Ramos Fabiana Tomé, Lobo Maria Cecília Yoshioka, Miot Hélio Amante, Minicucci Eliana Maria, Alencar Rúbia Aguiar
Universidade Estadual Paulista, Faculdade de Medicina, Botucatu, SP, Brazil.
Rev Esc Enferm USP. 2025 Sep 5;59:e20250004. doi: 10.1590/1980-220X-REEUSP-2025-0004en. eCollection 2025.
To evaluate the effectiveness of intravenous laser irradiation of blood in reducing viral load and increasing LT-CD4+ and LT-CD8+ in people living with HIV/AIDS.
Randomized, controlled, parallel, single-blind clinical trial. Twenty-eight participants were allocated to the intervention (ILIB n = 15) and control (CTRL n = 13) groups. The ILIB group received irradiation with red laser (660 nm), applied to the radial artery (30 minutes/day for 20 days), with a total energy of 180 J. The CTRL group received a sham intervention (without light emission). Viral load and LT-CD4+ and LT-CD8+ counts were assessed at the end.
Both groups showed a reduction in viral load (ILIB: -1.7 log; CTRL: -2.3 log). In the ILIB group, 61.5% of participants achieved an undetectable viral load (p = 0.449). There was no increase in CD4+ LT count (p = 0.287), but a non-significant reduction in CD8+ LT count was observed in the ILIB group (p = 0.173). There were no statistically significant differences between groups for any outcome (p > 0.17). The study was stopped prematurely during the interim analysis.
ILIB, as an adjuvant therapy to ART, did not show clinical or statistical superiority in the immunological and virological parameters evaluated.
BRAZILIAN REGISTRY OF CLINICAL TRIALS (REBEC): RBR-7j9rv5d (https://ensaiosclinicos.gov.br/trial/10848).
评估血液静脉激光照射对降低HIV/AIDS患者病毒载量以及增加长期CD4+和长期CD8+细胞数量的有效性。
随机、对照、平行、单盲临床试验。28名参与者被分配到干预组（ILIB，n = 15）和对照组（CTRL，n = 13）。ILIB组接受红色激光（660 nm）照射，照射桡动脉（每天30分钟，共20天），总能量为180 J。CTRL组接受假干预（无发光）。最后评估病毒载量以及长期CD4+和长期CD8+细胞计数。
两组的病毒载量均有所降低（ILIB组：-1.7 log；CTRL组：-2.3 log）。在ILIB组中，61.5%的参与者实现了病毒载量不可检测（p = 0.449）。CD4+长期细胞计数没有增加（p = 0.287），但在ILIB组中观察到CD8+长期细胞计数有非显著性降低（p = 0.173）。两组在任何结果上均无统计学显著差异（p > 0.17）。该研究在中期分析期间提前终止。
作为抗逆转录病毒治疗的辅助疗法，血液静脉激光照射在评估的免疫和病毒学参数方面未显示出临床或统计学上的优势。
巴西临床试验注册中心（REBEC）：RBR-7j9rv5d（https://ensaiosclinicos.gov.br/trial/10848）
