Sramek J J, Tansman M, Suri A, Hornig-Rohan M, Amsterdam J D, Stahl S M, Weisler R H, Cutler N R
California Clinical Trials, Beverly Hills, Calif., USA.
J Clin Psychiatry. 1996 Jul;57(7):287-91.
This study was designed to evaluate the anxiolytic efficacy of buspirone in patients with a diagnosis of generalized anxiety disorder (GAD) with coexisting mild depressive symptoms.
Patients who participated in this multicenter study scored >/= 18 on the Hamilton Rating Scale for Anxiety (HAM-A) and between 12 and 17 on the Hamilton Rating Scale for Depression (HAM-D). Following a 7- to 10-day placebo lead-in phase, patients who continued to qualify were randomly assigned to receive either buspirone titrated from 15 to 45 mg/day (N = 80) or placebo (N = 82) for the next 6 weeks. 121 patients completed 6 weeks of treatment. The primary efficacy measure was the HAM-A, taken weekly during the study.
Buspirone-treated patients averaged a 12.4-point reduction from their baseline total HAM-A score of 24.9, while their counterparts on placebo averaged a 9.5-point reduction from their mean baseline total HAM-A score of 25.6. This 2.9-point difference in HAM-A reductions between treatment groups was significantly different (p < .03). Buspirone patients decreased their HAM-D scores by an average 5.7 points from their mean baseline total HAM-D score of 15.8, while placebo patients decreased their HAM-D scores by an average 3.5 points from their mean baseline score of 16.3 (p < .05). Overall, the incidence of adverse events was similar for both treatment groups, but buspirone-treated patients reported significantly more nausea, dizziness, somnolence, and sweating than placebo patients.
Buspirone is superior to placebo in improving anxiety and depressive symptoms in GAD patients who have coexisting depressive symptoms.
本研究旨在评估丁螺环酮对诊断为广泛性焦虑障碍（GAD）且伴有轻度抑郁症状患者的抗焦虑疗效。
参与这项多中心研究的患者在汉密尔顿焦虑量表（HAM - A）上得分≥18分，在汉密尔顿抑郁量表（HAM - D）上得分在12至17分之间。在为期7至10天的安慰剂导入期后，仍符合条件的患者被随机分配接受丁螺环酮治疗，剂量从15毫克/天滴定至45毫克/天（N = 80），或接受安慰剂治疗（N = 82），为期6周。121名患者完成了6周的治疗。主要疗效指标是HAM - A，在研究期间每周测量一次。
接受丁螺环酮治疗的患者，其HAM - A总分从基线的24.9分平均降低了12.4分，而接受安慰剂治疗的患者，其HAM - A总分从平均基线的25.6分平均降低了9.5分。治疗组之间HAM - A降低分数的2.9分差异具有显著性（p < .03）。丁螺环酮治疗的患者，其HAM - D总分从平均基线的15.8分平均降低了5.7分，而安慰剂治疗的患者，其HAM - D总分从平均基线的16.3分平均降低了3.5分（p < .05）。总体而言，两个治疗组的不良事件发生率相似，但丁螺环酮治疗的患者报告的恶心、头晕、嗜睡和出汗症状明显多于安慰剂治疗的患者。
在改善伴有抑郁症状的GAD患者的焦虑和抑郁症状方面，丁螺环酮优于安慰剂。
