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.A retrospective analysis of hearing impairment caused by Gentamicin in children
Lu HUANG ; Jiaosheng ZHANG ; Yuejie ZHENG ; Yonghong YANG
Chinese Journal of Applied Clinical Pediatrics 2025;40(6):434-441
Objective:To assess the risk of hearing impairment caused by Gentamicin in Chinese children.Methods:A retrospective analysis.Related literature was retrieved and selected according to inclusion and exclusion criteria, and relevant data was extracted.An evidence-based analysis was conducted on the relationship between hearing impairment and the application of Gentamicin in children.Results:A total of 150 literature reports in Chinese and 483 in English were retrieved.After screening according to inclusion and exclusion criteria, 33 studies in Chinese and 20 in English were included for analysis.There were 13 clinical case reports, 17 retrospective studies and 4 prospective studies on hearing impairment after the application of the Gentamicin in Chinese children.There were 19 international clinical studies.In the 13 clinical case reports including 21 cases who had a history of Gentamicin, no relationship between hearing impairment and Gentamicin was described.A total of 13 419 patients with hearing impairment were included in 17 retrospective studies, and 3 063 (22.8%) of them had Gentamicin exposure in childhood.Among 19 international studies on the application of Gentamicin in children, 13 reported cases with hearing impairment.The incidence of hearing impairment in Gentamicin-treated patients ranged from 0.9% to 30.9%, and the reasons were family history of hearing impairment, otitis media, and sequelae of nervous system injuries.No children with hearing impairment were proved related to Gentamicin.Five studies with a control group (not the Gentamicin-treated group) showed no difference in the incidence of hearing impairment between the Gentamicin-treated group(0-30.9%) and the control group (0-31.4%).Conclusions:All the retrospective reports of hearing impairment caused by Gentamicin in Chinese children do not describe the causal relationship between hearing impairment and Gentamicin.In international studies, the incidence of hearing impairment is not higher in Gentamicin-treated children.Cohort and randomized controlled studies are needed to further assess the risk of hearing impairment in Chinese children.
3.Clinical characteristics of obstructive sleep apnea in children with Prader-Willi syndrome
Kaiping WU ; Qinghua LU ; Ailiang LIU ; Yuejie ZHENG ; Zhe SU ; Rongfei ZHENG ; Hongguang PAN ; Qin YANG
Chinese Pediatric Emergency Medicine 2025;32(8):591-596
Objective:To analyze the characteristics of obstructive sleep apnea(OSA)in children with Prader-Willi syndrome (PWS),and to improve the understanding of OSA during rapid eye movement sleep.Methods:The clinical data of 13 children with PWS aged 2-14 years admitted to Shenzhen Children's Hospital from June 2017 to June 2024 were retrospectively collected as the PWS group,and 12 children with snoring caused by adenoids,tonsil hypertrophy and/or obesity were selected as the control group.The gender,age,body mass index (BMI),obstructive apnea index (OAI),oxygen desaturation index (ODI),obstructive sleep apnea hypopnea index (OAHI),rapid eye movement period OAHI(OAHIrem),non-rapid eye movement period OAHI(OAHInrem) and OAHIrem/total sleep period OAHI ratio were compared between the two groups.Multivariate linear regression was used to assess the association between PWS and OAHIrem.Results:Among the 13 children in PWS group,there were 7 males and 6 females,with an average age of (7.63±4.05) years and an average BMI of (23.06±6.12) kg/m2.Among the 12 children in control group,there were 10 males and 2 females,with an average age of (7.28±3.92) years and an average BMI of (22.41±5.68) kg/m2.There were no statistically significant differences in age,gender,and BMI between the two groups ( P>0.05).All 13 children (100%) with PWS had OSA,with 8 cases (61.53%) of mild OSA and 5 cases (38.46%) of moderate to severe OSA.OAI and ODI in PWS group were significantly higher than those in control group ( P<0.05).OAHI and OAHInrem in PWS group were higher than those in control group,but the difference was not statistically significant ( P>0.05).OAHIrem and OAHIrem/ total sleep OAHI ratio were significantly higher than those in the control group,with statistical significance ( P<0.05).Multivariate linear regression analysis showed that PWS was significantly correlated with OAHIrem/ total sleep OAH ratio (square root) ( P=0.008). Conclusion:Children with PWS have a high incidence of OSA,with a high proportion of moderate to severe OSA.They are prone to OSA with hypoxemia during rapid eye movement sleep.It is recommended that respiratory monitoring of children with PWS during rapid eye movement sleep should be strengthened,and individualized treatment plan should be formulated according to the type and severity of OSA.
4.Clinical characteristics of obstructive sleep apnea in children with Prader-Willi syndrome
Kaiping WU ; Qinghua LU ; Ailiang LIU ; Yuejie ZHENG ; Zhe SU ; Rongfei ZHENG ; Hongguang PAN ; Qin YANG
Chinese Pediatric Emergency Medicine 2025;32(8):591-596
Objective:To analyze the characteristics of obstructive sleep apnea(OSA)in children with Prader-Willi syndrome (PWS),and to improve the understanding of OSA during rapid eye movement sleep.Methods:The clinical data of 13 children with PWS aged 2-14 years admitted to Shenzhen Children's Hospital from June 2017 to June 2024 were retrospectively collected as the PWS group,and 12 children with snoring caused by adenoids,tonsil hypertrophy and/or obesity were selected as the control group.The gender,age,body mass index (BMI),obstructive apnea index (OAI),oxygen desaturation index (ODI),obstructive sleep apnea hypopnea index (OAHI),rapid eye movement period OAHI(OAHIrem),non-rapid eye movement period OAHI(OAHInrem) and OAHIrem/total sleep period OAHI ratio were compared between the two groups.Multivariate linear regression was used to assess the association between PWS and OAHIrem.Results:Among the 13 children in PWS group,there were 7 males and 6 females,with an average age of (7.63±4.05) years and an average BMI of (23.06±6.12) kg/m2.Among the 12 children in control group,there were 10 males and 2 females,with an average age of (7.28±3.92) years and an average BMI of (22.41±5.68) kg/m2.There were no statistically significant differences in age,gender,and BMI between the two groups ( P>0.05).All 13 children (100%) with PWS had OSA,with 8 cases (61.53%) of mild OSA and 5 cases (38.46%) of moderate to severe OSA.OAI and ODI in PWS group were significantly higher than those in control group ( P<0.05).OAHI and OAHInrem in PWS group were higher than those in control group,but the difference was not statistically significant ( P>0.05).OAHIrem and OAHIrem/ total sleep OAHI ratio were significantly higher than those in the control group,with statistical significance ( P<0.05).Multivariate linear regression analysis showed that PWS was significantly correlated with OAHIrem/ total sleep OAH ratio (square root) ( P=0.008). Conclusion:Children with PWS have a high incidence of OSA,with a high proportion of moderate to severe OSA.They are prone to OSA with hypoxemia during rapid eye movement sleep.It is recommended that respiratory monitoring of children with PWS during rapid eye movement sleep should be strengthened,and individualized treatment plan should be formulated according to the type and severity of OSA.
5.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.
6.A retrospective analysis of hearing impairment caused by Gentamicin in children
Lu HUANG ; Jiaosheng ZHANG ; Yuejie ZHENG ; Yonghong YANG
Chinese Journal of Applied Clinical Pediatrics 2025;40(6):434-441
Objective:To assess the risk of hearing impairment caused by Gentamicin in Chinese children.Methods:A retrospective analysis.Related literature was retrieved and selected according to inclusion and exclusion criteria, and relevant data was extracted.An evidence-based analysis was conducted on the relationship between hearing impairment and the application of Gentamicin in children.Results:A total of 150 literature reports in Chinese and 483 in English were retrieved.After screening according to inclusion and exclusion criteria, 33 studies in Chinese and 20 in English were included for analysis.There were 13 clinical case reports, 17 retrospective studies and 4 prospective studies on hearing impairment after the application of the Gentamicin in Chinese children.There were 19 international clinical studies.In the 13 clinical case reports including 21 cases who had a history of Gentamicin, no relationship between hearing impairment and Gentamicin was described.A total of 13 419 patients with hearing impairment were included in 17 retrospective studies, and 3 063 (22.8%) of them had Gentamicin exposure in childhood.Among 19 international studies on the application of Gentamicin in children, 13 reported cases with hearing impairment.The incidence of hearing impairment in Gentamicin-treated patients ranged from 0.9% to 30.9%, and the reasons were family history of hearing impairment, otitis media, and sequelae of nervous system injuries.No children with hearing impairment were proved related to Gentamicin.Five studies with a control group (not the Gentamicin-treated group) showed no difference in the incidence of hearing impairment between the Gentamicin-treated group(0-30.9%) and the control group (0-31.4%).Conclusions:All the retrospective reports of hearing impairment caused by Gentamicin in Chinese children do not describe the causal relationship between hearing impairment and Gentamicin.In international studies, the incidence of hearing impairment is not higher in Gentamicin-treated children.Cohort and randomized controlled studies are needed to further assess the risk of hearing impairment in Chinese children.
7.Correlation of the emm genotyping and virulence genes with the isolation sites of Group A Streptococcus strains from children with impetigo
Dingle YU ; Yunmei LIANG ; Qinghua LU ; Lili JI ; Hesheng CHANG ; Xia ZHANG ; Xiaorong LIU ; Lin MA ; Yuejie ZHENG ; Yonghong YANG
Chinese Journal of Applied Clinical Pediatrics 2024;39(1):59-64
Objective:To investigate the correlation of the emm genotypes and virulence genes with the isolation sites of Group A Streptococcus (GAS). Methods:It was a retrospective study.The specimens were collected from children with impetigo in Beijing Children′s Hospital, Capital Medical University from 2006 to 2008 for GAS isolation and identification.A total of 24 GAS strains were isolated from 16 children with impetigo, among which 7 pairs of strains were isolated from the throat and skin of 7 children, and 1 pair of strains was isolated from the vulva and skin of one child, and the remaining 8 GAS strains were isolated from the skin pus samples of 8 children.Polymerase chain reaction was applied to detect the emm genotypes and 13 virulence genes ( speA, speB, speC, speF, speG, speH, speI, speJ, speK, speL, speM, smeZ and ssa). The correlation of the emm genotypes and virulence genes with the isolation sites of GAS strains was analyzed. Results:In this study, four emm genotypes were detected, including emm1.0 (15/24), emm12.0 (4/24), emm22.0 (2/24) and emm160.0 (1/24), and one subtype emm12.19 (2/24) was detected as well.The carrying rates of 13 virulence genes speA, speB, speC, speF, speG, speH, speI, speJ, speK, speL, speM, smeZ and ssa were 58.3%, 100%, 91.7%, 100%, 50.0%, 12.5%, 54.2%, 66.7%, 16.7%, 25.0%, 12.5%, 100% and 91.7%, respectively.All strains carried 5 to 11 virulence genes and they all carried speB, speF and smeZ.There were significant differences in the carrying rate of speA and speJ among the strains with different emm genotypes (all P<0.05). There was no significant difference in the distribution of virulence genes between skin isolates and pharyngeal isolates, including the 5 pairs of strains carrying the emm1.0 genotype (all P>0.05). Conclusions:The distribution of virulence gene of GAS in children with impetigo is significantly correlated with the emm genotype, rather than the isolation site.
8.Further attention to Group A Streptococcus
Dingle YU ; Yuejie ZHENG ; Kunling SHEN ; Yonghong YANG
Chinese Journal of Applied Clinical Pediatrics 2024;39(7):495-498
Since 2022, there has been an increasing trend in the incidence of scarlet fever and deaths due to Group A Streptococcus (GAS) in the UK and some European countries, with the paediatric population particularly affected, a phenomenon that has attracted widespread international attention.The author believes that GAS has not received sufficient attention and that there are significant national differences in early surveillance, treatment strategies, management and control.Here, author present professional insights on the unresolved scientific issues related to GAS infections, with a view to attracting the attention of domestic colleagues and jointly promoting GAS-related research, prevention and control.
9.Monkeypox is back with a vengeance
Qinghua LU ; Yuejie ZHENG ; Yonghong YANG
Chinese Journal of Applied Clinical Pediatrics 2024;39(10):721-722
The monkeypox epidemic has re-emerged and is at a stage of rapid development in Africa.It is rare that has been designated as a public health emergency of international concern twice in just 2 years since May 2022, which fully demonstrates the urgency of the current monkeypox epidemic.This outbreak is caused by a new monkeypox variant strain Ⅰb.It has a faster transmission rate and may have a higher fatality rate, especially in children.Therefore, medical staff, especially pediatricians, should attach great importance to this strain, do a good job in epidemic surveillance and strengthen vaccine research and development.Nip it in the bud.
10.The first strain of Group A Streptococcus M1 UK confirmed in the mainland of China
Dingle YU ; Yuejie ZHENG ; Wenjian WANG ; Yunsheng CHEN ; Kunling SHEN ; Yonghong YANG
Chinese Journal of Applied Clinical Pediatrics 2024;39(11):801-802
Group A Streptococcus (GAS) are important human pathogens.In recent years, the M1 UK strain has attracted widespread attention in the United Kingdom and other countries because it has been associated with a surge in scarlet fever and an increase in invasive GAS infections.Author conducted a whole-genome sequencing study of 42 GAS strains from 2016 to 2018 in Shenzhen, and found that a GAS strain isolated from a child with scarlet fever in Shenzhen area in 2018 was homologous to M1 UK, which is the first strain of M1 UK confirmed in the mainland of China.For this reason, hereby publish it with a view to attracting the attention of our domestic counterparts and safeguarding public health safety.

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