静注人免疫球蛋白在其适应证及超适应证中应用的研究进展

Progress in research on application of human immunoglobulin for intravenous injection in indications and off-label indications

静注人免疫球蛋白(human immunoglobulin for intravenous injection,IVIG)作为一种重要的人免疫球蛋白制品广泛应用于多种疾病的预防和治疗。目前,美国食品药品监督管理局(Food and Drug Administration,FDA)批准的IVIG适应证有8种,中国食品药品监督管理局(China Food and Drug Administration,CFDA)批准的适应证为4类。由于药品说明书内容的局限性、修订的滞后性及复杂性,在实际临床诊疗过程中,国内外更多的是将IVIG用于超适应证治疗。因此,本文就IVIG在其适应证及超适应证中应用的研究进展作一综述,以期深入了解国内外IVIG的超适应证用药情况,为IVIG的合理使用提供参考。

Human immunoglobulin for intravenous injection(IVIG),an important human immunoglobulin product,is widely used in the prevention and treatment of a variety of diseases. At present,there are eight indications for IVIG approved by the Food and Drug Administration(FDA),while only four by the China Food and Drug Administration(CFDA). However,due to the limitation of content of instruction as well as hysteresis and complexity of the revision,IVIG is more commonly used for the treatment of off-label indications in actual clinical diagnosis and treatment at home and abroad. Therefore,this paper reviews the progress in research on application of IVIG in indications and off-label indications,in order to deeply understand the application of IVIG in off-label indications at home and abroad and provide a reference for the rational use of IVIG.