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. 2020 May 14:17:19.
doi: 10.1186/s12950-020-00249-1. eCollection 2020.

Efficacy and safety of aerosol inhalation of recombinant human interferon α1b (IFNα1b) injection for noninfluenza viral pneumonia, a multicenter, randomized, double-blind, placebo-controlled trial

Rongmeng Jiang  1 , Bing Han  1 , Meihua Song  1 , Bing Xue  2 , Yongxiang Zhang  3 , Yanyan Ding  3 , Jin Chen  4 , Jing Zhu  4 , Jianhua Liu  5 , Qingrong Nie  6 , Xuefeng Han  6 , Xiuhong Jin  7 , Xiaoyin Shan  7 , Weian Guo  8 , Erming Zhang  8 , Zuoqing Zhang  9 , Changhong Zhang  9 , Jie Zhang  10 , Baozeng Wang  11 , Shuwen Dong  10 , Jiandong Li  12 , Xiaoguang Li  13 , Xingwang Li  1
Affiliations

Efficacy and safety of aerosol inhalation of recombinant human interferon α1b (IFNα1b) injection for noninfluenza viral pneumonia, a multicenter, randomized, double-blind, placebo-controlled trial

Rongmeng Jiang et al. J Inflamm (Lond). .

Abstract

Background: To investigate the efficacy and safety of aerosol inhalation of recombinant human interferon α1b (IFNα1b) injection for noninfluenza viral pneumonia.

Methods: One hundred sixty-four patients with noninfluenza viral pneumonia were divided into IFNα1b and control groups. The IFNα1b group received routine treatment + aerosol inhalation of recombinant human IFNα1b injection (50 μg × 2 injections, bid). The control group received routine treatment + IFN analog (two injections, bid). Overall response rate (ORR) of five kinds clinical symptoms. Further outcomes were daily average score and the response rate of each of the symptoms above.

Results: A total of 163 patients were included in the full analysis set (FAS) and 151 patients were included in the per-protocol set (PPS). After 7 days of treatment, ORR of clinical symptoms was higher in IFNα1b group than that in control group for both the FAS and PPS. Moreover, after 7 days of treatment, the daily score of three efficacy indexes including expectoration, respiratory rate, and pulmonary rales were improved. The ORRs for expectoration and pulmonary rales were higher in the IFNα1b group than in the control group (P < 0.05). There were no significant differences of the ORRs for coughing, chest pain and respiratory rate between the two groups (P > 0.05). The incidence of adverse events was 6.5% (n = 5) in IFNα1b group and 3.5% (n = 3) in control group (P > 0.05).

Conclusion: Aerosol inhalation of recombinant human IFNα1b is safe and it can improve the clinical symptoms of noninfluenza viral pneumonia.

Keywords: Aerosol inhalation; Clinical trial; Noninfluenza viral pneumonia; Recombinant human interferon α1b.

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Figures

Fig. 1
Fig. 1
Flow chart of this study
Fig. 2
Fig. 2
Daily Scores of Coughing (a), Expectoration (b), Chest Pain (c), Pulmonary Rales (d) and Respiratory Rate (e) in the IFNα1b Group and the Control Group
See this image and copyright information in PMC

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