中南药学

近年来，免疫检查点抑制剂(ICIs)在多种恶性肿瘤中显著改善预后，其适应证快速拓展，真实世界中出现大量基于指南、境外说明书及高质量证据支持的超说明书用药(OLDU)现象。然而，在保障患者获益的同时防止不当扩大适应证与滥用，已成为迫切的临床与管理问题。本综述围绕ICIs超说明书用药的法规基础、制度化管理进展、各省实践经验及循证证据等级体系进行系统梳理，重点呈现湖南省在制定地方共识过程中采用的多学科协作方式、条目化证据呈现路径及推荐级别的确定方法。本专家共识旨在为医疗机构规范ICIs超说明书用药、完善管理流程、落实知情同意及不良反应监测提供可操作的参考框架。

In recent years,immune checkpoint inhibitors (ICIs) have markedly improved clinical outcomes across various malignancies.Consequently,off-label drug use (OLDU) of ICIs,supported by clinical guidelines,foreign drug labels,and high-quality evidence,has become common in practice.Balancing patient benefit while preventing inappropriate indication expansion and misuse is an urgent challenge.This review summarized the regulatory foundations,institutionalized management progress,provincial experiences,and evidence grading systems related to OLDU of ICIs in China.We focused on the multidisciplinary development,evidence-based itemization,and grade recommendation in Hunan province consensus.This paper aims to provide a practical framework to support standardized use,management procedures,informed consent,and adverse event monitoring OLDU of ICIs in medical institutions.