睾酮治疗对男性心血管事件的影响：系统文献综述与荟萃分析方案

Effect of Testosterone Treatment on Cardiovascular Events in Men: Protocol for a Systematic Literature Review and Meta-Analysis.

作者信息

Chih HuiJun, Reid Christopher M, Yeap Bu B, Dwivedi Girish

机构信息

School of Public Health, Curtin University, Perth, Australia.

School of Public Health & Preventative Medicine, Monash University, Melbourne, Australia.

出版信息

JMIR Res Protoc. 2020 Oct 29;9(10):e15163. doi: 10.2196/15163.

DOI:10.2196/15163

PMID:33118952

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7661242/

Abstract

BACKGROUND

Testosterone prescriptions have increased dramatically in recent decades, with increasing usage in men. Despite epidemiological associations reported high circulating concentrations of endogenous androgens and low risk of cardiovascular events and mortality, the effects of exogenous androgens in the form of testosterone therapy for maintaining physiological circulating androgen concentrations on the cardiovascular system remain uncertain with no published meta-analysis on this topic.

OBJECTIVE

The aim of this study was to investigate the effects of prescribed testosterone treatment, in all forms and durations, from well-developed randomized controlled trials, on cardiovascular events in men aged 18 years or older.

METHODS

Peer-reviewed journal articles published from 1980 to 2019 will be searched from databases (ie CINAHL [Cumulated Index to Nursing and Allied Health Literature], Embase, Medline, Scopus, Cochrane Controlled Register of Trials as well as the Clinical Trial Registry). Randomized controlled trials or cluster randomized controlled trials with at least one intervention arm of testosterone and a control group of usual care or no testosterone treatment will be included in this review and meta-analysis. Studies on men with previous cardiovascular events or cardiac vascularization (coronary bypass surgery or percutaneous coronary intervention) will be excluded. Data related to primary outcomes such as clinical events of any type of stroke or transient ischemic attack, nonfatal myocardial infarction or acute coronary syndrome, emergency coronary artery revascularization, carotid surgery, cardiac mortality, and all-cause mortality will be extracted for analysis. The criteria for PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) will be followed in the evaluation of evidence.

RESULTS

Search terms have been piloted and finalized. This study will be completed by the end of 2020.

CONCLUSIONS

This protocol will guide a systematic literature review of the evidence around prescribed testosterone and its effect on cardiovascular events in men aged 18 years or older. The findings will inform clinical management of hypogonadal men.

TRIAL REGISTRATION

PROSPERO International Prospective Register of Systematic Reviews CRD42019134278; https://tinyurl.com/y6t7ggge.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15163.

摘要

背景

近几十年来，睾酮处方量急剧增加，男性使用量也在上升。尽管流行病学研究表明内源性雄激素循环浓度高与心血管事件及死亡率风险低相关，但睾酮治疗这种外源性雄激素形式在维持生理循环雄激素浓度方面对心血管系统的影响仍不明确，且尚无关于该主题的已发表荟萃分析。

目的

本研究旨在调查来自完善的随机对照试验的各种形式和疗程的处方睾酮治疗对18岁及以上男性心血管事件的影响。

方法

将从数据库（即护理及相关健康文献累积索引数据库[CINAHL]、Embase、Medline、Scopus、Cochrane对照试验注册库以及临床试验注册库）中检索1980年至2019年发表的经同行评审的期刊文章。本综述和荟萃分析将纳入至少有一个睾酮干预组以及常规护理或无睾酮治疗对照组的随机对照试验或整群随机对照试验。既往有心血管事件或心脏血管化（冠状动脉搭桥手术或经皮冠状动脉介入治疗）的男性的研究将被排除。将提取与主要结局相关的数据进行分析，这些主要结局包括任何类型的中风或短暂性脑缺血发作、非致命性心肌梗死或急性冠状动脉综合征、急诊冠状动脉血运重建、颈动脉手术、心脏死亡率和全因死亡率等临床事件。在证据评估中将遵循系统评价和荟萃分析的首选报告项目（PRISMA）标准。