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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

Other Titles
 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 
 김병수  ;  김준석  ;  김주항  ;  안중배  ;  박준오  ;  정익주  ;  임창열  ;  곽재용  ;  정태준  ;  이영렬  ;  강태영 
 Korean Journal of Biological Response Modifiers (한국 BRM학회지), Vol.10(2) : 131-140, 2000 
Journal Title
 Korean Journal of Biological Response Modifiers (한국 BRM학회지) 
Issue Date
Neutropenia ; rhG-CSF ; Leukokine®
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.
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Joo Hang(김주항)
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