenzhen ZHAI ; Yanan YU ; Wenjie YUAN ; Wen ZHANG ; Zhi WANG ; Qingzhou KONG ; Boshen LIN ; Yuming DING ; Meng WAN ; Wenlin ZHANG ; Miao DUAN ; Shuyan ZENG ; Yueyue LI ; Xiuli ZUO ; Yanqing LI
Chinese Medical Journal 2025;138(12):1439-1446
BACKGROUND:
The effect of the interval between previous Helicobacter pylori (H. pylori) eradication and rescue treatment on therapeutic outcomes remains unknown. The aim of this study was to investigate the association between eradication rates and treatment interval durations in H. pylori infections.
METHODS:
This prospective observational study was conducted from December 2021 to February 2023 at six tertiary hospitals in Shandong, China. We recruited patients who were positive for H. pylori infection and required rescue treatment. Demographic information, previous times of eradication therapy, last eradication therapy date, and history of antibiotic use data were collected. The patients were divided into four groups based on the rescue treatment interval length: Group A, ≥4 weeks and ≤3 months; Group B, >3 and ≤6 months; Group C, >6 and ≤12 months; and Group D, >12 months. The primary outcome was the eradication rate of H. pylori . Drug compliance and adverse events (AEs) were also assessed. Pearson's χ2 test or Fisher's exact test was used to compare eradication rates between groups.
RESULTS:
A total of 670 patients were enrolled in this study. The intention-to-treat (ITT) eradication rates were 88.3% (158/179) in Group A, 89.6% (120/134) in Group B, 89.1% (123/138) in Group C, and 87.7% (192/219) in Group D. The per-protocol (PP) eradication rates were 92.9% (156/168) in Group A, 94.5% (120/127) in Group B, 94.5% (121/128) in Group C, and 93.6% (190/203) in Group D. There was no statistically significant difference in the eradication rates between groups in either the ITT ( P = 0.949) or PP analysis ( P = 0.921). No significant differences were observed in the incidence of AEs ( P = 0.934) or drug compliance ( P = 0.849) between groups.
CONCLUSION:
The interval duration of rescue treatment had no significant effect on H. pylori eradication rates or the incidence of AEs.
REGISTRATION
ClinicalTrials.gov , NCT05173493.
Humans
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Helicobacter Infections/drug therapy*
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Helicobacter pylori/pathogenicity*
;
Male
;
Female
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Prospective Studies
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Middle Aged
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Anti-Bacterial Agents/adverse effects*
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Adult
;
Aged
;
Treatment Outcome
;
Proton Pump Inhibitors/therapeutic use*
6.Genetic and clinical phenotypic analysis of Usher syndrome-associated gene variants.
Heng ZHAO ; Xiuli MA ; Yanli QU ; Guo LI ; Ken LIN ; Rui HUANG ; Lijuan ZHOU ; Jing MA
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(8):736-742
Objective:To investigate the molecular characteristics and clinical heterogeneity of Usher syndrome(USH) -related gene variants in patients with hereditary hearing loss in southwest China, providing a basis for early diagnosis and clinical management. Methods:Thirteen patients from twelve families with hearing loss who attended the Affiliated Children's Hospital of Kunming Medical University between January 2017 and March 2021 were enrolled. All patients were identified as carrying USH-related gene variants through next-generation sequencing. Sanger sequencing was performed for all patients and their parents to validate the pathogenic variants. Comprehensive clinical evaluations, including medical history collection, otologic and ophthalmologic examinations, and vestibular function assessments, were conducted. Results:Among the 13 patients, 4 were diagnosed with USH type 1 and 2 with USH type 2. A total of 19 pathogenic or likely pathogenic variants were detected in USH-related genes, including MYO7A,CDH23,USH1C, and USH2A. The causative gene was MYO7A in 3 probands, CDH23 in 5, USH1C in 3, and USH2Ain 2. All patients exhibited an autosomal recessive inheritance pattern. Vestibular dysfunction was observed in 4 patients, and retinitis pigmentosa(RP) in 3 patients. Based on the genotype-phenotype correlation, 6 patients were initially diagnosed with USH, while 7 were classified as having non-syndromic hearing loss(NSHL). Conclusion:This study revealed the clinical heterogeneity of USH-related gene variants in patients with hereditary deafness in southwest China. Although the clinical manifestations of USH are complex and there are overlapping characteristics between different subtypes, genetic testing provides an important basis for early diagnosis and precise clinical management. Especially for those with typical hearing loss, early genetic diagnosis can provide a window of time for early detection and intervention of retinitis pigmentosa.
Humans
;
Usher Syndromes/genetics*
;
Myosin VIIa
;
Phenotype
;
Male
;
Female
;
Myosins/genetics*
;
Mutation
;
Cadherins/genetics*
;
Child
;
Extracellular Matrix Proteins/genetics*
;
Adolescent
;
Pedigree
;
High-Throughput Nucleotide Sequencing
;
Cadherin Related Proteins
;
Cytoskeletal Proteins
;
Cell Cycle Proteins
7.Erratum: Author correction to "Generation of αGal-enhanced bifunctional tumor vaccine" Acta Pharm Sin B 12 (2022) 3177-3186.
Jian HE ; Yu HUO ; Zhikun ZHANG ; Yiqun LUO ; Xiuli LIU ; Qiaoying CHEN ; Pan WU ; Wei SHI ; Tao WU ; Chao TANG ; Huixue WANG ; Lan LI ; Xiyu LIU ; Yong HUANG ; Yongxiang ZHAO ; Lu GAN ; Bing WANG ; Liping ZHONG
Acta Pharmaceutica Sinica B 2025;15(2):1207-1207
[This corrects the article DOI: 10.1016/j.apsb.2022.03.002.].
8.A high clinically translatable strategy to anti-aging using hyaluronic acid and silk fibroin co-crosslinked hydrogels as dermal regenerative fillers.
Jialing CHENG ; Zhiyang CHEN ; Demin LIN ; Yanfang YANG ; Yanjing BAI ; Lingshuang WANG ; Jie LI ; Yuchen WANG ; Hongliang WANG ; Youbai CHEN ; Jun YE ; Yuling LIU
Acta Pharmaceutica Sinica B 2025;15(7):3767-3787
An ideal dermal filler should integrate filling, repair, and anti-aging effects, with immediate tissue augmentation, slow degradation, and progressive stimulation of collagen regeneration. However, commonly used hyaluronic acid (HA) hydrogels, while effective for rapid filling, suffer from limited duration of support, weak cell adhesion, and an inability to promote collagen regeneration. Silk fibroin (SF), a natural protein from silkworm cocoons, is known for its excellent cell adhesion and collagen-stimulating abilities. However, its limited gelation capability restricts its potential application as a standalone injectable hydrogel. Based on a complementary strategy, this study combines the rapid gelling properties of HA with the collagen regenerative properties of SF to create a co-crosslinked HA-SF hydrogel. The composite hydrogel merges HA's rapid filling effect with SF's strong tissue adhesion and collagen-stimulating abilities. The formulation, physicochemical properties, degradation, biocompatibility, and filling effects of the HA-SF hydrogel were systematically investigated. HA-SF hydrogel exhibits excellent mechanical properties and ensures long-term support while maintaining injectability. Interestingly, after intradermal injection in the UVB-induced photoaging model, HA-SF hydrogel not only enhances hydrogel-cell interaction but also continues to stimulate collagen regeneration, especially type III collagen. This dual action achieves the biological effects of repair and anti-aging while maintaining the filling effect. Proteomic analysis confirms that repair and anti-aging effects are enhanced by the regulation of skin fibroblasts and modulation of amino acid and lipid metabolism. This composite hydrogel holds strong promise for clinical applications, offering a safer, long-lasting, and more natural injectable filler that combines filling, repair, and anti-aging into one system.
9.Analysis of the prevalence of norovirus infection in children with single center acute gastroenteritis during 2021-2022
Xiuli GU ; Xiaofei ZHANG ; Ying LIU ; Wei ZHANG ; Sixue WANG ; Qiliang LI
International Journal of Pediatrics 2024;51(3):193-197
Objective:To investigate the prevalence of norovirus and the correlation between norovirus infection and stool traits and clinical symptoms in children with acute gastroenteritis during 2021-2022.Method:A total of 2 195 anal swab samples were collected from cases of acute gastroenteritis in Beijing Children 's Hospital Affiliated to Capital Medical University from January 2021 to December 2022. PCR fluorescent probe assay was performed to detect norovirus,the clinical information and test results were performed by statistical analysis. Results:The detection rate of norovirus was 19.09%(419/2 195)in 2 195 children. The detection rates of male and female were 17.80%(244/1 371)and 21.24%(175/824),respectively,with statistically significant differences between genders( χ2=3.945, P<0.05). The positivity rate of noroviruses was higher in aged 1 month to 3 years[29.09%(64/220)~40.69%(94/231)],especially in 1 year[40.69%(94/231)]. The norovirus detection rate ranged from 2.44%(2/82)to 35.84%(62/173)in different months,with a high detection rate between January and March,higher in the winter and spring[28.36%(150/529),21.07%(146/693)],showing a clear seasonal distribution.Clinical symptoms of both vomiting and diarrhea were significantly more common among norovirus positive than negative children,the difference was statistically significant( χ2=57.29, P<0.05). Conclusion:In the high incidence season of winter and spring,for infants and young children aged 1 month to 3 years with diarrhea accompanied by vomiting symptoms,especially those aged 1 year,it is recommended to undergo norovirus related testing in time. Early treatment and isolation measures should be taken for diagnosed children to reduce cross infection and prevent outbreaks.
10.Relationship and clinical significance between CCR2 and CRP levels and the severity of stroke associated pneumonia in stroke patients
Jianhua JIAO ; Ruixue MA ; Honghong GU ; Xiuli CAO ; Youxiang LI ; Jianjun LI
International Journal of Laboratory Medicine 2024;45(2):184-187,193
Objective To detect the serum levels of CC chemokine receptor 2(CCR2)and C-reactive pro-tein(CRP)in stroke patients,and analyze their relationship with the severity of stroke associated pneumonia and their clinical significance.Methods A total of 78 patients with stroke associated pneumonia who were di-agnosed and treated in the hospital from October 2022 to February 2023 were collected as the study group,ac-cording to the severity of pneumonia,the study group was divided into mild group(31 cases),moderate group(29 cases),and severe group(18 cases),78 stroke patients who did not develop pneumonia were included into control group.Pearson method was applied to analyze the correlation between serum CCR2 and CRP levels in stroke associated pneumonia patients.Multivariate Logistic regression was applied to analyze the factors influ-encing the occurrence of stroke associated pneumonia.Receiver operating characteristic(ROC)curve was ap-plied to analyze the diagnostic value of serum CCR2 and CRP for stroke associated pneumonia.Results The National Institute of Health stroke scale(NIHSS)score,serum CCR2,and CRP levels in the study group were obviously higher than those in the control group(P<0.05).The levels of serum CCR2 and CRP increased with the aggravation of pneumonia(P<0.05).The levels of serum CCR2 and CRP in the study group were positively correlated(r=0.799,P<0.05).NIHSS score,CCR2,and CRP levels were risk factors for stroke associated pneumonia in stroke patients(P<0.05).The area under the curve(AUC)for the diagnosis of stroke associated pneumonia using serum CCR2 and CRP alone was 0.873 and 0.888,respectively,and the AUC for the combined detection of the two was 0.936,the combined detection of the two was superior to the individual detection of serum CCR2 and CRP(Zcombination-CCR2=1.987,Zcombination-CRP=1.832,P=0.041,0.047).Conclusion Serum CCR2 and CRP are closely related to the severity of stroke associated pneumonia,and their combined detection has high diagnostic value for stroke associated pneumonia.


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