Clinical Trial of Pegylated Interferon α-2b Via Nebulization for Treatment of Hand, Foot, and Mouth Disease .

Inclusion criteria

-1. Age: 1 year of age ≤ Age ≤ 6 years of age. 2.Gender: Both male and female. 3.Clinical symptoms/signs: Manifesting as common type HFMD (Stage 1, rash stage), with fever or rash symptoms first occurring within 72 hours prior to the signing of the informed consent form.

4.Informed consent: Guardians understand and sign the informed consent form (if the guardian is the parent, both parents must sign).

Exclusion criteria

• (1) Severe or Critical HFMD Presentation at Enrollment

• Manifesting as severe HFMD (Stage 2, neurological involvement phase)
• Manifesting as critical HFMD (Stage 3 or 4, cardiopulmonary failure phase) with any of:

Brainstem encephalitis, encephalomyelitis, or meningitis,Neurogenic pulmonary edema or respiratory failure requiring mechanical ventilation,Shock or circulatory collapse.

• Concurrent multi-organ failure requiring ICU monitoring

(2) Allergy History and Treatment History

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• Received interferon, ribavirin, acyclovir, ganciclovir, or vidarabine monophosphate within 30 days prior to screening or current use
• Received immunoglobulin or glucocorticoid therapy within 30 days prior to screening or current use
• Known hypersensitivity to interferon or its components, or other clinically significant allergies contraindicating participation
• Use of other investigational drugs within 3 months or 5 half-lives (whichever is longer) prior to screening, or current participation in medical device trials

(3) Medical History

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• Congenital heart disease, severe malnutrition, immune dysfunction, asthma, or other severe systemic diseases
• Active HBV, HCV, HIV, or Treponema pallidum infection
• History of malignant tumors (current or prior)
• History of epilepsy, neurological/psychiatric disorders, or relevant family history

(4) Clinical Parameters: Resting respiratory rate >40 breaths/min,Heart rate >160 bpm

(5) Other Considerations: Any condition deemed by investigators to render participation medically inadvisable