Browsing by Subject "safety"

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.

Objectives. School safety has long been a subject of wide-ranging debate, but scientific research on the subject has, however, been rather limited. Although the English language research is comprehensive, in educational sciences school safety has not been a common subject of research. Matti Waitinen's (2011) dissertation is the first school safety culture investigative research in Finland. Waitinen images safety culture of Helsinki comprehensive school, and points out that the differences in security levels can be explained by a different safety cultures. The purpose of this thesis is to find out what are the most common needs to develop safety work that are encountered in comprehensive schools. Research methods. The target group here are four comprehensive schools and their safety groups. The study was carried out as so-called mixed - methods study, where the research data came from both quantitative and qualitative orientation. The data - collection in the first phase of the research was a questionnaire sent to schools, the purpose of which was to orient the school safety team members to the subject. The next step was, Tutor audit, which the Rescue Department of Keski-Uusimaa had developed. The audit, data were generated as quantitative and qualitative, structured group interview section yielded precise values of the school, the level of security, but on the other hand recorded and eventually transcribed conversation around the subject produced a material for the later content analysis. Results and conclusions. Based on the results it can be concluded that the safety work of comprehensive schools found plenty of areas for development. The audits on the basis of the values obtained, it can be said that none of the schools reached in the overall interpretation of the law formed through the minimum requirement, that is, the basic level three. There were found seven development themes: documentation, everyday and communally safety work, risk management, preparedness and independent development of safety, safety skills and safety training, as well as safety communication and paying attention to substitutes and stakeholders. Although the number of results can not be generalized to the comprehensive schools in general, the results can get an understanding of what kind of developments must be done in schools. The general conclusion is that the security work must continue to pay great attention to.