OBJECTIVETo determine the relation between the change of immunotoxicology indexes of serum and the occurrence of anaphylaxis in patients induced by Qingkailing injection, which is composed by cholic acid, mother-of-pearl, gardenia, cornu bubali, isatis root, baicalin, honeysuckle, and to establish the method of detection of the type of anaphylaxis in patients induced by traditional Chinese medicine (TCM) injection.

METHODIn a prospective nested case-control study, we compared the concentration of IgE, IgG, IL-4, histamine of 18 cases in anaphylaxis induced by Qingkailing injection with those from 72 matched controls who remained normal after the using Qingkailing injection. The correlation between the change of IgE, IgG, IL-4, histamine of serum and the occurrence of anaphylaxis in patients induced by Qingkailing injection was determined, and we also evaluate the clinical values of IgE, IgG, IL-4, histamine of serum in diagnosis of anaphylaxis in patients induced by Qingkailing injection by receiver operating characteristic (ROC) curves.

RESULTThe concentrations of IgE, IgG, IL-4, histamine of serum of 18 cases were significantly higher than those in controls (P<0.05), the area under the curve (AUC) of IL-4, IgG, IgE, histamine were 0.362 (95.0% CI. for EXP was 0.978-2.405), 0.349 (95.0% CI. for EXP was 1.448-316.232), 0.350 (95.0% CI. for EXP was 1.262-601.306), 0.374 (95.0% CI. for EXP was 1.003-45.413), respectively.

CONCLUSIONThe allergic reaction caused by Qingkailing injection may be due to type I allergic reactions; The presence of IgE, IgG, IL-4, Histamine can serve as clinical evaluation indicators in evaluation the damage degree of immune system caused by anaphylaxis in patients induced by Qingkailing injection. Cytokines are more likely to become the effective evaluation index in diagnosis of anaphylaxis in patients induced by TCM injection.