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舍曲林治疗惊恐障碍:一项多中心、双盲、安慰剂对照、固定剂量研究。

Sertraline in the treatment of panic disorder. A multi-site, double-blind, placebo-controlled, fixed-dose investigation.

作者信息

Londborg P D, Wolkow R, Smith W T, DuBoff E, England D, Ferguson J, Rosenthal M, Weise C

机构信息

Summit Research Network, Seattle, Washington 98104, USA.

出版信息

Br J Psychiatry. 1998 Jul;173:54-60. doi: 10.1192/bjp.173.1.54.

DOI:10.1192/bjp.173.1.54
PMID:9850204
Abstract

BACKGROUND

This study compared the efficacy and safety of sertraline to placebo in treating panic disorder.

METHOD

178 out-patients with panic disorder who exhibited at least four panic attacks during the four weeks prior to screening and three during the two weeks of lead-in were randomly assigned to 12 weeks of double-blind treatment with sertraline (50, 100 or 200 mg) or placebo.

RESULTS

Sertraline was superior to placebo in reducing the number of panic attacks, situational attacks, unexpected attacks, limited symptom attacks, and time spent worrying (all P < 0.01) and the Hamilton Anxiety Scale (P < 0.05), although Clinical Global Impression (Improvement) did not significantly differentiate groups at 12 weeks and at end-point. No serious adverse events were associated with sertraline. No dose relationship was found for adverse events; overall drop-out rates were not different for sertraline or placebo, although more sertraline-treated subjects discontinued for adverse events, typically early in the study. Only dry mouth and ejaculation failure (primarily ejaculation delay) were associated significantly with sertraline.

CONCLUSIONS

Sertraline was effective and safe in reducing panic attacks. Higher doses were no more effective than the 50 mg dose.

摘要

背景

本研究比较了舍曲林与安慰剂治疗惊恐障碍的疗效和安全性。

方法

178例惊恐障碍门诊患者,在筛查前四周内至少有四次惊恐发作,导入期两周内有三次惊恐发作,被随机分配接受12周的舍曲林(50、100或200毫克)或安慰剂双盲治疗。

结果

舍曲林在减少惊恐发作次数、情境性发作、意外发作、有限症状发作以及担忧时间方面优于安慰剂(所有P<0.01),在汉密尔顿焦虑量表上也优于安慰剂(P<0.05),尽管临床总体印象(改善)在12周和终点时未显著区分两组。舍曲林未出现严重不良事件。未发现不良事件与剂量有关;总体脱落率在舍曲林组和安慰剂组之间无差异,尽管更多接受舍曲林治疗的受试者因不良事件而停药,通常在研究早期。只有口干和射精障碍(主要是射精延迟)与舍曲林有显著关联。

结论

舍曲林在减少惊恐发作方面有效且安全。较高剂量并不比50毫克剂量更有效。

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