Investigation of off-label use of immune checkpoint inhibitors in China
10.3969/j.issn.1673-9701.2025.23.011
- VernacularTitle:中国免疫检查点抑制剂超说明书用药现状调研
- Author:
Xuyin JIN
1
;
Xiaowei ZHENG
;
Xiaochun ZHENG
;
Jiang LOU
;
Ziqi YE
;
Wenxiu XIN
;
Bei SUI
;
Ping HUANG
Author Information
1. 浙江工业大学药学院,浙江 杭州 310014
- Publication Type:Journal Article
- Keywords:
Immune checkpoint inhibitors;
Off-label use;
Questionnaires
- From:
China Modern Doctor
2025;63(23):46-49
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the current situation of off-label use of immune checkpoint inhibitors(ICIs)in China and the cognition of medical staff.Methods From August 31 to September 9,2022,a nationwide survey questionnaire was sent to medical staff in the form of electronic questionnaire.The questionnaire included 13 questions,covering four dimensions:Drug allocation,current situation of medication beyond the instructions,cognition of medication beyond the instructions and current situation of medication beyond the instructions.Results A total of 745 questionnaires were collected.75.70％of respondents reported off-label use of ICIs in their hospitals,with the most common type being off-label indications.The primary reasons for such practices included support from authoritative domestic and international guidelines,clinical research data validation,and approved indications in foreign regulatory documents.85.37％of respondents believed off-label use could offer new hope for patients,while 68.86％considered it unlikely to increase adverse reactions.44.97％of respondents' hospitals had not established off-label use registration systems for ICIs.88.86％of respondents emphasized the need for stricter regulations governing off-label use of immunotherapeutic agents.Conclusion Off-label use of ICIs is common,and there is a lack of unified guidance in clinical practice.It is urgent to form norms and consensus on the management of off-label use of ICIs.
