Champalimaud Research and Clinical Centre, Champalimaud Foundation, Lisbon, Portugal.
Faculdade de Ciências Médicas, NOVA Medical School, NMS, FCM, Universidade NOVA de Lisboa, Lisbon, Portugal.
Adv Ther. 2024 Jan;41(1):34-64. doi: 10.1007/s12325-023-02700-0. Epub 2023 Oct 26.
Real-world evidence in treatment-resistant depression (TRD; commonly defined as non-response to ≥ 2 consecutive treatments at adequate dosage and duration) is lacking. A systematic literature review was conducted to understand disease burden and treatment outcomes for patients with TRD, studied in a real-world setting over the last decade.
A literature search was conducted in May 2022 in MEDLINE, Embase, The Cochrane Libraries and PsycINFO, comprising studies published from 2012 to 2022. Bibliographies of all relevant identified systematic reviews and relevant conference proceedings from 2020 to 2022 were manually hand-searched.
Real-world studies, including cohort, cross-sectional, case-control, chart review and registry studies, published in English and reporting outcomes in adults with TRD, were included.
Extracted data included study and baseline disease characteristics, treatment type, treatment response, clinical outcomes and health-related quality of life.
Twenty studies were included. Criteria for TRD varied, but patients typically experienced long-lasting depression (range 1.4 to 16.5 years). Across studies, mean disease severity scores demonstrated moderate to severe depression, reflecting a high burden of disease at baseline. Remission rates were typically low but generally increased with longer follow-up durations. However, the heterogeneity of interventions, follow-up durations (range 2 weeks to 9.4 years) and assessment tools precluded their quantitative synthesis. Studies were frequently limited by low sample size (range 14 to 411 patients) and health-related quality of life was infrequently assessed.
There is a lack of clinical consensus regarding the definition, assessment and monitoring of TRD in real-world practice. Nevertheless, TRD carries a high burden of illness and there is an unmet need for faster and more effective treatments. To better understand the personal burden of affected patients, future studies would benefit from standardisation of severity assessment and measures of treatment effectiveness, as well as greater consideration of health-related quality of life.
治疗抵抗性抑郁症（TRD；通常定义为在足够剂量和持续时间内对≥2 种连续治疗无反应）的真实世界证据不足。进行了系统文献综述，以了解过去十年中在真实环境中研究的 TRD 患者的疾病负担和治疗结果。
2022 年 5 月在 MEDLINE、Embase、Cochrane 图书馆和 PsycINFO 中进行了文献检索，包括 2012 年至 2022 年发表的研究。手动检索了所有相关系统评价的参考文献和 2020 年至 2022 年的相关会议论文集。
包括队列、横断面、病例对照、图表审查和登记研究在内的真实世界研究，以英文发表并报告 TRD 成人的结局，均被纳入。
提取的数据包括研究和基线疾病特征、治疗类型、治疗反应、临床结局和健康相关生活质量。
共纳入 20 项研究。TRD 的标准各不相同，但患者通常经历持续时间较长的抑郁症（1.4 至 16.5 年）。在各项研究中，平均疾病严重程度评分表明中重度抑郁，反映出基线时疾病负担较高。缓解率通常较低，但随着随访时间的延长而普遍增加。然而，干预措施的异质性、随访时间（2 周至 9.4 年）和评估工具使得它们无法进行定量综合。研究经常受到样本量小的限制（14 至 411 例患者），并且很少评估健康相关生活质量。
在真实实践中，TRD 的定义、评估和监测缺乏临床共识。然而，TRD 带来了很高的疾病负担，需要更快、更有效的治疗方法。为了更好地了解受影响患者的个人负担，未来的研究将受益于严重程度评估和治疗效果措施的标准化，以及对健康相关生活质量的更大考虑。
