녹동균 세포외막 단백질 백신 CFC-1-101의 안정성 및 면역원성 검토 : 임상 제 Ⅰ/Ⅱa상 시험

장인진,김익상,유경상,임동석,김형기,신상구,장우현,박완제,이나경,정상보,안동호,조양제,안보영,이윤하,김영지,남성우,김현수 대한감염학회 1998 감염 Vol.30 No.3

목적 : 제일제당에서는 녹농균의 세포외막 단밸질을 유효성분으로 하는 백신인 CFC-101을 개발하였으며, 동물시험에서 이 백신의 안전성과 유효성을 입증하였다. 본 연구에서는 이 녹농균 백신의 인체에 대한 안전성과 면역원성을 평가하는 동시에 인체 접종시의 최적 투여 용량을 결정하기 위하여 제 I/Ⅱa상 임상시험을 수행하였다. 방법 : 건강한 성인 남자를 피험자로 선별하여 각 용량군에 백신투여자 6명, 위약투여자 2명을 배정하였다. 백신 투여군은 0.25mg, 0.5mg 또는 1.0mg 용량의 녹농균 백신을 7일 간격으로 3회에 걸쳐 근육주사 하였으며, 위약 투여군에게는 세포외막 단백질을 제외한 동일한 성분을 투여하였다. 백신접종 후 국소적 또는 전신적인 반응의 발생여부를 관찰하고, 혈액시료를 체취하여 백신의 역가와 유효성을 검정하였다. 결과 : 녹농균 백신 CFC-101은 모든 접종자에서 양호한 내약성을 보였다. 또한 0.5mg 과 1.0mg 백신 투여군에서는 100%의 항체양전율을 나타내었다. 생성된 항체는 녹농균 세포외막단백질에 특이성을 보였고, 녹농균 감염에 대해 방어효능이 있었다. 결론 : 이와같은 결과로부터 이 녹농균 백신은 인체에 안전하게 투여할 수 있으며, 높은 항체 생성능으로 감염방어 효능을 보이고 0.5mg과 1.0mg이 최적용량인 것으로 판단되었다. Background : We developed a Pseudomonas aeruginosa outer membrane protein(OMP) vaccine CFC-101, and the prophylactic efficacy of which has been demonstrated in animal models. In order to evaluate the safety and immunogenicity of the P. aeruginosa vaccine, we carried out a phase I/Ⅱa clinical trial in healthy male volunteers. Methods : Groups of eight volunteers, including two placebo subjects, were vaccinated intramuscularly with three doses of 0.25, 0.5 or 1.0 mg of the vaccine at one week intervals. Sings of systemic and local reactions observed after vaccination were recorded for each vaccinee for 5 days. Physical examinations were performed on days 0, 1, 7, 8, 14, 15, 21, and 42, and clinical laboratory tests were done on days 0, 3, and 21. Blood samples for assay of serum antibody levels were obtained up to 42 days after the first vaccination. Results : The vaccine was generally well tolerated by all vaccinees, showing no significant side effects. In the three dosage groups, all vaccinees, except one receiving the 0.25 mg dose, showed significant elevation in serum IgG antibody titers against the vaccine proteins, indicating 100% seroconversion in 0.5 and 1.0 mg groups. The human antibodies induced by the vaccine were specific for P. aeruginosa OMPs, as confirmed by western blot analysis and immunoprecipitation assays. The capacity of the human antisera to enhance opsonophagocytic killing activity by polymorphonuclear leukocytes and to confer protection against P. aeruginosa infections indicates that the antibodies elicited by the vaccine have protective efficacy. Conclusion : We conclude that the P. aeruginosa OMP vaccine is safe and effective for human use and its optimal dose to be 0.5 or 1.0 mg.

사지의 주요 동맥손상의 처치: 23증례에 대한 분석

원형섭,김상은,배성만,박철완,이 근,조상훈,김상일,우병완 大韓應急醫學會 1996 대한응급의학회지 Vol.7 No.1

Extremity vascular trauma is common in most emergency centers, and controversy remains about the optimal management of arterial injuries. Retrospectively we reviewed the records of 23 patients who had upper or lower extremity arterial trauma from July 1994 to December 1995. The purpose of this study was to evaluate our department`s management policy to major arterial injuries. The leading cause of major arterial injuries was penetrating trauma. We found that there were clinical findings such as absence of or decreased strength of pulsation(82.6%), cool ischemic extremity(69.6%), large expanding hematoma(43.5%), major bleeding(17.4%) and bruit or thill(8.7%). We gave the priority to management of life-threatening injuries and applied the pressure dressing to wounds as early as possible. There were 18 men(78.3%) and 5 women(21.7%); the mean age was 35(range 20-56 years old) years. There were 12 arterial injuries(52.2%) in the upper extremity and 11 arterial injuries(47.8%) in the lower exteremity. The most commonly injured artery was the brachial artery in the upper(34.8%) and the femoral artery in the lower(30.4%) extremity. The etiology included knife stabbing in 10 patients(43.5%), motor vehicle accidents in 6(26.1%), industrial accidents in 4(17.4%), falls in 2(8.7%) and a farm equipment accident in 1 patient(4.3%). The associated injuries were muscle injuries(78.3%), fracture(56.5%), nerve injuries(52.2%), vein injuries(43.5%), shock(17.4%) and dislocation(13.0%). All patients with arterial injuries were given a preoperative prophylactic antibiotic and TIG(tetanus immunoglobulin). We used Doppler technique as a means of detecting the blood flow. Fourteen patients(60.9%) underwent preoperative arteriography in the radiology department. We performed surgical exploration as soon as major arterial injuries were suspected. The most common methods of treating major arterial injuries were interposition vein graft(69.6%) and end to end anastomosis(21.7%). Systemic or locally infused heparin was used for all vascular repairs. In many of our patients(56.5%), fasciotomy was performed before the vascular repair, as a part of the exploration of the distal arteries. There were 2 amputations(8.7%) but no death. The reason for secondary amputation were wound infection in one and failure to achieve sufficient arterial flow to the involved extremity with resulting gangrene in the other. As the time factor is vitally important in the management of arterial injuries, we advocate prompt and early surgical treatment within 6 hours of the trauma. In conclusion, we believe that the crucial factorsin successful management of major arterial injuries of the extremities are early diagnosis, prompt treatment, complete debridement, fasciotomy when indicated, and simultaneous treatment of concomitant injuries.

한국인 환자에서 Vancomycin의 집단약동학 (Population Pharmacokinetics)에 관한 연구

유경상,배균섭,이주연,조주연,장인진,신상구,신완균 大韓臨床藥理學會 1998 臨床藥理學會誌 Vol.6 No.2

요로감염이 진단되었거나 의심되는 영아에서 방광요관역류를 예측할 수 있는 임상적, 실험실적 지표들에 대한 연구

조승만,홍성완,홍찬의,정철주,노영일 朝鮮大學校 附設 醫學硏究所 2007 The Medical Journal of Chosun University Vol.32 No.3

Background: Vesicoureteral reflux (VUR) in infants may be the main cause of recurrent urinary tract infection (UTI) and renal scarring. So the early diagnosis of VUR is helpful to prevent recurrence of UTI and to alleviate the grade of VUR. This study is to examine the predictability of clinical and laboratory variables for VUR in infants with confirmed or suspected UTI. Material and Methods: Data of infants younger than 12 months who underwent voiding cystourethrography (VCUG) between 2003 and 2006 were evaluated retrospectively. Among the infants with suspected UTI, infants with VUR (Group 1) vs no VUR (Group 2) were compared. And among the Infants with confirmed UTI, infants with VUR (Group 3) vs no VUR (Group 4) were compared, Variables selected in this study were age at onset, gender, fever, laboratory data and imaging (ultrasonography). Results: Among the variables, the mean of C-reactive protein (CRP) in Group 1 and Group 2 were 5.24±6.82 and 2.46±3.75, respectively, showing that Group 1 had a higher value than Group 2 (P=0.0104). And the number of patients with fever □38.5℃ in Group 1 was higher than in Group 2 (U=0.0004). The mean of C-reactive protein (CRP) in Group 3 and Group 4 were 8.95±6.1 and 5.39±6.0, respectively, showing that Group 3 had a higher value than Group 4 (P=0.0409). Conclusion: Fever≥38.5℃ and CRP≥0.6 ㎎/dL were closely associated with VUR in infants with suspected UTI. And CRP□3.4㎎/dL was closely associated with VUR in infants with confirmed UTI. However, further evaluations and studies for these variables will be needed to use them as predictors for VUR.

수종의 CLEAN-UP technique이 법랑질 표면거칠기에 미치는 영향

조상완 慶北大學校 齒科大學 1996 慶北齒大論文集 Vol.13 No.-

교정치료를 목적으로 발거한 소구치 60개를 4군으로 나누고 치과용 저속 절삭기에서 18,500±300rpm으로 회전속도를 일정하게 하여 4가지 회전 마무리 기구(G1; No. 169L carbide fissure bur, G2; No.2 round bur, G3; No.4 round bur, G4; No.8 round bur)로 잔여 레진을 제거하고 러버컵과 pumice로 법랑질을 5초간 마무리하였을 때 법랑질 손상에 미치는 정도를 알아보기 위해 브라켓 부착전 러버컵과 pumice로 전처치한 후 (P1),각 군에 해당하는 방법으로 잔여 레진을 제거한 후 (P2), 러버컵과 pumice로 마지막 마무리 후 (P3)의 법랑질 표면거칠기를 표면거칠기 측정기에서 각각 측정하고 주사전자현미경하에서 관찰하여 다음과 같은 결과를 얻었다. . P2에서 법랑질의 표면거칠기는 G1군의 경우 2.60±0.55μm으로 가장 매끄럽게 나타났고 G2군의 경우 3.24±0.80μm,G3군의 경우 3.44±0.94μm으로 나타났고 G4군의 경우 3.89±0.54μm으로 가장 거칠게 나타났으며 G2군과 G3군은 통계학적으로 유의성이 없었다(P>0.05). . P3에서 법랑질의 표면거칠기는 G1군의 경우 2.29±0.47μm으로 가장 매끄럽게 나타났고 G2군의 경우 2.44±0.56μm,G3군의 경우 2.44±0.58μm으로 나타났고 G4군의 경우 2.92±0.43μm으로 가장 거칠게 나타났으며 G1군은 G2군,G3군과 G2군은 G3군과 통계학적으로 유의성이 없었다(P>0.05). . 모든 군에서 P2, P3는 P1보다, P2는 P3보다 표면거칠기가 거칠게 나타났다(P<0.01). . 아무 처치도 하지 않은 정상 법랑질에 러버컵과 pumice로 5초간 전처치한 경우 주사 전자현미경관찰에서 미세한 긁힘을 발견할 수 있었고 네군 모두에서 러버컵과 pumice로 연마 후에도 제거할 수 없는 흠을 남기며 러버컵과 pumice로 마무리후 육안관찰시 잔여 레진을 발견할 수 없었으나 주사전자 현미경하에서는 레진 잔사 등을 관찰할 수 있었다. Sixty premolars extracted for orthodontic treatment were divided into four groups, and the residual resin was removed with four different rotary finishing instruments at a fixed speed of 18,500±300 rpm on the low speed handpiece. The instruments were G1; No.169L carbide fissure bur, G2; No.2 round bur, G3; No.4 round bur, G4; No. 8 round bur. Then, the enamel received a 5-second polishing with a rubber cup and a pumice. To find the extent of loss on the enamel at this point, prophlaxis was done with the rubber cup and pumice prior to bonding of the bracket(P1) and removal of residual resin by means of appropriate procedure applicable to each respective group(P2) followed. The final polishing was done with the rubber cup and pumice(P3), and the enamel surface roughness was measured each by the suface measuring instrument. The whole process was observed under a scanning electron microscope to gain the following results: At P2, the enamel surface roughness in G1 showed most smoothly with 2.60±0.55μm; in G2, 3.24±0.80μm; in G3, 3.44±0.94μm; in G4, 3.89±0.54μm, the roughest. G2 and G3 showed no statiscal significance(P>0.005) At P3 the enamel surface roughness in G1 showed most smoothly with 2.29 ±0.47μm; in G2, G1 vs G2, G3, and G2 vs G3 had no statistical significances(P>0.05). In all groups, P2 and P3 showed rougher in surface roughness than P1, and P2 rougher than P3(P<0.01). In a case of 5-second prophylaxis with the rubber cup and the pumice on a virgin, normal enamel, fine scratches were found under the scanning electron microscope. In all four groups, unremovable gouges remained even after polishing with the rubber and pumice; residual resin was not observed with naked eye when finished with the rubber and pumice, but the resin debris was observed under the scanning electron microscope.

수종의 CLEAN-UP technique이 법랑질 표면거칠기에 미치는 영향

조상완,권오원 대한치과교정학회 1997 대한치과교정학회지 Vol.27 No.5

교정치료를 목적으로 발거한 소구치 60개를 4군으로 나누고 치과용 저속 절삭기에서 18,500±300rpm으로 회전속도를 일정하게 하여 4가지 회전 마무리 기구(G1; No. 169L carbide fissure bur, G2; No.2 round bur, G3l No.4 round bur, G4; No.8 round bur)로 잔여 레진을 제거하고 러버컵과 pumice로 법랑질을 5초간 마무리하였을때 법랑질 손상에 미치는 정도를 알아보기 위해 브라켓 부착전 러버컵과 pumice로 법랑질을 5초간 마무리하였을 때 법랑질 손상에 미치는 정도를 알아보기위해 브라켓 부착전 러버컵과 pumice로 전처치한 후 (P1), 각 군에 해당하는 방법으로 잔여레진을 제거한 후(P2), 러버컵과 pumice로 마지막 마무리후(P3)의 법랑질 표면거칠기를 표면거칠기 측정기에서 각가 측정하고 주사전자현미경하에서 관찰하여 다음과 같은 결과를 얻었다. 1. P2에서 법랑질의 표면거칠기는 G1군의 경우 2.60±0.55㎛으로 가장 매끄럽게 나타났고 G2군의 경우 3.24±0.80㎛, G3군의 경우 3.44±0.94㎛으로 나타났고 G4군의 경우 3.89±0.54㎛으로 가장 거칠게 나타났으며 G2군과 G3군은 통계학적으로 유의성이 없었다(P<0.05). 2. P3에서 법랑질의 표먼거칠기는 G1군의 경우 2.29±0.47㎛으로 가장 매끄럽게 나타났고 G2군의 경우 2.44±0.56㎛, G3군의 경우 2.44±0.58㎛으로 나타났고 G4군의 경우 2.92±0.43㎛으로 가장 거칠게 나타났으며 G1군은 G2군, G3군과, G2군은 G3군과 통계학적으로 유의성이 없었다(P<0.05). 3. 모든 군에서 P2, P3는 P1보다, P2는 P3보다 표면거칠기가 거칠게 나타났다(P<0.01) 4. 아무 처치도 하지 않은 정상 법랑질에 러버컵과 pumice로 5초간 전처치한 경우 주사전자현미경관찰에서 미세한 긁힘을 발견할 수 있었고 네군 모두에서 러버컵과 pumice로 연마후에도 제거할 수 없는 흠을 남기며 러버컵과 pumice로 마무리후 육안관찰시 자여 레진을 발견할 수 없었으나 주사전자현미경하에서는 레진 잔사등을 관찰할 수 있었다. Sixty premolars extracted for orthodontic treatment were divided into four groups, and the residual resin was removed with four different rotary finishing instruments at a fixed speed of 18,500±300rpm on the low speed handpiece. The instruments were G1; No. 169L carbide fissure bur, G2; No.2 round bur, G3l No.4 round bur, G4; No.8 round bur. Then, the enamel received a 5-second polishing with a rubber cup and a pumice. To find the extent of loss on the enamel at this point, prophylaxis was done with the rubber cup and a pumice. To find the extent of loss on the enamel at this point, prophylaxis was done with the rubber cup and pumice prior to bonding of the bracket(P1) and removal of residual resin by means of appropriate procedure applicable to each respective group(P2) followed. The final polishing was done with the rubber cup and pumice(P3), and the enamel surface roughness was measured each by the surface measuring instrument. The whole process was observed under a scanning electron microscope to gain the following results: At P2, the enamel surface roughness in G1 showed most smoothly with 2.60±0.55㎛; in G2, 3.24±0.80㎛; in G3, 3.44±0.94㎛; in G4, 3.89±0.54㎛, the roughest. G2 and G3 showed no statistical significance(P<0.05). At P3, the enamel surface roughness in G1 showed most smoothly with 2.29±0.47㎛; in G2, 2.44±0.56㎛; in G3, 2.44±0.58㎛; in G4, 2.92±0.43㎛, the roughest. G1 vs G2, G3, and G2 vs G3 had no statistical significances(P<0.05). In all groups, P2 and P3 showed rougher in surface roughness than P1, and P2 rougher than P3(P<0.01). In case of 5-second prophylaxis with the rubber cup and the pumice on a virgin, normal enamel, fine scratches were found under the scanning electron microscope. In all four groups, unremovable gouges remained even after polishing with the rubber and pumice; residual resin was not observed with naked eye when finished with the rubber and pumice, but the resin debris was observed under the scanning electron microscope.

흰쥐 젖샘신경으로 투사하는 중추신경내 Oxytocin 신경로에 관한 연구

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

Streptozotocin-유도된 당뇨 쥐에서 뇌 Synaptosome과 간세포내 자유기 발생에 관한 연구

김성완,조성락 한국노화학회 1998 한국노화학회지 Vol.8 No.3

成分未詳의 漢藥服用後 發生한 Stevens-Johnson 症候群 1例

허성호,조보연,최규완,강석영 대한의학협회 1975 대한의학협회지 Vol.18 No.10

타리비드 정(오플록사신 100㎎)에 대한 파비드 정의 생물학적동등성

박완수,조성희,이헌우,임호택,홍성제,서성훈,류재환,이경태 한국약제학회 2005 Journal of Pharmaceutical Investigation Vol.35 No.1

The purpose of the present study was designed to evaluate the bioequivalence of two ofloxacin tablets, Tarivid (Jell Pharm. Co., Ltd.) and Favid (ILHWA Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, 23.67±3.12 year in age and 68.50±7.23 kg in body weight, were divided into two groups and a randomized 2x2 cross-over study was employed. After four tablets containing 100 mg of ofloxacin were orally administered, blood was taken at predetermined time intervals and concentrations of ofloxacin in plasma were deter mined using HPLC. Pharmacokinetic parameters such as AUC_(t) and T_(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC_(t), and C_(max) and untransformed T_(max). There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log 0.8 to log 1.25 (e.g., log 0.94-log 1.04 and log 0.90-log 1.07 for AUC_(t) and C_(max) respectively). The major parameters. AUC_(t) and C_(max) met the criteria of KDFA for bioequivalence indicating that Favid tablet is bioequivalent to Tarivid tablet.