Alfonzo-Echeverri E, Troutman K C, George W
University of Texas Health Science Center at Houston.
Anesth Prog. 1990 Nov-Dec;37(6):277-81.
The purpose of this investigation was to compare the rate of absorption and clearance time of midazolam (Versed) when administered by the submucosal (SM) route), and the intramuscular (IM) route in ten healthy adult volunteers, ranging in age from 25 to 35 years. Each subject received midazolam 0.08 mg/kg, to a maximum of 5 mg, by the SM and IM routes at two week intervals. Vital signs and arterial oxygen saturation levels were monitored every five minutes throughout the 180 minute study period. Blood samples (3 ml) were collected via an intravenous line, prior to midazolam administration and at 2, 5, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes, centrifuged and analyzed by gas-liquid chromatography. The mean absorption rates and the mean elimination times of the two routes were not significantly different. The mean peak absorption was reached at 10 minutes by the SM route (80.4 ng/ml) and at 20 minutes (92.0 ng/ml) by the IM route, with considerable individual variability. Vital signs were stable throughout the study period in all subjects with both routes. All subjects reported pain at the injection site during SM injection which continued for up to 48 hours. No pain related to the IM injection was reported.
本研究的目的是比较10名年龄在25至35岁之间的健康成年志愿者通过黏膜下(SM)途径和肌肉内(IM)途径给药时咪达唑仑(速眠安)的吸收速率和清除时间。每位受试者每隔两周通过SM和IM途径接受0.08mg/kg的咪达唑仑,最大剂量为5mg。在整个180分钟的研究期间,每五分钟监测一次生命体征和动脉血氧饱和度水平。在咪达唑仑给药前以及给药后2、5、10、20、30、45、60、90、120、150和180分钟,通过静脉留置针采集血样(3ml),离心后用气相色谱法进行分析。两种途径的平均吸收速率和平均消除时间无显著差异。SM途径在10分钟时达到平均峰值吸收(80.4ng/ml),IM途径在20分钟时达到平均峰值吸收(92.0ng/ml),个体差异较大。在整个研究期间,两种途径给药的所有受试者生命体征均稳定。所有受试者在SM注射期间均报告注射部位疼痛,疼痛持续长达48小时。未报告与IM注射相关的疼痛。