Navegando por Palavras-chave "Randomized Controlled Trials As Topic"
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- ItemAcesso aberto (Open Access)Conservative interventions for treating middle third clavicle fractures in adolescents and adults(Inst Israelita Ensino & Pesquisa Albert Einstein, 2016) Lenza, Mario; Faloppa, Flavio [UNIFESP]Background Clavicle (collarbone) fractures account for around 4% of all fractures. Most (76%) clavicle fractures involve the middle-third section of the clavicle. Treatment of these fractures is usually non-surgical (conservative). Commonly used treatments are arm slings, strapping and figure-of-eight bandages. This is an update of a Cochrane review first published in 2009 and updated in 2014. Objectives To evaluate the effects (benefits and harms) of different methods for conservative (non-operative) treatment for acute (treated soon after injury) middle third clavicle fractures in adolescents and adults. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE (from 1966), Embase (from 1980), LILACS (from 1982), trial registers, orthopaedic proceedings and reference lists of articles. We applied no language or publication restrictions. The date of the last search was 5 January 2016. Selection criteria Randomised and quasi-randomised controlled trials testing conservative interventions for treating adolescents and adults with acute middle third clavicle fractures. The primary outcomes were shoulder function or disability, pain and treatment failure. Data collection and analysis For this update, two review authors selected eligible trials, independently assessed risk of bias and cross-checked data extraction. We calculated risk ratios and 95% confidence intervals for dichotomous variables, and mean differences and 95% confidence intervals for continuous variables. There was very limited pooling of data. Main results We included four trials in this review with 416 participants, who were aged 14 years or above. One new trial was included in this update. Very low quality evidence was available from three trials (296 participants) that compared the figure-of-eight bandage with an arm sling for treating acute middle third clavicle fractures. The three trials were underpowered and compromised by poor methodology. Shoulder function was assessed in different ways in the three trials (data for 51, 61 and 152 participants)
- ItemAcesso aberto (Open Access)Enzyme replacement therapy with idursulfase for mucopolysaccharidosis type ii (hunter syndrome)(Wiley, 2016) Silva, Edina Mariko Koga da [UNIFESP]; Strufaldi, Maria Wany Louzada [UNIFESP]; Andriolo, Regis Bruni; Silva, Laercio Antonio da [UNIFESP]Background Mucopolysaccharidosis II, also known as Hunter syndrome, is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase, which catalyses a step in the catabolism of glycosaminoglycans. The glycosaminoglycans accumulate within tissues affecting multiple organs and physiologic systems. The clinical manifestations include neurologic involvement, severe airways obstruction, skeletal deformities and cardiomyopathy. The disease has a variable age of onset and variable rate of progression. In those with severe disease, death usually occurs in the second decade of life, whereas those individuals with less severe disease may survive into adulthood. Enzyme replacement therapy with intravenous infusions of idursulfase has emerged as a new treatment for mucopolysaccharidosis type II. This is an update of a previously published version of this review. Objectives To evaluate the effectiveness and safety of enzyme replacement therapy with idursulfase compared to other interventions, placebo or no intervention, for treating mucopolysaccharidosis type II. Search methods We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register (date of last search 23 November 2015). We also searched Embase, PubMed and the Literature Latino-Americana e do Caribe em Ciencias da Saude (LILACS) (date of last search 28 November 2015). Selection criteria Randomised and quasi-randomised controlled trials of enzyme replacement therapy with idursulfase compared to no intervention, placebo or other options (e.g. behavioral strategies, transplantation). Data collection and analysis Two authors independently screened the trials identified, appraised quality of papers and extracted data. Main results One study (96 male participants) met the inclusion criteria, although the primary outcome of this review -z score for height and weight, was not assessed in the study. This trial was considered to be of overall good quality. Following 53 weeks of treatment, participants in the weekly idursulfase 0.5 mg/kg group demonstrated a significant improvement rate compared with placebo for the primary outcome: distance walked in sixminutes on the basis of the sum of ranks of change from baseline, mean difference 37.00 (95% confidence interval 6.52 to 67.48). The every-other-week idursulfase 0.5 mg/kg group also showed an improvement, which was not significant compared with placebo, mean difference 23.00 (95% confidence interval -4.49 to 50.49). After 53 weeks, there was no statistical significance difference in per cent predicted forced vital capacity between the three groups and absolute forced vital capacity was significantly increased from baseline in the weekly dosing group compared to placebo, mean difference 0.16 (95% confidence interval CI 0.05 to 0.27). No difference was observed between the every-other-week idursulfase 0.5 mg/kg group and placebo. In addition, liver and spleen volumes and urine glycosaminoglycan excretion were significantly reduced from baseline by both idursulfase dosing regimens. Idursulfase was generally well tolerated, but infusion reactions did occur. Idursulfase antibodies were detected in 31.7% of participants at the end of the study and they were related to a smaller reduction in urine glycosaminoglycan levels. Authors' conclusions The current evidence is limited. While the randomised clinical trial identified was considered to be of good quality, it failed to describe important outcomes. It has been demonstrated that enzyme replacement therapy with idursulfase is effective in relation to functional capacity (distance walked in six minutes and forced vital capacity), liver and spleen volumes and urine glycosaminoglycan excretion in people with mucopolysaccharidosis type II compared with placebo. There is no available evidence in the included study and in the literature on outcomes such as improvement in growth, sleep apnoea, cardiac function, quality of life and mortality. More studies are needed to obtain more information on the long-term effectiveness and safety of enzyme replacement therapy.
- ItemAcesso aberto (Open Access)Vaccines for preventing herpes zoster in older adults(Wiley-blackwell, 2016) Gagliardi, Anna Maria Zaragoza [UNIFESP]; Silva, Brenda Nazaré Gomes da [UNIFESP]; Torloni, Maria Regina [UNIFESP]; Soares, Bernardo Garcia de Oliveira [UNIFESP]Background Herpes zoster, also known as 'shingles', is a neurocutaneous disease characterised by the reactivation of the latent varicella zoster virus (VZV), the virus that causes chickenpox when immunity to VZV declines. It is an extremely painful condition that can last many weeks or months and it can significantly compromise the quality of life of affected individuals. The natural process of aging is associated with a reduction in cellular immunity and this predisposes older people to herpes zoster. Vaccination with an attenuated form of VZV activates specific T cell production avoiding viral reactivation. The Food and Drug Administration has approved a herpes zoster vaccine with an attenuated active virus for clinical use among older adults, which has been tested in large populations. A new adjuvanted recombinant VZV subunit zoster vaccine has also been tested. It consists of recombinant VZV glycoprotein E and a liposome-based AS01B adjuvant system. This new vaccine is not yet available for clinical use. Objectives To evaluate the effectiveness and safety of vaccination for preventing herpes zoster in older adults. Search methods For this 2015 update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 9), MEDLINE (1948 to the 3rd week of October 2015), EMBASE (2010 to October 2015), CINAHL (1981 to October 2015) and LILACS (1982 to October 2015). Selection criteria Randomised controlled trials (RCTs) or quasi-RCTs comparing zoster vaccine with placebo or no vaccine, to prevent herpes zoster in older adults (mean age >= 60 years). Data collection and analysis Two review authors independently collected and analysed data using a data extraction form. They also performed 'Risk of bias' assessment. Main results We identified 13 studies involving 69,916 participants. The largest study included 38,546 participants. All studies were conducted in high-income countries and included only healthy Caucasian individuals >= 60 years of age without immunosuppressive comorbidities. Ten studies used live attenuated varicella zoster virus (VZV) vaccines. Three studies tested a new type of vaccine not yet available for clinical use. We judged five of the included studies to be at low risk of bias. The incidence of herpes zoster, at up to three years of follow-up, was lower in participants who received the vaccine than in those who received a placebo: risk ratio (RR) 0.49 95% confidence interval (CI) 0.43 to 0.56, risk difference (RD) 2%, number needed to treat to benefit (NNTB) 50 GRADE: moderate quality evidence. The vaccinated group had a higher incidence of mild to moderate intensity adverse events. These date came from one large study that included 38,546 people aged 60 years or older. A study including 8122 participants compared the new vaccine (not yet available) to the placebo the group that received the new vaccine had a lower incidence of herpes zoster at 3.2 years of follow-up: RR 0.04, 95% CI 0.02 to 0.10, RD 3%, NNTB 33 GRADE: moderate quality evidence. The vaccinated group had a higher incidence of adverse events but most them were of mild to moderate intensity. All studies received funding from the pharmaceutical industry. Authors' conclusions Herpes zoster vaccine is effective in preventing herpes zoster disease and this protection can last three years. In general, zoster vaccine is well tolerated it produces few systemic adverse events and injection site adverse events of mild to moderate intensity. There are studies of a new vaccine (with a VZV glycoproteic fraction plus adjuvant), which is currently not yet available for clinical use.