정신분열병에 대한 리스페리돈의 효과 및 안정성

이민수,김용구,김영훈,연병길,오병훈,윤도준,윤진상,이철,정희연,강병조,김광수,김동언,김명정,김상훈,김희철,나철,노승호,민경준,박기창,박두병,백기청,백인호,손봉기,손진욱,양병환,양창국,우행원,이정호,이종범,이홍식,임기영,전태연,정영조,정영철,정인과,정인원,지익성,채정호,한상익,한선호,한진희,서광윤 大韓神經精神醫學會 1998 신경정신의학 Vol.37 No.1

연구목적 : 본 시험의 목적은 임상시험 시작전에 연구자들을 대상으로 PANSS Workshop을 통하여 PANSS, ESRS에 대한 국내에서의 표준화 작업을 구축하고 새로운 정신병 치료제인 리스페리돈의 효과와 안정성을 재확인하여 리스페리돈 사용에 대한 적정화를 이루는데 있다. 연구방법 : 1996년 4월부터 1996년 9월까지 국내 39개 대학병원 정신과에 입원중인 혹은 증상이 악화되어 입원하는 정신분열병 환자 377명을 대상으로 다시설 개방 연구를 시행하였다. 1주일간의 약물 배설기간을 가진후, 리스페리돈을 8주간 투여하였고, 기준점, 1주, 2주, 4주, 그리고 8주후에 평가되었다. 용량은 제1일에는 리스페리돈 1mg씩 1일 2회, 제2일에는 2mg씩 1일 2회, 제3∼7일에는 3mg씩 1일 2회 투여하였다. 이후 환자의 임상상태에 따라 임의로 증량할 수 있으며, 최대 일일 16mg을 초과하지 않도록 하였다. 추체외로 증상을 조절하기 위한 투약을 허용하였다. 임상증상 및 부작용의 평가는 PANSS(Positive and Negative Syndrome Scale), CGI(Clinical Global Impression) 그리고 ESRS(Extrapyramidal Symptom Rating Scale)을 사용하였다. 연구결과 : 377명중 343명(91%)이 8주간의 연구를 완결하였다. 치료 종결시점인 8주후 PANSS 총점수가 20% 이상 호전된 경우를 약물 반응군으로 정의할때, 약물반응군은 81.3%였다. 리스페리돈에 반응하는 예측인자로는 발병연령, 이전의 입원 횟수, 유병기간이 관련 있었다. 리스페리돈은 1주후부터 PANSS양성, 음성, 및 일반정신병리 점수상에 유의한 호전을 보여 효과가 빨랐다. CGI의 경우도 기준점에 비해 1주후부터 유의한 감소를 나타내었다. ESRS의 경우, 파킨슨 평가점수는 기준점과 비교해 투여 1주, 2주, 4주후 유의하게 증가되었다가 8주후 기준점과 차이가 없었다. Dystonia 평가점수는 1주후만 유의한 증가를 보였으며, dyskinesia 평가점수는 유의한 차이가 없었다. 혈압, 맥박수의 생명징후 및 일반 혈액학 검사, 생화학적 검사, 심전도 검사에서 유의한 변화는 없었다. 결 론 : 이상의 다시설 개방 임상 연구를 통해 리스페리돈은 정신분열병 환자에서 양성증상뿐만 아니라 음성증상 및 전반적인 증상에도 효과적인 것으로 사료된다. 보다 명확한 평가를 위해서는 다른 항정신병약물과의 이중맹검 연구가 필요할 것으로 생각되며, 또한 장기적 치료에 대한 평가도 함께 이루어져야 하겠다. Objective : The purpose of this study was to investigate the efficacy and safety of risperidone in the treatment of Korean schizophrenic patients. Method : This multicenter open study included 377 schizophrenic patients drawn from 39 university hospitals. After a wash-out period of 1 week, the schizophrenic patients were treated with risperidone for 8 weeks and evaluated at 5 points ; at baseline, and 1, 2, 4 and 8 weeks of treatment. The dose was increased from 2mg/day(1mg twice daily) to 6mg/day(3mg twice daily) during the first week and adjusted to a maximum of 16mg/day over the next 7 weeks according to the patient's clinical response. Medication to control extrapyramidal symptoms was permitted. The psychiatric and neurological status of the patients was assessed by PANSS, CGI, and ESRS scales. Results : 343(91%) of 377 patients completed the 8-week trial period. Clinical improvement, as defined by a 20% or more reduction in total PANSS score at end point, was shown by 81.3% of patients. The predictors of response to risperidone were associated older age, shorter duration of illness, fewer previous hospitalization. Risperidone had rapid onset of action ; a significant decrease of the total PANSS and three PANSS factor(positive, negative, general), and CGI was already noticed at the end of first week. For the ESRS, parkinsonism rating scores were significantly increased until week 4 comparing with baseline. Dystonia rating scores were significantly increased until week 1, and dyskinesia rating scores were not significantly changed during the study. Laboratory parameters including vital sign, EKG, hematological, and biochemical values showed no significant changes during the trial. Conclusions : This study suggests that risperidone is generally safe and effective against both the positive and negative symptoms in our group of patients.

자궁내막암 환자에서 복강경하 자궁적출술과 복식 자궁적출술의 비교 연구

김종혁,이상수,김천복,김대연,김용만,김영탁,목정은,남주현 대한부인종양 콜포스코피학회 2003 Journal of Gynecologic Oncology Vol.14 No.4

목적 : 자궁내막암 환자에서 시행된 복강경 수술의 임상적 결과를 평가하고 수술적 지표 및 재발률에 대하여 기존의 개복 수술과 비교하고자 하였다. 연구 방법 : 1997년 8월부터 2003년 11월까지 저자들은 임상적 병기 I기인 79명의 자궁내막암 환자에서 복강경하 자궁적출술과 골반 및 부대동맥 림프절 절제술을 시행하였다. 총 79명의 환자 중, 수술적 병기 I기와 II기로 판명된 74명의 환자를 연구 대상으로 하였다. 대조군으로는 같은 기간 동안에 개복수술을 시행한 환자중 복강경 수술군과 병기가 같은 168예를 선정하였다. 결과 : 평균 수술 기간, 수혈량은 양군에서 비슷하였으며, 평균 재원 기간은 복강경 수술군에서 유의하게 짧았다. 수술전후 및 만성 합병증의 발생은 개복 수술군에서 유의하게 증가되었으며, 획득한 림프절의 수는 복강경 수술군에서 유의하게 더 많았다. 복강경 수술군에서 1예, 개복 수술군에서는 2예에서 재발하였고, 2년 무병 생존률은 복강경 수술군과 개복 수술군에서 각각 97.5%와 98.6%으로 유의한 차이는 관찰되지 않았다. 결론 : 자궁내막암 치료로서 복강경 수술은 기존의 개복술을 대신할 수 있는 안전하고 효과적인 시술 방법이다. 개복 수술과 비교해 볼 때, 재발 및 생존율 면에서 차이가 없었지만, 향후 전향적이고 더 오랜 추적기간을 갖는 연구가 필요하다고 사료된다. Objective : To evaluate the outcomes of laparoscopic surgery and to compare surgical parameters and recurrence rate of these with those of conventional abdominal surgery in patients with endometrial cancer. Methods : From August 1997 to November 2003, we have performed 79 cases of LAVH (laparoscopically assisted vaginal hysterectomy) with or without lymph node dissection. Laparoscopic approach was adapted in patients with FIGO clinical stage I by imaging study. Of the 79 patients, 74 patients who were proved to be surgical stage I and II were enrolled in this comparative study. As a control group, We selected 168 cases for the laparotomy group of the same stages. Results : The mean duration of surgery, the amount of blood transfusion and hemoglobin chamges were similar in both the laparoscory and the convertional alparotomy group. The mean duration of hospital stay was significantly shorter in patients treated by laparoscopic surgery (10.2 vs. 15.5 days). The number of lymph node obtained was significantly higher in the laparoscopy group. Two year recurrence-free survival rates were 97.5% in laparoscopy group and 98.6% in laparotomy group (p=0.763). Conclusion : Laparoscopic surgery for the treatment of early stage endometrial cancer is safe and effective altematives in terms of perioperative complications. Overall and recurrence-free survival did not differ significantly in both groups however long term risk for recurrence and survival has yet to be defined.

일개 대학병원에서 경험한 방선균증의 임상상

정숙인,김연숙,기현균,김춘관,김신우,이혁,김성민,백경란,송재훈 대한화학요법학회 1999 대한화학요법학회지 Vol.17 No.3

배경 : 방선균증은 혐기성의 그람양성 간균에 의한 만성 화농성 감염으로, 경안면부, 흉부, 복부, 골반부 등을 주로 침범한다. 최근 구강 위생의 향상과 항생제의 사용으로 인해 방선균증의 빈도의 감소와 함께 그 임상양상 또한 크게 변화하였다. 저자들은 국내에서의 방선균증의 임상상을 분석하기 위해 본 연구를 시행하였다. 방법 : 1995년 5월부터 1998년 9월까지 삼성서울병원에서 방선균증으로 진단받은 환자를 대상으로 임상기록지를 토대로 감염병소와 임상경과 등을 후향적으로 조사하였다. 결과 : 방선균증 환자는 모두 12명으로 경안면부 1례, 흉부 3례, 복부 3례, 골반부 5례였다. 임상양상은 주로 종괴의 형태로 나타나 진단을 내리기까지 종양과의 감별에 어려웠으며 진단은 모두 조직검사나 흡인액에서 유황과립을 확인함으로써 이루어졌다. 방선균증으로 진단된 환자는 모두 호전소견을 보였다. 결론 : 국내에서도 방선균증이 드물지 않게 발생하고 있으며 임상양상이 다양하여 가장 많이 오진되는 질환 중의 하나이다. 방선균증은 조직검사나 균배양검사를 통해 진단하고 항생제를 통해 완치될 수 있는 질환이므로 환자 진단에 관심을 가지면 불필요한 수술을 피할 수 있을 것으로 생각된다. Background: Actinomycosis is an indolent, slowly progressive bacterial infection, caused by Actinomyces. a gram-positive, non-spore-forming anaerobic or microaerophilic rod. Actinomycosis affects nearly every organ and body site. The disease is classically divided into four types, depending on the anatomic sites involved: cervicofacial, thoracic, abdominal, and pelvic. It has been considered as a rare disease, and only several cases have been reported in Korea. We performed this study to analyse the clinical manifestations of actinomycosis in Korea. Method: We retrospectively reviewed the medical records of patients with actinomycosis at the Samsung Medical Center from May 1995 to December 1998. Results: During the study period, actinomycosis was diagnosed in 12 patients: 1 patient had cervicofacial lesion, 3 thoracic, 3 abdominal, and 5 pelvic. The male and female ratio was 1 : 2 and the mean age was 47.2 years. Sulfur granule was observed in the pathologic specimens from all cases, but organism did not grow at all. It was very difficult to differentiate actinomycosis from tumorous conditions without pathologic diagnosis. All patients were clinically improved with antibiotics or surgical procedures. Conclusion: Actinomycosis is not a rare disease nowadays and has various clinical manifestations. It can be diagnosed by pathologic examination or culture and cured by antibiotics without surgical management.

중증 재생불량성 빈혈 환자에서 신우신염에 대한 광범위항생제치료 중에 속발한 Saccharomyces cerevisiae 진균감염 1예

김철희,이정호,이정찬,강정현,곽상혁,배광봉,김현수,김종숙,조덕연,김삼용 충남대학교 의과대학 지역사회의학연구소 1999 충남의대잡지 Vol.26 No.1

Most patients with aplastic anemia who do not respond to immunosuppressive treatment or are not candidates for bone marrow transplantation die of infection or bleeding. The neutropenia in acute leukemia, aplastic anemia, or occurring subsequently to chemotherapy and bone marrow transplantation increases susceptibility to infection. In general, the number of infectious episodes correlate with the degree and duration of neutropenia. Global immunosuppression produced by conditioning for bone marrow transplantation or graft-versus-host disease, is associated with unusual bacterial and fungal pathogens, or serious viral and protozoan infections. In addition, repeated treatment with broad-spectrum antibiotics is associated with the emergence of resistant organisms and fungal diseases because of the altered microbial microenvironment of the host. The incidence of invasive fungal infection caused by Saccharomycetes eerevisiae in immunosuppressed patients is very rare, compared with that of infection by candida or aspcrgillus species. Cases of Saccharomycetes cerevisiae fungemia occurring in the course of treatment with broad-spectrum antibiotics are reported in patients with extensive burn or with prosthetic valve endocarditis. We experienced a case of urinary tract infection by Saccharomycetes cerevisiae in a 27-year old female patient with severe aplastic anemia. We report the case with a review of relevant literatures.

토끼 수막염 모델을 이용한 다제내성 폐렴구균에 대한 Meropenem의 치료 효과

김신우,진정화,강수정,정숙인,김연숙,기현균,김춘관,이혁,김성민,백경란,송재훈 대한화학요법학회 2001 대한화학요법학회지 Vol.19 No.1

목적 : 다제내성 폐렴구균에 의한 수막염은 기존과 단일 항생제로는 근치가 어려워 ceftriaxone과 vancomycin 혹은 rifampin의 병용요법이 권유되고 있다. 다제내성 폐렴구균에 사용할 수 있는 다른 약제 중 meropenem은 시험관내 폐렴구균에 대한 항균력이 좋고 경련 등의 중추신경계 부작용이 거의 없어 다제내성 폐렴구균에 의한 수막염의 치료에 이용할 수 있을 것으로 기대되나 이에 대한 자료가 매우 부족한 상태이다. 이에 연자 등은 meropenem과 meropenem+vancomycin의 병용요법이 다제내성 폐렴구균 수막염의 치료에 효과가 있는지를 토끼 수막염 동물 모델을 이용하여 검증하고자 하였다. 방법 : 인체에서 수막염을 일으킨 다제내성 폐렴구균 균주(penicillin MIC 2, ceftriaxone MIC 4, meropenem MIC 0.5㎍/㎖)를 토끼 척수강 내에 직접 주입하여 수막염을 유발한 후 ceftriaxone, vancomycin, rifampin, meropenem의 단일 항균요법, ceftriaxone+vancomycin, ceftriaxone+rifampin, meropenem+vancomycin의 병용요법 간에 치료 효과의 차이를 비교 하였다. 각 치료군은 6 마리의 토끼를 대상으로 하였다. 각각의 항생제는 5 시간 간격으로 2번 정주하였으며, ceftriaxone은 1회 투여하였다. 균주 주입 후 각 치료군이 토끼에서 치료 후 0, 5, 10, 24 시간에 척수액을 채취하여 균주의 수를 측정하여 24시간째의 살균 여부를 최종 치료 효과로 판정하였다. 결과 : meropenem 단독 요법은 10시간째에 모든 균주를 살균하였으나 24시간 째에 다시 균의 성장이 관찰되었으며, meropenem+vancomycin의 병용요법은 단독 약제보다 우수한 살균효과를 보였으나 상승작용은 없었다. 결론 : meropenem+vancomycin의 병용요법은 기존의 ceftriaxone+vancomycin보다 24시간째에 더 큰 균의 감소 경향을 보여(P=0.054) 임상에서 사용이 가능할 것으로 기대되며 향후 실제 수막염 환자에서의 임상효과를 증명하는 연구가 필요할 것으로 생각된다. Background : Because antimicrobial monotherapy for pneumococcal meningitis caused by penicillin-resistant strains is not satisfactory, ceftriaxone+vancomycin [C+V] or ceftriaxone+rifampin [C+R] regimens are recommended. Meropenern [M] is one of the monotherapy options for penicillin-resistant pneumococcal meningitis due to good in-vitro activity against pneumococci and rare adverse reactions in CNS. But there have been few reports in the efficacy of meropenern against pneumococcal meningitis. We evaluated therapeutic efficacy of the meropenern and meropenem+vancomycin in a rabbit model of meningitis caused by penicillin-resistant S. pneumoniae (PRSP). Methods : Meningitis was induced by intracistemal inoculation of a pneumococcal strain isolated from a patient with meningitis (MIC; penicillin 2, ceftriaxone 4, meropenem 0.5 g/㎖). Bacterial concentrations in the CSF were measured at 0, 5, 10, and 24 h after therapy was started. Therapeutic efficacy was evaluated by the final bacterial concentration in the CSF at 24 h. Results : C+V cleared the CSF at 10 h, but regrowth of bacteria was noted at 24 h. Meropenem monotherapy resulted in sterilization at 10 h but regrowth at 24 h. M+V was superior to M or V monotherapy but did not show synergism. Therapeutic efficacy of M+V was at least equal or superior to that of C+V (P = 0.054). Conclusion : Meropenem+vancomycin regimen could be one of the useful options in the treatment of PRSP meningitis. Clinical trials to evaluate the M or M +V are warranted in the future.

단기간의 저용량 Cytosine arabinoside 치료에 반응하였던 Down 증후군에 병발한 급성골수성백혈병 1례

김현수,이정호,이정찬,강정현,곽상혁,김철희,배광봉,김종숙,조덕연,김삼용 충남대학교 의과대학 지역사회의학연구소 1998 충남의대잡지 Vol.25 No.1

The incidence of hematologic disorders in patients with Down's syndrome is significantly increased, about 14∼30 - fold higher than in general population and includes neonatal transient abnormal myelopoieis and acute leukemias. The age of onset of leukemia in Down's syndrome is peaking first in the newborn period and then under 4 years of age. Down's syndrome with acute leukemia above the age of 20 is very rare and it's treatment oucome is unclear. The treatment of Down's syndrome with leukemia has been controversial because of toxicity and associated congenital cardiac and other abnormalities. But if treated adequately, children with Down's syndrome show a favorable response to anti-leukemia therapy. A 24-year-old man with Down's syndrome was first seen for the evaluation of anemia and thrombocytopenia. The peripheral blood morphology and bone marrow study revealed acute myelogenous leukemia, cytogenetic study of bone marrow showed trisomy 21. Beacuse of his sicioeconomic condition and medical abnormalities including deafness, visual loss, he was treated with low dose subcutaneous cytosine arabinoside(Ara-C) for 11 days. Complete remission was obtained after 37 days. The complete remission lasted for 5 months. He subsequently relapsed, and died 6 months later.

한국 기혼여성의 일상적 삶의 질 향상에 관한 연구 (3) : 한국 기혼여성의 삶의 질 향상을 위한 프로그램 개발 연구 Development of A Program for the Enhancement of Korean Married Women's Quality of Life

김정자,최순,김선희,정영숙,김경연,심혜숙,문소정 부산대학교 여성연구소 1999 여성학연구 Vol.9 No.1

The purpose of this study was to develop a program for the enhancement of Korean married women's quality of life(LQ) based on the results of the first year study(1996) and the second year research(1998). In order to construct a program, a psycological type test was conducted to 505 women and four preliminary programs were carried out focusing on self-esteem, understanding of one's own personality dynamics, efficient communication, positive emotion, social belongingness and expressions of feelings of unfinished business. For the final program, Jung's theory of psychological type(MBTI), Satir's family therapy approach and psychodrama were applied. An experimental and a control group were designed consisting 16 women for each group. The program was carried out for 6 weeks for the experimental group. The result of treatment were as follows: l)There was a difference statistically in LQ related to family harmony, self-achievement and improvement of relationship with in-laws. 2)There was a statistical change in psychological factors of expression of feelings, self-esttem, communication, and positive emotions. 3) The program participants self reports indicate that the program was effective for the reconstruction of family relationship, self-understanding, group coherence, and instillation of hope. The reports also shows that the program was effective for the perceptual changes in parent-child, wife-husband and siblings' relationships. In conclusion, the program developed for the enhancement of Korean married women's life quality(LQ) based on the Jung's psychological type theory, Satir's family therapy approach and psychodrama was effective for the improvement of LQ.

On the Strengthening Effects Affecting Tensile and Low Cycle Fatigue Properties of Low-Alloyed Seismic/Fire-Resistant Structural Steels

Jung‑Ho Sim,Tae‑Yeong Kim,Jun‑Yeon Kim,Chi‑Won Kim,Jun‑Ho Chung,Joonoh Moon,Chang‑Hoon Lee,Hyun‑Uk Hong 대한금속·재료학회 2022 METALS AND MATERIALS International Vol.28 No.2

In the present study, low carbon ferritic and bainitic steels with different contents of Mo, Ti, and Nb were designed for bothseismic and fire-resistant applications. The microstructure of steels containing 0.3 wt% Mo–0.02 wt% Nb (‘A’ hereinafter)was mainly composed of bainite. By contrast, the microstructure of steels with 0.2 wt% Mo–0.13 wt% Ti (‘B’ hereinafter)consisted of ferrite with a high density of nano-sized (Ti,Mo)-rich MX precipitates. The results showed that the bainiticmicrostructure (‘A’ steel) was quite favorable to high-temperature strength and thermal stability. The yield strength of ‘A’ steelat both room and 600 °C temperatures increased consistently with increasing thermal exposure time (600 °C/200–1000 h),since the precipitation of NbC particles occurred while maintaining bainitic ferrite platelets with a high density of dislocationsduring exposure. In the ‘B’ steel, the formation of nano-sized (Ti,Mo)-rich MX particles was effective to impededislocation movement, leading to excellent plasticity (lower yield ratio) at room temperature. However, their contributionto precipitation hardening was not so much at 600 °C, as compared to the bainitic strengthening. During low cycle fatiguetests at room temperature, the main different feature between the two steels is that the ‘A’ steel showed cyclic softeningwhile cyclic hardening was evident in the ‘B’ steel. The bainitic microstructure showed a better fatigue life due to increasedductility manifested by cyclic softening, by which dislocation cell was developed.

조직학적 진단된 chronic necrotizing pulmonary aspergillosis 2예

김연숙,정숙인,기현균,김춘관,김신우,한정호,김성민,백경란,송재훈 대한화학요법학회 2000 대한화학요법학회지 Vol.18 No.1

CNPA는 기존의 폐질환 및 폐절제술로 인해 국소방어기전에 저하가 있거나 비특이적 전신면역상태저하를 갖고 있는 환자들에게서 주로 발생하는 만성적인 공동성 폐질환이다. 현재까지 우리나라에서는 CNPA의 보고가 없는 상태이고, 저자들은 최근 조직학적으로 진단된 CNPA 2예를 경험하였기에 보고하는 바이다. 저자들이 경험한 CNPA 환자들은 만성알코올 중독 및 기관지확장증과 같은 기저질환과 폐절제술을 받은 병력이 있었다. Aspergillus가 폐실질을 침윤하고 있는 조직소견과 조직배양에서 Aspergillus가 검출되어 조직학적 진단이 가능하였고, amphotericin B의 정주요법 및 경구 itraconazole 투여와 폐절제술 등으로 성공적으로 치료되었다. 아직 많은 임상의들에게는 낯선 질환인 CNPA의 치료성적은 환자의 동반질환 및 CNPA 자체의 중증도, 진단과 치료 시작의 지연 등에 의해 크게 좌우되므로 만성적으로 진행하는 공동성 폐병변을 갖고 있는 환자에게서 CNPA를 감별하는 것이 중요하다. Chronic necrotizing pulmonary aspergillosis (CNPA) is a chronic cavitary form of pulmonary aspergillosis. Dozens of CNPA cases have been reported in patients with systemic immunologic dysfunction or altered local defense mechanism from preexisting pulmonary disease. Review of literatures revealed that no CNPA cases have been reported in Korea yet. We experienced two cases of CNPA proven by lung biopsy. A 53-year-old alcoholic male in poor nutritional state was admitted with generalized weakness and weight loss. Chest CT revealed a cavitary nodule surrounded with ground-glass attenuation. CT-guided fine needle aspiration and biopsy was done. The biopsy specimen demonstrated dichotomously branching septated hyphae consistent with those of Aspergillus sp. Another case was a 39-year-old man with bronchiectasis who was admitted with persistent hemoptysis. He had a past history of pulmonary tuberculosis. A parahilar lesion with intracavitary soft tissue mass was incidentally detected in high-resolution GT. Left lingular segmentectomy was done due to uncontrolled hemoptysis and CNPA was histologically diagnosed. Both patients were successfully treated with intravenous amphotericin B followed by oral itraconazole. Even though CNPA is unfamiliar to most clinicians, it should be included in differential diagnoses of chronic progressive cavitary pulmonary lesion, especially in patients with immunologic dysfunction.

Astromicin sulfate의 약동학 및 안전성 평가

정숙인,김연숙,오원섭,복혜숙,김명민,최경업,김연화,김성민,백경란,송재훈 대한화학요법학회 2001 대한화학요법학회지 Vol.19 No.3

목적 : Astromicin은 aminoglycoside계 항생제와 유사한 화학구조와 특성을 지니고, 기존의 aminoglycoside와 유사하거나 향상된 임상효과 및 부작용을 지닌 것으로 알려져 있다. 저자들은 astromicin의 약동학적 특성을 분석하고, astromicin 투여 환자를 대상으로 한국인에서 그 임상적 및 세균학적 효과와 안전성을 평가하고자 하였다. 대상 및 방법 : 약동학적 지표는 정상성인 남자를 대상으로 astromicin 200㎎을 30분간 정주한 후 24시간까지 혈장 및 뇨 검체를 수집하여 one-compartment open model에 따라 분석하였다. 중증으 세균감염이 있는 18세 이상의 환자를 대상으로 병용 또는 단독 투여한 후 임상적 효과와 세균학적 효과를 판정하였고, 치료전과 후의 순음청력검사와 혈청 크레아티닌으로 이독성과 신독성을 평가하였다. 결과 : 정상 성인 남자 12명을 대상으로 약동학적 지표를 평가하였고, 최고혈장농도는 투여 종료시점(C_(0))에서 16.87±1.68㎍/mL였으며, 반감기는 1.86±0.43 시간 이었고, AUC_(0-12h)은 38.12±10.57㎍ㆍhr/mL, Vd는 0.18±0.02L/㎏, CL은 5.25±2.07L/hr였다. 이러한 약동학적 지표는 다른 aminoglycoside와 유사한 결과를 보였다. 59명의 환자를 대상으로 시행한 임상적 효과 분석에서는 단독요법을 시행한 50명 중 임상적 치유율 94%, 세균학적 치유율 100%를 보였고, 순음청력검사를 시행한 48례의 환자중 의미있는 청력감소 소견은 관찰되지 않았으며, 신독성 또한 전혀 나타나지 않았다. 결론 : Astromicin의 약동학적 지표는 다른 aminoglycoside의 약동학적 지표와 비슷한 양상을 보이므로 향후 astromicin의 약물농도 감시에 있어서 다른 aminoglycoside의 치료적 약물 농도 감시 방법과 유사한 방법을 적용할 수 있으리라 기대된다. 또한 임상적 치유율이 우수하면서 신독성이나 이독성이 적어 세균 감염 환자의 치료에 있어서 단독 또는 병합 요법으로 비교적 안전하게 사용할 수 있으리라 생각된다. Astromicin(Fortimicin®) has some characteristics in common with other aminioglycoside antibiotics, although it has a unique chemical structure, which is different from them. This study was performed to elucidate the pharmacokinetic (PK) parameters of astromicin following single-dose intravenous infusion of 200 mg and to evaluate clinical efficacy and safety of astromicin in Korean populations. PK parameters of astromicin were determined in 12 healthy volunteers (65.5±5.2㎏). The plasma and urine samples were collected up to 24hrs. PK variables were calculated by fitting individual concentration-time curves to a one-compartment open model. Plasma level at the end of infusion was 16.87?1.68 ㎍/mL and declined to 1.05±0.35 (㎍/mL 8hr later. The half-life was 1.86±0.43 hr. Apparent volume of distribution was 0.18±0.02 L/㎏g, and total body clearance was 5.25±2.07 L/hr. These values were similar to those of other aminioglycosides. Clinical efficacy and safety were eviuated in 59 patients with moderate to severe bacterial infections who needed parenteral antibiotics. Among 50 patients who recieved astromicin monotherapy, 49 (98%) had favorable clinical reponse and 28 (100%) had favorable bacteriological response. Serial audiograms revealed no change in all of 48 patients. No nephrotoxicity was observed in all patients. Conclusively, our data suggest that therapeutic drug monitoring of astromicin can be conducted in a similar fashion as other aminioglycosides and astromicin is a useful and safe antibiotic in the treatment of severe bacterial infections.