Chabannes J P, Lemoine P
Clinique du Nivolet, CHS de Bassens, Chambery.
Therapie. 1990 Nov-Dec;45(6):467-70.
A multicentric study has been conducted with a new prazepam formulation (drop) which has been compared with 10 mg tablets. The aim of the study was to check the clinical equivalence of the two formulations. Nine generalists and 9 psychiatrists participated in this double blind study. One hundred fifty four patients with DSM III generalized anxiety criteria were included in this study and received prazepam at an average dosage of 20 mg per day. There were 11 drop outs: 6 in the tablet group and 5 in the drop group. The statistical analysis was done on 143 patients. Before treatment the two groups were equivalent. There was a very significant decrease (p less than 10(-4) in Hamilton anxiety scale scores, physician visual analogic scale and patient visual analogic scale with no difference between both groups. The vigilance, measured by the Mini-Folstein scale, was significantly increased (p less than 10(-4) in both groups. The tolerance was also similar: 14 patients in the tablet group and 10 in the drop one complained of asthenia and somnolence.
一项针对一种新的普拉西泮制剂（滴剂）开展的多中心研究，已将其与10毫克片剂进行了比较。该研究的目的是检验这两种制剂的临床等效性。9名全科医生和9名精神科医生参与了这项双盲研究。154名符合DSM III广泛性焦虑标准的患者被纳入该研究，并接受平均每日20毫克的普拉西泮治疗。有11名患者退出：片剂组6名，滴剂组5名。对143名患者进行了统计分析。治疗前两组相当。汉密尔顿焦虑量表评分、医生视觉模拟量表和患者视觉模拟量表均有非常显著的下降（p小于10⁻⁴），两组之间无差异。通过简易精神状态检查表测量的警觉性在两组中均显著提高（p小于10⁻⁴）。耐受性也相似：片剂组14名患者和滴剂组10名患者抱怨有乏力和嗜睡症状。
