Abstract

A rapid expansion of HFMD with enterovirus 71 infection outbreaks has occurred and caused deaths in recent years in China, but no vaccine or antiviral drug is currently available for EV71 infection. This study aims to provide treatment programs for HFMD patients. We conducted a randomized, double-blind, controlled trial and evaluated clinical efficacy of therapy with rHuIFN-α1b in HFMD patients with EV71 infection. There were statistical differences in outcomes including the fever clearance time, healing time of typical skin or oral mucosa lesions, and EV71 viral load of the HFMD patients among ultrasonic aerosol inhalation group, intramuscular injection group and control group. rHuIFN-α1b therapy reduced the fever clearance time, healing time of typical skin or oral mucosa lesions, and EV71 viral load in children with HFMD.Trial Registration: Chinese Clinical Trial Registry ChiCTR-TRC-14005153

Highlights

  • Hand, foot, and mouth disease (HFMD) is an important infectious disease in young children, in those less than 5 years old

  • 10 HFMD patients withdrew from the treatment trial because of parental request, and 21 HFMD patients withdrew because they developed critical illness requiring transfer to the intensive care unit (ICU). 274 HFMD subjects completed the rHuIFN-α1b treatment trial (Fig 1)

  • Enterovirus 71 (EV71) is a small, non-enveloped, positive-stranded RNA virus with a genome of approximately 7,400 bases, and it is a member of the genus Enterovirus in the family Picornaviridae [1]

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Summary

Introduction

Foot, and mouth disease (HFMD) is an important infectious disease in young children, in those less than 5 years old. HFMD epidemics have affected various countries in the past 40 years [1]. Large-scale outbreaks have been a serious public health issue in China since 2008 [2]. Human Enterovirus 71 (EV71) and Coxsackievirus A16 (CVA16) are common etiological agents of HFMD in children, but the former can cause severe complications, such as aseptic meningitis, acute flaccid paralysis (AFP), meningoencephalitis and cerebellitis, with mortality rates ranging from 10 to 25.7% [3,4,5]. A cyclical epidemic of HFMD has been. PLOS ONE | DOI:10.1371/journal.pone.0148907 February 16, 2016

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