血清免疫毒理学指标变化与清开灵注射液致患者过敏反应发生的相关性：一项临床研究

[Correlation between change of immunotoxicology indexes of cerum and the occurrence of anaphylaxis in patients induced by qingkailing injection: a clinical study].

作者信息

Zhao Yubin, Xiao Ying, Xie Yanming

机构信息

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2011 Sep;36(18):2579-83.

PMID:22256770

Abstract

OBJECTIVE

To determine the relation between the change of immunotoxicology indexes of serum and the occurrence of anaphylaxis in patients induced by Qingkailing injection, which is composed by cholic acid, mother-of-pearl, gardenia, cornu bubali, isatis root, baicalin, honeysuckle, and to establish the method of detection of the type of anaphylaxis in patients induced by traditional Chinese medicine (TCM) injection.

METHOD

In a prospective nested case-control study, we compared the concentration of IgE, IgG, IL-4, histamine of 18 cases in anaphylaxis induced by Qingkailing injection with those from 72 matched controls who remained normal after the using Qingkailing injection. The correlation between the change of IgE, IgG, IL-4, histamine of serum and the occurrence of anaphylaxis in patients induced by Qingkailing injection was determined, and we also evaluate the clinical values of IgE, IgG, IL-4, histamine of serum in diagnosis of anaphylaxis in patients induced by Qingkailing injection by receiver operating characteristic (ROC) curves.

RESULT

The concentrations of IgE, IgG, IL-4, histamine of serum of 18 cases were significantly higher than those in controls (P<0.05), the area under the curve (AUC) of IL-4, IgG, IgE, histamine were 0.362 (95.0% CI. for EXP was 0.978-2.405), 0.349 (95.0% CI. for EXP was 1.448-316.232), 0.350 (95.0% CI. for EXP was 1.262-601.306), 0.374 (95.0% CI. for EXP was 1.003-45.413), respectively.

CONCLUSION

The allergic reaction caused by Qingkailing injection may be due to type I allergic reactions; The presence of IgE, IgG, IL-4, Histamine can serve as clinical evaluation indicators in evaluation the damage degree of immune system caused by anaphylaxis in patients induced by Qingkailing injection. Cytokines are more likely to become the effective evaluation index in diagnosis of anaphylaxis in patients induced by TCM injection.

摘要

目的

探讨由胆酸、珍珠母、栀子、水牛角、板蓝根、黄芩、金银花组成的清开灵注射液致患者血清免疫毒理学指标变化与过敏反应发生的关系，建立中药注射剂致过敏反应类型的检测方法。

方法

采用前瞻性巢式病例对照研究，比较18例清开灵注射液致过敏反应患者与72例使用清开灵注射液后未出现不良反应的匹配对照者的血清IgE、IgG、IL-4、组胺浓度。确定血清IgE、IgG、IL-4、组胺变化与清开灵注射液致患者过敏反应发生的相关性，并通过受试者工作特征（ROC）曲线评估血清IgE、IgG、IL-4、组胺在诊断清开灵注射液致患者过敏反应中的临床价值。

结果

18例患者血清IgE、IgG、IL-4、组胺浓度显著高于对照组（P<0.05），IL-4、IgG、IgE、组胺的曲线下面积（AUC）分别为0.362（95.0%CI.EXP为0.978 - 2.405）、0.349（95.0%CI.EXP为1.448 - 316.232）、0.350（95.0%CI.EXP为1.262 - 601.306）、0.374（95.0%CI.EXP为1.003 - 45.413）。