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作 者 ：赵玉斌,肖颖,谢雁鸣

期 刊 ：中国中药杂志 2011年 36卷 10期 页码：1382.

关键词：清开灵注射液；细胞因子；过敏反应；免疫学；药物不良反应；

Keywords:Qingkailing injection, immunotoxicology, post-market study, anaphylaxis, cytokines, adverse drug reactions (ADR), pharmacovigilance,

摘 要 ：目的: 研究血清免疫球蛋白及相关指标的改变与清开灵注射液过敏反应发生之间的关系,从而明确中药注射剂过敏反应发生后人体免疫学指标的变化规律,探索中药注射剂发生过敏反应后的检测及预防方法。 方法 :采用嵌入式病例对照研究设计(清开灵注射液过敏组(病例组)20例和清开灵注射液非过敏组(对照组)60例),分析各项免疫学指标IgE,IgG,IL-2,IL-4在清开灵注射液过敏前后的变化。 结果 :与对照组相比,清开灵注射液过敏组患者血清中的IgE,IgG,IL-2,IL-4均有明显升高(P<0.05);而清开灵注射液过敏患者用药前后血清中各免疫学指标的变化有显著性差异(P<0.05)。 结论 :清开灵注射液所致人体过敏反应可能为Ⅰ型过敏反应为主,IgE,IgG,IL-2,IL-4可以作为检测清开灵注射液过敏患者免疫系统受损的临床评价指标。

Abstract:Objective : To 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. Method : In 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. Result : The concentrations of IgE, IgG, IL-2, IL-4 of serum of 20 cases were significantly higher than those in controls (P≤0.05). The concentrations of IgE, IgG, IL-2, IL-4 of serum of 20 cases after the treatment with Qingkailing injection were significantly higher than those before the treatment with Qingkailing injection (P≤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. Conclusion : The allergic reaction caused by Qingkailing injection may be due to typeⅠallergic 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.

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