Laakmann G, Schüle C, Lorkowski G, Baghai T, Kuhn K, Ehrentraut S
Department of Psychiatry, University of Munich, München, Germany.
Psychopharmacology (Berl). 1998 Apr;136(4):357-66. doi: 10.1007/s002130050578.
In this double-blind, placebo-controlled 10-week trial, the anxiolytic properties of the nonbenzodiazepine buspirone were compared with the benzodiazepine lorazepam and placebo in 125 outpatients with generalized anxiety disorder according to DSM-III. After a 3- to 7-day wash-out period, patients were allocated at random to receive orally 3 x 5 mg buspirone (n=58), 3 x 1 mg lorazepam (n=57), or placebo (n=10) over a 4-week period. The study also comprised a 2-week taper period and a 4-week placebo-control period to assess the stability of clinical improvement. The patient's clinical state was estimated on entry and at weekly intervals by general practitioners using the Hamilton Rating Scale for Anxiety (HAM-A) and Clinical Global Impression (CGI) assessment and by a self-rating scale (State Trait Anxiety Inventory X2=STAI-X2). Lorazepam treatment resulted in descriptively, but not significantly, greater improvement on the Hamilton Rating Scale for Anxiety during the whole treatment (week 0-4) and taper period (week 5, 6) than did buspirone. After treatment with active drugs had been discontinued, the 4-week placebo control period showed buspirone-treated patients to display a stability of clinical improvement, while the symptoms of lorazepam-treated patients worsened at week 7-10. Both buspirone and lorazepam were more efficacious in reducing anxiety symptoms than placebo during the treatment and taper period; however, in contrast to the active drugs (buspirone, lorazepam), patients of the placebo group showed further clinical improvement during the control period, especially in the HAM-A score, so differences between placebo and active drugs became smaller at the end of the study.
在这项双盲、安慰剂对照的10周试验中，根据《精神疾病诊断与统计手册》第三版（DSM-III），将非苯二氮䓬类药物丁螺环酮的抗焦虑特性与苯二氮䓬类药物劳拉西泮及安慰剂在125例广泛性焦虑症门诊患者中进行了比较。经过3至7天的洗脱期后，患者被随机分配，在4周内口服3×5mg丁螺环酮（n = 58）、3×1mg劳拉西泮（n = 57）或安慰剂（n = 10）。该研究还包括一个2周的减药期和一个4周的安慰剂对照期，以评估临床改善的稳定性。在入组时以及每周，由全科医生使用汉密尔顿焦虑量表（HAM-A）和临床总体印象（CGI）评估以及自评量表（状态-特质焦虑量表X2 = STAI-X2）对患者的临床状态进行评估。在整个治疗期（第0至4周）和减药期（第5、6周），劳拉西泮治疗在汉密尔顿焦虑量表上的改善在描述上大于丁螺环酮，但无显著差异。在停用活性药物治疗后，4周的安慰剂对照期显示，丁螺环酮治疗的患者临床改善具有稳定性，而劳拉西泮治疗的患者症状在第7至10周恶化。在治疗期和减药期，丁螺环酮和劳拉西泮在减轻焦虑症状方面均比安慰剂更有效；然而，与活性药物（丁螺环酮、劳拉西泮）不同，安慰剂组患者在对照期出现了进一步的临床改善，尤其是在HAM-A评分方面，因此在研究结束时安慰剂与活性药物之间的差异变小。
