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选择性5-羟色胺再摄取抑制剂西酞普兰和舍曲林的安慰剂对照比较

Placebo-controlled comparison of the selective serotonin reuptake inhibitors citalopram and sertraline.

作者信息

Stahl S M

机构信息

Department of Psychiatry, School of Medicine, University of California, San Diego, San Diego, California 92122, USA.

出版信息

Biol Psychiatry. 2000 Nov 1;48(9):894-901. doi: 10.1016/s0006-3223(00)00957-4.

DOI:10.1016/s0006-3223(00)00957-4
PMID:11074227
Abstract

BACKGROUND

Previous comparative studies of the selective serotonin reuptake inhibitors (SSRIs) have rarely included a placebo control group and have rarely demonstrated significant between-group differences. The study reported on here was a placebo-controlled comparison of the antidepressant effects of two SSRIs, citalopram and sertraline.

METHODS

Three hundred twenty-three patients with DSM-IV-defined major depressive disorder were randomized to 24 weeks of double-blind treatment with citalopram (20-60 mg/day), sertraline (50-150 mg/day), or a placebo. The primary efficacy measure was the Hamilton Depression Rating Scale (HAMD) and the primary statistical analysis was an analysis of variance comparing the change from baseline to the last observation carried forward in each treatment group.

RESULTS

Both citalopram and sertraline produced significantly greater improvement than placebo on the HAMD, the Montgomery-Asberg Depression Rating Scale, and the Clinical Global Impression Scale. Significant improvement was observed at earlier timepoints in the citalopram group than the sertraline group; however, sertraline treatment was associated with increased gastrointestinal side effects and a tendency toward early discontinuation, and analyses that excluded early dropouts revealed similar acute efficacy for the two active treatments. The Hamilton Anxiety Scale demonstrated a significant anxiolytic effect of citalopram, but not sertraline, relative to placebo.

CONCLUSIONS

This study confirms the antidepressant efficacy of two SSRIs, citalopram and sertraline. It is hypothesized that the more consistent evidence of antidepressant activity that was observed early in treatment in the citalopram group was related to more pronounced antianxiety effects and better tolerability upon initiation of therapy.

摘要

背景

既往对选择性5-羟色胺再摄取抑制剂(SSRI)的比较研究很少纳入安慰剂对照组,也很少显示出显著的组间差异。本文报道的这项研究是对两种SSRI(西酞普兰和舍曲林)的抗抑郁作用进行的安慰剂对照比较。

方法

323例符合《精神疾病诊断与统计手册》第四版(DSM-IV)定义的重度抑郁症患者被随机分为3组,分别接受为期24周的双盲治疗,治疗药物为西酞普兰(20 - 60毫克/天)、舍曲林(50 - 150毫克/天)或安慰剂。主要疗效指标为汉密尔顿抑郁量表(HAMD),主要统计分析为方差分析,比较各治疗组从基线到末次观察值的变化。

结果

在HAMD、蒙哥马利-阿斯伯格抑郁量表及临床总体印象量表上,西酞普兰和舍曲林均比安慰剂产生了显著更大的改善。西酞普兰组比舍曲林组在更早的时间点观察到显著改善;然而,舍曲林治疗与胃肠道副作用增加及早期停药倾向相关,排除早期退出者后的分析显示两种活性治疗的急性疗效相似。相对于安慰剂,汉密尔顿焦虑量表显示西酞普兰有显著抗焦虑作用,而舍曲林无。

结论

本研究证实了两种SSRI(西酞普兰和舍曲林)的抗抑郁疗效。据推测,西酞普兰组在治疗早期观察到的更一致的抗抑郁活性证据与更显著的抗焦虑作用及治疗开始时更好的耐受性有关。

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