针对抑郁症的个体化（N-of-1）试验：系统评价。
Personalized (N-of-1) Trials for Depression: A Systematic Review.
机构信息
From the Center for Behavioral Cardiovascular Health, Columbia University Medical Center, New York, NY.
出版信息
J Clin Psychopharmacol. 2018 Jun;38(3):218-225. doi: 10.1097/JCP.0000000000000864.
PURPOSE/BACKGROUND: Personalized (N-of-1) trials are single-patient, crossover-design trials that may be useful for personalizing the selection of depression treatments. We conducted a systematic review of published N-of-1 trials for depression to determine the feasibility and suitability of this methodology for personalizing depression care.
METHODS/PROCEDURES: Electronic databases were searched from database inception through October 2016. Studies were selected if they enrolled depressed patients, included a within-subject crossover design, and systematically assessed depressive symptoms during the N-of-1 trial.
FINDINGS/RESULTS: Five eligible studies reporting on 47 depressed patients (range, 1-18 patients) were identified. Two studies were conducted among adults with treatment-resistant depression, 1 study among depressed inpatients, and 2 studies among patients from special populations (geriatric nursing home, human immunodeficiency virus-associated encephalopathy). All studies evaluated the effects of pharmacologic treatments (methylphenidate, D-amphetamine, ketamine, and sulpiride). Three studies compared an off-label treatment with placebo, 1 study compared 2 off-label treatments, and 1 study compared escalating doses of an off-label treatment with placebo. All 4 studies with more than 1 participant demonstrated heterogeneous treatment effects. All studies produced data that could personalize treatment selection for individual patients. No studies reported on recruitment challenges, compliance with self-tracking, or satisfaction with participation.
IMPLICATIONS/CONCLUSIONS: The feasibility of N-of-1 trials for depression was demonstrated for a limited number of second-line pharmacologic treatments in treatment-resistant patients or in patients with comorbidities that would have excluded them from conventional randomized controlled trials. Additional research is needed to determine whether N-of-1 trials are suitable for improving the selection of depression treatments in clinical practice.
目的/背景：个性化（N-of-1）试验是一种单病例、交叉设计的试验，对于个性化选择抑郁症治疗方法可能有用。我们对已发表的抑郁症 N-of-1 试验进行了系统评价，以确定这种方法在个性化抑郁症治疗中的可行性和适用性。
方法/程序：从数据库创建到 2016 年 10 月，对电子数据库进行了搜索。如果研究纳入了抑郁患者，包括了一个个体内交叉设计，并且在 N-of-1 试验期间系统地评估了抑郁症状，则将其纳入研究。
结果/发现：确定了 5 项符合条件的研究，共纳入 47 名抑郁患者（范围为 1-18 名患者）。其中 2 项研究是在治疗抵抗性抑郁症患者中进行的，1 项研究是在住院抑郁症患者中进行的，2 项研究是在特殊人群（老年护理院、人类免疫缺陷病毒相关性脑病）中进行的。所有研究均评估了药物治疗（哌醋甲酯、苯丙胺、氯胺酮和舒必利）的效果。其中 3 项研究比较了一种非标签治疗与安慰剂，1 项研究比较了 2 种非标签治疗，1 项研究比较了非标签治疗的递增剂量与安慰剂。所有 4 项有 1 个以上参与者的研究均显示出治疗效果的异质性。所有研究都提供了可以为个体患者个性化选择治疗方法的数据。没有研究报告招募挑战、自我跟踪的依从性或参与满意度。
结论
对于治疗抵抗性患者或因合并症而被排除在传统随机对照试验之外的患者，有限数量的二线药物治疗的抑郁症 N-of-1 试验是可行的。需要进一步研究来确定 N-of-1 试验是否适合改善临床实践中抑郁症治疗方法的选择。
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