title: Efficacy and safety of interferon-α2b spray in the treatment of hand, foot, and mouth disease: a multicenter, randomized, double-blind trial.
abstract: Hand, foot, and mouth disease (HFMD) is a common infectious enterovirus disease, occurring mostly in infants and children younger than 7 years with potentially fatal complications. Therefore, we evaluated the clinical efficacy and safety of recombinant human interferon (IFN)-α2b spray for treating mild HFMD in 400 patients in a randomized, open, controlled clinical trial. The patients were randomized to the IFN-α2b spray and placebo groups, and their temperature, skin rash, oral lesions, and appetite were monitored, while pathogen levels and safety were evaluated with a 7-day follow-up. The mean age of the patients was 20.1 ± 10.2 months. The median duration of fever, oral ulcers or vesicles (or both), and skin rash in addition to median time to regain appetite in the IFN-α2b spray group were shorter than they were in the placebo group. The number of virus-positive cases differed statistically between the two groups for the three follow-up detections. Additionally, the incidences of adverse events (AEs) and severe AEs (SAEs) were not significantly different between the two groups, and the SAEs were evidently unrelated to the IFN-α2b spray or placebo. Therefore, the IFN-α2b spray is suitable for topical treatment of HFMD, and it rapidly relieved fever, promoted oral lesions and subsidence of rash, enhanced appetite, promoted disease recovery, and was safe for application.
authors: Department of Pediatric Infection, The Second Affiliated Hospital of Wenzhou Medical University, 109th Xueyuanxi Road, Wenzhou, Zhejiang, China.
authors: Hailong
authors: H
authors: Lin
authors: Department of Pediatric Infection, The Second Affiliated Hospital of Wenzhou Medical University, 109th Xueyuanxi Road, Wenzhou, Zhejiang, China.
authors: Leting
authors: L
authors: Huang
authors: Department of Pediatrics, The first people's Hospital of Yongkang, Jinhua, China.
authors: Jian
authors: J
authors: Zhou
authors: Department of Pediatrics, The first people's Hospital of Yongkang, Jinhua, China.
authors: Kaichun
authors: K
authors: Lin
authors: Department of Pediatrics, The Affiliated Children's Hospital of Zhejiang University Medical College, Hangzhou, China.
authors: Hongjiao
authors: H
authors: Wang
authors: Department of Pediatrics, The Affiliated Children's Hospital of Zhejiang University Medical College, Hangzhou, China.
authors: Xia
authors: X
authors: Xue
authors: Department of Pediatric Infection, The Second Affiliated Hospital of Wenzhou Medical University, 109th Xueyuanxi Road, Wenzhou, Zhejiang, China. lanqi20@163.com.
authors: Chan
authors: http://orcid.org/0000-0002-1666-6339
authors: C
authors: Xia
mesh_terms: D000336:Aerosols / Q000008:administration & dosage*; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006232:Hand, Foot and Mouth Disease / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007223:Infant; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000336:Aerosols; D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D010919:Placebos; D011994:Recombinant Proteins