替考拉宁治疗药物监测进展
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摘要
替考拉宁是临床上用于治疗各种革兰阳性菌严重感染的糖肽类抗菌药物,具有时间依赖性特征,其杀菌效应与其血药浓度超过最低抑菌浓度的时间及抗菌药物后效应有关。开展治疗药物监测(therapeutic drug monitoring,TDM),实施个体化给药方案,可显著提高临床疗效。本文从TDM指标、适应证临床实践、安全用药和体内药物分析技术等4个方面进行综述,阐明了开展替考拉宁TDM的临床意义,提供了临床有效性、安全性和监测技术手段的循证数据,有助于掌握TDM相关研究动态,指导开展有效的临床个体化治疗。
Teicoplanin was a glycopeptide antibiotic that was clinically used to treat serious Gram-positive infections, which had a time-dependent characteristic, its bactericidal effect was related to the time when the blood concentration exceeds the minimum inhibitory concentration and the post-antimicrobial effect. To conduct therapeutic drug monitoring(TDM) and implement individualized dosage regimen can effectively improve clinical efficacy. This article reviews from four aspects including the TDM indicators, clinical practice of different indications, medication safety and biopharmaceutical analysis, clarifies the clinical significance of developing TDM on teicoplanin, provides evidence-based data for clinical effectiveness, safety and monitoring techniques, which helps to grasp the relevant research trends of TDM and guide the development of effective individualized treatment.
Teicoplanin was a glycopeptide antibiotic that was clinically used to treat serious Gram-positive infections, which had a time-dependent characteristic, its bactericidal effect was related to the time when the blood concentration exceeds the minimum inhibitory concentration and the post-antimicrobial effect. To conduct therapeutic drug monitoring(TDM) and implement individualized dosage regimen can effectively improve clinical efficacy. This article reviews from four aspects including the TDM indicators, clinical practice of different indications, medication safety and biopharmaceutical analysis, clarifies the clinical significance of developing TDM on teicoplanin, provides evidence-based data for clinical effectiveness, safety and monitoring techniques, which helps to grasp the relevant research trends of TDM and guide the development of effective individualized treatment.
引文
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[2] 李朋梅,陈文倩,王晓雪,等.替考拉宁的药动学影响因素及治疗药物监测研究进展[J].中国医院用药评价与分析,2016,16(7):865-868.
[3] 郭冬杰,张相林.氨基糖苷类和糖肽类抗菌药物的治疗药物监测[J].实用药物与临床,2013,16(2):145-147.
[4] Craig WA.Basic pharmacodynamics of antibacterials with clinical applications to the use of beta-lactams,glycopeptides,and linezolid[J].Infect Dis Clin North Am,2003,17(3):479-501.
[5] Hagihara M,Umemura T,Kimura M,et al.Exploration of optimal teicoplanin dosage based on pharmacokinetic parameters for the treatment of intensive care unit patients infected with methicillin resistant Staphylococcus aureus[J].J Infect Chemother,2012,18(1):10-16.
[6] Ramos-Martín V,Johnson A,McEntee L,et al.Pharmacodynamics of teicoplanin against MRSA[J].J Antimicrob Chemother,2017,72(12):3382-3389.
[7] Roberts JA,Stove V,De Waele JJ,et al.Variability in protein binding of teicoplanin and achievement of therapeutic drug moni-toring targets in critically ill patients:Lessons from the DALI Study[J].Int J Antimicrob Agents,2014,43(5):423-430.
[8] Byrne CJ,Roberts JA,McWhinney B,et al.Population phar-macokinetics of teicoplanin and attainment of pharmacokinetic/phar-macodynamic targets in adult patients with haematological malignancy[J].Clin Microbiol Infect,2017,23(9):674.e7-674.e13.
[9] Wang T,Li N,Hu S,et al.Factors on trough teicoplanin levels,associations between levels,efficacy and safety in patients with gram-positive infections[J].Int J Clin Pharmacol Ther,2015,53(5):356-362.
[10] Dong YL,Dong HY,Hu SS,et al.An assessment of teicoplanin use and monitoring serum levels in a Chinese teaching hospital[J].Int J Clin Pharmacol Ther,2011,49(1):14-22.
[11] Brink AJ,Richards GA,Lautenbach EE.Albumin concentration significantly impacts on free teicoplanin plasma concentrations in non-critically ill patients with chronic bone sepsis[J].Int J Antimicrob Agents,2015,45(6):647-651.
[12] Nakamura Y,Yokoyama I,Hashimoto N,et al.Appropriate use of anti-methicillin-resistant Staphylococcus aureus agents in a retrospective study[J].Yakugaku Zasshi.2008,128(7):1073-1079.
[13] Pea F,Brollo L,Viale P,et al.Teicoplanin therapeutic drug monitoring in critically ill patients:a retrospective study emphasizing the importance of a loading dose[J].J Antimicrob Chemother,2003,51(4):971-975.
[14] Matthews PC,Chue AL,Wyllie D,et al.Increased teicoplanin doses are associated with improved serum levels but not drug toxicity[J].J Infect,2014,68(1):43-49.
[15] Sato M,Chida K,Suda T,et al.Recommended initial loading dose of teicoplanin,established by therapeutic drug monitoring,and outcome in terms of optimal trough level[J].J Infect Chemother,2006,12(4):185-189.
[16] El Samad Y,Lanoix JP,Bennis Y,et al.Tolerability and Plasma Drug Level Monitoring of Prolonged Subcutaneous Teicoplanin Treatment for Bone and Joint Infections[J].Antimicrob Agents Chemother,2016,60(10):6365-6368.
[17] Shiohira H,Nakamatsu M,Kise Y,et al.Long-term Treatment of Teicoplanin for Methicillin-resistant Staphylococcus aureus Sternal Osteomyelitis with Renal Impairment:A Case of High Teicoplanin Trough Levels Maintained by Therapeutic Drug Monitoring[J].Yakugaku Zasshi,2016,136(9):1313-1317.
[18] Sato Y,Hiramatsu K,Suzuki Y,et al.Optimal Trough Concentration of Teicoplanin in Febrile Neutropenic Patients with Hematological Malignancy[J].Chemotherapy,2018,63(1):29-34.
[19] Ogawa R,Kobayashi S,Sasaki Y,et al.Population pharmacokinetic and pharmacodynamic analyses of teicoplanin in Japanese patients with systemic MRSA infection[J].Int J Clin Pharmacol Ther,2013,51(5):357-366.
[20] Boast A,Gwee A,Gwee A.Teicoplanin-Should We Be Doing Routine Therapeutic Drug Monitoring in Children?[J].Pediatr Infect Dis J,2017,36(11):1110.
[21] Yamada T,Kubota T,Yonezawa M,et al.Evaluation of Teicoplanin Trough Values After the Recommended Loading Dose in Children with Associated Safety Analysis[J].Pediatr Infect Dis J,2017,36(4):398-400.
[22] Zhao W,Zhang D,Storme T,et al.Population pharmacokinetics and dosing optimization of teicoplanin in children with malignant haema-tological disease[J].Br J Clin Pharmacol,2015,80(5):1197-1207.
[23] Uhart M,Leroy B,Michaud A,et al.Inter-individual and intra-individual pharmacokinetic variability during teicoplanin therapy in geriatric patients[J].Med Mal Infect,2013,43(7):295-298.
[24] Yagasaki K,Gando S,Matsuda N,et al.Pharmacokinetics of teicoplanin in critically ill patients undergoing continuous hemo-diafiltration[J].Intensive Care Med,2003,29(11):2094-2095.
[25] Nakano T,Nakamura T,Nakamura Y,et al.Effects of Teicoplanin on the PT-INR Controlled by Warfarin in Infection Patients[J].Yakugaku Zasshi,2017,137(7):909-916.
[26] Mori T,Shimizu T,Kato J,et al.Nephrotoxicity of concomitant use of tacrolimus and teicoplanin in allogeneic hematopoietic stem cell transplant recipients[J].Transpl Infect Dis,2014,16(2):329-332.
[27] 徐硕,徐文峰,金鹏飞,等.替考拉宁分析方法的研究进展[J].中国药师,2017,20(12):2221-2224.
[28] Deltombe O,Mertens T,Eloot S,et al.Development and validation of an ultra-high performance liquid chromatography-high resolution mass spectrometry method for the quantification of total and free teicoplanin in human plasma[J].Clin Biochem,2019,65:29-37.
[29] Begou O,Kontou A,Raikos N,et al.An ultra-high pressure liquid chromatography-tandem mass spectrometry method for the quantification of teicoplanin in plasma of neonates[J].J Chromatogr B Analyt Technol Biomed Life Sci,2017,1047:215-222.
[30] Tsai IL,Sun HY,Chen GY,et al.Simultaneous quantification of antimicrobial agents for multidrug-resistant bacterial infections in human plasma by ultra-high-pressure liquid chromatography-tandem mass spectrometry[J].Talanta,2013,116:593-603.
[31] 王艳红,任秋霞,赵庆国.超高效液相色谱法测定替考拉宁血药浓度[J].中国药物应用与监测,2018,15(4):207-210.
[32] Shi M,Zhao X,Wang T,et al.A LC-MS-MS assay for simultaneous determination of two glycopeptides and two small molecule compou-nds in human plasma[J].J Chromatogr Sci,2018,56(9):828-834.
[33] 邓晶晶,卫薇.糖肽类抗生素替考拉宁的分析方法研究进展[J].西南军医,2009,11(5):925-926.
[34] 耿艳辉,刘素彦,贺广锋.替考拉宁的HPLC法测定[J].现代中西医结合杂志,2014,23(3):307-309.
[35] 叶合,项迎春,韩奇,等.液相色谱-质谱法测定替考拉宁在重症感染患者血浆中的浓度[J].中国临床药理学杂志,2018,34(5):572-575.
[36] 侯桂雪,王全会,刘斯奇.多重反应监测(MRM):靶标蛋白质定量的新方法[J].中国科学:化学,2014,44(5):746-752.
[37] Ramos-Martín V,Neely MN,Padmore K,et al.Tools for the Individualized Therapy of Teicoplanin for Neonates and Children[J].Antimicrob Agents Chemother,2017,61(10):e00707-e00717.
[38] 替考拉宁临床应用剂量专家共识组.替考拉宁临床应用剂量专家共识[J].中华结核和呼吸杂志,2016,39(7):500-508.
[2] 李朋梅,陈文倩,王晓雪,等.替考拉宁的药动学影响因素及治疗药物监测研究进展[J].中国医院用药评价与分析,2016,16(7):865-868.
[3] 郭冬杰,张相林.氨基糖苷类和糖肽类抗菌药物的治疗药物监测[J].实用药物与临床,2013,16(2):145-147.
[4] Craig WA.Basic pharmacodynamics of antibacterials with clinical applications to the use of beta-lactams,glycopeptides,and linezolid[J].Infect Dis Clin North Am,2003,17(3):479-501.
[5] Hagihara M,Umemura T,Kimura M,et al.Exploration of optimal teicoplanin dosage based on pharmacokinetic parameters for the treatment of intensive care unit patients infected with methicillin resistant Staphylococcus aureus[J].J Infect Chemother,2012,18(1):10-16.
[6] Ramos-Martín V,Johnson A,McEntee L,et al.Pharmacodynamics of teicoplanin against MRSA[J].J Antimicrob Chemother,2017,72(12):3382-3389.
[7] Roberts JA,Stove V,De Waele JJ,et al.Variability in protein binding of teicoplanin and achievement of therapeutic drug moni-toring targets in critically ill patients:Lessons from the DALI Study[J].Int J Antimicrob Agents,2014,43(5):423-430.
[8] Byrne CJ,Roberts JA,McWhinney B,et al.Population phar-macokinetics of teicoplanin and attainment of pharmacokinetic/phar-macodynamic targets in adult patients with haematological malignancy[J].Clin Microbiol Infect,2017,23(9):674.e7-674.e13.
[9] Wang T,Li N,Hu S,et al.Factors on trough teicoplanin levels,associations between levels,efficacy and safety in patients with gram-positive infections[J].Int J Clin Pharmacol Ther,2015,53(5):356-362.
[10] Dong YL,Dong HY,Hu SS,et al.An assessment of teicoplanin use and monitoring serum levels in a Chinese teaching hospital[J].Int J Clin Pharmacol Ther,2011,49(1):14-22.
[11] Brink AJ,Richards GA,Lautenbach EE.Albumin concentration significantly impacts on free teicoplanin plasma concentrations in non-critically ill patients with chronic bone sepsis[J].Int J Antimicrob Agents,2015,45(6):647-651.
[12] Nakamura Y,Yokoyama I,Hashimoto N,et al.Appropriate use of anti-methicillin-resistant Staphylococcus aureus agents in a retrospective study[J].Yakugaku Zasshi.2008,128(7):1073-1079.
[13] Pea F,Brollo L,Viale P,et al.Teicoplanin therapeutic drug monitoring in critically ill patients:a retrospective study emphasizing the importance of a loading dose[J].J Antimicrob Chemother,2003,51(4):971-975.
[14] Matthews PC,Chue AL,Wyllie D,et al.Increased teicoplanin doses are associated with improved serum levels but not drug toxicity[J].J Infect,2014,68(1):43-49.
[15] Sato M,Chida K,Suda T,et al.Recommended initial loading dose of teicoplanin,established by therapeutic drug monitoring,and outcome in terms of optimal trough level[J].J Infect Chemother,2006,12(4):185-189.
[16] El Samad Y,Lanoix JP,Bennis Y,et al.Tolerability and Plasma Drug Level Monitoring of Prolonged Subcutaneous Teicoplanin Treatment for Bone and Joint Infections[J].Antimicrob Agents Chemother,2016,60(10):6365-6368.
[17] Shiohira H,Nakamatsu M,Kise Y,et al.Long-term Treatment of Teicoplanin for Methicillin-resistant Staphylococcus aureus Sternal Osteomyelitis with Renal Impairment:A Case of High Teicoplanin Trough Levels Maintained by Therapeutic Drug Monitoring[J].Yakugaku Zasshi,2016,136(9):1313-1317.
[18] Sato Y,Hiramatsu K,Suzuki Y,et al.Optimal Trough Concentration of Teicoplanin in Febrile Neutropenic Patients with Hematological Malignancy[J].Chemotherapy,2018,63(1):29-34.
[19] Ogawa R,Kobayashi S,Sasaki Y,et al.Population pharmacokinetic and pharmacodynamic analyses of teicoplanin in Japanese patients with systemic MRSA infection[J].Int J Clin Pharmacol Ther,2013,51(5):357-366.
[20] Boast A,Gwee A,Gwee A.Teicoplanin-Should We Be Doing Routine Therapeutic Drug Monitoring in Children?[J].Pediatr Infect Dis J,2017,36(11):1110.
[21] Yamada T,Kubota T,Yonezawa M,et al.Evaluation of Teicoplanin Trough Values After the Recommended Loading Dose in Children with Associated Safety Analysis[J].Pediatr Infect Dis J,2017,36(4):398-400.
[22] Zhao W,Zhang D,Storme T,et al.Population pharmacokinetics and dosing optimization of teicoplanin in children with malignant haema-tological disease[J].Br J Clin Pharmacol,2015,80(5):1197-1207.
[23] Uhart M,Leroy B,Michaud A,et al.Inter-individual and intra-individual pharmacokinetic variability during teicoplanin therapy in geriatric patients[J].Med Mal Infect,2013,43(7):295-298.
[24] Yagasaki K,Gando S,Matsuda N,et al.Pharmacokinetics of teicoplanin in critically ill patients undergoing continuous hemo-diafiltration[J].Intensive Care Med,2003,29(11):2094-2095.
[25] Nakano T,Nakamura T,Nakamura Y,et al.Effects of Teicoplanin on the PT-INR Controlled by Warfarin in Infection Patients[J].Yakugaku Zasshi,2017,137(7):909-916.
[26] Mori T,Shimizu T,Kato J,et al.Nephrotoxicity of concomitant use of tacrolimus and teicoplanin in allogeneic hematopoietic stem cell transplant recipients[J].Transpl Infect Dis,2014,16(2):329-332.
[27] 徐硕,徐文峰,金鹏飞,等.替考拉宁分析方法的研究进展[J].中国药师,2017,20(12):2221-2224.
[28] Deltombe O,Mertens T,Eloot S,et al.Development and validation of an ultra-high performance liquid chromatography-high resolution mass spectrometry method for the quantification of total and free teicoplanin in human plasma[J].Clin Biochem,2019,65:29-37.
[29] Begou O,Kontou A,Raikos N,et al.An ultra-high pressure liquid chromatography-tandem mass spectrometry method for the quantification of teicoplanin in plasma of neonates[J].J Chromatogr B Analyt Technol Biomed Life Sci,2017,1047:215-222.
[30] Tsai IL,Sun HY,Chen GY,et al.Simultaneous quantification of antimicrobial agents for multidrug-resistant bacterial infections in human plasma by ultra-high-pressure liquid chromatography-tandem mass spectrometry[J].Talanta,2013,116:593-603.
[31] 王艳红,任秋霞,赵庆国.超高效液相色谱法测定替考拉宁血药浓度[J].中国药物应用与监测,2018,15(4):207-210.
[32] Shi M,Zhao X,Wang T,et al.A LC-MS-MS assay for simultaneous determination of two glycopeptides and two small molecule compou-nds in human plasma[J].J Chromatogr Sci,2018,56(9):828-834.
[33] 邓晶晶,卫薇.糖肽类抗生素替考拉宁的分析方法研究进展[J].西南军医,2009,11(5):925-926.
[34] 耿艳辉,刘素彦,贺广锋.替考拉宁的HPLC法测定[J].现代中西医结合杂志,2014,23(3):307-309.
[35] 叶合,项迎春,韩奇,等.液相色谱-质谱法测定替考拉宁在重症感染患者血浆中的浓度[J].中国临床药理学杂志,2018,34(5):572-575.
[36] 侯桂雪,王全会,刘斯奇.多重反应监测(MRM):靶标蛋白质定量的新方法[J].中国科学:化学,2014,44(5):746-752.
[37] Ramos-Martín V,Neely MN,Padmore K,et al.Tools for the Individualized Therapy of Teicoplanin for Neonates and Children[J].Antimicrob Agents Chemother,2017,61(10):e00707-e00717.
[38] 替考拉宁临床应用剂量专家共识组.替考拉宁临床应用剂量专家共识[J].中华结核和呼吸杂志,2016,39(7):500-508.