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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 18期 页码：2579.

关键词：清开灵注射液；免疫毒理学；上市后研究；过敏反应；细胞因子；药物不良反应；

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

摘 要 ：目的: 研究人群免疫毒理学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群免疫毒理学检测指标的变化规律,初步探索中药注射剂发生过敏反应后的检测及预防方法。 方法 :采用巢式病例对照研究设计(病例18例和对照72例),通过条件Logistic回归模型分析各项免疫毒理学指标IgE,IgG,IL-4,组胺在清开灵注射液过敏后的变化规律及其两者的相关性。 结果 :与对照组相比,清开灵注射液过敏患者血清中的IgE,IgG,IL-4,组胺均有明显升高(P<0.05)。 结论 :清开灵注射液过敏反应是由于Ⅰ型过敏反应、类过敏反应的同时存在而造成的;IgE,IgG,IL-4,组胺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;细胞因子更有可能成为评价中药注射剂过敏原的有效指标。

Abstract:Objective : To 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. Method : In 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. Result : The 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. Conclusion : The allergic reaction caused by Qingkailing injection may be due to typeⅠallergic 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.

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