Abstract
Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.
概要
多黏菌素 B 是治疗广泛耐药革兰氏阴性细菌感染的最后“一道防线”, 但因剂量限制性肾毒性及低剂量可能出现治疗失败和耐药性, 临床上迫切需要通过治疗药物监测 (TDM) 优化其使用. 多黏菌素 B TDM 专家共识以及规范操作程序的制定将有助于确保 TDM 的准确性并为其合理使用提供依据. 中国药理学学会治疗药物监测研究专业委员会及上海医学会感染与化疗专科分会共同发起制定多黏菌素 B 的 TDM 专家共识. 共识小组由来自中国不同省份的临床药学、 临床医学和临床微生物学专家, 及两位澳大利亚莫纳什大学专家组成, 就多黏菌素 B 进行 TDM 的目标浓度、 样本采集、 测定、 报告和 TDM 结果解释提出了建议. 该指南共识的制定旨在指导多黏菌素 B 的个体化精准治疗.
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This work was supported by the Shanghai Leading Talents Award, Shanghai Municipal Health Commission (No. LJ2016-01) and the Clinical Research Plan of Shanghai Hospital Development Center (No. SHDC2022CRW004). We thank Yalin DONG (the First Affiliated Hospital of Xi’an Jiaotong University), Zhanjun DONG (Hebei General Hospital), Dong LIU (Tongji Medical College of Huazhong University of Science and Technology), Maobai LIU (Fujian Medical University Union Hospital), Xuemei LUO (Nanjing Drum Tower Hospital), Xueyan LIU (Shenzhen People’s Hospital), Suiqin NI (Guangzhou First People’s Hospital), Qi PEI (the Third Xiangya Hospital of Central South University), Yi QIN (the First Affiliated Hospital of Soochow University), Jingwen WANG (Xijing Hospital), Li WEI (the First Affiliated Hospital of Guangzhou Medical University), Yanzhe XIA (the First Affiliated Hospital, Sun Yat-sen University), Hengjie YUAN (Tianjin Medical University General Hospital), Mingjie YU (the Southwest Hospital of Army Medical University), Qiwen YANG (Peking Union Medical College Hospital), Xiuling YANG (the Second Hospital of Hebei Medical University), Yuetian YU (Renji Hospital, School of Medicine, Shanghai Jiao Tong University), Chunhong ZHANG (the First Affiliated Hospital of Wenzhou Medical University), Kanghuai ZHANG (the Second Affiliated Hospital of Xi’ an Jiaotong University), Pengcheng ZHENG (the First People’s Hospital of Yunnan Province), Suodi ZHAI (Peking University Third Hospital), Xianglin ZHANG (China-Japan Friendship Hospital), and Xiaojian ZHANG (the First Affiliated Hospital of Zhengzhou University) for providing expert reviews and suggestions.
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Xiaofen LIU, Chenrong HUANG, and Phillip J. BERGEN wrote and edited the manuscript. Liyan MIAO and Jing ZHANG initiated the consensus. Jian LI, Jingjing ZHANG, Yijian CHEN, Yongchuan CHEN, Beining GUO, Fupin HU, Jinfang HU, Linlin HU, Xin LI, Hongqiang QIU, Hua SHAO, Tongwen SUN, Yu WANG, Ping XU, Jing YANG, Yong YANG, Zhenwei YU, Bikui ZHANG, Huaijun ZHU, Xiaocong ZUO, Yi ZHANG, Liyan MIAO, and Jing ZHANG were consensus panel. All authors have read and approved the final manuscript.
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Jian LI licensed his new peptide antibiotics to Qpex Biopharma and has received research grants, speaking honoraria and consulting fees from Northern Antibiotics, Avexa, Genentech, Healcare, CTTQ, MedCom, Jiayou Medicine, Aosaikang, DanDi BioScience, and Qpex Biopharma. Xiaofen LIU, Chenrong HUANG, Phillip J. BERGEN, Jingjing ZHANG, Yijian CHEN, Yongchuan CHEN, Beining GUO, Fupin HU, Jinfang HU, Linlin HU, Xin LI, Hongqiang QIU, Hua SHAO, Tongwen SUN, Yu WANG, Ping XU, Jing YANG, Yong YANG, Zhenwei YU, Bikui ZHANG, Huaijun ZHU, Xiaocong ZUO, Yi ZHANG, Liyan MIAO, and Jing ZHANG declare that they have no conflict of interest.
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Liu, X., Huang, C., Bergen, P.J. et al. Chinese consensus guidelines for therapeutic drug monitoring of polymyxin B, endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. J. Zhejiang Univ. Sci. B 24, 130–142 (2023). https://doi.org/10.1631/jzus.B2200466
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DOI: https://doi.org/10.1631/jzus.B2200466