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来自欧洲治疗抵抗性抑郁症患者队列研究的真实世界证据:治疗模式和临床结局。

Real-world evidence from a European cohort study of patients with treatment resistant depression: Treatment patterns and clinical outcomes.

机构信息

Janssen EMEA, Neuss, Germany.

University of Pisa, Department of Clinical and Experimental Medicine, Pisa, Italy.

出版信息

J Affect Disord. 2021 Jul 1;290:334-344. doi: 10.1016/j.jad.2021.03.073. Epub 2021 Apr 1.

DOI:10.1016/j.jad.2021.03.073
PMID:34044256
Abstract

BACKGROUND

Treatment resistant depression (TRD) characterizes a subgroup of 10-30% of patients with major depressive disorder, and is associated with considerable morbidity and mortality. A consensus treatment for TRD does not exist, which often leads to wide variations in treatment strategies. Real-world studies on treatment patterns and outcomes in TRD patients in Europe are lacking and could help elucidate current treatment strategies and their efficacy.

METHODS

This non-interventional cohort study of patients with TRD (defined as treatment failure on ≥2 oral antidepressants given at adequate dose and duration) with moderate to severe depression collected real-world data on treatment patterns and outcomes in several European countries. Patients were started on a new treatment for depression according to routine clinical practice.

RESULTS

Among 411 patients enrolled, after 6 months, only 16.7% achieved remission and 73.5% showed no response. At Month 12, while 19.2% achieved remission and 69.2% showed no response, 33.3% of those in remission at Month 6 were no longer in remission. Pharmacological treatments employed were heterogenous; 54 different drugs were recorded at baseline, and the top 5 treatment types according to drug classes accounted for 40.0% of patients. Even though remission rates were very low, at Month 12, 60.0% of patients had not changed treatment since enrolment.

CONCLUSIONS

The heterogeneity of treatments highlights a lack of consensus. Moreover, despite low response rates, patients often remained on treatments for substantial periods of time. These data further support existence of an unmet treatment need for TRD patients in Europe.

摘要

背景

治疗抵抗性抑郁症(TRD)是 10-30%的重度抑郁症患者的亚组特征,与相当大的发病率和死亡率有关。TRD 没有共识的治疗方法,这通常导致治疗策略的广泛差异。欧洲 TRD 患者的治疗模式和结果的真实世界研究缺乏,这可能有助于阐明当前的治疗策略及其疗效。

方法

这项非干预性队列研究纳入了 TRD 患者(定义为在足够剂量和持续时间内使用≥2 种口服抗抑郁药治疗失败),这些患者有中度至重度抑郁症,收集了几个欧洲国家的治疗模式和结果的真实世界数据。根据常规临床实践,患者开始接受新的抗抑郁治疗。

结果

在 411 名入组患者中,6 个月后,仅有 16.7%达到缓解,73.5%无反应。12 个月时,虽然 19.2%达到缓解,69.2%无反应,但 6 个月时缓解的患者中有 33.3%不再缓解。使用的药物治疗方法存在异质性;基线时记录了 54 种不同的药物,根据药物类别,前 5 种治疗类型占 40.0%的患者。尽管缓解率非常低,但在 12 个月时,60.0%的患者自入组以来没有改变治疗方案。

结论

治疗的异质性突出了缺乏共识。此外,尽管反应率低,但患者经常长时间使用治疗方法。这些数据进一步支持欧洲 TRD 患者存在未满足的治疗需求。

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