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筛查甲基苯丙胺滥用者的肺动脉高压(SOPHMA):一项多中心、横断面研究的原理和设计。

Screening Of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA): rationale and design of a multicentre, cross-sectional study.

机构信息

Department of Medicine, The University of Hong Kong, Hong Kong.

Institute of Mental Health, Castle Peak Hospital, Hong Kong.

出版信息

BMJ Open. 2019 Aug 1;9(8):e027193. doi: 10.1136/bmjopen-2018-027193.

DOI:10.1136/bmjopen-2018-027193
PMID:31375608
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6688696/
Abstract

INTRODUCTION

Methamphetamine misuse is classified as a 'likely' risk factor for pulmonary arterial hypertension (PAH). Nevertheless, the actual prevalence of and a screening strategy for PAH in methamphetamine users have not been established. We plan to study the prevalence of PAH and identify its independent risk factors among methamphetamine users.

METHODS AND ANALYSIS

The Screening Of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA) study will be a multicentre, cross-sectional screening study that will involve substance abuse clinics, hospitals and rehabilitation facilities in Hong Kong that cater to more than 20 methamphetamine users. A total of 400 patients who (1) are ≥18 years at enrolment; (2) report methamphetamine use in the last 2 years; (3) are diagnosed with methamphetamine use disorder; and (4) voluntarily agree to participate by providing written informed consent will be included. Patients will undergo standard echocardiography-based PAH screening procedures recommended for those with systemic sclerosis. Right heart catheterisation will be offered to participants with intermediate or high echocardiographic probability of PAH. For participants with a low echocardiographic probability of PAH, rescreening will be performed within 1 year. The primary measure will be the prevalence of PAH in methamphetamine users. The secondary measures will be the risk factors and a prediction model for PAH in methamphetamine users.

ETHICS AND DISSEMINATION

The SOPHMA study has been approved by the institutional review board. The findings of this study will provide the necessary evidence to establish universal guidelines for screening of PAH in methamphetamine users. Our results will be disseminated through immediate feedback to study participants, press release to the general public, as well as presentation in medical conferences and publications in peer-reviewed journals to healthcare providers and academia worldwide.

摘要

简介

甲基苯丙胺滥用被归类为肺动脉高压(PAH)的“可能”危险因素。然而,PAH 在甲基苯丙胺使用者中的实际患病率以及筛查策略尚未确定。我们计划研究 PAH 在甲基苯丙胺使用者中的患病率,并确定其独立危险因素。

方法和分析

筛查甲基苯丙胺滥用者中的肺动脉高压(SOPHMA)研究将是一项多中心、横断面筛查研究,涉及香港的药物滥用诊所、医院和康复设施,这些机构为 20 多名甲基苯丙胺使用者提供服务。共纳入 400 名符合以下条件的患者:(1)入组时年龄≥18 岁;(2)报告在过去 2 年内使用过甲基苯丙胺;(3)诊断为甲基苯丙胺使用障碍;(4)自愿同意参与并提供书面知情同意书。患者将接受基于超声心动图的 PAH 筛查程序,该程序适用于系统性硬化症患者。对于超声心动图中 PAH 中等或高度可能性的参与者,将进行右心导管检查。对于超声心动图中 PAH 低度可能性的参与者,将在 1 年内进行重新筛查。主要测量指标为甲基苯丙胺使用者中 PAH 的患病率。次要测量指标为甲基苯丙胺使用者中 PAH 的危险因素和预测模型。

伦理与传播

SOPHMA 研究已获得机构审查委员会的批准。本研究的结果将为建立甲基苯丙胺使用者 PAH 筛查的通用指南提供必要的证据。我们的研究结果将通过及时反馈给研究参与者、向公众发布新闻稿,以及在医学会议上展示和在同行评议期刊上发表,向全球医疗保健提供者和学术界传播。

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