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Objetivo: O objetivo deste estudo foi avaliar clínica e hitologicamente a reação do material de preenchimento em dois sítios diferentes. Método: Vinte e duas femêas de ratos Wistar (Rattus novergicus) foram submetidas a aplicação de PMMA testando duas técnicas: subcutânea e transmuscular. Passados 3 meses do ato cirúrgico os ratos foram eutanasiados e as áreas injetadas foram excisadas, submetidas a técnica de inclusão em parafina e coloração por hematoxilina e eosina. As lâminas foram analisadas observando-se a resposta local à injeção do corpo estranho quanto ao grau de inflamação. Resultados: Foi encontrada diferença significativamente estatística entre os sítios muscular e subdérmico quanto a formação de granuloma (p<0,05), sendo que o grupo subdérmico obteve melhores resultados. Conclusão: A aplicação de materiais de preenchimento, que provoca maior trauma e sangramento nos tecidos, é a casusa de reações adversas. / Objective: The objective of this study was to evaluate clinical and hitopathology the reaction of the fill material at two different sites. Method: Twenty-two female Wistar rats (Rattus norvegicus) submitted the application of PMMA testing two techniques: subcutaneous and trans. After 3 months of surgery, the rats were euthanized and the injected areas were excised, subjected to paraffin embedding technique and stained with hematoxylin and eosin. The slides were analyzed by observing the local response to injection of foreign body in the degree of inflammation. Results: We found statistically significant differences between sites and subdermal muscle as granuloma formation (p <0.05), and the subdermal group achieved better results. Conclusion: The application of filling materials, which causes more injury and bleeding in the tissues, is Casusa of adverse reactions.

<b>Background:</b> The aim of this thesis was to develop an evidence-based approach to the post-marketing withdrawal of medicinal products when harms are attributed to their use. <b>Methods:</b> Electronic and non-electronic searches were conducted to identify medicinal products withdrawn from the market because of adverse reactions. Data relating to the time periods between launch, first adverse reaction reports and withdrawals, the mechanism through which the adverse reactions occurred, and the countries of withdrawal were extracted. Standard criteria were used to document the levels of evidence used by drug regulators to make the withdrawal decisions; scatter plots and two-by-two tables used to explore the trends over time. A previously published algorithm was used to examine the justification for withdrawals. To examine the benefits and harms of medicinal products before regulatory approval, searches were conducted on drug regulatory websites and scientific databases. The Cochrane criterion was used to examine the risk of bias, Review Manager Software for meta-analysis, and GRADE criterion to rate the quality of evidence. <b>Results:</b> Improvements in pharmacovigilance over the past six decades have resulted in quicker detection of harms caused by approved medicinal products; however, there have not been corresponding improvements in how quickly harmful products are withdrawn from the market following the reports of harms. Harmful drugs are significantly less likely to be withdrawn in low resource settings. The quality of evidence in drug trials for which regulatory approval decisions are based is on the whole, poor. There is a lack of consistency in the methods used by drug regulators to assess the harms of medicinal products before granting marketing licences. <b>Conclusions:</b> Universally accepted guidelines for deciding when to withdraw approved medicinal products from the market should be developed. Pharmacovigilance systems in low-resource settings should be strengthened. The methods used to assess harms in clinical trials require improvement.

Objetivo: O objetivo deste estudo foi avaliar clínica e hitologicamente a reação do material de preenchimento em dois sítios diferentes. Método: Vinte e duas femêas de ratos Wistar (Rattus novergicus) foram submetidas a aplicação de PMMA testando duas técnicas: subcutânea e transmuscular. Passados 3 meses do ato cirúrgico os ratos foram eutanasiados e as áreas injetadas foram excisadas, submetidas a técnica de inclusão em parafina e coloração por hematoxilina e eosina. As lâminas foram analisadas observando-se a resposta local à injeção do corpo estranho quanto ao grau de inflamação. Resultados: Foi encontrada diferença significativamente estatística entre os sítios muscular e subdérmico quanto a formação de granuloma (p<0,05), sendo que o grupo subdérmico obteve melhores resultados. Conclusão: A aplicação de materiais de preenchimento, que provoca maior trauma e sangramento nos tecidos, é a casusa de reações adversas. / Objective: The objective of this study was to evaluate clinical and hitopathology the reaction of the fill material at two different sites. Method: Twenty-two female Wistar rats (Rattus norvegicus) submitted the application of PMMA testing two techniques: subcutaneous and trans. After 3 months of surgery, the rats were euthanized and the injected areas were excised, subjected to paraffin embedding technique and stained with hematoxylin and eosin. The slides were analyzed by observing the local response to injection of foreign body in the degree of inflammation. Results: We found statistically significant differences between sites and subdermal muscle as granuloma formation (p <0.05), and the subdermal group achieved better results. Conclusion: The application of filling materials, which causes more injury and bleeding in the tissues, is Casusa of adverse reactions.

Objetivo: O objetivo deste estudo foi avaliar clínica e hitologicamente a reação do material de preenchimento em dois sítios diferentes. Método: Vinte e duas femêas de ratos Wistar (Rattus novergicus) foram submetidas a aplicação de PMMA testando duas técnicas: subcutânea e transmuscular. Passados 3 meses do ato cirúrgico os ratos foram eutanasiados e as áreas injetadas foram excisadas, submetidas a técnica de inclusão em parafina e coloração por hematoxilina e eosina. As lâminas foram analisadas observando-se a resposta local à injeção do corpo estranho quanto ao grau de inflamação. Resultados: Foi encontrada diferença significativamente estatística entre os sítios muscular e subdérmico quanto a formação de granuloma (p<0,05), sendo que o grupo subdérmico obteve melhores resultados. Conclusão: A aplicação de materiais de preenchimento, que provoca maior trauma e sangramento nos tecidos, é a casusa de reações adversas. / Objective: The objective of this study was to evaluate clinical and hitopathology the reaction of the fill material at two different sites. Method: Twenty-two female Wistar rats (Rattus norvegicus) submitted the application of PMMA testing two techniques: subcutaneous and trans. After 3 months of surgery, the rats were euthanized and the injected areas were excised, subjected to paraffin embedding technique and stained with hematoxylin and eosin. The slides were analyzed by observing the local response to injection of foreign body in the degree of inflammation. Results: We found statistically significant differences between sites and subdermal muscle as granuloma formation (p <0.05), and the subdermal group achieved better results. Conclusion: The application of filling materials, which causes more injury and bleeding in the tissues, is Casusa of adverse reactions.

No commercial use is permitted unless otherwise expressly granted. Abciximab, the first approved glycoprotein (GP IIb/IIIa) inhibitor, is being widely used during acute coronary syndromes and offers the promising approach to antithrombotic therapy. We present a case of a young woman who initially received abciximab infusion for undergoing percutaneous coronary intervention of left anterior descending artery and was eventually diagnosed with abciximab-induced delayed thrombocytopaenia. This case outlines the importance of close follow-up of these patients to prevent serious adverse events.

Magistro baigiamojo darbo tikslas – retrospektyviai išnagrinėti veterinarijos farmakologinio budrumo sistemos vykdymą Lietuvoje nuo 2004 iki 2013 metų. Siekiant nurodyto tikslo buvo iškelti tokie uždaviniai: susipažinti su prieinama moksline literatūra lietuvių ir anglų kalbomis, išanalizuoti veterinarijos farmakologinio budrumo organizavimą ir atitinkamus teisės aktus, reglamentuojančius veterinarijos farmakologinį budrumą; atlikti Lietuvos veterinarijos farmakologinio budrumo dešimties metų analizę, už budrumą atsakingoje institucijoje; įvertinti veterinarijos farmakologinio budrumo sistemos efektyvumą Lietuvoje; išsiaiškinti problemas, lemiančias tokius rezultatus. Pirmajame darbo skyriuje yra nagrinėjama veterinarijos farmakologinio budrumo samprata, su tuo susiję teisės aktai, reguliavimas ir vykdymas Lietuvoje. Antrame skyriuje atlikus tyrimą gauti rezultatai parodė, kad Lietuvoje vykdomo veterinarijos farmakologinio budrumo sistema yra menka, gaunamas pranešimų skaičius yra vos keli pranešimai per metus. Prieita išvados, kad Lietuvoje vykdomo veterinarijos farmakologinio budrumo efektyvumas yra labai blogas. Nustatyta viena iš pagrindinių priežasčių, lemiančių tokį rezultatą – menkas visuomenės ir veterinarų praktikų aktyvumas ir nenoras pranešti apie pastebėtas nepalankias veterinarinių vaistų reakcijas. Darbo apimtis 32 puslapis, darbe yra 4 lentelės ir 2 paveikslai, buvo panaudoti 25 literatūros šaltiniai. / Master’s final thesis aims was to perform the retrospective analysis of veterinary pharmacovigilance system in Lithuania in the period from 2004 to 2013. To achieve this objective, the below goals were stated: to analyse available scientific literature in the Lithuanian and English languages concerning topic; to reveal veterinary pharmacovigilance concept; to analyse Lithuanian legislation governing veterinary pharmacovigilance; to make analysis of veterinary pharmacovigilance for the period of 10 years in the institutions in charge; to evaluate efficiency of veterinary pharmacovigilance system in Lithuania; to find out the problems leading to such results. The first part of the thesis analyses the concept of veterinary pharmacovigilance and the related legislation governing and implementing it in Lithuania. In the second part of the thesis the obtained results are presented that showed that the system of veterinary pharmacovigilance in Lithuania is weak. Only a few cases have been reported within a year. It suggests that efficiency of veterinary pharmacovigilance system in Lithuania is equal to zero. One of the main reasons responsible for poor results has been found i.e. unwillingness of the society and veterinary practicians to report detected reactions to veterinary medications. Volume of master thesis 32 pages, with 4 tables and 2 pictures. 25 references have been used.

Wen Er Ya Jane. / Thesis (M.Phil.)--Chinese University of Hong Kong, 1995. / Includes bibliographical references (leaves 130-134). / Table of contents --- p.ii / List of tables --- p.iv / List of figures --- p.vi / Abstract --- p.vii / Glossary of abbreviations --- p.ix / Acknowledgments --- p.x / Chapter CHAPTER 1 --- INTRODUCTION --- p.1 / Chapter 1.1 --- DEFINITIONS AND CLASSIFICATIONS...............................Error! Bookmark not defined / Chapter 1.1.1 --- Classification of drug-related problems --- p.2 / Chapter 1.1.2 --- Adverse drug reactions (ADRs) --- p.2 / Chapter 1.1.3 --- Drug interactions (DI) --- p.7 / Chapter 1.1.4 --- Therapeutic failures (TF) --- p.8 / Chapter 1.1.5 --- Non-compliance --- p.10 / Chapter 1.1.6 --- Drug overdoses (DO) or drug poisonings --- p.11 / Chapter 1.1.7 --- Drug-related hospitalizations (DRH) --- p.12 / Chapter 1.1.8 --- Other relevant definitions --- p.13 / Chapter 1.2 --- LITERATURE REVIEW --- p.16 / Chapter 1.2.1 --- Adverse drug reactions --- p.16 / Chapter 1.2.2 --- Hospital admission due to ADRs --- p.18 / Chapter 1.2.3 --- Drug-related hospitalizations (DRH) --- p.22 / Chapter 1.2.4 --- Discussion --- p.24 / Chapter 1.3 --- PURPOSE OF THIS STUDY --- p.27 / Chapter CHAPTER 2 --- METHODS --- p.30 / Chapter 2.1 --- BACKGROUND --- p.30 / Chapter 2.2 --- DATA COLLECTION --- p.31 / Chapter 2.2.1 --- The patients --- p.31 / Chapter 2.2.2 --- The drug history --- p.31 / Chapter 2.2.3 --- Patients knowledge of drugs they were taking --- p.33 / Chapter 2.2.4 --- Compliance --- p.33 / Chapter 2.2.5 --- Previous episodes of adverse drug reactions --- p.34 / Chapter 2.2.6 --- Diagnosis and outcome --- p.34 / Chapter 2.2.7 --- Laboratory Results --- p.34 / Chapter 2.2.8 --- Demographic characteristics of the patients --- p.35 / Chapter 2.2.9 --- The data sheet --- p.36 / Chapter 2.3. --- CASE REVIEW (REASSESSMENT) --- p.41 / Chapter 2.4 --- CODING OF DATA --- p.41 / Chapter 2.4.1 --- Coding of general data except diagnoses and drugs --- p.41 / Chapter 2.4.2 --- Coding of diagnoses --- p.42 / Chapter 2.4.3 --- Coding of drugs --- p.42 / Chapter 2.5 --- STATISTICAL ANALYSIS --- p.42 / Chapter CHAPTER 3 --- RESULTS --- p.43 / Chapter 3.1 --- THE PATIENTS --- p.43 / Chapter 3.1.1 --- Age and sex distributions --- p.43 / Chapter 3.1.2 --- Patients' ADL and living environments --- p.47 / Chapter 3.1.3 --- Baseline liver and renal function tests --- p.50 / Chapter 3.1.4 --- Diagnoses --- p.52 / Chapter 3.2 --- DRUG USE PRIOR TO ADMISSION --- p.54 / Chapter 3.2.1 --- Overview --- p.54 / Chapter 3.2.2 --- Consumption patterns for the prescribed drugs --- p.61 / Chapter 3.2.3 --- Sources and durations for the prescribed drugs --- p.69 / Chapter 3.2.4 --- Consumption patterns for self-medications --- p.71 / Chapter 3.2.5 --- Source and duration of the self-medications --- p.73 / Chapter 3.2.6 --- Drug overdose patterns --- p.75 / Chapter 3.3 --- PATIENTS' KNOWLEDGE OF THE EFFECTS AND SIDE-EFFECTS OF DRUGS --- p.74 / Chapter 3.3.1 --- Overview --- p.74 / Chapter 3.3.2 --- Patients' knowledge of the effects of their prescribed drugs --- p.74 / Chapter 3.3.3 --- Patients' knowledge of the side-effects of their prescribed drugs --- p.77 / Chapter 3.4 --- COMPLIANCE --- p.79 / Chapter 3.5 --- DRUG-RELATED HOSPITALIZATIONS (DRH) --- p.82 / Chapter 3.5.1 --- Overview --- p.82 / Chapter 3.5.2 --- Adverse drug reactions (ADRs) --- p.84 / Chapter 3.5.3 --- Outcome of ADRs --- p.98 / Chapter 3.5.4 --- "Therapeutic failures (Non-compliance, Inappropriate dose reduction)" --- p.100 / Chapter 3.5.5 --- Drug overdoses --- p.104 / Chapter CHAPTER 4 --- DISCUSSION --- p.106 / Chapter 4.1 --- ABOUT THE PATIENTS --- p.106 / Chapter 4.2 --- DISEASE PATTERNS AND DRUG CONSUMPTION PATTERNS --- p.107 / Chapter 4.2.1 --- Diagnoses on admission --- p.107 / Chapter 4.2.2 --- Drug consumption patterns --- p.109 / Chapter 4.2.3 --- About the sources and durations of the prescribed drugs --- p.112 / Chapter 4.2.4 --- About the self-medications --- p.113 / Chapter 4.3 --- ABOUT PATIENTS' KNOWLEDGE OF THE DRUGS --- p.114 / Chapter 4.4 --- ABOUT COMPLIANCE --- p.116 / Chapter 4.5 --- ABOUT ADRS AND DRUGS INTERACTIONS --- p.118 / Chapter 4.5.1 --- The incidence of ADRs --- p.118 / Chapter 4.5.2 --- The patterns of ADRs --- p.119 / Chapter 4.5.3 --- The drugs and ADRs --- p.119 / Chapter 4.5.4 --- Self-medications and ADRs --- p.121 / Chapter 4.5.5 --- The risk factors for ADRs --- p.122 / Chapter 4.5.6 --- Drug interactions --- p.125 / Chapter 4.6 --- ABOUT THERAPEUTIC FAILURES --- p.126 / Chapter 4.7 --- ABOUT DRUG OVERDOSES --- p.127 / Chapter 4.8 --- CONCLUSIONS --- p.128 / BIBLIOGRAPHY --- p.130