跨性别者接受激素治疗的临床和生化结局：系统评价方案。

Clinical and Biochemical Outcomes in Transgender Individuals Undergoing Hormone Therapy: Protocol for a Systematic Review.

机构信息

Department of Public Health, Norton College of Medicine, SUNY Upstate Medical University, Syracuse, NY, United States.

Section of Adolescent Medicine, SUNY Upstate Medical University, Syracuse, NY, United States.

出版信息

JMIR Res Protoc. 2024 Nov 12;13:e57931. doi: 10.2196/57931.

DOI:10.2196/57931

PMID:39531266

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11599881/

Abstract

BACKGROUND

Monitoring of various clinical outcomes and parameters, such as lipid levels, is recommended in transgender individuals undergoing hormone therapies. However, comprehensive data to inform these recommendations is scarce.

OBJECTIVE

This study aims to conduct a systematic review and meta-analysis to synthesize evidence from existing literature on the effect of exogenous hormone therapy on clinical and biochemical outcomes for transgender adolescents and adults.

METHODS

We will search multiple electronic databases and will include prospective and retrospective observational studies with and without a control group. The study population will include transgender individuals undergoing hormone therapy with testosterone or estrogen. Comparisons will include age-matched, cisgender individuals and changes from baseline. Primary outcomes include changes in or the development of abnormal lipid parameters. Secondary outcomes include BMI, weight, height, and blood pressure for age, serum testosterone or estrogen levels, and development of disease including hypertension, diabetes, fatty liver disease, obesity, adverse cardiac events, as well as all-cause mortality. The meta-analysis will pool the studies where applicable, and meta-regressions will be conducted to evaluate effect modifiers. The GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach will be used to evaluate the overall certainty of evidence.

RESULTS

We will summarize the selection of the eligible studies using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flowchart. The results will be presented in a table summarizing the evidence. Data collection is ongoing, and the paper is expected to be published in Spring 2025.

CONCLUSIONS

This systematic review will summarize and evaluate the evidence of the clinical and biochemical outcomes associated with hormone therapies for transgender individuals.

TRIAL REGISTRATION

PROSPERO CRD42024483138; https://tinyurl.com/yc4sfvnb.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/57931.

摘要

背景

接受激素治疗的跨性别个体需要监测各种临床结局和参数，如血脂水平。然而，目前缺乏全面的数据来支持这些建议。

目的

本研究旨在进行系统回顾和荟萃分析，综合现有文献中关于外源性激素治疗对跨性别青少年和成人的临床和生化结局影响的证据。

方法

我们将检索多个电子数据库，并纳入有和无对照组的前瞻性和回顾性观察性研究。研究人群将包括接受雄激素或雌激素治疗的跨性别个体。比较包括年龄匹配的顺性别个体和从基线的变化。主要结局包括异常血脂参数的变化或发展。次要结局包括 BMI、体重、身高和年龄相关的血压、血清睾酮或雌激素水平以及高血压、糖尿病、脂肪肝疾病、肥胖、不良心脏事件以及全因死亡率等疾病的发生。如果适用，将对研究进行荟萃分析，并进行荟萃回归以评估效应修饰剂。将使用 GRADE（推荐评估、制定与评价）方法评估证据的总体确定性。