《中国大剂量甲氨蝶呤循证用药指南》解读  

Interpretation for Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China

作　　者：宋再伟 刘爽 赵荣生[1,2] 翟所迪 张相林[3] 李幼平 杜冠华[5] 石远凯[6] 缪丽燕 张伶俐[8] 景红梅[9] SONG Zaiwei;LIU Shuang;ZHAO Rongsheng;ZHAI Suodi;ZHANG Xianglin;LI Youping;DU Guanhua;SHI Yuankai;MIAO Liyan;ZHANG Lingli;JING Hongmei(Dept.of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China;Dept.of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China;Chinese Evidence-based Medicine Center,West China Hospital of Sichuan University,Chengdu 610041,China;Beijing Key Laboratory of Drug Target Identification and Drug Screening,Institute of Materia Medica,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100050,China;Dept.of Internal Medicine,Cancer Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100021,China;Dept.of Pharmacy,the First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215006,China;Dept.of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610044,China;Dept.of Hematology,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]北京大学第三医院药剂科,北京100191 [2]北京大学医学部药物评价中心,北京100191 [3]中日友好医院药学部,北京100029 [4]四川大学华西医院中国循证医学中心,成都610041 [5]中国医学科学院北京协和医学院药物研究所药物靶点研究与新药筛选北京市重点实验室,北京100050 [6]中国医学科学院北京协和医学院肿瘤医院内科,北京100021 [7]苏州大学附属第一医院药学部,苏州215006 [8]四川大学华西第二医院药学部,成都610044 [9]北京大学第三医院血液内科,北京100191

出　　处：《中国药房》2022年第16期2032-2039,共8页China Pharmacy

基　　金：国家自然科学基金资助项目(No.72074005)。

摘　　要：《中国大剂量甲氨蝶呤循证用药指南》于2022年2月发表在British Journal of Clinical Pharmacology上,该指南严格遵从临床实践指南的最新定义与世界卫生组织指南制订的方法学规范,采用推荐分级的评价、制定与评估(GRADE)工具进行证据质量评价与推荐意见强度分级,最终形成涵盖大剂量甲氨蝶呤临床用药全流程的28条推荐意见,涉及用药前评估(肝肾功能、胸腔积液与腹水、合并用药、基因检测)、预处理与常规给药方案(水化碱化预处理、尿液碱化、常规给药方案)、治疗药物监测(必要性、方法、时机、目标浓度)、亚叶酸钙解救(解救时机、解救方案、解救剂量优化)、不良事件管理(肝肾功能监测、支持治疗、血液净化治疗)等。本文旨在对指南的推荐意见进行中文版本的总结和解读,以促进指南更好地在我国进行推广实施,为大剂量甲氨蝶呤全程个体化给药提供全面的技术支撑和使用建议。Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China was published in the British Journal of Clinical Pharmacology in February 2022.The guideline followed the latest definition of clinical practice guideline and the methodology specification for the guideline development of WHO.The Grading of Recommendations Assessment,Development,and Evaluation(GRADE)approach was applied to rate the quality of evidence and determine the strength of recommendations.Finally,this guideline presents 28 recommendations covering the whole process of clinical medication of high-dose methotrexate,involving evaluation prior to administration(liver and renal function,pleural effusion and ascites,comedication,genetic testing),pre-treatment and routine dosing regimen(pretreatment of hydration and alkalization,urine alkalization,routine dosing regimen),therapeutic drug monitoring(necessity,method,timing,target concentration),leucovorin rescue(rescue timing,rescue regimen,rescue dose optimization),and management of toxicities(liver and kidney function monitoring,supportive treatment,blood purification treatment).This article aims to summarize and interpret the recommendations of this guideline,so as to promote the better promotion and implementation of this guideline and provide comprehensive technical support and suggestions for whole-course individualized administration of high-dose methotrexate in China.

关 键 词：临床实践指南 大剂量甲氨蝶呤 循证用药 治疗药物监测 个体化给药 

分 类 号：R979.1[医药卫生—药品] R969.3[医药卫生—药学] R733