A multicenter controlled clinical study on the efficacy and safety of recombinant human interferon α2b spray in the treatment of hand, foot and mouth disease in children

Objective To evaluate the curative effect of recombinant human Interferon α2b (rhIFN α2b) spray in hand, foot and mouth disease (HMFD). Methods In total, 313 HMFD children were enrolled from Beijing Ditan Hospital affiliated to Capital Medical University, Tianjing Second People′s Hospital, Hebei Children′s Hospital, the Second Hospital affiliated to Wenzhou Medical College, Kunming Maternal and Child Health Hospital and Guiyang Public Health Treatment Center from March, 2015 to February, 2017. They were divided into rhIFN α2b group (148 cases) and ribavirin group (165 cases). The children in rhIFN α2b group were given with the rhIFN α2b spray, and those in ribavirin group were given with the ribavirin spray. Meanwhile, the children were given unified standard interventions for basic treatment. The curative effect and safety between two groups was compared. The t test was used for intergroup comparison and the Wilcoxon rank test was used for non-normal quantitative data. Results At the end of the follow-up period, all kids reached the recovery level, with 144 cases in the rhIFN α2b group and 164 cases in the ribavirin group. Fever, herpes and rashes all disappeared with 7-day follow-up. The total efficiency of the rhIFN α2b group measured at the 72h after treatment was 74.15%, which showed significant differences compared with the ribavirin group with 49.09% efficiency (Z=4.44, P<0.01). As the secondary outcome measures, the complete disappearance time of fever and the immediate disappearance time of fever in the rhIFN α2b group were significantly shorter than those in the ribavirin group ([27.03±21.99] vs [33.21±26.71], t=-2.13; [23.56±13.96] vs [28.51±18.84], t=-2.07, both P<0.05). The appetite improvement and the disappearance times of oral herpes and rashes in the rhIFN α2b group were shorter than those in the ribavirin group, with significant differences (χ2=4.94, 3.17 and 3.55, respectively, all P=0.000). No adverse event in both groups. Conclusions rhIFN α2b spray treatment in HMFD is proved significantly effective, particularly, it can evidently relieve fever symptoms and promote the disappearance of oral herpes symptoms, and no adverse event is observed throughout the study, which indicates a good safety of the rhIFN α2b spray. Clinical trial registration Chinese Clinical Trial Registry, ChiCTR-OIN-17013182. Key words: Hand, foot and mouth disease; Recombinant human interferon α2b spray; Antiviral agents