• Title/Summary/Keyword: Drug monitoring

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Pharmacokinetic Interaction Between Atorvastatin and Nifedipine (아톨바스타틴과 니페디핀의 약물동태학적 상호작용)

  • Moon, Hong-Seop;Choi, Jun-Shik
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.1
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    • pp.25-29
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    • 2010
  • The purpose of this study was to investigate the effect of atorvastatin on the pharmacokinetics of nifedipine (6 mg/kg) after oral administration of nifedipine with or without atorvastatin (0.5 and 2.0 mg/kg) in rats, and also was to evaluate to the effect of atorvastatin on the CYP3A4 activity. The 50% inhibiting concentration ($IC_{50}$) values of atorvastatin on CYP3A4 activity is 46.1 ${\mu}M$. Atorvastatin inhibited CYP3A4 enzyme activity in a concentration-dependent manner. Coadministration of atorvastatin increased significantly (p<0.05, 2.0 mg/kg) the plasma concentration-time curve (AUC) and the peak concentration ($C_{max}$) of nifedipine compared to the control group. The relative bioavailability (RB%) of nifedipine was increased from 1.15- to 1.37-fold. Coadministration of atorvastatin did not significantly change the terminal half-life ($T_{1/2}$) and the time to reach the peak concentration ($T_{max}$) of nifedipine. Based on these results, we can make a conclusion that the significant changes of these pharmacokinetic parameters might be due to atorvastatin, which possesses the potency to inhibit the metabolizing enzyme (CYP3A4) in the liver and intestinal mucosa, and also inhibit the P-glycoprotein (P-gp) efflux pump in the intestinal mucosa. It might be suggested that atorvastatin altered disposition of nifedipine by inhibition of both the first-pass metabolism and P-glycoprotein efflux pump in the small intestine of rats. In conclusion, the presence of atorvastatin significantly enhanced the oral bioavailability of nifedipine, suggesting that concurrent use of atorvastatin with nifedipine should require close monitoring for potential drug interation.

Rituximab Infusion-related Adverse Events and Risk Factors (Rituximab 주입관련 부작용발생 및 위험인자 분석)

  • Lee, Eun Jung;Kim, Young Joo;Rhie, Sandy J
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.3
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    • pp.223-231
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    • 2013
  • Objective: This study aimed to identify the status and risk factors of rituximab infusion-related adverse events (ADE) in rituximab-na$\ddot{i}$ve patients with cancer diseases. Method: A retrospective analysis using electronic medical records review was conducted. Inclusions were patients with a diagnosis of cancer disease with the initiation of rituximab-included treatment who were na$\ddot{i}$ve to rituximab during January 2011 to March 2013 at National Cancer Center (NCC) in Korea. Result: Total 110 patients, 582 cases of rituximab administrations, were reported in the study. About 57.2% of patients were 51-70 years old and evenly distributed between two genders and 72.7% were BMI less than $25kg/m^2$. All of study patients were diagnosed with non-Hodgkin lymphoma. Fifty patients (45.4%) and 54 cases (9.3%) were experienced rituximab infusion-related AEs even with conservative administration protocol at NCC. The most frequently occurring AEs were shivering followed by rash and itching. In single variant analysis, we found that the early stage of NHL, low exposure to rituximab administrations, high white blood cell counts, high lymphocyte counts, high absolute neutrophil count and low lactate dehydrogenase were associated with infusion-related AEs (p<0.05). The early stage of disease, high lymphocyte counts, low exposure to rituximab administrations were also related significantly with AEs in multiple variants analysis (p<0.05). Conclusion: Rituximab infusion-related AEs for patients who were na$\ddot{i}$ve to rituximab were still a concern with conservative administration protocol. The adverse drug reactions were significantly associated with early stage of NHL, higher lymphocyte counts and low exposure to rituximab administrations. The factors need to be considered with close monitoring to prevent rituximab infusion-related AE.

Development of Infusion Pump System using Photodiode Array (광 다이오드 어레이 센서를 이용한 인퓨전 펌프 시스템의 개발)

  • Kwon, Jang-Woo;Park, Jung-Sun;Lee, Dong-Hun;Lee, Eung-Huyk;Hong, Seung-Hong
    • Journal of Sensor Science and Technology
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    • v.5 no.3
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    • pp.65-73
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    • 1996
  • One of the important factor in drug stuffs to a patient is to inject exact amount with stable flow rates. Since improper injection amount and flow rates would cause bad effect to recovery of a patient, the detecting sensors with high sensitivity is required for an injection pump systems' performance improvement. In this study, the three sensors, piezo film sensor, photo transistor and photo array, were compared to find best one for an injection pump monitoring system. Using suggested data processing technique and photo array sensors, we could minimize the effect of interference, disturbance, illumination, and sensitivity change caused by sensor's position. According to the experiments, the photo array showed the higher reliance than any other the three types of sensors.

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Photopolymerization and Properties of PCL-Based Biodegradable Molecularly Imprinted Polymers (PCL 기반 생분해성 분자 날인 고분자의 광중합 및 물성)

  • Kim, Sun-Hui;Lee, Kyung-Soo;Kim, Yong-Hoon;Choi, Woo-Jin;Kim, Beom-Soo;Kim, Eung-Kook;Kim, Dae-Su
    • Polymer(Korea)
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    • v.31 no.2
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    • pp.153-159
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    • 2007
  • Biodegradable molecularly imprinted polymers (MIPs) can be applied in the biomedical area of biosensors, drug delivery, etc. Therefore, in this study, biodegradable theophylline MIPs were synthesized via photopolymerization using a poly $(\varepsilon-caprolactone)$ (PCL) macromer as a cross-linker and their physical properties were investigated. The yield for the synthesis of the PCL macromer with terminal acrylate groups was ca. 78 mol%. The products were characterized by the combination of FT-IR and $^1H-NMR$ spectroscopic analyses. UV/Visible spectroscopic analysis for removing and rebinding theophylline was performed by monitoring the theophylline concentration in the solution. In vitro biodegradation tests of the theophylline MIPs performed in phosphate buffered saline (PBS) solution at $37^{\circ}C$ showed good biodegradability of the MIPs.

Easy and Safe Catheterization of the Innominate Vein (무명정맥의 쉽고 안전한 삽관)

  • 이흥섭;조창욱
    • Journal of Chest Surgery
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    • v.29 no.12
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    • pp.1401-1404
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    • 1996
  • Central venous line insertion is an essential procedure in a cardiac operation. For this, percuteneous Insertion is usually done in the internal jugular vein or the subclavian vein. However, this method can create such complications as pneumothorax and hemothorax, and repeated failure in inserting the cathet r, especially in infant and child patients, can waste excessive time. Consequently, in our hospital, catheterization of the innominate vein was done after the completion of sternotomy in the cardiac operation of infant and child patients weighing under 1 Okg. During operation, the catheter was placed in the left atrium through the foramen ovate or pulmonary artery to be used for pressure monitoring. When the patient's hemodynamic became stabilized, the catheter was withdrawn to either the right atrium or superior vena casa to be used as the channel for fluid replacement or drug administration. In our hospital, this procedure has been used in 96 cases since 1989. No complications such as pneumothorax and hemothorax occilrred, and neither bleeding after the removal of the catheter was seen.

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Economic Evaluation of Rosuvastatin and Atorvastatin for the Treatment of Dyslipidemia from a Korean Health System Perspective (이상지질혈증 환자에게 사용되는 Rosuvastain과 Atorvastatin의 경제성 평가)

  • Suh, Sunghwan;Jung, Chang Hee;Hong, Soon-Jun;Kim, Jung-Sun;Song, Byung Ju;Sohn, Hyun Soon;Choi, Sung Hee
    • Journal of Lipid and Atherosclerosis
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    • v.5 no.1
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    • pp.61-77
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    • 2016
  • Objective: This study aims to analyze cost-effectiveness of two most-commonly used statins from the perspective of the Korean national health system. Methods: The scope of the analysis included rosuvastatin (5 mg, 10 mg, and 20 mg) and atorvastatin (10 mg, 20 mg, 40 mg, and 80 mg). Effectiveness was defined as percentage (%) and absolute (mg/dL) reductions of low-density lipoprotein cholesterol (LDL-C) from the baseline. They were derived from published randomized controlled studies for rosuvastatin and atorvastatin. Effectiveness was defined as reductions in LDL-C levels per mg dose of the drugs. The annual direct medical costs including drug acquisition costs and monitoring costs over the one-year time horizon were calculated for each alternative. The average cost-effectiveness ratios (ACERs) and incremental cost-effectiveness ratios (ICERs) for each statin dose were calculated. Results: The ACERs for all doses of rosuvastatin (5 mg, 10 mg, and 20 mg) were lower than those for all doses of atorvastatin (10 mg, 20 mg, 40 mg, and 80 mg). Rosuvastatin 10 mg was the most cost-effective statin for LDL-C reduction. In cost-effectiveness analyses for corresponding doses of rosuvastatin and atorvastatin, rosuvastatin was the superior strategy which suggests both higher effectiveness and lower costs than atorvastatin. However, we have to consider this analysis is highly influenced by current price of statins in each market. Conclusion: For reduction of LDL-C levels in Korean patients with dyslipidemia, rosuvastatin 10mg is the most cost-effective statin in the current Korean market.

Analysis of Adverse Events in Weight Loss Program in Combination with 'Gamitaeeumjowee-Tang' and Low-Calorie Diet (가미 태음조위탕과 저열량 식이를 병행한 체중 감량 프로그램에서 발생한 이상 반응 분석)

  • Yoon, Na-Ra;Yoo, Young-Jae;Kim, Min-ji;Kim, Seo-Young;Lim, Young-Woo;Lim, Hyung Ho;Park, Young-Bae
    • Journal of Korean Medicine for Obesity Research
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    • v.18 no.1
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    • pp.1-9
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    • 2018
  • Objectives: The objective of this study was to assess the safety of 'Gamitaeeumjowee-tang' by analyzing adverse events in weight loss program in combination with 'Gamitaeeumjowee-tang' and low-calorie diet. Methods: A retrospective review of adverse events in weight loss program in combination with 'Gamitaeeumjowee-tang' and low-calorie diet from the electronic medical chart (n=124) between June 2015 and December 2016 was conducted. Three Korean Medicine Doctors (KMDs) reviewed adverse events for two times, during week 2 to 4 and at week 10, after starting weight loss program. Adverse events were evaluated in terms of causality, severity and system-organ classes. Also, agreement among the three KMDs was made through further discussion in case of disagreement after independent review. Results: The overall rate of adverse events was 37.1% during week 2 to 4 and 16.9% at week 10. For causality of adverse events using the World Health Organization-Uppsala Monitoring Centre causality categories, 52.2% were evaluated 'possible' at week 2-4 and 57.1% were evaluated 'unlikely' at week 10. All symptoms were evaluated as 'mild' by LDS scale. Nausea (15, 12.1%) was the most frequent adverse event at week 2-4 and dizziness (6, 4.8%) was the most common at week 10. Conclusions: Adverse events decreased over time. There were no serious adverse events and none of the subjects were dropped due to adverse events. Continuous study is needed to prove the safety of 'Gamitaeeumjowee-tang' for treating obesity.

Development and validation of LC-MS/MS for bioanalysis of hydroxychloroquine in human whole blood

  • Park, Jung Youl;Song, Hyun Ho;Kwon, Young Ee;Kim, Seo Jin;Jang, Sukil;Joo, Seong Soo
    • Journal of Biomedical and Translational Research
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    • v.19 no.4
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    • pp.130-139
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    • 2018
  • This study aimed to analyze a high-performance liquid chromatography (HPLC) separation using a pentafluorophenyl column of parent drug hydroxychloroquine (HCQ) and its active metabolite, desethylhydroxchloroquine (DHCQ) applying to determine bioequivalence of two different formulations administered to patients. A rapid, simple, sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for bioanalysis of HCQ and its metabolite DHCQ in human whole blood using deuterium derivative $hydroxychloroquine-D_4$ as an internal standard (IS). A triple-quadrupole mass spectrometer was operated using electrospray ionization in multiple reaction monitoring (MRM) mode. Sample preparation involves a two-step precipitation of protein techniques. The removed protein blood samples were chromatographed on a pentafluorophenyl (PFP) column ($50mm{\times}4.6mm$, $2.6{\mu}m$) with a mobile phase (ammonium formate solution containing dilute formic acid) in an isocratic mode at a flow rate of 0.45 mL/min. The standard curves were found to be linear in the range of 2 - 500 ng/mL for HCQ; 2 - 2,000 ng/mL for DHCQ in spite of lacking a highly sensitive MS spectrometry system. Results of intra- and inter-day precision and accuracy were within acceptable limits. A run time of 2.2 min for HCQ and 2.03 min for DHCQ in blood sample facilitated the analysis of more than 300 human whole blood samples per day. Taken together, we concluded that the assay developed herein represents a highly qualified technology for the quantification of HCQ in human whole blood for a parallel design bioequivalence study in a healthy male.

Liquid Biopsy: Current Status and Future Perspective in Gastric Cancer and Helicobacter Infection (액체 생검(Liquid Biopsy): 위암 및 헬리코박터 감염증에서 적응과 전망)

  • Kang, Eun A;Han, Young Min;Park, Jong Min;Yoo, In Kyung;Hong, Sung Pyo;Hahm, Ki Baik
    • The Korean journal of helicobacter and upper gastrointestinal research
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    • v.18 no.3
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    • pp.150-156
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    • 2018
  • Precision medicine stands for 4Ps - precise, preventive, participatory, and personal; in which "precision" is important because the current modern medicine starts from "trial and error," and "one does not fit all". Current targeted therapies for cancer have changed treatment approaches and led the precision medicine; however, clinical use of liquid biopsy, using blood or other liquid specimens to characterize circulating tumor cells (CTC) or tumor genes instead of biopsies of tumor tissues, still awaits availability of more information regarding non-invasive cancer detection and characterization, prediction of treatment response, monitoring the disease course and relapse possibilities, identification of mechanisms of drug resistance, and newer pathogenesis. In this review, we will introduce the basic concept of CTC, circulating cell free DNA, and exosomes and their possible application for gastric cancer relevant with Helicobacter pylori infection.

Comparison of Adverse Events between High-intensity and Moderate- to Low-intensity Statin Group (의약품부작용보고시스템 데이터베이스를 이용한 고강도 statin과 중·저강도 statin 관련 이상사례 비교 분석)

  • Lee, Sera;Ock, Miyoung;Kim, Hyunah
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.4
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    • pp.293-299
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    • 2018
  • Background: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) effectively reduce serum levels of low-density lipoprotein (LDL) and total cholesterol. High-intensity statins are recommended for all patients aged ${\leq}75$ with clinical atherosclerotic cardiovascular disease (ASCVD), diabetes mellitus aged 40-75 with ${\geq}7.5%$ estimated 10-year ASCVD risk and LDL-C ${\geq}190mg/dL$. High-intensity statins associated with more frequent adverse events (AEs) compared to moderate- to low-intensity statins. The aim of this study was to compare AEs between high-intensity and moderate- to low-intensity statin group using the Korea Adverse Event Reporting System (KAERS) database. Methods: Adults (${\geq}18years$) with statin-associated AEs from July 2009-June 2014 were included. Only AEs classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Center criteria were analyzed. Results: In total, 247 AEs from 196 patients [high-intensity statin group (HG), n = 25 (13%); moderate- to low-intensity statin group (MLG), n = 171 (87%)] were included. Mean age was higher in HG compared with MLG ($67{\pm}14$ vs $62{\pm}12$). The HG showed a significant higher frequency of liver/biliary system disorders (37% vs 14%, p = 0.001). Hepatic function abnormal was reported more frequently in HG compared to MLG (26% vs 9%, p = 0.006). Conclusion: According to KAERS data, liver/biliary system disorders were more frequently reported in HG compared to MLG.