OBJECTIVETo determine the relation between the change of immunology indexes of serum and the occurrence of anaphylaxis in patients induced by Qingkailing injection, 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-2, IL-4 of 20 cases in anaphylaxis induced by Qingkailing injection with those from 60 matched controls who remained normal after the using Qingkailing injection. The correlation between the change of IgE, IgG, IL-2, IL-4 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-2, IL-4 of serum in diagnosis of anaphylaxis in patients induced by Qingkailing injection by Binary-Logistic regression analysis.

RESULTThe concentrations of IgE, IgG, IL-2, IL-4 of serum of 20 cases were significantly higher than those in controls (P < or = 0. 05). The concentrations of IgE, IgG, IL-2, IL4 of serum of 20 cases after the treatment with Qingkailing injection were significantly higher than those before the treatment with Qingkailing injection (P < or = 0.05). The Exp(B) of IgE, IgG, IL-2, IL-4 were 22. 018 (95.0% CI for EXP was 3.268-310.831), 11.271 (95.0% CI for EXP was 1.91-3.024), 23.612 (95.0% CI for EXP was 3.012-421.187), 16.486 (95.0% CI for EXP was 1.233-205.413), respectively.

CONCLUSIONThe allergic reaction caused by Qingkailing injection may be due to type I allergic reactions; The presence of IgE, IgG, IL-2, IL-4 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.