Abstract:Objective To observe the clinical efficacy of Angong Niuhuang Pill in the treatment of severe hand, foot, and mouth disease (HFMD), and to preliminarily investigate its mechanism of action. Methods A total of 62 children with severe HFMD were randomly and equally divided into control group and observation group. The control group received antiviral treatment, intracranial pressure-reducing medication, and gamma globulin, while the observation group received Angong Niuhuang Pill in addition to the treatment for the control group. Treatment was carried out for 7 days in both groups. The therapeutic effect was assessed based on serum levels of neuron specific enolase (NSE), S-100β, tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) before and after treatment. Results The observation group had a significantly better clinical outcome than the control group (P<0.05). The observation group had significantly shorter fever clearance time, time to disappearance of rash, and length of hospital stay than the control group (P<0.05). After 7 days of treatment, both groups showed significant decreases in serum levels of NSE, S-100β, TNF-α, and IL-6 (P<0.05), but the treatment group had significantly greater decreases than the control group (P<0.05). Conclusion For children with severe HFMD, Angong Niuhuang Pill combined with conventional treatment can effectively reduce inflammatory response and improve clinical outcome.