经皮穴位电刺激对合并苯丙胺滥用的HIV/AIDS免疫无应答者的疗效：一项随机对照试验的研究方案

Efficacy of transcutaneous electrical acupoint stimulation for immunological non-responder in HIV/AIDS combined with amphetamine abuse: study protocol for a randomized controlled trial.

作者信息

Li Tao, Liu Jun, Li Zuoliang, Wang Shoujun, Zhang Su, Zhou Xin, Ren Yulan

机构信息

School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.

Drug Rehabilitation Administration of Sichuan Province, Medical Rehabilitation Department, Chengdu, China.

出版信息

BMC Complement Med Ther. 2024 Dec 24;24(1):424. doi: 10.1186/s12906-024-04724-7.

DOI:10.1186/s12906-024-04724-7

PMID:39719577

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11668002/

Abstract

BACKGROUND

Amphetamine-type stimulant (ATS) abuse is strongly associated with an elevated risk of HIV infection and transmission. Antiretroviral therapy (ART) serves as the primary approach for managing HIV infection and AIDS progression. However, ATS abuse diminishes the efficacy of ART in HIV/AIDS patients, amplifying the vulnerability to immunological non-response (INR) and ultimately increasing the incidence rate and mortality of opportunistic infections. Currently, no effective interventions targeting INR exist. Acupuncture has demonstrated promise in bidirectionally modulating the body's immune response and may be beneficial for INR in HIV/AIDS combined with ATS abuse. Nevertheless, further research and comprehensive evaluation are imperative to substantiate these findings.

METHODS

This study is a two-center, randomized, non-acupoint controlled, single-blind clinical trial. It will be conducted in two large drug rehabilitation centers in western China, involving 114 INR patients receiving ART. The participants will be randomly assigned to either the Transcutaneous Electrical Acupoint Stimulation (TEAS) + ART group or the sham-TEAS + ART group, in a 1:1 ratio. Both groups will receive a 48-week treatment. The primary outcome measure assessed after treatment is the CD4 + T cell count. Secondary outcome measures include the immune reconstitution efficiency of HIV patients, CD4/CD8 ratio, CD4 + CD45RA + and CD4 + CD45RO + counts, CD4 + CD28 + counts, CD4 + CD38 + and CD8 + CD38 + counts, CD4 + ki67 + and CD8 + ki67 + counts, JC mitochondrial membrane potential testing, the incidence of opportunistic infections, and the HIV/AIDS PRO scale. Adverse events occurring during the study observation period will be documented.

DISCUSSION

This study will investigate the effect of TEAS on immune reconstitution in patients with amphetamine abuse and HIV infection.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, ChiCTR 2300076363. Registered on October 7, 2023, https://www.chictr.org.cn/ .

摘要

背景

苯丙胺类兴奋剂（ATS）滥用与HIV感染和传播风险升高密切相关。抗逆转录病毒疗法（ART）是管理HIV感染和艾滋病进展的主要方法。然而，ATS滥用会降低ART在HIV/AIDS患者中的疗效，增加免疫无应答（INR）的易感性，并最终增加机会性感染的发病率和死亡率。目前，尚无针对INR的有效干预措施。针灸已显示出双向调节机体免疫反应的潜力，可能对合并ATS滥用的HIV/AIDS患者的INR有益。尽管如此，仍需进一步研究和综合评估来证实这些发现。

方法

本研究是一项两中心、随机、非穴位对照、单盲临床试验。将在中国西部的两个大型戒毒中心进行，纳入114例接受ART的INR患者。参与者将按1:1的比例随机分配到经皮穴位电刺激（TEAS）+ART组或假TEAS+ART组。两组均接受为期48周的治疗。治疗后评估的主要结局指标是CD4+T细胞计数。次要结局指标包括HIV患者的免疫重建效率、CD4/CD8比值、CD4+CD45RA+和CD4+CD45RO+计数、CD4+CD28+计数、CD4+CD38+和CD8+CD38+计数、CD4+ki67+和CD8+ki67+计数、JC线粒体膜电位检测、机会性感染的发生率以及HIV/AIDS患者报告结局量表。将记录研究观察期内发生的不良事件。