研究方案：一项关于 HIV 患者痛苦、免疫功能和持续性疼痛的观察性研究。

Study protocol: an observational study of distress, immune function and persistent pain in HIV.

机构信息

Pain Research Team, Department of Anaesthesia and Perioperative Medicine, Neuroscience Institute, University of Cape Town, Cape Town, South Africa

HIV Mental Health Research Unit, Department of Psychiatry and Mental Health, Neuroscience Institute, University of Cape Town, Cape Town, South Africa.

出版信息

BMJ Open. 2022 Jun 3;12(6):e059723. doi: 10.1136/bmjopen-2021-059723.

DOI:10.1136/bmjopen-2021-059723

PMID:36691234

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9171212/

Abstract

INTRODUCTION

Many people with HIV report both distress and pain. The relationship between distress and pain is bidirectional, but the mechanisms by which distress exacerbates pain are unclear. The inflammatory response to challenge (inflammatory reactivity, IR) may be a partial mediator, given that neuroimmune interactions provide a substrate for IR to also influence neurological reactivity and, thus, pain-related neural signalling. This prospective, observational, case-control study will characterise the relationships between distress, IR, pain-related signalling as captured by induced secondary hyperalgesia (SH), and pain, in people with HIV who report persistent pain (PP) (cases) or no pain (controls).

METHODS AND ANALYSIS

One hundred people with suppressed HIV, reporting either PP or no pain, will be assessed two or four times over 6 months. The primary outcomes are distress (Hopkins 25-item symptom checklist), IR (multiplex assay after LPS challenge), and PP (Brief Pain Inventory), assessed at the baseline timepoint, although each will also be assessed at follow-up time points. Induced SH will be assessed in a subsample of 60 participants (baseline timepoint only). To test the hypothesis that IR partly mediates the relationship between distress and pain, mediation analysis will use the baseline data from the PP group to estimate direct and indirect contributions of distress and IR to pain. To test the hypothesis that IR is positively associated with SH, data from the subsample will be analysed with generalised mixed effects models to estimate the association between IR and group membership, with SH as the dependent variable.

ETHICS AND DISSEMINATION

Information obtained from this study will be published in peer-reviewed journals and presented at scientific meetings. The study has been approved by the Human Research Ethics Committee of the University of Cape Town (approval number: 764/2019) and the City of Cape Town (ref: 24699).

TRIAL REGISTRATION NUMBER

NCT04757987.

摘要

简介

许多感染 HIV 的人既感到痛苦又感到苦恼。痛苦和疼痛之间存在双向关系，但痛苦加剧疼痛的机制尚不清楚。挑战的炎症反应（炎症反应性，IR）可能是部分介导因素，因为神经免疫相互作用为 IR 也影响神经反应性，从而影响与疼痛相关的神经信号提供了基础。这项前瞻性、观察性、病例对照研究将描述在报告持续性疼痛（病例）或无疼痛（对照）的 HIV 感染者中，痛苦、IR、通过诱导性二次痛觉过敏（SH）捕获的疼痛相关信号之间的关系。

方法和分析

将在 6 个月内评估 100 名报告持续性疼痛或无疼痛的 HIV 抑制感染者两次或四次。主要结局指标是在基线时间点评估的苦恼（霍普金斯 25 项症状清单）、IR（脂多糖挑战后的多指标检测）和疼痛（简明疼痛量表），尽管每个指标也将在随访时间点评估。将在 60 名参与者的亚样本中评估诱导性 SH（仅基线时间点）。为了检验 IR 部分介导痛苦和疼痛之间关系的假设，中介分析将使用 PP 组的基线数据来估计痛苦和 IR 对疼痛的直接和间接贡献。为了检验 IR 与 SH 呈正相关的假设，将使用亚样本的数据进行广义混合效应模型分析，以估计 IR 与组别的关联，SH 作为因变量。