中国临床药理学与治疗学 ›› 2026, Vol. 31 ›› Issue (4): 568-576.doi: 10.12092/j.issn.1009-2501.2026.04.017
• 综述与讲座 • 上一篇
田泽萱(
), 刘世卓, 王丽楠, 张钰恬, 马颖超, 杨秀岭()
收稿日期:2025-03-20
修回日期:2025-08-15
出版日期:2026-04-26
发布日期:2026-04-30
通讯作者:
杨秀岭
E-mail:2645152965@qq.com;26700002@hebmu.edu.cn
作者简介:田泽萱，女，研究生在读，研究方向：临床药学。E-mail：基金资助:
Zexuan TIAN(), Shizhuo LIU, Linan WANG, Yutian ZHANG, Yingchao MA, Xiuling YANG()
Received:2025-03-20
Revised:2025-08-15
Online:2026-04-26
Published:2026-04-30
Contact:
Xiuling YANG
E-mail:2645152965@qq.com;26700002@hebmu.edu.cn
摘要：
多黏菌素B（polymyxin B）作为治疗碳青霉烯类耐药革兰氏阴性菌（carbapenem-resistant gram-negative bacilli，CR-GNB）感染的关键药物，其药动学（PK）特征在特殊人群中存在差异，需依据患者特征制定个体化给药方案。本文总结了多黏菌素B在特殊人群中的PK及药效学（PD）特点和应用：儿童患者推荐剂量为1.5～3.0 mg·kg?1·d?1；老年患者推荐固定剂量100～150 mg q12h；肥胖患者推荐基于调整体重（adjusted body weight，ABW）给予负荷剂量2.5 mg/kg，维持剂量1.25～1.5 mg/kg q12h，且日剂量上限为250 mg；肝功能障碍患者可按指南推荐剂量（1.25～1.5 mg/kg q12h）给药，无需调整；肾功能不全患者需根据肌酐清除率（creatinine clearance，CrCL）调整剂量，轻度肾功能不全患者（60≤CrCL<90 mL/min）推荐固定给药剂量75 mg q12h，中度肾功能不全患者（30≤CrCL<60 mL/min）推荐50 mg q12h；重度肾功能不全患者（15≤CrCL<30 mL/min）推荐30～40 mg q12h；接受连续肾脏替代治疗（continuous renal replacement therapy，CRRT）治疗的患者，推荐固定剂量100 mg q12h。
中图分类号:
田泽萱, 刘世卓, 王丽楠, 张钰恬, 马颖超, 杨秀岭. 多黏菌素B在特殊人群中的药动学及药效学研究进展[J]. 中国临床药理学与治疗学, 2026, 31(4): 568-576.
Zexuan TIAN, Shizhuo LIU, Linan WANG, Yutian ZHANG, Yingchao MA, Xiuling YANG. Research progress in pharmacokinetics and pharmacodynamics of polymyxin B in special populations[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2026, 31(4): 568-576.
| Patient population | Study | N (male/female) | Dosage regimen | PK parameters | Dosage adjustment recommendations |
| Pediatric patients | Wang et al. 2022[ | 19 (12/7) | 1.33-2.53 mg·kg?1·d?1 | CL=2.04 L/h, Vc=5.47 L, Q=3.75 L/h, AUCss,24h=36.97 mg·h·L?1 | MIC<1 mg/L: 1.5-3.0 mg·kg?1·d?1 |
| Elderly patients | Zeng et al. 2024[ | 23 (16/7) | LD: 2.0-2.5 mg/kg; MD: 1.25-1.5 mg/kg | t1/2=11.21h, CL=2.37 L/h, V=25.50 L Css, avg=4.32 mg/L | MIC≤0.5 mg/L: 75 mg q12h; MIC=1 mg/L: 100-150 mg q12h. |
| Wang et al. 2022[ | 23 (20/3) | 1.20-2.59 mg·kg?1·d?1 | CL=1.87 L/h, Vc=8.13 L, Vp=19.67 L, Q=6.45 L/h, AUCss,24h=68.68 mg·h·L?1 | ||
| Obese patients | Kubin et al. 2018[ | 43 (30/13) | 120-240 mg/d 1.5-3.0 mg·kg?1·d?1; infusion time ≥ 1 h | CL=2.37 L/h, Vc=34.4 L | Based on ABW, LD: 2.5 mg/kg MD: 1.25-1.5 mg/kg q12h (total daily dose<250 mg) |
| Wang et al. 2021[ | 26 (17/9) | LD: 100-200 mg; MD: 50-100 mg q12h | CL=2.86 L/h, Vc=11.24 L, Vp=39.70 L, Q=7.36 L/h | ||
| Patients with hepatic impairment | Li et al. 2023[ | 138 (106/32) | 1.81 (1.54- 2.31) mg/kg | CL=2.43 L/h, V=23.11 L | No dose adjustment required |
| Patients with renal impairment | Surovoy et al.2023[ | 37(28/9) | 100-150 mg q12h (2.5-3 mg·kg?1·day?1) | Preserved renal function: AUC0～24h=67.3 mg·h·L?1, AUC0～24h/dose=1 mg·h·L?1; Css,avg=2.8 mg/L, Cmax=5.8 mg/L, CL=3.9 L/h, V1=20.7 L, V2=146.2 L, Q=24.7 L/h Impaired renal function: AUC0～24h=87 mg·h·L?1, AUC0～24h/dose=1.6 mg·h·L?1; Css,avg=3.7 mg/L, Cmax=5.9 mg/L, CL=2.1 L/h, V1=20.3 L, V2=103.9 L, Q=27.7 L/h | MIC=1 mg/L: 15≤CrCL<30 mL/min: 30-40 mg q12h 30≤CrCL<60 mL/min: 50 mg q 12h 60≤CrCL<90 mL/min: 75 mg q12h |
| Fang et al. 2024[ | 22 (13/9) | Single dose: 0.75 mg/kg | Cmax=2.80 mg/L, t1/2=15.2 h CL=1.5 L/h, V=32.4 L, AUC0-last=31.30 mg·h·L?1, AUC0-inf=32.30 mg·h·L?1 | ||
| Wang et al. 2021[ | 70 (58/12) | LD: 100-150 mg MD: 50-100 mg q12 h; Infusion time: 1 h | Normal renal function group (CrCL ≥ 80 mL/min): CL=2.19 L/h, Vc=6.87 L, Vp=11.97 L, Q=13.83 L/h Renal insufficiency group (CrCL < 80 mL/min): CL=1.58 L/h, Vc=6.98 L, Vp=10.57 L, Q=10.28 L/h | ||
| Yu et al. 2021[ | 32 (26/6) | 100-200 mg/d (1.04-3.45 mg·kg?1·d?1) | CL=1.59 L/h, CL=1.59×(CrCL/ 80) ^0.408 L/h, V=20.5 L | ||
| Patients receiving CRRT | Luo et al. 2022[ | 63 (42/21) | Modeling group: LD: 1.73(1.25-2.73) mg/kg MD: 2.22(1.52-3.00) mg·kg?1·d?1 Validation group: LD:1.66(1.25-2.24) mg/kg MD:2.13(1.25-2.94) mg·kg?1·d?1 | CL=1.5 L/h, Vc=11.7 L, Vp=17.9 L, Q=1.34 L/h, CRRT on CL=1.95L/h | 100 mg q12h |
| Wang et al. 2022[ | 80 (44/36) | LD: 100-200 mg; MD: 50-100 mg q12h; Infusion time ≥1 h | CL=1.95 L/h, Vc=15.00 L, Vp=6.54 L, Q=2.28 L/h | 100 mg q12h | |
| Hanafin et al.2023[ | 142(91/51) | 1.33-6 mg·kg?1·d?1 | Non-RRT patients: CL=1.17 L/h, t1/2=13.6 h, AUC0～24h=118 mg·h·L?1 RRT patients: CL=2.58 L/h, t1/2= 6.92 h, AUC0～24h=75.1 mg·h·L?1 | ||
| Surovoy et al.2023[ | 37(28/9) | 100-150 mg q12h (2.5-3 mg·kg?1·d?1) | CVVHD: AUC0～24h=110.6 mg·h·L?1, AUC0～24h/dose=1.8 mg·h·L?1; Css, avg=4.6 mg/L, Cmax=8.1 mg/L, CL=2 L/h, V1=19.6 L, V2=56 L, Q= 14.6 L/h | 100 mg q12h | |
| Wang et al. 2024[ | 35 (20/15) | LD: MD:2 0000 U·kg?1·d?1 q12h | Cmin=0.99 μg/mL, Cmax=4.85 μg/mL, C1/2t=2.16 μg/mL |
表 1
Table 1 Pharmacokinetic parameters and dose adjustment recommendations of polymyxin B in special populations
| Patient population | Study | N (male/female) | Dosage regimen | PK parameters | Dosage adjustment recommendations |
| Pediatric patients | Wang et al. 2022[ | 19 (12/7) | 1.33-2.53 mg·kg?1·d?1 | CL=2.04 L/h, Vc=5.47 L, Q=3.75 L/h, AUCss,24h=36.97 mg·h·L?1 | MIC<1 mg/L: 1.5-3.0 mg·kg?1·d?1 |
| Elderly patients | Zeng et al. 2024[ | 23 (16/7) | LD: 2.0-2.5 mg/kg; MD: 1.25-1.5 mg/kg | t1/2=11.21h, CL=2.37 L/h, V=25.50 L Css, avg=4.32 mg/L | MIC≤0.5 mg/L: 75 mg q12h; MIC=1 mg/L: 100-150 mg q12h. |
| Wang et al. 2022[ | 23 (20/3) | 1.20-2.59 mg·kg?1·d?1 | CL=1.87 L/h, Vc=8.13 L, Vp=19.67 L, Q=6.45 L/h, AUCss,24h=68.68 mg·h·L?1 | ||
| Obese patients | Kubin et al. 2018[ | 43 (30/13) | 120-240 mg/d 1.5-3.0 mg·kg?1·d?1; infusion time ≥ 1 h | CL=2.37 L/h, Vc=34.4 L | Based on ABW, LD: 2.5 mg/kg MD: 1.25-1.5 mg/kg q12h (total daily dose<250 mg) |
| Wang et al. 2021[ | 26 (17/9) | LD: 100-200 mg; MD: 50-100 mg q12h | CL=2.86 L/h, Vc=11.24 L, Vp=39.70 L, Q=7.36 L/h | ||
| Patients with hepatic impairment | Li et al. 2023[ | 138 (106/32) | 1.81 (1.54- 2.31) mg/kg | CL=2.43 L/h, V=23.11 L | No dose adjustment required |
| Patients with renal impairment | Surovoy et al.2023[ | 37(28/9) | 100-150 mg q12h (2.5-3 mg·kg?1·day?1) | Preserved renal function: AUC0～24h=67.3 mg·h·L?1, AUC0～24h/dose=1 mg·h·L?1; Css,avg=2.8 mg/L, Cmax=5.8 mg/L, CL=3.9 L/h, V1=20.7 L, V2=146.2 L, Q=24.7 L/h Impaired renal function: AUC0～24h=87 mg·h·L?1, AUC0～24h/dose=1.6 mg·h·L?1; Css,avg=3.7 mg/L, Cmax=5.9 mg/L, CL=2.1 L/h, V1=20.3 L, V2=103.9 L, Q=27.7 L/h | MIC=1 mg/L: 15≤CrCL<30 mL/min: 30-40 mg q12h 30≤CrCL<60 mL/min: 50 mg q 12h 60≤CrCL<90 mL/min: 75 mg q12h |
| Fang et al. 2024[ | 22 (13/9) | Single dose: 0.75 mg/kg | Cmax=2.80 mg/L, t1/2=15.2 h CL=1.5 L/h, V=32.4 L, AUC0-last=31.30 mg·h·L?1, AUC0-inf=32.30 mg·h·L?1 | ||
| Wang et al. 2021[ | 70 (58/12) | LD: 100-150 mg MD: 50-100 mg q12 h; Infusion time: 1 h | Normal renal function group (CrCL ≥ 80 mL/min): CL=2.19 L/h, Vc=6.87 L, Vp=11.97 L, Q=13.83 L/h Renal insufficiency group (CrCL < 80 mL/min): CL=1.58 L/h, Vc=6.98 L, Vp=10.57 L, Q=10.28 L/h | ||
| Yu et al. 2021[ | 32 (26/6) | 100-200 mg/d (1.04-3.45 mg·kg?1·d?1) | CL=1.59 L/h, CL=1.59×(CrCL/ 80) ^0.408 L/h, V=20.5 L | ||
| Patients receiving CRRT | Luo et al. 2022[ | 63 (42/21) | Modeling group: LD: 1.73(1.25-2.73) mg/kg MD: 2.22(1.52-3.00) mg·kg?1·d?1 Validation group: LD:1.66(1.25-2.24) mg/kg MD:2.13(1.25-2.94) mg·kg?1·d?1 | CL=1.5 L/h, Vc=11.7 L, Vp=17.9 L, Q=1.34 L/h, CRRT on CL=1.95L/h | 100 mg q12h |
| Wang et al. 2022[ | 80 (44/36) | LD: 100-200 mg; MD: 50-100 mg q12h; Infusion time ≥1 h | CL=1.95 L/h, Vc=15.00 L, Vp=6.54 L, Q=2.28 L/h | 100 mg q12h | |
| Hanafin et al.2023[ | 142(91/51) | 1.33-6 mg·kg?1·d?1 | Non-RRT patients: CL=1.17 L/h, t1/2=13.6 h, AUC0～24h=118 mg·h·L?1 RRT patients: CL=2.58 L/h, t1/2= 6.92 h, AUC0～24h=75.1 mg·h·L?1 | ||
| Surovoy et al.2023[ | 37(28/9) | 100-150 mg q12h (2.5-3 mg·kg?1·d?1) | CVVHD: AUC0～24h=110.6 mg·h·L?1, AUC0～24h/dose=1.8 mg·h·L?1; Css, avg=4.6 mg/L, Cmax=8.1 mg/L, CL=2 L/h, V1=19.6 L, V2=56 L, Q= 14.6 L/h | 100 mg q12h | |
| Wang et al. 2024[ | 35 (20/15) | LD: MD:2 0000 U·kg?1·d?1 q12h | Cmin=0.99 μg/mL, Cmax=4.85 μg/mL, C1/2t=2.16 μg/mL |
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