Ropert R, Bernes J, Dachary J M
Encephale. 1987 Mar-Apr;13(2):89-95.
Double-blind study comparing efficacy and safety of alprazolam and bromazepam in 119 ambulatory anxious patients receiving flexible dosage. 119 ambulatory anxious patients (global score on the Hamilton anxiety rating scale between 18 and 35) have been included in this double-blind trial (duration 4 weeks) comparing alprazolam and bromazepam given at flexible dosage. The global score on the Hamilton anxiety rating scale improved by 57.8% and 55.3% for alprazolam and bromazepam respectively. The percentage of therapeutic success according to the psychiatrist and the patient were respectively 82.7% and 79.3% for alprazolam compared to 74.1% and 71.9% for bromazepam. Fewer side-effects were recorded in the alprazolam group (97) than in the bromazepam group (120) and global safety of alprazolam seemed superior (p = 0.07). At trial-end, mean dosage reached 1.70 mg/day for alprazolam and 10.35 mg for bromazepam, but no correlation was found between anxiety intensity and optimal daily dosage used; however, a correlation has been found between the improvement of the overall Hamilton rating scale score and the dosage given (p = 0.02). The overall results suggest that the efficacy/safety ratio is better for alprazolam.
双盲研究比较阿普唑仑和溴西泮在119例接受灵活剂量治疗的门诊焦虑症患者中的疗效和安全性。119例门诊焦虑症患者(汉密尔顿焦虑量表总分在18至35之间)被纳入这项双盲试验(为期4周),比较灵活剂量给药的阿普唑仑和溴西泮。阿普唑仑和溴西泮治疗后,汉密尔顿焦虑量表总分分别改善了57.8%和55.3%。根据精神科医生和患者评估,阿普唑仑的治疗成功率分别为82.7%和79.3%,而溴西泮分别为74.1%和71.9%。阿普唑仑组记录的副作用(97例)少于溴西泮组(120例),且阿普唑仑的总体安全性似乎更高(p = 0.07)。试验结束时,阿普唑仑的平均剂量达到1.70毫克/天,溴西泮为10.35毫克,但未发现焦虑强度与所用最佳日剂量之间存在相关性;然而,发现汉密尔顿评定量表总分的改善与给药剂量之间存在相关性(p = 0.02)。总体结果表明,阿普唑仑的疗效/安全性比更佳。