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重组人干扰素α1b(IFNα1b)注射液雾化吸入治疗非流感病毒性肺炎的疗效和安全性:一项多中心、随机、双盲、安慰剂对照试验

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.

作者信息

Jiang Rongmeng, Han Bing, Song Meihua, Xue Bing, Zhang Yongxiang, Ding Yanyan, Chen Jin, Zhu Jing, Liu Jianhua, Nie Qingrong, Han Xuefeng, Jin Xiuhong, Shan Xiaoyin, Guo Weian, Zhang Erming, Zhang Zuoqing, Zhang Changhong, Zhang Jie, Wang Baozeng, Dong Shuwen, Li Jiandong, Li Xiaoguang, Li Xingwang

机构信息

1Department of Infectious Disease, Beijing Ditan Hospital, Capital Medical University, No. 8 East Jingshun Street, Chaoyang District, Beijing, 100015 China.

2Department of Respiratory Medicine, Beijing Chuiyangliu Hospital, Beijing, 100022 China.

出版信息

J Inflamm (Lond). 2020 May 14;17:19. doi: 10.1186/s12950-020-00249-1. eCollection 2020.

DOI:10.1186/s12950-020-00249-1
PMID:32431566
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC7221328/
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 ( < 0.05). There were no significant differences of the ORRs for coughing, chest pain and respiratory rate between the two groups ( > 0.05). The incidence of adverse events was 6.5% ( = 5) in IFNα1b group and 3.5% ( = 3) in control group ( > 0.05).

CONCLUSION

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

摘要

背景

探讨雾化吸入重组人干扰素α1b注射液治疗非流感病毒性肺炎的疗效及安全性。

方法

将164例非流感病毒性肺炎患者分为干扰素α1b组和对照组。干扰素α1b组接受常规治疗+雾化吸入重组人干扰素α1b注射液(50μg×2支,每日2次)。对照组接受常规治疗+干扰素类似物(每日2次,每次2支)。观察5种临床症状的总体缓解率(ORR)。进一步观察指标为上述各症状的每日平均评分及缓解率。

结果

全分析集(FAS)纳入163例患者,符合方案集(PPS)纳入151例患者。治疗7天后,干扰素α1b组FAS和PPS的临床症状ORR均高于对照组。此外,治疗7天后,咳痰、呼吸频率和肺部啰音3项疗效指标的每日评分均有所改善。干扰素α1b组咳痰和肺部啰音的ORR高于对照组(P<0.05)。两组咳嗽、胸痛和呼吸频率的ORR差异无统计学意义(P>0.05)。干扰素α1b组不良事件发生率为6.5%(n=5),对照组为3.5%(n=3)(P>0.05)。

结论

雾化吸入重组人干扰素α1b治疗非流感病毒性肺炎安全有效,可改善临床症状。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89f4/7222493/602f7aa65008/12950_2020_249_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89f4/7222493/bb88880f04ea/12950_2020_249_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89f4/7222493/602f7aa65008/12950_2020_249_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89f4/7222493/bb88880f04ea/12950_2020_249_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89f4/7222493/602f7aa65008/12950_2020_249_Fig2_HTML.jpg

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