皮下注射人免疫球蛋白药物的临床研究进展  

Progress in clinical research of subcutaneous immunoglobulin

作　　者：兰志龙 王磊 张松 李智慧 王俊龙 倪娜 LAN Zhilong;WANG Lei;ZHANG Song;LI Zhihui;WANG Junlong;NI Na(Clinical Research Center,China State Institute of Pharmaceutical Industry,Shanghai 200437,China;Shanghai InnoClinic Pharmaceutical Development Co,Ltd.,Shanghai 200437,China)

机构地区：[1]中国医药工业研究总院药物临床研究中心,上海200437 [2]上海益临思医药开发有限公司,上海200437

出　　处：《世界临床药物》2024年第7期794-798,共5页World Clinical Drug

摘　　要：免疫球蛋白被认为可用于治疗多种疾病,不仅因其能够作为替代疗法对抗感染,而且还具有免疫调节作用。适当使用免疫球蛋白能挽救生命。然而,其给药途径可能会导致许多不良反应和潜在的其他不良后果,目前国内临床上使用的以静脉注射免疫球蛋白为主,但在临床使用过程中不良反应偏多,患者依从性也不高。迫于这种未被满足的临床需求,在国外研制出皮下注射人免疫球蛋白(subcutaneous immunoglobulin,SCIg),目前已在多个临床适应证领域被应用,但国内SCIg尚处于前期探索和研发阶段,面对国内巨大的临床需求,促使国内血液制品研发企业加快研发不同规格及针对不同适应证的SCIg药物。该文主要就SCIg在治疗原发性免疫缺陷病、自身免疫性神经肌肉疾病及其他罕见病领域最新临床研究进展作综述,以期为我国血液制品研发企业提供新的研发思路及建议。Immunoglobulin is recognized to be used for the treatment of various diseases,not only because it can serve as an alternative therapy against infections,but also because of its immunomodulatory effects.Appropriate use of immunoglobulins can save lives.However,its route of administration may lead to many adverse events and potential other adverse consequences.At present,intravenous immunoglobulin is the main clinical use in China,but there are more adverse events in the process of clinical use,and the patient compliance is not high.Due to this unmet clinical need,subcutaneous immunoglobulin(SCIg)has been developed abroad,which has been used in multiple clinical indications.However,SCIg in China is still in the early stage of exploration and research and development.Faced with the huge clinical needs in China,domestic blood product research and development companies have been encouraged to accelerate the research and development of SCIg drugs of different specifications and different indications to meet the treatment needs of domestic patients.This article reviewed the latest clinical research progress of SCIg in the treatment of primary immunodeficiency diseases,autoimmune neuromuscular diseases and other rare diseases,in order to provide new research and development ideas and suggestions for blood product research and development enterprises in China.

关 键 词：皮下注射人免疫球蛋白 原发性免疫缺陷病 自身免疫性神经肌肉疾病 罕见病 

分 类 号：R945[医药卫生—微生物与生化药学]