PMID- 27518403 OWN - NLM STAT- MEDLINE DCOM- 20170126 LR - 20181202 IS - 1432-8798 (Electronic) IS - 0304-8608 (Linking) VI - 161 IP - 11 DP - 2016 Nov TI - Efficacy and safety of interferon-alpha2b spray in the treatment of hand, foot, and mouth disease: a multicenter, randomized, double-blind trial. PG - 3073-80 LID - 10.1007/s00705-016-3012-7 [doi] AB - 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)-alpha2b spray for treating mild HFMD in 400 patients in a randomized, open, controlled clinical trial. The patients were randomized to the IFN-alpha2b 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-alpha2b 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-alpha2b spray or placebo. Therefore, the IFN-alpha2b 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. FAU - Lin, Hailong AU - Lin H AD - Department of Pediatric Infection, The Second Affiliated Hospital of Wenzhou Medical University, 109th Xueyuanxi Road, Wenzhou, Zhejiang, China. FAU - Huang, Leting AU - Huang L AD - Department of Pediatric Infection, The Second Affiliated Hospital of Wenzhou Medical University, 109th Xueyuanxi Road, Wenzhou, Zhejiang, China. FAU - Zhou, Jian AU - Zhou J AD - Department of Pediatrics, The first people's Hospital of Yongkang, Jinhua, China. FAU - Lin, Kaichun AU - Lin K AD - Department of Pediatrics, The first people's Hospital of Yongkang, Jinhua, China. FAU - Wang, Hongjiao AU - Wang H AD - Department of Pediatrics, The Affiliated Children's Hospital of Zhejiang University Medical College, Hangzhou, China. FAU - Xue, Xia AU - Xue X AD - Department of Pediatrics, The Affiliated Children's Hospital of Zhejiang University Medical College, Hangzhou, China. FAU - Xia, Chan AU - Xia C AUID- ORCID: 0000-0002-1666-6339 AD - Department of Pediatric Infection, The Second Affiliated Hospital of Wenzhou Medical University, 109th Xueyuanxi Road, Wenzhou, Zhejiang, China. lanqi20@163.com. LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20160812 PL - Austria TA - Arch Virol JT - Archives of virology JID - 7506870 RN - 0 (Aerosols) RN - 0 (Antiviral Agents) RN - 0 (Interferon alpha-2) RN - 0 (Interferon-alpha) RN - 0 (Placebos) RN - 0 (Recombinant Proteins) SB - IM MH - Aerosols/*administration & dosage MH - Antiviral Agents/*administration & dosage/adverse effects MH - Child, Preschool MH - Double-Blind Method MH - Female MH - Hand, Foot and Mouth Disease/*drug therapy/pathology MH - Humans MH - Infant MH - Interferon alpha-2 MH - Interferon-alpha/*administration & dosage/adverse effects MH - Male MH - Placebos/administration & dosage MH - Recombinant Proteins/administration & dosage/adverse effects MH - Treatment Outcome EDAT- 2016/08/16 06:00 MHDA- 2017/01/27 06:00 CRDT- 2016/08/13 06:00 PHST- 2016/05/16 00:00 [received] PHST- 2016/08/07 00:00 [accepted] PHST- 2016/08/13 06:00 [entrez] PHST- 2016/08/16 06:00 [pubmed] PHST- 2017/01/27 06:00 [medline] AID - 10.1007/s00705-016-3012-7 [pii] AID - 10.1007/s00705-016-3012-7 [doi] PST - ppublish SO - Arch Virol. 2016 Nov;161(11):3073-80. doi: 10.1007/s00705-016-3012-7. Epub 2016 Aug 12.