Ciprofloxacin 제제의 생물학적 동등성에 관한 연구

최철희,신재국,신완균,유호진,이경훈,정원석,장인진,신상구 대한화학요법학회 1991 대한화학요법학회지 Vol.9 No.1

국내 시판중인 ciprofloxacin 제제인 Citopcin®(250㎎ tablet)의 동등성을 검토하기 위해 제조원인 Bayer사의 Citopcin®(250㎎ tablet)를 기준제제로 하여 18명의 건강한 남성 피험자를 대상으로 500㎎ 1회 교차 경구 투여후 약동학적 성상을 분석비교한 결과는 다음과 같다. 시험제제의 생체 이용율의 지표인 AUC, C_(mao), T_(max) 및 MRT들의 평균치는 백분율차이에 있어 모든 기준제제 지표의 ± 20% 이내였으며, 이들 생체 이용율 지표들은 분산분석 검정에서 차이를 인지할 수 없었다.생체 이용율 지표들의 기준제제에 대한 백분율 90% 대칭 신뢰구간 검토시 모든 경수들에서 ± 20% 이내의 조건을 만족하였으며 AUC의 경우에는 대칭형 신뢰구간으로 변환시 95% 신뢰구간에서도 동등성의 조건을 만족하였다, 이상의 시험결과로 시험제제인 Citopcin®은 기준제제인 Ciprobay®와 생물학적 동등한 제제로 판단되었다. The pharmacokinetics of ciprofloxacin was studied for the evaluation of the bioequivalence of the generic ciproflocacin products. Two single doses of 500㎎ each of ciprofloxacin(Ciprobay® 250㎎ tablet as a reference compound and Citopcin® 250㎎ tablet s a test compound) were administered orally to ighteen male volunteers in a balanced, randomized crossover design. Pek plasma levels of ciprofloxacin were observed about 1 hour after the doses and the peak concentrations of both products were similar(Ciprobay®, 3.18㎍/㎖; Citopcin®, 2.89㎍/㎖). The values of other pharmacokinetic parameter of ciprofloxacin computed for Ciprobay® are presented in that order: AUC=13.53:12.47㎍·h/㎖, T_(max)=1.28:1.14 hours; MRT=5.30:5.08 hours; t_(1/2)β=3.65:3.47 hours. No satistically significant, differences were detected when AUC and the other parameters were compared with the method of ANOVA. Using the criteria of 90% confidence interval for the assessment of bioequivalence al the parameters were acceptable. The products were found to be equivalent on the premise that no significant difference was detected when the relevant pharmacokinetic parameters were compared, and the confidence limit analysis showed acceptable results.

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.

다량의 하부위장관출혈이 병발된 Vibrio vulnificus 패혈증 1예

최주연,유진홍,한석원,이대훈,최민호,박순민,김연식,김선우,신완식,강문원,강성구 대한화학요법학회 1996 대한화학요법학회지 Vol.14 No.2

최근 저자들은 Vibrio vulnificus 감염에 의해 패혈증 및 이차성 피부 병변을 보인 42세의 남자 환자의 치료중 하부 위장관 출혈이 병발된 1예를 경험하였기에 보고하는 바이다. We experienced a case of Vibrop vulnificus septicemia which showed an unusual manifestation such as hematochezia. The patient was a 42-year-old man with chronic liver disease. The blood and wound culture revealed the organism. During intensive care, he suffered from massive hematochezi for several days. Colonoscopy and abdominal CT showed findings suspicious of ischemic colitis. To our knowledge, this is the first unusual case of V.vulnificus infection which showed massive lower gastrointestinal bleeding.

중년여성에서 등속성 운동 시 세트간의 휴식시간이 등속성 근기능 및 생리적 변인에 미치는 영향

최보성,한상완 한국전문물리치료학회 2001 한국전문물리치료학회지 Vol.8 No.3

The purpose of this study was to investigate the effects of resting periods between exercise sets during isokinetic contraction on recovery from muscle fatigue, strength, heart rate, blood pressure, and lactate level. Sixteen women performed 10 repetitions of isokinetic exercise for three sets in three different conditions. During the sets, they rested 50, 100, and 150 seconds in each condition. And the results were: 1) In this population, the peak torque of extensor during the isokinetic exercise in 100 second resting condition was significantly higher than that in 50 and 150 second resting conditions (p<.01). The total work of extensor was significant in the second and third sets in 50 and 100 second resting conditions (p<.01). 2) During the isokinetic exercise, the heart rate was progressively increased as the sets were advanced in all resting conditions (p<.01). And the increase was significant during the second and third sets than the first in 50 second resting condition (p<.01), while it was significantly greater after the third set than the first in 100 and 150 second resting conditions (p<.01). 4) No difference was found between the resting periods in blood lactate level and blood pressure during the isokinetic exercise. However, differences were found between the sets in these variables (p<.01).

TFD 소자의 전기적 특성에 관한 상위전극의 영향

최희동,이명재,고동완,곽성관,김동식,정관수 慶熙大學校 레이저 工學硏究所 2002 레이저공학 Vol.13 No.-

In this work, we examined the electrical and mechanical characteristics of TFD devices for various top electrode materials by measuring barrier height and performing ASE depth profile. It was found that the shift of current-voltage(Ⅰ-Ⅴ) characteristics of TFD device depends on the top electrode material. The main reason of the asymmetry in Ⅰ-Ⅴ curve was the differences in barrier height of top and bottom electrodes, and chemical composition at the interface region between top electrode and insulator layer also was important reason. The barrier heights(φ_B) evaluated from temperature dependence of the Ⅰ-Ⅴ relation are 0.7795(Al) 1.0287(Ti) and 1.2928(Ta) eV.

Methotrexate 치료를 받고 있는 활동성 류마티스 관절염 환자에서 etanercept의 유효성과 안전성에 관한 연구

최병렬,강태영,정청일,이혜순,엄완식,김태환,전재범,유대현,배상철 대한내과학회 2004 대한내과학회지 Vol.66 No.5

목적 : 류마티스 관절염을 앓고 있는 한국인 중에 기존 DMARDs로 치료 실패하였고, 고정용량의 MTX를 복용하고 있는 환자들에 있어서 etanercept의 유효성과 안전성을 평가하고자 하였다. 방법 : 기존 DMARDs로 치료 실패한 활동성 류마티스 관절염 환자 76명을 대상으로 하여 단일군, 공개시험을 하였다. 대상 환자들은 고정용량의 MTX를 복용하면서 etanercept 25 mg을 1주일에 두 번 피하 주사하였으며 12주간 투여하였다. 유효성은 ACR 20, ACR 50,조조강직 시간으로 평가하였고, 약제의 안전성은 이상반응 등으로 평가하였다. 결과 : 대상 환자는 총 76명으로 평균 연령은 45.2세, 남자 5명, 여자 71명이었다. 84.4%인 54명이 12주째에 ACR 20을 만족하였고, 53.1%인 34명이 12주째에 ACR 50을 만족하였다. 조조 강직 시간은 치료 전 203.3분에서 치료 12주째 42.6분을 평균 74.5% 호전되었다. 가장 흔한 이상반응은 주사부위 반응이었다. 이외에도 상기도 감염, 오심, 안면부종 등이 발생하였으나 심각한 부작용은 없었다. 결론 : etanercept는 효과적이고, 안전한 류마티스 관절염 치료 방법이며 특히 MTX치료에도 불구하고 활동성인 류마티스 관절염에 기대되는 치료라고 할 수 있다. Background : This study was performed to investigate the efficacy and safety of etanercept in active rheumatoid arthritis patients with stable dose of methotrexate in Korean. Methods : In a 12 week, single arm, open trial, we assigned 76 patients with active rheumatoid arthritis who had an inadequate response to disease-modifying antirheumatic drugs. Patients received twice-weekly subcutaneous injections of etanercept 25 ㎎ while containing to receive methotrexate at a stable dose of 7.5~25 ㎎ per week. The clinical response was defined as the percent improvement in disease activity according to the criteria of the American Collage of Rheumatology (ACR) at 12 weeks. Results : Etanrecept led to significant improvements in disease activity and was safe and well tolerated. At 12 week, 84.4% of the patients receiving 25 ㎎ of etanercept achieved a 20% ACR response, and 53.1% of those receiving etanercept achieved a 50% ACR response. The most common adverse event was injection-site reaction. Other advanse events were upper respiratory infection, nausea, and facial edema, but there were no serious adverse events associated with etanercept. Conclusion : In active rheumatoid arthritis patients, etanercept was safe, well tolerated, and provided rapid clinical improvements.

면외하중하의 이방성체 등속 계면균열 선단의 원주 전단응력

최성렬,박재완 嶺南大學校 工業技術硏究所 2004 工業技術硏究所論文集 Vol.32 No.2

The asymptotic circumferential shear stress of the propagating interfacial crack with constant velocity in bonded anisotropic materials under out of plane loadings is obtained. The maximum circumferential shear stress moves out of the interface as the crack velocity attains certain critical speed which is dependent an the properties of materials near to the interface. Referring to the maximum stress criteria, it could be shown that the three types of crack growth could be formed, such as straight/kinked/branched crack.

TERUDERMIS를 이용한 골 혹은 건이 노출된 창상의 치료

최민호,이상복,황정욱,양완석,이강길 大韓成形外科學會 1999 Archives of Plastic Surgery Vol.26 No.3

Deep skin and soft tissue defects with exposed bone and tendon is difficult to treat, because skin graft rarely survives and flap surgery is sacrifice of donor site. Since "Stage I" membrane was developed by Yannas and Bruke in 1980, numerous kinds of artificial skin have been developed. The adaptability of "Terudermis", developed by the Terumo Co., as an artificial skin composed of sponge made of a fibrillar atelocollagen and a heat-denatured atelocollagen, was clinically evaluated on application to 13 cases presenting deep skin and soft tissue defect with exposed bones and tendons from October 1997 to march 1998. Terudermis has the advantage of allowing early incorporation of fibroblasts and capillaries into its collagen sponge due to very weak dehydrothermal cross-linking. Before Terudermis graft, several days of wet dressing and debridement were required to prepare healthy well- vascularized bed because Terudermis was weak on unsanitary wounds. After bed preparation, Terudermis was grafted like usual skin graft. Tie-over bolster dressing or compressive dressing was used case by case. The dressing was opened 2~3 days after Terudermis grafting. Wet dressing was done daily until the skin graft was done. Autologous skin graft was done 2∼3 weeks after Terudermis graft. Our clinical results indicated that Terudermis was beneficial in treating 77% of our patients. Through the use of this new method, treatment of severe skin and soft tissue defects that are usually treated by musculocutaneous or other conventional skin flaps can be replaced by Terudermis as an new artificial dermis.

직업적 디메틸아세트아미드(Dimethylacetamide) 노출에 의해 집단적으로 발생한 독성간염

최태성,우극현,김진석,박완섭,함정오,정상재,유재영 대한산업의학회 2001 대한직업환경의학회지 Vol.13 No.2

목적 : DMAC에 노출된 후 집단적으로 발생한 독성 간염 7례보고. 방법 : 2000년 2월 신설된 스판덱스 섬유제조 공장에 근무하는 생산직 근로자 178명중 2000년 2월 부터 8월까지 7명이 간장질환이 발생하였다. 환례들의 나이는 23∼47세였고, 남자 5명, 여자 2명이었다. 이들에 대해 혈액검사, 간 초음파 검사 등의 임상검사와 작업장 조사를 실시하였다. 결과 : 근무 부서는 중합 1명, 방사 1명, 권취 4명, 그리고 포장 1명이며 평균근무기간은 10주였다. 주 호소 증상은 심한 피로감, 어지럼증 및 황달이었고, 검사실 소견상 독성간염의 소견을 보였다. A, B 및 C형 간염 표지자 검사는 모두 음성이었고, 간초음파 소견상 특이 소견이 없었다. 문진 상 알코올 성 간염을 일으킬 정도의 음주력이나 최근 약물 복용력을 가지고 있는 환례는 없었다. 입원 후 보존적인 치료로 모두 급속히 호전되었다. 초기에 발생했던 환례에서 퇴원후 DMAC에 재 노출되어 독성 간염이 재발되었다. 이후 모든 환례들은 퇴원 후 DMAC 비노출 부서로 전환하였고, 퇴원후 지속적인 추적검사에서 간 효소 수치가 완전히 정상화되었고, 정상화되는 기간은 1∼2개월 정도 소요되었다. 결론 : 환례들의 임상증상, 검사결파, 노출력 및 과거력상 DMAC에 의한 독성간염으로 추정된다. Dimethylacetamide is widely used in the production of plasics, resins, synthetic fibers, and gums and in purification and crystallization processes. Inhalation of the vapor or skin absorption of the liquid of dimethylacetamide (DMAC) can cause liver damage. Toxic hepatitis possibly attributable to DMAC exposure occurred in seven works among 178 employees who had worked on a new spandex-fiber production line. A large amount of DMAC is used as a spinning solvent for synthetic fibers in the factory. The patients were aged 23-47 years old and composed of five males and two females. They were involved in the process of polymerization(1 patient), spinning(1), take-up(4) and packaging(1). The mean duration of exposure was 10 weeks. They experienced fatigue, dizziness and jaundice. The patients showed elavated total bilirubln, alanlne aminotransferase (ALT), and aspartate aminotransferase (AST) levels. The serologic test for viral hepatitis A, B and C were negative, as were the abdominal ultrasonographic scans. Based on the presumptive diagnosis of DMAC-induced toxic hepatitis, they were removed from the workplaces. One or two months after removal from the work, the transaminase levels returned to normal. The patients had no history of significant alcohol use, blood transfusion, recent medication, and drug abuse. As a result, authors could not find any attributable cause of toxic hepatitis but the toxicity by DMAC exposure.

흰쥐 젖샘신경으로 투사하는 중추신경내 Oxytocin 신경로에 관한 연구

백상호,강기동,김은아,조경제,최완성,이봉희 대한해부학회 1997 Anatomy & Cell Biology Vol.30 No.6