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.Study on mechanism of compound Banlangen Granules for epidemic encephalitis B, hepatitis and parotitis based on UPLC-MS/MS and network pharmacology
Yuwei XIE ; Zhiliang SUN ; Youtian DENG ; Yidong YANG ; Yuan LI ; Baoyi HONG ; Guocheng FU ; Yun WEI ; Haigang CHEN ; Pengfei YANG ; Suyun LU
International Journal of Traditional Chinese Medicine 2024;46(9):1178-1186
Objective:To clarify the transitional components in the blood of compound Banlangen Granules; To explore the mechanism of drugs in the treatment of epidemic encephalitis B, hepatitis and parotitis.Methods:The transitional components in blood of compound Banlangen Granules were analyzed by ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS/MS). The regulatory targets and pathways of compound Banlangen Granules in the treatment of epidemic encephalitis B, hepatitis and parotitis were analyzed based on UPLC-MS/MS and network pharmacology.Results:A total of 9 blood components were identified, of which 8 were prototype components, including sucrose, o-aminobenzoic acid, uridine, adenosine, guanosine, indole-3-acetonitrile-2 murine-S-β-D-glucopyranoside and salicylic acid. Through network pharmacological analysis, it was concluded that compound Banlangen Granules may treat epidemic encephalitis B, hepatitis and parotitis by regulating lipid and atherosclerosis, insulin resistance, IL-17 and other signal pathways.Conclusion:The 9 blood components of compound Banlangen Granules may treat epidemic encephalitis B, hepatitis and parotitis by regulating lipid and atherosclerosis, insulin resistance, IL-17 and other signal pathways.
4.Value of optimal machine learning model combined with serological antibodies in the diagnosis of Hashimoto′s thyroiditis
Ru CAO ; Guocheng LU ; Jiali MA ; Juan WANG ; Shanshan YU ; Jue JIANG ; Qi ZHOU
Chinese Journal of Ultrasonography 2024;33(12):1023-1029
Objective:To explore the diagnostic value of different machine learning models and optimal machine learning model combined with clinical data for diagnosing Hashimoto′s thyroiditis (HT).Methods:The thyroid gland images of 643 patients with 643 thyroid nodules who underwent preoperative ultrasound examination and had pathological results in the Second Affiliated Hospital of Xi′an Jiaotong University from December 2018 to March 2024 were retrospectively collected, and the images were divided into training set and test set according to a ratio of 7 to 3. Twenty ultrasound imaging omics models were constructed using pairwise combination of 5 feature screening components and 4 classifiers. The area under the curve (AUC) of each model in the test set was compared. Meanwhile, 3 basic network models were respectively used to construct deep learning models for diagnosing HT, and the diagnostic efficacies of the deep learning models and the ultrasound imaging omics models for HT were compared. The model with the greatest efficacy was selected as the optimal machine learning model. Further, the optimal machine learning model was combined with clinical data to construct a combined model. The ROC curves were plotted to compare the diagnostic efficacy of the optimal machine learning model and the combined model for HT.Results:In the comparison of the efficacies of ultrasound imaging omics models and deep learning models in diagnosing HT, the efficacy of stable feature screening-logistic regression (LR) model was the greatest, and the accuracy, sensitivity and specificity of using the LR model in diagnosing HT in the test set were 78%, 75%, 74%, respectively, with an AUC of 0.82(95% CI=0.76-0.88). After combining the LR model with clinical data, the accuracy, sensitivity, and specificity of the combined model in the test set were 87%, 74%, and 95%, respectively, with an AUC of 0.91(95% CI=0.87-0.95), which was strongly consistent with pathology (Kappa value=0.708, P<0.001). Conclusions:The optimal machine learning model (LR model) constructed in this study demonstrates a strong ability to diagnose HT and can accurately detect patients with atypical ultrasound manifestations of HT. The combination with clinical data can improve its diagnostic efficacy with higher accuracy and specificity.
5.Value of optimal machine learning model combined with serological antibodies in the diagnosis of Hashimoto′s thyroiditis
Ru CAO ; Guocheng LU ; Jiali MA ; Juan WANG ; Shanshan YU ; Jue JIANG ; Qi ZHOU
Chinese Journal of Ultrasonography 2024;33(12):1023-1029
Objective:To explore the diagnostic value of different machine learning models and optimal machine learning model combined with clinical data for diagnosing Hashimoto′s thyroiditis (HT).Methods:The thyroid gland images of 643 patients with 643 thyroid nodules who underwent preoperative ultrasound examination and had pathological results in the Second Affiliated Hospital of Xi′an Jiaotong University from December 2018 to March 2024 were retrospectively collected, and the images were divided into training set and test set according to a ratio of 7 to 3. Twenty ultrasound imaging omics models were constructed using pairwise combination of 5 feature screening components and 4 classifiers. The area under the curve (AUC) of each model in the test set was compared. Meanwhile, 3 basic network models were respectively used to construct deep learning models for diagnosing HT, and the diagnostic efficacies of the deep learning models and the ultrasound imaging omics models for HT were compared. The model with the greatest efficacy was selected as the optimal machine learning model. Further, the optimal machine learning model was combined with clinical data to construct a combined model. The ROC curves were plotted to compare the diagnostic efficacy of the optimal machine learning model and the combined model for HT.Results:In the comparison of the efficacies of ultrasound imaging omics models and deep learning models in diagnosing HT, the efficacy of stable feature screening-logistic regression (LR) model was the greatest, and the accuracy, sensitivity and specificity of using the LR model in diagnosing HT in the test set were 78%, 75%, 74%, respectively, with an AUC of 0.82(95% CI=0.76-0.88). After combining the LR model with clinical data, the accuracy, sensitivity, and specificity of the combined model in the test set were 87%, 74%, and 95%, respectively, with an AUC of 0.91(95% CI=0.87-0.95), which was strongly consistent with pathology (Kappa value=0.708, P<0.001). Conclusions:The optimal machine learning model (LR model) constructed in this study demonstrates a strong ability to diagnose HT and can accurately detect patients with atypical ultrasound manifestations of HT. The combination with clinical data can improve its diagnostic efficacy with higher accuracy and specificity.
6.Chinese experts′ consensus statement on diagnosis, treatment and prevention of Group A Streptococcus infection related diseases in children
Dingle YU ; Qinghua LU ; Yuanhai YOU ; Hailin ZHANG ; Min LU ; Baoping XU ; Gang LIU ; Lin MA ; Yunmei LIANG ; Ying LIU ; Yaoling MA ; Yanxia HE ; Kaihu YAO ; Sangjie YU ; Hongmei QIAO ; Cong LIU ; Xiaorong LIU ; Jianfeng FAN ; Liwei GAO ; Jifeng YE ; Chuanqing WANG ; Xiang MA ; Jianghong DENG ; Gen LU ; Huanji CHENG ; Wenshuang ZHANG ; Peiru XU ; Jun YIN ; Zhou FU ; Hesheng CHANG ; Guocheng ZHANG ; Yuejie ZHENG ; Kunling SHEN ; Yonghong YANG
Chinese Journal of Applied Clinical Pediatrics 2022;37(21):1604-1618
Group A Streptococcus (GAS) is a very important pathogen, especially for children.On a global scale, GAS is an important cause of morbidity and mortality.But the burden of disease caused by GAS is still unknown in China and also has not obtained enough attention.For this purpose, the expert consensus is comprehensively described in diagnosis, treatment and prevention of GAS diseases in children, covering related aspects of pneumology, infectiology, immunology, microbiology, cardiology, nephrology, critical care medicine and preventive medicine.Accordingly, the consensus document was intended to improve management strategies of GAS disease in Chinese children.
7.Strategies and tools for metabolic engineering in Bacillus subtilis.
Xueqin LÜ ; Yaokang WU ; Lu LIN ; Xianhao XU ; Wenwen YU ; Shixiu CUI ; Jianghua LI ; Guocheng DU ; Long LIU
Chinese Journal of Biotechnology 2021;37(5):1619-1636
As a typical food safety industrial model strain, Bacillus subtilis has been widely used in the field of metabolic engineering due to its non-pathogenicity, strong ability of extracellular protein secretion and no obvious codon preference. In recent years, with the rapid development of molecular biology and genetic engineering technology, a variety of research strategies and tools have been used to construct B. subtilis chassis cells for efficient synthesis of biological products. This review introduces the research progress of B. subtilis from the aspects of promoter engineering, gene editing, genetic circuit, cofactor engineering and pathway enzyme assembly. Then, we also summarized the application of B. subtilis in the production of biological products. Finally, the future research directions of B. subtilis are prospected.
Bacillus subtilis/genetics*
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Bacterial Proteins/genetics*
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Gene Editing
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Metabolic Engineering
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Promoter Regions, Genetic
8. Guidance on strengthening the management processes of children′s fever in outpatient department during the novel coronavirus pneumonia epidemic period (First Edition)
Guocheng ZHANG ; Xiaoning CHENG ; Hui DING ; Zhaoling SHI ; Ruying LI ; Zhou FU ; Qiang CHEN ; Dongchi ZHAO ; Runming JIN ; Guoming NIE ; Jirong LU ; Changshan LIU ; Deyu ZHAO ; Jiahua PAN ; Zhichun FENG ; Yuan SHI ; Zhengkun XIA ; Chengzhong ZHENG ; Jinjin JIANG ; Junxia WANG ; Yuejie ZHENG ; Yunxiao SHANG ; Wei XIANG ; Baoping XU ; Kunling SHEN ; Tianyou WANG ; Yonghong YANG ; Quan LU
Chinese Journal of Applied Clinical Pediatrics 2020;35(2):97-104
Novel Coronavirus Pneumonia (NCP) is a class B infectious disease, which is prevented and controlled according to class A infectious diseases. Recently, children′s NCP cases have gradually increased, and children′s fever outpatient department has become the first strategic pass to stop the epidemic. Strengthening the management of the fever diagnosis process is very important for early detection of suspected children, early isolation, early treatment and prevention of cross-infection. This article proposes prevention and control strategies for fever diagnosis, optimizes processes, prevents cross-infection, health protection and disinfection of medical staff, based on the relevant diagnosis, treatment, prevention and control programs of the National Health and Health Commission and on the diagnosis and treatment experience of experts in various provinces and cities. The present guidance summarizes current strategies on pre-diagnosis; triage, diagnosis, treatment, and prevention of 2019-nCoV infection in common fever, suspected and confirmed children, which provide practical suggestions on strengthening the management processes of children′s fever in outpatient department during the novel coronavirus pneumonia epidemic period.
9.Advances in core protein allosteric modulators
Qianqian GAO ; Kailin HAN ; Guocheng WANG ; Tao LU
Journal of China Pharmaceutical University 2019;50(5):516-522
The core protein allosteric modulator targets the core protein and inhibits hepatitis B virus(HBV)replication by regulating the formation of covalently closed circular DNA(cccDNA), which is expected to completely cure hepatitis B and overcome the drug resistance of nucleoside drugs. This paper reviews the replication process of HBV, the function of core proteins, the mechanism, classification and research progress of core protein allosteric modulators, lists 12 drugs, and summarizes their mechanisms, categories, chemical structures, safety, anti-HBV effects, combined drug use, etc. In addition, the advantages and problems of core protein allosteric modulators are discussed to provide references for the development of new anti-HBV drugs.
10.Mechanism and clinical value of sacral plexus perfusion in rachi lumbocrural pain
Guocheng YU ; Haiqin LU ; Songgen WANG
Chinese Journal of Biochemical Pharmaceutics 2017;37(2):205-208
Objective To investigate the mechanism and clinical value of sacral plexus perfusion method in the treatment of rachi lumbocrural pain.Methods 80 cases of patients with rachi lumbocrural pain in our hospital from May 2014 to May 2016 were selected, they were randomly divided into sacral plexus perfusion method treatment group ( study group) and infrared short medium long frequency therapeutic instrument combined with acupuncture and massage therapy group (control group) two groups, 40 cases in each group.The main clinical symptoms scores, main clinical signs scores, thoracolumbar spine flexion, VAS scores, clinical efficacy of the two groups were statistically analyzed.Results The low back pain, cold limbs, numbness, leg redicular pain scores of the study group were significantly lower, the difference was statistically significant (P<0.05), the both sides L3 transverse tip tenderness scores, VAS score were significantly lower, the difference was statistically significant (P<0.05), the thoracolumbar flexion was significantly higher, the difference was statistically significant (P<0.05), the total treatment efficiency 92.5%(37/40) was significantly higher than the control group 67.5%(27/40), the difference was statistically significant (P<0.05).Conclusion The clinical value of sacral plexus perfusion method in the treatment of rachi lumbocrural pain is higher than infrared short medium long frequency therapeutic instrument combined with acupuncture and massage therapy, it can more effectively improve the clinical symptoms and signs, relieve the pain, enhance the thoracolumbar flexion and total treatment efficiency of patients.

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