在健康参与者中,西洛斯塔和罗斯瓦斯塔丁之间的药物药物相互作用
Dong Ho Kim1,2, Jang Hee Hong1,3, Won Tae Jung4
1Clinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.
概括
同时使用西洛斯塔和罗斯瓦斯塔丁在健康成年人中显示了轻微的药物动力学相互作用. 组合治疗是安全的,耐受性很好,类似于单独使用药物,并且不需要调整剂量.
科学领域:
- 药理动力学 药理动力学
- 药物相互作用 药物相互作用
- 临床药理学 临床药理学
背景情况:
- 奇洛斯塔治疗缺血症状,并防止中风复发.
- 罗斯瓦斯塔丁用于降低胆固醇.
- 没有先前的研究评估了健康成年人中西洛斯塔和罗斯瓦斯塔丁的药理学相互作用.
研究的目的:
- 为了评估cilostazol和rosuvastatin之间的药理动力学相互作用.
- 为了评估同时服用西洛斯塔和罗斯瓦斯塔丁的安全性和耐受性.
- 为了确定是否需要剂量调整用于联合治疗.
主要方法:
- 随机,开放标签,多剂量,两期研究在健康的男性.
- 参与者接受了西洛斯塔 (每天200毫克) 或罗斯瓦斯塔丁 (每天20毫克) 治疗7天,然后进行洗期.
- 随后,两种药物同时服用了7天,并通过液体染色学-并联质谱分析了血度.
主要成果:
- 57名参与者被随机分配;44人完成了研究.
- 根据Cmax,ss和AUCtau,ss,没有观察到基洛斯塔和罗斯瓦斯塔丁之间显著的药理动力相互作用.
- 安全性概况与单个药物管理情况相似,没有报告重大不良事件.
结论:
- 重复同时使用西洛斯塔和罗斯瓦斯塔丁导致了轻微的药理动力学相互作用.
- 综合疗法显示出与单个药物使用相似的安全性和耐受性.
- 该研究表明,组合疗法耐受性良好,不需要调整剂量.
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