RESUMO
OBJECTIVES: Comparison of two doses of bio-optimized Curcuma longa extract (BCL) in the management of symptomatic knee osteoarthritis (OA). METHODS: A prospective, randomized, 3-month, double-blind, multicenter, three-group, placebo-controlled trial assessing Patient Global Assessment of Disease Activity (PGADA) and serum sColl2-1, a biomarker of cartilage degradation, as co-primary endpoints. Pain on visual analog scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), and paracetamol/non-steroidal anti-inflammatory drug (NSAID) consumption were used as secondary endpoints. RESULTS: One hundred fifty patients with knee OA were followed for 90 days. Low and high doses of BCL showed a greater decrease of PGADA than placebo. Analysis of sColl2-1 showed in the placebo and BCL low-dose groups, but not in the BCL high-dose group, a transient but non-significant increase of sColl2-1 between T0 and T1. Thereafter, in all groups, sColl2-1 decreased between T1 and T3 (all p < 0.01), but no difference between the groups was found. Pain reduction at day 90 in the low- and high-dose BCL groups (- 29.5 mm and - 36.5 mm) was higher than that in the placebo (- 8 mm; p = 0.018). The global KOOS significantly decreased overtime, but changes were comparable across treatment arms. The ratio of patients with adverse events (AE) related to the product was similar in the placebo and treatment groups, but the number of AE linked to the product was higher in the high-dose BCL group compared to the placebo (p = 0.012). CONCLUSIONS: BCL appeared safe and well-tolerated with no evidence of severe adverse effects. Efficacy analysis suggested positive trends for measurements of PGADA and serum levels of an OA biomarker and showed a rapid and significant decrease of pain in knee OA (Trial registration: ISRCTN, ISRCTN12345678. Registered 21 September 2016-retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02909621?term=osteoarthritis+curcumin&rank=5-Evaluation of FLEXOFYTOL® Versus PLACEBO (COPRA) NCT02909621).
Assuntos
Antioxidantes/uso terapêutico , Artralgia/tratamento farmacológico , Osteoartrite do Joelho/tratamento farmacológico , Extratos Vegetais/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Artralgia/diagnóstico , Artralgia/etiologia , Curcuma , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/complicações , Osteoartrite do Joelho/diagnóstico , Medição da Dor/métodos , Estudos Prospectivos , Resultado do TratamentoRESUMO
PURPOSE: To evaluate functional assessment and rehabilitation in eosinophilic fasciitis. METHOD: Description of a clinical case of eosinophilic fasciitis, including the evolution of functional assessment after treatment with corticotherapy and rehabilitation. CASE REPORT: Our case was a 33-year-old patient with major walking disability and pain in the left calf. Biological examination and imaging, including nuclear magnetic resonance and bone scintigraphy, showed inflammation of the adipose and muscular tissues of the posterior area of the leg. Cutaneomuscular biopsy confirmed the diagnosis of eosinophilic fasciitis. Corticotherapy was then instituted in parallel with rehabilitation to limit deficiencies and disability function. DISCUSSION-CONCLUSION: Functional assessment used as indicating objective could, in partnership with follow-up of the biological inflammatory syndrome, lead to decreased use of corticoids in iosinophilic fasciitis. Moreover, supplemental rehabilitation could limit deficiencies and the functional disability resulting from the fasciitis.
Assuntos
Eosinofilia/reabilitação , Fasciite/reabilitação , Corticosteroides/administração & dosagem , Corticosteroides/uso terapêutico , Adulto , Biópsia , Osso e Ossos/diagnóstico por imagem , Emergências , Eosinofilia/diagnóstico , Eosinofilia/diagnóstico por imagem , Eosinofilia/tratamento farmacológico , Eosinofilia/patologia , Eosinofilia/fisiopatologia , Terapia por Exercício , Fasciite/diagnóstico , Fasciite/diagnóstico por imagem , Fasciite/tratamento farmacológico , Fasciite/patologia , Fasciite/fisiopatologia , Feminino , Seguimentos , Humanos , Imageamento por Ressonância Magnética , Cintilografia , Pele/patologia , Fatores de Tempo , Resultado do Tratamento , CaminhadaRESUMO
BACKGROUND AND STUDY AIMS: Large international clinical trials conducted in the past 5 years rapidly improved the treatment of chronic hepatitis C; however, it is unclear whether the advances seen in clinical trials are being paralleled by similar improvements in routine clinical practice. PegIntrust is a Belgian community-based trial evaluating the sustained virological response. PATIENTS AND METHODS: Observational study of 219 patients receiving pegylated interferon alfa-2b (1.5 microg/kg/wk) and weight-based ribavirin (800-1200 mg/day) for 48 weeks. Primary study end point was sustained virological response (SVR), defined as undetectable HCV RNA 6 months after the completion of treatment. RESULTS: In total, 108 patients (49.3 %) had undetectable HCV RNA at the end of therapy, 91 (41.6%) attaining SVR. Of the 111 patients without an end-of-treatment response, 28 were non-responders, and 21 had virological breakthrough. In total, 134 patients attained early virological response (EVR); 88 (65.7%) of those patients attained SVR. In contrast, 82 (96.5 %) of the 85 patients who did not attain EVR also did not attain SVR. Age, fibrosis score and baseline viral load were identified as important predictors of treatment outcome. The most frequently reported serious adverse events resulting in treatment discontinuation were anemia (n = 10), fatigue/asthenia/malaise (n = 6) and fever (n = 3). CONCLUSION: Our data indicate that treatment of chronic hepatitis C with PEG-IFN alfa-2b plus weight-based ribavirin results in favourable treatment outcomes in a Belgian cohort of patients treated in community-based clinical practice.
Assuntos
Antivirais/administração & dosagem , Hepatite C Crônica/tratamento farmacológico , Interferon-alfa/administração & dosagem , Polietilenoglicóis/administração & dosagem , Ribavirina/administração & dosagem , Adulto , Bélgica , Estudos de Coortes , Quimioterapia Combinada , Feminino , Humanos , Interferon alfa-2 , Masculino , Pessoa de Meia-Idade , Proteínas Recombinantes , Resultado do TratamentoRESUMO
BACKGROUND AND STUDY AIMS: In Belgium, 10-15% of patients infected with the human immunodeficiency virus (HIV) are coinfected with hepatitis C virus (HCV). Because of increased incidence of antiretroviral drug-related hepatotoxicity and more rapid clinical evolution towards end-stage liver disease, treatment of chronic hepatitis C becomes a priority. We report the results of a multi-centred Belgian study evaluating efficacy and safety of peginterferon alpha-2b plus ribavirin in HIV-HCV co-infected patients without AIDS and without decompensated liver disease. PATIENTS AND METHODS: Forty-one patients, all genotypes, were screened to participate. Eventually 37 received treatment with peginterferon alpha-2b (1.5 microg/kg/week) plus daily weight-based ribavirin for 52 weeks. About one third of the patients were genotypes 1, 2/3, and genotype 4, most of the latter being of Central African origin. About 56% of the patients had severe fibrosis (Metavir score > or = F3). RESULTS: Sustained viral response (SVR) at 24 weeks of follow-up was observed in 10/37 (27%) of patients. SVR was higher in genotype 2/3 compared to genotype 1/4 (46.7% versus 13.6%; p = 0.06) and in low (F0-F1) versus high (F2-F4) grade fibrosis (p = 0.06). Treatment was withdrawn for side effects in 11/37 patients (30%). One Child A cirrhosis patient at the start of therapy died 7 months after treatment withdrawal as a result of severe haemolytic anaemia. CONCLUSIONS: It can be concluded that weight-based peginterferon alpha-2b plus ribavirin can be successful in selected HIV-HCV co-infected patients. Caution should be applied in patients with advanced liver disease.
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Infecções por HIV/tratamento farmacológico , Hepatite C Crônica/tratamento farmacológico , Interferon-alfa/administração & dosagem , Polietilenoglicóis/administração & dosagem , Ribavirina/administração & dosagem , Adolescente , Adulto , Bélgica , Comorbidade , Quimioterapia Combinada , Feminino , Infecções por HIV/epidemiologia , Hepatite C Crônica/epidemiologia , Humanos , Interferon alfa-2 , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Proteínas Recombinantes , Resultado do Tratamento , Adulto JovemRESUMO
The prevalence of articular chondrocalcinosis was studied in a group of 100 patients with seropositive rheumatoid arthritis (RA). Articular chondrocalcinosis was observed less frequently (3%) than in a control group (19%) of 221 age and sex matched patients with low back pain or extraarticular rheumatism. This difference is statistically significant (p less than 0.001). Articular chondrocalcinosis occurred in the older patients with RA, and was observed in those with the shortest duration of the disease.