RESUMO

BACKGROUND: Musculoskeletal disorders are an important cause of work absence. Clinical practice guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs) for grade I-II cervical sprains. The combination of thiamine + pyridoxine + cyanocobalamin vitamins has been used, alone and in combination with NSAIDs, for pain and inflammation in musculoskeletal disorders. OBJECTIVE: The objective of this study was to demonstrate the analgesic synergy of dexketoprofen, and the combination of vitamins thiamine + pyridoxine + cyanocobalamin in a fixed-dose combination (FDC) for the treatment of acute pain caused by grade I-II cervical sprains. METHODS: We conducted a multicentre, prospective, randomized, double-blind, phase IIIb clinical study comparing two treatment groups: (1) dexketoprofen 25 mg/vitamin B (thiamine 100 mg, pyridoxine 50 mg and cyanocobalamin 0.50 mg) in an FDC (two or more active ingredients combined in a single dosage form) versus (2) dexketoprofen 25 mg monotherapy (single drug to treat a particular disease), one capsule or tablet orally, every 8 h for 7 days. Final mean, average change, and percentage change in pain perception (measured using a visual analogue scale [VAS]) were compared with baseline between groups. A p value < 0.05 was considered statistically significant. Analyses were conducted using SPSS software, v.29.0. RESULTS: A statistically significant reduction in pain intensity was observed from the third day of treatment with the FDC compared with monotherapy (- 3.1 ± - 1.5 and - 2.6 ± - 1.1 cm, respectively) measured using the VAS (p = 0.011). Regarding the degree of disability, using the Northwick Park Neck Pain Questionnaire (NPQ), statistical difference was observed for the final measurement (7.5%, interquartile range [IQR] 2.5, 10.5; vs. 7.9%, IQR 5.0, 13.8; p = 0.028). A lower proportion of adverse events was reported when using the FDC. CONCLUSIONS: The FDC of dexketoprofen/thiamine + pyridoxine + cyanocobalamin vitamins demonstrated superior efficacy and a better safety profile compared with dexketoprofen monotherapy for pain treatment in patients with grade I-II cervical sprains. CLINICAL TRIALS REGISTRATION: NCT05001555, registered 29 July 2021 ( https://clinicaltrials.gov/study/NCT05001555 ).

Assuntos

Anti-Inflamatórios não Esteroides , Combinação de Medicamentos , Cetoprofeno , Piridoxina , Tiamina , Trometamina , Vitamina B 12 , Humanos , Método Duplo-Cego , Tiamina/administração & dosagem , Tiamina/análogos & derivados , Tiamina/uso terapêutico , Cetoprofeno/administração & dosagem , Cetoprofeno/análogos & derivados , Feminino , Adulto , Piridoxina/administração & dosagem , Piridoxina/uso terapêutico , Masculino , Anti-Inflamatórios não Esteroides/administração & dosagem , Vitamina B 12/análogos & derivados , Vitamina B 12/administração & dosagem , Vitamina B 12/uso terapêutico , Pessoa de Meia-Idade , Trometamina/administração & dosagem , Estudos Prospectivos , Complexo Vitamínico B/administração & dosagem , Complexo Vitamínico B/uso terapêutico , Medição da Dor/métodos , Adulto Jovem

RESUMO

Ni-based superalloys are materials utilized in high-performance services that demand excellent corrosion resistance and mechanical properties. Its usages can include fuel storage, gas turbines, petrochemistry, and nuclear reactor components, among others. On the other hand, hydrogen (H), in contact with metallic materials, can cause a phenomenon known as hydrogen embrittlement (HE), and its study related to the superalloys is fundamental. This is related to the analysis of the solubility, diffusivity, and permeability of H and its interaction with the bulk, second-phase particles, grain boundaries, precipitates, and dislocation networks. The aim of this work was mainly to study the effect of chromium (Cr) content on H diffusivity in Ni-based superalloys; additionally, the development of predictive models using artificial intelligence. For this purpose, the permeability test was employed based on the double cell experiment proposed by Devanathan-Stachurski, obtaining the effective diffusion coefficient (Deff), steady-state flux (Jss), and the trap density (NT) for the commercial and experimentally designed and manufactured Ni-based superalloys. The material was characterized with energy-dispersed X-ray spectroscopy (EDS), atomic absorption, CHNS/O chemical analysis, X-ray diffraction (XRD), brightfield optical microscopy (OM), and scanning electron microscopy (SEM). On the other hand, predictive models were developed employing artificial neural networks (ANNs) using experimental results as a database. Furthermore, the relative importance of the main parameters related to the H diffusion was calculated. The Deff, Jss, and NT achieved showed relatively higher values considering those reported for Ni alloys and were found in the following orders of magnitude: [1 × 10-8, 1 × 10-11 m2/s], [1 × 10-5, 9 × 10-7 mol/cm2s], and [7 × 1025 traps/m3], respectively. Regarding the predictive models, linear correlation coefficients of 0.96 and 0.80 were reached, corresponding to the Deff and Jss. Due to the results obtained, it was suitable to dismiss the effect of Cr in solid solution on the H diffusion. Finally, the predictive models developed can be considered for the estimation of Deff and Jss as functions of the characterized features.