1.Effect of astragaloside Ⅳ on a mouse model of carbon tetrachloride-induced liver fibrosis and its mechanism
Wanchun ZHU ; Jiahao QIU ; Yu CUI ; Yijing ZHANG ; Zhi SHANG ; Yueqiu GAO ; Lingying HUANG
Journal of Clinical Hepatology 2026;42(3):608-617
ObjectiveTo investigate the liver-protecting and anti-liver fibrosis effects of astragaloside Ⅳ (AS-Ⅳ) in vitro and in vivo, as well as its mechanism of action in intervention against liver fibrosis. MethodsIn the animal experiment, C57BL/6J mice were divided into control group, model group, low-dose AS-Ⅳ (20 mg/kg) group, and high-dose AS-Ⅳ (80 mg/kg) group. The mice were given intraperitoneal injection of carbon tetrachloride for 6 weeks to induce liver fibrosis, and since week 3 of injection, the mice in the low-dose AS-Ⅳ group and the high-dose AS-Ⅳ group were given AS-Ⅳ by gavage at a dose of 20 mg/kg and 80 mg/kg, respectively. The serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were measured after 4 weeks of administration, as well as the serum levels of hyaluronic acid (HA), laminin (LN), procollagen Ⅲ N-terminal peptide (PⅢNP), and collagen type Ⅳ (Col-Ⅳ). HE staining, picrosirius red staining, and Masson staining were used to observe liver histopathology and collagen deposition; RT-qPCR was used to measure the mRNA expression levels of Acta2, Col1a1, and Col3a1 in liver tissue, and Western blot was used to measure the protein expression levels of α-smooth muscle actin (α-SMA), collagen type Ⅲ (Col-Ⅲ), phosphatidylinositol 3-kinase (PI3K), phosphorylated PI3K (pPI3K), protein kinase B (Akt), and phosphorylated AKT (p-Akt) in liver tissue; transcriptome sequencing was performed for liver tissue to identify differentially expressed genes and perform a bioinformatics analysis. In the cell experiment, transforming growth factor-β (TGF-β) was used to induce the activation of LX-2 cells, and the PI3K inhibitor LY294002 and the PI3K activator 740 Y-P were used for intervention. The cells were divided into control group, model group, AS-Ⅳ group, LY294002 group, and AS-Ⅳ+740 Y-P group, and the cells were harvested after 36 hours of intervention. Changes in the protein expression levels of α-SMA, Col-Ⅲ, pPI3K/PI3K, and pAkt/Akt in LX-2 cells were measured, as well as changes in the relative mRNA expression levels of Acta2, Col1a1, and Col3a1. A one-way analysis of variance was used for comparison of continuous data between multiple groups, and the least significant difference t-test was used for further comparison between two groups. ResultsIn the animal experiment, compared with the model group, the AS-Ⅳ treatment group had significant reductions in the serum levels of ALT, AST, HA, LN, PⅢNP, and Col-Ⅳ (all P<0.01), the mRNA expression levels of Acta2, Col1a1, and Col3a1 in liver tissue (all P<0.05), and the protein expression levels of α-SMA, Col-Ⅲ, pPI3K, and pAkt (Ser473) in liver tissue (all P<0.05). In the cell experiment, compared with the control group, the model group had significant increases in the protein expression levels of α-SMA, Col-Ⅲ, pPI3K, and pAkt (Ser473) after TGF-β induction (all P<0.05); compared with the model group, the AS-Ⅳ group had significant reductions in the protein expression levels of α-SMA, Col-Ⅲ, pPI3K, and pAkt (Ser473) (all P<0.05), and both the AS-Ⅳ group and the LY294002 group had significant reductions in the protein expression level of pPI3K and the relative mRNA expression levels of Acta2, Col1a1, and Col3a1 (all P<0.05). Compared with the AS-Ⅳ group, there were significant increases in the protein expression level of pPI3K and the relative mRNA expression levels of Acta2, col1a1, and Col3a1 after 740 Y-P intervention (all P<0.05). ConclusionAS-Ⅳ can inhibit hepatic stellate cell activation and improve liver fibrosis, possibly by inhibiting the PI3K/Akt signaling pathway.
2.TCM Syndrome Distribution Patterns and Clinical Characteristics in Patients with Chronic Hepatitis B Comorbid with Metabolically Associated Fatty Liver Disease
Dingqi LI ; Liang HUANG ; Baixue LI ; Rui ZHAO ; Zhenglong ZHENG ; Yichen PENG ; Yu LIANG ; Caiying HE ; Jingdong CUI ; Zilin XIONG ; Xiyang LIU ; Quansheng FENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(14):259-270
ObjectiveThis paper aims to investigate the distribution patterns of traditional Chinese medicine syndromes in patients with chronic hepatitis B (CHB) comorbid with metabolically associated fatty liver disease (MAFLD) and analyze their correlation with clinical characteristics and the progression of liver fibrosis. MethodsA cross-sectional study method was employed, and 506 patients with CHB comorbid with MAFLD who attended the Hepatology Outpatient Department of Public Health Clinical Center of Chengdu from June 2024 to December 2024 were enrolled. General information, traditional Chinese medicine syndromes information, laboratory indicators, and imaging examination results were collected using case report forms (CRF). Tongue images of patients were acquired using a tongue diagnosis instrument, and tongue feature parameters were extracted using computer image processing technology. Frequency analysis, factor analysis, and cluster analysis, and other methods were used to explore syndrome categories and distribution patterns. Non-parametric tests were used to compare the differences in clinical characteristics among different syndromes. Univariate and multivariate logistic regression analyses were performed to investigate the correlation between traditional Chinese medicine syndromes and the progression of liver fibrosis. ResultsThe main traditional Chinese medicine syndromes in patients with CHB comorbid with MAFLD were mainly dominated by damp-heat accumulation syndrome, liver stagnation and spleen deficiency syndrome, and phlegm-blood stasis syndrome, with damp-heat accumulation syndrome accounting for the highest proportion (41.89%). Compared with those without damp-heat accumulation syndrome, patients with damp-heat accumulation syndrome had significantly lower tongue proper H value, tongue coating H value, and tongue coating a* value (P<0.05), significantly higher tongue coating b* value (P<0.05), significantly increased levels of white blood cell (WBC), red blood cell (RBC), hemoglobin (HGB), and glucose (GLU), increased CAP values (P<0.05), a higher proportion of males (P<0.05), and a younger age (P<0.05). Univariate and multivariate logistic regression analyses show that age, hepatitis B surface antigen (HBsAg), diabetes, and damp-heat accumulation syndrome are independent risk factors for liver fibrosis (P<0.05), and that damp-heat accumulation syndrome is predominantly distributed in liver fibrosis stage F0-F1. ConclusionDamp-heat accumulation syndrome is a typical syndrome in patients with CHB comorbid with MAFLD, which is significantly associated with enhanced inflammatory response, metabolic disorders, and early liver fibrosis, and is a key link in disease progression. Clinical attention and early intervention are needed.
3.Siwu decoction prevents radiation immune damage through Sirt1-PI3K-Akt-mTOR pathway
Ting-yu YANG ; Lin LIN ; Jia-lu CUI ; Ming-yue HUANG ; Ye-hui GAO ; Yue GAO ; Zeng-chun MA
Chinese Pharmacological Bulletin 2025;41(9):1783-1792
Aim To investigate the protective effect of Siwu decoction(SWD)on immune injury induced by 60Coγ-rays in mice and the related mechanism.Meth-ods C57BL/6J mice were randomly divided into six groups:Control group(Control),Model group(Mod-el),Siwu decoction low-dose group(SWD-L),Siwu decoction medium-dose group(SWD-M),Siwu decoc-tion high-dose group(SWD-H)and resveratrol positive group(Resveratrol,Res).The drug was continued to be administered 11 days before and after irradiation,with a single whole-body irradiation of 4 Gy,and all in-dexes were detected three days after irradiation.The changes of peripheral blood and organ indexes were de-tected.Serum levels of cytokine interferon gamma(IFN-γ),interleukin-1 β(IL-1 β),IL-2,IL-4,IL-6,IL-10,IL-17,transforming growth factor-β(TGF-β),tumor necrosis factor(TNF)-α,and immunoglobulin A(IgA),IgG,IgM,and complement protein 3(C3),C4 content were detected by enzyme-linked immunosorbent assay(ELISA).B lymphocytes,T lymphocytes,NK cells in spleen and T lymphocytes in thymus were de-tected by flow cytometry.The pathological changes of spleen and thymus were analyzed by hematoxylin-eosin(HE)staining.The expression of Sirt 1 protein in spleen after radiation was detected by immunofluores-cence staining.The protein contents of Sirt1,PI3K,Akt,p-Akt and mTOR in spleen were detected by Western blot assay.Results SWD could significantly increase LYMPH%and reduce pathological injury of spleen and thymus.Flow cytometry showed that SWD could significantly increase the percentage of CD19+B lymphocytes in spleen,decrease the percentage of NK lymphocytes and the ratio of CD4+/CD8+in spleen and thymus.ELISA results showed that SWD signifi-cantly inhibited the expression of IL-1 β,IL-2,IL-6,IL-17,IFN-γ,TGF-β,TNF-α,and increased the content of anti-inflammatory factors IL-4 and IL-10.At the same time,SWD significantly inhibited the increase of IgA,IgG,IgM,C3 and C4 induced by radiation.The results of immunofluorescence staining and Western blot showed that SWD could decrease the expression of PI3K,Akt,p-Akt and mTOR protein,and enhance the expression of Sirt1 protein.Conclusions SWD has obvious preventive effect on immune damage induced by 60Co gamma radiation in mice.The mechanism may be related to Sirt1-PI3K-Akt-mTOR.
4.Expert recommendations on mass population vaccination
Wen WANG ; Chunhuan ZHANG ; Yong HUANG ; Qi ZHU ; Shiheng CUI ; Yan LIU ; Zhiwei ZHU ; Fang HUANG ; Lin TANG ; Zhoubin ZHANG ; Wenzhou YU
Chinese Journal of Preventive Medicine 2025;59(1):1-7
Mass vaccination represents a highly effective strategy for accelerating disease control while simultaneously reducing incidence and mortality rates. By developing comprehensive plans and standards for mass vaccination, it is feasible to optimize resource allocation and swiftly enhance vaccination coverage, thereby preventing, controlling, or interrupting outbreaks or epidemics of specific infectious diseases. To standardize the mass vaccination process and establish a population immunity barrier in an orderly, efficient, and safe manner, a panel of experts was convened to develop the Recommendations on Mass Vaccination. These recommendations are grounded in the requirements of relevant policies and regulations in China, as well as the insights gained from the mass vaccination campaign for COVID-19 vaccines conducted in the country. The recommendations outline the system requirements pertaining to initiation conditions, departmental coordination, responsibilities, mobilization, operational specifications, and responses to vaccine reactions, among other aspects of mass vaccination implementation, so as to serve as a reference for future mass vaccination initiatives and the formulation of related policies.
5.A nomogram prediction model of postoperative recurrence/metastasis of breast cancer based on the clinic-pathological-imaging combined model
Hao HUANG ; Li-hua ZHU ; Jing TANG ; Yong-jiang YU ; Zhu-hong CUI ; Jin LIU
Chinese Journal of Current Advances in General Surgery 2025;28(1):34-39
Objective:To investigate the clinical significance of constructing a nomogram based on a combined model of clinical-pathological-imaging data for predicting postoperative recurrence/metastasis of breast cancer.Meth-ods:A retrospective study was conducted on 194 breast cancer patients who were admitted to the department of breast and thyroid surgery from June 2019 to June 2022.unvariate and multivariate Logistic regression analyses were used to screen independent predictors of postoperative recurrence/metastasis of breast cancer,and a model was con-structed based on the independent predictors.Another 83 breast cancer patients from July 2022 to February 2023 were taken as the validation set to verify the model with the ratio of 7∶3(training set∶validation set).Results:The postopera-tive recurrence/metastasis rate of breast cancer was 29.90%.Ki-67 expression level ≥20%,tumor location in the inner upper quadrant and outer upper quadrant,lesion size ≥20 mm,multiple lesions,and BI-RADS grade of 5 were indepen-dent risk factors for postoperative recurrence/metastasis of breast cancer(P<0.05).PR positive expression was an inde-pendent protective factor for postoperative recurrence/metastasis of breast cancer(P<0.05).The diagnostic performance of the combined clinical-pathological-imaging model(AUC:0.900)was superior to that of the clinical-pathological pa-rameters(AUC:0.655)and the MRI parameter model(AUC:0.857).In its nomogram model constructed based on a com-bined clinical-pathological-imaging model to predict breast cancer recurrence/metastasis after surgery,the AUC in the training set was 0.900(95%CI:0.859~0.942)with good discrimination,the maximum Yoden value was 0.710,the sensi-tivity was 0.931,and the specificity was 0.779,and the AUC in the validation set was 0.820(95%C/:0.712~0.928),well differentiated,with a maximum Yoden value of 0.554,a sensitivity of 0.630,and a specificity of 0.914.The theoretical and actual values of the calibration curves of the two sets were in good agreement,and the decision curve indicated the net benefit of the breast cancer recurrence-metastasis prediction model after surgery,which showed good predictive ability.Conclusion:The nomogram constructed based on the combined model of clinical-pathological-imaging data has good predictive ability,accuracy,and clinical applicability,which is helpful for clinicians to evaluate the risk of postoperative re-currence/metastasis of breast cancer.
6.Cross-sectional survey of healthcare-associated infection in 5 736 medical institutions across China in 2024
Cui ZENG ; Wuqiang GAO ; Fu QIAO ; Hui ZHAO ; Xu FANG ; Linping LI ; Xiuwen CHEN ; Jiansen CHEN ; Dan LI ; Yuan ZHOU ; Lingli YU ; Qinglan MENG ; Xia MOU ; Lijuan XIONG ; Weiguang LI ; Ding LIU ; Jiaqing XIAO ; Limei OU ; Baozhen LI ; Jun YIN ; Haojun ZHANG ; Qiang FU ; Qun LU ; Biao WU ; Ya-wei XING ; Shumei SUN ; Shuncai WANG ; Longmin DU ; Jingping ZHANG ; Wen-ying HE ; Gui CHENG ; Nan REN ; Xun HUANG ; Anhua WU
Chinese Journal of Infection Control 2025;24(11):1572-1583
Objective To understand the current situation of healthcare-associated infection(HAI)in China,pro-vide data support and decision-making basis for formulating scientific and effective strategies for HAI prevention and control.Methods A nationwide cross-sectional survey on HAI was conducted among various types and levels of medical institutions in China according to a unified protocol of bedside surveys and case investigations.Results In 2024,a total of 5 736 medical institutions and 2 751 765 patients were surveyed.Among them,34 889 HAI cases were identified,with a prevalence rate of 1.27%.The number of HAI episodes was 38 032,and case prevalence rate was 1.38%.The prevalence rate of HAI in medical institutions in different regions of China ranged from 0.66%to 2.35%.Among medical institutions of different scales,those with a bed capacity of ≥900 had the high-est incidence of HAI,reaching 1.65%.The most common infection site was the lower respiratory tract(44.66%),followed by the urinary tract(12.94%),surgical site(9.32%),upper respiratory tract(7.02%),and bloodstream infection(5.78%).The top 3 departments with the highest HAI rates were the general intensive care unit(10.02%),department of neurosurgery(5.51%),and department(group)of hematology(5.34%).A total of 23 238 strains of HAI pathogens were detected,with 10 714 strains(46.10%)from lower respiratory tract speci-mens.The top 5 detected strains were Klebsiella pneumoniae(14.76%),Pseudomonas aeruginosa(13.33%),Escherichia coli(12.79%),Acinetobacter baumannii(9.23%),and Staphylococcus aureus(7.88%).231 944 pa-tients underwent class Ⅰ incision surgery were monitored,with 1 647 cases experienced surgical site infection,and the prevalence rate of surgical site infection was 0.71%.The number of patients who should undergo pathogen de-tection(patients receiving therapeutic and therapeutic combined prophylactic antimicrobial agents)was 715 179,while the actual number was 480 492,with a pathogen detection rate of 67.18%.425 225 patients received patho-genic detection before treatment,with a detection rate of 59.46%.Conclusion The overall HAI prevalence in Chi-na is lower,showing disparities among medical institutions of different regions and scales.Therefore,precise imple-mentation of measures is necessary for HAI prevention and control,with a focus on high-risk institutions and high-risk departments,key areas,and critical procedures.All levels of medical institutions should continuously reduce the incidence of HAI by strengthening monitoring,standardizing the use of antimicrobial agents,and reinforcing basic HAI prevention and control measures.
7.Clinical observation on the efficacy of modified anterior approach transpupillary silicone oil removal combined with phacoemulsification and intraocular lens implantation
Chenxiao SHEN ; Liang ZHANG ; Zhongning HUANG ; Zhixing CHENG ; Dan CAO ; Ying CUI ; Yesheng CHEN ; Ruoyu CHEN ; Honghua YU ; Anyi LIANG
Chinese Journal of Ocular Fundus Diseases 2025;41(10):780-786
Objective:To investigate and evaluate the clinical efficacy and safety of a modified anterior approach for transpupillary silicone oil removal combined with phacoemulsification and intraocular lens (IOL) implantation.Methods:A retrospective case-control study. A total of 148 patients (148 eyes) who underwent silicone oil removal combined with cataract surgery at the Department of Ophthalmology, Guangdong Provincial People's Hospital between January 2020 and November 2024 were included in the study. All affected eyes underwent preoperative examinations including best-corrected visual acuity (BCVA), intraocular pressure, corneal topography, and optical coherence tomography (OCT). Based on the method of silicone oil removal, the eyes were divided into two groups: group A (modified anterior approach transpupillary silicone oil removal combined with phacoemulsification and IOL implantation, 99 eyes) and group B (standard pars plana vitrectomy for silicone oil removal combined with phacoemulsification and IOL implantation, 49 eyes). The surgical duration, changes in BCVA and intraocular pressure at 1 day, 7 days, and 1 month postoperatively, as well as the incidence of complications such as corneal edema and its resolution, conjunctival congestion, iris prolapse, posterior capsule rupture, nucleus drop, IOL position, residual silicone oil in the vitreous cavity or anterior chamber, vitreous hemorrhage, recurrent retinal detachment (RD), and choroidal detachment or hemorrhage, were compared between the two groups. The independent sample t-test was used for the comparison of measurement data between the two groups, and the χ2 test was used for the comparison of count data. Results:The operation time of group A and group B was (17.01±1.28) min and (31.62±2.32) min, respectively. The operation time of group A was significantly shorter than that of group B, and the difference was statistically significant ( t=?41.002, P<0.001). The comparison of BCVA ( t =?0.561, ?0.833, ?1.386) and IOP ( t=?0.055, 1.375, ?0.507) between the two groups of affected eyes before surgery and at 1 day and 7 days after surgery showed no statistically significant differences ( P>0.05). There was no silicone oil residual in group A, while 3 eyes in group B were observed with silicone oil residual (6.1%, 3/49). Neovascular glaucoma was observed in one eye. Compared to group A, group B exhibited a statistically significant increase in the incidence of postoperative conjunctival congestion, silicone oil retention, and posterior capsular opacification ( χ2=10.600, 6.187, 92.617; P<0.05). In contrast, no statistically significant differences were observed between the groups in the incidence of corneal edema or recurrent retinal detachment (RD) ( χ2=0.272, 1.557; P>0.05). No intraoperative complications, such as iris prolapse, posterior capsular rupture, nucleus drop, zonular dehiscence, choroidal detachment, or hemorrhage, occurred in any of the operated eyes. Furthermore, no postoperative complications, including corneal endothelial decompensation, IOL displacement, or endophthalmitis, were observed during the follow-up period. Conclusion:Compared to the conventional pars plana approach for silicone oil removal combined with cataract surgery, the modified anterior perfusion transpupillary approach demonstrated significantly shorter surgical duration and a reduced incidence of postoperative complications.
8.The efficacy and safety of nebulized inhalation of recombinant human interferon α1b in the treatment of pediatric respiratory syncytial viral associated lower respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled phase Ⅲ clinical study
Xiaohui LIU ; Baoping XU ; Yunxiao SHANG ; Han ZHANG ; Zhenkun ZHANG ; Guangyu LIN ; Ju YIN ; Aihua CUI ; Guocheng ZHANG ; Zhaoling SHI ; Liwei GAO ; Chunming JIANG ; Junmei BIAN ; Yongjian HUANG ; Rongfang ZHANG ; Xiaomei LIU ; Xiaoqing YANG ; Yu TANG ; Lili ZHONG ; Hongmei QIAO ; Chuangli HAO ; Yuqing WANG ; Qubei LI ; Ling CAO ; Yungang YANG ; Ling LU ; Rongjun LIN ; Xingzhen SUN ; Wei ZHOU ; Qiang CHEN ; Jikui DENG ; Yuejie ZHENG ; Lin ZHAO ; Tao AI ; Xiaohong LIU ; Xiaoxia LU ; Ning JIANG ; Ming LI
Chinese Journal of Applied Clinical Pediatrics 2025;40(3):180-186
Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.
9.The efficacy and safety of nebulized inhalation of recombinant human interferon α1b in the treatment of pediatric respiratory syncytial viral associated lower respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled phase Ⅲ clinical study
Xiaohui LIU ; Baoping XU ; Yunxiao SHANG ; Han ZHANG ; Zhenkun ZHANG ; Guangyu LIN ; Ju YIN ; Aihua CUI ; Guocheng ZHANG ; Zhaoling SHI ; Liwei GAO ; Chunming JIANG ; Junmei BIAN ; Yongjian HUANG ; Rongfang ZHANG ; Xiaomei LIU ; Xiaoqing YANG ; Yu TANG ; Lili ZHONG ; Hongmei QIAO ; Chuangli HAO ; Yuqing WANG ; Qubei LI ; Ling CAO ; Yungang YANG ; Ling LU ; Rongjun LIN ; Xingzhen SUN ; Wei ZHOU ; Qiang CHEN ; Jikui DENG ; Yuejie ZHENG ; Lin ZHAO ; Tao AI ; Xiaohong LIU ; Xiaoxia LU ; Ning JIANG ; Ming LI
Chinese Journal of Applied Clinical Pediatrics 2025;40(3):180-186
Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.
10.Molecular characteristics of the HA genes of H9N2 subtype avian influenza viruses originating from wild birds in wetlands in Fujian
Zhen CHEN ; Chun-hua ZHU ; Cui-teng CHEN ; Bin-qiong LIU ; Guo-zhang CAI ; Chun-he WAN ; Yu HUANG ; Shao-hua SHI
Chinese Journal of Zoonoses 2025;41(3):227-234
This study was aimed at evaluating the characteristics of H9N2 subtype avian influenza viruses(AIVs)origina-ting from wild birds in major wetlands in Fujian.Five H9N2 subtype AIVs isolated from fecal samples from wild birds in wet-lands of the Minjiang River,Jiulong River,Sandu Bay,Xinghua Bay,and Quanzhou Bay in Fujian were sequenced.Sequence a-nalysis of the HA genes of the five H9N2 subtype AIVs indicated that the five isolates shared 89.8%-99.4%nucleotide se-quence identity.All five isolates belonged to the same h9.4.2.5c evolutionary branch.The cleavage site motifs of HA were all PSRSSR ↓ GLF,thus indicating molecular characteristics of AIVs with low pathogenicity.The HA proteins of the viruses orig-inating from wild birds bore eight identical potential glycosylation sites,among which the glycosylation site at position 313 was located near the HA protein cleavage site.The 226th amino acid of HA in the receptor binding site was leucine in each virus,thus indicating that HAs of the five H9N2 subtype AIVs had mammalian sialic acid α-2,6 receptor binding affinity.In conclu-sion,the five H9N2 subtype AIVs originating from wild birds in Fujian had low pathogenicity,and the HAs had mammalian sialic acid α-2,6 receptor binding affinity.

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