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최리화,정병호,고원중,이수연 대한진단검사의학회 2017 Annals of Laboratory Medicine Vol.37 No.2
Although tuberculosis is largely a curable disease, it remains a major cause of morbidity and mortality worldwide. Although the standard 6-month treatment regimen is highly effective for drug-susceptible tuberculosis, the use of multiple drugs over long periods of time can cause frequent adverse drug reactions. In addition, some patients with drug-susceptible tuberculosis do not respond adequately to treatment and develop treatment failure and drug resistance. Response to tuberculosis treatment could be affected by multiple factors associated with the host-pathogen interaction including genetic factors and the nutritional status of the host. These factors should be considered for effective tuberculosis control. Therefore, therapeutic drug monitoring (TDM), which is individualized drug dosing guided by serum drug concentrations during treatment, and pharmacogenetics-based personalized dosing guidelines of anti-tuberculosis drugs could reduce the incidence of adverse drug reactions and increase the likelihood of successful treatment outcomes. Moreover, assessment and management of comorbid conditions including nutritional status could improve anti-tuberculosis treatment response.
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Drug-induced Hepatotoxicity of Anti-tuberculosis Drugs and Their Serum Levels
정인아,박종선,조영재,윤호일,송정한,이춘택,이재호 대한의학회 2015 Journal of Korean medical science Vol.30 No.2
The correlation between serum anti-tuberculosis (TB) drug levels and the drug-inducedhepatotoxicity (DIH) remains unclear. The purpose of this study was to investigate whetheranti-TB DIH is associated with basal serum drug levels. Serum peak levels of isoniazid (INH),rifampicin (RMP), pyrazinamide (PZA), and ethambutol (EMB) were analyzed in bloodsamples 2 hr after the administration of anti-TB medication. Anti-TB DIH and mild liverfunction test abnormality were diagnosed on the basis of laboratory and clinical criteria. Serum anti-TB drug levels and other clinical factors were compared between thehepatotoxicity and non-hepatotoxicity groups. A total of 195 TB patients were included inthe study, and the data were analyzed retrospectively. Seventeen (8.7%) of the 195patients showed hepatotoxicity, and the mean aspartate aminotransferase/alanineaminotransferase levels in the hepatotoxicity group were 249/249 IU/L, respectively. Among the 17 patients with hepatotoxicity, 12 showed anti-TB DIH. Ten patients showedPZA-related hepatotoxicity and 2 showed INH- or RMP-related hepatotoxicity. However,intergroup differences in the serum levels of the 4 anti-TB drugs were not statisticallysignificant. Basal serum drug concentration was not associated with the risk anti-TB DIH inpatients being treated with the currently recommended doses of first-line anti-TBtreatment drugs.
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( Minyoung Kim ),( Jae-gook Shin ),( Dong-hyun Kim ),( Eun-young Kim ),( Jong-lyul Ghim ),( Ji- Hye Kim ) 대한결핵 및 호흡기학회 2019 대한결핵 및 호흡기학회 추계학술대회 초록집 Vol.127 No.-
Backgrouod: Chemotherapy of multidrug-resistant tuberculosis is prescribed in combination for at least 2 years. According to WHO guideline, at least 5 drugs are simultaneously administered for successful therapy. TDM could be a useful tool for successful clinical practice. In this regards, a high-throughput analytical tool for the simultaneous determination of 24 anti-tuberculosis drugs covering all anti-TB drugs currently prescribed for the treatment of tuberculosis. Method: Two protein precipitation methods were adopted; one with methanol containing 0.13 N HCl for amikacin, kanamycin and streptomycin (group 1) and the other with acetonitrile for amoxicillin, bedaquiline, ciprofloxacin, clarithromycin, clofazimine, cycloserin, delamanid, DM-6705, ethambutol, ethionamide, isoniazid, levofloxacin, linezolid, moxifloxacin, PAS, prothionamide, pyrazinamide, rifabutin, rifampin, rifapentine and roxithromycin (group 2). Separation was done either on an HILIC silica column with a gradient elution (group 1) or a reversed-phase dC18 column with a gradient elution (group 2). Detection was carried out in selected MRM mode. Results: All drugs were well separated with high specificity. The calibration curves were linear over a 50-fold concentration range, with correlation coefficients (r) greater than 0.99 for all drugs. The limits of quantification were between 0.01 and 2.0 μg/ml. The intra- and inter-day precision was less than 14.3%, and the accuracy was between 85.7 and 109.5%. The recovery was more than 25% with RSD less than 16.0%. Most of the tested drugs were stable after 24 hours at room temperature, Freeze Thaw cycles, 12 hours of post-treatment. Delamanid was spontaneously degraded into the metabolite DM- 6705 and stable only within 5 hours at ice condition. Conclusion: This report describes the development and validation of the method for the simultaneous quantification of 24 anti-tuberculosis agents in human plasma by LC-MS/MS. The validated method is simple, fast, accurate, and precise. This assay can be applied to therapeutic drug monitoring in tuberculosis patients.
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Juseop Kang,Yoo-Sin Park,Shin-Hee Kim,Sang-Hyun Kim,Min-Young Jun 대한생리학회-대한약리학회 2011 The Korean Journal of Physiology & Pharmacology Vol.15 No.2
Epilepsy is a chronic disease occurring in approximately 1.0% of the world s population. About 30% of the epileptic patients treated with availably antiepileptic drugs (AEDs) continue to have seizures and are considered therapy-resistant or refractory patients. The ultimate goal for the use of AEDs is complete cessation of seizures without side effects. Because of a narrow therapeutic index of AEDs, a complete understanding of its clinical pharmacokinetics is essential for understanding of the pharmacodynamics of these drugs. These drug concentrations in biological fluids serve as surrogate markers and can be used to guide or target drug dosing. Because early studies demonstrated clinical and/or electroencephalographic correlations with serum concentrations of several AEDs, It has been almost 50 years since clinicians started using plasma concentrations of AEDs to optimize pharmacotherapy in patients with epilepsy. Therefore, validated analytical method for concentrations of AEDs in biological fluids is a necessity in order to explore pharmacokinetics, bioequivalence and TDM in various clinical situations. There are hundreds of published articles on the analysis of specific AEDs by a wide variety of analytical methods in biological samples have appears over the past decade. This review intends to provide an updated, concise overview on the modern method development for monitoring AEDs for pharmacokinetic studies, bioequivalence and therapeutic drug monitoring.
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Kang, Ju-Seop,Park, Yoo-Sin,Kim, Shin-Hee,Kim, Sang-Hyun,Jun, Min-Young The Korean Society of Pharmacology 2011 The Korean Journal of Physiology & Pharmacology Vol.15 No.2
Epilepsy is a chronic disease occurring in approximately 1.0% of the world's population. About 30% of the epileptic patients treated with availably antiepileptic drugs (AEDs) continue to have seizures and are considered therapy-resistant or refractory patients. The ultimate goal for the use of AEDs is complete cessation of seizures without side effects. Because of a narrow therapeutic index of AEDs, a complete understanding of its clinical pharmacokinetics is essential for understanding of the pharmacodynamics of these drugs. These drug concentrations in biological fluids serve as surrogate markers and can be used to guide or target drug dosing. Because early studies demonstrated clinical and/or electroencephalographic correlations with serum concentrations of several AEDs, It has been almost 50 years since clinicians started using plasma concentrations of AEDs to optimize pharmacotherapy in patients with epilepsy. Therefore, validated analytical method for concentrations of AEDs in biological fluids is a necessity in order to explore pharmacokinetics, bioequivalence and TDM in various clinical situations. There are hundreds of published articles on the analysis of specific AEDs by a wide variety of analytical methods in biological samples have appears over the past decade. This review intends to provide an updated, concise overview on the modern method development for monitoring AEDs for pharmacokinetic studies, bioequivalence and therapeutic drug monitoring.
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박승화,최수임,이은경 한국병원약사회 2001 병원약사회지 Vol.18 No.2
The survey on adverse drug reaction in patients admitted by drug toxicity was conducted. We reviewed the charts of hospitalized patients from February to August 1999. Approximately, 0.12% (n=15) of all the patients had been diagnosed as drug induced adverse reaction in the charts and 67% (n=10) of them were over sixty years old. 43% (n=7) of drug was carbamazepine and digoxin, which has known as having a narrow range of therapeutic drug concentration of blood and the other drugs were isoniazide, NSAIDs, etc. We could conclude the appropriate dosage adjustment through therapeutic drug monitoring is needed to reduce the drug-related adverse reaction, especially when the medications which may cause severe adverse reaction are prescribed to elderly patients.
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강주섭,Yoo-Sin Park,Shin-Hee Kim,Sang-Hyun Kim,전민영 대한약리학회 2011 The Korean Journal of Physiology & Pharmacology Vol.15 No.2
Epilepsy is a chronic disease occurring in approximately 1.0% of the world’s population. About 30% of the epileptic patients treated with availably antiepileptic drugs (AEDs) continue to have seizures and are considered therapy-resistant or refractory patients. The ultimate goal for the use of AEDs is complete cessation of seizures without side effects. Because of a narrow therapeutic index of AEDs, a complete understanding of its clinical pharmacokinetics is essential for understanding of the pharmacodynamics of these drugs. These drug concentrations in biological fluids serve as surrogate markers and can be used to guide or target drug dosing. Because early studies demonstrated clinical and/or electroencephalographic correlations with serum concentrations of several AEDs, It has been almost 50 years since clinicians started using plasma concentrations of AEDs to optimize pharmacotherapy in patients with epilepsy. Therefore, validated analytical method for concentrations of AEDs in biological fluids is a necessity in order to explore pharmacokinetics, bioequivalence and TDM in various clinical situations. There are hundreds of published articles on the analysis of specific AEDs by a wide variety of analytical methods in biological samples have appears over the past decade. This review intends to provide an updated, concise overview on the modern method development for monitoring AEDs for pharmacokinetic studies, bioequivalence and therapeutic drug monitoring.
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이경훈,전선희,한민제,송상훈,박종선,이재호,박경운,송정한 대한진단검사의학회 2016 Annals of Laboratory Medicine Vol.36 No.5
As dried blood spots (DBSs) have various advantages over conventional venous blood sampling, some assays for detection of one or two anti-tuberculosis (TB) drugs in DBSs have been developed. However, there are no assays currently available for the simultaneous measurement of three or more anti-TB drugs in DBSs. In this study, we developed and evaluated a multiplex method for detecting nine anti-TB drugs including streptomycin, kanamycin, clarithromycin, cycloserine, moxifloxacin, levofloxacin, para-aminosalicylic acid, prothionamide, and linezolid in DBSs by using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). Seventy-nine patient samples of DBS were analyzed on the UPLC-MS/MS system. All drug concentrations were determined within 4 min, and assay performance was evaluated. All drugs were clearly separated without ion suppression. Within-run and between-run precisions were 1.7-13.0% and 5.7-17.0%, respectively, at concentrations representing low and high levels for the nine drugs. Lower limits of detection and quantification were 0.06-0.6 and 0.5-5.0 μg/mL, respectively. Linearity was acceptable at five level concentrations for each drug. Correlations between drug concentrations in plasma and DBSs by using Passing-Bablock regression and Pearson’s rho (ρ, 0.798-0.989) were acceptable. In conclusion, we developed a multiplex assay to measure nine second-line anti-TB drugs in DBSs successfully. This assay provided convenient and rapid drug quantification and could have applications in drug monitoring during treatment.
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비만 환자의 조혈모세포이식 후 체중 적용 기준에 따른 Cyclosporine 초기 농도 비교
권지은,박애령,김순주,나현오 한국병원약사회 2014 病院藥師會誌 Vol.31 No.6
Cyclosporine is the most common immunosuppressant agent against graft-versus-hostdisease (GVHD) in patients with hematopoietic stem cell transplantation (HSCT). The therapeuticrange of cyclosporine is narrow, and there is significant inter-individual and intra-individual variabilityin the pharmacokinetics of the drug. Therefore, therapeutic drug monitoring of cyclosporine isessential to optimize immunosuppressant therapy. In Seoul St. Mary’s hospital, the dose ofcyclosporine is based on the actual body weight. Cyclosporine 5 mg/kg/day is given the day beforeHSCT by 24hrs intravenous infusion. The dose is then changed to 3 mg/kg/day after HSCT. We conductedtherapeutic drug monitoring for the optimal therapeutic range of cyclosporine. The concentrationof cyclosporine is often higher for obese patients than the initial therapeutic range of200~300 ng/ml. As a result, obese patients have a greater risk of cyclosporine side effects than nonobese patients. We evaluated the effects of cyclosporine at an initial dose based on ideal body weightin obese patients. We retrospectively collected the data from obese patients (actual body weight > 120% ideal bodyweight) who received cyclosporine therapy after HSCT, at the Catholic BMT (blood and marrowtransplantation) center from April 2009 to September 2011. Pharmacokinetic parameters were calculatedfrom data collected from monitored patient profiles and actual blood concentration ofcyclosporine. We subsequently calculated the concentration of cyclosporine, according to the dosebased on ideal body weight. Out of 32 patients who received cyclosporine therapy after HSCT, 1 patient who receivedcyclosporine based on actual body weight reached the therapeutic range (3.1%). However, 7 patientswho received cyclosporine based on ideal body weight reached the therapeutic range (21.9%). Theresults showed a significant difference (p=0.014). The median gap between the actual blood concentrationand the upper limit of therapeutic range was 164.1 (-25.3~440.0) ng/ml in patients whoreceived cyclosporine based on actual body weight. The median gap between the calculated bloodconcentration and the upper limit of therapeutic range was 67.7 (-74.0~239.0) ng/ml in patients whoreceived cyclosporine based on ideal body weight. The blood concentration of cyclosporine based onideal body weight was indicative of a more efficient approach to a therapeutic range of cyclosporine. In conclusion, this study suggested that the administration of cyclosporine based on ideal bodyweight might lead to optimal blood concentration and a reduction in cyclosporine side effects. Thecurrent observation needs to be confirmed by prospective investigation in order to determine appropriatecyclosporine therapy in obese patients.
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