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KMID : 0379520080240040289
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한국독성학회지
2008 Volume.24 No. 4 p.289 ~ p.295
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Assessment of General and Cardiac Toxicities of Astemizole in Male Cynomolgus Monkeys: Serum Biochemistry and Action Potential Duration
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Lee Jong-Hwa
Kim Do-Geun
Seo Joung-Wook
Lee Hyang-Ae
Oh Jeong-Hwa
Shin Ho-Chul
Yoon Seok-Joo
Kim Choong-Yong
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Abstract
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Toxicology screening following treatment with astemizole, a histamine receptor antagonist, at oral doses of 0, 10, 30 and 60 ㎎/㎏ was carried out in male cynomolgus monkeys (Macaca fascicularis). No dose-related changes in mortality, clinical signs, body weight changes, food consumption, or urine analysis occurred in any animal compared to the vehicle control. However, the high-dose group showed a decrease in BUN and ALP compared to vehicle control group. In addition, the levels of TG, AST, ALP and CK increased. Although astemizole did not produce significant toxicological changes at any dose tested, we predict that it can cause toxicological changes of the liver and heart based on the changes in the serum parameters related to the heart and liver. The Action Potential Duration (APD) was prolonged in the heart of 60 ㎎/㎏ treatment group compared to the control group. The APD increase in 60 ㎎/㎏ treatment group along the other related changes in toxicological parameters imply that astemizole has major cardiotoxic effects in the cynomolgus monkey. This study is a valuable assessment for predicting the general toxicity and cardiotoxic effects of antihistamine drugs using nonhuman primates.
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KEYWORD
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Astemizole, Cardiotoxicity, Cynomolgus monkey, APD, Serum biochemistry
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