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维持性血液透析患者抑郁症治疗的疗效比较:一项随机临床试验。

Comparative Efficacy of Therapies for Treatment of Depression for Patients Undergoing Maintenance Hemodialysis: A Randomized Clinical Trial.

机构信息

University of Washington, Seattle, Washington (R.M., T.R., P.H., A.D., N.G.).

State University of New York Downstate Medical Center, Brooklyn, New York (D.C., N.V.).

出版信息

Ann Intern Med. 2019 Mar 19;170(6):369-379. doi: 10.7326/M18-2229. Epub 2019 Feb 26.

DOI:10.7326/M18-2229
PMID:30802897
Abstract

BACKGROUND

Although depression is common among patients receiving maintenance hemodialysis, data on their acceptance of treatment and on the comparative efficacy of various therapies are limited.

OBJECTIVE

To determine the effect of an engagement interview on treatment acceptance (phase 1) and to compare the efficacy of cognitive behavioral therapy (CBT) versus sertraline (phase 2) for treating depression in patients receiving hemodialysis.

DESIGN

Multicenter, parallel-group, open-label, randomized controlled trial. (ClinicalTrials.gov: NCT02358343).

SETTING

41 dialysis facilities in 3 U.S. metropolitan areas.

PARTICIPANTS

Patients who had been receiving hemodialysis for at least 3 months and had a Beck Depression Inventory-II score of 15 or greater; 184 patients participated in phase 1, and 120 subsequently participated in phase 2.

INTERVENTION

Engagement interview versus control visit (phase 1) and 12 weeks of CBT delivered in the dialysis facility versus sertraline treatment (phase 2).

MEASUREMENTS

The primary outcome for phase 1 was the proportion of participants who started depression treatment within 28 days. For phase 2, the primary outcome was depressive symptoms measured by the Quick Inventory of Depressive Symptoms-Clinician-Rated (QIDS-C) at 12 weeks.

RESULTS

The proportion of participants who initiated treatment after the engagement or control visit did not differ (66% vs. 64%, respectively; P = 0.77; estimated risk difference, 2.1 [95% CI, -12.1 to 16.4]). Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, -1.84 [CI, -3.54 to -0.13]; P = 0.035). Adverse events were more frequent in the sertraline than the CBT group.

LIMITATION

No randomized comparison was made with no treatment, and persistence of treatment effect was not assessed.

CONCLUSION

An engagement interview with patients receiving maintenance hemodialysis had no effect on their acceptance of treatment for depression. After 12 weeks of treatment, depression scores were modestly better with sertraline treatment than with CBT.

PRIMARY FUNDING SOURCE

Patient-Centered Outcomes Research Institute, Dialysis Clinic, Kidney Research Institute, and National Institute of Diabetes and Digestive and Kidney Diseases.

摘要

背景

尽管维持性血液透析患者中普遍存在抑郁,但有关其对治疗的接受程度以及各种治疗方法的比较疗效的数据有限。

目的

确定参与式访谈对治疗接受度的影响(第 1 阶段),并比较认知行为疗法(CBT)与舍曲林(第 2 阶段)对血液透析患者抑郁的疗效。

设计

多中心、平行组、开放标签、随机对照试验。(ClinicalTrials.gov:NCT02358343)。

地点

美国 3 个大都市区的 41 个透析中心。

参与者

接受血液透析至少 3 个月且贝克抑郁量表 II 评分≥15 分的患者;184 名患者参加了第 1 阶段,随后有 120 名患者参加了第 2 阶段。

干预

参与式访谈与对照访视(第 1 阶段)和在透析中心进行的 12 周认知行为疗法与舍曲林治疗(第 2 阶段)。

测量

第 1 阶段的主要结局是在 28 天内开始治疗的参与者比例。第 2 阶段的主要结局是在 12 周时使用抑郁症状快速清单-临床评定(QIDS-C)测量的抑郁症状。

结果

在接受参与式访谈或对照访视后开始治疗的参与者比例没有差异(分别为 66%和 64%;P=0.77;估计风险差异,2.1 [95%CI,-12.1 至 16.4])。与 CBT 相比,舍曲林治疗在 12 周时 QIDS-C 抑郁评分较低(效应估计值,-1.84 [CI,-3.54 至 -0.13];P=0.035)。舍曲林组的不良事件发生率高于 CBT 组。

局限性

未与无治疗进行随机比较,未评估治疗效果的持久性。

结论

对接受维持性血液透析的患者进行参与式访谈对其接受抑郁治疗没有影响。治疗 12 周后,舍曲林治疗的抑郁评分较 CBT 略有改善。

主要资金来源

患者为中心的结果研究所、透析诊所、肾脏研究所和国家糖尿病、消化和肾脏疾病研究所。

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