Biologic therapy use and pregnancy outcomes in women with immune-mediated inflammatory rheumatic diseases.

INTRODUCTION: Concerns about the side effects and interactions of biologic drugs with reproduction and pregnancy have been always an issue between experts. The safety of these therapies during conception and/or pregnancy is not fully understood. The aim of this study was to assess the exposure to biologic drugs before and/or during conception/pregnancy and the risk of adverse pregnancy outcomes in women with rheumatic diseases. METHODS: We conducted a cohort study of pregnancies reported in women with immune-mediated rheumatic diseases registered at the Rheumatic Diseases Portuguese Registry (Reuma.pt) and exposed to biologic drugs. Data concerning fetal and maternal outcomes (live birth, spontaneous abortion, neonatal and intrauterine death, intrauterine growth restriction, premature delivery, congenital malformations, neonatal lupus, voluntary or medical interruption of pregnancy, disease flares and need for treatment with other drugs) was extracted. RESULTS: In total, 69 pregnancies from 56 females were analysed, the majority with the diagnosis of spondyloarthritis or rheumatoid arthritis. In almost half of the cases (n=32, 46.4%) the biologic was stopped for pregnancy planning, in 31 cases (44.9%) it was stopped when pregnancy was diagnosed and in 6 pregnancies (8.7%) biologic therapy was maintained, at least until the 2nd trimester. There were 76.8% of live births and 22% of spontaneous abortions. Congenital anomalies were reported in 2 newborns. CONCLUSIONS: In half cases, it was decided to stop biologic therapy in the family planning period. Using biologic disease-modifying anti-rheumatic drugs before and/or during pregnancy doesn't seem to affect the overall maternal and fetal outcomes. Pregnancy planning and treatment options should be discussed and a shared decision should be established between physician and patient.

[Ozone Therapy in Knee Osteoarthritis: A Systematic Review]. / Ozonoterapia na Osteoartrose do Joelho: Revisão Sistemática.

INTRODUCTION: The aim of this study was to conduct a systematic review in order to examine the effectiveness of ozone therapy on knee osteoarthritis. The objectives were to evaluate the effect over time of ozone therapy in terms of knee pain, functional improvement and radiographic progression. MATERIAL AND METHODS: A search was carried out on PubMed, Embase, Cochrane Library, Scopus and Web of Science databases to identify randomized and controlled studies focusing on this association. The following descriptors were used in English: ozone therapy, knee osteoarthritis. A descriptive summary and quality assessment was made of all studies included for analysis. RESULTS: Six randomized and controlled studies were identified. The risk of bias assessment demonstrated that one study was considered as having a moderate risk of bias and the remainder a high risk of bias. No quantitative analysis of the data was performed, as the studies included were not sufficiently homogeneous. The participants in the studies were generally elderly patients with mild to moderate knee osteoarthritis. DISCUSSION: The variability of ozone therapy and the comparators demonstrates that there is no standardized therapy. Few studies reported adverse effects, and where they occurred, they were mild and associated with the procedure. CONCLUSION: Ozone therapy proved effective in the short-term in relation to placebo and when combined with hyaluronic acid, but it was not superior to other current treatments. More randomised and controlled studies are needed to evaluate the risks/benefits of ozone therapy, both in the short term and the medium/long term.

Introdução: O presente estudo teve por objetivo realizar uma revisão sistemática de forma a analisar a eficácia da ozonoterapia na osteoartrose do joelho. Os objetivos visaram avaliar o efeito temporal da ozonoterapia na dor no joelho, na melhoria funcional e na progressão radiográfica.Material e Métodos: Realizou-se uma pesquisa nas bases de dados PubMed, Embase, Cochrane Library, Scopus e Web of Science a fim de identificar estudos aleatorizados e controlados que tratassem dessa associação. Utilizaram-se os seguintes descritores em língua inglesa: 'ozone therapy', 'knee osteoarthritis'. Realizou-se um resumo descritivo e avaliação de qualidade de todos os estudos incluídos para análise.Resultados: Identificaram-se seis estudos aleatorizados e controlados relacionados com o objetivo deste trabalho. A avaliação do risco de viés mostrou que um estudo foi considerado como risco moderado de viés e os restantes como risco alto de viés. Não se realizou a análise quantitativa dos dados pois os estudos incluídos não foram suficientemente homogéneos. Os participantes dos estudos eram em geral doentes idosos com osteoartrose do joelho leve a moderada.Discussão: A variabilidade nas intervenções de ozonoterapia e comparadores, demonstra que não existe uma terapêutica estandardizada. Foram poucos os estudos que relataram os efeitos adversos, e quando aconteceu, estes eram ligeiros e associados ao procedimento.Conclusão: A ozonoterapia mostrou eficácia a curto prazo, em relação ao placebo e quando combinada com ácido hialurónico, sem ser promissora em relação aos restantes tratamentos vigentes. É importante que novos estudos aleatorizados e controlados avaliem os benefícios/riscos da ozonoterapia tanto a curto como a médio/longo prazo.