Jensen S, Knudsen L, Kirkegaard L
Department of Anaesthesia, Aarhus Kommunehospital, University Hospital, Denmark.
Eur J Anaesthesiol Suppl. 1988;2:161-6.
In two double-blind, randomized trials the efficacy and safety of flumazenil, the first benzodiazepine antagonist, were assessed in 100 adult patients undergoing gastroscopy under diazepam or midazolam sedation. The criteria of efficacy were the degree of sedation and anterograde amnesia. The median gastroscopy time was 20 min (range 5-40 min). The diazepam group received median 30 mg (range 15-60 mg) Diazemuls and the midazolam group median 15 mg (range 10-40 mg) Dormicum. Both groups were antagonized by median 0.42 mg flumazenil (range 0.4-0.6 mg). There was no inter-group difference with regard to blood pressure, heart rate and respiration rate. There was a significantly faster recovery of the patients after injection of flumazenil than after placebo. Patients were awake shortly after flumazenil, but remained drowsy or asleep after placebo administration. All patients, regardless of diazepam or midazolam sedation, antagonized with flumazenil were awake within 5 min and remained awake during the whole observation period of 3 h. The amnesia was totally eliminated by flumazenil. There were no significant differences in side-effects between the groups.
在两项双盲随机试验中，对100例接受地西泮或咪达唑仑镇静下行胃镜检查的成年患者评估了首个苯二氮䓬拮抗剂氟马西尼的疗效和安全性。疗效标准为镇静程度和顺行性遗忘。胃镜检查的中位时间为20分钟（范围5 - 40分钟）。地西泮组接受的地西泮乳剂中位剂量为30毫克（范围15 - 60毫克），咪达唑仑组接受的多美康中位剂量为15毫克（范围10 - 40毫克）。两组均用中位剂量0.42毫克氟马西尼（范围0.4 - 0.6毫克）进行拮抗。在血压、心率和呼吸频率方面两组无差异。注射氟马西尼后患者的恢复明显快于注射安慰剂后。注射氟马西尼后患者很快清醒，但注射安慰剂后仍昏昏欲睡或处于睡眠状态。所有患者，无论接受地西泮还是咪达唑仑镇静，用氟马西尼拮抗后均在5分钟内清醒，并在3小时的整个观察期内保持清醒。氟马西尼完全消除了遗忘。两组间副作用无显著差异。
