Marion M H, Stocchi F, Malcolm S L, Quinn N P, Jenner P, Marsden C D
University Department of Neurology, GB-Denmark Hill, London, UK.
Eur Neurol. 1987;27 Suppl 1:54-8. doi: 10.1159/000116193.
The clinical effects and pharmacokinetic profiles of single doses of Madopar HBS were compared with those of standard Madopar in two studies in patients with Parkinson's disease and 'on-off' fluctuations. In the first study, 10 fasting patients received equivalent doses (200 mg levodopa plus 50 mg benserazide) of each preparation. The clinical response to Madopar HBS was delayed and brief; the relative bioavailability was only 50%. In the second study in 7 non-fasted patients, the effects of 3 capsules of Madopar HBS 125 were compared with those of 2 capsules of standard Madopar 125. Delay to turn on was longer with HBS, but duration of time on, and delay to turn off, were longer with this preparation. The area under the concentration-time curve for plasma levodopa was greater with HBS, and the maximum levodopa concentration was similar to, but achieved later than standard Madopar.
在两项针对帕金森病伴“开-关”波动患者的研究中，比较了单剂量美多芭HBS与标准美多芭的临床疗效和药代动力学特征。在第一项研究中，10名空腹患者接受了每种制剂的等效剂量（200毫克左旋多巴加50毫克苄丝肼）。美多芭HBS的临床反应延迟且短暂；相对生物利用度仅为50%。在第二项针对7名非空腹患者的研究中，比较了3粒美多芭HBS 125胶囊与2粒标准美多芭125胶囊的效果。HBS开启延迟时间更长，但该制剂开启后的持续时间和关闭延迟时间更长。血浆左旋多巴浓度-时间曲线下面积HBS更大，最大左旋多巴浓度与标准美多芭相似，但达到时间晚于标准美多芭。
