Pregabalin in generalized anxiety disorder: A placebo-controlled trial
Pregabalin in generalized anxiety disorder: A placebo-controlled trial
复制标题
DOI：
10.1176/appi.ajp.160.3.533
复制
发表时间：
2003-03-01
影响因子：
17.7
通讯作者：
Liu-Dumaw, M
中科院分区：
文献类型：
--
作者：
Pande, AC;Crockatt, JG;Liu-Dumaw, M
目的：目前广泛性焦虑症的药物治疗存在局限性。在一项对照试验中，新的药物普瑞巴林研究广泛性焦虑症患者的治疗方法：在这个双盲研究中，患者与DSM-IV广泛性焦虑症随机分配到接受普瑞巴林（150毫克/天或600毫克/天），劳拉西泮（6毫克/天），或安慰剂。1周安慰剂导入后进行4周治疗，然后进行1周剂量递减。主要疗效指标为终点时的汉密尔顿焦虑评定量表评分。结果：共有276例患者被随机分配到治疗组，并接受至少一剂其分配的药物。接受劳拉西泮（59%，N=40/68）的患者完成试验的人数少于接受安慰剂（73%，N=50/69）、600 mg/天普瑞巴林（71%，N=50/76）或150 mg/天普瑞巴林（90%，N=62/69）的患者。接受150 mg/天普瑞巴林（-9.2）、600 mg/天普瑞巴林（-10.3）和劳拉西泮（-12.0）治疗的患者中，汉密尔顿焦虑量表总分从基线到终点的平均下降幅度显著大于接受安慰剂治疗的患者（-6.8）。早在第1周观察时，与安慰剂相比，普瑞巴林显著降低了总汉密尔顿焦虑状态评分。普瑞巴林和劳拉西泮最常见的不良事件是嗜睡和头晕。有没有严重的不良事件报告的患者给予普瑞巴林，并没有戒断综合征与普瑞巴林treatment.Conclusions：这些结果表明，普瑞巴林是一种有效的，迅速行动，广泛性焦虑症的安全治疗。在短期治疗中，普瑞巴林似乎没有与苯二氮卓类药物相关的戒断症状。
Objective: Current drug therapies for generalized anxiety disorder have limitations. In a controlled trial, the novel agent pregabalin was studied for the treatment of patients with generalized anxiety disorder.Method: in this double-blind study, patients with DSM-IV generalized anxiety disorder were randomly assigned to receive pregabalin (150 mg/day or 600 mg/day), lorazepam (6 mg/day), or placebo. A 1-week placebo lead-in was followed by 4 weeks of treatment and then a 1-week dose taper. The primary efficacy measure was the Hamilton Anxiety Rating Scale score at endpoint.Results: A total of 276 patients were randomly assigned to a treatment group and received at least one dose of their assigned medication. Fewer patients given lorazepam (59%, N=40 of 68) completed the trial than did those given placebo (73%, N=50 of 69), 600 mg/day of pregabalin (71%, N=50 of 76), or 150 mg/day or pregabalin (90%, N=62 of 69). The mean baseline-to-endpoint decreases in total Hamilton anxiety scale score in the patients given 150 mg/day of pregabalin (-9.2), 600 mg/day of pregabalin (-10.3), and lorazepam (-12.0) were significantly greater than the decrease in those given placebo (-6.8). As early as the week 1 observation, pregabalin significantly reduced the total Hamilton anxiety stale score compared with placebo. The most frequent adverse events reported for pregabalin and lorazepam were somnolence and dizziness. There were no serious adverse events reported by patients given pregabalin, and no withdrawal syndrome was associated with pregabalin treatment.Conclusions: These results indicate that pregabalin is an effective, rapidly acting, and safe treatment for generalized anxiety disorder. In short-term treatment, pregabalin does not appear to have the withdrawal symptoms associated with the benzodiazepines.