Bioequivalence Evaluation of Two Brands of Cefixime 100 mg Capsule (Suprax and Alpha-Cefixime) in Korean Healthy Volunteers

( Dong Hyun Choi ),( Jin Pil Burm ) 한국응용약물학회 2007 Biomolecules & Therapeutics(구 응용약물학회지) Vol.15 No.3

Cefixime is an orally absorbed cephalosporin with a broad spectrum of activity against Gram-negative bacteria and is highly resistant to beta-lactamase degradation. The purpose of the present study was to evaluate the bioequivalence of two cefixime capsules, Suprax capsule (Dong-A Pharmaceutical Co., reference drug) and Alpha-Cefixime capsule (Alpha Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal subjects, 23.5±3.72 years in age and 68.3±8.89 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. There was one week washout period between the doses. After one capsule containing 100 mg of cefixime was orally administered, plasma was taken at predetermined time intervals and the concentrations of cefixime in plasma were determined using HPLC with UV detector. The pharmacokinetic parameters such as AUC(t), C(max) and T(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC(t), C(max) and T(max) between two products were -3.91%, -2.23% and -3.18%, respectively, when calculated against the reference drug. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8≤δ≤log1.25 (e.g., log0.8786≤δ≤log1.0523 and log0.8889≤δ≤log1.0512 for AUC(t) and C(max), respectively). The 90% confidence intervals using untransformed data was within ±20% (e.g., -10.37%≤δ≤6.73% for T(max)). All parameters met the criteria of KFDA for bioequivalence, indicating that Alpha-Cefixime capsule (Alpha Pharmaceutical Co.) is bioequivalent to Suprax capsule (Dong-A Pharmaceutical Co.).

Induction of Apoptosis by Cordycepin via Reactive Oxygen Species Generation in Human Leukemia Cells

Jin-Woo Jeong,Cheng-Yun Jin,Gi Young Kim,Cheol Park,Yung Hyun Choi,Jae Dong Lee 한국버섯학회 2009 한국버섯학회지 Vol.7 No.4

Cordycepin (3’-deoxyadenosin), a polyadenylation specific inhibitor, is the main functional component in Cordyceps militaris which is one of the top three famous traditional Chinese medicine. It has been shown to possess many pharmacological activities including immunologically stimulating, anti-cancer, anti-bacterial, and anti-virus, anti-infection effects. However, its anti-cancer molecular mechanisms are poorly understood. In this study, the apoptotic effects by cordycepin were investigates in human leukemia cells. Treatment of cordycepin significantly inhibited cells growth in a concentrationdependent manner by inducing apoptosis, as evidenced by morphological change and apoptotic cell death such as formation of apoptotic bodies, DNA fragmentation and increased populations of sub-G1. Induction of apoptosis by cordycepin was associated with modulation of Bcl-2 and inhibitor of apoptosis proteins (IAP) family expression. Cordycepin also increased reactive oxygen species (ROS) generation, activation of casepase-3, caspase-8, caspase-9, cleavage of poly(ADP-ribose) polymerase (PARP), β-catenin and phospholipase C (PLC)-γ1 protein. The quenching of ROS generation by N-acetyl-L-cysteine administration, a scavenger of ROS, reversed the cordycepin-induced apoptosis effects. Theresults suggested that cordycepin may be a potential chemotherapeutic agent for the treatment of leukemia patients [This work was supported by Blue-Bio Industry RIC at Dong-Eui University as a RIC (08-06-07) program of ITEP under Ministry of Knowledge Economy].

Bioequivalence Evaluation of Two Brands of Cefixime 100 mg Capsule (Suprax and Alpha-Cefixime) in Korean Healthy Volunteers

Choi, Dong-Hyun,Burm, Jin-Pil The Korean Society of Applied Pharmacology 2007 Biomolecules & Therapeutics(구 응용약물학회지) Vol. No.

Cefixime is an orally absorbed cephalosporin with a broad spectrum of activity against Gram-negative bacteria and is highly resistant to beta-lactamase degradation. The purpose of the present study was to evaluate the bioequivalence of two cefixime capsules, Suprax capsule (Dong-A Pharmaceutical Co., reference drug) and Alpha-Cefixime capsule (Alpha Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal subjects, $23.5{\pm}3.72$ years in age and $68.3{\pm}8.89$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. There was one week washout period between the doses. After one capsule containing 100 mg of cefixime was orally administered, plasma was taken at predetermined time intervals and the concentrations of cefixime in plasma were determined using HPLC with UV detector. The pharmacokinetic parameters such as $AUC_{t}$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_{t}$, $C_{max}$ and $T_{max}$ between two products were -3.91%, -2.23% and -3.18%, respectively, when calculated against the reference drug. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of $log0.8{\leq}{\delta}{\leq}log1.25$ (e.g., $log0.8786{\leq}{\delta}{\leq}log1.0523$ and $log0.8889{\leq}{\delta}{\leq}log1.0512$ for $AUC_{t}$ and $C_{max}$, respectively). The 90% confidence intervals using untransformed data was within ${\pm}20%$(e.g., $-10.37%{\leq}{\delta}{\leq}6.73%$ for $T_{max}$). All parameters met the criteria of KFDA for bioequivalence, indicating that Alpha-Cefixime capsule (Alpha Pharmaceutical Co.) is bioequivalent to Suprax capsule (Dong-A Pharmaceutical Co.).

조혈모세포이식 환자에서 침습성 진균 감염에 대한 Micafungin의 예방 효과 및 안전성

김시현,이동건,최수미,권재철,박선희,최정현,유진홍,이성은,조병식,김유진,이석,김희제,민창기,조석구,김동욱,이종욱,민우성,박종원 대한감염학회 2010 감염과 화학요법 Vol.42 No.3

Background: Micafungin, a potent inhibitor of 1,3-β-D-glucan synthase, is a novel antifungal agent of the echinocandin class. In vitro study showed that micafungin was effective against Aspergillus species as well as Candida species, but clinical data on the prophylactic efficacy against invasive fungal infections (IFIs) other than candidiasis are still lacking. Materials and Methods: We identified 60 consecutive adult hematopoietic stem cell transplantation (HSCT) recipients who received at least 3 doses of micafungin during neutropenic period. Micafungin was started as an alternative in patients who were intolerant or had adverse events (AEs) to primary prophylactic antifungal agents. We retrospectively reviewed the medical records and analyzed the efficacy and safety of micafungin for prophylaxis against IFIs. Results: The patients either had autologous (n=9) or allogeneic (n=51: 1 syngeneic, 24 sibling, 26 unrelated donor) HSCT. Itraconazole oral solution (n=58) was the most frequently used first line antifungal agent for prophylaxis and was administered for median 11 days. The most frequent cause of switch to micafungin was vomiting (n=42). The duration of neutropenia and micafungin administration was median 13 and 12 days, respectively. A successful outcome was achieved in 45 (75%) patients. Empirical antifungal therapy was initiated in 13 (22%) patients. There were 2 cases (3.3%) of breakthrough fungal infections which comprised a probable invasive pulmonary aspergillosis and a possible invasive fungal sinusitis. There was no case of invasive candidiasis. A total of 53 (88%) patients experienced at least one AE regardless of causality during micafungin administration. The most frequent AEs were hypokalemia, vomiting, diarrhea, and elevated serum aspartate aminotransferase or alanine aminotransferase. Among the aforementioned AEs, only 1 case of diarrhea could be classified as a probable relation with micafungin when causality was assessed. There was no AEs that caused discontinuation of micafungin. Conclusions: Micafungin seems to be a safe and effective agent for prophylaxis of IFIs including aspergillosis as well as candidiasis in HSCT recipients. However, further large, prospective, and randomized comparative studies are warranted for aspergillosis.

Methylation Status and Expression of E-cadherin in Oral Squamous Cell Carcinomas Compared to Benign Oral Epithelial Lesions

Son, Hyun-Jin,Chu, Jung-Youb,Cho, Eui-Sic,Lee, Dong-Geun,Min, Myung-Gee,Lee, Suk-Keun,Cho, Nam-Pyo The Korean Academy of Oral Biology 2006 International Journal of Oral Biology Vol.31 No.2

Expression of invasion/metastasis suppressor, E-cadherin, is reduced in many types of human carcinomas. Although somatic and germline utations in the CDH1, which encodes the human E-cadherin, have frequently been reported in cases with diffuse gastric and lobular breast ancers, irreversible genetic inactivations are rare in other human carcinomas. Recently, it has been well documented that some genes in human cancers may be inactivated by altered CpG methylation. Herein, we determined the expression and methylation status of E-cadherin in oral squamous cell carcinoma (SCC) by immunohistochemistry and methylation-specific PCR. The expression of E-cadherin was significantly higher in the well-differentiated oral SCCs than the moderately or poorly differentiated ones. None of eight tested benign pithelial hyperplasias showed aberrant methylation, whereas five of 12 oral squamous cell carcinomas showed aberrant methylation. When we compared E-cadherin expression with methylation status, oral SCCs with normal methylation showed a higher expression of E-cadherin than those with methylation. These findings suggest that aberrant CpG methylation of CDH1 promoter region is closely associated with transcriptional inactivation and might be involved in tumor progression of the oral mucosa.

조혈모세포이식 환자에서 발생한 Cytomegalovirus 질환의 특징 : 일개 대학변원에서 최근 10년간의 경험

최수미,이동건,박선희,김시현,김유진,민창기,김희제,이석,최정현,유진홍,김동욱,이종욱,민우성,신완식,김춘추 대한감염학회 2009 감염과 화학요법 Vol.41 No.1

Background : Studies on cytomegalovirus (CMV) diseases in Korean hematopoietic stem cell transplant (HSCT) recipients are lacking and do not reflect the recent trends of advances and changes. Therefore, we tried to analyze the clinical features of CMV diseases in HSCT recipients over the past 10 years at a tertiary university hospital in Korea. Methods : Retrospective review of medical records was done for all adult HSCT patients who received transplant at the Catholic HSCT Center from January 1998 to January 2008. Results : Forty-four cases (2.2%) of CMV diseases were identified. CMV pneumonia was diagnosed in 17 patients, retinitis in 16 patients, enterocolitis in 7 patients, esophagitis 1 patient, gastritis in 1 patient, duodenitis in 1 patient, and hepatitis in 1 patient. The median onset of symptom was 90 days after transplantation. Late CMV diseases accounted for 47.7%. CMV related death varied from 0 to 58.8% according to the involved organ. CMV retinitis was diagnosed relatively later in the course of transplantation mostly in patients who had chronic graft versus host disease (GVHD). On the contrary, CMV enterocolitis mainly occurred in patients who suffered from acute GVHD. The overall concurrent CMV reactivation was documented to be 63.6%: the concurrent CMV reactivation was observed only in 37.5% of patients with retinitis. Conclusions : We observed some differences in the pattern of CMV disease manifestation according to the involved organ and reconfirmed the fact that CMV pneumonia is the most common and fatal disease in HSCT recipients. Additionally, CMV retinitis was not uncommon in HSCT recipients. Since specific marker does not exist in predicting retinitis, regular ocular examination should be done thoroughly, especially in patients with chronic GVHD.

Staphylococcus aureus와 Coagulase-Negative Staphylococcus Species에 대한 Arbekacin의 시험관내 항균력

위성헌,강진한,허동호,이동건,김상일,김양리,최정현,김종현,유진흥,허재균,신완식,강문원 대한감염학회 2001 감염 Vol.33 No.4

Background : Most strains of methicillin-resistant Staphylococcus aureus (MRSA) now exhibit high-level resistance to various antibiotics, such as β -lactam antibiotics, aminoglycosides, macrolides, tetracyclines and quinolones. Recent reports describing the therapeutic failure of vancomycin for MRSA infections have arisen considerable concerns regarding the emergence of MRSA strains, which will require new therapeutic agents. Arbekacin, an aminoglycoside antibiotic, has antibacterial activity against both gram-positive and gram-negative bacteria and is stable in the presence of aminoglycoside inactivating enzymes produced by S. aureus. In this study, we compared the antibacterial activity of arbekacin with those of vancomycin, gentamicin, and amikacin against Staphylococcus aureus (S. aureus) and coagulase-negative staphylococci (CNS). Methods : For a collection of 549 S. aureus and 251 CNS isolates from three Catholic University Hospitals in Korea, minimum inhibitory concentrations (MICs) of arbekacin, vancomycin, amikacin and gentamicin were determined by agar dilution method using Mueller-Hinton agar according to NCCLS (National Committee for Clinical Laboratory Standards, USA)criteria. Results : Among 549 S. aureus isolates, 278 isolates were MRSA and 271 isolates were methicil sensitive S. aureus (MSSA). MIC50 & MIC90 of arbekacin against 549 S. aureus were 0.5 & 1 ㎍/mL, and MIC50 & MIC90 of vancomycin were 1 & 1 ㎍/mL. MIC of arbekacin against 549 S. aureus isolates ranges from 0.03 to 4 ㎍/mL, and MIC of vancomycin against 549 S. aureus ranges from 0.25 to 2 ㎍/mL. MIC90 of amikacin against 549 S. aureus was 32㎍/mL, and that of gentamicin was 128 ㎍/mL. MICs of amikacin and gentamicin were variable, ranging from 0.125 to 256, and otherwise arbekacin and vancomycin revealed relatively narrow range of MICs. MIC90 of arbekacin against 278 MRSA isolates & 271 MSSA were 1 & 0.5 ㎍/mL, and those of vancomycin against MRSA & MSSA were 1 & 1 ㎍/mL. MIC90 of amikacin against 278 MRSA & 271 MSSA isolates were 32 & 4 ㎍/mL, and that of gentamicin against MRSA & MSSA isolates were 128 & 32 ㎍/mL respectively. Among 251 CNS isolates, 122 isolates were MRCNS and 129 were MSCNS. MICSO & MIC90 of arbekacin against 251 CNS isolates were 0.25 & 2 ㎍/mL, and those of vancomycin were 1 & 2 ㎍/mL. MIC of arbekacin against 251 CNS isolates ranges from 0.015 to 32 ㎍/mL, and that of vancomycin isolates ranges from 0.25 to 2 ㎍/mL, MIC90 of arbekacin against 122 MRCNS & 129 MSCNS isolates were 2&0.3 ㎍/ML, and those of vancomycin were 2&s ㎍/ML. MIC90 of amikacin against 251 CNS isolates was 32 ㎍/ML, and that of gentamicin was 128 ㎍/ML for CNS. MIC90 of amikacin against 122 MRCNS & 129 MSCNS isolates were 128 & 8㎍/mL, and those of gentamicin ere 256 & 32 ㎍/mL. Conclusion : Considering above results, arbekacin can be useful agent against most strains of MRSA and MRCMS, which exhibit high-level resistance to amikacin and gentamicin. (Korea J Infect Dis 33:254~260, 2001)

트레드밀 운동시 흡기근 테이핑이 폐활량에 미치는 영향

김민지,신수영,송월섭,조수진,최동락,황미진,황진규,박진현,김경,Dennis W. Fell 대구대학교 특수교육재활과학연구소 2011 再活科學硏究 Vol.29 No.1

이 연구는 트레드밀 운동과 키네시오 테이핑의 효과에 따른 폐활량의 변화를 알아보기 위해 26명의 비흡연자가 참가하였으며 키네시오 테이핑을 적용하지 않은 그룹과 키네시오 테이핑을 적용한 두 그룹으로 무작위로 배정하고 각 군들을 주 3회 6주간의 트레드밀 훈련을 실시하였다. 실험 전과 후, 스파이로미터를 사용하여 키네시오 테이핑의 적용 따른 폐활량 변화 효과를 측정하였다. 이 연구의 결과를 종합해보면 키네시오 테이핑을 적용 그룹에서 적용하지 않은 그룹에 비해 FVC, FEV1에서 유의한 증가를 보였다. 이러한 결과는 건강한 성인에서 키네시오 테이핑을 적용한 경우 키네시오 테이핑을 적용하지 않고 트레드밀 운동을 한 경우보다 폐활량의 향상에 효과적이라고 생각되어진다. The purpose of this study was to investigate the variation of vital capacity(VC) according to the effects of kinesio taping with treadmill exercise. Twenty-six non-smokers were participated in this research and these subjects were randomly assigned into two groups. To measure the VC variation effects of kinesio taping, spirometer was used. The collected data were analyzed statistically by using a paired Mauchly test and repeated measure ANOVA. The results of this study were as follows; A group: treadmill with kinesio taping B group: treadmill without kinesio taping. Between A and B, there were significant differences. In the case of A group, there was 11.66% increase of VC, during 3 weeks experiment(p<.01). In the case of B group, there were significant differences, 3.35% increase of VC, during 3 weeks taping intervention(p<.01). After 6 weeks experiment, the improvement of VC shown a significant difference with intergroup (p<.05). From this result, it was revealed that treadmill exercise with kinesio taping was effective to improve VC to healthy adult than treadmill exercise without kinesio taping.

운동 유발성 횡문근 융해를 동반한 요로결석 2례

허진,최원혁,조진혁,함영희,홍정범,정성규,김현,허동 고신대학교 의과대학 2010 고신대학교 의과대학 학술지 Vol.25 No.2

Two men were admitted to hospital with flank pain, hematuria, which was diagnosised as ureteral stone. Elevation of aspartate aminotransferase (AST) without typical pattern of toxic hepatitis was observed. Careful history taking, several laboratory tests, abdominal and pelvis computered tomography was done. Findings from theses examinations supported the clinical diagnosis of ureteral stone complicated of exercised induced rabdomyolysis. Early recognization of rhabdomyolysis in clinical setting is important, because clinical manifestations have ranged from asymtomatic elevation of creatine kinase to acute renal failure which is a life threating medical emergency. Authors report two cases of exercised induced rhabdomyolysis initially admittied as ureteral stone managed with hydration

주행속도에 따른 부상마그네트의 특성을 고려한 상전도 자기부상시스템의 부상제어에 관한 연구

玄東石,洪正杓,鄭因城,許眞,尹相伯 창원대학교 공작기계기술연구센터 1999 연구업적집 Vol.1 No.1

A collective controller for electromagnetic suspension (EMS) system considering the speed characteristics of electromagnets is presented. The speed characteristics of the electromagnet are analyzed by finite element method (FEM) and Neural Network algorithm is used for the controller considering speed. The proposed controller is examined and the dynamic characteristics are compared with those of other controllers. The simulation results show that proposed controller has a better performance at high speed.