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Expert Consensus on Polymyxin Antimicrobial Susceptibility Testing and Clinical Interpretation
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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。Abstract: Polymyxin was an important antimicrobial agent against resistant Gram-negative bacilli. In 2020, the American Clinical and Laboratory Standards Institute changed the clinical breakpoints of polymyxin, eliminating the "susceptible" interpretive category, and only reporting intermediate (I≤2 mg/L) and resistant(R≥4 mg/L) ones. However, the European Committee on Antimicrobial Susceptibility Testing recommended the use of susceptible (S≤2 mg/L), resistant (R > 2 mg/L) as the clinical breakpoints. The international disunity of clinical breakpoints of polymyxin brings great trouble to the domestic clinical staffs. Therefore, how to accurately carry out the susceptibility test of polymyxin and standardize the interpretation of its report is an urgent problem to be solved in the field of antibacterial drug application and anti-infection in China. To this end, we organized experts in related fields to normalize and interpret the susceptibility test of polymyxin and its results, and put forward corresponding suggestions of experts for reference.
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Key words:
- polymyxin /
- drug sensitivity /
- clinical interpretation /
- expert consensus
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 
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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
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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
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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
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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
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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
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