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재조합 인 과립구 콜로니 자극인자 DA-3030의 랫드에 대한 4주 정맥내 반복투여 독성연구
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  • 재조합 인 과립구 콜로니 자극인자 DA-3030의 랫드에 대한 4주 정맥내 반복투여 독성연구
  • Four-week Intravenous Toxicity Study of DA-3030, a Recombinant Human G-CSF, in Rats
저자명
강경구,김옥진,안병옥,백남기,이순복,김원배,양중익
간행물명
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
권/호정보
1994년|2권 3호|pp.270-280 (11 pages)
발행정보
한국응용약물학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

This study was conducted to evaluate the repeated dose toxicity of DA-3030, a recombinant human granulocyte colony stimulating factor(rhG-CSF), in rats. DA-3030 was administered intravenously once a day for 4 weeks to 20 males and 20 females per group at doses of 0(control), 115 and 1150 $mu extrm{g}$/kg, and to 15 males and 15 females per group at doses of 1.15 and 11.5$mu extrm{g}$/kg. After the administration period, 5 males and 5 females per group in the 0,115 and 1150 $mu extrm{g}$/kg groups were placed on withdrawal for 2 weeks. Through-out the study, all the rats survived. The administration of DA-3030 induced, a marked increase in the number of peripheral neutrophils, elevation of serum alkaline phosphatase activity, and splenomegaly in the rats of both sexes receiving 115 or 1150 $mu extrm{g}$/kg. Histopathologic examination revealed extramedullary granulopoiesis in spleen and liver, and increase in the number of activated macrophages in spleen in rats of both sexes in 115 and 115 $mu extrm{g}$/kg groups, and increased M/E ratio in 11.5, 115 and 1150$mu extrm{g}$/kg groups. Most of the changes produced by DA-3030 were thought to be attributable to exaggerated pharmacological effect of the drug, and subsided or disappeared after the recovery period. Under the present condition, no effect dose of DA-3030 is estimated at 1.15 $mu extrm{g}$/kg/day.