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.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.
3.Preliminary study on the mechanism of dexmedetomidine regulating lncRNA HOTAIR to improve lung injury in septic mice
Jianping YANG ; Yan LI ; Fengning WEI ; Junmei CAO ; Shenglei YIN ; Yibiao WANG ; Lichao SUN ; Xiaoyan ZHANG
Chinese Journal of Emergency Medicine 2023;32(6):768-774
Objective:To investigate the mechanism of dexmetomidine (DEX) in improving lung injury in septic mice.Methods:Male C57BL/6 mice were randomly assigned to the blank group (NC), sham operation group (sham), cecal ligation and puncture group (CLP), and Dex treatment group (CLP+DEX), 36 mice per group. Mice in the CLP group were intraperitoneally injected with 1 mL sterile saline 15 min before CLP, and mice in the CLP + DEX group were intraperitoneally injected with 50 μg/kg DEX 15 min before CLP. The survival rate was recorded within 24 h after CLP. The mice were sacrificed at 0, 3, 6, 12, and 24 h after CLP, and lung tissues were collected. The expression levels of cytokines (IL-6, IL-1β, TNF-α) and lncRNA-HOTAIR in the lung of mice were detected by qPCR. RAW264.7 cell were cultured in vitro, LPS (100 ng/mL) and DEX (1 μ mol/L) were used to establish a cell model for studying the mechanism of Dex, and the expression of cytokines (IL-6, IL-1β, TNF-α) and lncRNA-HOTAIR in RAW264.7 cell model were detected by qPCR. In addition, the effect of lncRNA-HOTAIR on sepsis was explored in vivo and in vitro by knockdown or overexpression of HOTAIR.Results:The survival rate of the CLP+DEX group was higher than that of the CLP group within 24 h after surgery, and the levels of IL-6, IL-1β, and TNF-α in the lungs were significantly lower than those in the CLP group at 6, 12, and 24 h after surgery ( P<0.05). In addition, the level of lncRNA HOTAIR showed that the expression level of lncRNA HOTAIR in the lungs of mice were decreased after Dex treatment, and were decreased 1.1 times ( P<0.05), 4.0 times ( P<0.01) and 3.8 times ( P<0.01) at 6, 12, and 24 h, respectively. Compared with the NC group, knockdown of HOTAIR significantly decreased the levels of IL-1β, IL-6, and TNF-α in septic mice ( P<0.05), and overexpression of HOTAIR significantly increased the levels of IL-1β, IL-6, and TNF-α in septic mice ( P<0.01). Conclusions:DEX can reduce the production of inflammatory factors in the lungs of septic mice and improve the survival rate of septic mice. The mechanism may be related to the inhibition of HOTAIR expression.
4.Clinicopathological features and prognosis of 128 children with idiopathic membranous nephropathy
Junmei LIU ; Peipei SHI ; Limin JIA ; Lu CAO ; Huating ZHANG ; Qin WANG ; Jianjiang ZHANG
Chinese Journal of Applied Clinical Pediatrics 2023;38(6):452-456
Objective:To analyze the clinicopathological features and prognosis of idiopathic membranous nephropathy (IMN) in children, and to investigate the factors influencing their prognosis.Methods:The clinical and pathological data of 128 children with IMN hospitalized in the First Affiliated Hospital of Zhengzhou University from January 2012 to December 2019 were retrospectively analyzed.They were divided into 2 groups according to the pathological manifestations: group A[typical membranous nephropathy(MN) group] and group B (atypical MN group), and the clinicopathological characteristics of the 2 groups were compared.Different treatment regimens and their efficacy were summarized, and the prognosis and its influencing factors were analyzed.The primary endpoint event at follow-up was the occurrence of end stage renal disease (ESRD), and the secondary endpoint event was the occurrence of renal insufficiency.Children with IMN were further divided into endpoint event group and non-endpoint event group according to the presence or absence of endpoint events at the last follow-up.Survival analysis was performed using the Kaplan-Meier survival curve method.The Cox proportional risk model method was used to analyze the factors influencing the prognosis of poor kidney outcomes in children with IMN. Results:(1)A total of 128 children were included, with the male-to-female ratio of 1.13∶1.00.The median age of onset and peak age of onset were 13.0 (10.3, 15.0) years, and 12-16 years (68.8%), respectively.Massive proteinuria was detected in 119 cases (93.0%), including 103 cases (80.5%) with massive proteinuria and hematuria, 4 cases(3.1%) with simple hematuria, and 5 cases (3.9%) with non-renal proteinuria.There were 29 cases (22.7%) in group A and 99 cases (77.3%) in group B. (2)Blood triacylglycerol level was significantly higher in group B than that of group A[2.1 (1.5, 3.0) mmol/L vs.1.7(1.1, 2.5) mmol/L], while high-density lipoprotein[1.5(1.1, 1.8) mmol/L vs.1.8(1.4, 2.1) mmol/L], serum albumin[22.0(17.0, 27.3) g/L vs.25.5 (21.0, 32.5) g/L] and complement C3[(1.1±0.2) g/L vs.(1.2±0.2) g/L] were significantly lower in group B than those of group A (all P<0.05). (3)Complete clinical data during hospitalization and follow-up data were obtained from 91 children with IMN, with a median follow-up time of 87.0 (49.0, 104.5) months.Among them, 5 cases (5.5%) progressed to ESRD, involving 3 cases received renal transplantation, and 9 cases (9.9%) had secondary endpoints.Cumulative renal survival rate for ESRD at 5 and 10 years were 96.2% and 92.9%, respectively, which, for the secondary endpoints at 5 and 10 years were 95.2% and 84.8%, respectively.(4)Kaplan-Meier survival analysis showed no significant difference in the cumulative renal survival between group A and group B ( P>0.05). Multifactorial Cox regression analysis showed that tubular atrophy/interstitial fibrosis was an independent risk factor for renal insufficiency in children with IMN ( HR=0.102, 95% CI: 0.011-0.940, P<0.05). Conclusions:Massive proteinuria combined with hematuria is the major clinical manifestation of IMN in children, and atypical MN is the major pathological manifestation.Tubular atrophy/interstitial fibrosis is an independent risk factor for renal insufficiency in children with IMN.
5.Clinical Characteristics and Treatment of Blau Syndrome in Chinese Children-a National Multicenter Study
Junmei ZHANG ; Xiaozhen ZHAO ; Xuemei TANG ; Yi'nan ZHAO ; Li LI ; Fengqiao GAO ; Xinwei SHI ; Yanliang JIN ; Yu ZHANG ; Lanfang CAO ; Wei YIN ; Jihong XIAO ; Weiying KUANG ; Jianghong DENG ; Jiang WANG ; Xiaohua TAN ; Chao LI ; Shipeng LI ; Haiyan XUE ; Cuihua LIU ; Xiaohui LIU ; Dongmei ZHAO ; Yuqing CHEN ; Wenjie ZHENG ; Caifeng LI
JOURNAL OF RARE DISEASES 2022;1(3):252-258
6.Construction and demonstration of mobile health management model for elderly patients with coronary heart disease
Henan XIE ; Gairong HUANG ; Junmei ZHANG ; Xuanchao CAO ; Lu WANG ; Jie WU
Chinese Journal of Geriatrics 2022;41(2):143-146
Objective:To observe the construction of mobile health management model for elderly patients with coronary heart disease, and to conduct empirical research.Methods:A total of 86 elderly patients with coronary heart disease treated in Henan Provincial People's Hospital from January 2019 to January 2021 were selected.They were randomly divided into 2 groups: the control group receiving routine intervention(n=43), and the observation group receiving mobile health management mode as an add-on to routine interventions(n=43).After 3 months of intervention in control versus observation groups, angina, readmission risk factors were assessed, and status of target criteria for low-density lipoprotein cholesterol(LDL-C), resting heart rate, systolic, and diastolic blood pressure as readmission risk factors were evaluated.Before and 3 months after intervention, the self-care ability of patients was evaluated.Results:Number of angina pectoris attacks was less in observation(0.53±0.18)than in control group(0.64±0.15)( t=3.079, P=0.003).Duration of the angina pectoris was shorter in observation(2.72±0.40)min than in control group(3.06±0.55)min, ( t=3.278, P=0.002).Rate of achieving effectiveness of indicators for the risk factors of readmission was higher in observation group than in control group as following data: LDL-C(90.7% and 72.1%, χ2=4.914, P=0.027), resting heart rate(95.4% and 81.4%, χ2=4.074, P=0.044), systolic blood pressure(86.1% and 60.5%, χ2=7.182, P=0.007)and diastolic blood pressure(88.4% and 67.4%, χ2=5.472, P=0.019).The scores of self responsibility, health knowledge, self-care skills and self-concept were higher in the observation group than in the control group, with a statistical significant difference(all P<0.05). Conclusions:The construction of mobile health management model and its application in elderly patients with coronary heart disease are beneficial to improve the symptoms of angina pectoris, reduce the risk factors of readmission and improve the ability of self-care of patients.
7.Construction of multi-parameter emergency database and preliminary application research.
Junmei WANG ; Tongbo LIU ; Yuyao SUN ; Peiyao LI ; Yuzhuo ZHAO ; Zhengbo ZHANG ; Wanguo XUE ; Tanshi LI ; Desen CAO
Journal of Biomedical Engineering 2019;36(5):818-826
The analysis of big data in medical field cannot be isolated from the high quality clinical database, and the construction of first aid database in our country is still in the early stage of exploration. This paper introduces the idea and key technology of the construction of multi-parameter first aid database. By combining emergency business flow with information flow, an emergency data integration model was designed with reference to the architecture of the Medical Information Mart for Intensive Care III (MIMIC-III), created by Computational Physiology Laboratory of Massachusetts Institute of Technology (MIT), and a high-quality first-aid database was built. The database currently covers 22 941 medical records for 19 814 different patients from May 2015 to October 2017, including relatively complete information on physiology, biochemistry, treatment, examination, nursing, etc. And based on the database, the first First-Aid Big Data Datathon event, which 13 teams from all over the country participated in, was launched. The First-Aid database provides a reference for the construction and application of clinical database in China. And it could provide powerful data support for scientific research, clinical decision making and the improvement of medical quality, which will further promote secondary analysis of clinical data in our country.
Big Data
;
Critical Care
;
Databases, Factual
;
Humans
;
Medical Informatics
8.Application of video education combined with Teach-back in patients with rheumatoid arthritis
Kaimin ZHOU ; Xianxiu WEN ; Yuqiong CAO ; Junmei TAN ; Mao MA ; Shan ZENG ; Li LONG
Chinese Journal of Modern Nursing 2019;25(28):3583-3588
Objective? To explore the effect of video education combined with Teach-back on the compliance of patients with rheumatoid arthritis(RA) to exercise at home and the condition of disease activity. Methods? By convenience sampling, 80 patients with RA who were hospitalized in the Rheumatology and Immunology Department of Sichuan Provincial People's Hospital from March to November 2018 were included in the study. By random number table, the patients were divided into the intervention group and control group, the control group was given routine discharge instruction and the patients were taught about the functional exercise orally; on the basis of that, the intervention group was given the video education combined with Teach-back and assisted to download videos, Family Exercise Compliance Scale and Disease Activity Score in 28 Joints(DAS28) were used to evaluate the patients' compliance in functional exercise at home and disease activity condition before intervention, 1 month and 3 months after intervention. Results? Finally, 73 cases(37 cases in the control group, 36 cases in the intervention group) in two groups completed the research plan. One and 3 months after intervention, the compliance with family functional exercise of the intervention group was better than the control group from the same period with statistical significance(P<0.05); the scores of Tender Joint Coun(t TJC28), Swollen Joint Coun(t SJC28), Patient General Health(GH) of the intervention group were all lower than the control group from the same period with statistical significance (P<0.05), however, the scores of Erythrocyte Sedimentation Rate(ESR) and DAS28 didn't demonstrate obvious intervention effects (P>0.05). Conclusions? Video education combined with Teach-back can effectively improve the compliance of RA patients with home functional exercise, help to cultivate healthy behavior, and hence reduce the number of tender joint, swelling joints, reduce the degree of pain, improve the prognosis of patients.
9.Pilot research: construction of emergency rescue database
Yuzhuo ZHAO ; Junmei WANG ; Fei PAN ; Peiyao LI ; Lijing JIA ; Kaiyuan LI ; Cong FENG ; Tongbo LIU ; Zhengbo ZHANG ; Desen CAO ; Tanshi LI
Chinese Critical Care Medicine 2018;30(6):609-612
Objective To construct a database containing multiple kinds of diseases that can provide "real world"data for first-aid clinical research. Methods Structured or non-structured information from hospital information system, laboratory information system, emergency medical system, emergency nursing system and bedside monitoring instruments of patients who visited department of emergency in PLA General Hospital from January 2014 to January 2018 were extracted. Database was created by forms, code writing, and data process. Results Emergency Rescue Database is a single center database established by PLA General Hospital. The information was collected from the patients who had visited the emergency department in PLA General Hospital since January 2014 to January 2018. The database included 530 585 patients' information of triage and 22 941 patients' information of treatment in critical rescue room, including information related to human demography, triage, medical records, vital signs, lab tests, image and biological examinations and so on. There were 12 tables (PATIENTS, TRIAGE_PATIENTS, EMG_PATIENTS_VISIT, VITAL_SIGNS, CHARTEVENTS, MEDICAL_ORDER, MEDICAL_RECORD, NURSING_RECORD, LAB_TEST_MASTER, LAB_RESULT, MEDICAL_EXAMINATION, EMG_INOUT_RECORD) that containing different kinds of patients' information. Conclusions The setup of high quality emergency databases lay solid ground for scientific researches based on data. The model of constructing Emergency Rescue Database could be the reference for other medical institutions to build multiple-diseases databases.
10.Hepatic progenitor cell activation in liver repair
Bria ADAM ; Marda JORGENSEN ; Zhou JUNMEI ; Sun XIAOWEI ; Cao QI ; E.Petersen BRYON ; Pi LIYA
Liver Research 2017;1(2):81-87
The liver possesses an extraordinary ability to regenerate after injury.Hepatocyte-driven liver regener-ation is the default pathway in response to mild-to-moderate acute liver damage.When replication of mature hepatocytes is blocked,facultative hepatic progenitor cells(HPCs),also referred to as oval cells(OCs)in rodents,are activated.HPC/OCs have the ability to proliferate clonogenically and differentiate into several lineages including hepatocytes and bile ductal epithelia.This is a conserved liver injury response that has been studied in many species ranging from mammals(rat,mouse,and human)to fish.In addition,improper HPC/OC activation is closely associated with fibrotic responses,characterized by myofibroblast activation and extracellular matrix production,in many chronic liver diseases.Matrix remodeling and metalloprotease activities play an important role in the regulation of HPC/OC prolifer-ation and fibrosis progression.Thus,understanding molecular mechanisms underlying HPC/OC activa-tion has therapeutic implications for rational design of anti-fibrotic therapies.

Result Analysis
Print
Save
E-mail