氯氟乙酯(21例)和地西泮(22例)治疗焦虑障碍的疗效和安全性比较

目的 :评价氯氟乙酯与地西泮治疗焦虑障碍的疗效和安全性。方法 :采用双盲、双模拟、随机、平行对照研究。完成 4wk治疗的病人共 4 3例。其中试验组 (氯氟乙酯组 ) 2 1例于早、午餐后服氯氟乙酯安慰剂及地西泮安慰剂各 1片 ,晚餐后服氯氟乙酯 2mg及地西泮安慰剂各 1片 ,对照组(地西泮组 ) 2 2例于早、午、晚餐后服氯氟乙酯安慰剂及地西泮 2 .5mg各 1片 ,疗程均为 4wk。结果 :治疗 4wk后 ,试验组的HAMA总分显著降低 ,HAMA减分率达 (6 6± 10 ) % ,临床总有效率达95 % ,与对照组相比无显著意义 (P >0 .0 5 )。试验组的不良反应的发生率为 14 % ,与对照组相比无显著意义 (P >0 .0 5 )。结论 :氯氟乙酯治疗焦虑障碍有明显疗效 ,无明显不良反应。

Efficacy and safety of ethyl loflazepate(21 patients) vs diazepam(22 patients) in treatment of anxiety disorders

AIM: To evaluate the efficacy and safety of ethyl loflazepate(ELof) in treating anxiety disorders. METHODS: This was a randomized, double blind, double modeling, and parallel controlled study. Fourty-three patrients completed the whole 4 wk study. Twenty-one patients in ELof group were treated with placebo of ELof one tablet and placebo of diazepam one tablet after breakfast and dinner; ELof 2 mg and placebo of diazepam one tablet after supper. Another 22 patients in diazepam group were treated with placebo of ELof and diazepam 2.5 mg each after breakfast, dinner and supper. RESULTS: After 4 wk treatment, HAMA total score in ELof group was significantly reduced. HAMA scores reduction rate and overall clinical effective rate in ELof group were (66±10) % and 95 %. Compared with diazepam group, no statistical significance was observed(P> 0.05). The rate of adverse reactions in ELof group was 14 %, which had no significant difference compared with that of the diazepam group (P>0.05).CONCLUSION: ELof is an effective agent in treatment of anxiety disorders without obvious adverse reaction.