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该文从痰热清注射液从上市后临床应用着眼,采用前瞻性、多中心、大样本、注册登记式临床安全性监测嵌套巢式病例对照设计,检测与分析过敏反应患者相关血液指标,探讨其过敏反应可能的机制。共监测使用痰热清注射液的患者3006例,出现不良反应的患者3例,其中2例为过敏反应。每例过敏反应患者,按1:4匹配4例未发生不良反应的患者作为对照组,同时纳入5例健康志愿者组成健康组,对各组之间总IgE,IgA,IgG,C3,C4,IFN-g,IL-2,IL-4,IL-6,IL-10等过敏反应相关检测指标进行比较。基于现有的研究数据发现痰热清注射液的过敏反应可能为由IgE介导的Ⅰ型过敏反应,这也为促进临床安全合理用药起到促进作用。
This article from Tanreqing injection from the clinical application of the market focus on the use of prospective, multicenter, large sample, registered clinical safety monitoring nested nested case-control design, detection and analysis of allergic reaction-related blood parameters, To investigate the possible mechanism of allergic reaction. A total of 3006 patients were treated with Tanreqing injection and 3 patients with adverse reactions, of which 2 were allergic reactions. In each case of allergic reaction, 4 patients with no adverse reactions were matched by 1: 4 as the control group, and 5 healthy volunteers were enrolled to form the healthy group. The total IgE, IgA, IgG, C3, C4, IFN-g, IL-2, IL-4, IL-6, IL-10 and other allergic reaction-related indicators were compared. Based on the available data, it is found that the allergic reaction of Tanreqing injection may be IgE-mediated type I allergic reaction, which is also helpful to promote the safe and rational drug use in clinic.