盐酸安非他酮缓释片与草酸艾司西酞普兰治疗中国抑郁症患者的疗效和安全性：一项随机、双盲、非劣效性试验的结果。

Efficacy and safety of bupropion hydrochloride extended-release versus escitalopram oxalate in Chinese patients with major depressive disorder: Results from a randomized, double-blind, non-inferiority trial.

机构信息

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.

Depression Treatment Center, Beijing Anding Hospital, Capital Medical University, Beijing, China.

出版信息

J Affect Disord. 2019 Oct 1;257:143-149. doi: 10.1016/j.jad.2019.07.023. Epub 2019 Jul 5.

DOI:10.1016/j.jad.2019.07.023

PMID:31301615

Abstract

BACKGROUND

This study evaluated the non-inferiority of bupropion extended-release (XL) compared to escitalopram for acute-phase treatment of Chinese patients with major depressive disorder (MDD).

METHODS

This randomized (1:1), double-blind, active-control study conducted between February 2015 and October 2016 included patients with MDD (DSM-IV) (N = 538). The treatment phase had three dose levels (level 1 [Week 1], level 2 [Week 2-4], and level 3 [Week 5-8]), which included either bupropion XL 150 mg, 300 mg, 300 mg or escitalopram 10 mg, 10 mg, 10-20 mg (once-daily), respectively. Primary outcome was mean change from baseline in Hamilton Depression Rating Scale-17 (HAMD-17) total score at Week 8.

RESULTS

Overall, 534 patients (bupropion XL, n = 266; escitalopram, n = 268) received at least one dose of study medication. The least square mean (standard error) change from baseline in HAMD-17 total score at Week 8 was -14.5 (0.41) in bupropion XL group and -15.4 (0.39) in escitalopram group (mean difference: 0.8 [-0.27, 1.94]). The response rate was 69.6% versus 72.9%, remission rate was 39.7% versus 47.2%, sustained response rate was 51.6% versus 56.3%, and sustained remission rate was 25.5% versus 28.6%, respectively, for bupropion XL versus escitalopram group. Adverse events were reported by 313 patients (bupropion XL, n = 157; escitalopram, n = 156); the most common on-treatment adverse event in both groups was nausea (10.5% versus 18.7%, respectively).

LIMITATIONS

A non-inferiority short-term (8 weeks) study without a placebo arm.

CONCLUSION

Results from this study demonstrated that the efficacy of bupropion XL was non-inferior to that of escitalopram in Chinese patients with MDD.

摘要

背景

本研究评估了安非他酮缓释片（XL）与艾司西酞普兰相比在治疗中国重度抑郁症（MDD）患者急性期的非劣效性。

方法

这是一项于 2015 年 2 月至 2016 年 10 月期间进行的随机（1:1）、双盲、阳性药物对照研究，纳入了 MDD（DSM-IV）患者（N=538）。治疗阶段有三个剂量水平（第 1 级[第 1 周]、第 2 级[第 2-4 周]和第 3 级[第 5-8 周]），分别包括安非他酮 XL 150mg、300mg、300mg 或艾司西酞普兰 10mg、10mg、10-20mg（每日一次）。主要结局是第 8 周时汉密尔顿抑郁量表-17（HAMD-17）总分的基线变化均值。

结果

共有 534 例患者（安非他酮 XL 组，n=266；艾司西酞普兰组，n=268）接受了至少一剂研究药物。安非他酮 XL 组第 8 周时 HAMD-17 总分的最小二乘均值（标准误）从基线的变化为-14.5（0.41），艾司西酞普兰组为-15.4（0.39）（差值：0.8[-0.27，1.94]）。安非他酮 XL 组和艾司西酞普兰组的反应率分别为 69.6%和 72.9%，缓解率分别为 39.7%和 47.2%，持续反应率分别为 51.6%和 56.3%，持续缓解率分别为 25.5%和 28.6%。安非他酮 XL 组和艾司西酞普兰组分别有 313 例（安非他酮 XL 组，n=157；艾司西酞普兰组，n=156）患者报告了不良事件；两组中最常见的治疗期间不良事件为恶心（分别为 10.5%和 18.7%）。