It is unclear whether recombinant β interferons (IFNβ) can be effective in secondary progressive multiple sclerosis (SPMS). The aim was to determine whether IFNβ can reduce the risk of disability and ...cognitive impairment progression in SPMS.
Using Cochrane methodology, we reviewed all randomised placebo controlled trials of IFNβ in SPMS patients (1995-March 2012).
5 trials (3082 patients) were included. After 3 years, interferons did not reduce disability progression, confirmed at 6 months (RR 0.98, 95% CI 0.82 to 1.16). A small reduction in the number of patients who had relapses during the first 3 years of treatment (RR 0.91, 0.84 to 0.97) was found. No analysis of cognitive data was possible. More treated than placebo patients dropped out for adverse events.
3 year treatment with IFNβ does not delay permanent disability in SPMS but reduces relapse risk, indicating that the anti-inflammatory effect of IFNβ is unable to prevent MS progression once it has become established.
Background
Therapy with either recombinant beta‐1a or beta‐1b interferons (IFNs) is worldwide approved for Relapsing Remitting Multiple Sclerosis (RRMS). A major unanswered question is whether this ...treatment is able to safely reverse or retard the progressive phase of the disease.
Objectives
The main objective was to verify whether IFNs treatment in Secondary Progressive Multiple Sclerosis (SPMS) is more effective than placebo in reducing the number of patients who experience disability progression.
Search methods
We searched the Cochrane Multiple Sclerosis Group's Trials Register (1995 to 15 February 2011), the reference lists of relevant articles and conference proceedings. Regulatory agencies were used as additional sources of information.
Selection criteria
We included all randomised, double or single blind, placebo‐controlled trials (RCTs) evaluating the efficacy of IFNs versus placebo in SPMS patients.
Data collection and analysis
Two review authors independently assessed all reports retrieved from the search. They independently extracted clinical, safety and MRI data, using a predefined data extraction form, resolving disagreements after discussion with a third reviewer. Risk of bias was evaluated to assess the quality of the studies. Treatment effect was measured using Risk Ratio (RR) with 95% confidence intervals (CI) for the binary outcomes and Standard Mean Difference with 95% CI for the continuous outcomes.
Main results
Five RCTs met the inclusion criteria, from which 3122 (1829 IFN and 1293 placebo) treated patients contributed to the analysis. Included population was heterogeneous in terms of baseline clinical characteristics of the disease, in particular the percentage of patients affected by secondary progression with superimposed relapse ranging from 72% to 44%. IFN beta 1a and 1b did not decrease the risk of progression sustained at 6 months (RR, 95% CI: 0.98, 0.82‐1.16) after three years of treatment. A significant decrease of the risk of progression sustained at 3 months (RR, 95% CI: 0.88 0.80, 0.97) and of the risk of developing new relapses at three years (RR 0.91, 0.84‐0.97) were found. The risk of developing new active brain lesions decreased over time but this data was obtained from single studies on Magnetic Resonance Imaging (MRI), performed in subgroups of patients; in spite of no effect on progression, the radiological data supported an effect on MRI parameters. The safety profile reflects what is commonly reported in MS IFN‐treated patients.
Authors' conclusions
Well designed RCTs, evaluating a high number of patients were included in the review. Recombinant IFN beta does not prevent the development of permanent physical disability in SPMS. We were unable to verify the effect on cognitive function for the lack of comparable data. This treatment significantly reduces the risk of relapse and of short ‐term relapse‐related disability.
Overall, these results show that IFNs' anti‐inflammatory effect is unable to retard progression, when established. In the future, no new RCTs for IFNs versus placebo in SPMS will probably be undertaken, because research is now focusing on innovative drugs. We believe that this review gives conclusive evidence on the clinical efficacy of IFNs versus placebo in SPMS.
Poly(ethylene terephthalate) (PET) is one of the most used commodity polymers, especially for food and beverage applications, and its recycling is of great importance because of the possible use in ...the textile and construction industries. On the other hand, the interest in biodegradable polymers has led, in recent years, to the use of materials such as poly(lactic acid) (PLA) also in the food and beverage industry. The presence of small amounts of PLA in the PET waste can significantly affect the post-consumer recycling process. In this work, the effect of the presence of small amounts of PLA on the recycling of PET bottles is investigated by rheological, mechanical, morphological and thermogravimetric analysis. The results indicate that this presence can significantly affect the rheological properties under non-isothermal elongational flow, while the mechanical properties were considerably affected only in some circumstances and the thermal stability was not significantly modified.
The subcommittee of the International Headache Society for headache classification (ICHD-II) has recently recognised that secondary headaches may occur in patients affected by inflammatory diseases ...(ID) of the central nervous system (CNS), classifying them among the headaches attributed to non-vascular intracranial disorders. The aim of the study was to verify the association between headache and inflammatory non-infectious diseases of the CNS, by a review of the literature data on the topic, integrated by personal cases and data. Secondary headaches may occur in four main disorders: neurosarcoidosis (sec 7.3.1), aseptic (non-infectious) meningitis (7.3.2), other non-infectious ID (7.3.3) and lymphocytic hypophysitis (7.3.4). Headache and/or primary headaches are frequently reported in patients with neurosarcoidosis (30%), Behcet's syndrome (BS) (55%) and acute disseminated encephalomyelitis (45-58%). Recent data show a high incidence of headache also in multiple sclerosis (MS) (58%) (not mentioned in ICHD-II). The association between headache and inflammatory dysimmune diseases of the CNS, in particular BS and MS, might suggest a pathogenetic relationship.
An excellent outcome after microvascular decompression for medically intractable trigeminal neuralgia in patients with multiple sclerosis is reported in seven of 15 cases. A dual cause could be ...hypothesised in some patients with multiple sclerosis and trigeminal neuralgia, and that microvascular decompression can be a therapeutic option.
The effect of organically modified clay on the morphology, rheology and mechanical properties of high-density polyethylene (HDPE) and polyamide 6 (PA6) blends (HDPE/PA6=75/25 parts) is studied. ...Virgin and filled blends were prepared by melt compounding the constituents using a twin-screw extruder. The influence of the organoclay on the morphology of the hybrid was deeply investigated by means of wide-angle X-ray diffractometry, transmission and scanning electron microscopies and quantitative extraction experiments. It has been found that the organoclay exclusively places inside the more hydrophilic polyamide phase during the melt compounding. The extrusion process promotes the formation of highly elongated and separated organoclay-rich PA6 domains. Despite its low volume fraction, the filled minor phase eventually merges once the extruded pellets are melted again, giving rise to a co-continuous microstructure. Remarkably, such a morphology persists for long time in the melt state. A possible compatibilizing action related to the organoclay has been investigated by comparing the morphology of the hybrid blend with that of a blend compatibilized using an ethylene–acrylic acid (EAA) copolymer as a compatibilizer precursor. The former remains phase separated, indicating that the filler does not promote the enhancement of the interfacial adhesion. The macroscopic properties of the hybrid blend were interpreted in the light of its morphology. The melt state dynamics of the materials were probed by means of linear viscoelastic measurements. Many peculiar rheological features of polymer-layered silicate nanocomposites based on single polymer matrix were detected for the hybrid blend. The results have been interpreted proposing the existence of two distinct populations of dynamical species: HDPE not interacting with the filler, and a slower species, constituted by the organoclay-rich polyamide phase, which slackened dynamics stabilize the morphology in the melt state. In the solid state, both the reinforcement effect of the filler and the co-continuous microstructure promote the enhancement of the tensile modulus. Our results demonstrate that adding nanoparticles to polymer blends allows tailoring the final properties of the hybrid, potentially leading to high-performance materials which combine the advantages of polymer blends and the merits of polymer nanocomposites.
Wood flour/polymer composites (WPC) gained a significant interest during the last decades, due to several advantages related to the use of a natural-organic filler rather than an inorganic-mineral ...one. However, most of the studies have been performed on composites based on polyolefin matrices. A further step is the use of biodegradable polymers instead of traditional ones.
In this work, wood flour (WF), under the form of short fibers, with two different sizes (coarse and fine) was added to a corn starch based biodegradable polymer of the Mater-Bi
® family. The effect of WF size, WF content, thermal treatment on the mechanical properties was investigated. The tensile mechanical tests showed an increase of rigidity of the composites upon increasing the WF content, together with a sharp decrease of the elongation at break. With regard to the tensile strength, no remarkable differences were observed upon changing wood flour size or type. In both cases, on average, there were often slightly better results with the samples which had underwent a drying pre-treatment. The increased rigidity was confirmed also by the impact tests, even though it decreased upon increasing the WF content. The heat deflection temperature followed the same trend as the elastic modulus. The immersion tests suggested that these materials are not suitable to prolonged contact with water. Humidity absorption tests revealed that the matrix plays a fundamental role in humidity absorption.
