[Establishment of new evaluation standards for systemic anaphylactoid reactions using mouse model]

Area of Science:

• Pharmacology
• Immunology
• Toxicology

Background:

• Drug-induced anaphylactoid reactions pose a significant global health challenge.
• Current animal models and testing methods lack maturity and reliability for these reactions.

Purpose of the Study:

• To establish robust test methods and evaluation standards for anaphylactoid reactions specific to injectable drugs.
• To develop a reliable animal model for assessing drug-induced anaphylactoid reactions.

Main Methods:

• Induction of anaphylactoid reactions in mice using intravenous drugs (C48/40, Tween 80).
• Development of a systemic anaphylactoid reaction symptom evaluation standard using a symptom intensity coefficient (K).
• Integration of blood marker analysis (histamine, tryptase, IgE) with symptom evaluation.

Main Results:

• The established method demonstrated high correlation between reaction severity (K), histamine levels, and drug dosage.
• Tryptase levels showed variable changes, while IgE levels decreased or remained steady, distinguishing reactions from Type I allergies.
• Validation with various injectable drugs showed high consistency with clinical observations.

Conclusions:

• The developed systemic anaphylaxis test in mice is sensitive, specific, and clinically relevant.
• This novel method offers a reliable approach for evaluating drug-induced anaphylactoid reactions.
• Further validation and widespread adoption of this method are recommended.