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首页> 外文期刊>麻酔 >Neuromuscular blocking effects, pharmacokinetics and safety of Org 9426 (rocuronium bromide) in Japanese patients
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Neuromuscular blocking effects, pharmacokinetics and safety of Org 9426 (rocuronium bromide) in Japanese patients

机译：Org 9426（罗库溴铵）对日本患者的神经肌肉阻滞作用，药代动力学和安全性

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BACKGROUND: The purpose of this study was to examine pharmacodynamics, pharmacokinetics and safety of Org 9426 (rocuronium bromide) in Japanese patients. METHODS: Seventy-eight patients anesthetized with thiopental, droperidol, fentanyl and nitrous oxide, were randomized to receive either a single dose of Org 9426 0.3 mg x kg(-1), 0.6 mg x kg(-1) or 0.9 mg x kg(-1). Contraction of the adductor pollicis to the ulnar nerve stimulation (0.1 Hz) was measured by acceleromyography. Blood was sampled over 6 hr and pharmacokinetic variables were calculated by plasma concentrations of Org 9426. RESULTS: Onset times for patients receiving 0.3 mg x kg(-1), 0.6 mg x kg(-1) or 0.9 mg x kg(-1) were 271.5 s, 140.0s and 125.4s, respectively. There was a dose-dependent increase in clinical durations until 25% recovery of twitch height (17.4 min in 0.3 mg x kg(-1) group, 37.2 min in 0.6 mg x kg(-1) and 60.4 min in 0.9 mg x kg(-1) group). Pharmacokinetic study revealed that elimination half life, steady state volume of distribution and plasma clearance of Org 9426 were 48-76 min, 146-181 ml x kg(-1), and 3.8-4.5 ml x min(-1) x kg(-1), respectively. No adverse effects were found except a case of local erythema on a forearm. CONCLUSIONS: The efficacy of neuromuscular block, stable pharmacokinetic behavior and excellent safety of Org 9426 were also confirmed in Japanese surgical patients.
机译：背景：这项研究的目的是检查Org 9426（罗库溴铵）在日本患者中的药效学，药代动力学和安全性。方法：将78名接受硫喷妥钠，氟哌利多，芬太尼和一氧化二氮麻醉的患者随机分组接受Org 9426单剂0.3 mg x kg（-1），0.6 mg x kg（-1）或0.9 mg x kg （-1）。通过加速度描记术测量内收肌的收缩对尺神经的刺激（0.1Hz）。在6个小时内采样血液，并通过Org 9426的血浆浓度计算药代动力学变量。结果：接受0.3 mg x kg（-1），0.6 mg x kg（-1）或0.9 mg x kg（-1）的患者的发病时间）分别为271.5 s，140.0s和125.4s。直到抽搐高度恢复25％为止，临床持续时间呈剂量依赖性增加（0.3 mg x kg（-1）组为17.4分钟，0.6 mg x kg（-1）组为37.2分钟，而0.9 mg x kg为60.4分钟） （-1）组）。药代动力学研究表明，Org 9426的消除半衰期，稳态分布体积和血浆清除率分别为48-76分钟，146-181 ml x kg（-1）和3.8-4.5 ml x min（-1）x kg（ -1）。除前臂局部红斑外，未发现不良反应。结论：日本外科患者还证实了神经肌肉阻滞的疗效，稳定的药代动力学行为和Org 9426的安全性。

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