This research aimed to measure the effect on health outcomes of implementing selected recommendations of the Grampian Joint Drug Formulary in primary care. Antibiotics used in the treatment of uncomplicated lower urinary tract infections (UTIs), ulcer healing agents and peripheral vasodilators were selected for study, thereby reflecting both acute and chronic prescribing. For the UTI study, 12 randomly selected high and low prescribers of trimethoprim, the recommended agent, each agreed to distribute 20 patient questionnaires. Following a period of 18 months and despite repeated contact with the GPs, only 89/480 (19%) questionnaires had been distributed. Patient response was, however, very high with 80 (90%) questionnaires returned. Health outcome measures identified that trimethoprim resulted in no or mild symptoms in 40/45 (91 %) of patients. These findings must be interpreted with caution due to the low level of questionnaire distribution and thus cannot be extrapolated to the total population of patients. In addition, the poor questionnaire distribution did not permit comparison between trimethoprim and non-recommended therapy. One hundred and eighty four patients receiving repeat prescriptions for ulcer healing agents were identified from one general practice. Therapy in 95 patients did not adhere to formulary recommendations. Changes to therapy were considered inappropriate in 11 patients due to factors such as severe depression and a further 8 were deemed unsuitable for participation for non-clinical reasons. The remaining 76 patients were contacted with 19 (25%) refusing to participate. Fifty seven patients were interviewed using the Glasgow Dyspepsia Severity Score and Short Form 36 (SF-36). Changes in health outcomes were measured for 21 patients where a change in therapy had taken place. These results were difficult to interpret due to the diversity of changes recommended and the lack of data relating to those patients not participating. Work involving peripheral vasodilators aimed to determine the effect on health outcomes of cessation of therapy. Forty five patients receiving these agents in 2 practices were identified, although 8 had not requested a prescription in the previous year. Two further patients were excluded from the study due to cancer and old age. The remaining 35 agreed to be interviewed using the Walking Impairment Questionnaire and SF-36. All patients were subsequently instructed to stop therapy for 2 months, although 6 (17%) refused to follow this instruction, one patient was seriously ill thus was excluded and 3 refused to be reinterviewed. Of the remaining 25 patients, no significant differences were observed in the domains studied. Seventeen patients (68%) expressed no desire to restart therapy, generating considerable savings. These results must be interpreted with caution since those not stopping therapy or refusing re-interview are likely to have responded differently to those completing the study. The measurement of health outcomes following formulary implementation deserves further work.

Thesis (M.S.)--University of Wisconsin--Madison, 1984. / Typescript. eContent provider-neutral record in process. Description based on print version record. Includes bibliographical references (leaves 6-7).

The oral route of drug administration is convenient since it is acceptable to most patients and the manufacturing processes used to produce tablets and capsules are relatively simple when compared to those used to manufacture other types of dosage forms. Metronidazole (MTZ) and Ranitidine (RTD) have been used in combination, as part of triple therapy for the treatment of ulcers. However the use of large numbers of tablets and long duration of therapy makes adherence to drug treatment challenging for patients. Therefore the formulation of a fixed dose combination (FDC) of MTZ and RTD may improve patient adherence to therapy and consequently may reduce morbidity and mortality due to ulcers. A stability indicating HPLC method for the simultaneous analysis of MTZ and RTD was developed and validated according to the International Conference on Harmonization (ICH) guidelines. The method was sensitive, selective, precise, accurate and linear.Preformulation studies were performed on the active pharmaceutical ingredients (API) alone and in combination with potential excipients. Differential scanning calorimetry (DSC) studies revealed a potential interaction between MTZ and RTD, however the interaction was not apparent following IR analysis of the same samples. DSC analyses of the API in combination with potential excipients revealed that the compounds were compatible with most materials with the exception of a binary mixture of RTD and Dibasic calcium phosphate (DCP) that exhibited a potential interaction. Thermal gravimetric analysis (TGA) of MTZ and RTD revealed that both compounds exhibited thermal stability. The Carrs Index (CI) and Hausner Ratio (HR) values of MTZ and RTD indicated that both compounds exhibited poor flow and compressibility properties, whereas the CI and HR values for (Microcrystalline cellulose) MCC and DCP indicated better flowability and compressibility characteristics.Direct compression and wet granulation processes were assessed to identify a suitable method of manufacture of FDC tablets of MTZ and RTD. The blends were evaluated using bulk and tapped density and the resultant tablets were evaluated for weight uniformity, crushing strength, tensile strength and disintegration time. The wet granulation method of manufacture produced tablets that showed acceptable pharmacotechnical properties: this approach was therefore used as the method of manufacture of FDC tablets of MTZ and RTD. Tablet formulations comprised of API, viz. MTZ and RTD and different compositions of MCC, DCP, Sodium starch glycolate (SSG) and Croscarmellose sodium (CCS), were manufactured in order to screen for an appropriate diluent and disintegrant composition for use in response surface studies. Assays of tablet content and in vitro drug release were undertaken using the validated HPLC method. Tablets in which MCC and CCS were used appeared to produce better assay and dissolution results as compared to those manufactured using DCP and SSG. Consequently a formulation comprised of MCC and CCS was selected and used in studies in which the effect(s) of level two formulation and composition changes as described in the Scale and Post Approval Changes for Immediate Release (SUPAC-IR) Guidelines on tablet disintegration and in vitro release were assessed. A Box-Behnken statistical design was used for the investigation of the effect of input factors, viz. CCS, (Polyvinyl pyrollidone K30) PVP-K30 and magnesium stearate on measured responses, viz. disintegration time and percent drug release in 10 minutes (Q10). CCS appeared to have an inverse linear relationship on disintegration time and a linear relationship with the Q10 for MTZ and RTD, whereas PVP-K30 and magnesium stearate appeared to have an antagonistic effect on the measured responses. Furthermore CCS and magnesium stearate exhibited an interaction that had an agonistic effect on the Q10 value for RTD. A numerical optimization approach was used to predict a formulation composition that would produce tablets that exhibited a disintegration time and Q10 values for MTZ and RTD that fell within the constraints set in our laboratory. The resultant model was found to be accurate and had a percent prediction error of < 5% for all measured response variables.FDC tablets of MTZ and RTD have been successfully produced. The disintegration of the tablet and dissolution of the API were within compendial specifications and the tablets are of suitable quality and have the potential to be further investigated to reduce the pill burden in the treatment of ulcers.

Made available in DSpace on 2014-06-11T19:25:25Z (GMT). No. of bitstreams: 0 Previous issue date: 2012-05-03Bitstream added on 2014-06-13T20:13:49Z : No. of bitstreams: 1 angelis_cd_me_botib.pdf: 1154127 bytes, checksum: 1ef7fdb7f18fb78d78420a1fd718bde4 (MD5) / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) / Este projeto se propôs a avaliar a ação farmacológica do nerol na prevenção de úlcera péptica. Nerol na dose de 60 mg/Kg por via oral exerceu proteção contra lesão gástrica induzida por etanol e por droga anti-inflamatória não esteróide (DAINE) em ratos, mas não protegeu contra úlcera duodenal induzida por cisteamina. Experimentos foram realizados para a elucidação dos mecanismos ação e verificou-se que a proteção exercida pelo Nerol não é por bloqueio dos radicais livres, por redução da secreção gástrica ou por aumento de muco, sua ação também não ocorre por formação de barreira mecânica. Verificou-se, contudo, que houve redução da motilidade gastrointestinal, o que pode ser um indicativo de redução do esvaziamento gástrico, o que contribui para o efeito gastroprotetor. A redução da motilidade gastrointestinal assim como a redução do acúmulo intestinal exercido pelo nerol foi revertida pela administração de naloxona (antagonista de receptores opióides), indicando, portanto, o envolvimento destes receptores. Através do bloqueio de fatores protetores da mucosa gástrica, verificou-se que a gastroproteção exercida pelo nerol é independente da via do óxido nítrico, de prostaglandinas e dos receptores mu opióides, porém, é dependente de compostos sulfidrílicos. Mostrou-se através da quantificação dos níveis de glutationa (GSH) e da atividade da enzima mieloperoxidase (MPO) que o tratamento com nerol mantém os níveis de compostos sulfidrílicos não-protéicos e reduz a infiltração de neutrófilos na mucosa gástrica em animais com lesão gástrica induzida por etanol. A administração aguda de nerol (doses de 60, 300, 600, 1250, 2500 ou 5000 mg/Kg) não provocou mortes nem alterações significantes nos parâmetros comportamentais até a dose de 600 mg/Kg. Neste trabalho portanto, ficou... / The present project proposed to evaluate the pharmacologic action of nerol in the prevection of peptic ulcer. It was seen that 60 mg/kg (p.o.) of nerol prevented gastric lesions induced by ethanol and no steroidal anti-inflammatory drugs (NSAID) in rats, however nerol did not have protected duodenal mucosa against cysteamine. Assays were performed to elucidation of the mechanisms of action and it was found that protection exerted by Nerol does not by block of free radicals, nor decrease gastric acid secretion nor increase mucus, its action is not by create a mechanical barrier. However It was found that nerol reduced gastrointestinal motility, this might be an indicative of slower gastric emptying that contribute to the gastric protective effect. Reduction of gastrointestinal motility, as well as the reduction of intestinal accumulation exerted by nerol was reverted by naloxone administration (antagonist of opioid receptors), therefore indicating involvement of the cited receptors. By blocking protective factors of gastric mucosa, it was verified that nerol’s gastroprotective effect does not involve nitric oxide, prostaglandin nor mu opioid receptors, but is dependent of sulfhydryl compounds. It was shown by quantifying glutathione levels (GSH) and myeloperoxidase (MPO) action that treatment with nerol keeps the levels of non proteic sulfhydryl compounds and decreases the neutrophil infiltration into the gastric mucosa in animals with ethanol-induced gastric damage. Acute administration of nerol (60, 300, 600, 1250, 2500 and 5000 mg/Kg) presented no deaths, neither significant behavior changes to doses of 60, 300 and 600 mg/kg. In this work, nerol showed a gastroprotective effect against ethanol- and indomethacin-induced lesions, and the depence of sulfhydryl compounds. The involvement of opioid receptors and the gastrointestinal... (Complete abstract click electronic access below)

Made available in DSpace on 2014-06-11T19:25:25Z (GMT). No. of bitstreams: 0 Previous issue date: 2012-02-29Bitstream added on 2014-06-13T20:32:58Z : No. of bitstreams: 1 silva_lp_me_botib.pdf: 563622 bytes, checksum: 1127f9077b3edb602419139bfa626408 (MD5) / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) / Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) / Terminalia catappa Linn é uma espécie comumente utilizada para arborização nas regiões tropical e subtropical. Essa espécie é também utilizada, em países da Ásia, como Taiwan, Índia, Flipinas e Indonésia, para tratamento de distúrbios hepáticos e do trato gastrointestinal. A literatura aponta que seus constituintes encontrados nos extratos polares das folhas são principalmente compostos polifenólicos, em especial os taninos. A partir desses dados e da ausência de registros na literatura sobre a ação antiulcerogênica desta espécie foram realizados estudos para avaliação dessa atividade das frações e caracterização da fração mais ativa, assim como a determinação do mecanismo de ação gastroprotetor e cicatrizante da fração ativa. A partir do extrato etanólico bruto das folhas, que em estudo anterior realizado pelo grupo demonstrou atividade gastroprotetora, antisecretória e cicatrizante, foi feita a partição com três solventes de diferentes polaridades (hexano, acetato de etila e metanol/água). As três frações oriundas destas extrações apresentaram ação gastroprotetora em úlcera induzida por etanol absoluto, porém a fração mais efetiva foi a aquosa na dose de 25 mg/Kg, selecionada para caracterizar os mecanismos de ação envolvidos na ação antiulcerogênica como: óxido nítrico (NO), prostaglandinas (PG), aumento de muco e atividade antioxidante por meio da manutenção dos níveis de glutationa e redução da atividade da enzima mieloperoxidase (MPO). Não foram observadas a participação dos grupamentos sulfidrila e ação antisecretória. Foi constatada atividade cicatrizante tanto com 7 como com 14 dias de tratamento, consecutivos, da fração aquosa. Durante o tratamento com a partição aquosa ocorreu uma... / Terminalia catappa Linn is a specie commonly used for afforestation in tropical and subtropical regions. It is used, in Asian countries, as Taiwan, India, Filipines and Indonesia, for treatment of hepatic and gastrointestinal disorders. Studies point to poliphenols as main components of polar leaves extract, specially the tannins. Based on this and in the lack of information about a possible gastroprotective action of this specie, studies for avaliation of this activity were done with fractions of the ethanolic extract, and gastroprotective action mechanisms were characterized in the most active fraction. A previous study done by our group showed the ethanolic extract as gastroprotective, antisecretory and healing. The ethanol extract were partitioned with three different solvents, hexane, etil acetate and methanol/water. The three fractions showed gastroprotective action in the model of ulcer induced by ethanol, but the most effective was aquous fraction in a dose of 25 mg/Kg, which was the one selected to the characterization of the mechanisms involved in the antiulcerogenic activity as: nitric oxide (NO), prostaglandins (PG), mucus and antioxidant activity by maintenance of glutathione levels and reduction in mieloperoxidase (MPO) enzyme activity. No participation of sulphidryls compounds and antisecretory activity were detected. The aquous fraction also showed healing action in the treatment for 7 and 14 days, in both of them was detected a down-regulation in metalloproteinase-2 (MPP-2). In a subchronic toxicity avaliation, the aquous fraction in 25 mg/Kg doesn´t presented a toxic potential. In the model of gastric ulcer induced by indomethacin, the aquous fraction in a dose of 50 mg/Kg, aggravated the lesions, which showed an evidence for antiinflamatory activity, it was confirmed in Formalin test and ear edema induced by... (Complete abstract click electronic access below)

Made available in DSpace on 2014-06-11T19:26:42Z (GMT). No. of bitstreams: 0 Previous issue date: 2011-02-28Bitstream added on 2014-06-13T19:13:52Z : No. of bitstreams: 1 oliveira_mg_me_botfm.pdf: 765631 bytes, checksum: 770d8b935d3cfcc2b0617ece4f83fe51 (MD5) / Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) / As úlceras venosas são impactantes e representam um grande desafio médico devido ao entrelaçamento de comorbidades e causas multifatoriais, sendo de suma importância o surgimento de inovações tecnológicas na abordagem terapêutica que sejam acessíveis aos seus portadores. Diante dessa realidade, este trabalho se propôs a abordar as úlceras venosas comparando um produto existente no mercado, Hidrocolóide (HC), com uma proposta in house, o Gel de Plaquetas (GP), através da diminuição da área, avaliação descritiva da vascularização e queixas referidas. Participaram do estudo 17 pacientes, perfazendo um total de 22 úlceras venosas que foram acompanhados durante 90 dias, utilizando um dos produtos citados, de acordo com o randomização, em associação com o uso de faixas elásticas. A distribuição do grupo, segundo a randomização foi de 13 lesões no grupo de hidrocolóide e 9 no grupo de gel de plaquetas. A média percentual de redução das áreas das feridas foi de 57,78% para hidrocolóide e de 53,45% para gel de plaquetas, não apresentando diferenças estatisticamente significativas. O desempenho dos produtos estudados apresentaram grande similaridade no percentual de redução de área, o que indica que é preciso um estudo amostral maior para evidenciar superioridade de um produto sobre o outro. Porém quando comparados, quanto ao menor tempo de acompanhamento (D15), o gel de plaquetas apresentou melhor desempenho, com redução maior do que o hidrocolóide em tempo reduzido semelhante. A análise histológica no momento pré e pós tratamento sugere que o GP atua de forma a estimular a regeneração dos tecidos (estroma coeso) e de forma mais definitiva (distribuição dos vasos difusa na derme reticular). O aspecto do fechamento da lesão é mais consistente quando comparado com os pacientes que usaram HC onde se observou a formação de uma fina epiderme frágil... / Venous ulcers are striking and represent a major challenge due to the commingling of medical comorbidities and multifactorial causes, with the emergence of great importance to technological innovations in therapeutic approaches that are accessible to their patients. Given this reality, this study proposes to address venous ulcers comparing a product on the market, hydrocolloid (HC) with a proposed in-house, the Platelet Gel (GP), by decreasing the area and descriptive evaluation of vascularization complaints referred. The study included 17 patients, a total of 22 venous ulcers who were followed for 90 days, using one of the products listed, according to the randomization, in association with the use of compression elastic. The distribution of the group, according to randomization was 13 injuries in the hydrocolloid group and 9 in the group of platelet gel. The average percentage reduction of wound areas was 57.78% for hydrocolloid and 53.45% for platelet gel, showing no statistically significant differences. The performance of the products studied showed great similarity in the percentage of area reduction, which indicates that it is necessary to study a larger sample to demonstrate the superiority of one product over another. But when compared, for the shortest time of follow-up (D15), the platelet gel performed better, with greater reductions than the hydrocolloid in a short time like that. Histological analysis in the D0 and D90 of the treatment suggests that the GP acts to stimulate the regeneration of tissues (stroma together) and more definite form (diffuse distribution of vessels in the reticular dermis). The appearance of the closure of the injury is more consistent when compared with patients who used HC we observed the formation of a thin skin, fragile, observed in histological sections showed that a distribution of vessels in the papillary dermis. Histological sections confirmed... (Complete abstract click electronic access below)

Orientador: Clélia Akiko Hiruma-Lima / Banca: Wagner Villegas / Banca: Walter Toma / Resumo: Terminalia catappa Linn é uma espécie comumente utilizada para arborização nas regiões tropical e subtropical. Essa espécie é também utilizada, em países da Ásia, como Taiwan, Índia, Flipinas e Indonésia, para tratamento de distúrbios hepáticos e do trato gastrointestinal. A literatura aponta que seus constituintes encontrados nos extratos polares das folhas são principalmente compostos polifenólicos, em especial os taninos. A partir desses dados e da ausência de registros na literatura sobre a ação antiulcerogênica desta espécie foram realizados estudos para avaliação dessa atividade das frações e caracterização da fração mais ativa, assim como a determinação do mecanismo de ação gastroprotetor e cicatrizante da fração ativa. A partir do extrato etanólico bruto das folhas, que em estudo anterior realizado pelo grupo demonstrou atividade gastroprotetora, antisecretória e cicatrizante, foi feita a partição com três solventes de diferentes polaridades (hexano, acetato de etila e metanol/água). As três frações oriundas destas extrações apresentaram ação gastroprotetora em úlcera induzida por etanol absoluto, porém a fração mais efetiva foi a aquosa na dose de 25 mg/Kg, selecionada para caracterizar os mecanismos de ação envolvidos na ação antiulcerogênica como: óxido nítrico (NO), prostaglandinas (PG), aumento de muco e atividade antioxidante por meio da manutenção dos níveis de glutationa e redução da atividade da enzima mieloperoxidase (MPO). Não foram observadas a participação dos grupamentos sulfidrila e ação antisecretória. Foi constatada atividade cicatrizante tanto com 7 como com 14 dias de tratamento, consecutivos, da fração aquosa. Durante o tratamento com a partição aquosa ocorreu uma... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: Terminalia catappa Linn is a specie commonly used for afforestation in tropical and subtropical regions. It is used, in Asian countries, as Taiwan, India, Filipines and Indonesia, for treatment of hepatic and gastrointestinal disorders. Studies point to poliphenols as main components of polar leaves extract, specially the tannins. Based on this and in the lack of information about a possible gastroprotective action of this specie, studies for avaliation of this activity were done with fractions of the ethanolic extract, and gastroprotective action mechanisms were characterized in the most active fraction. A previous study done by our group showed the ethanolic extract as gastroprotective, antisecretory and healing. The ethanol extract were partitioned with three different solvents, hexane, etil acetate and methanol/water. The three fractions showed gastroprotective action in the model of ulcer induced by ethanol, but the most effective was aquous fraction in a dose of 25 mg/Kg, which was the one selected to the characterization of the mechanisms involved in the antiulcerogenic activity as: nitric oxide (NO), prostaglandins (PG), mucus and antioxidant activity by maintenance of glutathione levels and reduction in mieloperoxidase (MPO) enzyme activity. No participation of sulphidryls compounds and antisecretory activity were detected. The aquous fraction also showed healing action in the treatment for 7 and 14 days, in both of them was detected a down-regulation in metalloproteinase-2 (MPP-2). In a subchronic toxicity avaliation, the aquous fraction in 25 mg/Kg doesn't presented a toxic potential. In the model of gastric ulcer induced by indomethacin, the aquous fraction in a dose of 50 mg/Kg, aggravated the lesions, which showed an evidence for antiinflamatory activity, it was confirmed in Formalin test and ear edema induced by... (Complete abstract click electronic access below) / Mestre

Orientador: Clélia Akiko Hiruma-Lima / Banca: Elfriede Marianne Bacchi / Banca: Luiz Claudio Di Stasi / Resumo: Este projeto se propôs a avaliar a ação farmacológica do nerol na prevenção de úlcera péptica. Nerol na dose de 60 mg/Kg por via oral exerceu proteção contra lesão gástrica induzida por etanol e por droga anti-inflamatória não esteróide (DAINE) em ratos, mas não protegeu contra úlcera duodenal induzida por cisteamina. Experimentos foram realizados para a elucidação dos mecanismos ação e verificou-se que a proteção exercida pelo Nerol não é por bloqueio dos radicais livres, por redução da secreção gástrica ou por aumento de muco, sua ação também não ocorre por formação de barreira mecânica. Verificou-se, contudo, que houve redução da motilidade gastrointestinal, o que pode ser um indicativo de redução do esvaziamento gástrico, o que contribui para o efeito gastroprotetor. A redução da motilidade gastrointestinal assim como a redução do acúmulo intestinal exercido pelo nerol foi revertida pela administração de naloxona (antagonista de receptores opióides), indicando, portanto, o envolvimento destes receptores. Através do bloqueio de fatores protetores da mucosa gástrica, verificou-se que a gastroproteção exercida pelo nerol é independente da via do óxido nítrico, de prostaglandinas e dos receptores mu opióides, porém, é dependente de compostos sulfidrílicos. Mostrou-se através da quantificação dos níveis de glutationa (GSH) e da atividade da enzima mieloperoxidase (MPO) que o tratamento com nerol mantém os níveis de compostos sulfidrílicos não-protéicos e reduz a infiltração de neutrófilos na mucosa gástrica em animais com lesão gástrica induzida por etanol. A administração aguda de nerol (doses de 60, 300, 600, 1250, 2500 ou 5000 mg/Kg) não provocou mortes nem alterações significantes nos parâmetros comportamentais até a dose de 600 mg/Kg. Neste trabalho portanto, ficou... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: The present project proposed to evaluate the pharmacologic action of nerol in the prevection of peptic ulcer. It was seen that 60 mg/kg (p.o.) of nerol prevented gastric lesions induced by ethanol and no steroidal anti-inflammatory drugs (NSAID) in rats, however nerol did not have protected duodenal mucosa against cysteamine. Assays were performed to elucidation of the mechanisms of action and it was found that protection exerted by Nerol does not by block of free radicals, nor decrease gastric acid secretion nor increase mucus, its action is not by create a mechanical barrier. However It was found that nerol reduced gastrointestinal motility, this might be an indicative of slower gastric emptying that contribute to the gastric protective effect. Reduction of gastrointestinal motility, as well as the reduction of intestinal accumulation exerted by nerol was reverted by naloxone administration (antagonist of opioid receptors), therefore indicating involvement of the cited receptors. By blocking protective factors of gastric mucosa, it was verified that nerol's gastroprotective effect does not involve nitric oxide, prostaglandin nor mu opioid receptors, but is dependent of sulfhydryl compounds. It was shown by quantifying glutathione levels (GSH) and myeloperoxidase (MPO) action that treatment with nerol keeps the levels of non proteic sulfhydryl compounds and decreases the neutrophil infiltration into the gastric mucosa in animals with ethanol-induced gastric damage. Acute administration of nerol (60, 300, 600, 1250, 2500 and 5000 mg/Kg) presented no deaths, neither significant behavior changes to doses of 60, 300 and 600 mg/kg. In this work, nerol showed a gastroprotective effect against ethanol- and indomethacin-induced lesions, and the depence of sulfhydryl compounds. The involvement of opioid receptors and the gastrointestinal... (Complete abstract click electronic access below) / Mestre

Orientadores: Ana Terezinha Guillaumon, Maria Beatriz Puzzi / Tese (doutorado) - Universidade Estadual de Campinas. Faculdade de Ciências Médicas / Made available in DSpace on 2018-08-16T04:02:11Z (GMT). No. of bitstreams: 1 Bosnardo_CarlaAparecidaFaccio_D.pdf: 1290843 bytes, checksum: bad65c993cc70377c548424ff8f543bc (MD5) Previous issue date: 2010 / Resumo: Introdução: A úlcera venosa é uma complicação da insuficiência venosa crônica, atinge indivíduos adultos, afastando-os do trabalho e do convívio social normal. Objetivo: Demonstrar uma nova terapêutica para o tratamento das úlceras venosas através do enxerto de queratinócitos autólogos. Casuística e Método: Foram selecionados, de forma aleatória no ambulatório de Moléstias Vasculares Periféricas da Faculdade de Ciências Médicas da UNICAMP - Vinte e Cinco ( 25) doentes com úlcera de venosa, CEAP 6 , que não obtiveram cicatrização, das mesmas, com tratamentos convencionais; divididos em dois grupos, Grupo I- 11 doentes, 10 mulheres e 1 homem; Grupo II- 14 doentes, 11 mulheres e 3 homens. Ambos os grupos foram submetidos à aplicação do autoenxerto de queratinócitos sobre o leito limpo da úlcera; e ao grupo II, foi também ministrada dose de diosmina hesperidina micronizada a cada 12 horas. A todos os doentes, foi solicitado um repouso de 30 minutos em Trendelemburg para duas horas de atividade habitual. Os queratinócitos foram cultivados no Laboratório de Cultura de Células da Pele, CIPED- FCM - UNICAMP. Resultados: Após a aplicação de testes estatísticos não paramétricos, devido ao tipo da amostra, foi observada cicatrização e/ou melhora das úlceras com redução do leito nos dois grupos, sendo que o Grupo II obteve resultados mais precoces. Conclusão . Esse método mostra ser uma boa opção terapêutica no auxílio à cicatrização das úlceras venosas / Abstract: The venous stasis ulcer is the most severe complication of venous insufficiency, affecting adults and keeping them away from work and from normal social life. Objective: To demonstrate a new therapeutic method for accelerating healing. Methods: Twenty-five (25) patients with venous stasis ulcers, CEAP VI, who have not healed with conventional treatments were selected from the Clinic of Peripheral Vascular Diseases, Faculty of Medical Sciences, UNICAMP - were treated with autograft keratinocytes, grown in the skub cell culture laboratory, CIPED-FCM - UNICAMP. They were divided into two groups, Group I-11 patients, 10 female and male, Group II-14 patients, 11 female and 3 male. Both groups were treated with autograft keratinocytes on the clean ulcer bed, and group II, was also given a dose of micronized diosmin hesperidin every 12 hours. All the patients were asked to take a 30-minute rest in the Trendelenburg position for two hours of usual activity. Results: After the evaluation of data with statistics methods no parametric Healing and/or improvement of the ulcers with significant reduction of the bed in both groups were observed, with Group II obtaining precocious results. Conclusion? This method proves to be a good therapeutic option to help in the healing of stasis ulcers / Doutorado / Cirurgia / Doutor em Cirurgia

CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior / O presente estudo teve como meta desenvolver definiÃÃes conceituais e operacionais para o Resultado de Enfermagem Integridade Tissular direcionado a pacientes com Ãlcera venosa. O capÃtulo 1 descreve as etapas da revisÃo integrativa implementada para o desenvolvimento inicial das definiÃÃes conceituais e operacionais para os elementos do Resultado em questÃo aplicado à avaliaÃÃo de Ãlceras venosas. Nesta revisÃo,a busca foi realizada em bases de dados e no acervo do periÃdico International Journal of Nursing Terminologies and Classifications. Oito artigos compuseram a amostra. As informaÃÃes que se referiam aos conceitos do resultado Integridade Tissular e seus indicadores foram reunidas, comparada e agrupadas. Foram propostas definiÃÃes conceituais e operacionais para o Resultado Integridade Tissular, assim como inserido indicadores fictÃcios. O desenvolvimento das definiÃÃes do Resultado Integridade Tissular pÃde possibilitar melhor compreensÃo do seu uso segundo o contexto de Ãlceras venosas. No segundo capÃtulo, apresenta-se a construÃÃo das definiÃÃes conceituais e operacionais para apreciaÃÃo de 29 especialistas, realizando assim a validaÃÃo de conteÃdo. Para seleÃÃo dos especialistas utilizou-se os parÃmetros propostos por Fehring. A captaÃÃo dos participantes foi realizada por busca ativa na plataforma Lattes (CNPq). Foram remetidos dois instrumentos: um relativo ao perfil do especialista, e outro de anÃlise conceitual e operacional dos indicadores. A partir do valor atribuÃdo pelos especialistas, foi calculado o Ãndice de validade de conteÃdo (IVC) com ponto de corte de 0,8 e aplicado o teste binomial para anÃlise da proporÃÃo de adequaÃÃo das definiÃÃes por parte dos especialistas. O projeto foi aprovado pelo comità de Ãtica e pesquisa sob protocolo n097/10. Dos especialistas, 92,9% utilizam ou jà utilizaram o processo de enfermagem em sua prÃtica. A versÃo final do instrumento apresentou 18 indicadores, sendo trÃs fictÃcios. Foram excluÃdos trÃs indicadores propostos pela Nursing Outcomes Classifications (NOC), assim como o item Fadiga (fictÃcio). As colocaÃÃes e sugestÃes realizadas pelos especialistas foram analisadas e acatadas a maioria. Por fim, no capÃtulo 3, apresenta-se o processo de validaÃÃo clÃnica das definiÃÃes propostas com pacientes portadores de Ãlceras venosas. O estudo de validaÃÃo foi executado com 22 pacientes. Os instrumentos utilizados compreenderam dados clÃnicos e de identificaÃÃo, alÃm de indicadores com definiÃÃes operacionais. Dez enfermeiros aplicaram os instrumentos, metade com as definiÃÃes operacionais desenvolvidas e a outra metade nÃo. O teste de Friedman foi aplicado para verificar a diferenÃa de mediana entre os grupos de avaliadores. As anÃlises pos-hoc foram procedidas pelo mÃtodo da diferenÃa mÃnima significante (DMS). AlÃm disso, foi calculado o coeficiente de correlaÃÃo intraclasse para anÃlise da congruÃncia entre as avaliaÃÃes. Com exceÃÃo do indicador Textura, o teste de Friedman e mÃtodo DMS mostraram que os indicadores apresentaram diferenÃas estatÃsticas significantes entre os dois grupos de avaliadores (com e sem definiÃÃes operacionais). Entretanto, o mÃtodo da DMS mostrou nÃo haver diferenÃas estatisticamente significantes nas avaliaÃÃes realizadas pelos examinadores que utilizaram definiÃÃes operacionais denotando boa congruÃncia entre as mesmas. Observou-se que os valores de correlaÃÃo intraclasse do grupo sem definiÃÃes foram inferiores ao do grupo que utilizou tais definiÃÃes. As definiÃÃes operacionais construÃdas, com exceÃÃo do indicador Textura, possibilitaram maior uniformidade e similaridade entre avaliaÃÃes de pacientes com Ãlceras venosas. Diante disso, pode-se confirmar a tese de que o uso de definiÃÃes na avaliaÃÃo de pacientes com Ãlceras venosas possibilitou uma avaliaÃÃo mais acurada que a nÃo utilizaÃÃo das mesmas. / The present study aims at developing conceptual and operational definitions to the results from Tissue Integrity Nursing addressed to venous ulcers patients. In chapter 1, definitions to concepts related to the referred results applied to the evaluation of venous ulcers. In order to do so, an integrative review was made based on the data collection from the periodical International Journal of Nursing Terminologies and Classifications. The sample was composed of eight articles. The information regarding the concepts from Tissue Integrity Nursing and its indicators were gathered, compared, and grouped. Operational and conceptual definitions were proposed to Tissue Integrity Nursing, as well as fictitious indicators were added. The development of definitions from the Tissue Integrity Result enabled a better understanding of its use according to venous ulcers contexts. In chapter 2, the construction of the operational and conceptual definitions was presented to the appreciation of 29 experts, thus validating the content. The selection of the experts was made based on Fehringâs standards. The choice of the participants was made through search on Lattes plataform (CNPq). Two instruments were used: one related to the expertâs profile, and the other related to the analysis of the conceptual and operational indicators. The instrumentâs final version showed 18 indicators, and three of them were fictitious. Three indicators proposed by Nursing Outcomes Classifications NOC were excluded, as well as the item Fatigue (fictitious). The expertsâ suggestions and remarks were analyzed and most of them were also abided by. Finally, in chapter 3, we dealt with the execution of the clinical validation of the proposed definitions along with the patients afflicted with venous ulcers. The validation study was held with 22 patients. The instruments used were clinical and identification data, and also indicators with operational definitions. Ten nurses applied the instruments, some of them had operational definitions and the others did not. Friedmanâs test showed the average difference between the evaluatorsâ groups. The differences were calculated in at least one of the groups by the Minimal Detectable Change (MDC) method, besides the intraclass correlation coefficient. Except from the indicator âtextureâ, Friedmanâs test and the MDC method showed that the indicators presented significant statistical differences between the two groups (with or without operational definitions). However, the MDC method showed that the evaluation differences between the evaluators from the group that used the operational definitions was not significant. It was noticed that the intraclass correlation values from the group without the definitions were inferior to the one that used those definitions. The operational definitions built, except from the indicator âtextureâ, enabled greater uniformity and similarity between the evaluations of patients affected with venous ulcers. Bearing this in mind, the thesis that the use of definitions in the evaluation of patients afflicted with venous ulcers enables more accurate evaluation can be confirmed.