生物类似药临床应用的循证评价及循证指南制定方案

Clinical medication of biosimilars:an evidence-based review and protocol of clinical practice guideline

生物类似药的临床应用面临诸多问题,临床长期应用的有效性与安全性监测、未获批适应证的外推应用、互换用药及药物警戒等方面亟待规范。目前国内外尚无基于循证医学证据的生物类似药用药指南,制定一部循证指南对规范生物类似药的临床全流程应用十分必要。本文对现有生物类似药相关指导文件和系统评价进行全面检索与循证分析,结合生物类似药临床应用现状,对《中国生物类似药临床应用循证指南》制定方案进行详细介绍。本指南由北京大学第三医院药剂科发起,中国药学会循证药学专业委员会、中国药学会医院药学专业委员会、中国药理学会治疗药物监测研究专业委员会、海峡两岸医药卫生交流协会医院药学专业委员会批准制定。指南已在国际实践指南注册平台注册,注册号:IPGRP-2020CN172。指南制定过程将基于循证医学证据,严格参照世界卫生组织指南制定手册的制定步骤,参考美国医学研究所最新指南定义、GRADE工具、指南研究与评价工具及卫生保健实践指南报告条目标准,并由多学科多地域专家共同完成。本指南的制定旨在为生物类似药临床应用全流程提供循证指导,以提高生物类似药用药的安全性、有效性与经济性。

Currently many problems persist in clinical medication of biosimilars,lacking guidance on efficacy and safety monitoring,unapproved indication extrapolation,interchangeability and pharmacovigilance.Thus it is urgent to develop an evidence-based guideline for dosing biosimilars as there is no such existing clinical practice guideline.Along with a current status review of clinical medication of biosimilars,this article conducted a comprehensive evidence-based analysis of the existing guidance and systematic reviews related to biosimilars and introduced the protocol of clinical practice guideline for clinical medication of biosimilars.This guideline is initiated by Department of Pharmacy,Peking University Third Hospital and endorsed by the following organizations:Evidence-based Pharmacy Professional Committee of Chinese Pharmaceutical Association,Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association,Chinese Pharmacology Society-Division of Therapeutic Drug Monitoring,Hospital Pharmacy Professional Committee of Cross-Straits Medicine Exchange Association.The guideline has been registered with International Practice Guidelines Registration Platform under the registration number of IPGRP-2020CN172.In accordance with IOM's latest definition of practice guideline,framework of GRADE instrument,AGREE II instrument and RIGHT criterion,this evidence-based guideline widely covers multiple disciplines.The development of this clinical practice guideline shall promote to standardize the clinical medication of biosimilars,effectively guide the evidence-based practice and improve the efficacy,safety and economic efficiency of biosimilars in clinical applications.