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唑吡坦、磷酸可待因及安慰剂对呼吸的影响。一项针对志愿者的双盲交叉研究。

Effects of zolpidem, codeine phosphate and placebo on respiration. A double-blind, crossover study in volunteers.

作者信息

Cohn M A

机构信息

Sleep Disorders Center of Southwest Florida, Naples.

出版信息

Drug Saf. 1993 Oct;9(4):312-9. doi: 10.2165/00002018-199309040-00009.

DOI:10.2165/00002018-199309040-00009
PMID:8260124
Abstract

The effects of zolpidem, codeine phosphate and placebo on respiration were evaluated in a double-blind, randomised, crossover study involving 12 healthy men. Single oral doses of zolpidem 10 or 20 mg, codeine phosphate 60 mg or placebo were administered in the morning. Each treatment was separated by a washout period of at least 72 h. Ventilatory responses to carbon dioxide and mouth occlusion pressure, measured 1 h before and at 1 and 3 h after doses, were not significantly affected by either zolpidem dose; however, codeine phosphate produced a small but significant respiratory suppressant effect at 3 h. Mean inspiratory flow was noninvasively assessed using respiratory inductive plethysmography 1 h predose and at 1 to 5 h postdose. No significant change in mean inspiratory flow was noted after zolpidem 10 mg. Two hours after administration of zolpidem 20 mg, mean inspiratory flow was significantly lower than after placebo, possibly related to some individuals falling asleep during data collection. All volunteers reported adverse events; the most common were slurred speech (in 1 after 10 mg and in 5 after 20 mg of zolpidem), dizziness (in 4 after both 10 mg and 20 mg of zolpidem) and diplopia/blurred vision (in 4 after 20 mg of zolpidem). Zolpidem appears to be well tolerated, with no respiratory suppression up to doses of 10 mg and minimal suppression of mean inspiratory drive at doses of 20 mg.

摘要

在一项涉及12名健康男性的双盲、随机、交叉研究中,评估了唑吡坦、磷酸可待因和安慰剂对呼吸的影响。早晨单次口服10毫克或20毫克唑吡坦、60毫克磷酸可待因或安慰剂。每次治疗之间间隔至少72小时的洗脱期。在给药前1小时以及给药后1小时和3小时测量的对二氧化碳的通气反应和口腔闭塞压,两种唑吡坦剂量均未产生显著影响;然而,磷酸可待因在3小时时产生了轻微但显著的呼吸抑制作用。使用呼吸感应体积描记法在给药前1小时以及给药后1至5小时无创评估平均吸气流量。10毫克唑吡坦后平均吸气流量未发现显著变化。服用20毫克唑吡坦两小时后,平均吸气流量显著低于服用安慰剂后,这可能与一些个体在数据收集期间入睡有关。所有志愿者均报告了不良事件;最常见的是言语不清(10毫克唑吡坦后1例,20毫克唑吡坦后5例)、头晕(10毫克和20毫克唑吡坦后均为4例)和复视/视力模糊(20毫克唑吡坦后4例)。唑吡坦似乎耐受性良好,剂量达10毫克时无呼吸抑制作用,剂量达20毫克时平均吸气驱动力仅有轻微抑制。

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