Sex differences in clinical presentation and response in panic disorder: pooled data from sertraline treatment studies

Sex differences in clinical presentation and response in panic disorder: pooled data from sertraline treatment studies
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DOI:
10.1007/s00737-005-0111-y
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发表时间:
2006-05-01
影响因子:
4.5
通讯作者:
Clary, C. M.
Clary, C. M.
中科院分区:
医学2区
文献类型:
--
作者:
Clayton, A. H.;Stewart, R. S.;Clary, C. M.

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目标。对诊断为DSM-III-R惊恐障碍伴或不伴广场恐怖症的患者进行临床表现和对舍曲林治疗反应的性别差异分析。数据汇集自4项双盲、安慰剂对照门诊研究(男性,N = 335;女性,N = 338)。两个是12周的固定剂量研究(舍曲林50 mg、100 mg、200 mg),两个是10周的灵活剂量研究(舍曲林50-200 mg)。主要结果测量包括临床总体印象改善量表(CGI-I)和惊恐发作频率的变化。惊恐障碍的临床表现相似,只是男性报告的发病年龄更早,病程更短,酒精和/或物质依赖/滥用史明显更频繁。在两项主要结果测量中,舍曲林在女性和男性中都明显比安慰剂更有效。当性别间疗效比较时,女性在恐慌频率和CGI-I方面的改善明显大于男性,但在所有其他措施上都有同等的改善。在研究完成率或不良事件方面,性别间无显著差异。在急性舍曲林治疗结束时,女性表现出较好的疗效,这是一个适度但一致的趋势。这种性别效应只是偶尔才有意义,还需要进一步的治疗研究来证实。
Objective. Gender differences in clinical presentation and response to sertraline treatment were examined for patients diagnosed with DSM-III-R panic disorder with or without agoraphobia.Method. Data was pooled from 4 double-blind, placebo-controlled outpatient studies (males, N = 335; females, N = 338). Two were 12-week fixed-dose studies (sertraline 50 mg vs. 100 mg vs. 200 mg) and 2 were 10-week flexible-dose studies (sertraline 50-200 mg). Primary outcome measures consisted of the Clinical Global Impression-Improvement scale (CGI-I) and change in panic attack frequency.Results. The clinical presentation of panic disorder was similar except that men reported an earlier age of onset, shorter duration of illness, and significantly more frequent history of alcohol and/or substance dependence/abuse. Sertraline was significantly more effective than placebo in both women and men on the 2 primary outcome measures. When between-sex efficacy was compared, women achieved significantly greater improvement than men on panic frequency and CGI-I, but had equivalent improvement on all other measures. There was no significant between-sex difference in study completion rates, or in adverse event profiles.Conclusions. There was a modest but consistent trend for women to show superior efficacy at the end of acute sertraline treatment. This gender effect only occasionally achieved significance, and must be confirmed by future treatment research.