Department of Psychiatry, Chonnam National University Medical School, Gwangju, Korea.
Psychology and Neuroscience, King's College London, Institute of Psychiatry, London, UK; South London and Maudsley NHS Foundation Trust, London, UK.
J Affect Disord. 2020 Sep 1;274:315-325. doi: 10.1016/j.jad.2020.05.002. Epub 2020 May 22.
To investigate the effects of stepwise pharmacotherapy based on early clinical decision-making on short- and long-term treatment outcomes in outpatients with depressive disorders in a naturalistic one-year prospective design.
Patients were recruited at a University hospital in South Korea from March 2012 to April 2017. At baseline, 1262 patients received antidepressant monotherapy. For patients with an insufficient response or uncomfortable side effects, next treatment steps (1, 2, 3, and 4 or over) with alternative strategies (switching, augmentation, combination, and mixtures of these approaches) were administered considering measurements and patient preference at every 3 weeks in the acute treatment phase (3, 6, 9, and 12 weeks) (N=1246), and at every 3 months in the continuation treatment phase (6, 9, and 12 months) (N=1015). Remission was defined as a Hamilton Depression Rating Scale score of ≤ 7.
Remission was more frequently achieved with increasing treatment steps and advanced treatment strategies over the treatment period, while the superior effect of treatment Step 4 or over no longer persisted in the continuation treatment phase. Augmentation + combination strategy was associated with the best outcome, with least benefit associated with a switching strategy compared to monotherapy continuation. Adverse events were more frequent with increasing treatment steps and advanced treatment strategies, while numbers of visits did not statistically differ by treatment steps or strategies.
The lack of a comparison group without early clinical decision due to the descriptive nature of study design limits to prove directly the study question.
A stepwise pharmacotherapy approach based on early clinical decision-making in the light of measurements and patient preference could enhance both short- and long-term treatment outcomes in depressive disorders.
本研究采用自然前瞻性一年设计，旨在探究基于早期临床决策的逐步药物治疗对门诊抑郁障碍患者短期和长期治疗结局的影响。
本研究于 2012 年 3 月至 2017 年 4 月在韩国一所大学附属医院招募患者。在基线时，1262 名患者接受了抗抑郁药单药治疗。对于反应不足或出现不良反应的患者，在急性治疗阶段（第 3、6、9 和 12 周）每隔 3 周（N=1246）和在延续治疗阶段（第 6、9 和 12 个月）每隔 3 个月（N=1015），根据测量结果和患者偏好，采用替代策略（换药、增效、联合治疗和上述方法的混合）进行下一治疗步骤（1、2、3 和 4 或以上）。缓解定义为汉密尔顿抑郁评定量表（Hamilton Depression Rating Scale，HDRS）评分≤7。
随着治疗步骤的增加和治疗策略的推进，在治疗期间缓解率更高，而在延续治疗阶段，治疗第 4 步或以上的效果不再持续。增效联合治疗策略的效果最佳，与继续单药治疗相比，换药治疗的获益最小。随着治疗步骤和治疗策略的增加，不良事件的发生率更高，但就诊次数的差异没有统计学意义。
由于研究设计的描述性性质，缺乏不进行早期临床决策的对照组，因此无法直接证明研究问题。
根据测量结果和患者偏好进行早期临床决策的逐步药物治疗方法可以提高抑郁障碍的短期和长期治疗结局。
