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氟西汀治疗早泄的有效性和安全性:一项系统评价方案

Effectiveness and safety of fluoxetine for premature ejaculation: Protocol for a systematic review.

作者信息

Li Xiao, Li Juntao, Li Xianrui, Wang Jisheng, Dai Hengheng, Wang Jingshang

机构信息

Department of Andrology, Dongzhimen Hospital, Beijing.

Department of Andrology, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou.

出版信息

Medicine (Baltimore). 2019 Feb;98(7):e14481. doi: 10.1097/MD.0000000000014481.

Abstract

BACKGROUND

Premature ejaculation (PE) is one of the most common male sexual dysfunctions, which can directly harm men's self-esteem and affect the stability of the relationship between husband and wife. To some extent, PE even affects the harmony and stability of society. So, men's health has gained more and more attention. As one of the long-acting selective serotonin reuptake inhibitors (SSRIs), fluoxetine has been proven to be effective in the treatment of PE by many trails. In this study, we aim to evaluate the effectiveness and safety of fluoxetine for PE to provide the newest evidence for clinical use.

METHODS AND ANALYSIS

Literature research will be divided into 2 parts: electronic search and manual search. We will search PubMed, EMBASE, The Cochrane Library, the China National Knowledge Infrastructure (CNKI), China Biology Medicine disc (CBMdisc), the China Science and Technology Journal database (VIP), and the Wanfang database online. We will select the eligible studies published up to December 31, 2018. Manual searches mainly retrieve dissertations, ongoing trails, internal reports, and so on. We use intravaginal ejaculatory latency time (IELT) as the primary outcome of PE and we also care about the following indexes: PE Diagnostic Tool (PEDT); Arabic index of PE (AIPE); Index of PE (IPE). In addition, we will carefully observe the patient's adverse reactions during the medication. Two reviewers will read the articles, extract the data information, and assess the risk of bias independently. Data analysis will be used the software such as RevMan V.5.3.5; EndNote X7 and Stata 13.0.

RESULTS

This study will provide a high-quality synthesis of current evidence of fluoxetine for PE from several aspects, including IELT, PEDT, AIPE, IPE, and adverse events.

CONCLUSION

This systematic review will provide evidence to assess the effectiveness and safety of fluoxetine in the treatment of PE.

TRIAL REGISTRATION NUMBER

PROSPERO CRD42018109722.

摘要

背景

早泄(PE)是最常见的男性性功能障碍之一,它会直接损害男性自尊,影响夫妻关系的稳定性。在某种程度上,早泄甚至会影响社会的和谐与稳定。因此,男性健康越来越受到关注。作为长效选择性5-羟色胺再摄取抑制剂(SSRIs)之一,氟西汀已被多项试验证明对早泄治疗有效。在本研究中,我们旨在评估氟西汀治疗早泄的有效性和安全性,为临床应用提供最新证据。

方法与分析

文献研究将分为两部分:电子检索和手工检索。我们将检索PubMed、EMBASE、考克兰图书馆、中国知网(CNKI)、中国生物医学文献数据库(CBMdisc)、中国科技期刊数据库(VIP)和万方数据库。我们将选取截至2018年12月31日发表的符合条件的研究。手工检索主要检索论文、进行中的试验、内部报告等。我们将阴道内射精潜伏期(IELT)作为早泄的主要结局指标,同时我们也关注以下指标:早泄诊断工具(PEDT);阿拉伯早泄指数(AIPE);早泄指数(IPE)。此外,我们将仔细观察患者用药期间的不良反应。两名评审员将阅读文章,提取数据信息,并独立评估偏倚风险。数据分析将使用RevMan V.5.3.5、EndNote X7和Stata 13.0等软件。

结果

本研究将从多个方面提供关于氟西汀治疗早泄的当前证据的高质量综合分析,包括IELT、PEDT、AIPE、IPE和不良事件。

结论

本系统评价将为评估氟西汀治疗早泄的有效性和安全性提供证据。

试验注册号

PROSPERO CRD42018109722。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d88e/6407935/e086075d6b16/medi-98-e14481-g001.jpg

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