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舍曲林治疗卒中后抑郁的疗效:一项随机对照试验的系统评价方案

Efficacy of sertraline for post-stroke depression: A systematic review protocol of randomized controlled trial.

作者信息

Bai Zheng-Fa, Wang Liu-Yi

机构信息

Department of Orthopedics, The Fourth People's Hospital of Shaanxi, Xi'an.

Second Ward of Neurology Department, Cardiovascular and Cerebrovascular Specialist Section of Yan'an University Affiliated Hospital, Yan'an, China.

出版信息

Medicine (Baltimore). 2019 Apr;98(16):e15299. doi: 10.1097/MD.0000000000015299.

Abstract

BACKGROUND

Depression is a prevalent disorder for patients with stroke. Clinical researches indicate that sertraline is utilized to treat post-stroke depression (PSD) effectively. However, no systematic review has investigated this issue yet presently. Thus, this study aims to systematically assess the efficacy and safety of sertraline for patients with PSD.

METHODS

Literature sources will be divided into 2 sections: electronic sources and manual sources. We will search electronic literature sources as follows: EMBASE, MEDICINE, Web of Science, Cochrane Library, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure from their inceptions to the February 28, 2019. Manual sources include dissertations, ongoing trials, and conference abstracts. Two reviewers will select the literatures, extract and collect data information, and evaluate the risk of bias independently. Statistical analysis will be carried out by using RevMan 5.3 software.

RESULTS

Primary outcome is depression. It can be measured by Hamilton depression scale, Beck Depression Inventory, or any other scales. Secondary outcome are anxiety (as assessed by Hamilton anxiety scale, or other tools) response rate, activities of daily living (as measured by Barthel Index, or other scales), quality of life (as measured by 36-Item Short Form Health Survey), and safety.

CONCLUSIONS

The results of this systematic review may summarize the up-to-date evidence on the efficacy and safety of sertraline for patients with PSD.

ETHICS AND DISSEMINATION

This systematic review will not need any ethical approval, because it will not analyze any individual patient data. The findings of this study are expected to disseminate at peer-reviewed journals.

摘要

背景

抑郁症是中风患者中一种常见的疾病。临床研究表明,舍曲林可有效治疗中风后抑郁症(PSD)。然而,目前尚无系统评价对此问题进行研究。因此,本研究旨在系统评价舍曲林治疗PSD患者的疗效和安全性。

方法

文献来源将分为两部分:电子来源和手工来源。我们将按以下方式检索电子文献来源:EMBASE、MEDICINE、科学网、考克兰图书馆、补充与替代医学数据库、中国生物医学文献数据库和中国知网,检索时间从建库至2019年2月28日。手工来源包括学位论文、正在进行的试验和会议摘要。两名评价员将独立选择文献、提取和收集数据信息,并评估偏倚风险。将使用RevMan 5.3软件进行统计分析。

结果

主要结局为抑郁。可通过汉密尔顿抑郁量表、贝克抑郁量表或任何其他量表进行测量。次要结局为焦虑(通过汉密尔顿焦虑量表或其他工具评估)、缓解率、日常生活活动能力(通过巴氏指数或其他量表测量)、生活质量(通过简明健康状况调查量表测量)和安全性。

结论

本系统评价的结果可能总结了舍曲林治疗PSD患者疗效和安全性的最新证据。

伦理与传播

本系统评价无需任何伦理批准,因为它不会分析任何个体患者数据。本研究结果有望在同行评审期刊上发表。

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