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Archives of Virology

, Volume 161, Issue 11, pp 3073–3080 | Cite as

Efficacy and safety of interferon-α2b spray in the treatment of hand, foot, and mouth disease: a multicenter, randomized, double-blind trial

  • Hailong Lin
  • Leting Huang
  • Jian Zhou
  • Kaichun Lin
  • Hongjiao Wang
  • Xia Xue
  • Chan Xia
Original Article

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.

Keywords

Oral Lesion Oral Ulcer Mouth Disease Andrographolide Viral Infectious Disease 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

This work was supported by the Medical Science and Technology Project of Zhejiang Province, China (No. 2013RCB011) and Hualida Pharmaceutical Co., Ltd., People’s Republic of China.

Compliance with ethical standards

Conflict of interest

We declare there is no financial and personal conflict of interest with other people or any organizations.

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Copyright information

© Springer-Verlag Wien 2016

Authors and Affiliations

  1. 1.Department of Pediatric InfectionThe Second Affiliated Hospital of Wenzhou Medical UniversityWenzhouChina
  2. 2.Department of PediatricsThe first people’s Hospital of YongkangJinhuaChina
  3. 3.Department of PediatricsThe Affiliated Children’s Hospital of Zhejiang University Medical CollegeHangzhouChina

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