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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。
OBJECTIVE: To study the relationship between the change of immunotoxin index in human population and the occurrence of anaphylaxis in Qingkailing Injection so as to clarify the changing rules of immunotoxicity detection index in Chinese population after anaphylaxis, and to explore the allelopathic effect of traditional Chinese medicine injection The detection and prevention methods. Methods: The nested case-control study design (18 cases and 72 cases) was used to analyze the immunotoxicity indexes IgE, IgG and IL-4 by conditional Logistic regression model. The changing law and the correlation between them. Results: Compared with the control group, the levels of serum IgE, IgG, IL-4 and histamine in Qingkailing injection hypersensitivity patients were significantly increased (P <0.05). Conclusion: The allergic reaction of Qingkailing Injection is caused by the simultaneous presence of type I anaphylaxis and anaphylactoid reactions. IgE, IgG, IL-4 and histamine can be used as the immune system to detect allergic reactions in Qingkailing Injection Clinical evaluation of indicators; cytokines are more likely to be effective indicators of evaluation of Chinese medicine injection allergens.