Abstract：Objective To evaluate the efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease (HFMD). Methods A randomized, double-blind, placebo-controlled trial was performed. A total of 119 children with mild HFMD were randomly divided into an observed group (n=59) and a control group (n=60). In the observed group, ribavirin aerosol was given four times within the first hour, followed by once every other hour for the remaining time of the day and day 2; from days 3 to 7, it was given 4 times per day, with 2-3 sprays every time, for 7 days. In the control group, placebo was given in the same way as in the observed group. Additionally, both groups used oral antiviral liquid. The scores of clinical symptoms including oral ulcer, skin rash, nasal congestion, runny nose, sneezing, cough, and fever before and after treatment were recorded to evaluate treatment outcomes. Throat swabs were taken before treatment and 5-7 days after treatment to measure viral load by RT-PCR and to compare the negative conversion rate between the two groups. Results Fifty-seven patients in the observed group and 56 patients in the control group were tested according to the original research design. After 5-7 days of treatment, the observed group had a significantly higher overall negative conversion rate of enterovirus than the control group (P<0.01). The overall marked response rate and overall response rate of the observed group were 89% and 89%, respectively, significantly higher than those of the control group (29% and 43%). During treatment, there were no adverse reactions such as dizziness, vomiting, and notable decreases in hemoglobin, white blood cells, and platelets in the two groups. Conclusions Ribavirin aerosol can be effectively and safely used for treating mild HFMD. With low dosage and few adverse reactions, it holds promise for clinical application.
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