免疫检查点抑制剂超说明书用药实践指南

Practice Guideline for Off-label Use of Immune Checkpoint Inhibitors

摘要:
目的为免疫检查点抑制剂(immune checkpoint inhibitors，ICIs)超说明书用药提供参考，促进ICIs临床合理用药。
方法组建多学科的专家团队，在循证证据的基础上，通过多轮专家研讨，形成ICIs超说明书用药实践指南。
结果共纳入有充分循证证据支持的超说明书用药条目212条，其中CTL-A4抑制剂20条，PD-1抑制剂179条，PD-L1抑制剂13条。
结论本指南明确了循证证据充分的ICIs超说明书用药范围，为ICIs的超说明书用药管理提供了实用的参考资料。

Abstract:
OBJECTIVE To provide reference for the off-label use of immune checkpoint inhibitor(ICIs), and to promote the clinical rational use of ICIs.
METHODS A multi-disciplinary expert team was set up, and the practice guidelines was formed through many rounds of expert discussion on the basis of evidence-based medicine.
RESULTS A total of 212 items of off-label use supported by sufficient evidence were included, including 20 items about CTL-A4 inhibitors, 179 items about PD-1 inhibitors and 13 items about PD-L1 inhibitors.
CONCLUSION This guide clarify the off-label use of ICIs with sufficient evidence, and provides a practical reference for ICIs off-label use management.