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.Multimodal neuroimaging evaluation of dopaminergic function, cortical metabolism, and functional connectivity alterations in early-onset Parkinson′s disease
Yan CHANG ; Xiaodan XU ; Jiajin LIU ; Shuwei SUN ; Yungang LI ; Hengge XIE ; Chao WEI ; Yuanyan CAO ; Ruozhuo LIU ; Ruimin WANG
Chinese Journal of Radiology 2025;59(11):1260-1266
Objective:To evaluate alterations in dopaminergic neurons, cortical metabolism, and functional connectivity networks in patients with early-onset Parkinson′s disease (EOPD) using multimodal neuroimaging.Methods:In this prospective cross-sectional study, 26 patients with EOPD and 16 healthy controls (HC group) were recruited from the PLA General Hospital between April and November 2023. All participants underwent integrated 11C-β-CFT PET/MR, 18F-FDG PET/CT brain imaging and resting-state functional MRI. Clinical assessments were conducted using the Unified Parkinson′s Disease Rating Scale and Hoehn-Yahr staging. Cognitive status was evaluated using the Mini-Mental State Examination and Montreal Cognitive Assessment. Standardized uptake value ratios for both 11C-β-CFT and 18F-FDG PET images were calculated using cerebellar gray matter as the reference region. Voxel-wise two-sample t-tests were performed to identify regions with significant group differences in tracer uptake. Seed regions showing altered 11C-β-CFT or 18F-FDG uptake were used to compute seed-based functional connectivity (FC) with all other brain voxels, and group differences in FC were assessed. Correlations between imaging metrics and clinical scales were evaluated using Pearson or Spearman analyses as appropriate. Results:Compared with HC group, EOPD group showed significantly reduced 11C-β-CFT uptake in the bilateral putamen, globus pallidus, and left temporal pole ( P<0.05), and decreased 18F-FDG uptake in the right superior frontal gyrus and anterior cingulate cortex ( P<0.05). Relative to HC group, EOPD group exhibited markedly lower FC between the right putamen and the left gyrus rectus as well as the right parahippocampal gyrus; the right superior frontal gyrus and the left gyrus rectus; the anterior cingulate cortex and the olfactory area of the frontal lobe, the left gyrus rectus, and the right superior parietal gyrus; the left temporal pole and the left orbitofrontal cortex as well as the left olfactory area ( P<0.05). Correlation analyses revealed no statistically significant associations between altered FC values and clinical scale scores in the EOPD group. Conclusions:Patients with EOPD demonstrate impaired nigrostriatal dopaminergic function, regional cortical hypometabolism, and aberrant functional connectivity across multiple brain networks.
3.Multimodal neuroimaging evaluation of dopaminergic function, cortical metabolism, and functional connectivity alterations in early-onset Parkinson′s disease
Yan CHANG ; Xiaodan XU ; Jiajin LIU ; Shuwei SUN ; Yungang LI ; Hengge XIE ; Chao WEI ; Yuanyan CAO ; Ruozhuo LIU ; Ruimin WANG
Chinese Journal of Radiology 2025;59(11):1260-1266
Objective:To evaluate alterations in dopaminergic neurons, cortical metabolism, and functional connectivity networks in patients with early-onset Parkinson′s disease (EOPD) using multimodal neuroimaging.Methods:In this prospective cross-sectional study, 26 patients with EOPD and 16 healthy controls (HC group) were recruited from the PLA General Hospital between April and November 2023. All participants underwent integrated 11C-β-CFT PET/MR, 18F-FDG PET/CT brain imaging and resting-state functional MRI. Clinical assessments were conducted using the Unified Parkinson′s Disease Rating Scale and Hoehn-Yahr staging. Cognitive status was evaluated using the Mini-Mental State Examination and Montreal Cognitive Assessment. Standardized uptake value ratios for both 11C-β-CFT and 18F-FDG PET images were calculated using cerebellar gray matter as the reference region. Voxel-wise two-sample t-tests were performed to identify regions with significant group differences in tracer uptake. Seed regions showing altered 11C-β-CFT or 18F-FDG uptake were used to compute seed-based functional connectivity (FC) with all other brain voxels, and group differences in FC were assessed. Correlations between imaging metrics and clinical scales were evaluated using Pearson or Spearman analyses as appropriate. Results:Compared with HC group, EOPD group showed significantly reduced 11C-β-CFT uptake in the bilateral putamen, globus pallidus, and left temporal pole ( P<0.05), and decreased 18F-FDG uptake in the right superior frontal gyrus and anterior cingulate cortex ( P<0.05). Relative to HC group, EOPD group exhibited markedly lower FC between the right putamen and the left gyrus rectus as well as the right parahippocampal gyrus; the right superior frontal gyrus and the left gyrus rectus; the anterior cingulate cortex and the olfactory area of the frontal lobe, the left gyrus rectus, and the right superior parietal gyrus; the left temporal pole and the left orbitofrontal cortex as well as the left olfactory area ( P<0.05). Correlation analyses revealed no statistically significant associations between altered FC values and clinical scale scores in the EOPD group. Conclusions:Patients with EOPD demonstrate impaired nigrostriatal dopaminergic function, regional cortical hypometabolism, and aberrant functional connectivity across multiple brain networks.
4.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.
5.Comparative study of fluorescence and inflation-deflation methods in defining the intersegmental plane in thoracoscopic anatomical lung segmentectomy
SHAO Feng ; SUN Yungang ; WANG Zhao ; LIU Zhengcheng ; CAO Hui ; SHI Ye ; YANG Rusong
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2019;26(9):899-904
Objective To analyze the feasibility, advantages and disadvantages of the fluorescence method and the inflation-deflation method in defining the intersegmental plane during thoracoscopic lung segmental resection. Methods From February to October 2018, 60 patients underwent thoracoscopic anatomical segmentectomy in Thoracic Surgery Department of Nanjing Chest Hospital, with 28 males and 32 females, aged from 25 to 82 years. Three-dimension computed tomography bronchography and angiography was used to reconstruct pulmonary vessels, bronchus and virtual intersegmental plane. Among them, 20 patients used the fluorescence method to define the intersegmental plane, and the other 40 patients used the traditional inflation-deflation method to define the intersegmental plane. Results Fluorescent injection of indocyanine green (ICG) showed a clear intersegmental line with a duration sufficient to complete the label. With the fluorescence method, the intersegmental plane occurrence time was significantly shortened (10.75±3.78 s vs. 988.00±314.24 s, P<0.001) and had satisfactory repeatability. The lungs did not need to be inflated, which was convenient for the operation. And the operation time was shortened (108.75±31.28 min vs 138.00±32.47 min, P=0.002). No obvious ICG injection-related concurrency symptoms was found. Conclusion Compared with the traditional inflation-deflation method, the fluorescence method can display the intersegmental line quickly, accurately and clearly, reduce the difficulty of surgery, shorten the operation time, and provide reliable technical support for thoracoscopic anatomical segmentectomy. The fluorescence is a safe and effective method that is worthy of clinical application.
6.Efficacy Observation of dl-3-Butylphthalide in the Sequential Treatment of Acute Middle Cerebral Artery Infarction
Yungang CAO ; Ting YANG ; Man QU ; Xianda LIN ; Linlei ZHANG ; Zhao HAN
China Pharmacist 2016;19(10):1889-1890,1896
Objective:To evaluate the efficacy and safety of dl-3-butylphthalide ( NBP) injection and soft capsules in the treat-ment of acute middle cerebral artery infarction. Methods:Sixty-one patients with acute cerebral infarction in the left middle cerebral artery in 72 hours of onset of ischemic stroke with score of 5-25 according to the national institutes of health stroke scale ( NIHSS) were randomly divided into the observation group (n=31) and the control group (n=30). The control group was treated with the routine treatment, while the observation group was sequentially treated with NBP injection and soft capsules additionally. The treatment course was 90 days. Before the treatment, the NIHSS score was evaluated in both groups to compare the neurologic impairment degree. After the treatment, the daily living skills assessment was performed by Barthel index ( BI) and modified Rankin score ( mRS) , and the ad-verse reactions were recorded. Results:Before the treatment, the NIHSS score in the two groups had no statistical significance ( P>0. 05). After the treatment, the BI in the observation group and the control group was (88. 55 ± 16. 74) and (70. 67 ± 26. 18), and mRS was (1. 87 ± 1. 02) and (2. 53 ± 1. 40), respectively, suggesting the observation group had more favorable outcome than the con-trol group (P≤0. 05). The incidence of adverse reactions had no significant difference between the groups. Conclusion: dl-3-Bu-tylphthalide sequential therapy should be regarded as an effective and safe method for acute cerebral infarction, which can improve the daily living skills and 90-day outcome of patients.
7.Protective Effect and its Mechanism of Hemoperfusion on Methomyl Poisoning Rabbit Myocardium
Ting YANG ; Yungang CAO ; Zheng WANG ; Zhiyi WANG
China Pharmacist 2015;18(12):2070-2072
Objective:To observe the effect and its mechanism of hemoperfusion on injured myocardium under acute toxication of methomyl in rabbits. Methods:Twenty-four rabbits were randomly divided into three groups:control group ( N group) , acute metho-myl intoxication group ( P group) , hemoperfusion group ( HP group) . P group and HP group was treated by methomyl intoxication, and with 2-hour sham-hemoperfusion and hempoperfusion respectively. Then the pathological changes of myocardium were observed under optical microscope. The activity of SOD and content of MDA in myocardium were measured by colorimetry. The experimental data were analyzed by SPSS 16. 0 package. Results:There were congestion, edema and other pathological changes in group P, while no obvious changes in N group and HP group. The activity of SOD decreased while MDA content increased in P group versus N and HP group ( P< 0. 05). Conclusion:Hemoperfusion can alleviate the myocardial injury induced by methomyl poisoning through the mechanism of the resistance to oxidative damage.
8.Incidence and risk factors of spontaneous hemorrhagic transformation in cardioembolism and large artery atherosclerotic infarction
Meijuan XIAO ; Weiyong YIN ; Zusen YE ; Yungang CAO ; Bei SHAO ; Zhao HAN
Chinese Journal of General Practitioners 2014;13(10):848-850
To explore the incidence and risk factors for spontaneous hemorrhagic transformation (HT) of cardioembolism (CE,n =150) and large artery atherosclerotic infarction (LAA,n =370).The incidence of HT was 29.3% in CE.And it was significantly higher than 9.7% (P <0.05).Infarct size,low-density lipoprotein-cholesterol (LDL-C) and admission National Institutes of Health Stroke Scale (NIHSS) score were independent predictors of spontaneous hemorrhagic transformation in LAA.OR values were 3.92,2.96 and 1.45 respectively.Infarct size,admission NIHSS score and random blood glucose level were independent predictors of spontaneous hemorrhagic transformation in CE.OR values were 4.86,2.42 and 1.42 respectively.As compared with LAA,CE was more prone to HT.LAA and CE-related factors of hemorrhagic transformation are not completely identical.
9.Analysis of prognosis in 41 patients with primary pontine hemorrhage
Zusen YE ; Zhao HAN ; Xiaoya HUANG ; Kai FAN ; Yungang CAO ; Yuanyuan GENG ; Hongfei JING ; Liangtong HUANG
Chinese Journal of Neurology 2011;44(9):608-612
ObjectiveTo evaluate prognosis and its clinical factors in patients with primary pontine hemorrhage. Methods Patients with primary pontine hemorrhage who were hospitalized in the First Affiliated Hospital of Wenzhou Medical College within 24 hours after stroke onset between April 2007 and April 2009 were registered conscutively. The patients were followed up for one year. Kaplan-Meier methods were used to analyze survival rate. Cox proportional hazards model was used to study risk factors for 1-year mortality. ResultsA total of 41 patients with primary pontine hemorrhage were studied. Their mean age was (63.5 ± 10. 1 ) years.The overall 1-year mortality rate was 61.0%, the median survival time was (80. 0 ±54.4) days (95% CI 0-186. 64). After one-year follow-up, the mortality rate in patients with primary dorsal pontine hemorrhage( 18.2% ) was significantly lower than that in patients with primary ventral pontine hemorrhage(72. 7% ; x2 = 8. 800, P = 0. 003 ). Patients with massive primary pontine hemorrhage had significantly higher mortality rate than patients with dorsal primary pontine hemorrhage( x2 = 8. 927, P =0. 003). The average hematoma volume of the survivor group and mortality group was (3. 043 ± 1. 718) ml and (5. 984 ± 2. 707) ml, respectively, showing statistical significance (t = 3. 661, P = 0. 001 ). Analysis with Cox proportional hazards model showed that the risk factors associated with mortality were hematoma location ( RR = 2. 428, 95 % CI 1. 055-5. 587 ), hematoma volume ( RR = 1. 283, 95 % CI 1. 044-1. 577 ),GCS score on admission(RR =3. 389, 95% CI 1. 177-9. 756). Patients with pontine hematomas in dorsal had a significantly better outcome than in other locations.Conclusions The survival and prognosis in primary dorsal pontine hemorrhage are better than with hemorrhaging in other parts of pontine. A significant correlation was observed between poor prognosis and hematoma volume, hematoma location and GCS score on admission.
10.ORIGIN OF CELLS OF SPINOCEREBELLAR TRACTS IN THE RABBIT, STUDIED WITH THE METHOD OF RETROGRADE TRANSPORT OF HORSERADISH PEROXIDASE
Qunyuan XU ; Wu CAO ; Yuansheng WANG ; Yungang ZHANG
Acta Anatomica Sinica 1953;0(01):-
Horseradish peroxidase (HRP) was injected unilaterally or bilaterally into the cerebellum of 11 rabbits in order to trace the distribution of labeled neurons in the whole length of the spinal cord. To investigate the ascending side of the axons, hemisections were made unilaterally in the lower thoracic cord of 4 rabbits before injection. The distribution of labeled spinocerebellar tract neurons was rather wide. Neurons in the cervical segments were located in (1) the central cervical nucleus (CCN) in Q_(1-4), (2) the medial part of lamina VI in C_2-T_1, (3) the central part of lamina VII in C_(4-8) and (4) lamina IV-V in C_(5-8). The labeled neurons located in segments caudal to thoracic cord could be divided into two groups. Neurons of the uncrossed tract were located in (1) Clarke's column in T_2-L_4, (2) laminae IV-VI in T_2-L_6. Neurons of the crossed tract were found in (1) the spinal border cells (SBC)in L_(3-6), (2) the medial part of the lamina VII in segments caudal to L_6, (3) lamina V in the sacrococcygeal cord and (4) laminae VII-VIII in the sacrococcygeal cord. The present study suggests that the location and fiber course of the spinocerebellar neurons in the rabbit are quite the same as those in the cat. These results should form a basis for further anatomical and physiological studies of spinocerebellar system in the rabbit.

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