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欧洲临床微生物和感染病学会药敏委员会华人抗菌药物敏感性试验委员会, 中国医药教育协会感染疾病专业委员会, 杨启文, 马筱玲, 胡付品, 张菁, 孙同文, 陈佰义, 徐英春, 刘又宁. 多黏菌素药物敏感性检测及临床解读专家共识[J]. 协和医学杂志, 2020, 11(5): 559-570. doi: 10.3969/j.issn.1674-9081.2020.05.011
引用本文: 欧洲临床微生物和感染病学会药敏委员会华人抗菌药物敏感性试验委员会, 中国医药教育协会感染疾病专业委员会, 杨启文, 马筱玲, 胡付品, 张菁, 孙同文, 陈佰义, 徐英春, 刘又宁. 多黏菌素药物敏感性检测及临床解读专家共识[J]. 协和医学杂志, 2020, 11(5): 559-570. doi: 10.3969/j.issn.1674-9081.2020.05.011
Chinese Committee on Antimicrobial Susceptibility Testing, European Committee on Antimicrobial Susceptibility Testing, European Society of Clinical Microbiology and Infectious Diseases, Expert Committee on Infectious Diseases, China Medical Education Association, YANG Qi-wen, MA Xiao-ling, HU Fu-pin, ZHANG Jing, SUN Tong-wen, CHEN Bai-yi, XU Ying-chun, LIU You-ning. Expert Consensus on Polymyxin Antimicrobial Susceptibility Testing and Clinical Interpretation[J]. Medical Journal of Peking Union Medical College Hospital, 2020, 11(5): 559-570. doi: 10.3969/j.issn.1674-9081.2020.05.011
Citation: Chinese Committee on Antimicrobial Susceptibility Testing, European Committee on Antimicrobial Susceptibility Testing, European Society of Clinical Microbiology and Infectious Diseases, Expert Committee on Infectious Diseases, China Medical Education Association, YANG Qi-wen, MA Xiao-ling, HU Fu-pin, ZHANG Jing, SUN Tong-wen, CHEN Bai-yi, XU Ying-chun, LIU You-ning. Expert Consensus on Polymyxin Antimicrobial Susceptibility Testing and Clinical Interpretation[J]. Medical Journal of Peking Union Medical College Hospital, 2020, 11(5): 559-570. doi: 10.3969/j.issn.1674-9081.2020.05.011

多黏菌素药物敏感性检测及临床解读专家共识

doi: 10.3969/j.issn.1674-9081.2020.05.011
基金项目: 

国家重点研发计划“生物安全关键技术研发”重点专项 2018YFC1200100

国家重点研发计划“生物安全关键技术研发”重点专项 2018YFC1200105

科技部“重大新药创制”科技重大专项资助项目 2017ZX09304005

详细信息
    通讯作者:

    徐英春  电话:010-69159766,E-mail: xycpumch@139.com

    刘又宁  电话:010-66939114,E-mail: liuyn301@126.com

  • 中图分类号: R378.99+1; R378.2

Expert Consensus on Polymyxin Antimicrobial Susceptibility Testing and Clinical Interpretation

Funds: 

National Key Research & Development Program 2018YFC1200100

National Key Research & Development Program 2018YFC1200105

Major Research and Development Project of Innovative Drugs, Ministry of Science and Technology of China 2017ZX09304005

More Information
  • 摘要: 多黏菌素是耐药革兰阴性杆菌的重要治疗药物。2020年美国临床和实验室标准协会变更了多黏菌素药物敏感性折点,取消了多黏菌素敏感折点,仅报告中介(I≤2 mg/L)与耐药(R≥4 mg/L),而欧洲抗菌药物敏感性试验委员会则建议采用敏感(S≤2 mg/L)、耐药(R>2 mg/L)作为临床折点。多黏菌素药物敏感性试验的操作难度以及国际药物敏感性折点的不统一给国内临床实验室一线人员带来极大困扰。因此,如何精准开展多黏菌素药物敏感性检测,规范其报告解读是当前国内抗菌药物应用和抗感染领域亟待解决的问题。本共识对多黏菌素药物敏感性试验方法及结果进行规范解读,并提出相应建议。
    利益冲突:无
  • 表  1  多黏菌素不同药物敏感性试验方法的性能评价

    方法和菌种 分析药物 根据BMD-MIC区分的菌株数(%) 性能评价(%)
    MIC≤2 mg/L MIC≥4 mg/L EA CA VME ME
    E-test
      肠杆菌目 多黏菌素B[4] 220(95.7) 10(4.4) 95.6 99.1 20.0 0
      肠杆菌目 多黏菌素B[5] 53(69.7) 23(30.3) 48.7 89.5 26.1 1.9
      肠杆菌目 黏菌素[5] 51(67.1) 25(32.9) 75.0 92.1 12.0 5.9
      肠杆菌目 黏菌素[6] 219(67.4) 106(32.6) 80.6 96.3 9.4 0.9
      大肠埃希菌 黏菌素[6] 48(90.6) 5(9.4) 92.5 96.2 40.0 0
      肺炎克雷伯菌 黏菌素[6] 126(61.2) 80(38.8) 79.8 99.0 1.6 2.5
      阴沟肠杆菌 黏菌素[6] 23(59.0) 16(41.0) 72.2 87.2 25.0 4.3
      铜绿假单胞菌 黏菌素[8] 78(100) 0(0) 79.5 93.6 - 6.4
      鲍曼不动杆菌 黏菌素[7] 2(10) 18(90) 55.0 65.0 38.9 0
      鲍曼不动杆菌 黏菌素[9] 42(100) 0(0) 11.9 100 - 0
      鲍曼不动杆菌 多黏菌素B[9] 42(100) 0(0) 85.7 100 - 0
    纸片扩散法
      肠杆菌目 IE IE IE NA IE IE IE
      铜绿假单胞菌 黏菌素[8] 78(100) 0(0) NA 100 - 0
      鲍曼不动杆菌 IE IE IE NA IE IE IE
    BD Phoenix
      肠杆菌目 黏菌素[5] 219(67.4) 106(32.6) 76.1 92.0 24.5 0
      大肠埃希菌 黏菌素[5] 48(90.6) 5(9.4) - 98.1 20 0
      肺炎克雷伯菌 黏菌素[5] 126(61.2) 80(38.8) - 96.1 10 0
      阴沟肠杆菌 黏菌素[5] 23(59.0) 16(41.0) - 64.1 87.5 0
      铜绿假单胞菌 IE IE IE IE IE IE IE
      鲍曼不动杆菌 黏菌素[10] 88(75.2) 29(24.8) 91.5 88.9 41.4 1.1
    Microscan
      革兰阴性杆菌 黏菌素[11] 52(28.1) 133(71.9) IE 91.9 0.8 26.9
      肠杆菌目 黏菌素[5] 44(57.9) 32(42.1) IE 88.2 4.0 15.8
      肠杆菌目 黏菌素[11] 32(21.9) 114(78.1) IE 99.3 0 3.1
      非发酵菌 黏菌素[11] 20(51.3) 19(48.7) IE 64.1 5.3 65.0
    Vitek 2
      肠杆菌目 黏菌素[5] 60(75.9) 16(24.1) 93.4 88.2 36.0 0
      肠杆菌目 多黏菌素B[5] 47(61.8) 29(38.2) 96.1 94.7 3.7 6.1
      肠杆菌目 黏菌素[6] 219(67.4) 106(32.6) 75.9 90.5 29.2 0
      大肠埃希菌 黏菌素[6] 48(90.6) 5(9.4) - 94.3 60.0 0
      肺炎克雷伯菌 黏菌素[6] 126(61.2) 80(38.8) 81.7 94.2 15.0 0
      肺炎克雷伯菌 黏菌素[7] 1(2.4) 40(97.6) 75.6 100 0 0
      阴沟肠杆菌 黏菌素[6] 23(59.0) 16(41.0) - 66.7 81.3 0
      铜绿假单胞菌 IE IE IE IE IE IE IE
      鲍曼不动杆菌 黏菌素[10] 88(75.2) 29(24.8) 88.9 89.7 37.9 1.1
      鲍曼不动杆菌 黏菌素[9] 42(100) 0(0) 26.2 100 - 0
      鲍曼不动杆菌 多黏菌素B[9] 42(100) 0(0) 57.1 100 - 0
    琼脂稀释法
      鲍曼不动杆菌 黏菌素[10] 88(75.2) 29(24.8) 93.2 87.2 3.4 15.9
      鲍曼不动杆菌 黏菌素[9] 42(100) 0(0) 92.8 85.7 - 16.7
      鲍曼不动杆菌 多黏菌素B[9] 42(100) 0(0) 76.2 100 - 0
    黏菌素琼脂试验
      肠杆菌目 黏菌素[12] 152(43.7) 196(56.3) 99.7 99.7 0.5 0
      铜绿假单胞菌 黏菌素[12] 135(91.2) 13(8.8) 99.3 100 0 0
      鲍曼不动杆菌 黏菌素[12] 60(45.8) 71(54.2) 88.5 92.3 14.3 0
    黏菌素肉汤纸片洗脱试验
      肠杆菌目 黏菌素[12] 152(43.7) 196(56.3) 94.3 98.6 2.5 0
      铜绿假单胞菌 黏菌素[12] 135(91.2) 13(8.8) 96.6 99.3 0 0.7
      鲍曼不动杆菌 黏菌素[12] 60(45.8) 71(54.2) 93.1 95.4 5.6 3.3
    BMD-MIC:肉汤微量稀释法的最低抑菌浓度;MIC:最低抑菌浓度;EA:基本一致率;CA:分类一致率;VME:非常重大误差;ME:重大误差;-:数据无法计算;NA:不适用;IE:数据不足
    下载: 导出CSV

    表  2  国际组织公布的多黏菌素药物敏感性试验折点[1-3, 13-14]

    菌种 美国CLSI 2019 (mg/L) 美国CLSI 2019 (mg/L) 美国CLSI 2020 (mg/L) EUCAST 2020 (mg/L) USCAST 2020 (mg/L)* 美国FDA 2020 (mg/L)
    黏菌素 多黏菌素B 黏菌素或多黏菌素B 黏菌素 黏菌素或多黏菌素B 黏菌素或多黏菌素B
    S I R S I R I R S R ATU S R I R
    肠杆菌目 - - - - - - ≤2 ≥4 ≤2 >2 - ≤2 ≥4 - -
    铜绿假单胞菌 ≤2 - ≥4 ≤2 4 ≥8 ≤2 ≥4 ≤2 >2 4 ≤2 ≥4 Re# Re#
    鲍曼不动杆菌 ≤2 - ≥4 ≤2 - ≥4 ≤2 ≥4 ≤2 >2 - ≤2 ≥4 N N
    CLSI:临床和实验室标准协会;EUCAST:欧洲抗菌药物敏感性试验委员会;USCAST:美国抗菌药物敏感性试验委员会;FDA:国家食品药品监督管理局;S:敏感(susceptible);I:中介(intermediate);R:耐药(resistant);ATU:技术不确定区(area of technical uncertainty);-:无数据;*对于黏菌素,该折点不推荐用于下呼吸道感染,对于多黏菌素B,该折点不推荐用于下呼吸道感染和下尿路感染;#已采纳美国CLSI M100的数据折点;尚未采纳CLSI M100的数据折点
    下载: 导出CSV

    表  3  EUCAST公布的黏菌素对不同菌种的ECOFF值(截至2020年7月)[15]

    菌种 ECOFF(mg/L) 观察数
    大肠埃希菌 2.0 6014
    产气克雷伯菌 2.0 266
    产酸克雷伯菌 2.0 405
    肺炎克雷伯菌 2.0 1805
    阴沟肠杆菌 2.0 849
    铜绿假单胞菌 4.0 19 482
    鲍曼不动杆菌 2.0 2879
    EUCAST:同表 2;ECOFF:流行病学折点
    下载: 导出CSV

    表  4  多黏菌素对不同革兰阴性杆菌的PK/PD(fAUC24 h/MIC)靶值

    药物 模型 菌种 达到药理效应所需靶值
    菌落数降低
    log10
    菌落数降低
    2log10
    黏菌素 小鼠大腿感染模型[16] 铜绿假单胞菌 6.6~10.9* 7.4~13.7*
    鲍曼不动杆菌 3.5~13.9* 7.4~17.6*
    小鼠肺炎感染模型[16] 铜绿假单胞菌 43.3~57.9* 51.8~105*
    鲍曼不动杆菌 20.8 36.8
    多黏菌素B 小鼠大腿感染模型[17] 肺炎克雷伯菌 3.7~28.0* /
    PK/PD:药代动力学/药效学;MIC:同表 1f:药物在血浆中的游离分数;/:无法达到菌落数下降2log10*靶值的中位数范围
    下载: 导出CSV

    表  5  不同肾功能情况下CMS推荐给药剂量的PTA和CFR

    给药方案 肺炎克雷伯菌 大肠埃希菌
    PTA(%) CFR PTA(%) CFR
    MIC50为0.5 MIC90为2 MIC50、MIC90均为0.5
    CrCl≥80 mL/min
      150 mg, q12 h(EMA[19], FDA[20]) 92.7 64.4 85.4 92.7 90.4
      180 mg, q12 h(Nation等[21]) 97.9 69.2 87.9 97.9 92.3
      150 mg, q8 h(Rattanaumpawan等[22]) 98.7 79.7 92.0 98.7 95.1
    CrCl 51~79 mL/min
      114 mg, q12 h(美国FDA[20]) 96.0 72.0 89.9 96.0 94.1
      150 mg, q12 h(EMA[19], Nation等[21]) 97.3 78.3 92.7 97.3 95.8
    CrCl 30~50 mL/min
      150 mg, q12 h(美国FDA[20]) 97.6 71.1 91.3 97.6 95.6
      100 mg, q12 h (Rattanaumpawan等[22]) 98.9 85.7 95.7 98.9 97.9
      110 mg, q12 h(Nation等[21]) 99.0 87.4 96.4 99.0 98.2
      125 mg, q12 h(EMA[19]) 99.2 89.8 97.2 99.2 98.5
    CrCl 11~29 mL/min
      60 mg, q24 h(美国FDA[20]) 96.3 56.2 86.3 96.3 97.9
      150 mg, q24 h(EMA[19], Rattanaumpawan等[22]) 99.7 89.4 97.4 99.7 99.6
      180 mg, q24 h(Nation等[21]) 99.6 89.3 97.4 99.6 99.9
    CrCl ≤10 mL/min
      60 mg, q24 h(美国FDA[20]) 99.5 77.1 94.5 99.5 100
      120 mg, q24 h(EMA[19]) 99.9 94.9 98.9 99.9 100
      150 mg, q24 h(Nation等[21]) 100 97.4 99.5 100 100
    CMS:黏菌素甲磺酸盐;MIC、FDA:同表 1;PTA:达标概率;CFR:累积响应百分率;CrCl:肌酐清除率;q12 h:每12小时使用1次;q24 h:每24小时使用1次;EMA:欧洲药品管理局
    下载: 导出CSV

    表  6  不同肾功能的囊性纤维患者在多黏菌素B给药方案下的PTA[24]

    CrCl (mL/min) 病原菌MIC (mg/L) 不同多黏菌素B给药方案下的PTA(%)
    1.5 mg/(kg·d) 2.0 mg/(kg·d) 2.5 mg/(kg·d) 3.0 mg/(kg·d) 负荷剂量
    2.5 mg/kg+2.5 mg/(kg·d)
    34 0.031 25 100 100 100 100 100
    0.062 5 100 100 100 100 100
    0.125 100 100 100 100 100
    0.25 99.3 99.8 99.9 99.9 100
    0.5 19.0 64.0 97.0 99.3 99.8
    1 0.1 1.8 3.0 7.6 19.5
    2 0 0 0 0.1 1.7
    105 0.031 25 100 100 100 100 100
    0.062 5 100 100 100 100 100
    0.125 96.0 99.0 100 100 100
    0.25 69.0 84.0 92.0 96.0 99.0
    0.5 15.0 38.0 57.9 70.0 81.0
    1 0.1 0.2 7.0 15.0 35.0
    2 0 0 0 0.1 1.7
    178 0.031 25 100 100 100 100 100
    0.062 5 100 100 100 100 100
    0.125 74.0 97.0 99.0 100 100
    0.25 15.0 32.0 56.0 78.0 94.0
    0.5 1.0 4.0 8.0 15.0 27.0
    1 0 0 0.6 1 0
    2 0 0 0 0 0
    MIC:同表 1;PTA、CrCl:同表 5
    下载: 导出CSV

    表  7  不同MIC和多黏菌素B推荐剂量下的PTA*[26]

    剂量方案 患者体质量(kg) 不同MIC下的PTA(%)
    0.125 mg/L 0.25 mg/L 0.5 mg/L 1 mg/L 2 mg/L 4 mg/L 8 mg/L
    100 mg q12 h 50 100 100 100 39.1 2.0 0.2 0
    75 100 100 99.9 24.7 1.1 0.1 0
    110 100 100 94.3 16.5 0.8 0 0
    1 mg/kg TBW q12 h 50 100 100 39.1 2.0 0.2 0 0
    75 100 100 82.1 7.7 0.3 0 0
    110 100 100 97.6 24.4 0.2 0.1 0
    1.5 mg/kg TBW q12 h 50 100 100 93.5 10.7 0.3 0 0
    75 100 100 99.7 40.2 2.1 0.1 0
    110 100 100 100 74.7 7.6 0.3 0
    2.5 mg/kg负荷剂量+100 mg q12 h 50 100 100 100 61.3 3.1 0.2 0
    75 100 100 100 81.3 8.2 0.3 0
    110 100 100 100 93.1 16.8 0.9 0
    2.5 mg/kg负荷剂量+1.5 mg/kg TBW q12 h 50 100 100 100 45.0 2.0 0.2 0
    75 100 100 100 85.5 9.0 0.3 0
    110 100 100 100 98.2 26.8 1.5 0.1
    MIC:同表 1;PTA、q12 h:同表 5;TBW:总体质量;*以AUC0~24/MIC达到50(mg·h)/L为达到有效暴露量的目标靶值
    下载: 导出CSV

    表  8  多黏菌素药物敏感性试验报告

    病原菌 抗菌药物 MIC折点(mg/L) 注释
    敏感(S) 耐药(R)
    肠杆菌目* 黏菌素或多黏菌素B# ≤2 ≥4 多黏菌素药物敏感性试验结果必须附加注释
    铜绿假单胞菌 ≤2 ≥4=
    鲍曼不动杆菌 ≤2 ≥4
    MIC:同表 1*在肠杆菌目中摩根菌科(包括变形杆菌属、摩根菌属、普罗威登菌属)和粘质沙雷菌等对多黏菌素天然耐药,无需测试多黏菌素的敏感性;#黏菌素和多黏菌素B的药物敏感性结果等效,测试一种药物可预测另一种药物的敏感性;须使用可靠的方法检测多黏菌素类药物的MIC
    下载: 导出CSV
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