喹硫平单药治疗双相抑郁症患者的焦虑症状：两项双盲、随机、安慰剂对照研究结果的汇总分析
Quetiapine monotherapy as treatment for anxiety symptoms in patients with bipolar depression: a pooled analysis of results from 2 double-blind, randomized, placebo-controlled studies.
作者信息
Lydiard R Bruce, Culpepper Larry, Schiöler Helena, Gustafsson Urban, Paulsson Björn
机构信息
Southeast Health Consultants and Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
出版信息
Prim Care Companion J Clin Psychiatry. 2009;11(5):215-25. doi: 10.4088/PCC.08m00659.
OBJECTIVE
To evaluate the efficacy and tolerability of quetiapine monotherapy for anxiety symptoms in patients with bipolar disorder experiencing depression in the BipOLar DEpRession (BOLDER I and II) studies.
METHOD
A post hoc analysis of anxiety symptoms in 1,051 acutely depressed patients with bipolar I or II disorder (DSM-IV) from 2 double-blind, randomized, placebo-controlled 8-week studies of quetiapine (300 or 600 mg once daily) was conducted. Anxiety symptoms were assessed using Hamilton Anxiety Rating Scale (HARS) total and psychic (items 1-6, 14) and somatic (items 7-13) anxiety subscale scores (mixed-model repeated measure and last-observation-carried-forward analysis of change from baseline at each assessment). The BOLDER I study was conducted between September 2002 and October 2003, and the BOLDER II study was conducted between June 2004 and August 2005.
RESULTS
Mean baseline HARS total scores were similar across the treatment groups (300 mg/d: 18.9, 600 mg/d and placebo: both 18.6). There was a significantly greater improvement from baseline in mean HARS total scores at the first evaluation (week 1) in both quetiapine groups compared with placebo (300 mg/d: -4.6, P < .001 and 600 mg/d: -4.1, P = .003 vs placebo: -2.8). These improvements were sustained through week 8 with both quetiapine doses (300 mg/d: -10.1, P < .001 and 600 mg/d: -10.5, P < .001 vs placebo: -6.9). At week 8, there was also significant improvement from baseline in HARS psychic and somatic anxiety subscale scores compared with placebo (P < .001). The baseline severity of anxiety did not impact the improvement in depressive symptoms. Common adverse events included dry mouth, sedation, somnolence, and dizziness.
CONCLUSIONS
In this pooled analysis, quetiapine monotherapy was more effective than placebo and generally well tolerated for the treatment of both depressive and anxiety symptoms in patients with bipolar disorder.
TRIAL REGISTRATION
clinicaltrials.gov Identifiers: NCT00060489 (BOLDER I) and NCT00083954 (BOLDER II).
目的
在双相抑郁（BOLDER I和II）研究中，评估喹硫平单药治疗双相情感障碍抑郁发作患者焦虑症状的疗效和耐受性。
方法
对来自两项为期8周的双盲、随机、安慰剂对照研究的1051例双相I型或II型障碍（DSM-IV）急性抑郁患者进行了焦虑症状的事后分析。这两项研究中，患者接受喹硫平（每日一次，300或600mg）治疗。使用汉密尔顿焦虑量表（HARS）总分、精神性（第1 - 6项、第14项）和躯体性（第7 - 13项）焦虑分量表评分评估焦虑症状（采用混合模型重复测量以及每次评估时相对于基线变化的末次观察结转分析）。BOLDER I研究于2002年9月至2003年10月进行，BOLDER II研究于2004年6月至2005年8月进行。
结果
各治疗组的HARS总分基线均值相似（300mg/d组：18.9，600mg/d组和安慰剂组均为18.6）。与安慰剂相比，在首次评估（第1周）时，两个喹硫平组的HARS总分较基线均有显著更大程度的改善（300mg/d组：-4.6，P <.001；600mg/d组：-4.1，P =.003；安慰剂组：-2.8）。两种喹硫平剂量在第8周时这些改善仍持续存在（300mg/d组：-10.1，P <.001；600mg/d组：-10.5，P <.001；安慰剂组：-6.9）。在第8周时，与安慰剂相比，HARS精神性和躯体性焦虑分量表评分较基线也有显著改善（P <.001）。焦虑的基线严重程度并未影响抑郁症状的改善。常见不良事件包括口干、镇静、嗜睡和头晕。
结论
在这项汇总分析中，喹硫平单药治疗比安慰剂更有效，且对于双相情感障碍患者抑郁和焦虑症状的治疗总体耐受性良好。
试验注册
clinicaltrials.gov标识符：NCT00060489（BOLDER I）和NCT00083954（BOLDER II）。
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