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Browsing by Subject "teho"

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  • Mäkinen, Arttu (2018)
    This is a systematic review aiming to investigate the efficacy, effectiveness, and safety of biosimilars in the treatment of inflammatory bowel diseases. Biosimilar drugs used to treat inflammatory bowel diseases include biosimilar infliximab and biosimilar adalimumab. Biosimilar infliximab has been authorized by the European Medicines Agency (EMA) in 2013 and by the US Food and Drug Administration (FDA) in 2016. Biosimilar adalimumab has been authorized by EMA and FDA in 2017 and, at the time the literary search for this systematic review was conducted no studies were found regarding the treatment of adalimumab biosimilar for inflammatory bowel diseases. To acquire marketing authorization for biosimilars, it must be proven that the biosimilar is biologically similar to the original medicinal product. Bioequivalence is demonstrated through physicochemical trials and clinical trials. However, clinical trials do not have to be performed with all of the indications for which the original medical product is registered. After proving bioequivalence with one or more indication it is possible to extrapolate the biosimilar to be used in all of the original medical products indications. This has raised the question of whether biosimilars are really comparable to the originator in indications for which no clinical trials have been conducted. This systematic review was implemented using the Cochrane Handbook for Systematic Reviews and Interventions. Systematic literature searches were made in Cochrane, Medline (Ovid®), PubMed and Scopus databases on 12.05.2017. 14 observational studies, one systematic review and a randomized clinical trial that met the inclusion criteria were included in the systematic review. The quality of the publications was evaluated using the STROBE-, NOS- and CONSORT-checklists and information regarding the efficacy, effectiveness and safety of biosimilars was extracted. CD-patients receiving tumor necrosis factor alpha inhibitors for the first time, the clinical response was achieved in 50.0 % to 97.2 % of patients depending on patient population and the duration of treatment. Similarly, for UC-patients, the clinical response was achieved in 62.2 % to 100.0 %. The clinical remission was achieved among 28.9 % to 84.4 % of CD-patients and among 28.9 % to 84.4 % of UC-patients, depending on patient population and treatment follow-up. After the switch from original infliximab to biosimilar, the proportion of patients in clinical remission during follow-up ranged from 62.3 % to 100.0 % in CD-patients and from 45.5 % to 100.0 % in UC-patients. Clinical remission was sustained throughout the whole follow-up in 70 % to 100 % of CD-patients and 66.7 % to 92.0 % of UC-patients. The incidence of adverse events leading to the discontinuation of drug treatment was between 0.0 % and 25.0 %, and the incidence of all adverse events ranged from 0.0 % to 93.6 % in CD- and UC-patients. Biosimilar infliximab seems to be comparable to the original product regarding the efficacy, effectiveness and safety. This result is supported by the systematic literature review published earlier. Conducting a meta-analysis of the information contained in this systematic literature review could have led to a more final decision considering efficacy, effectiveness and safety of biosimilar-infliximab in the treatment of inflammatory bowel diseases.
  • Uusitalo, Tuomas (2013)
    Sulfonylureas is large, widely, especially in cereal production, used herbicide group since 1980’. Continual unilateral use of sulfonylureas has resulted in development of sulfonylurea resistant weeds. Common chickweed [Stellaria media (L.) Vill.] is common weed in Finland, which is known to have developed sulfonylurea resistance. The aim of this work was to investigate herbicides to control sulfonylurea resistant chickweed as well as to optimize the timing of the weed control. Further attention paid to the effect of weed control to the barley grain yield and its quality. This study was organized as a field experiment in Somero during summer 2012 a randomized complete block design. Sulfonylurea resistant chickweed population was found from this specific field. Experiment included 14 herbicide treatments. One of the herbicides studied was sulfonylurea. Herbicides applied at early and late timing. After treatments, the number of chickweed was counted, its biomass was weighed and N content analysed. Furthermore, the coverage of chickweed and the herbicide efficacy was evaluated visually. Barley was harvested and the grain yield and its quality was analysed. Sulfonylurea Express 50 SX did not control chickweed as effectively as expected. Starane 180 was effective only when 0,6L/ha dosage was used. Ariane S, K-Trio and Primus were effective, with efficacies over 90%. Efficacies of these herbicides were not dependent of timing. Oxyril did not control chickweed as well as was assumed. Efficacy of Oxytril was better when applied at early timing. It seems that the best options to for weed management in case of sulfonylurea resistant chickweed are Starane 180, K-Trio and Ariane S.