摘要
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 tion in the real world To observe the occurrence and possible mechanism of allergic reactions of Xiyanping Injec- Methods The patients used Xiyanping Injection were monitored from September 2012 to October 2013 with a prospective, multi-center, large sample and registered method. An embedded nested case-control study was conducted to analyze the patients with allergic reactions. One allergic patient was matched with 5 healthy volunteers by taking gender and age ± 5 years as the matching factors. The blood samples of the patients and healthy subjects were collected. The immunoglobulin A （IgA）, immunoglobulin G （IgG）, total immunoglobulin E （TIgE）, complement 3 （ C3 ）, complement 4 （ C4 ） , interleukin-2 （ IL-2 ）, interleukin-4 （ IL-4 ） , interleukin-6 （ IL-6 ） , interleukin-10 （IL-10） and interferon-g （IFN-g） were detected and analyzed. Results There was one allergic patient （male, 90. 1 years old） in 4023 patients used Xiyanping Injection. He was admitted to hospital suffering from pneumonia and bronchitis. His blood sample test results showed that the levels of TIgE, IgA, IgG, C3, C4 and IL-2 were within the normal range, IL-4 was slightly higher than that in the healthy group and the levels of IFN-g, IL- 6 and IL-IO were significantly higher than those in the healthy group and normal range Conclusion This study suggests that Xiyanping Injection may be associated with the occurrence of allergic reactions but the primary disease and age may be the influencing factors of allergic reactions.
出处
《中医杂志》
CSCD
北大核心
2014年第15期1335-1338,共4页
Journal of Traditional Chinese Medicine
基金
国家中医药管理局中医药行业科研专项资助项目(200907001-5-6)
关键词
喜炎平注射液
过敏反应
免疫因子
Xiyanping Injection
allergic reaction
immune factors
