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Paroxetine in the treatment of chronic posttraumatic stress disorder: results of a placebo-controlled, flexible-dosage trial.

机译:帕罗西汀治疗慢性创伤后应激障碍:安慰剂对照,灵活剂量试验的结果。

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BACKGROUND: The objective of this double-blind, placebo-controlled study was to investigate the efficacy and safety of paroxetine in outpatients with posttraumatic stress disorder (PTSD). METHOD: Male and female outpatients 18 years and older who met DSM-IV criteria for PTSD and had baseline scores of 50 or greater on the Clinician Administered PTSD Scale (CAPS-2) were randomly assigned to treatment with paroxetine (20-50 mg/day) or placebo for 12 weeks. The primary efficacy variables were the change from baseline to the 12-week endpoint in the CAPS-2 total score and the proportion of responders on the Clinical Global Impressions-Global Improvement scale (CGI-1). Additional key outcome measures were the change from baseline in the reexperiencing, avoidance/ numbing, and hyperarousal scores of the CAPS-2 and in the total scores of the Treatment Outcome PTSD Scale and the patient-rated Davidson Trauma Scale and Sheehan Disability Scale (SDS). Depressive symptoms were assessed with the Montgomery-Asberg Depression Rating Scale. The proportion of patients achieving response and remission was also determined. RESULTS: 307 patients constituted the intent-to-treat population. At week 12, compared with the placebo group (N = 156), the paroxetine group (N = 151) showed significantly greater reduction of PTSD symptoms on both of the primary and all of the secondary outcome measures. Significantly greater improvement on the CAPS-2 total score was observed for paroxetine compared with placebo from week 4 (p < .05), and significantly greater proportions of paroxetine-treated patients achieved response (p < .001) and remission (p = .008) by week 12. The improvement in PTSD symptoms was similar in male and female patients. Functional improvement at the study endpoint was significantly greater (p < .05) in the paroxetine group in all 3 domains of the SDS (work, social life, family life). Treatment with paroxetine was well tolerated, with the frequency and type of adverse events recorded for the paroxetine group corresponding to the known safety profile of this medication. Conclusion: Paroxetine in doses of 20 to 50 mg once daily is effective as a treatment for chronic PTSD. Improvement is obtained for all 3 symptom clusters (reexperiencing, avoidanceumbing, hyperarousal) and is associated with significant reduction in disability after 12 weeks of treatment.
机译:背景:这项双盲,安慰剂对照研究的目的是研究帕罗西汀在创伤后应激障碍(PTSD)门诊患者中的疗效和安全性。方法:将符合DSM-IV PTSD标准且在临床医生管理的PTSD量表(CAPS-2)上达到50分或更高的基线的18岁及以上的男性和女性门诊患者,随机分配帕罗西汀(20-50 mg /天)或安慰剂治疗12周。主要疗效变量是CAPS-2总评分从基线到12周终点的变化,以及临床总体印象-总体改善量表(CGI-1)的应答者比例。其他主要结局指标是CAPS-2的重新体验,避免/麻木和兴奋度得分与基线水平的变化,以及治疗结果PTSD量表和患者评分的Davidson Trauma量表和Sheehan残疾量表(SDS)的总分)。使用蒙哥马利-阿斯伯格抑郁量表评估抑郁症状。还确定了达到缓解和缓解的患者比例。结果:意向性治疗人群共有307例。与安慰剂组(N = 156)相比,在第12周时,帕罗西汀组(N = 151)在主要和所有次要结局指标中均显示出PTSD症状的明显减轻。从第4周开始,与安慰剂相比,帕罗西汀在CAPS-2总评分上的观察到显着更大的改善(p <.05),帕罗西汀治疗的患者达到缓解(p <.001)和缓解(p =。 008)到第12周。男性和女性患者PTSD症状的改善相似。帕罗西汀组在SDS的所有三个领域(工作,社交生活,家庭生活)中,研究终点的功能改善显着更大(p <.05)。帕罗西汀的治疗耐受性良好,帕罗西汀组记录的不良事件的频率和类型与该药物的已知安全性相对应。结论:帕罗西汀每天20至50 mg剂量可有效治疗慢性PTSD。所有3种症状群(再次体验,避免/麻木,过度刺激)均得到改善,并且与治疗12周后的残疾显着降低有关。

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