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진행성 악성종양 환자에서 화학요법 후 발생한 호중구 감소증에 대한 Leukokine (Filgrastim, 고G-CSF) 의 유호성 및 안전성을 평가하기 위한 무작위 선정 타 약물 비교 공개 제 III상 임상시험
DC Field | Value | Language |
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dc.contributor.author | 김주항 | - |
dc.date.accessioned | 2019-11-11T07:04:05Z | - |
dc.date.available | 2019-11-11T07:04:05Z | - |
dc.date.issued | 2000 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/172516 | - |
dc.description.abstract | Purpose: The aim of this study was to evaluate the effectiveness and toxicity of newly developed rhG-CSF (Filgrastim; Leukokine®, Cheiljedang Co., Korea). Methods: This study was designed as an open randomized active control comparative cross-over phase Ⅲ study involving Leukokine® and Gracin® (Amgen/Kirin Co, USA/Japan). rhG-CSF was subcutaneously injected with the dose of 75 ㎍/day from 24 hours after the end of chemotherapy and continued for 14 days. The main point of assessment was the duration of neutrophil recovery to 2,000/㎣. Moreover, 'neutropenia duration', 'nadir count of neutrophil' and 'the duration of recovery from neutropenia to normal status', were assessed. The toxicity was evaluated with WHO criteria. Results: 91 patients were enrolled in this study, and seventy four were possible for assessment. The main assessment point was evaluable in 50 patients. The neutrophil recovery duration to 2,000/㎣ of Leukokine® group (14.14±3.48 days) showed no difference with that (13.98±2.52 days) of Gracin® group (P=0.7723). And, the results of other assessment points revealed no difference between the Leukokine® group and Gracin® group. The toxicity was found in seven cases and all were mild and controllable with symptomatic cares. Conclusion: Leukokine® has the same effectiveness and safety alike with those of Gracin® for the control of the neutropenia induced by myelo-suppressive chemotherapy in advanced cancer patients. | - |
dc.description.statementOfResponsibility | prohibition | - |
dc.language | Korean | - |
dc.publisher | 한국BRM학회 | - |
dc.relation.isPartOf | Korean Journal of Biological Response Modifiers (한국 BRM학회지) | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 진행성 악성종양 환자에서 화학요법 후 발생한 호중구 감소증에 대한 Leukokine (Filgrastim, 고G-CSF) 의 유호성 및 안전성을 평가하기 위한 무작위 선정 타 약물 비교 공개 제 III상 임상시험 | - |
dc.title.alternative | The Randomized and Active Control Comparative Open Phase Ⅲ Study to Evaluate the Effectiveness and Safety of Leukokine® (Filgrastim, rhG-CSF) for the Neutropenia Induced by Chemotherapy in Advanced Cancer Patients | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | 김병수 | - |
dc.contributor.googleauthor | 김준석 | - |
dc.contributor.googleauthor | 김주항 | - |
dc.contributor.googleauthor | 안중배 | - |
dc.contributor.googleauthor | 박준오 | - |
dc.contributor.googleauthor | 정익주 | - |
dc.contributor.googleauthor | 임창열 | - |
dc.contributor.googleauthor | 곽재용 | - |
dc.contributor.googleauthor | 정태준 | - |
dc.contributor.googleauthor | 이영렬 | - |
dc.contributor.googleauthor | 강태영 | - |
dc.contributor.localId | A00945 | - |
dc.relation.journalcode | J03698 | - |
dc.subject.keyword | Neutropenia | - |
dc.subject.keyword | rhG-CSF | - |
dc.subject.keyword | Leukokine® | - |
dc.contributor.alternativeName | Kim, Joo Hang | - |
dc.contributor.affiliatedAuthor | 김주항 | - |
dc.citation.volume | 10 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 131 | - |
dc.citation.endPage | 140 | - |
dc.identifier.bibliographicCitation | Korean Journal of Biological Response Modifiers (한국 BRM학회지), Vol.10(2) : 131-140, 2000 | - |
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