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.Development and reliability and validity tests of the Recurrence Fear Scale for Patients with Atrial Fibrillation after Catheter Ablation
Xiaohong LU ; Jizhe WANG ; Hanxu LANG ; Shaoting SHI ; Jing HAN ; Xiaojie WANG ; Maojing WANG ; Xu ZHANG ; Lili WEI
Chinese Journal of Modern Nursing 2025;31(2):192-197
Objective:To develop a Recurrence Fear Scale for Patients with Atrial Fibrillation after Catheter Ablation and conduct psychometric testing for its reliability and validity.Methods:Based on the common-sense model of self-regulation, the scale was developed through a literature review and semi-structured interviews to construct an item pool. The scale draft was formed through expert consultation and a pre-survey. Using convenience sampling, 361 patients with atrial fibrillation who had undergone catheter ablation and were either hospitalized or attending outpatient follow-up at the Department of Cardiology, Affiliated Hospital of Qingdao University, between January and March 2024, were selected for questionnaire survey. Item analysis and reliability and validity tests were performed on the scale.Results:Exploratory factor analysis identified five common factors, with a cumulative variance contribution rate of 74.375%. Confirmatory factor analysis showed good model fit. The final scale included five dimensions and 24 items: trigger factors, recurrence risk perception, disease uncertainty, psychological burden, and coping strategies. The content validity index at the scale level was 0.864, and the item-level content validity index ranged from 0.684 to 0.947. The Cronbach's α coefficient of the scale was 0.919, the split-half reliability coefficient was 0.834, and the test-retest reliability coefficient was 0.872.Conclusions:The development of the Recurrence Fear Scale for Patients with Atrial Fibrillation after Catheter Ablation is scientific and standardized, and the scale has good reliability and validity. It can effectively assess the level of recurrence fear in these patients.
3.Effect of TINCR-MAF:MAFB transcription factor network on proliferation and differentiation of human kerathnocytes
Jinfen ZHENG ; Cuiping SHI ; Yunxia LING ; Dehua ZHANG ; Qianyu ZHAI ; Lijia ZHU ; Doukou JIANG ; Xiaohong WANG ; Yonghui LAI
The Journal of Practical Medicine 2025;41(4):509-514
Objective To explore the impact of the TINCR-MAF:MAFB transcription factor network on the expression of proliferation and differentiation-related genes in keratinocytes,to verify the role of this network in the occurrence and development of psoriasis and its potential mechanisms.Methods Employed RNA interference technology to knock down TINCR gene expression,and the proliferation ability of keratinocytes was assessed using the CCK-8 method.Additionally,qRT-PCR and Western blot analyses were conducted to evaluate the RNA and protein expression levels of TINCR,MAFB,and KLF4 genes.Immunohistochemical methods were used to detect the expression of KLF4 protein in psoriasis tissues.Results After TINCR gene siRNA interference,the proliferation ability of keratinocytes significantly decreased at 24,48,and 72 hours(P<0.001),indicating that the TINCR gene plays a critical role in cell proliferation.The results of qRT-PCR and Western blot analyses showed that the RNA and protein expression levels of TINCR,MAFB,and KLF4 genes were significantly reduced(P<0.001),suggesting that TINCR may influence the differentiation of keratinocytes by regulating the expression of MAFB transcription factor and KLF4 differentiation-related genes.Furthermore,immunohistochemical results indicated that the expression of KLF4 protein was significantly elevated in psoriasis tissues compared to normal skin tissues,suggesting that KLF4 plays an important role in the pathogenesis of psoriasis.Conclusions The TINCR-MAF:MAFB transcription factor network may participate in the occurrence and development of psoriasis by affecting the proliferation and differentiation of keratinocytes.This finding provides a new perspective on the pathogenesis of psoriasis and potential targets for future therapeutic strategies.
4.Clinical study of Hewei Jiangni Formula in patients with non-erosive gastroesophageal reflux disease and cold-heat complex syndrome
Shuangyuan ZHANG ; Hanqing CHEN ; Junxiang LI ; Tangyou MAO ; Lei SHI ; Zhengdao LIN ; Chuchu XUE ; Xiaohong LI
Journal of Beijing University of Traditional Chinese Medicine 2025;48(8):1107-1114
Objective To observe and analyze the clinical efficacy of Hewei Jiangni Formula in treating patients with non-erosive gastroesophageal reflux disease(NERD)and cold-heat complex syndrome and explore its regulatory mechanism on visceral hypersensitivity.Methods Sixty patients with NERD and cold-heat complex syndrome diagnosed at the Gastroenterology Clinic of Dongfang Hospital,Beijing University of Chinese Medicine from January 2021 to Decemer 2023,were randomly divided into the Hewei Jiangni Formula group and omeprazole group,with 30 patients per group.The Hewei Jiangni Formula group was treated with Hewei Jiangni Formula and omeprazole enteric-coated tablets placebo,whereas the omeprazole group was treated with omeprazole enteric-coated tablets and Hewei Jiangni Formula placebo.The treatment period was scheduled to last for 8 weeks.The primary outcome indicators(Gastroesophageal Reflux Disease Quality of Life Questionnaire(GERD-Q)scale score:response rate,total score,and single symptom score)and secondary outcome indicators(traditional Chinese medicine clinical scores scale)were recorded before and after treatment in both groups.Ten healthy individuals were recruited from the Physical Examination Center of Dongfang Hospital,Beijing University of Chinese Medicine,as the healthy control group.The expression levels of mast cell tryptase(MCT),protease-activated receptor 2(PAR2),transient receptor potential vanilloid 1(TRPV1),substance P(SP),calcitonin gene-related peptide(CGRP),5-hydroxytryptamine(5-HT),and 5-hydroxytryptamine 3 receptor(5-HT3R)were recorded.These indicators were then used for the following comparisons:the NERD patients vs.the healthy group before treatment;the Hewei Jiangni Formula group vs.the omeprazole group after treatment;the intra-group comparisons within both NERD groups.Changes in serum levels of these indicators were observed before and after treatment in both NERD groups.Results According to the GERD-Q scores before and after treatment,the effective rate was 90.00%in the Hewei Jiangni Formula group and 86.67%in the omeprazole group,with no significant differences.Both groups exhibited improved symptoms of heartburn,regurgitation,upper abdominal pain,and sleep disorders caused by heartburn or regurgitation(P<0.05);however,neither group exhibited significantly improved nausea(P>0.05).Before treatment,MCT,PAR2,TRPV1,SP,CGRP,5-HT,and 5-HT3R expression levels in both NERD groups were significantly higher than those in the healthy control group(P<0.05).After treatment with Hewei Jiangni Formula or omeprazole enteric-coated tablets,the expression levels of these indicators decreased in both groups(P<0.05).The omeprazole group was superior to Hewei Jiangni Formula in reducing 5-HT3R expression(P<0.05).Conclusion Hewei Jiangni Formula significantly improves the symptoms of patients with NERD and cold-heat complex syndrome,with efficacy comparable to that of omeprazole enteric-coated tablets.It is superior to omeprazole in improving symptoms of spleen yang deficiency,such as loss of appetite,fatigue,borborygmus with loose stools,and cold extremities.Hewei Jiangni Formula reduces MCT,PAR2,TRPV1,SP,CGRP,5-HT,and 5-HT3R expression levels,regulates related signaling pathways,and alleviates visceral hypersensitivity.
5.Progress in monitoring and protection against electrosurgical smoke hazards and exposure risks in operating room
Pingping SHI ; Ya LUO ; Weimin XIAO ; Xiaohong HUANG
Journal of Environmental and Occupational Medicine 2025;42(10):1275-1280
The operating room is the core settings of various surgical treatments, and exhibits distinct attributes and systemic complexities. Medical staff who work long term in operating rooms face multiple exposures to potential health hazards. Especially with the progress of electrosurgical technology and the frequent use of electrosurgical equipment, the possible health effects of the resulting electrosurgical smoke to those working in operating rooms have gradually attracted attention. This paper reviewed the composition, hazard, exposure risk monitoring, and protective measures of electrosurgical smoke, aiming to deepen the understandings of potential health risks of electrosurgical smoke, improve the self-protection awareness of medical staff, strengthen attention to electrosurgical smoke protection in all hospitals, and ensure the occupational safety of medical staff.
6.Pathogen spectrum of diarrheal disease surveillance in Fengxian District, Shanghai, 2013‒2023
Meihua LIU ; Yuan ZHUANG ; Xiaohong XIE ; Hongwei ZHAO ; Yuan SHI ; Lijuan DING ; Yi HU ; Lixin TAO
Shanghai Journal of Preventive Medicine 2025;37(4):336-341
ObjectiveTo investigate the pathogenic spectrum and epidemiological characteristics of diarrheal disease in Fengxian District of Shanghai, and to provide scientific basis for the prevention and control of diarrheal diseases. MethodsBasic information of the initial adult cases visited diarrheal disease surveillance sentinel hospital in Fengxian District, Shanghai, was collected from August 2013 to 2023, and fecal samples were collected at 1∶5 sampling intervals to isolate and identify 5 kinds of diarrheagenic Escherichia coli (DEC), Salmonella (SAL), Vibrio parahaemolyticus, Campylobacter, Vibrio cholerae, Shigella and Yersinia enterocolitica (YE). Simultaneously, nucleic acid detection was performed for 3 kinds of rotavirus, 2 kinds of norovirus, intestinal adenovirus, astrovirus and sapovirus. ResultsA total of 1 861 cases of newly diagnosed diarrheal disease were reported, with the peak in July to August. Additionally, 704 surveillance samples were detected, with a total positive detection rate of 50.57%. The detection rates of bacterial, viral and mixed infection were 25.14%, 21.02% and 4.40%, respectively. Among the pathogens detected, DEC accounted for the highest (17.61%, 124/704), followed by norovirus (16.48%, 116/704), rotavirus (6.39%, 45/704), SAL (5.97%, 42/704) and Campylobacter (3.84%, 27/704). DEC detected were mainly enteroaggregative Escherichia coli and enterotoxigenic Escherichia coli, with no detection of Vibrio cholerae, Shigella and YE. The highest total pathogen detection rate was observed from June to September, and the detection peaks of norovirus were from March to June and from October to December, whereas that of DEC was from June to October. The detection rate of rotavirus peaked from January to February, but which was not detected between 2020‒2023. The SAL positive rate peak was in September, whereas that of Campylobacter was from July to September. ConclusionThe main pathogens detected in Fengxian District from 2013‒2019 are DEC, norovirus, rotavirus, SAL and Campylobacter. Different pathogens have different detection peaks, with bacteria predominating in summer and viruses in winter and spring. Prevention and control measures should be carried out according to the epidemiological characteristics of different seasons.
7.Bendamustine combined with anti-CD20 monoclonal antibody in the first-line treatment of older patients with indolent B-cell non-Hodgkin lymphoma: a multicenter retrospective study
Shuchao QIN ; Yi MIAO ; Zhaoliang ZHANG ; Jie ZHANG ; Yuye SHI ; Yuqing MIAO ; Weiying GU ; Weicheng ZHENG ; Zhuxia JIA ; Guoqiang LIN ; Haiwen NI ; Xiaohong XU ; Min XU ; Xiaoyan XIE ; Ling WANG ; Yun ZHUANG ; Wei ZHANG ; Ping LIU ; Jianyong LI ; Wenyu SHI
Chinese Journal of Hematology 2025;46(9):820-826
Objective:To investigate the efficacy and safety of bendamustine combined with anti-CD20 monoclonal antibody in the first-line treatment of older patients with indolent B-cell non-Hodgkin lymphoma (B-iNHL) .Methods:The clinical data of 159 patients with B-iNHL enrolled in 16 hospitals from Jiangsu Cooperative Lymphoma Group from December 1, 2019, to April 20, 2024, were analyzed for regimen efficacy and safety. Bendamustine plus rituximab (BR) and bendamustine plus obinutuzumab (BG) were administered to 139 (87.4% ) and 20 (12.6% ) patients, respectively.Results:Among the 159 patients, 101 (63.5% ) were male and 58 (36.5% ) were female, with a median age of 69 years (range: 60–84). Efficacy could be assessed in 138 (86.8% ) patients. The efficacy assessment demonstrated that the overall response rate was 92.0% with complete and partial remissions in 75 (54.3% ) and 52 (37.7% ) cases, respectively. With a median follow-up of 24 months (range: 4–64), the progression-free survival rate was (87.5 ± 3.0) % and the overall survival rate was (83.2 ± 3.3) %. Of the 27 patients who died, 6 (22.2% ) died due to disease progression. The mean applied dose of bendamustine per cycle was 73.0 (50.8–89.7) mg/m 2 per day, administered on days 1 and 2. Adverse events of grade 3 or higher were reported in 53 (33.3% ) patients, with infection (30 cases,18.9% ) and neutropenia (24 cases, 15.1% ) demonstrating the highest incidence. Conclusion:Bendamustine combined with anti-CD20 monoclonal antibody demonstrated good efficacy and is well-tolerated in the first-line treatment of elderly patients with B-iNHL.
8.Clinical features analysis of fulminant type 1 diabetes mellitus
Min GAO ; Yonghao FENG ; Xiaohong SHI
Chinese Journal of Clinical Medicine 2025;32(3):472-478
Objective To explore the clinical features of fulminant type 1 diabetes mellitus (FT1DM). Methods The clinical data of 6 patients with FT1DM who were hospitalized in Jinshan Hospital of Fudan University from April 2020 to August 2024 were retrospectively analyzed. Their data were compared with that of 30 patients diagnosed with non-fulminant type 1 diabetes mellitus (NFT1DM) and diabetic ketosis or diabetic ketoacidosis (DKA) who were admitted to the hospital during the same period. The clinical characteristics of FT1DM were summarized. Results All 6 patients with FT1DM were male, with a disease course of 2.00 (1.75, 4.00) d. Three cases exhibited a history of prior infection, four tested positive for glutamic acid decarboxylase antibody (GADA), and five developed severe DKA. The glycated hemoglobin A1C (HbA1C) was (6.30±0.67) %, fasting C-peptide (FCP) was 0.07 (0.03, 0.15) ng/mL, 2-hour postprandial C-peptide (2h-CP) was 0.09 (0.03, 0.16) ng/mL. At discharge, all 6 patients received 4-injection insulin regimen, with a dose (0.69±0.15) U·kg−1·d−1. The body mass index (BMI), blood glucose/HbA1C, blood potassium/HbA1C, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2h-PG), high-sensitivity C-reactive protein (hs-CRP), alanine aminotransferase (ALT), serum creatinine, and blood potassium levels in the FT1DM group were higher than those in the NFT1DM group (P<0.05), while HbA1C and glycated albumin (GA) levels were lower than NFT1DM group (P<0.05). Conclusions FT1DM usually presents with an acute onset of DKA, may be accompanied by a history of preceding infection, and GADA can be positive. Patients with FT1DM have elevated blood glucose/HbA1C, blood potassium/HbA1C, FPG, 2h-PG, hs-CRP, ALT, serum creatinine, blood potassium levels, and require insulin therapy, while the HbA1C and GA levels are lower.
9.Expert consensus on classification and diagnosis of congenital orofacial cleft.
Chenghao LI ; Yang AN ; Xiaohong DUAN ; Yingkun GUO ; Shanling LIU ; Hong LUO ; Duan MA ; Yunyun REN ; Xudong WANG ; Xiaoshan WU ; Hongning XIE ; Hongping ZHU ; Jun ZHU ; Bing SHI
West China Journal of Stomatology 2025;43(1):1-14
Congenital orofacial cleft, the most common birth defect in the maxillofacial region, exhibits a wide range of prognosis depending on the severity of deformity and underlying etiology. Non-syndromic congenital orofacial clefts typically present with milder deformities and more favorable treatment outcomes, whereas syndromic congenital orofacial clefts often manifest with concomitant organ abnormalities, which pose greater challenges for treatment and result in poorer prognosis. This consensus provides an elaborate classification system for varying degrees of orofacial clefts along with corresponding diagnostic and therapeutic guidelines. Results serve as a crucial resource for families to navigate prenatal screening results or make informed decisions regarding treatment options while also contributing significantly to preventing serious birth defects within the development of population.
Humans
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Cleft Lip/diagnosis*
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Cleft Palate/diagnosis*
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Consensus
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Prenatal Diagnosis
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Female
10.Mechanism of Xiakucao Xiaoliu Mixture against non-small cell lung cancer by network pharmacology
Yue HU ; Yong YIN ; Liuhui SHI ; Xiaohong XU ; Jianyong ZHU ; Hua NIAN
Journal of Pharmaceutical Practice and Service 2025;43(12):591-598
Objective To explore the mechanism of Xiakucao Xiaoliu Mixture against non-small cell lung cancer (NSCLC). Methods The effective components of Xiakucao Xiaoliu Mixture were screened by TCMSP, BATMAN-TCM database and literature reviews. The targets of effective components were predicted. NSCLC related targets were collected by GeneCards, OMIM, PharmGKB, TTD and Drugbank, combined with the differential genes of Xiakucao Xiaoliu Mixture against Lewis lung cancer mice. The intersection targets of Xiakucao Xiaoliu Mixture against NSCLC were obtained. Cytoscape software was used to construct the network diagram of traditional Chinese medicine-active ingredients-core targets. STRING database was used to construct PPI network diagram. GO function enrichment analysis and KEGG pathway enrichment analysis of the intersection targets were performed by Metascape database to predict the key targets and active components of Xiakucao Xiaoliu Mixture against NSCLC, and Schrodinger software was used to perform molecular docking verification. Results The 32 active components and 24 intersection targets of Xiakucao Xiaoliu Mixture against NSCLC were obtained. 11 core targets such as ESR1, MAPK1 were found. The mechanism of action may be related to 30 signaling pathways such as cellular senescence, receptor activation, prolactin signaling pathway. Conclusion The active components of Xiakucao Xiaoliu Mixture act on multiple targets and signaling pathways to regulate complex biological processes. By regulating ESR1 agsinst NSCLC, it may play an important role in improving the survival rate and prognosis of female patients.

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