국내 시판 항생제의 허가 용량 및 용법의 적정성에 대한 고찰 : 국내 약제사용설명서(package insert)와 미국 Physicians' Desk Reference의 비교 Comparison of Domestic Package Inserts with Physicians' Desk Reference

이재갑,이연주,황병연,정혜원,정성주,김성범,정희진,김우주,김민자,박승철 대한감염학회 2003 감염과 화학요법 Vol.35 No.5

목적 : 국내 시판중인 항생제의 1일 투여량과 투여간격의 적정성을 확인하고 적응증 및 중증도에 따른 항생제 용량 제시 여부를 확인하기 위하여 항생제 시판시 KFDA의 허가사항을 담은 약제사용설명서을 미국 FDA 공인 약제에 대한 사용지침으로 쓰이고 있는 PDR(Physicians' Desk Peference)과 비교하였다. 방법 : PDR에 등재되어 있는 항생제 중에서 시럽 및 도포용 항생제를 제외한 총 61종에서, 국내에 시판되어 있는 51종 항생제의 약제사용설명서를 대상으로 1일 투여량, 투약횟수, 적응증 및 중증도에 따른 설명 정도를 비교하였다. 결과 : 1) 1일 투여량 비교 : 비교 가능한 전체 항생제에서, 약제사용설명서가 PDR보다 적은 용량을 제시한 경우는 경구용 8종, 주사용 11종으로 총 19종(37%)였으며, 많은 용량을 제시한 경우는 경구용만 2(4%)종이었고, 동일하거나 비슷한 용량을 제시한 경우는 경구용 15종, 주사용 15종으로 총 30(59%)종이었다. 약제사용설명서에서 적은 용량이 제시된 항생제 중 경구용인 cefdnir, cefixime, cefpodoxime, ofloxacin, levofloxacin, norfloxacin(6종), 주사용인 cefazolin, cefotetan, ceftizoxime, meropenem (4종) 등 반수이상의 약제가 일본제약회사로부터 국내에 수입된 약들이었으며 일본의 약제 사용설명서와 동일한 용량을 제시한 것을 알 수 있다. 2) 투여간격 비교 : 비교가능한 항생제 51종 중에서 국내약제사용설명서가 PDR과 동일한 투약횟수, 투여간격을 제시한 항생제는 30종(59%)이었다. 국내 약제사용설명서가 PDR보다 적은 투약횟수, 긴 투여간격을 제시한 항생제는 9종(17%)이었다. 오히려 많은 투약횟수, 짧은 투여간격을 제시한 항생제가 12종(24%)이나 되었다. 경구용만 비교하였을 경우 국내 약제사용설명서가 PDR보다 적은 투약횟수를 제시한 항생제는 없었으며, 동일하세 제시한 경우는 15종, 빈번한 투약횟수를 제시한 경우는 10종이었다. 주사용 항생제에서 국내 약제사용설명서가 PDR보다 긴 투여간격을 제시한 항생제는 9종, 동일한 경우는 15종, 짧은 투여간격을 제시한 경우는 2종이었다. 3) 적응증 및 중증도에 따른 비교 : 약제사용설명서에서 적응증 또는 중증도에 따른 용량에 대한 설명이 부족한 경우는 경구용 13종, 주사용 7종으로 총 20종(39%)이었으며, PDR에서는 경구용 1종, 주사용 2종으로 총 3종(6%)이었다. 결론 : 항생제에 첨부되는 약제사용설명서 및 약제사용설명서를 바탕으로 편집되는 의약품집이 항생제를 처방하는 의사들이 용법과 용량을 결정함에 있어 참고 역할을 하고 있으나, 국내의 시판 허가사항을 담은 약제사용설명서가 많은 수에서 적응증 또는 중증도에 따른 1일 투여량과 투여간격에 대한 정확한 정보를 제공하고 있지 못하고 있다. Background : The appropriate usage of antibiotics needs informations such as its effectiveness for a given infection, administration route, the amount of effective dose, and the dose intervals. In this study, in order to find any significant discrepancy regarding to the details of explanation of the necessary information for appropriate antibiotic usages, we compares informations about 51 antibiotics, one from package inserts in Korea and the other from physician's desk reference (PDR) certified by FDA in the United States of America. Materials and Methods : Package inserts about antibiotics, only oral or parenteral agent, wereperused to collect three categories of data: the recommended dosage, dose interval, and adjustment of dose to indications or the severity of infection. These data available in Korea were compared with 61 antibiotics (32 oral and 29 parenteral agents) cited in PDR. Results : Package inserts for 51 antibiotics were gathered, because the remaining 10 antibiotics in PDR are not domestically commercialized. Among data on antibiotics comparable with those in PDR, 59% (30 cases: 15 oral and 15 parenteral agents) suggested the dose similar to that of PDR, 37% (19 cases: 8 oral and 11 parenteral agents) recommend less dose, and 4% in only 2 oral agents showed more dose. About half of the drugs recommending lower dosage were imported from Japanese pharmaceutical company, and the recommended doses of these antimicrobial agents were similar to those in Japan. About 59% (30 cases: 15 oral and 15 parenteral agents) directed dose interval or duration similar to those of PDR and 17% (9 parenteral agents) suggested less administration or longer duration. Surprisingly, in contrast to only 6% (3 cases) of PDR, 24% (12 cases : 10 oral and 2 parenteral agents) recommended more administration or shorter duration. About 39% (24 cases: 13 oral and 7 parenteral agents) revealed no information for dose adjustment commons to indications or the severity of infection. Conclusion : This study revealed that many guidelines in Korea recommend lower doses and/or unreasonable dose intervals. In future studies, improved antibiotic usage guidelines should be established based on pharmacokinetic and pharmacodynamic researches, on the aspect of optimal dosage, dose interval, and dose adjustment commensurate to the indications and the severity of the infection.

서울의 Penicillinase Producing Neisseria gonorrhoeae 발생빈도(1998)

김재홍,김준호,반재용,이정우,황성주,정준규,정성태,강진문,조흔정,홍창의,정혜신,이한승,김이선,이봉길,이종호,선영우,한기덕,윤성필,이성훈,안종성,박석범,문승현,조항래,김형섭,류지호,황재영,박준홍,손상욱 한양대학교 의과대학 2001 한양의대 학술지 Vol.21 No.1

In recent years, gonorrhea has been pandemic and remains one of the most common STDs in the world, especially in developing countries. For the detection of a more effective therapeutic regimen and assessing the prevalence of Penicillinase Producing Neisseria gonorrhoeae(PPNG), we have been trying to study the patients who have visited the Venereal Disease Clinic of Choong-Ku Public Health Center in Seoul since 1980 by menas of the chromogenic cephalosporin method. In 1998, 93 strians of N. genorrhoeae were isolated, among which 60(64.5%) were PPNG. The prevalence of PPNG in Seoul, which had been decreased to 39% in 1996 after a peak of 74.3% in 1993, is increased to 64.5% in 1998.

다제내성 그람양성균에 대한 Linezolid(Zyvox^(�))의 시험관내 항균력 비교

박대원,정희진,엄중식,황병연,김성범,이재갑,이연주,정혜원,정성주,박재형,이진수,손장욱,김우주,김민자,박승철 대한감염학회 2003 감염과 화학요법 Vol.35 No.5

배경 : MRSA, VRE, VRSA같은 다제 내성 그람 양성균의 등장에 따라 glycopeptide를 대체할 새로운 항생제의 개발이 필요하게 되었고 결과적으로 새로운 항생제인 linezolid라는 항생제가 개발되었다. Linezolid는 이전의 항생제와는 다른 새로운 계열의 oxazolidinone으로 경구 이용률이 우수하다. 원내 및 원외감염의 중요한 원인균이 되고 있는 MRSA, VRE에 대한 적절한 경구용 항균제가 없는 국내에서 폐렴 및 피부 연조직 감염에서 경구용으로 사용해 볼 수 있는 약제이다. 본 연구에서는 고대 구로 병원에서 분리된 MRSA, VRE 등을 대상으로 다른 여러 항균제와 비교한 linezolid의 시험관내 항균력을 조사하고자 하였다. 재료 및 방법 : 연구대상은 1998년 1월부터 2000년 12월까지 본원에서 입원 및 외래를 통하여 피부 연조직 감염증 및 호흡기 감염증, 요로감염증으로 진단된 환자들의 가검물로부터 분리된 MRSA 60균주, VRE 43균주, PRSP 25균주를 액체배지 또는 한천배지 희석법을 통하여 linezolid 및 기타 항균제에 대한 최소발육억제농도를 구하였다. 결과 : 실험에 사용한 S. aureus는 모두 MRSA였고 이들은 linezolid에 대해 MIC_(90) 2㎍/㎖(MIC 범위 1-2㎍/㎖), Enterococcus spp는 모두 VRE로 linezolid의 MIC_(90)은 2㎍/㎖로 MIC 범위는 1-4㎍/㎖였다. 한 개의 균주에서 MIC 4㎍/㎖로 중등도 감수성을 보였으나 MIC breakpoint가 (8㎍/㎖인 내성균주는 없고 모두 감수성을 보였다. S. pneumoniae의 경우 penicillin 내성이었고, linezolid MIC_(90) 1㎍/㎖ (MIC 범위 0.5-1㎍/㎖)로 전부 감수성을 보였다. 결론 : Linezolid는 MRSA를 위시한 VRE, PRSP 등의 다제 내성 그람 양성균에 대하여 우수한 시험관내 항균력을 보임을 알 수 있었다. Background : The emergence of multi-drug resistant Gram-positive cocci, such as MRSA, VRE, and VRSA, necessitated to develop new antibiotics, which could replace the glycopeptide. As a result, a new antibiotics named linezolid was developed. Linezolid is different line of oxazolidinones with a good oral bioavailability, compared to other antibiotics. Since appropriate oral antibiotics are not presently available for MRSA, which is a major cause of nosocomial and community acquired infections, the introduction of linezolid will have favorable effect on treatment of infections such as pneumonia or skin infections. In this study, we investigated the antibiotic effect of linezolid on MRSA and VRE isolated from patients who were treated in Korea University Guro Hospital. Material and Methods : By using broth microdilution and agar dilution method we measured minimum inhibitory concentration (MIC) with sixty S. aureus, forty three Enterococcus spp., and twenty five S. pneumoniae isolates from patients who were diagnosed as skin, soft tissue, respiratory, and urinary infections in Korea University Guro Hospital from January, 1998 to December, 2002. Results : All of S. aureus used in this study were MRSA, and MIG_(90) of linezolid was below 2 ㎍/㎖ (MIC ranged between 1-2 ㎍/㎖). All of Enterococcus spp. were VRE, and had MIG_(90) of 2 ㎍/㎖ (MIC ranged between 1 to 4 ㎍/㎖). One of the VRE showed intermediate susceptibility with MIC of 4 ㎍/㎖. However, none was resistant with MIC breakpoint above 8 ㎍/㎖. All of S. pneumoniae were resistant to penicillin, but they were susceptible to linezolid with MICao of 1 ㎍/㎖(MIC range 0.5-1㎍/㎖). Conclusion : In conclusions, linezolid has an excellent in vitro antibiotic effect on multi-drug resistant Gram-positive cocci, such as MRSA, PRSP, and VRE.

일부 제조업 사업장의 작업환경실태 및 특수건강진단에 대한 조사 연구

황주성,황규윤,안규동,이병국 순천향대학교 산업의학연구소 1997 순천향산업의학 Vol.3 No.1

The purpose of this study was to obtain information on the working environment, rate of environmental measurement over TLVs, the number of workers who were exposed to hazardous agents and, the examined rate of special health examination(SHE) in different types of industries. Authors investigate the reports on the working environmental status of the 101 industries in Cheonan area and result of SHE of those industries. The results were as follows : 1. Out of 101 industries under study, only 54 industries took special health examination. 2. While 85.3%(6,590) of 7,726 workers working in 101 industries were exposed to one or more hazardous agents, 88.4% of 5,867 workers working in 54 industries with special health examination were exposed to those agents & 75..4% of 1,859 workers working in 47 industries without any special health examination were exposed to those agents. But according to the criteria of selecting eligible workers for special health examination, only 32%(1,935/5,867) of total workers in the later industries were classified as eligible for the special health examination. 3. While rate of environment measurement of 101 industries TLVs who 25.5%, that of 54 industries with SHE was 29.8 & that of 47 industries without SHE was 16.1%, while the rate of noise and dust measurement over TLVs of 54 industries with SHE was 31.7%, and 25.3%, those of 47 industries without SHE was 13.6% & 35.6%, among 54 industries with SHE the rate of environmental measurement over TLVs was highest in clothes & leathers(47.0%) and that of foods(32.3%) and primary metal(31.3%). One the other hand, among 47 industries without SHE the rate of environmental measurement over TLVs was highest in paper & printing(44.9%) and that primary metal(15.8%), metaloid mineral(15.5%). 4. The examined rate of SHE of 54 industries was 92.7% as a whole. By type of industries the rate of primary metal(221.4%), foods(181.7%), chemicals(120.4%) were exceeded expected percent(100%) but the rate of metalloid mineral(53.0%), paper & printing(63.8%), machinery(72.2%) were far below the expected percent. 5. Only 4.7% of total workers working in 47 industries without SHE were classified as eligible workers for SHE. Among those eligible workers 48.9% were belonged to potential workers for SHE of noise. 6. The response rate of questionnaire was 70.4%(38/54) in 54 industries wirh SHE & 48.9%(23/47) in 47 industries. The necessity of environment measure was positively answer in 81.6% of 38 with SHE & 87% of 23 without SHE. On the other hand, the necessity of SHE was positively answered in 68.4% with SHE & 21.7% without SHE.

菩提達摩 傳記에 對한 硏究

黃尙周 동국대학교 불교대학 1974 東國思想 Vol.7 No.-

Alginate Bead를 이용한 고분자 약물의 제어방출형 약물수송체

황성주,이계주,조항범,이기명,김종국 충남대학교 약학대학 의약품개발연구소 1993 藥學論文集 Vol.9 No.-

The purpose of this paper is to explore the possible applicability of alginate beads as an oral controlled release system of polymeric drugs. Cellulases was used as a model polymeric drug. The release of cellulase from alginate beads was moderately affected by the ratio of cellulase to sodium alginate and strongly affected by CaCl_2 concentration. However, the release was not particularly affected by the other factors such as sodium alginate concentration and curing time. The drug was not released from alginate beads at pH 1.2 but was released continuously up to 8 hr at pH 6.8. At pH 6.8, the beads were swollen highly up to 3 hr, thereafter, were eroded into the bulk solution up to 6 hr, completely. Drug release from the beads can be caused due to diffusion and erosion of the matrix. Activity of cellulase was reduced when alginate beads containing cellulase were stored in simulated gastric juice. Further investigation would be necessary to improve the acid resistance of beads. Since the release of cellulase as a model polymeric drug could be controlled by tthe regulation of the preparation conditions of alginate beads, the alginate beads may be used for a potential oral controlled release system of such polymeric drugs as polypeptide drugs.

복부 초음파에서 신우암으로 오인된 신동맥류 1예

황인철,김영주,이충현,장성구,김진일,이선주 경희대학교 2000 慶熙醫學 Vol.16 No.3-4

동종 골수이식 후 만성 이식편대숙주질환과 동반된 그레이브스병

황호인,이제중,조상희,김여경,이병환,정익주,김형준 대한조혈모세포이식학회 2002 대한조혈모세포이식학회지 Vol.7 No.1

저자들은 중증 재생불량성빈혈로 동종 골수이식 및 추가적인 동종 말초혈액 조혈모세포이식을 시행 받은 후 만성 이식편대숙주질환이 발생하여 면역억제제로 조절되었으나 자가면역성 갑상선기능항진증이 병발한 1예를 경험하였기에 이를 보고하는 바이다. Chronic graft-versus-host disease (GVHD), which is a frequent complication following bone marrow transplantation (BMT), is characterized by fibrosis of the skin, liver, lungs, and gastrointestinal tract, immunodeficiency, and the production of autoantibodies. Endocrine dysfunction, in particular thyroid disease, has been described following BMT, but this has previously meant hypothyroidism secondary to total body irradiation or transfer of autoimmune hyperthyroidism from a donor with Graves’ disease rather than in association with chronic GVHD. We report a case of a 26-year-old man who developed Graves’ disease eight years after BMT and who had remission of chronic GVHD. He received an allogeneic BMT for severe aplastic anemia. Eighteen months after BMT, diarrhea and chronic GVHD developed and were treated with cyclosporine and steroid. Four years after ceasing the cyclosporine, the patient developed weight loss, palpitations, fever, and anterior neck swelling, and was diagnosed with Graves’ disease based on typical thyroid function tests. The signs and symptoms in the patient improved with propylthiouracil and propranolol.

점액성췌장 낭종 1예

황석주,김영운,오성광,김대영,임선재,박승욱,이두용,이헌영 충남대학교 의과대학 지역사회의학연구소 1995 충남의대잡지 Vol.22 No.2

Pancreatic cystadenoma is very rare, slow growing tumor and generally preoperative differential diagnosis may be difficult. A 43-year-old female was admitted to our hospital with the complaint of abdominal discomfort in the epigastrium for about preceeding 5 years. Ultrasonography and Computed tomography were performed. When endoscopic retrograde cholangio-pancreatogram was performed, displacement of distal pancreatic duct by huge mass was noted and injected dye was drained irregulary into the cavity of mass. Distal pancreatectomy was performed with splenectomy. The mass size of distal pancreas was 7X4cm, and the cyst contained with yellowish thick mucoid fluid. Diagnosis was confirmed the mutinous cystadenoma of the pancreas on histologic examination.

서울 강서지역 1개 대학병원에서 성인 급성 신우신염의 원인균과 항생제 감수성

황병연,이재갑,박대원,이연주,김성범,엄중식,손장욱,정희진,김우주,김민자,박승철 대한감염학회 2003 감염과 화학요법 Vol.35 No.5

목적 : 3년간 서울시 강서지역의 1개 대학병원에서 입원치료를 받은 성인 급성 신우신염 환자를 대상으로 원인균과 항생제 감수성을 조사하고, 향후 급성 신우신염의 초기 경험적 치료 항생제를 제안하고자 하였다. 방법 : 1999년 1월부터 2001년 12월까지 3년간 고려대학교 의과대학 구로병원에 상부요로감염으로 내원한 16세 이상 환자 229명의 의무 기록을 검토를 통하여, 인구학적 특성, 원인균, 항생제 감수성, 초기 항생제 사용 양상과 입원기간을 조사하였다. 결과 : 연구에 포함된 229명을 118명의 단순 신우신염군과 111명의 복잡 신우신염군으로 구분 하였다. 단수 신우신염의 평균 발생 연령은 38.2세와 복잡 신우신염 56.1세로 복잡 신우신염 환자의 연령이 유의하게 높았다(P<0.001). 양군 모두에서 원인균 중 E. coli의 분리율이 가장 높았으며 항생제 감수성 결과 ampicillin, trimethoprim-sulfame-thoxazole에는 높은 내성률을 보였고, ciprofloxacin, gentamicin, cefotaxime에 대한 감수성은 비교적 높았으나 복잡 신우신염의 경우 단순 신우신염에 비하여 ciprofloxacin, gentamicin에 대한 감수성이 다소 낮은 것을 확인할 수 있었다. 평균 입원 기간, 항생제 투여 기간에 있어서도 복잡 신우신염군에서 유의하게 길었다. 결과 : 본 연구의 결과 서울의 강서 지역에서 대학병원급에 치료 의뢰되는 단순 급성 신우신염의 치료에 있어 1차 항생제로 3세대 cephalosporin, aminoglycoside, quinolone 중 한가지를 초기 경험적 치료제로 사용을 고려하여야 할 것으로 사료된다. Background : The purpose of this study is to recommend the initial therapeutic regimen for adult patients with acute pyelonephritis (APN) according to the changes of antimicrobial susceptibility patterns of causative microorganisms isolated from patients with APN. Methods : We reviewed medical charts of 229 APN patients, who had been treated at Korea University Guro Hospital from 1st of January. 1999 to 31st of December, 2001. We investigated the demographic data, clinical findings, durations of hospital treatment, antimicrobial susceptibility patterns of the causative microorganisms and initial antibiotic regimens in patients with APN. Results : In this study, 229 adult patients with APN were classified into simple APN patients (118 patients, 51.5%) and complicated APN patients (111 patients, 48.4%). Mean age of patients with simple APN was 38.2±14.1 years old and that of patients with complicated APN was 56.1±14.9 years old. Mean age of patients with complicated APN was significantly higher than that of simple APN patients (P<0.0001). Escherichia coli was the most common microorganism both in simple APN (96.7%) group and in complicated APN (90.6%) group. Antimicrobial susceptibility of E. coli was at the low level of ampicillin (31%/20%) and trimethoprim-sulfamethoxazole (42.6%/34.2%) in each group. In contrast, ciprofloxacin (11.5%/22.7%), gentamicin (16.4%/22%) and cefotaxime (0%/8.2%) resistance remained at relatively lower level. In comparison of simple APN with complicated APN, ciprofloxacin and gentamicin resistances were higher in complicted APN group. Average duration of hospitalization (5.9±2.3 days/8.2±4.6 days) and duration of antibiotic use (12.1±3.9 days/15.3±10.0 days) were significantly longer in complicated APN. Conclusions: The results of this study suggests that 3rd cephalosporin, aminoglycoside or quinolone antibiotic would considered as one of the initial therapeutic regimen for patients with simple APN in southwestern Seoul.