采用AGREEⅡ工具评价抗肿瘤药物心脏毒性预防用药指南  

Appraisal of Guidelines on Drug Prevention for Cardiotoxicity of Cancer Therapy with the AGREEⅡTool

作　　者：胡志强 漆婷婷 蒋倩[1] 程凯[1] 马雪[1] 蒋刚[1] 肖洪涛 Hu Zhiqiang;Qi Tingting;Jiang Qian;Cheng Kai;Ma Xue;Jiang Gang;Xiao Hongtao(Department of Pharmacy,Sichuan Cancer Hospital,Chengdu 610041,China)

机构地区：[1]四川省肿瘤医院药学部,成都610041

出　　处：《药物流行病学杂志》2020年第4期268-275,共8页Chinese Journal of Pharmacoepidemiology

基　　金：四川省干部保健科研课题(编号:川干研2018-804);中华医学会临床药学分会吴阶平医学基金会科研课题(编号:320.6750.19090-27)。

摘　　要：目的:评价抗肿瘤药物相关心脏毒性预防指南的质量,比较推荐预防用药的异同,为临床决策提供循证依据。方法:计算机检索PubMed、EMbase、CNKI、WanFang Data、SinoMed、国际指南联盟(GIN)、美国国家指南文库(NGC)、国家卫生与临床优化研究所(NICE)及美国国立综合癌症网络(NCCN)、欧洲肿瘤内科学会(ESMO)、美国临床肿瘤学会(ASCO)等中英文数据库、指南和协会网站,收集抗肿瘤药物相关心脏毒性的指南,采用指南研究与评价工具Ⅱ(AGREEⅡ)评价纳入指南的方法学质量,比较各指南药物推荐的异同。结果:共纳入7篇指南,分别来自美国(ASCO)、加拿大(CCS)、欧洲(ESC、ESMO)、意大利(ISC)和中国(CSCO)。3篇为循证指南(ASCO、CCS、ESMO),其中2篇采用GRADE证据分级标准,1篇采用IDSA-USPHS标准。AGREEⅡ评价结果显示,仅1篇高质量指南(ASCO),中等质量3篇(CCS、ESC、ESMO),低质量3篇(ISC两篇、CSCO)。循证指南在"参与人员""制定的严谨性""应用性"和"编辑的独立性"等领域得分明显高于非循证指南。蒽环类药物和曲妥珠单抗所致左心室功能障碍(LVD)/心力衰竭(HF)的预防用药,国外基本一致,但与中国不同。国外指南强调对高风险心脏毒性人群的识别和评估,推荐的有效预防药物包括血管紧张素转换酶抑制药(ACEI)、血管紧张素受体阻断药(ARB)、β受体阻断药、右雷佐生等,但强调右雷佐生不作为常规预防使用,仅推荐用于蒽环类高累积剂量者。中国指南仅推荐右雷佐生作为预防用药,且强调首次使用蒽环类药物时应用。结论:循证指南整体质量高于非循证指南,中国尚缺乏高质量的循证指南指导临床实践。ACEI、ARB、β受体阻断药为目前高质量指南推荐用于抗肿瘤药物相关心脏毒性预防的主要药物,但推荐的证据质量不高,仍需更多高质量大样本随机对照试验证实。Objective:To systematically review the quality of clinical practice guidelines on medication therapy for cardiotoxicity induced by antitumor therapy,and compare and analyze the drugs recommended from different guidelines,in order to provide references for clinical application.Methods:PubMed,Embase,CNKI,WanFang Data,SinoMed,National Guideline Clearinghouse(NGC),Guidelines International Network(GIN),and National institute of health and clinical excellence(NICE)and relevant web sites(such as NCCN,ESMO,ASCO)were searched to collect guidelines.Methodological quality of included studies was assessed according to the appraisal of Guidelines for Research and EvaluationⅡ(AGREEⅡ)instrument,and the differences and similarities among recommendations were compared.Results:Seven guidelines were identified from America(ASCO),Canada(CSC),Europe(ESC,ESMO),Italy(ISC)and China(CSCO).Three of them were evidence-based guidelines(EBGs)and two used GRADE method,one used IDSA-USPHS evidence grading system.(1)According to the AGREEⅡinstrument,only one high-quality guideline(ASCO),3 moderate-quality guidelines(CCS,ESC,ESMO),3 low-quality guidelines(2 ISC,CSCO).EBGs were better than non-EBGs for reporting in"stakeholder involvement""rigor of development""applicability"and"editorial independence".(2)Therapeutic drugs of patients with heart failure induced by anthracyclines and trastuzumab the different guidelines consistently recommend angiotensin converting enzyme inhibitors(ACEI),angiotensin receptor blockers(ARB),and beta blockers(BB).However,recommendations on prophylactic drugs from Chinese and non-Chinese guidelines were different.①Non-Chinese guidelines emphasize the identification and evaluation of high-risk groups of cardiotoxicity,the ACEI,ARB,BB,and dexrazoxane were recommended as the effective prophylactic drugs.However,dexrazoxane was not recommended routinely used and recommended as a cardioprotectant only for patients who have already had received high cumulative doses of anthracycline therapy before initiation of dex

关 键 词：抗肿瘤治疗 心脏毒性 指南 指南研究与评价工具Ⅱ 心脏保护药物 

分 类 号：R979.1[医药卫生—药品]