辅助使用布瑞哌唑对重度抑郁症患者平静度和生活参与度的影响：来自临床试验结束访谈中患者报告结局的事后分析
Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews.
作者信息
Weiss Catherine, Meehan Stine R, Brown T Michelle, Gupta Catherine, Mørup Michael F, Thase Michael E, McIntyre Roger S, Ismail Zahinoor
机构信息
Otsuka Pharmaceutical Development & Commercialization Inc., 508 Carnegie Center Drive, 1 University Square Drive, Princeton, NJ, 08540, USA.
H. Lundbeck A/S, Valby, Copenhagen, Denmark.
出版信息
J Patient Rep Outcomes. 2021 Dec 11;5(1):128. doi: 10.1186/s41687-021-00380-4.
BACKGROUND
Though often overlooked, calming patients and increasing their life engagement are key factors in the treatment of major depressive disorder (MDD). This study aimed to test the hypothesis that adjunctive brexpiprazole increases calmness and life engagement among patients with MDD, based on clinical trial exit interviews.
METHODS
This was a pooled analysis of exit interview data from three exploratory, open-label studies of adjunctive brexpiprazole 1-3 mg/day. The studies enrolled 105 outpatients with MDD (DSM-IV-TR criteria), a current depressive episode, and inadequate response to antidepressant treatment during the current episode. Patients were interviewed if they completed the end-of-treatment visit (Week 6 or Week 12, depending on the study). Exit interviews took the form of semi-structured telephone interviews in which patients were asked mostly qualitative questions about their symptoms prior to the start of the study, and about improvements they had noted during treatment. Interview transcripts were reviewed and codes were assigned to calmness and life engagement vocabulary, allowing aggregation of the frequency of improvement in various domains.
RESULTS
79.8% (83/104) of patients described improvements consistent with at least one calmness term, most commonly feeling less anxious (46.2%) or less irritable (44.2%). A four-domain concept of patient life engagement was developed in which 88.6% (93/105) of patients described improvements consistent with at least one domain, specifically, emotional (77.1%), physical (75.2%), social (41.9%), and/or cognitive (36.2%). Of the patients who described improvement in calmness, 96.4% (80/83) also described improvement in life engagement.
CONCLUSIONS
Analysis of exit interview data suggests that patients were calmer and more engaged with life following treatment with adjunctive brexpiprazole. Thus, adjunctive brexpiprazole may provide a benefit on subjective patient outcomes in addition to the improvement in depressive symptoms shown by clinical rating scale data.
TRIAL REGISTRATION
Data used in this post hoc analysis came from ClinicalTrials.gov identifiers: NCT02012218, NCT02013531, NCT02013609.
背景
尽管常常被忽视，但安抚患者并提高他们对生活的参与度是重度抑郁症（MDD）治疗的关键因素。本研究旨在基于临床试验结束访谈，验证辅助使用布瑞哌唑可提高MDD患者的平静程度和生活参与度这一假设。
方法
这是一项对三项探索性、开放标签研究的结束访谈数据进行的汇总分析，这些研究使用的布瑞哌唑剂量为每日1 - 3毫克。研究招募了105名符合MDD（DSM-IV-TR标准）、目前处于抑郁发作期且在当前发作期对抗抑郁治疗反应不佳的门诊患者。如果患者完成了治疗结束访视（第6周或第12周，取决于研究），则对其进行访谈。结束访谈采用半结构化电话访谈形式，向患者询问的大多是关于研究开始前症状以及治疗期间所注意到的改善情况的定性问题。对访谈记录进行审查，并对平静程度和生活参与度相关词汇进行编码，以便汇总各个领域改善情况的频率。
结果
79.8%（83/104）的患者描述了与至少一个平静程度相关术语相符的改善情况，最常见的是焦虑减轻（46.2%）或易怒减轻（44.2%）。构建了一个患者生活参与度的四领域概念，其中88.6%（93/105）的患者描述了与至少一个领域相符的改善情况，具体为情绪（77.1%）、身体（75.2%）、社交（41.9%）和/或认知（36.2%）。在描述平静程度有改善的患者中，96.4%（被忽视，但安抚患者并提高他们对生活的参与度是重度抑郁症（MDD）治疗的关键因素。本研究旨在基于临床试验结束访谈，验证辅助使用布瑞哌唑可提高MDD患者的平静程度和生活参与度这一假设。
方法
这是一项对三项探索性、开放标签研究的结束访谈数据进行的汇总分析，这些研究使用的布瑞哌唑剂量为每日1 - 3毫克。研究招募了105名符合MDD（DSM-IV-TR标准）、目前处于抑郁发作期且在当前发作期对抗抑郁治疗反应不佳门诊患者。如果患者完成了治疗结束访视（第6周或第12周，取决于研究），则对其进行访谈。结束访谈采用半结构化电话访谈形式，向患者询问的大多是关于研究开始前症状以及治疗期间所注意到的改善情况的定性问题。对访谈记录进行审查，并对平静程度和生活参与度相关词汇进行编码，以便汇总各个领域改善情况的频率。
结果
79.8%（83/104）的患者描述了与至少一个平静程度相关术语相符的改善情况，最常见的是焦虑减轻（46.2%）或易怒减轻（44.2%）。构建了一个患者生活参与度的四领域概念，其中88.6%（93/105）的患者描述了与至少一个领域相符的改善情况，具体为情绪（77.1%）、身体（75.2%）、社交（41.9%）和/或认知（36.2%）。在描述平静程度有改善的患者中，96.4%（80/83）也描述了生活参与度的改善。
结论
对结束访谈数据的分析表明，辅助使用布瑞哌唑治疗后患者更加平静，对生活的参与度更高。因此，辅助使用布瑞哌唑除了能改善临床评定量表数据所显示的抑郁症状外，还可能对患者的主观治疗结果有益。
试验注册
本事后分析中使用的数据来自ClinicalTrials.gov标识符：NCT02012218、NCT02013531、NCT02013609。 80/83）也描述了生活参与度的改善。
结论
对结束访谈数据的分析表明，辅助使用布瑞哌唑治疗后患者更加平静，对生活的参与度更高。因此，辅助使用布瑞哌唑除了能改善临床评定量表数据所显示的抑郁症状外，还可能对患者的主观治疗结果有益。
试验注册
本事后分析中使用的数据来自ClinicalTrials.gov标识符：NCT02012218、NCT02013531、NCT02013609。
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