西酞普兰与西酞普兰治疗抑郁症的疗效和安全性：一项为期 6 周、多中心、随机、双盲、剂量灵活的研究。

Efficacy and safety of escitalopram versus citalopram in major depressive disorder: a 6-week, multicenter, randomized, double-blind, flexible-dose study.

机构信息

Mental Health Institute of The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.

出版信息

Psychopharmacology (Berl). 2011 Feb;213(2-3):639-46. doi: 10.1007/s00213-010-1822-y. Epub 2010 Mar 26.

DOI:10.1007/s00213-010-1822-y

PMID:20340011

Abstract

RATIONALE

S-citalopram (escitalopram) is the very active moiety of citalopram. It has been shown in many studies to be an effective and safe antidepressant for treating major depressive disorder (MDD).

OBJECTIVE

The aim of our study was to compare the efficacy and safety of escitalopram vs citalopram in Chinese MDD patients.

METHODS

In the double-blind study, 240 MDD patients were randomly assigned to treatment for 6 weeks either with escitalopram (10-20 mg/d) or citalopram (20-40 mg/d). The primary efficacy measurement was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline to the end of study. The secondary efficacy measurements were response and remission rates. The adverse events (AEs) were recorded by the investigator.

RESULTS

Two hundred and three (85%) patients completed the trial. The average dose was 13.9 mg/d in the escitalopram group and 27.6 mg/d in the citalopram group. No significant differences were found between the two groups in the change in HAMD-17 total score, response, and remission rate. These results were similar in severe MDD patients. No significant differences were found between the two groups in AEs. No serious AEs were observed in this study.

CONCLUSIONS

The study suggests that escitalopram 10-20 mg/d are as effective and safe as citalopram 20-40 mg/d in the short-term treatment for Chinese MDD patients.

摘要

背景

S-西酞普兰（艾司西酞普兰）是西酞普兰的活性部分。多项研究表明，它是治疗重度抑郁症（MDD）的一种有效且安全的抗抑郁药。

目的

本研究旨在比较艾司西酞普兰与西酞普兰在中国 MDD 患者中的疗效和安全性。

方法

在这项双盲研究中，240 例 MDD 患者被随机分配接受 6 周的治疗，分别接受艾司西酞普兰（10-20 mg/d）或西酞普兰（20-40 mg/d）治疗。主要疗效测量指标是从基线到研究结束时 17 项汉密尔顿抑郁评定量表（HAMD-17）总分的变化。次要疗效测量指标为反应率和缓解率。由研究者记录不良事件（AE）。