精蛋白生物合成人胰岛素(预混30R)诱发外源性胰岛素抗体综合征1例

A case of extrinsic insulin antibody syndrome induced by protamine biosyn thetic human insulin(premix 30R)

目的:本文主要是探讨一种预混人胰岛素(诺和灵30R)引起的外源性胰岛素抗体综合征(EIAS),以及其对病人的影响,旨在提高对此类疾病的认识、探讨含鱼精蛋白的重组人胰岛素产生免疫原性的可能机制。方法:临床药师全程参与了一例EIAS患者的治疗,以确保其获得最佳疗效。梳理患者的既往用药史、疾病史及本次住院治疗的全过程,分析疾病产生的原因,分析在有限检测技术下区分胰岛素抗体(insulin antibody,IAb)和胰岛素自身抗体(insulin autoantibody,IAA)的方法,分析诺和灵30R中能被机体识别的抗原成分。结果:通过排除体内可能产生IAA的因素,使检测的胰岛素相关抗体仅反映IAb的实际含量,从而解决了现有检测技术难以区分IAb和IAA的难题。诺和灵30R诱导IAb产生的原因可能是其中的鱼精蛋白诱导机体产生了较强的免疫原性。结论:不同胰岛素因其结构特点或附加成分的不同,诱发机体产生免疫原性的机制具有一定差异,借助于这种差异性可以为IAb易感患者或已诊断为EIAS的患者选择胰岛素种类提供更多的参考,从而提高药物使用的安全性和有效性。

Objective:To investigate the exogenous insulin antibody syndrome(EIAS)caused by a premix human insulin(Norheline 30R)and its effects on patients,in order to improve the understanding of this disease and explore the possible mechanism of immunogenicity of recombinant human insulin containing protamine.Methods:Clinical pharmacists were fully involved in the treatment of a patient with EIAS to ensure optimal outcomes.Summarize the patient’s previous medication history,disease history and the whole process of hospitalization,and analyze the causes of the disease.Methods of distinguishing insulin antibody(IAb)from insulin autoantibody(IAA)with limited detection techniques were analyzed to analyze the antigenic components of Norhorin 30R that are recognized by the body.Results:By eliminating the factors that may produce IAA,the insulin-related antibodies detected only reflect the actual content of IAb,thus solving the problem that the existing detection technology is difficult to distinguish IAb and IAA.The reason why norheline 30R induced IAb might be that protamine induced strong immunogenicity in the body.Conclusion:Different insulins have different mechanisms to induce immunogenicity due to their different structural characteristics or additional components.This difference can provide more references for IAB-prone patients or patients diagnosed with EIAS to select insulin types,so as to improve the safety and effectiveness of drug use.