[Evaluation criteria for rat skin anaphylactoid test]

Area of Science:

• Pharmacology
• Toxicology
• Immunology

Background:

• The rat skin anaphylactoid test is a common method for evaluating drug-induced anaphylactoid reactions.
• Existing evaluation criteria, such as blue spot diameter, may lack objectivity and be influenced by individual animal factors.

Purpose of the Study:

• To explore characteristic indexes for evaluating the rat skin anaphylactoid test.
• To define and validate the K value as a novel evaluation criterion.

Main Methods:

• Comparing optical density (OD) values of skin blue spots at treated and control sites within the same animal.
• Utilizing common contrast agents, traditional Chinese medicine injections, and active pharmaceutical ingredients/excipients as test drugs.
• Defining the K value based on OD ratios to classify reactions as positive, doubtable, or negative.

Main Results:

• The K value effectively minimizes errors caused by individual animal variations.
• The K value's three-level criteria (positive, doubtable, negative) are more objective and accurate than two-level diameter criteria.
• The K value evaluation aligns with and potentially improves upon classic criteria for assessing anaphylactoid reactions.

Conclusions:

• The K value serves as a more reliable and accurate evaluation criterion for the rat skin anaphylactoid test.
• This novel approach enhances the objectivity and precision of anaphylactoid reaction assessment in preclinical studies.
• The K value method is applicable for evaluating various test drugs, including those from traditional Chinese medicine.