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

IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES
Yuichi Shibata, Arufumi Shiota, Nobuaki Mori, Nobuhiro Asai, Mao Hagihara, Hiroshige Mikamo
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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 × 104/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.

应用治疗药物监测评价替地唑胺的临床疗效和安全性。
泰地唑胺(TZD)引起的血小板减少症有报道,但比利奈唑胺少。只有少数报道调查了服用TZD的有效性和安全性之间的关系。本研究旨在测定TZD浓度,探讨其疗效与安全性的关系。这项研究是在爱知医科大学医院进行的。所有接受TZD治疗的患者均被纳入;采用LM1010高效液相色谱法测定TZD血清谷浓度(Cmin)。从临床和微生物学两方面评价疗效。临床疗效定义为在TZD治疗结束后2周内无复发,无需额外治疗。微生物功效被定义为在TZD治疗期间和之后没有细菌。安全性评估采用血小板减少。血小板减少定义为血小板计数与基线水平相比减少≥25%,最小计数为4/μL。纳入17例患者。16例患者的Cmin为80%。14.3%(2/14)的患者发生血小板减少。2例血小板减少患者Cmin分别为0.14和0.28 μg/mL。肝硬化患者血清中TZD浓度可能升高;可能需要进行治疗药物监测。不论其血清浓度如何,都可能发生由TZD引起的血小板减少症,因此需要监测血小板计数。
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来源期刊
Journal of Infection and Chemotherapy
Journal of Infection and Chemotherapy INFECTIOUS DISEASES-PHARMACOLOGY & PHARMACY
CiteScore
4.10
自引率
4.50%
发文量
303
审稿时长
47 days
期刊介绍: The Journal of Infection and Chemotherapy (JIC) — official journal of the Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases — welcomes original papers, laboratory or clinical, as well as case reports, notes, committee reports, surveillance and guidelines from all parts of the world on all aspects of chemotherapy, covering the pathogenesis, diagnosis, treatment, and control of infection, including treatment with anticancer drugs. Experimental studies on animal models and pharmacokinetics, and reports on epidemiology and clinical trials are particularly welcome.
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