一项关于米氮平治疗重度抑郁症及焦虑症状患者的八项随机、双盲、对照临床试验的荟萃分析。

A meta-analysis of eight randomized, double-blind, controlled clinical trials of mirtazapine for the treatment of patients with major depression and symptoms of anxiety.

作者信息

Fawcett J, Barkin R L

机构信息

Department of Psychiatry, Rush Medical College, Rush Presbyterian-St. Luke's Medical Center, Chicago, Ill 60612, USA.

出版信息

J Clin Psychiatry. 1998 Mar;59(3):123-7.

PMID:9541155

Abstract

BACKGROUND

Patients diagnosed with major depression and prominent symptoms of anxiety often have a poor prognosis for recovery. A meta-analysis was performed to assess the efficacy of mirtazapine in comparison with placebo and amitriptyline for the relief of anxiety/agitation or anxiety/somatization in patients with major depressive illness.

METHOD

A meta-analysis of eight randomized, double-blind, placebo-controlled clinical trials was conducted for 161 mirtazapine-treated and 132 placebo-treated patients with a DSM-III diagnosis of major depression, baseline Hamilton Rating Scale for Depression (HAM-D) scores > or = 18, and a baseline score > or = 6 for the sum of HAM-D items 9, 10, and 11 (anxiety/agitation). Four of the clinical trials included an amitriptyline control group (N = 92).

RESULTS

Mirtazapine-treated patients demonstrated a statistically significant (p < or = .05) reduction in the sum of HAM-D items 9, 10, and 11 (anxiety/agitation) compared with placebo-treated patients at Weeks 1, 2, 4, and 6 and at the endpoint. There was no statistically significant difference between the mirtazapine- and amitriptyline-treated patients at Weeks 1, 3, 4, 5, and 6 and at the endpoint. Similar results were found for the analysis of the mean of HAM-D items 10, 11, 12, 13, 15, 17 (anxiety/somatization or HAM-D Factor Score I) using all treated patients with a post-baseline evaluation in all 8 studies. Mirtazapine-treated patients demonstrated a statistically significant (p < or = .03) greater reduction at Weeks 1-6 compared with placebo, and improvement in the mirtazapine group was comparable to improvement in the amitriptyline group at Weeks 1-6.

CONCLUSION

In this meta-analysis of eight randomized, double-blind, controlled clinical trials, mirtazapine was found to be superior to placebo and comparable to amitriptyline for the treatment of patients with major depression with symptoms of anxiety/agitation or anxiety/somatization.

摘要

背景

被诊断为重度抑郁症且伴有明显焦虑症状的患者，康复预后往往较差。进行了一项荟萃分析，以评估米氮平与安慰剂及阿米替林相比，在缓解重度抑郁疾病患者的焦虑/激越或焦虑/躯体化症状方面的疗效。

方法

对八项随机、双盲、安慰剂对照临床试验进行荟萃分析，这些试验涉及161例接受米氮平治疗的患者和132例接受安慰剂治疗的患者，他们均符合《精神疾病诊断与统计手册》第三版（DSM - III）中重度抑郁症的诊断标准，汉密尔顿抑郁量表（HAM - D）基线评分≥18，且HAM - D第9、10和11项（焦虑/激越）的基线总分≥6。其中四项临床试验包括一个阿米替林对照组（N = 92）。

结果

在第1、2、4和6周以及研究终点时，与接受安慰剂治疗的患者相比，接受米氮平治疗的患者在HAM - D第9、10和11项（焦虑/激越）的总分上有统计学显著降低（p≤0.05）。在第1、3、4、5和6周以及研究终点时，接受米氮平治疗的患者与接受阿米替林治疗的患者之间无统计学显著差异。在对所有八项研究中接受治疗且有基线后评估的所有患者进行的HAM - D第10、11、12、13、15、17项（焦虑/躯体化或HAM - D因子得分I）均值分析中，也发现了类似结果。与安慰剂相比，接受米氮平治疗的患者在第1 - 6周有统计学显著更大程度的降低（p≤0.03），且米氮平组在第1 - 6周的改善情况与阿米替林组相当。