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.Research progress of LncRNA NEAT1 in lung diseases
Wenyan ZHOU ; Liyi QIAO ; Yi ZHANG ; Guangyu LIU ; Tianbo XIE ; Jing YAO
Journal of Chinese Physician 2023;25(12):1917-1920
Long chain non coding RNA (LncRNA) is widely involved in various biological processes such as intracellular chromatin modification, transcriptional regulation, nuclear transport, and protein function regulation, and is closely related to various key physiological functions such as immunity and metabolism in the body. NEAT1 (nuclear parapackle assembly transcript 1) is a newly discovered LncRNA, which is an important component of the nuclear substructural paraplaques. It has been proven to regulate downstream protein expression by binding to various miRNAs, thereby regulating the expression of inflammatory factors, epithelial mesenchymal transition, autophagy, apoptosis, proliferation, migration, and other biological processes, Its abnormal expression plays an important role in the pathogenesis of lung diseases such as asthma, chronic obstructive pulmonary disease, pneumonia, pulmonary fibrosis, and lung cancer, and is closely related to the prognosis of non-small cell lung cancer and the sensitivity of anti-tumor drugs. It is expected to become a new biological marker and therapeutic intervention target. This article mainly reviews the latest research progress on the role of NEAT1 in lung diseases.
4.The relationship between plasma fibrinogen levels and disease duration in elderly patients with type 2 diabetes
Guangyu WANG ; Shushu YU ; Jinling QIAO ; Kunwei WANG
Chinese Journal of Geriatrics 2021;40(1):43-47
Objective:To investigate the relationship between normal plasma fibrinogen(FIB)levels and disease duration in elderly patients with type 2 diabetes mellitus(T2DM).Methods:Clinical data and biochemical test results of 1 116 elderly subjects with T2DM admitted to the Department of Endocrinology of Shanghai Tianyou Hospital from January 2016 to October 2019 were retrospectively collected and analyzed.Subjects were classified into four groups based on the duration of DM: the Q1 group(n=276, < 2.0 years), the Q2 group(n=278, 2.0-7.9 years), the Q3 group(n=280, 8.0-13.9 years)and the Q4 group(n=282, ≥ 14.0 years). The correlation between FIB and the duration of DM was analyzed.Results:With the prolongation of DM duration, FIB levels increased significantly( P<0.05). Pearson correlation analysis showed that the duration of DM was positively correlated with FIB, age and serum creatinine( P<0.01). Multiple stepwise regression analysis showed that the duration of DM was an independent factor for FIB( β=0.104, P<0.01). Logistic multiple regression analysis showed that after adjusting for sex, age, body mass index, systolic pressure, diastolic pressure, total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, serum creatinine, alanine aminotransferase, fasting plasma glucose, glycosylated hemoglobin, smoking and drinking, the risk of hyperfibrinogenemia was 2.436 and 2.104 times higher, respectively, in Group Q4 and Group Q3 than in Group Q1(95% CI: 1.317-4.507, P<0.01; 95% CI: 1.144-3.871, P<0.05). With the third-quartile FIB(3.70 g/L)as the cut-off value, the optimal cut-off point of the DM course was 9.5 years as calculated by receiver operating characteristic(ROC)curve analysis of DM duration and hyperfibrinogenemia. Conclusions:The FIB level is positively correlated with DM duration in elderly patients with T2DM.
5. Treatment of single one-stage posterior atlantoaxial fixation in Chiari malformation
Lenian LU ; Rui ZONG ; Xiaobing XU ; Xinguang YU ; Guangyu QIAO
Chinese Journal of Surgery 2017;55(6):446-450
Objective:
To explore the effects of surgical technique of single one-stage posterior C1-2 screw rod fixation of Chiari malformation (CM) associated with occipitalization and without atlantoaxial dislocation.
Methods:
A total of 23 patients with CM treated between January 2014 and October 2015 in Department of Neurosurgery of Chinese People′s Liberation Army General Hospital were retrospective reviewed. All of them were diagnosis with CM associated with occipitalization and without atlantoaxial dislocation, including 8 males and 15 females, aging from 11 to 57 years (mean (35.5±10.52) years). Single one-stage posterior C1-2 screw rod fixation with bone grafting fusion was performed. Operation time and intraoperative blood loss were recorded. Japanese Orthopaedic Association (JOA) scores and Odom rating were used to evaluate the clinical effects at pre- and post-operative. Regression of the cerebellar tonsillar was measured by MRI. The results were analyzed by paired samples
6.Intraoperative lumbar cathetering for prevention of postoperative cerebrospinal fluid leakage in lumbosacral vertebral canal
Benzhang TAO ; Haihao GAO ; Cheng CHENG ; Guangyu QIAO ; Aijia SHANG
Journal of Regional Anatomy and Operative Surgery 2016;25(5):347-349,350
Objective To study the technique of lumbar cathetering in lumbosacral vertebral canal operation and its effect on prevention of postoperative cerebrospinal fluid leakage.Methods Retrospectively analyzed the clinical data of patients who underwent lumbosacral ver-tebral canal surgery and suffered from difficult dural repair during the operation in Department of Neurosurgery from August 2015 to October 2015.These patients were divided into the observation group (11 cases)and the control group (12 cases)according to whether lumbar cathe-ter were placed during the operation or not.Volume of drainage was strictly controlled after surgery.Remove the epidural drainage after primi-tive healing of the dura mater.The lumbar catheter was removed after 7 to 10 days.The indwelling time of each patient was collected and sta-tistical analyzed.Results The observation group got obvious shorter epidural drainage indwelling time than the control group(P <0.05). Short-term postoperative complications did occur in some cases in observation group,however,there was no obvious increase of infection rate in patients with lumbar continuous drainage indwelling.Conclusion Lumbar cathetering during the operation could be an effective method to solve difficult problem of placeing a lumbar drainage after lumbar puncture and to prevent cerebrospinal fluid leakage after operations of lum-bosacral vertebral canal.But it can not replace the delicate operation and tight dural suture.Drainage should be used only as a remedial measure of dural repair failure.
7.Awareness of diagnostic criteria for irritable bowel syndrome in physicians in Shanghai
Guangyu CHEN ; Yuqi QIAO ; Huiqing ZHOU ; Yingwei CHEN ; Dingguo LI
Chinese Journal of General Practitioners 2010;9(6):401-404
Objective To investigate physicians' awareness of diagnostic criteria for irritable bowel syndrome (IBS). Methods Questionnaire was used to investigate awareness of diagnostic criteria for IBS among 782 physicians in 34 hospitals in Shanghai during August 2008. Results Overall, 82. 7 percent (647/782) of physicians surveyed thought they knew or partly knew diagnostic criteria for IBS. More than 70. 0 percent of physicians knew Rome criteria, but less than 25.0 percent knew other criteria. Awareness of current Rome criteria, whether mental symptoms included in it, and its time frame differed significantly among physicians in varied specialties (P < 0. 01 ). Gastroenterologists had more knowledge about Rome criteria than other specialists, but most physicians, including gastroenterologists, did not fully understand its applicability. Conclusions Although gastroenterologists knew more about diagnostic criteria for IBS, their knowledge still needed to be perfected and updated. Awareness of diagnostic criteria for IBS was poor in nongastroenterological physicians and general practitioners knew it to certain extent.
8.Design of questionnaire on factors for diagnosis of irritable bowel syndrom for physicians
Yuqi QIAO ; Guangyu CHEN ; Huiqing ZHOU ; Yingwei CHEN ; Dingguo LI
Journal of Shanghai Jiaotong University(Medical Science) 2009;29(10):1218-1221
Objective To design a questionnaire on factors that affect diagnosis of irritable bowel syndrome for physicians, and determine the retest reliability. Methods The questionnaire was completed after literature review, and 9 experts were invited to revise the questionnaire. Thirty-four physicians filled the questionnaire for pre-test and did it again for re-test 4 weeks later. Kappa value of each question of the questionnaire was calculated. Results Content validity and face validity were assured by experts. Kappa values were over 0.61 in all items, which achieved substantial level. Conclusion The questionnaire designed has fairly good reliability and validity, and can be used in investigation of irritable bowel syndrome for physicians.
9.Retrospective analysis of intraspinal enterogenous cyst
Guangyu QIAO ; Yuanzheng ZHANG ; Dingbiao ZHOU ; Bo PU ; Tao ZHOU ; Zhenghui SUN
Journal of Third Military Medical University 2003;0(08):-
Objective To improve the diagnosis and treatment of neurenteric cyst. Methods The clinical manifestations, MRI characteristics and surgical results of 11 cases of intraspinal neurenteric cysts were analyzed. Results Positive pathological signs and paresis appeared in all cases, and radicular pain in 9 cases. The symptoms were episodic in 2 cases whose courses were more than 3 years. MRI could clearly demonstrate the exact extension of the cyst and the surrounding structures. These cysts showed as slightly long T 1, long T 2 homogeneous signal on MRI. Their neurological functions improved steadily after complete resection in 8 cases, subtotal resection in 3 cases. Conclusion Neurenteric cysts are rare congenital lesions, often associated with vertebral anomalies and occurred at subdural cervical location, anterior to the cord. MRI is a more effective and convenient method for neurenteric cyst image investigation. Total or subtotal resection of neurenteric cysts with subsequent recovery in neurological function is usually possible.
10.Stable expression of targeting complement inhibitor CR2-CD59 in Chinese hamster ovary cells
Yan GUO ; Zhihua KOU ; Shihui SUN ; Chuanfu ZHANG ; Guangyu ZHAO ; Hong YU ; Hongbin SONG ; Fei QIAO ; Wanrong CHEN ; Yusen ZHOU
Journal of Third Military Medical University 2003;0(09):-
Objective To obtain Chinese hamster ovary (CHO) cell lines that stably express a targeting complement inhibitor CR2-CD59.Methods The recombinant plasmid PEE14.1-CR2-CD59 was constru-cted by cloning the DNA fragment CR2-CD59 into plasmid PEE14.1,and the obtained plasmid was transfected into CHO cells by FuGENE 6.The clones with stable high expression of target fragment were selected by methionine sulfoximine (MSX),the expression of CR2-CD59 was analyzed by ELISA,SDS-PAGE and Western blotting analysis.Results Several stable expression clones were obtained,and CR2-CD59 was highly expressed in the secret form in CHO cells.SDS-PAGE analysis showed that the molecular weight of the recombined protein CR2-CD59 was consistent with the predicted one.ELISA and Western blotting results revealed that the CR2-CD59 could react with both anti-human CR2 and anti-human CD59 polyclonal antibodies.Compared with serum-containing medium,the protein was highly expressed in serum-free medium (P

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