Photobiomodulation Therapy to Treat Snakebites Caused by Bothrops atrox: A Randomized Clinical Trial.

Autor: Carvalho ÉDS; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil.; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil., Souza ARDN; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil.; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil., Melo DFC; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.; School of Medicine, Universidade Federal do Amazonas, Manaus, Brazil., de Farias AS; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil.; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil., Macedo BBO; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil., Sartim MA; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil.; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.; Universidade Nilton Lins, Manaus, Brazil., Caggy MC; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil., Rodrigues BA; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil., Ribeiro GS; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil., Reis HN; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil., Araújo FQ; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil., da Silva IM; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil.; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil., Sachett A; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil.; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil., Sampaio VS; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil.; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil., Balieiro AADS; Instituto Leônidas e Maria Deane - ILMD/Fiocruz, Manaus, Brazil., Zamuner SR; Universidade Nove de Julho, Uninove, São Paulo, Brazil., Vissoci JRN; Department of Emergency Medicine and Duke Global Health Institute (DGHI), Duke University, Durham, North Carolina., Cabral LN; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil., Monteiro WM; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil.; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil., Sachett JAG; School of Health Sciences, Universidade do Estado do Amazonas, Manaus, Brazil.; Department of Teaching and Research, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.; Department of Teaching and Research, Fundação Alfredo da Matta, Manaus, Brazil.
Jazyk: angličtina
Zdroj: JAMA internal medicine [JAMA Intern Med] 2024 Jan 01; Vol. 184 (1), pp. 70-80.
DOI: 10.1001/jamainternmed.2023.6538
Abstrakt: Importance: Bothrops venom acts almost immediately at the bite site and causes tissue damage.
Objective: To investigate the feasibility and explore the safety and efficacy of low-level laser therapy (LLLT) in reducing the local manifestations of B atrox envenomations.
Design, Setting, and Participants: This was a double-blind randomized clinical trial conducted at Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, in Manaus, Brazil. A total of 60 adult participants were included from November 2020 to March 2022, with 30 in each group. Baseline characteristics on admission were similarly distributed between groups. Data analysis was performed from August to December 2022.
Intervention: The intervention group received LLLT combined with regular antivenom treatment. The laser used was a gallium arsenide laser with 4 infrared laser emitters and 4 red laser emitters, 4 J/cm2 for 40 seconds at each application point.
Main Outcomes and Measures: Feasibility was assessed by eligibility, recruitment, and retention rates; protocol fidelity; and patients' acceptability. The primary efficacy outcome of this study was myolysis estimated by the value of creatine kinase (U/L) on the third day of follow-up. Secondary efficacy outcomes were (1) pain intensity, (2) circumference measurement ratio, (3) extent of edema, (4) difference between the bite site temperature and that of the contralateral limb, (5) need for the use of analgesics, (6) frequency of secondary infections, and (7) necrosis. These outcomes were measured 48 hours after admission. Disability assessment was carried out from 4 to 6 months after patients' discharge. P values for outcomes were adjusted with Bonferroni correction.
Results: A total of 60 patients (mean [SD] age, 43.2 [15.3] years; 8 female individuals [13%] and 52 male individuals [87%]) were included. The study was feasible, and patient retention and acceptability were high. Creatine kinase was significantly lower in the LLLT group (mean [SD], 163.7 [160.0] U/L) 48 hours after admission in relation to the comparator (412.4 [441.3] U/L) (P = .03). Mean (SD) pain intensity (2.9 [2.7] vs 5.0 [2.4]; P = .004), circumference measurement ratio (6.6% [6.6%] vs 17.1% [11.6%]; P < .001), and edema extent (25.8 [15.0] vs 40.1 [22.7] cm; P = .002) were significantly lower in the LLLT group in relation to the comparator. No difference was observed between the groups regarding the mean difference between the bite site temperature and the contralateral limb. Secondary infections, necrosis, disability outcomes, and the frequency of need for analgesics were similar in both groups. No adverse event was observed.
Conclusions and Relevance: The data from this randomized clinical trial suggest that the use of LLLT was feasible and safe in a hospital setting and effective in reducing muscle damage and the local inflammatory process caused by B atrox envenomations.
Trial Registration: Brazilian Registry of Clinical Trials Identifier: RBR-4qw4vf.
Databáze: MEDLINE