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.Literature Data Analysis on the Evolution Pattern of Traditional Chinese Medicine Syndromes in Psoriasis Vulgaris
Kewen GUAN ; Xiuli XIE ; Chuanjian LU
Journal of Traditional Chinese Medicine 2025;66(8):834-840
ObjectiveTo explore the distribution and evolution patterns of traditional Chinese medicine (TCM) syndromes and syndrome elements in psoriasis vulgaris (PV). MethodsLiterature related to TCM syndromes of PV published in databases including China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform (Wanfang), VIP Chinese Technology Periodical Database (VIP), Chinese Biomedical Literature Database (CBM), PubMed, Embase, and Web of Science from their inception to December 31, 2023, was retrieved. Statistical analysis was conducted on the distribution of TCM syndromes and syndrome elements in the included studies. The data were further categorized into five-year periods to analyze the dynamic changes in syndromes and syndrome elements over time. ResultsA total of 2,853 studies were included, with 5,896 syndrome occurrences. The most common TCM syndromes in PV were blood-heat syndrome (2,167 occurrences, 36.75%), blood-stasis syndrome (1,219 occurrences, 20.68%), blood-dryness syndrome (1,124 occurrences, 19.06%), and damp-heat syndrome (263 occurrences, 4.46%). The most frequent syndrome categories included blood syndromes (4,680 occurrences, 79.38%) and dampness syndromes (347 occurrences, 5.89%). The most common syndrome elements related to disease location were blood division (4,874 occurrences, 94.38%) and spleen (99 occurrences, 1.92%). The most common syndrome elements related to disease nature were blood-heat (2,213 occurrences, 25.96%), blood-dryness (1,434 occurrences, 16.82%), and blood-stasis (1,330 occurrences, 15.60%). Except for the period 1978-1983, blood-heat, blood-stasis, and blood-dryness syndromes consistently ranked among the top three, with their combined proportion showing an overall upward trend (from 67.65% to 81.69%). The proportion of spleen deficiency with damp obstruction syndrome also increased (from 0.24% to 1.46%). In terms of syndrome classification, the proportion of blood syndromes showed an overall upward trend (from 67.65% to 83.46%), ranking first in all periods. The proportion of dampness syndromes showed a general downward trend (from 17.65% to 4.54%), ranking second after blood syndromes in most periods except for 1994-1998 and 1999-2003. The proportion of spleen-related syndromes showed an overall increase (from 0.24% to 1.85%). Regarding disease location elements, the proportion of blood division remained stable above 90%, while the proportion of spleen involvement increased (from 0.68% to 3.23%). As for disease nature elements, blood-heat (from 19.23% to 33.27%) and blood-stasis (from 1.92% to 20.83%) significantly increased, while dampness initially decreased and then slightly increased (from 11.54% to 5.73%). ConclusionIn the distribution of PV-related TCM syndromes, blood-heat, blood-stasis, and blood-dryness syndromes are the most common. Blood syndromes dominate syndrome classification, with disease location primarily in the blood division and disease nature characterized by blood-heat, blood-stasis, and blood-dryness. Evolutionary trends indicate that blood-heat, blood-stasis, and blood-dryness syndromes remain predominant and are increasing in proportion, while spleen deficiency with damp obstruction syndrome is also rising. Among syndrome classifications, the proportion of blood syndromes is increasing, dampness syndromes are decreasing, and spleen-related syndromes are on the rise. In terms of syndrome elements, blood division remains dominant, while spleen involvement is increasing. The proportion of blood-heat and blood-stasis is significantly increasing, while dampness first declines and then slightly rebounds. Overall, the mainstream TCM perspective of treating PV based on blood differentiation remains unchanged, with syndrome distribution focusing on blood division. The increasing importance of spleen deficiency and dampness in disease pathogenesis represents a new trend.
4.2,3,5,4′-tetrahydroxyldiphenylethylene-2-O-glucoside Attenuates Cerebral Ischemia-reperfusion Injury via PINK1/LETM1 Signaling Pathway
Hongyu ZENG ; Kaimei TAN ; Feng QIU ; Yun XIANG ; Ziyang ZHOU ; Dahua WU ; Chang LEI ; Hongqing ZHAO ; Yuhong WANG ; Xiuli ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):145-154
ObjectiveTo investigate the mechanism by which 2,3,5,4'-tetrahydroxyldiphenylethylene-2-O-glucoside (THSG) mitigates cerebral ischemia/reperfusion (CI/R) injury by regulating mitochondrial calcium overload and promoting mitophagy. MethodsSixty male SD rats were randomized into sham, model, SAS (40 mg·kg-1), and low-, medium- and high-dose (10, 20, 40 mg·kg-1, respectively) THSG groups, with 10 rats in each group. The middle cerebral artery occlusion/reperfusion (MCAO/R) model was established by the modified Longa suture method. An oxygen-glucose deprivation/reoxygenation (OGD/R) model was constructed in PC12 cells. Neurological deficits were assessed via Zea Longa scoring, and cerebral infarct volume was measured by 2,3,5-triphenyltetrazolium chloride (TTC) staining. Structural and functional changes of cortical neurons in MCAO/R rats were assessed by hematoxylin-eosin and Nissl staining. PC12 cell viability was detected by cell counting kit-8 (CCK-8) assay, and mitochondrial calcium levels were quantified by Rhod-2 AM. Immunofluorescence was used to detect co-localization of PTEN-induced kinase 1 (PINK1) and leucine zipper/EF-hand-containing transmembrane protein 1 (LETM1) in neurons. Transmission electron microscopy (TEM) was employed to observe mitochondrial morphology in neurons. Western blot was employed to analyze the expression of translocase of outer mitochondrial membrane 20 (TOMM20), autophagy-associated protein p62, microtubule-associated protein light chain 3 (LC3), cysteinyl aspartate-specific proteinase-9 (Caspase-9), B-cell lymphoma 2-associated protein X (Bax), and cytochrome C (Cyt C). ResultsCompared with the sham group, the model group exhibited increased infarct volume (P<0.01) and neurological deficit scores (P<0.01), neuronal structure was disrupted with reduced Nissl bodies. (P<0.01), mitochondrial swelling/fragmentation, decreased PINK1/LETM1 co-localization (P<0.01), upregulated protein levels of LC3Ⅱ/LC3Ⅰ, TOMM20, Caspase-9, Bax, and Cyt C (P<0.01), downregulated protein level of p62 (P<0.05), weakened PC12 viability (P<0.01), and elevated mitochondrial calcium level (P<0.01). Compared with the model group, THSG and SAS groups showed reduced infarct volumes (P<0.05,P<0.01) and neurological deficit scores (P<0.05,P<0.01), mitigated mitochondrial damage, and increased PINK1/LETM1 co-localization (P<0.01). Medium/high-dose THSG and SAS alleviated the neurological damage, increased Nissl bodies (P<0.05,P<0.01), downregulated the protein levels of p62, TOMM20, Caspase-9, Bax, and Cyt C (P<0.05,P<0.01), and elevated the LC3Ⅱ/LC3Ⅰ level (P<0.05,P<0.01). High-dose THSG enhanced PC12 cell viability (P<0.01), increased PINK1/LETM1 co-localization (P<0.01), and reduced mitochondrial calcium (P<0.01). ConclusionTHSG may exert the neuroprotective effect on CI/R injury by activating the PINK1-LETM1 signaling pathway, reducing the mitochondrial calcium overload, and promoting mitophagy.
5.2,3,5,4′-tetrahydroxyldiphenylethylene-2-O-glucoside Attenuates Cerebral Ischemia-reperfusion Injury via PINK1/LETM1 Signaling Pathway
Hongyu ZENG ; Kaimei TAN ; Feng QIU ; Yun XIANG ; Ziyang ZHOU ; Dahua WU ; Chang LEI ; Hongqing ZHAO ; Yuhong WANG ; Xiuli ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):145-154
ObjectiveTo investigate the mechanism by which 2,3,5,4'-tetrahydroxyldiphenylethylene-2-O-glucoside (THSG) mitigates cerebral ischemia/reperfusion (CI/R) injury by regulating mitochondrial calcium overload and promoting mitophagy. MethodsSixty male SD rats were randomized into sham, model, SAS (40 mg·kg-1), and low-, medium- and high-dose (10, 20, 40 mg·kg-1, respectively) THSG groups, with 10 rats in each group. The middle cerebral artery occlusion/reperfusion (MCAO/R) model was established by the modified Longa suture method. An oxygen-glucose deprivation/reoxygenation (OGD/R) model was constructed in PC12 cells. Neurological deficits were assessed via Zea Longa scoring, and cerebral infarct volume was measured by 2,3,5-triphenyltetrazolium chloride (TTC) staining. Structural and functional changes of cortical neurons in MCAO/R rats were assessed by hematoxylin-eosin and Nissl staining. PC12 cell viability was detected by cell counting kit-8 (CCK-8) assay, and mitochondrial calcium levels were quantified by Rhod-2 AM. Immunofluorescence was used to detect co-localization of PTEN-induced kinase 1 (PINK1) and leucine zipper/EF-hand-containing transmembrane protein 1 (LETM1) in neurons. Transmission electron microscopy (TEM) was employed to observe mitochondrial morphology in neurons. Western blot was employed to analyze the expression of translocase of outer mitochondrial membrane 20 (TOMM20), autophagy-associated protein p62, microtubule-associated protein light chain 3 (LC3), cysteinyl aspartate-specific proteinase-9 (Caspase-9), B-cell lymphoma 2-associated protein X (Bax), and cytochrome C (Cyt C). ResultsCompared with the sham group, the model group exhibited increased infarct volume (P<0.01) and neurological deficit scores (P<0.01), neuronal structure was disrupted with reduced Nissl bodies. (P<0.01), mitochondrial swelling/fragmentation, decreased PINK1/LETM1 co-localization (P<0.01), upregulated protein levels of LC3Ⅱ/LC3Ⅰ, TOMM20, Caspase-9, Bax, and Cyt C (P<0.01), downregulated protein level of p62 (P<0.05), weakened PC12 viability (P<0.01), and elevated mitochondrial calcium level (P<0.01). Compared with the model group, THSG and SAS groups showed reduced infarct volumes (P<0.05,P<0.01) and neurological deficit scores (P<0.05,P<0.01), mitigated mitochondrial damage, and increased PINK1/LETM1 co-localization (P<0.01). Medium/high-dose THSG and SAS alleviated the neurological damage, increased Nissl bodies (P<0.05,P<0.01), downregulated the protein levels of p62, TOMM20, Caspase-9, Bax, and Cyt C (P<0.05,P<0.01), and elevated the LC3Ⅱ/LC3Ⅰ level (P<0.05,P<0.01). High-dose THSG enhanced PC12 cell viability (P<0.01), increased PINK1/LETM1 co-localization (P<0.01), and reduced mitochondrial calcium (P<0.01). ConclusionTHSG may exert the neuroprotective effect on CI/R injury by activating the PINK1-LETM1 signaling pathway, reducing the mitochondrial calcium overload, and promoting mitophagy.
6.Chlorinated perfluoroalkyl ether sulfonate impairs proliferation and differentiation of neural stem cells via oxidative stress
Yaxin HAN ; Longfei FENG ; Zhijun ZHOU ; Xiuli CHANG
Journal of Environmental and Occupational Medicine 2025;42(6):684-690
Background Chlorinated perfluoroalkyl ether sulfonate Cl-PFAES, trade name F-53B, a novel per- and polyfluoroalkyl substance (PFAS), has been shown to induce multi-organ toxicity in humans and cross the blood-brain barrier. However, its toxic effects and underlying mechanisms on neural stem cells (NSCs) remain unclear. Objective To investigate the impact of F-53B on NSCs proliferation and differentiation through oxidative stress and explore its potential molecular mechanisms in associations with mitochondrial function damage and the expression of autophagy-related gene (PINK1/Parkin). Methods Primary NSCs isolated from neonatal C57BL/6 mice were used as a model and exposed to F-53B at concentrations of 0, 33, or 100 μmol·L−1 for 24 h. Cell viability was assessed using the cell counting kit-8 (CCK-8) assay, while proliferation was evaluated by the 5-ethynyl-2’-deoxyuridine (EdU) incorporation assay. Immunofluorescence staining was performed to observe differentiation phenotypes. Intracellular and mitochondrial reactive oxygen species (ROS) levels were quantified using dihydroethidium (DHE) and MitoSOX probes, respectively. Mitochondrial morphology was observed using MitoTracker Green. ATP level was measured with a commercial kit. Additionally, real-time quantitative polymerase chain reaction (qPCR) was conducted to quantify the expression of PINK1 and Parkin genes. Results Exposure to 100 μmol·L⁻¹ F-53B significantly reduced cell viability to 93.6% of the control group (P<0.01), and decreased the proportion of EdU⁺ cells (P<0.01), indicating proliferation inhibition. The differentiation analysis showed a reduction in neuronal generation, axonal shortening, and an increase in astrocytes. The 100 μmol·L−1 F-53B exposure elevated intracellular ROS to 122% (P<0.01) and mitochondrial ROS (MitoROS) to 135% (P<0.001) of the control levels, leading to mitochondrial fragmentation. The ATP levels after the F-53B exposure decreased to 62.4% relative to the control group (P<0.001). Furthermore, the mRNA expression levels of PINK1 and Par after the F-53B exposure were notably reduced (P<0.05). Conclusion F-53B may induce oxidative stress, thereby disrupting mitochondrial morphology and function while inhibiting the PINK1/Parkin-mediated mitophagy pathway, ultimately leading to impaired neural stem cell proliferation and abnormal differentiation. This study provides new insights into the neurotoxicity mechanisms of F-53B.
7.Early screening and risk factors for stroke-related sarcopenia
Journal of Apoplexy and Nervous Diseases 2025;42(5):454-458
Objective To investigate the incidence rate of sarcopenia and related risk factors in patients with stroke. Methods A retrospective analysis was performed for the patients with stroke who were admitted to the stroke center of a grade A tertiary hospital in Changchun, China, from March 2023 to June 2024. The method of bioelectrical impedance was used to perform body composition analysis for all patients on day(7.0±1.0)after admission, and the incidence rate of stroke-related sarcopenia was analyzed. A binary logistic regression analysis was used to investigate the risk factors for stroke-related sarcopenia. Results A total of 666 patients were included in the study, among whom 150(22.5%) developed sarcopenia (95%CI 0.193‒ 0.257). Low body mass index, low phase angle, low triglyceride, advanced age, and low Barthel index were risk factors for the early onset of sarcopenia in patients with stroke. Conclusion There is a relatively high incidence rate of sarcopenia in stroke patients, with complex influencing factors. Medical staff should pay more attention to the elderly stroke patients, as well as those patients with emaciation, low phase angle, low triglyceride, and limited activities of daily living. Early nutritional supplementation and functional exercise can help to prevent the onset of stroke-related sarcopenia.
Stroke
;
Sarcopenia
8.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.
9.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
10.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*
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Male
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Female
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Prospective Studies
;
Middle Aged
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Anti-Bacterial Agents/adverse effects*
;
Adult
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Aged
;
Treatment Outcome
;
Proton Pump Inhibitors/therapeutic use*


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