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Medication Therapy of High-Dose Methotrexate: An Evidence-Based Practice Guideline Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society
  • +39
  • Song Zaiwei,
  • Yang Hu,
  • Shuang Liu,
  • Guanru Wang,
  • Suo-Di Zhai,
  • Xianglin Zhang,
  • Youping Li,
  • Guanhua Du,
  • Yuankai Shi,
  • Yaolong Chen,
  • Mei Dong,
  • Guo Rui-chen,
  • Wei Guo,
  • Hongbing Huang,
  • Xiaojun Huang,
  • Hongmei Jing,
  • Xiaoyan Ke,
  • Guohui Li,
  • Liyan Miao,
  • Xiaohui Niu,
  • Feng Qiu,
  • Jingnan Shen,
  • Jingyan Tang,
  • Tian-You Wang,
  • Xiaoling Wang,
  • Zhuo Wang,
  • Jiuhong Wu,
  • Si-Yan Zhan,
  • Bi-kui Zhang,
  • Lingli Zhang,
  • Yanhua Zhang,
  • Wei Zhang,
  • Li Zhao,
  • Li-bo Zhao,
  • Jiancun Zhen,
  • Huyong Zheng,
  • Zhu Zhu,
  • Dan Jiang,
  • Zhencheng Huang,
  • Zhiyuan Tan,
  • Qiaonan Lin,
  • Rongsheng Zhao
Song Zaiwei
Peking University Third Hospital

Corresponding Author:songzw445@126.com

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Yang Hu
Peking University Third Hospital
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Shuang Liu
Peking University Third Hospital
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Guanru Wang
Peking University Third Hospital
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Suo-Di Zhai
Peking University Third Hospital
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Xianglin Zhang
China-Japan Friendship Hospital
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Youping Li
Sichuan University West China Hospital
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Guanhua Du
Chinese Academy of Medical Sciences and Peking Union Medical College
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Yuankai Shi
Chinese Academy of Medical Sciences and Peking Union Medical College
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Yaolong Chen
Lanzhou University School of Basic Medical Sciences
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Mei Dong
Harbin Medical University Third Hospital
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Guo Rui-chen
Shandong University Qilu Hospital
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Wei Guo
Peking University People's Hospital
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Hongbing Huang
Sun Yat-sen University Cancer Center
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Xiaojun Huang
Peking University People's Hospital
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Hongmei Jing
Peking University Third Hospital
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Xiaoyan Ke
Peking University Third Hospital
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Guohui Li
Chinese Academy of Medical Sciences and Peking Union Medical College
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Liyan Miao
First Affiliated Hospital of Soochow University
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Xiaohui Niu
Beijing Jishuitan Hospital
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Feng Qiu
The First Affiliated Hospital of Chongqing Medical University
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Jingnan Shen
Sun Yat-sen University First Affiliated Hospital
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Jingyan Tang
Shanghai Childrens Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
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Tian-You Wang
Beijing Children's Hospital Capital Medical University
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Xiaoling Wang
Beijing Children's Hospital Capital Medical University
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Zhuo Wang
Changhai Hospital
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Jiuhong Wu
The 306th Hospital of People's Liberation Army
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Si-Yan Zhan
Peking University School of Public Health
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Bi-kui Zhang
Second Xiangya Hospital
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Lingli Zhang
Sichuan University West China Second University Hospital
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Yanhua Zhang
Peking University Cancer Hospital
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Wei Zhang
Jishuitan Hospital and Fourth Medical College of Peking University
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Li Zhao
Shengjing hospital of China medical university
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Li-bo Zhao
Beijing Children's Hospital Capital Medical University
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Jiancun Zhen
Jishuitan Hospital and Fourth Medical College of Peking University
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Huyong Zheng
Beijing Children's Hospital Capital Medical University
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Zhu Zhu
Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,
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Dan Jiang
Peking University Third Hospital
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Zhencheng Huang
Peking University Third Hospital
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Zhiyuan Tan
Peking University Third Hospital
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Qiaonan Lin
Peking University Third Hospital
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Rongsheng Zhao
Peking University Third Hospital
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Abstract

Objectives: 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. Methods: 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. Results: 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 medication (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. Conclusions: 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 medication to health care providers.
17 May 2021Submitted to British Journal of Clinical Pharmacology
21 May 2021Submission Checks Completed
21 May 2021Assigned to Editor
03 Jun 2021Reviewer(s) Assigned
23 Jul 2021Review(s) Completed, Editorial Evaluation Pending
10 Aug 2021Editorial Decision: Revise Minor
22 Aug 20211st Revision Received
23 Aug 2021Submission Checks Completed
23 Aug 2021Assigned to Editor
23 Aug 2021Review(s) Completed, Editorial Evaluation Pending
16 Sep 2021Editorial Decision: Revise Minor
26 Sep 20212nd Revision Received
01 Oct 2021Submission Checks Completed
01 Oct 2021Assigned to Editor
01 Oct 2021Review(s) Completed, Editorial Evaluation Pending
15 Oct 2021Editorial Decision: Accept