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.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.
4.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
5.Investigation of abuse tendency among disabled elderly caregivers
Cuilan CHU ; Tingting LIN ; Ying ZHOU ; Guocheng WANG ; Zhi YANG ; Lexin YUAN ; Xiashu YAN ; Honglian RUAN
Chinese Journal of Practical Nursing 2018;34(8):573-576
Objective To investigate the abuse tendency of disabled elderly caregivers and analyze its causes.Methods With the convenience sampling method,The main caregivers of 300 disabled elderly people were investigated by the general questionnaire, Activities Daily Living Scale (ADLs) and Caregiver Abuse Screen (CASE) in Guangzhou. Results The degree of disability of the elderly was moderate to severe degree.The average score of the elderly caregiver′s propensity for abuse tendency was(3.3 ± 2.3).178 (59.4 %, 178/300) of the elderly caregivers have abuse tendency (the average score was more than 3). Conclusion Caregivers′ abuse tendency against the elderly is high. The situation of the elderly is not optimistic.
6.Current situation and influence factors of innovation ability of nursing graduate students
Zhi YANG ; Ying ZHOU ; Tingting LIN ; Qiubi TANG ; Guocheng WANG
Chinese Journal of Modern Nursing 2018;24(6):717-721
Objective To investigate the current situation and influence factors of innovation ability of nursing graduate students. Methods A total of 270 nursing graduate students from 42 universities were surveyed using the Innovation & Creativity Effectiveness Assessment (ICEA) by convenience sampling between March 2016 and November 2016. Results There were 88.1% of nursing graduate students with a total innovation ability score of lower than 4 points, which was at a lower level. Ages, international conferences, other academic activities and the time of supervisors on supervising students significantly affected scores of innovation ability on nursing students(P<0.05). Conclusions The current cultivation situation of innovation ability of nursing graduate students was not optimistic. The cultivation of the innovation ability is a systematic and complicated program which acquires multiply strategies to improve students' innovation ability.
7.Correlation between resilience and psychological status of main caregivers among disabled elderly
Cuilan CHU ; Tingting LIN ; Ying ZHOU ; Guocheng WANG ; Zhi YANG ; Xiashu YAN ; Lexin YUAN ; Honglian RUAN ; Guilian HE
Chinese Journal of Modern Nursing 2018;24(26):3168-3171
Objective To explore the correlation between resilience and psychological status of main caregivers among disabled elderly of Guangzhou region.Methods From June 2015 to December 2015, a total of 300 main caregivers of disabled elders were investigated with the general information questionnaire, the Chinese version of Connor-Davidson Resilience Scale (CD-RISC), Activities Daily Living Scale (ADLS), Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) by convenience sampling.Results The total score of resilience, standard score of anxiety and depression were (58.2±15.8), (49.05±10.5) and (51.73±11.52) respectively among main caregivers of disabled elders. The competence dimension of CD-RISC had negative correlations with anxiety (r=-0.260,P<0.01) and depression (r=-0.316,P<0.01) in main caregivers of disabled elders, and the toughness dimension was negatively correlated with the depressive symptoms (r=-0.147,P<0.05).Conclusions Main caregivers of disabled elderly of Guangzhou region are with poor resilience along with the high ratio of detection in anxiety and depression suggesting that the mental status is not optimistic.
8.Progress in digital PCR technology and application.
Jiaqi LIN ; Guocheng SU ; Wenjin SU ; Changyi ZHOU
Chinese Journal of Biotechnology 2017;33(2):170-177
Digital PCR is an emerging analysis technology for absolute quantification after realtime-PCR. Through digital PCR, single DNA molecules are distributed into isolated reactions, and the product with fluorescence signal can be detected and analyzed after amplification. With the advantages of higher sensitivity and accuracy, digital PCR, independent of a standard curve, is developing rapidly and applied widely to the next generation sequencing and detection fields, such as gene mutation, copy number variation, microorganism, and genetically modified food. In this article, we reviewed the quantitative method and research progress of digital PCR technology in the main application fields.
9.Evaluation of the diagnostic criteria of gestational metabolic syndrome and analysis of the risk factors
Jianmin NIU ; Qiong LEI ; Lijuan Lü ; Jiying WEN ; Xiaohong LIN ; Dongmei DUAN ; Xi CHEN ; Yuheng ZHOU ; Caiyuan MAI ; Guocheng LIU ; Mingmin HOU ; Lina ZHAO ; Jing YI
Chinese Journal of Obstetrics and Gynecology 2013;(2):92-97
Objectives To investigate gestational multiple metabolic abnormalities aggregation and diagnostic criteria for gestational metabolic syndrome(GMS),and to analyze the risk factors of GMS.Methods A cohort study recruiting 309 pregnant women with preeclampsia,627 pregnant women with gestational diabetes mellitus(GDM)and 1245 normal pregnant women was performed from January 2008 to December 2011 in Guangdong Women and Children's Hospital.Information regarding age,gestational weeks,basic blood pressure,admission blood pressure,height and body mass index(BMI)before pregnancy was recorded.Biochemical indicators including fasting plasma glucose(FPG),fasting insulin (FINS),total cholesterol(TC),triglyceride(TG),high density lipoprotein(HDL-C),low density lipoprotein(LDL-C),free fatty acids(FFA)were tested.GMS was diagnosed with three or all of the following conditions:(1)overweight and/or obesity before pregnancy(BMI ≥ 25 kg/m2);(2)hypertension with blood pressure ≥ 140/90 mm Hg(1 mm Hg =0.133 kPa);(3)hyperglycemia:diagnosed as GDM;(4)dyslipidemia with TG≥3.23 mmol/L The incidence of GMS of the three groups were calculated and the risk factors were analyzed.Results(1)The age,gestational weeks,basic blood pressure,admission blood pressure,BMI before pregnancy of women with preeclampsia and women with GDM were significantly different compared to normal women,respectively(P < 0.01).(2)Biochemical indicators of women with preeclampsia were as following:FPG(4.6 ± 1.0)mmol/L,FINS(10.1 ± 5.6)mU/L,TC(6.3 ±1.6)mmol/L,TG(3.9 ± 1.8)mmol/L,HDL-C(1.4 ±0.4)mmol/L,LDL-C(3.0 ± 1.0)mmol/L,FFA (0.8 ±0.4)mmol/L.And those in women with GDM were:FPG(4.7 ± 0.9)mmoL/L,FINS(10.2 ± 5.8)mU/L,TC(5.7 ± 1.3)mmol/L,TG(3.2 ± 1.1)mmol/L,HDL-C(1.4 ± 0.4)mmol/L,LDL-C (2.7 ± 0.9)mmol/L,FFA(0.6 ± 0.3)mmol/L In normal pregnant women they were:FPG(4.3 ±0.5)mmol/L,FINS(9.0±4.4)mU/L,TC(5.7 ±1.1)mmol/L,TG(2.8 ±1.1)mmol/L,HDL-C (1.5 ± 0.4)mmol/L,LDL-C(2.9 ± 0.8)mmol/L,FFA(0.6 ± 0.2)mmol/L Statistic differences were found in preeclampsia and GDM women compared to normal women respectively(P < 0.01).(3)The prevalence of GMS in preeclampsia group and in GDM group was 26.2%(81/309)and 13.6%(85/627),statistically different from that of the control group(0)(P <0.01).(4)Compared to normal women,women with preeclampsia had higher risk of developing GMS(OR =1.62,95 % CI 1.31-2.00,P < 0.01).The risk factors were BMI(OR =1.29,95% CI 1.13-1.47)and TG(OR =2.49,95% CI 1.87-3.31).Also,women with GDM had higher risk of developing GMS than normal women(OR =1.27,95% CI 1.09-1.49,P < 0.01),and the risk factors were BMI(OR =1.13,95 % CI 1.04-1.23)and TG(OR =1.16,95 % CI 1.02-1.33).TG was the independent risk factor in both preeclampsia women and GDM women(P < 0.01,P < 0.05).HDL-C seemed to have less importance in identifying GMS(P > 0.05).Conclusions According to the GMS diagnostic criteria used in this study,some preeclampsia patients and some GDM women had aggregation of multiple metabolic abnormalities including pre-pregnancy overweight/obesity,hyperglycemia,high blood pressure and dyslipidemia.TG was the independent risk factor for GMS.HDL-C seemed to have less importance in identifying GMS.
10.The speciifc inhibition of siRNAs targeting 5' untranslated region of the enterovirus 71 genome
Junxia DENG ; Xue LIU ; Guocheng ZHANG ; Chaofeng MA ; Yingfeng LEI ; Ruiqing LIU ; Haibo LIN
Journal of Clinical Pediatrics 2013;(12):1163-1168
Objective To screen and identify effective small interfering RNA (siRNAs) targeting the conserved 5’ untrans-lated region (UTR) of the enterovirus 71 (EV71) genome. Methods Double-stranded siRNAs were designed to target the 5’UTR of the EV71 genome. The cytotoxicity effect of siRNAs on rhabdomyosarcoma (RD) cells was evaluated. The cytopathic effect on EV71-infected RD cells was observed under phase-contrast microscopy and the effective siRNAs were screened out by cell viability assay and real-time TaqMan RT-PCR assay. Results All the siRNAs did not exhibit any cytotoxic effects on the viability and growth of RD cells. Transfection of si-1 and si-2 targeting the 5’ UTR in EV71 genome into RD cells signiifcantly delayed and alleviated the cytopathic effects of EV71 infection, increased cell viability and reduced the EV71 RNA transcripts. And the inhibitory effect of si-1/si-2 on EV71 replication was sequence-speciifc. Conclusions The 2 siRNAs (si-1 and si-2) targeting the conserved 5’UTR of the EV71 genome may have broad spectrum antiviral effects on many epidemic EV71 strains.

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