1.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.
2.Patient-specific quality assurance for non-normal radiotherapy plans based on statistical process control
Juan DENG ; Gaoyuan LIU ; Chuou YIN ; Jiang LIU ; Guojian MEI ; Ling HUA ; Shutong YU ; Xinhui FU ; Chen LIN ; Tian LI ; Yibao ZHANG
Chinese Journal of Radiological Medicine and Protection 2025;45(4):296-301
Objective:To apply statistical process control (SPC) techniques to the quality assurance of non-normal radiotherapy plans through Johnson transformation, establishing patient-specific tolerance and action limits based on treatment sites and dose/distance assessment criteria, thereby enhancing the intensity-modulated radiation therapy (IMRT) verification accuracy and dose delivery precision.Methods:In this study, 951 gamma analysis data of patient-specific quality assurance (PSQA) executed on the Halcyon accelerator platform were selected and categorized into six groups based on treatment sites, including brain (102 cases), head and neck (100 cases), breast (229 cases), lung (154 cases), esophagus (223 cases), and pelvic (143 cases) groups. The six groups of data were statistically analyzed through Anderson-Darling normality tests ( α = 0.05) using Minitab 21 software. Non-normal data were transformed into normal data through Johnson transformation and then were used to establish treatment site-specific tolerance and action limits, which were compared with the Shewhart control charts based on normal distributions. Results:The PSQA result of the six groups all exhibited non-normal distributions ( P < 0.05). Through Johnson transformation, the tolerance and action limits for the head and neck, breast, lung, esophagus, and pelvic areas under the 3%/2 mm criterion ranged from 95.13% to 96.16% and 94.19% to 95.91%, respectively. In contrast, the tolerance and action limits ranged from 91.15% to 94.86% and 89.94% to 94.78% under the 2%/2 mm criterion. Directly applying Shewhart control charts without normality assumptions yielded higher tolerance limits compared to the application of Johnson transformation, increasing the false positive rate in the non-normal PSQA process. Conclusions:Applying the SPC techniques directly to a non-normal process can lead to an increased false alarm rate and wrong process interpretation. The SPC techniques combined with Johnson transformation enable more effective monitoring of a non-normal PSQA process, facilitating timely identification of potential factors that may lead to an out-of-control process based on the treatment site-specific limits.
3.Effect of an obstetric artificial intelligence assistant combined with a family-centered health education model on mothers and their spouses: a prospective randomized controlled trial
Suyu ZHANG ; Xueling ZHANG ; Qianqian QI ; Keting ZENG ; Xingxing DENG ; Lin YU ; Lili DU ; Fang HE ; Yong WANG ; Shuang ZHANG ; Dunjin CHEN
Chinese Journal of Perinatal Medicine 2025;28(10):835-841
Objective:To evaluate the effect of an obstetric artificial intelligence (AI) assistant combined with a family-centered health education model on maternal self-care ability, comfort status, and spousal caregiving ability.Methods:This prospective, single-center, parallel randomized controlled trial used 1∶1 randomization and was conducted as a superiority trial. Postpartum mothers and their spouses admitted to family-style single rooms at the Third Affiliated Hospital of Guangzhou Medical University between October 2024 and April 2025 were enrolled and randomly assigned to control or intervention groups using a random number table. The control group received conventional health education, while the intervention group received conventional health education plus the AI-assisted family-centered model. Interventions were administered at 2 hours, 6 hours, and 24 hours postpartum, and before discharge. Outcomes included maternal self-care ability, comfort status, and spousal caregiving ability, which were assessed at 2 hours postpartum and before discharge. Data were analyzed using independent and paired t-tests and Chi square tests. Results:Of the 88 mother-spouse dyads initially recruited, four were excluded due to mother-infant separation (e.g., neonatal jaundice), leaving 84 dyads (42 per group). After the intervention, the intervention group showed significantly higher maternal self-care ability scores [(192.81±13.80) vs. (181.00±21.41) scores, t=3.00], higher maternal comfort scores [(104.43±7.52) vs. (96.00±14.29) scores, t=3.38], and better spousal caregiving ability [(6.07±3.13) vs. (9.50±5.02) scores, t=-3.76] compared to the control group (all P<0.05). Conclusion:The obstetric AI assistant combined with a family-centered health education model significantly improved maternal self-care ability and comfort status, as well as spousal caregiving ability.
4.The Analysis of SLC26A4 Gene Testing in 34 Nuclear Families
Jinge XIE ; Lin DENG ; Xiaohua CHENG ; Liping ZHAO ; Yu RUAN ; Cheng WEN ; Yiding YU ; Yue LI ; Shan GAO ; Lihui HUANG
Journal of Audiology and Speech Pathology 2025;33(1):29-33
Objective To investigate the sequencing results of the SLC26A4 gene in 34 nuclear families and the genetic diagnosis on the offspring in the nuclear families who have been screened for SLC26A4 gene single-allele mutation in the deafness genetic screening,to provide a basis for genetic consulting.Methods A retrospective anal-ysis was performed on the results of SLC26A4 gene testing in 34 nuclear families,in which the offspring with SLC26A4 gene single-allele mutation in deafness genetic screening of each nuclear family.The offspring of 34 nucle-ar families with the second mutation site detected by sequencing,their audiological results were included in the anal-ysis;and if they suffered from hearing loss,the results of temporal bone CT or inner ear MRI were also included in the analysis.Results The sequencing results of 34 nuclear families showed that there were 23 offsprings(67.65%,23/34)with SLC26A4 gene single-allele mutation,and one parent was SLC26A4 gene single-allele mutation.There were 11 offsprings(32.35%,11/34)with second site,among which 7 offsprings(63.64%,7/11)with SLC26A4 gene complex heterozygous mutations,and their parents were SLC26A4 gene single-allele mutations.Among the 7 offsprings with SLC26A4 gene complex heterozygous mutation,3 cases were with hearing loss,all of which were diagnosed as large vestibular aqueduct syndrome,and the other 4 cases were normal.While 4 offsprings(36.36%,4/11)with SLC26A4 gene double heterozygous mutation(cis mutation),and one parent was SLC26A4 gene double heterozygous mutation.The hearing 4 offsprings with SLC26A4 gene double heterozygous mutations were normal.Among the 34 nuclear families,3 pairs of parents were SLC26A4 gene single-allele mutation,and both mutation sites were pathogenic,risk of reproducing children with hereditary hearing loss was 25%.Conclusion The detec-tion sites of deafness gene chip are limited.Using gene sequencing technology to sequence the nuclear family can fur-ther clarify the gene mutation type in offspring and provide guidance for parents to reproduce.
5.Association of hippocampal subfield volumes and cross-domain associative memory impairment in patients with schizophrenia
Zhao-lin ZHAI ; Di CHANG ; Xuan LI ; Chang LU ; Yu-ke DONG ; Yan WANG ; Chun-hong SHAO ; Qing KANG ; Deng-tang LIU
Fudan University Journal of Medical Sciences 2025;52(6):775-782
Objective To investigate the possible association between cross-domain associative memory(AM)impairment and hippocampal subfield volumes in patients with schizophrenia(SCZ).Methods We enrolled 28 SCZ patients from Shanghai Mental Health Center,Shanghai Jiao Tong University School of Medicine,and 28 healthy controls(HCs)between 2019 and 2021.Based on an innovative AM paradigm and automated segmentation,3D-T1 weighted data of the objects were processed with PhiPipe and FreeSurfer.Differences in subfield volums between the two groups were analyzed using ANCOVA,while their relationship with AM scores was assessed using Pearson correlation.Results SCZ patients exhibited significantly poorer AM performance across three conditions compared with HCs.Marginally significant reductions were observed in the total volume of bilateral hippocampus,encompassing both the hippocampal head and body.Significant volume reductions were identified in the bilateral presubiculum and parasubiculum.The volumes of bilateral presubiculum head(r=0.273,P=0.042),parasubiculum(r=0.397,P=0.002),and CA1 head(r=0.382,P=0.004)exhibited positive correlations with cross-domain AM performance.Conclusion The bilateral presubiculum and parasubiculum,as hippocampal subregions significantly associated with cross-modal AM deficits in SCZ,may play a crucial role in the pathology of AM.
6.Intermittent fasting alleviates insulin resistance through autophagy in a polycystic ovary syndrome mouse model
Zhouying TAN ; Yu LI ; Dingyan LUO ; Jiaoyang FENG ; Yan DENG ; Lin ZHANG ; Qian WANG ; Han ZHANG ; Ying ZHANG ; Xiaoying YUAN ; Xin LIAO
Chinese Journal of Endocrinology and Metabolism 2025;41(6):482-492
Objective:To investigate whether intermittent fasting alleviates insulin resistance in a polycystic ovary syndrome(PCOS) mouse model through the regulation of autophagy.Methods:Fifty 3-week-old female C57BL/6J mice were randomly assigned into the following groups using a random number table: normal control(NC) group( n=10), maintained on a standard chow diet; high-fat diet(HFD) group( n=10) fed a diet with 60% of calories derived from fat; and PCOS model group( n=30), established by combining a HFD with dehydroepiandrosterone(DHEA) administration. Successful modeling was confirmed by disrupted estrous cycles, hyperandrogenism, and polycystic ovarian morphology. The PCOS model mice were further divided into three groups: PCOS group( n=9), PCOS with intermittent fasting group(PCOS+ IF, n=9), and PCOS with intermittent fasting plus the autophagy inhibitor 3-methyladenine(3-MA) group(PCOS+ IF+ 3-MA, n=9). Autophagy levels were assessed by detecting markers LC3 and p62 and observing autophagosomes via transmission electron microscopy. Glucose tolerance test(GTT) and insulin tolerance test(ITT) were performed, and the area under the curve(AUC) was calculated to evaluate insulin resistance. Western blotting was used to detect phosphorylation levels of phosphatidylinositol 3-kinase(PI3K), protein kinase B(Akt), mammalian target of rapamycin(mTOR), and p70S6 kiase(p70S6K). Results:Compared with the NC group, the PCOS model group showed absent estrous cycles, significantly elevated serum testosterone, sex hormone binding globulin, and luteinizing hormone(LH) levels( P<0.001), and polycystic ovarian changes on hematoxylin-eosin staining, confirming successful model establishment. Immunohistochemistry, transmission electron microscopy, and Western blotting demonstrated that autophagy levels were increased in the PCOS+ IF group compared with the PCOS group, while 3-MA administration reduced the intermittent fasting - induced autophagy. The AUC values for both GTT and ITT were significantly lower in the PCOS+ IF group than those in the PCOS group( P<0.001, P=0.003), but increased in the PCOS+ IF+ 3-MA group compared to the PCOS+ IF group( P<0.001, P=0.020). Western blotting analysis showed that phosphorylation levels of PI3K, Akt, mTOR, and p70S6K were significantly decreased in the PCOS+ IF group compared with the PCOS group( P=0.002, P=0.001, P=0.001, and P<0.001, respectively), and increased in the PCOS+ IF+ 3-MA group compared with the PCOS+ IF group( P=0.021, P=0.041, P=0.047, and P=0.024, respectively). Conclusions:Intermittent fasting alleviates insulin resistance in a PCOS mouse model through inhibitiing PI3K/Akt/mTOR signaling pathway and promoting autophagy.
7.Patient-specific quality assurance for non-normal radiotherapy plans based on statistical process control
Juan DENG ; Gaoyuan LIU ; Chuou YIN ; Jiang LIU ; Guojian MEI ; Ling HUA ; Shutong YU ; Xinhui FU ; Chen LIN ; Tian LI ; Yibao ZHANG
Chinese Journal of Radiological Medicine and Protection 2025;45(4):296-301
Objective:To apply statistical process control (SPC) techniques to the quality assurance of non-normal radiotherapy plans through Johnson transformation, establishing patient-specific tolerance and action limits based on treatment sites and dose/distance assessment criteria, thereby enhancing the intensity-modulated radiation therapy (IMRT) verification accuracy and dose delivery precision.Methods:In this study, 951 gamma analysis data of patient-specific quality assurance (PSQA) executed on the Halcyon accelerator platform were selected and categorized into six groups based on treatment sites, including brain (102 cases), head and neck (100 cases), breast (229 cases), lung (154 cases), esophagus (223 cases), and pelvic (143 cases) groups. The six groups of data were statistically analyzed through Anderson-Darling normality tests ( α = 0.05) using Minitab 21 software. Non-normal data were transformed into normal data through Johnson transformation and then were used to establish treatment site-specific tolerance and action limits, which were compared with the Shewhart control charts based on normal distributions. Results:The PSQA result of the six groups all exhibited non-normal distributions ( P < 0.05). Through Johnson transformation, the tolerance and action limits for the head and neck, breast, lung, esophagus, and pelvic areas under the 3%/2 mm criterion ranged from 95.13% to 96.16% and 94.19% to 95.91%, respectively. In contrast, the tolerance and action limits ranged from 91.15% to 94.86% and 89.94% to 94.78% under the 2%/2 mm criterion. Directly applying Shewhart control charts without normality assumptions yielded higher tolerance limits compared to the application of Johnson transformation, increasing the false positive rate in the non-normal PSQA process. Conclusions:Applying the SPC techniques directly to a non-normal process can lead to an increased false alarm rate and wrong process interpretation. The SPC techniques combined with Johnson transformation enable more effective monitoring of a non-normal PSQA process, facilitating timely identification of potential factors that may lead to an out-of-control process based on the treatment site-specific limits.
8.Construction and application of a quality and safety evaluation index system for the daytime chemotherapy
Yanping DENG ; Feng HUANG ; Jian SHI ; Yujiao YU ; Lanlan ZHANG ; Xiaxiang XUE ; Xiaohua WU ; Peicheng LIN ; Yang SUN
Chinese Journal of Hospital Administration 2025;41(8):609-613
Objective:To establish a quality and safety evaluation index system for the daytime chemotherapy in the Day Medical Management Quality Control Center of Fujian Province, providing references for objectively evaluating the quality of day chemotherapy.Methods:From December 2023 to August 2024, this study screened the initial indexes of the quality and safety evaluation index system for daytime chemotherapy through literature search and expert discussions. An index system and its weights were determined by using two rounds of Delphi method and precedence chart method. The quality of daytime chemotherapy services in 8 hospitals was evaluated by using a thousand point scale checklist based on this index system.Results:The expert motivation of both rounds of Delphi method was 100%, and the expert authority coefficient was 0.92. The quality and safety evaluation index system for daytime chemotherapy included 3 first-level indicators, 13 second-level indicators, and 54 third-level indicators; Among them, the weights of the first-level indicator included structure quality, process quality, and result quality were 0.334, 0.556, and 0.110, respectively. The quality and safety scores of daytime chemotherapy in 8 hospitals ranged from 812 to 980 points, with an average of 933 points.Conclusions:The quality and safety evaluation index system for daytime chemotherapy could objectively and comprehensively evaluate the quality and safety of hospital daytime chemotherapy.
9.Association of hippocampal subfield volumes and cross-domain associative memory impairment in patients with schizophrenia
Zhao-lin ZHAI ; Di CHANG ; Xuan LI ; Chang LU ; Yu-ke DONG ; Yan WANG ; Chun-hong SHAO ; Qing KANG ; Deng-tang LIU
Fudan University Journal of Medical Sciences 2025;52(6):775-782
Objective To investigate the possible association between cross-domain associative memory(AM)impairment and hippocampal subfield volumes in patients with schizophrenia(SCZ).Methods We enrolled 28 SCZ patients from Shanghai Mental Health Center,Shanghai Jiao Tong University School of Medicine,and 28 healthy controls(HCs)between 2019 and 2021.Based on an innovative AM paradigm and automated segmentation,3D-T1 weighted data of the objects were processed with PhiPipe and FreeSurfer.Differences in subfield volums between the two groups were analyzed using ANCOVA,while their relationship with AM scores was assessed using Pearson correlation.Results SCZ patients exhibited significantly poorer AM performance across three conditions compared with HCs.Marginally significant reductions were observed in the total volume of bilateral hippocampus,encompassing both the hippocampal head and body.Significant volume reductions were identified in the bilateral presubiculum and parasubiculum.The volumes of bilateral presubiculum head(r=0.273,P=0.042),parasubiculum(r=0.397,P=0.002),and CA1 head(r=0.382,P=0.004)exhibited positive correlations with cross-domain AM performance.Conclusion The bilateral presubiculum and parasubiculum,as hippocampal subregions significantly associated with cross-modal AM deficits in SCZ,may play a crucial role in the pathology of AM.
10.Total Saponins of Dioscoreae Nipponicae Rhizoma Alleviates Gouty Arthritis by Down-regulating COX-2-mediated M1 Macrophage Reprogramming
Lin HUANG ; Shumin LIU ; Huijuan SUN ; Geyu DENG ; Donghua YU ; Yu WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):200-207
ObjectiveTo explore the mechanism of total saponins of Dioscoreae Nipponicae Rhizoma (TSDN) in treating gouty arthritis (GA) by regulating cyclooxygenase-2 (COX-2)-mediated M1 macrophage reprogramming by in vivo and in vitro experiments. MethodsIn vivo experiment: 24 male SD rats were randomly allocated into blank, model (GA), TSDN, and celecoxib groups, with 6 rats in each group. After 7 days of administration, pathological changes in the ankle synovial tissue were observed via hematoxylin-eosin (HE) staining. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to quantify the mRNA levels of NOD-like receptor protein 3 (NLRP3) inflammasome, apoptosis-associated speck-like protein (ASC), Caspase-1, COX-2, interleukin-1β (IL-1β), and tumor necrosis factor-α (TNF-α) in the synovial tissue. Enzyme-linked immunosorbent assay (ELISA) was employed to measure the serum levels of inducible nitric oxide synthase (iNOS), IL-1β, CD86, CD80, CD206, and arginase-1 (Arg-1). In vitro experiment: The GA model was established by lipopolysaccharide (LPS) + MSU induction, and the inhibitor concentration was screened by the methyl thiazolyl tetrazolium (MTT) assay. RAW264.7 cells were allocated into blank, model, TSDN, dexamethasone, COX-2 inhibitor (celecoxib), and TSDN + COX-2 inhibitor groups. The levels of iNOS, IL-1β, CD86, CD80, CD206, and Arg-1 in the cell supernatant of each group were determined by enzyme-linked immunosorbent assay (ELISA). The mRNA and protein levels of NLRP3 inflammasome, COX-2, IL-1β, and TNF-α in each group were determined by Real-time PCR and Western blot, respectively. ResultsIn vivo experiment: compared with the model group, TSDN reduced the mRNA levels of NLRP3 inflammasome, COX-2, IL-1β, and TNF-α in the synovial tissue (P<0.05, P<0.01). ELISA results showed that TSDN lowered the serum levels of iNOS, IL-1β, CD86, and CD80 (P<0.01) while increasing the serum levels of CD206 and Arg-1 (P<0.01). In vitro experiment: compared with the model group, TSDN and inhibitor down-regulated the mRNA levels of NLRP3 inflammasome, COX-2, IL-1β, and TNF-α and the protein levels of NLRP3 inflammasome, COX-2, cleaved IL-1β, and TNF-α (P<0.01). Compared with TSDN alone, TSDN + COX-2 inhibitor further reduced the mRNA and protein levels of the markers above (P<0.01). Compared with the model group, TSDN and COX-2 inhibitor decreased the levels of IL-1β, iNOS, CD80, and CD86 (P<0.01) and increased the levels of CD206 and Arg-1 (P<0.01) in cells. Compared with TSDN alone, TSDN + COX-2 inhibitor reduced IL-1β, iNOS, CD80, and CD86 levels (P<0.05, P<0.01) and elevated CD206 and Arg-1 levels (P<0.01) in cells. ConclusionTSDN can alleviate GA by downregulating COX-2-mediated M1 macrophage reprogramming and suppressing the inflammatory factors.

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