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目的初步观察喜炎平注射液上市后在真实世界人群中过敏反应发生情况并分析其可能原因。方法采用前瞻性、多中心、大样本、注册登记式医院集中监测2012年9月至2013年10月使用喜炎平注射液的患者,对发生过敏反应的患者嵌套前瞻性巢式病例对照设计,按性别、年龄±5岁等匹配因素,每发生1例过敏反应患者,匹配5例健康志愿者作为健康组。对患者和健康组受试者进行血液样本采集,检测免疫球蛋白A(IgA)、免疫球蛋白G(IgG)、总免疫球蛋白E(TIgE)、血清总补体C3(C3)、血清总补体C4(C4)、白细胞介素2(IL-2)、白细胞介素4(IL-4)、白细胞介素6(IL-6)、白细胞介素10(IL-10)、重组人干扰素γ(IFN-g)过敏反应相关指标,进行描述性分析。结果 4023例使用喜炎平注射液患者中,1例发生过敏反应,男性,90.1岁,因肺炎、支气管炎入院,血液样本检测结果 TIgE、IgA、IgG、C3、C4、IL-2均在正常范围内,IL-4略高于健康组,IFN-g、IL-6、IL-10明显高于正常范围及健康组。结论本研究仅提示喜炎平注射液可能与发生过敏反应有关,但患者原患疾病、年龄等可能为过敏反应的影响因素。
Objective To observe the occurrence of allergic reactions in the real world crowd after Xiyanping injection goes on the market and analyze its possible causes. Methods A prospective, multicentre, large sample, and registered hospital intensive monitoring of patients using Xiyanping injection from September 2012 to October 2013 was performed in a prospective, nested case-control study of patients with anaphylactic reactions , According to gender, age ± 5 years and other matching factors, each occurred in 1 case of allergic reactions, matching 5 healthy volunteers as a healthy group. Blood samples were collected from patients and healthy subjects, and immunoglobulin A (IgA), immunoglobulin G (IgG), total immunoglobulin E (TIgE), total serum complement C3 (C3), total serum complement C4 (C4), interleukin 2 (IL-2), interleukin 4 (IL-4), interleukin 6 (IL-6), interleukin 10 (IL-10), recombinant human interferon gamma (IFN-g) allergic reaction related indicators, a descriptive analysis. Results In 4023 patients with Xiyanping injection, 1 patient developed anaphylactic reaction, and the male was 90.1 years old. The results of blood sample examination showed that TIgE, IgA, IgG, C3, C4, and IL-2 were all normal in hospital due to pneumonia and bronchitis admission Within the range, IL-4 slightly higher than the healthy group, IFN-g, IL-6, IL-10 was significantly higher than the normal range and healthy group. Conclusion This study only suggests that Xiyanping injection may be related to anaphylactic reaction, but the original disease, age may be the influencing factors of allergic reaction.