一项比较舍曲林和氟西汀治疗门诊重度抑郁症患者的双盲多中心试验。

A double-blind multicenter trial comparing sertraline and fluoxetine in outpatients with major depression.

作者信息

Bennie E H, Mullin J M, Martindale J J

机构信息

Leverndale Hospital, Glasgow, UK.

出版信息

J Clin Psychiatry. 1995 Jun;56(6):229-37.

PMID:7775364

Abstract

BACKGROUND

Sertraline and fluoxetine have pharmacokinetic and pharmacologic differences, which may be of clinical relevance.

METHOD

A randomized, double-blind, parallel-group study of 6 weeks' duration comparing the efficacy and safety of sertraline (50-100 mg/day) with those of fluoxetine (20-40 mg/day) was conducted in 286 psychiatric outpatients with DSM-III-R major depression or bipolar disorder (depressed). Primary efficacy measurements consisted of the 17-item Hamilton Rating Scale for Depression (HAM-D) and the Clinical Global Impressions (CGI) scale. Secondary measurements included the Hamilton Rating Scale for Anxiety (HAM-A), the Raskin Depression Scale, the Covi Anxiety Scale, and the Leeds Sleep Questionnaire. Additionally, scores for two items and five factors from the HAM-D were analyzed.

RESULTS

Efficacy was based on 124 evaluable patients in each treatment group. As measured by HAM-D and CGI-Severity scores, there was a significant (p < .001) improvement from baseline to each follow-up visit in both treatment groups with no statistically significant difference between groups. There was also no significant difference in the proportion of responders in each group. CGI-Improvement responder rates were 69% for sertraline and 67% for fluoxetine. Results of secondary efficacy measurements followed the same trend, although from the second week of treatment there was a numerical advantage (not statistically significant) for sertraline over fluoxetine in improving anxiety symptoms as measured by the total HAM-A score. Headache and nausea were the most frequently reported events for both drugs. The incidence of early patient withdrawals due to treatment-emergent adverse events was 14% for sertraline and 13% for fluoxetine. The starting dosage (sertraline 50 mg/day, fluoxetine 20 mg/day) was the final dosage in 76% of patients in both treatment groups.

CONCLUSION

Sertraline and fluoxetine were equally effective and well tolerated in patients with major depression and associated anxiety.

摘要

背景

舍曲林和氟西汀在药代动力学和药理学方面存在差异，这可能具有临床相关性。

方法

对286例患有DSM-III-R重度抑郁症或双相情感障碍（抑郁发作）的精神科门诊患者进行了一项为期6周的随机、双盲、平行组研究，比较舍曲林（50 - 100毫克/天）和氟西汀（20 - 40毫克/天）的疗效和安全性。主要疗效指标包括17项汉密尔顿抑郁评定量表（HAM-D）和临床总体印象（CGI）量表。次要指标包括汉密尔顿焦虑评定量表（HAM-A）、拉斯金抑郁量表、科维焦虑量表和利兹睡眠问卷。此外，还对HAM-D中的两项和五个因子的得分进行了分析。

结果

每个治疗组有124例可评估患者用于疗效分析。根据HAM-D和CGI-严重程度评分，两个治疗组从基线到每次随访均有显著改善（p <.001），组间无统计学显著差异。每组的缓解者比例也无显著差异。舍曲林的CGI-改善缓解率为69%，氟西汀为67%。次要疗效指标的结果遵循相同趋势，尽管从治疗第二周起，以HAM-A总分衡量，舍曲林在改善焦虑症状方面比氟西汀有数值上的优势（无统计学显著差异）。头痛和恶心是两种药物最常报告的事件。因治疗中出现的不良事件导致的早期患者停药发生率，舍曲林为14%，氟西汀为13%。两个治疗组中76%的患者起始剂量（舍曲林50毫克/天，氟西汀20毫克/天）即为最终剂量。