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| 清开灵注射液过敏反应患者血清免疫毒理学指标变化规律的巢式病例对照研究 | |
| 引用本文： | 赵玉斌,肖颖,谢雁鸣,黎元元.清开灵注射液过敏反应患者血清免疫毒理学指标变化规律的巢式病例对照研究[J].中成药,2011,33(5):746-751. |
| 作者姓名： | 赵玉斌 肖颖 谢雁鸣 黎元元 |
| 作者单位： | 1. 中国中医科学院中医临床基础医学研究所,北京,100700;河北医科大学附属石家庄第三医院,河北石家庄,050011 2. 石家庄学院,河北,石家庄,050035 3. 中国中医科学院中医临床基础医学研究所,北京,100700 |
| 基金项目： | 科技部“重大新药创制”科技重大专项“中药上市后再评价关键技术研究”(2009ZX09502-030); 中国中医科学院自主选题“基于中医证候的上市中药注射剂免疫毒理学评价指标的筛选及其示范研究”(Z02101) |
| 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、His-tamine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、Histamine均有明显升高(P<0.05);IL-4、IgG、IgE的升高与清开灵注射液过敏反应的发生密切相关(P<0.05):其OR值分别为1.534、21.4、27.552、6.748.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、Histamine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. |
| 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 |
Change of serum immunotoxicology indexes in patients with anaphylaxis induced by Qinkailing Injection: prospective nested case-control study |
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| ZHAO Yu-bin , XIAO Ying , XIE Yan-ming , LI Yuan-yuan.Change of serum immunotoxicology indexes in patients with anaphylaxis induced by Qinkailing Injection: prospective nested case-control study[J].Chinese Traditional Patent Medicine,2011,33(5):746-751. | |
| Authors: | ZHAO Yu-bin XIAO Ying XIE Yan-ming LI Yuan-yuan |
| Institution: | ZHAO Yu-bin1,2,XIAO Ying3,XIE Yan-ming1*,LI Yuan-yuan1(1.Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China,2.Shijiazhuang The Third Hospital Affiliated to Hebei Medical University,Shijiazhuang 050011,3.Chemistry Department,Shijiazhuang College,Shijiazhuang 050035,China) |
| Abstract: | AIM To determine the relationship between the change of immunotoxicology indexes of serum and the occurrence in patients with anaphylaxis induced by Qingkailing Injection,which was composed of cholic acid,mother-of-pearl,gardenia,cornu bubali,isatis root,baicalin,honeysuckle,and to establish the method of detection of the type of in patients with anaphylaxis induced by traditional Chinese medicine injection.METHODS In a prospective nested case-control study,we compared the concentration of IgE,IgG,IL-4,hist... |
| Keywords: | Qingkailing Injection immunotoxicology post-market study anaphylaxis cytokines adverse drug reactions(ADR) pharmacovigilance |
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