과립구 감소증 환자의 감염에서 Imipenem/Cilastatin 단독요법과 Piperacillin과 Amikacin 병합요법의 비교

양영상,한치화,신완식,박종원,강문원,김춘추,김동집,정희영 대한화학요법학회 1990 대한화학요법학회지 Vol.8 No.2

We studied a prospective, randomized trial to assess the clinical efficacy of monotherapy with imipenem/cilastatin relative to piperacillin plus amikacin as empiric antibacterial therapy in the treatment of infections in ueuropenic patients. Among 32 evaluable cases of infections in neutropenic patients, 16 were treated with imipenem/cilastatin, and the other 16 were treated with piperacillin plus amikacin. Among etiologic agents, gram-positive bacteria were 66.7%, gram-negative bacteria 26.7%, and fungi 6.6%. Results of therapy according to initial granulocyte count showed no significant difference in cure or improvement rate between imipenem/cilastatin and piperacillinplus amicacin but imipenem/cilastatin was prior in the group of granulocyte counts 500-1000×10^(6)/L, piperacillin plus amikacin was prior in the group of granulocyte counts less than 500×10^(6)/L. The clinical response rates in total patients were 69% for imipenem/cilastatin therapy and 63% for piperacillinplus amikacin, which showed more excellent efficacy of imipenem/cilastatin therapy, but without statistical significance. There was no major difference of incidence of side effect between the two regimens. We conclude that monotherapy with imipenem/cilastatin will be a good alternative to the combination therapy with piperacillin plus amikacin for infections in neutropenic patients.

요로감염증 환자의 치료에서 메로페넴(Meropenem)과 이미페넴/실라스타틴(Imipenem/Cilastatin)의 임상효과 및 안정성

김세웅,이승주,이지열,조용현,신완식,윤문수 대한화학요법학회 1999 대한화학요법학회지 Vol.17 No.1

목적 :메로페넴은 실라스타틴을 복합투여하지 않아도 되는 새로운 계열의 카바페넴계 항생물질이다. 요로감염 치료에 있어서의 메로페넴의 효과와 안전성을 평가하기 위하여 기존의 카바페넴계 항생물질인 이미페넴/실라스타틴과 동시에 비교임상실험을 실시하였다. 방법 : 본 임상시험은 전향적, 무작위 방법을 통하여 시행하였다. 1996년 10월부터 1998년 2월까지 가톨릭대학교 의과대학 부속 성모병원 및 울산대학교 외과대학 부속 중앙병원 비뇨기과에 입원한 신우신염과 복잡성방광염 환자 115명을 대상으로 하였고, 연속적 무작위 배정방법을 통하여 메로페spa군 58명과 이미페넴/실라스타틴군 57명으로 분류하였다. 두가지 약제는 모두 0.5 g을 12시간 간격으로 정맥주사 하였고, 평균 투약기간은 4일 (3-8일) 이었다. 임상효과, 세균학적 평가 및 부작용을 비교 관찰하였다. 결과 : 총 67명의 환자가 시험을 완료하여 평가가 가능하였고, 이 중 메로페넴군은 34명이었고, 이미페넴/실라스타틴군은 33명이었다. 증상의 치료 및 개선을 임상적 유효성이 있는 경우로 하였을 때, 메로페넴투여군은 34례중 32례 (94.1%)에서, 이미페넴/실라스타틴투여군은 33례중 29례 (87.9%)에서 유효율을 보였다. 세균학적 평가에서 메로페넴 투여군은 34례중 32례 (94.1%)에서, 이미페spa/실라스타틴투여군은 33례중 29례 (87.9%)에서 세균학적 소실율을 보였다. 세균학적 재발 은 각각 4명과 7명이 나타났고, 재감염은 메로페넴군은 나타나지 않았지만, 이미페넴/실라스타틴군은 2명이 나타났다. 임상효과와 세균학적 평가에서는 두 약제간의 통계학적 차이는 없었다. 부작용은 메로페spa투여군 56례중 1례 (1.8%)에서, 이미페넴/실라스타틴투여군 53례중 1례 (1.9%)에서 나타났으며, 임상검사치 이상은 메로페넴투여군 45례중 10례 (22.2%)에서, 이미페넴 실라스타틴투여군 44례중 8례 (18.2%)에서 나타났으나 전체적으로 특별히 문제가 된 증례는 없었다. 결론 :결론적으로 메로페spa은 신우신염 및 복잡성방광염과 같은 요로감염에 대하여 이미페넴/실라스타틴과 동등한 효과를 나타내는 유용한 약제라고 생각된다. Background : Metopenem is the first of a new class carbapenems which may be administered without cilastatin. The clinical study was carried out to assess efficacy and safety of metopenem in the treatment of urinary tract infections, in comparison to imipenem/cilastatin. Methods : This was a controlled, two-center, prospective, randomized study with two parallel groups. From October 1996 until February 1998, a total of 115 consecutive patients with urinary tract infections, such as pyeolonephritis and complicated cystitis, were randomly allocated into two groups, 58 in the meropenem group and 57 in the imipenem/cilastatin group. Both drugs were administered intravenously, at a dose of 0.5 g every 12 hours. The mean duration of therapy was 4 days (3-8 days) for both treatment. Clinical and bacteriological reponses were assessed at the begining of treatment, during treatment, at the end of treatment, and follow-up (1-2 weeks). Results : A total of 67 patients, 34 of meropenem and 33 of imipenem/cilastatin, were evaluable for response. Overall, a positive clinical response (recovery and improvement) was observed in 32 (94.1%) of 34 patients treated with meropenem and in 29 (87.9%) of 33 patients with imipenem/cilastin and the corresponding eradication rates of the primary pathogens were 32 (94.1%) of 34 patients and 29 (87.9%) of 33 patients, respectively. The microbiological relapse after the treatment completion was recorded in 4 patients treated with meropenem and 7 patients given imipenem/cilastath and superinfections occurred in none and 2 patients, respectively. No statistically significant differences in the clinical or bacteriological outcome were observed between the treatment groups. Both drugs were well tolerated with adverse events considered to be related to therapy being recorded for 1 (1.8%) of 56 patients treated with meropenem and 1 (1.9%) of 53 of those who had been given imipenenjcilastatin. Conclusion : Empirial monotherapy with meropenem was therefore as effective and as well tolerated as that with imipenem/cilastatin for the treatment of urinary tract infections.

Imipenem/Cilastatin의 약물 사용 평가

김민선,최경업,이숙향 한국병원약사회 2002 병원약사회지 Vol.19 No.4

Imipenem is a member of carbapenem class of antibiotics. Its bacteria spectrum is very broad and encompasses most gram-positive, gram-negative bacteria and anaerobes. Its side effect should be monitored carefully for seizure. Dosage of imipenem should be adjusted in patients with renal impairment. Frequent use can cause emergence of resistance. The objective of this study was to evaluate the use of imipenem. This retrospective study was performed on 66 patients on imipenem for longer than 3 continuous days at K university hospital from 1 January 1999 to 31 December 2000. The criteria for drug use evaluation included justification of indication, process indicators, outcomes and monitoring of side effects. As results, the isolated microorganisams were A. baumannii (54.2%), E. cloacae(20.3%), P. aeruginosa(10.2%) and others with less than 10%. The incidence of infection in this study were lower respiratory tract infection (46.4%), wound infection (23.2%), neutropenic fever (11.6%), abdominal infection (10.1%) and others. The mean duration of use was 12.7days. Imipenem monotherapy was 41 cases (59.4%) and combination therapy was 28 cases (40.6%). The criteria for justification of use were met in 58 cases (84.1%) and culture & sensitivity (C&S) were performed before initial dose in 54 cases (78.2%). Liver function test (LFT) was performed before initial dose in 13 cases (18.8%). serum creatinine level was measured before initial dose in 56 cases (81.1%), and was monitored at least twice weekly in 48 cases (69.6%). Dosage regimen was appropriate in 54 cases (78.3%). Drug related adverse effects were reported in 10 cases. Abnormal LFT was noted in 4 cases and diarrhea in 2 cases. There was no seizure occurrence. Negative cultures at 24 hours after discontinuation of imipenem were 6 cases out of 8 cases and the remaining cases did not have culture at the end of imipenem therapy. In summary, the antibiotic use protocol of imipenem showed high justification of use but low in the process indicators. The uses of imipenem require improvement in monitoring for therapeutic outcomes and prevention of side effects.

관해유도 화학요법을 받는 급성 백혈병 환자에서 발생한 감염증에서 Imipenem 단독요법과 Ceftizoxime + Amikacin 병용요법의 효과 및 안전성에 관한 전향적 비교 연구

신형식,김성민,이기형,최희정,김남중,오명돈,박선량,김병국,최강원 대한화학요법학회 1996 대한화학요법학회지 Vol.14 No.2

A total of 40 febrile granulocytopenic patients with acute leukemia were randomized to receive imipenem-cilastatin or ceftizoxime plus amikacin as initial empirical therapy to compare the efficacy and safety of imipenem monotherapy with that of ceftizoxime/amikacin combination therapy. 21 patients were randomized to the imipenem monotherapy, while 19 patients to the ceftizoxime/amikacin combination therapy. On 72 hour assessment success rates accordings to NCI criteria were 100% in both groups, success rates according to IHS (Immunocompremised Host Society) criteria were 55.0% in imipenem group and 66.7% in ceftizoxime/amikacin group. On overall assessment success rates according to NCI criteria were 90.0% in imipenem group and 94.7% in combination group, success rates according to IHS criteria were 50% in both groups. There was no statistical difference in success rate between two groups. Hepatotoxicity was the most common side effect in both groups(imipenem 15.0% vs. ceftizoxime/amikacin 15.8%). There was no CNS tixicity in both groups. Nausea and vomiting occurred in 9.5% of imipenem recipients, and 1 patients was unable to complete therapy due to intolerance. In summary, imipemem monotherapy was effective and safe empirical antibiotic therapy as compared with ceftizoxime/amikacin combination therapy.

Clinical and Microbiologic Efficacy and Safety of Imipenem/Cilastatin/Relebactam in Complicated Infections: A Meta-analysis

Syeda Sahra,Abdullah Jahangir,Rachelle Hamadi,Ahmad Jahangir,Allison Glaser 대한감염학회 2021 Infection and Chemotherapy Vol.53 No.2

Background: Antimicrobial resistance is on the rise. The use of redundant and inappropriate antibiotics is contributing to recurrent infections and resistance. Newer antibiotics with more robust coverage for Gram-negative bacteria are in great demand for complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), hospital-acquired bacterial pneumonia (HABP), and ventilator-associated bacterial pneumonia (VABP). Materials and Methods: We performed this meta-analysis to evaluate the efficacy and safety profile of a new antibiotic, Imipenem/cilastatin/relebactam, compared to other broad-spectrum antibiotics for complicated infections. We conducted a systemic review search on PubMed, Embase, and Central Cochrane Registry. We included randomized clinical trials-with the standard of care as comparator arm with Imipenem/cilastatin/relebactam as intervention arm. For continuous variables, the mean difference was used. For discrete variables, we used the odds ratio. For effect sizes, we used a confidence interval of 95%. A P-value of less than 0.05 was used for statistical significance. Analysis was done using a random-effects model irrespective of heterogeneity. Heterogeneity was evaluated using the I2 statistic. Results: The authors observed similar efficacy at clinical and microbiologic response levels on early follow-up and late follow-up compared to the established standard of care. The incidence of drug-related adverse events, serious adverse events, and drug discontinuation due to adverse events were comparable across both groups. Conclusion: Imipenem/cilastatin/relebactam has a non-inferior safety and efficacy profile compared to peer antibiotics to treat severe bacterial infections (cUTIs, cIAIs, HABP, VABP).