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
10.3760/cma.j.cn101070-20241028-00694
- VernacularTitle:雾化吸入重组人干扰素α1b治疗小儿呼吸道合胞病毒下呼吸道感染的有效性和安全性多中心、随机、双盲、安慰剂对照Ⅲ期临床研究
- Author:
Xiaohui LIU
1
;
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
Author Information
1. 国家儿童医学中心，国家呼吸系统疾病临床医学研究中心，首都医科大学附属北京儿童医院呼吸中心，北京 100045
- Publication Type:Journal Article
- Keywords:
Recombinant human interferon α1b;
Nebulization inhalation;
Respiratory syncytial virus;
Lower respiratory tract infection
- From:
Chinese Journal of Applied Clinical Pediatrics
2025;40(3):180-186
- CountryChina
- Language:Chinese
-
Abstract:
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.
