Work

Efficacy and safety of aerosol inhalation of recombinant human interferon-α2b injection in children hospitalized with human adenovirus pneumonia: a prospective, multicenter, randomized, controlled trial in China

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: BACKGROUND: Human adenovirus (HAdV) pneumonia represents one of the gravest threats to child health worldwide. However, effectively and safely antiviral strategies for HAdV infections remain limited. In this study, we aimed to comprehensively investigate the efficacy and safety of aerosol inhalation of recombinant human interferon-α2b (IFN-α2b) injection in children hospitalized with HAdV pneumonia. METHODS: This randomized controlled trial recruited children aged ≤5 years hospitalized for HAdV pneumonia from nine hospitals in China. Subjects were randomized 1:1 to receive either aerosol inhalation of IFN-α2b (200 000 IU/kg) plus routine supportive treatment or aerosolized normal saline plus supportive therapy, with a 7-day treatment period. Primary outcome indexes were viral DNA negative conversion rate and overall effective rate, while the secondary indexes included disappearance time of various symptoms, overall symptom improvement rate (OSIR), and levels of inflammatory indicators (TNF-α, IL-6, CRP, and LDH). Noteworthily, besides common clinical and laboratory indexes, two crucial effector proteins [2',5'-oligoadenylate synthetase (OAS), β2 microglobulin (β2M)] of IFN-mediated antiviral responses were assayed using the ELISA method. Additionally, safety assessment parameters consisted of vital signs, biochemical indicators of liver and kidney function (ALT, AST, urea, creatinine), and incidence of adverse events. RESULTS: A total of 140 eligible subjects were enrolled, including 70 in the IFN-α2b group and 70 in the control group. After 7-day therapy, compared to control group, the IFN-α2b group demonstrated significant superiority in therapeutic effects, including shorter disappearance time of various clinical symptoms, greater OSIR (0.84 ± 0.14 vs. 0.72 ± 0.11, P = 0.039), lower levels of inflammatory indicators (TNF-α, IL-6, CRP), and higher rates of viral DNA negative conversion [71.4 vs. 52.9%, RR (95% CI) = 1.35 (1.04-1.76), P = 0.023] and overall clinical effective [97.1 vs. 85.7%, RR (95% CI) = 1.13 (1.02-1.26), P = 0.016] with a more prominent clinical cure proportion [70.0 vs. 48.6%, RR (95% CI) = 1.44 (1.08-1.92), P = 0.010]. Meanwhile, higher serum OAS [85.1 (78.3-91.5) vs. 67.4 (63.5-71.0) U/mL, P = 0.003] and β2M [5.3 (4.8-6.5) vs. 3.8 (3.4-4.6) mg/L, P < 0.001] levels were confirmed in the IFN-α2b group than the control group after 7-day intervention. In terms of safety, there were no remarkable between-group differences regarding vital signs, liver/kidney function indexes, and incidence of adverse events. CONCLUSION: Aerosol inhalation of recombinant human IFN-α2b injection is safe and effective for treating pediatric HAdV pneumonia.

Source: International Journal of Surgery

DOI: 10.1097/js9.0000000000004635