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혈액투석에 환자에서 유전자 재조합 인 Erythropoietin (Epokine®) 의 효과와 안전성에 관한 연구

Other Titles
 Phase Ⅲ Clinical Trial Evaluating Efficacy and Safety of Recombinant Human Eythropoietin(Epokine®) in Hemodialysis Patients 
 이인희  ;  신석균  ;  강신욱  ;  노현진  ;  서보정  ;  박형천  ;  최규헌  ;  하성규  ;  이호영  ;  한대석  ;  이은영  ;  강덕희  ;  최규곱  ;  윤견일 
 Korean Journal of Nephrology (대한신장학회지), Vol.17(3) : 466-475, 1998 
Journal Title
 Korean Journal of Nephrology (대한신장학회지) 
Issue Date
To evaluate the clinical efficacy and safety of newly developed recombinant human erythropoietin (Epokine®®), a phase III clinical trial was performed in patients with end-stage renal disease undergoing maintenance hemodialysis. Epokine®® was given ini- tially at a dosage of 50unit/kg, intravenously, three times a week after each dialysis session and the dosage was adjusted according to the changes in hemoglobin level. Out of total 79 patients who were enrolled initially, data of 64 patients who have completed 12 weeks study period were analyzed. The results were as following: 1) Hemoglobin(g/dL) and hematocrit(%) increased significantly from baseline levels beginning from 2 weeks after Epokine® administration. Hemoglobin increased significantly from 6.8±0.8 to 10.4±1.3 and hematocrit increased significantly from 20.9±2.2 to 31.1±5.2 after 12 weeks(P<0.05). Corrected reticulo- cyte count(%) increased significantly from 0.6±0.4 to 1.4± 0.7 after 2 weeks and to 1.3±0.6 after 12 weeks(P<0.05). 2) A significant increase in platelet count was ob- served from 2 weeks after Epokine® administration (P<0.05). 3) Serum ferritin and serum iron decreased signi- ficantly and total iron binding capacity increased significantly after 2 weeks(P<0.05). 4) The mean of pre-hemodialysis systolic blood pressure(mmHg) increased significantly from 148+21 to 154±25 at 12 weeks(P<0.05). Also, post-hemodia- lysis blood pressure(systolic/diastolic) at 12 weeks increased significantly from baseline levels(146±28/ 82±15 vs. 153±25/87±14mmHg, P<0.05). 5) Anti-erythropoietin antibody was not detected in all subjects. 6) Side effects observed in this study were simi- lar to those reported by earlier reports. Headache(9 cases), and flu-like syndrome(7 cases) were the most common side effects. These side effects were not severe and disappeared without discontinuation of Epokine® administration in most of the patients. In conclusion, Epokine® is safe and effective in treating anemia of hemodialysis patients with end stage renal disease.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kang, Shin Wook(강신욱) ORCID logo https://orcid.org/0000-0002-5677-4756
Park, Hyeong Cheon(박형천) ORCID logo https://orcid.org/0000-0002-1550-0812
Choi, Kyu Hun(최규헌) ORCID logo https://orcid.org/0000-0003-0095-9011
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