Medication Therapy of High-Dose Methotrexate: An Evidence-Based Practice Guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society.
机构：[1]Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China[2]Institute for drug evaluation, Peking University Health Science Center, Beijing 100191, China[3]Therapeutic Drug Monitoring and Clinical Toxicology Center, Peking University, Beijing 100191, China[4]Department of Pharmacy, China-Japan Friendship Hospital, Beijing 100029, China[5]Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China四川大学华西医院[6]Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100050, China[7]Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Cancer Center/National Clinical Research Center for Cancer, Beijing 100021, China[8]Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China[9]Department of Pharmacy, Harbin Medical University Cancer Hospital, Harbin 150040, China[10]Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan 250012, China[11]Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing 100044, China[12]Department of Pharmacy, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou 510060, China[13]Peking University Institute of Hematology, Peking University People's Hospital, National Clinical Research Center for Hematologic Disease, Beijing 100044, China[14]Department of Hematology, Peking University Third Hospital, Beijing 100191, China[15]Department of Pharmacy, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Cancer Center/National Clinical Research Center for Cancer, Beijing 100021, China[16]Department of Clinical Pharmacology, First Affiliated Hospital of Soochow University, Suzhou 215006, China[17]Department of Orthopedic Oncology, Beijing Jishuitan Hospital and Fourth Medical College of Peking University, Beijing 100035, China[18]Department of Pharmacy, The first Affiliated Hospital of Chongqing Medical University, Chongqing 400042, China重庆医科大学附属第一医院[19]Department of Musculoskeletal Oncology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, China中山大学附属第一医院[20]Department of Hematology/Oncology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Key Lab of Pediatric Hematology & Oncology of China Ministry of Health, Shanghai 200127, China[21]Hematology Oncology Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China首都医科大学附属北京儿童医院[22]Department of Pharmacy, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China首都医科大学附属北京儿童医院[23]Department of Pharmacy, Shanghai Changhai Hospital, Second Military Medical University, Shanghai 200433, China[24]Pharmacy Department, The 306th Hospital of PLA, Beijing 100101, China[25]Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100083, China[26]Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China[27]Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha 410011, China[28]Department of Pharmacy/Evidence-Based Pharmacy Centre, West China Second University Hospital, Sichuan University, Chengdu 610041, China[29]Department of Pharmacy, Peking University Cancer Hospital and Institute, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing 100142, China[30]Department of Pharmacy, Jishuitan Hospital and Fourth Medical College of Peking University, Beijing 100035, China[31]Department of Pharmacy, Shengjing Hospital of China Medical University, Shenyang 110004, China中国医科大学附属盛京医院[32]Hematology Oncology Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China首都医科大学附属北京儿童医院[33]Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China
A lot of medication risks related to high-dose methotrexate (HDMTX) therapy still remain to be identified and standardized. This study aims to establish an evidence-based practice guideline for individualized medication of HDMTX.The practice guideline was launched by the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society. The guideline was developed following the WHO handbook for guideline development and the methodology of evidence-based medicine (EBM). The guideline was initially registered in the International Practice Guidelines Registry Platform (IPGRP-2017CN021). Systematic reviews were conducted to synthesis available evidence. A multicenter cross-sectional study was conducted by questionnaires to evaluate patients' perception and willingness on individualized medication of HDMTX. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to rate the quality of evidence and to grade the strength of recommendations.Multidisciplinary working groups were included in this guideline, including clinicians, pharmacists, methodologists, pharmacologists and pharmacoeconomic specialists. A total of 124 patients were involved to integrate patient values and preferences. Finally, the guideline presents 28 recommendations, regarding evaluation prior to administration (renal function, liver function, pleural effusion, comedications, genetic testing), pre-treatment and routine dosing regimen, therapeutic drug monitoring (necessity, method, timing, target concentration), leucovorin rescue (initial timing, dosage regimen and optimization), management of toxicities. Of them, 12 are strong recommendations.We developed an evidence-based practice guideline with respect to HDMTX medication using a rigorous and multidisciplinary approach. This guideline provides comprehensive and practical recommendations involving the whole process of HDMTX administration to health care providers.This article is protected by copyright. All rights reserved.
基金：
This work was supported by the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society, and the National Natural Science Foundation of China (NSFC) (grant number 72074005).
第一作者机构：[1]Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China[2]Institute for drug evaluation, Peking University Health Science Center, Beijing 100191, China[3]Therapeutic Drug Monitoring and Clinical Toxicology Center, Peking University, Beijing 100191, China
通讯作者：
通讯机构：[1]Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China[2]Institute for drug evaluation, Peking University Health Science Center, Beijing 100191, China[3]Therapeutic Drug Monitoring and Clinical Toxicology Center, Peking University, Beijing 100191, China[*1]Department of Pharmacy, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.
推荐引用方式(GB/T 7714)：
Zaiwei Song,Yang Hu,Shuang Liu,et al.Medication Therapy of High-Dose Methotrexate: An Evidence-Based Practice Guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society.[J].BRITISH JOURNAL OF CLINICAL PHARMACOLOGY.2022,88(5):2456-2472.doi:10.1111/bcp.15134.
APA：
Zaiwei Song,Yang Hu,Shuang Liu,Guanru Wang,Suodi Zhai...&Rongsheng Zhao.(2022).Medication Therapy of High-Dose Methotrexate: An Evidence-Based Practice Guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society..BRITISH JOURNAL OF CLINICAL PHARMACOLOGY,88,(5)
MLA：
Zaiwei Song,et al."Medication Therapy of High-Dose Methotrexate: An Evidence-Based Practice Guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society.".BRITISH JOURNAL OF CLINICAL PHARMACOLOGY 88..5(2022):2456-2472
