新型冠状病毒感染治疗超说明书用药专家共识

标题: 新型冠状病毒感染治疗超说明书用药专家共识
title: Expert Consensus on Off-label Use in the Treatment of COVID-19 Infection
版本: 原创版
version: Original
分类: 专家共识
classification: Experts consensus
领域: 治疗
field: Treatment
国家和地区: 中国
Country and region: China
指南使用者: 各级临床医生(包括药学和其他领域)
Guide users: Clinical physicians at all levels (including pharmacy and other relevant fields)
证据分级方法: Thomson分级系统
Evidence grading method: Thomson grading system
制定单位: 中山大学孙逸仙纪念医院
Formulating unit: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
注册时间: 2023-01-08
Registration time:
注册编号: PREPARE-2023CN017
Registration number:
指南制订的目的: 近年来,新型冠状病毒感染的治疗一直是医疗领域的重点,尽管国内已有一些针对新冠病毒感染治疗的药物上市,但随着新冠病毒治疗方案的不断更新,以及药物的可及性等问题,药品说明书所批准的适应证、适用人群、用法用量、给药途径等不足以满足真实世界的治疗需求,药品超说明书用法客观存在,其科学性、合理性亟待探讨。本共识旨在基于国内外药品说明书注册内容、指南共识、临床研究等循证医学证据内容,对新冠病毒感染治疗中的超说明书用法进行循证评价,然后由专家组形成新冠病毒感染治疗超药品说明书用药的专家推荐意见,为临床医生提供合理用药依据,进一步规范新冠病毒感染治疗超药品说明书用药的临床应用。
Purpose of the guideline: In recent years, the treatment of patients with COVID-19 infection has been a major focus in the medical field. Although a number of drugs have been marketed for the treatment of COVID-19 infection in China, with the continuous updating of COVID-19 treatment regimens and the accessibility of drugs, the approved indications, applicable population, dosage, and route of administration of drug label are not sufficient to meet the real-world treatment needs. The off-label use of drugs indeed exists objectively, and its scientificity and rationality is in urgent need of discussion. This consensus aims to conduct evidence-based evaluation of off-label use in the treatment of COVID-19 infection based on the contents of domestic and foreign drug label registration, guideline, consensus, clinical research and other evidence-based medical evidence, and then the expert recommendation of off-label use in the treatment of COVID-19 infection will be formed by the expert group, so as to provide the basis for rational drug use for clinicians and further standardize the clinical application of off-label use of drugs for COVID-19 infection.