免疫治疗药物和抗新型冠状病毒药物在新型冠状病毒感染中的OLDU指引——特殊人群用药

Off-Label Drug Use Medication Guidelines of Immunotherapy Drugs and COVID-19 Antiviral Drugs for COVID-19 in Vulnerable Populations

超药品说明书用药(OLDU)在世界范围内是非常普遍的现象。但是OLDU如无充分的循证证据支持,一旦发生不良事件,易引起纠纷。特别是对于老年人、儿童、妊娠期妇女等特殊人群的OLDU需要格外谨慎。该文参考国内外药品说明书和最新指南、临床研究等循证医学证据,对新型冠状病毒感染(新冠)治疗中免疫治疗药物和抗新型冠状病毒药物的超说明书内容进行整理汇总,特别关注特殊人群的OLDU,形成对应的OLDU指引,以期为临床用药需求提供参考,促进合理用药。

Off-label drug use(OLDU)is extremely common worldwide.However,if the safety of OLDU cannot be supported by sufficient evidence-based medicine,it will lead to legal disputes when it causes adverse events.OLDU should be considered with cautions especialy for vulnerable populations,such as the elderly,children and pregnant women.In this article,according to of-lab contents and upto-date guidelines,clinical trials and other evidence-based medicine at home and abroad,OLDU medication guidelines of immunotherapy drugs and COVID-19 antiviral drugs for COVID-19 therapy were collected and compiled.OLDU guidelines were formulated especially for the vulnerable populations,aiming to provide reference for clinical drug requirement and promote rational drug use.