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使用治疗药物监测评估替加环素的临床疗效和安全性

Clinical efficacy and safety assessment of tedizolid using therapeutic drug monitoring.

作者信息

Shibata Yuichi, Shiota Arufumi, Mori Nobuaki, Asai Nobuhiro, Hagihara Mao, Mikamo Hiroshige

机构信息

Department of Infection Prevention and Control, Aichi Medical University Hospital, Nagakute, Aichi, Japan; Department of Pharmacy, Aichi Medical University Hospital, Nagakute, Aichi, Japan.

Department of Infection Prevention and Control, Aichi Medical University Hospital, Nagakute, Aichi, Japan; Department of Clinical Infectious Diseases, Aichi Medical University Hospital, Nagakute, Aichi, Japan.

出版信息

J Infect Chemother. 2025 Mar;31(3):102582. doi: 10.1016/j.jiac.2024.12.011. Epub 2024 Dec 10.

DOI:10.1016/j.jiac.2024.12.011
PMID:39667558
Abstract

Thrombocytopenia derived from tedizolid (TZD) has been reported but less frequently than that from linezolid. Only a few reports have investigated the relationship between the efficacy and safety of TZD administration. This study aimed to measure TZD concentration and investigate the relationship between efficacy and safety. The study was conducted at the Aichi Medical University Hospital. All patients administered TZD were included; the serum trough concentration (Cmin) of TZD was measured using LM1010 high-performance liquid chromatography. Efficacy was assessed as clinical and microbiological efficacy. Clinical efficacy was defined as no recurrence and no need for additional treatment until 2 weeks after the end of TZD therapy. Microbiological efficacy was defined as the absence of bacteria during and after TZD therapy. Safety was assessed using thrombocytopenia. Thrombocytopenia was defined as a decrease in platelet count of ≥25 % compared with baseline levels and a minimum count of <10 × 10/μL. Seventeen patients were included. The Cmin in 16 patients was <0.5 μg/mL; one patient had a Cmin of 1.01 μg/mL complicated by hepatic cirrhosis. Clinical and microbiological efficacy was found in >80 % of the patients. Thrombocytopenia occurred in 14.3 % (2/14) of the patients. The Cmin in two patients with thrombocytopenia were 0.14 and 0.28 μg/mL, respectively. The serum concentration of TZD might increase in patients with hepatic cirrhosis; therapeutic drug monitoring may be required. Thrombocytopenia due to TZD could occur regardless of its serum concentration, necessitating monitoring for platelet count.

摘要

已有关于替加环素(TZD)所致血小板减少症的报道,但比利奈唑胺所致的情况少见。仅有少数报告研究了TZD给药的疗效与安全性之间的关系。本研究旨在测定TZD浓度并研究疗效与安全性之间的关系。该研究在爱知医科大学医院进行。纳入所有接受TZD治疗的患者;使用LM1010高效液相色谱法测定TZD的血清谷浓度(Cmin)。疗效评估包括临床疗效和微生物学疗效。临床疗效定义为在TZD治疗结束后2周内无复发且无需额外治疗。微生物学疗效定义为TZD治疗期间及之后无细菌。安全性评估采用血小板减少症。血小板减少症定义为血小板计数较基线水平降低≥25%且最低计数<10×10⁹/μL。共纳入17例患者。16例患者的Cmin<0.5μg/mL;1例患者Cmin为1.01μg/mL,合并肝硬化。超过80%的患者有临床和微生物学疗效。14.3%(2/14)的患者发生血小板减少症。两名血小板减少症患者的Cmin分别为0.14和0.28μg/mL。肝硬化患者的TZD血清浓度可能会升高;可能需要进行治疗药物监测。TZD所致血小板减少症可能与其血清浓度无关,因此有必要监测血小板计数。

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