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猫每日服用卡莫瑞林的安全性评估。

Evaluation of the safety of daily administration of capromorelin in cats.

作者信息

Wofford J A, Zollers B, Rhodes L, Bell M, Heinen E

机构信息

Aratana Therapeutics, Inc., Leawood, KS, USA.

ClinData Services, Inc., Fort Collins, CO, USA.

出版信息

J Vet Pharmacol Ther. 2018 Apr;41(2):324-333. doi: 10.1111/jvp.12459. Epub 2017 Oct 22.

Abstract

Capromorelin is a ghrelin receptor agonist that is FDA approved for appetite stimulation in dogs. The objective of this study was to evaluate the safety of daily oral administration of capromorelin to cats over a range of doses and for an extended period. Two randomized, controlled studies were conducted: in Study 1, cats (n = 6 per group) received placebo or capromorelin at a dose of 9, 15, 30 or 60 mg/kg once daily for 14 days; and in Study 2, cats received capromorelin at 6 mg/kg (n = 8) or placebo (n = 4) once daily for 91 days. Cats were evaluated using clinical observations and clinical pathology test results for both studies, with the addition of postmortem examination in Study 1 and measurements of growth hormone and insulin-like growth factor 1 in Study 2. Abnormal clinical observations were limited to emesis, hypersalivation, lethargy/depression, head shaking and lip smacking, which occurred more frequently in the capromorelin-treated groups than in the placebo group. There were no clinically relevant differences in clinical pathology test results between the capromorelin and placebo groups in either study.

摘要

卡莫瑞林是一种胃饥饿素受体激动剂,已获美国食品药品监督管理局(FDA)批准用于刺激犬类食欲。本研究的目的是评估在一系列剂量下长期每日口服卡莫瑞林对猫的安全性。进行了两项随机对照研究:在研究1中,猫(每组n = 6)接受安慰剂或剂量为9、15、30或60 mg/kg的卡莫瑞林,每日一次,持续14天;在研究2中,猫接受6 mg/kg的卡莫瑞林(n = 8)或安慰剂(n = 4),每日一次,持续91天。在两项研究中,均使用临床观察和临床病理学检测结果对猫进行评估,研究1还增加了尸检,研究2则增加了生长激素和胰岛素样生长因子1的测量。异常的临床观察结果仅限于呕吐、流涎过多、嗜睡/抑郁、摇头和咂嘴,这些情况在卡莫瑞林治疗组中比在安慰剂组中更频繁出现。在两项研究中,卡莫瑞林组和安慰剂组的临床病理学检测结果均无临床相关差异。

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