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

Exclusion Criteria

• •(1) Severe or Critical HFMD Presentation at Enrollment
• •1. Manifesting as severe HFMD (Stage 2, neurological involvement phase)
• •2. 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.
• •3. Concurrent multi-organ failure requiring ICU monitoring
• •(2) Allergy History and Treatment History
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• •1. Received interferon, ribavirin, acyclovir, ganciclovir, or vidarabine monophosphate within 30 days prior to screening or current use
• •2. Received immunoglobulin or glucocorticoid therapy within 30 days prior to screening or current use
• •3. Known hypersensitivity to interferon or its components, or other clinically significant allergies contraindicating participation
• •4. 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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• •1. Congenital heart disease, severe malnutrition, immune dysfunction, asthma, or other severe systemic diseases
• •2. Active HBV, HCV, HIV, or Treponema pallidum infection
• •3. History of malignant tumors (current or prior)
• •4. 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