Efficacy and safety of paroxetine treatment for chronic PTSD: A fixed-dose, placebo-controlled study
Efficacy and safety of paroxetine treatment for chronic PTSD: A fixed-dose, placebo-controlled study
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DOI：
10.1176/appi.ajp.158.12.1982
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发表时间：
2001-12-01
影响因子：
17.7
通讯作者：
Zaninelli, R
中科院分区：
文献类型：
--
作者：
Marshall, RD;Beebe, KL;Zaninelli, R
目的：本研究评估帕罗西汀治疗慢性创伤后应激障碍 (PTSD) 患者的有效性和安全性。方法：根据 DSM-IV 标准且临床医生管理的 PTSD 量表第 2 部分得分为 50 分或以上的慢性 PTSD 门诊患者被随机分配服用安慰剂 (N=186)、20 毫克/天帕罗西汀 (N=183) 或 40 毫克/天帕罗西汀 (N=182) 12 周。通过检查临床医生管理的创伤后应激障碍量表（第 2 部分）从基线到终点的总分变化以及临床总体印象量表总体改善的反应率（“大大改善”或“大大改善”）来评估疗效。结果：在意向治疗分析中，与安慰剂治疗的患者相比，两个剂量组的帕罗西汀治疗的患者在主要结局指标上均表现出显着更大的改善。此外，与安慰剂相比，帕罗西汀治疗在所有三种 PTSD 症状群（重新体验、回避/麻木和过度警觉）、社交和职业障碍以及共病抑郁症方面均取得了统计学上显着的改善。帕罗西汀对男性和女性均有效。治疗反应并不因创伤类型、创伤后时间、基线 PTSD 或抑郁症状的严重程度而变化。两种剂量的耐受性均良好。结论：帕罗西汀 20 毫克/天和 40 毫克/天的剂量在治疗患有慢性 PTSD 的成人中有效且耐受性良好。
Objective: This study evaluated the efficacy and safety of paroxetine for the treatment of patients with chronic posttraumatic stress disorder (PTSD).Method: Outpatients with chronic PTSD according to DSM-IV criteria and a score of 50 or more on the Clinician-Administered PTSD Scale, part 2, were randomly assigned to take placebo (N=186), 20 mg/day of paroxetine (N=183), or 40 mg/day of paroxetine (N=182) for 12 weeks. Efficacy was assessed by examining the change in total score from baseline to endpoint on the Clinician-Administered PTSD Scale, part 2, and rates of response ("very much improved" or "much improved") for global improvement on the Clinical Global Impression scale.Results: Paroxetine-treated patients in both dose groups demonstrated significantly greater improvement on primary outcome measures compared to placebo-treated patients in the intent-to-treat analysis. Moreover, paroxetine treatment resulted in statistically significant improvement compared to placebo on all three PTSD symptom clusters (reexperiencing, avoidance/numbing, and hyperarousal), social and occupational impairment, and comorbid depression. Paroxetine was effective for both men and women. Treatment response did not vary by trauma type time since trauma, or severity of baseline PTSD or depressive symptoms. Both doses were well tolerated.Conclusions: Doses of 20 and 40 mg/day of paroxetine are effective and well tolerated in the treatment of adults with chronic PTSD.