劳拉西泮与地西泮注射液治疗焦虑状态的随机双盲平行对照研究

A multicenter,randomized,and double-blind controlled clinical trial of lorazepam injection vs diazepam injection in treatment of anxiety state

目的：评价劳拉西泮注射液治疗焦虑状态的疗效和安全性。方法：采用多中心随机双盲、阳性药平行对照的方法。以地西泮为对照,受试者分别肌内注射劳拉西泮2～6 mg·d^(-1)与地西泮10～30 mg·d^(-1),疗程7 d。结果：125名受试者参加研究。劳拉西泮组63人,地西泮组62人。治疗结束时,2组HAMA总分与基线相比有非常显著差异(P＜0．01),2组减分绝对值比较无显著差异(P＞0．05)。以HAMA总分减分率(50%)判断有效率,劳拉西泮组为67%,地西泮组为71%,2组间比较无显著差异(P＞0．05)。2药常见的不良反应为胃肠道和中枢神经系统症状,多为轻度、一过性；2组不良反应发生的频率比较无显著差异(P＞0．05)。结论：劳拉西泮注射液与地西泮注射液相似,是安全有效的治疗焦虑状态的药物。

AIM： To evaluate the efficacy and safety of lorazepam injection in the treatment of anxiety state. METHODS： A muhicenter, randomized, double-blind, and positive drug parallel controlled clinical trial was conducted for treating anxiety state. The lorazepam group was given lorazepam 2-6 mg·d^-1, im, and the diazepam group was given diazepam 10-30 mg·d^-1, im, during a course of 7 d treatment. RESULTS： One hundred and twenty-five patients in anxiety state were enrolled including 63 patients in the lorazepam group and 62 patients in the diazepam group. The scores of HAMA at the endpoint were significantly reduced in comparison with the baseline before treatment in both groups （P 〈 0.01）, with no statistical significant difference before the two medications （P 〉 0.05） . The efficacy rates were 67 % in lorazepam group and 71% in the diazepam group, based on the critical efficacy rate of total HAMA reduction rate, showed no statistical significant difference between two groups （P 〉 0.05） Adverse reactions were mainly minor, including transitory symptoms in gastrointestinal system and central nervous system, with no significant difference between two groups （P 〉 0.05） . CONCLUSION： Lorazepam injection is as effective and safe as diazepam injection for the treatment of anxiety state.