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Estudo de utilização de medicamentos antieméticos no serviço de oncologia pediátrica de um hospital do sul do BrasilSampaio, Gabriella Calvi January 2014 (has links)
A náusea e o vômito são um importante efeito adverso do tratamento antineoplásico. Impactam na redução da qualidade de vida, sendo citados como as piores manifestações pelos pacientes oncológicos. O fator de risco primário para o desenvolvimento destes sintomas é o Potencial Emetogênico da Quimioterapia. Sendo assim, é importante a utilização de uma adequada farmacoterapia antiemética com as alternativas terapêuticas eficazes e seguras disponíveis. Neste contexto, os Estudos de Utilização de Medicamentos são uma ferramenta valiosa para verificar padrões de utilização de medicamentos em instituições de cuidado em saúde. Além disto, alia-se a importância da discussão sobre este tema em crianças, visto que esta faixa etária é especialmente vulnerável e não participa de estudos clínicos para a aprovação de fármacos. O objetivo deste estudo foi avaliar a prescrição e utilização dos medicamentos antieméticos na unidade de oncologia pediátrica do Hospital de Clínicas de Porto Alegre. Trata-se de um estudo descritivo, transversal e retrospectivo, através de consulta ao prontuário eletrônico dos pacientes. Foram analisadas um total de 262 internações. Observou-se o predomínio da prescrição de quimioterapia de moderado e de alto Potencial Emetogênico. Constatou-se a presença de vômito em 82 internações, enquanto que a náusea ocorreu em 117 internações. Na maioria das internações foram administrados de 2 a 3 antieméticos com intervalos fixos, porém uma grande parte das prescrições não seguiu o recomendado pelos guidelines consultados, observando-se a falta de um protocolo antiemético. É importante a escolha do tratamento apropriado para cada paciente, levando-se em consideração a história pregressa do aparecimento de náuseas e vômitos para que se obtenha a melhor resposta terapêutica. A oncologia pediátrica necessita continuidade de Estudos de Utilização de Medicamentos para ampliar o conhecimento nesta área de forma a garantir a melhor qualidade de vida destes pacientes. / Nausea and vomiting are an important adverse effect of antineoplastic treatment. Their impact consists of a significant reduction in the quality of life, being mentioned by these patients as the worst side effects. The primary risk factor for the development of these symptoms is the emetogenic potential of chemotherapy. Therefore, it is important to use an appropriate antiemetic pharmacotherapy with the safest and most effective therapeutic alternatives available. In this context, the Drug Utilization Studies are a valuable tool to check patterns of medication use in health care institutions. Furthermore, it is necessary to emphasize the importance of discussion on this topic concerning children, since this age group is particularly vulnerable and does not participate in clinical trials for the approval of drugs. The objective of this study was to evaluate the prescription and use of antiemetic medications in the pediatric oncology unit in Hospital de Clínicas de Porto Alegre. This is a descriptive, cross-sectional retrospective study, made by consulting the electronic medical records of patients. A total of 262 hospitalization cases were analyzed. There was a predominance of prescriptions of chemotherapy with moderate and high emetogenic potential. There was vomiting in 82 cases, while there was nausea in 117 cases. In most hospitalizations, 2-3 antiemetics were administered at fixed intervals, but a large proportion of prescriptions did not follow what is recommended by the guidelines consulted, which highlights the fact that no antiemetic protocol is followed. It is important to choose the appropriate treatment for each patient, taking into account their past history of nausea and vomiting in order to obtain the best therapeutic response. The pediatric oncology needs further Drug Utilization Studies to contribute to the knowledge in this area to ensure the best quality of life of these patients.
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Estudo de utilização de medicamentos antieméticos no serviço de oncologia pediátrica de um hospital do sul do BrasilSampaio, Gabriella Calvi January 2014 (has links)
A náusea e o vômito são um importante efeito adverso do tratamento antineoplásico. Impactam na redução da qualidade de vida, sendo citados como as piores manifestações pelos pacientes oncológicos. O fator de risco primário para o desenvolvimento destes sintomas é o Potencial Emetogênico da Quimioterapia. Sendo assim, é importante a utilização de uma adequada farmacoterapia antiemética com as alternativas terapêuticas eficazes e seguras disponíveis. Neste contexto, os Estudos de Utilização de Medicamentos são uma ferramenta valiosa para verificar padrões de utilização de medicamentos em instituições de cuidado em saúde. Além disto, alia-se a importância da discussão sobre este tema em crianças, visto que esta faixa etária é especialmente vulnerável e não participa de estudos clínicos para a aprovação de fármacos. O objetivo deste estudo foi avaliar a prescrição e utilização dos medicamentos antieméticos na unidade de oncologia pediátrica do Hospital de Clínicas de Porto Alegre. Trata-se de um estudo descritivo, transversal e retrospectivo, através de consulta ao prontuário eletrônico dos pacientes. Foram analisadas um total de 262 internações. Observou-se o predomínio da prescrição de quimioterapia de moderado e de alto Potencial Emetogênico. Constatou-se a presença de vômito em 82 internações, enquanto que a náusea ocorreu em 117 internações. Na maioria das internações foram administrados de 2 a 3 antieméticos com intervalos fixos, porém uma grande parte das prescrições não seguiu o recomendado pelos guidelines consultados, observando-se a falta de um protocolo antiemético. É importante a escolha do tratamento apropriado para cada paciente, levando-se em consideração a história pregressa do aparecimento de náuseas e vômitos para que se obtenha a melhor resposta terapêutica. A oncologia pediátrica necessita continuidade de Estudos de Utilização de Medicamentos para ampliar o conhecimento nesta área de forma a garantir a melhor qualidade de vida destes pacientes. / Nausea and vomiting are an important adverse effect of antineoplastic treatment. Their impact consists of a significant reduction in the quality of life, being mentioned by these patients as the worst side effects. The primary risk factor for the development of these symptoms is the emetogenic potential of chemotherapy. Therefore, it is important to use an appropriate antiemetic pharmacotherapy with the safest and most effective therapeutic alternatives available. In this context, the Drug Utilization Studies are a valuable tool to check patterns of medication use in health care institutions. Furthermore, it is necessary to emphasize the importance of discussion on this topic concerning children, since this age group is particularly vulnerable and does not participate in clinical trials for the approval of drugs. The objective of this study was to evaluate the prescription and use of antiemetic medications in the pediatric oncology unit in Hospital de Clínicas de Porto Alegre. This is a descriptive, cross-sectional retrospective study, made by consulting the electronic medical records of patients. A total of 262 hospitalization cases were analyzed. There was a predominance of prescriptions of chemotherapy with moderate and high emetogenic potential. There was vomiting in 82 cases, while there was nausea in 117 cases. In most hospitalizations, 2-3 antiemetics were administered at fixed intervals, but a large proportion of prescriptions did not follow what is recommended by the guidelines consulted, which highlights the fact that no antiemetic protocol is followed. It is important to choose the appropriate treatment for each patient, taking into account their past history of nausea and vomiting in order to obtain the best therapeutic response. The pediatric oncology needs further Drug Utilization Studies to contribute to the knowledge in this area to ensure the best quality of life of these patients.
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Controle da náusea pela ativação de um só ponto de acupuntura durante procedimento de moldagem intra-oral = Nausea control by activating a single acupuncture point during intraoral impression taking procedure / Nausea control by activating a single acupuncture point during intraoral impression taking procedureZotelli, Vera Lucia Rasera, 1957- 24 August 2018 (has links)
Orientador: Maria da Luz Rosário de Sousa / Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba / Made available in DSpace on 2018-08-24T14:31:18Z (GMT). No. of bitstreams: 1
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Previous issue date: 2014 / Resumo: A ocorrência de náusea durante a realização de procedimentos odontológicos constitui uma grande limitação para prover um tratamento dentário de boa qualidade. Objetivo: Avaliar a efetividade do ponto de acupuntura PC6 (Neiguan) no controle do reflexo da náusea durante moldagem intra-oral. Materiais e Métodos: Trata-se de um estudo clínico controlado, duplo cego, realizado na Faculdade de Odontologia de Piracicaba (FOP), Universidade Estadual de Campinas (UNICAMP), em Piracicaba (São Paulo), de fevereiro a agosto de 2013, com 33 voluntários de 19 a 62 anos de idade. O estudo incluiu pacientes adultos, de ambos os sexos, que declararam ter apresentado os sintomas do reflexo da náusea em atendimentos realizados previamente, nos quais houve limitação ou impossibilidade de realização dos procedimentos odontológicos. Os pacientes foram distribuídos aleatoriamente em grupo estudo e controle que receberam, respectivamente, tratamento com acupuntura real e acupuntura sham não penetrante, no acuponto PC6. Os dois grupos tiveram duas moldagens (ou tentativa de moldagem) da arcada superior, sendo uma antes e outra após acupuntura. O grau de náusea foi avaliado antes da acupuntura pelo índice GSI (Gagging Severity Index) e após acupuntura pelo índice pelo índice GPI (Gagging Prevention Index), ambos foram registrados em três estágios da moldagem: 1) quando a moldeira vazia foi provada na boca; 2) quando a moldeira com alginato foi inserida na boca e 3) habilidade de tolerar a moldeira dentro da boca até a presa final do alginato. A náusea também foi avaliada pela Escala Visual Analógica (VAS), antes e após acupuntura. A expectativa dos voluntários para redução da náusea através da acupuntura foi avaliada pela escala Lickert. Na análise estatística foram utilizados os testes t e de correlação de Spearman, (p < 0,05). Resultados: Na avaliação pelos índices GSI/GPI houve diminuição da náusea no grupo acupuntura real (p < 0,01). Na avaliação pela escala VAS a redução de náusea foi semelhante nos dois grupos, (p > 0,05). Não houve correlação entre expectativa e redução de náusea em nenhum dos grupos. Conclusão: O acuponto PC6 foi efetivo no controle da náusea em procedimento de moldagem da arcada superior. A expectativa do paciente não influenciou nos resultados. Acupuntura real foi mais efetiva que acupuntura sham quando avaliadas pelos índices GSI/GPI / Abstract: The occurrence of nausea while performing dental procedures is a major limitation to provide a high quality dental treatment. Objective: To evaluate the effectiveness do acupuncture point PC6 (Neiguan) in controlling the gag reflex during intraoral impression taking. Materials and Methods: This was a controlled clinical study, double -blind trial conducted at the Piracicaba Dental School (FOP), State University of Campinas (UNICAMP), in Piracicaba (São Paulo), from February to August 2013. The study was carried out with 33 volunteers aged 19 to 62 years. This study included adult patients of both sexes, who reported having presented gag reflex symptoms on previously made appointments, where there was limited or impossibility of performing dental procedures. They were randomly divided into study and control groups that were treated respectively with real acupuncture and non-penetrating sham acupuncture. The two groups had two upper impressions (or an attempt to make it), being the first one done before and the second one after acupuncture. In both of the groups the gagging reflex assessment was undertaken before acupuncture by the Gagging Severity Index (GSI), and after acupuncture by the Gagging Prevention Index (GPI), at three stages of the impression taking procedure: 1) when the empty impression tray was tried in the mouth; 2) when the loaded tray was inserted into the mouth and 3) the ability to tolerate the impression in the mouth until alginate set. The nausea was also evaluated by the Visual Analogue Scale (VAS). The expectation of the volunteers to reduce nausea trough acupuncture was assessed by Lickert scale. In the statistical analysis we used t test and Spearman correlation, (p < 0,05). Results: When using GSI/GPI, in the real acupuncture group the nausea decreased in all the three stages with p < 0,01. Assesment by VAS, there was similar reduction of nausea in both groups with p > 0,05. There was no correlation between expectation and reducing nausea in none of the two groups. Conclusion: The acupoint PC6 was effective to control nausea in upper impression procedure. Real acupuncture was more effective than sham acupuncture when it was assessed by GSI/GPI index. The expectation of the patient has not influenced the results / Mestrado / Saude Coletiva / Mestra em Odontologia
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Patienters skattning av postoperativt illamående och kräkning efter robotassisterad prostatektomi / Patients evaluation of postoperative nausea and vomiting after robotic- assisted prostatectomyAgheli, Nahal, Svensson, Johan January 2011 (has links)
Robotassisterad prostatektomi innebär speciella omständigheter för patienten avseende positionering där de ligger i ett extremt så kallat Trendelenburgläge med huvudet sänkt 45 grader samt att buken blåses upp med koldioxid. Dessa två faktorer predisponerar för att patienten drabbas av postoperativt illamående och kräkningar. Syftet med studien var att undersöka förekomsten av postoperativt illamående och kräkningar 24 timmar efter robotassisterad prostatektomi. Patienterna själva skattade sitt illamående enligt MANE- skalan som är en 7-punktsskala. Metoden som användes är en kvantitativ icke experimentell pilotstudie. 20 patienter deltog i studien. Resultatet visade att mer än en tredjedel av patienterna drabbades av postoperativt illamående och/eller kräkning inom 24 timmar efter operationsslut. Av samtliga 20 deltagare hade enbart en patient erhållit antiemetika i förebyggande syfte. Slutsatsen för denna studie var att man bör gå vidare och undersöka fler patienter för att se om behov finns för att eventuellt justera antiemetikaprofylax för denna patientgrupp i framtiden. / Robotic assisted prostatectomy requires special circumstances for the patient regarding their positioning. They lay with the head tilted down 45 degrees in a position called Trendelenburg and their bowel is insufflated with carbon dioxide which both can cause nausea and vomiting. The aim of this study was to investigate the frequency of postoperative nausea and vomiting 24 hours after a robotic assisted prostatectomy. The patients valued their own nausea according to the MANE-scale which is a 7-pointed scale. The method used was a quantitative non- experimental pilot study. 20 patients participated in the study. The result showed that more than a third of the patients were nauseas or vomited within 24 hours after surgery. Of all 20 participants only one had received antiemetics in preventing purpose. The conclusion was that this study should be proceeded and a larger number of patients should be evaluated too see if there is a need to adjust the antiemethic prophylaxis for this patientgroup in the future.
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Efekat antiemetske terapije u hemioterapijskom lečenju primarnog karcinoma dojke po protokolu fluorouracil, adriamicin, ciklofosfamid / Antiemetic Effect in Treatment of Primary BreastCancer based on Chemotherapy ProtocolFluorouracil, Adriamycin, CyclophosphamideIlić Maja 30 March 2016 (has links)
<p>Antiemetska terapija u hemioterapijom izazvanoj mučnini i povraćanju se bazira na znanju o etiologiji, fiziologiji, kliničkoj slici, posledicama i uticaju povraćanja na kvalitet života. Za izbor antiemetske terapije presudno je poznavanje emetogenog potencijala antineoplastika, mehanizma delovanja, indikacija, puta primene, doziranja, neželjenih delovanja, farmakokinetike, interakcija i kontraindikacija tri najznačajnije grupe lekova koje se primenjuju kao antiemetici prema međunarodnim preporukama. Značajno je i poznavanje bolesnika, odnosno njegovih individualnih karakteristika i to: starost, pol, istorija kinetoze, istorija konzumiranja alkohola, istorija jutarnjih mučnina u trudnoći, pridružene bolesti i dr. Cilj doktorske teze je analiza efikasnosti kombinacije antiemetika ondansetron, deksametazon, aprepitant u drugom ciklusu hemioterapije po protokolu fluorouracil, doksorubicin, ciklofosfamid u odnosu na ondansetron, deksametazon u bolesnica sa dijagnozom karcinoma dojke, efikasnosti kombinacije antiemetika ondansetron, deksametazon, aprepitant u drugom ciklusu hemioterapije po protokolu fluorouracil, doksorubicin, ciklofosfamid u odnosu na palonosetron, deksametazon u bolesnica sa dijagnozom karcinoma dojke i da se ispita kvalitet života bolesnica nakon prvog i drugog ciklusa. Materijal i metode: uzorak su bolesnice sa dijagnostikovanim karcinomom dojke lečene hemioterapijom po protokolu fluorouracil, doksorubicin, ciklofosfamid. Bolesnice koje su nakon prvog ciklusa hemioterapije uz antiemetsku terapiju ondansetron, deksametazon iskusile mučninu i povraćanje podeljene su u grupe koje su primale dve različite kombinacije antiemetika uz drugi ciklus hemioterapije i to: ondansetron, deksametazon i aprepitant ili palonosetron i deksametazon. Bolesnice su praćene pet dana tokom kojih su se izjašnjavale o mučnini i povraćanju, kao i o kvalitetu života. Mučnina je praćena pomoću numeričke skale, povraćanje kao broj epizoda povraćanja tokom 5 dana i kvalitet života je praćen popunjavanjem upitnika o kvalitetu života. Rezultati: Analiza rezultata ukazala je na postojanje statistički značajne razlike u efikasnosti između tri primenjene kombinacije antiemetika. Trojna kombinacija ondansetron, deksametazon i aprepitant značajno sprečava mučninu i povraćanje u odnosu na kombinaciju ondansetron, deksametazon, ali značajnost nije toliko izražena u odnosu na kombinaciju palonosetron, deksametazon zbog inicijalne razlike između početne grupe ispitanika. Slični rezultati su uočeni u ispitivanju svih aspekata kvaliteta života. Zaključak: Zaključak proizilazi iz rezultata kliničkog ispitivanja kojima se potvrđuju postavljene hipoteze. Trojna kombinacija ondansetron, deksametazon i aprepitant je efikasnija u sprečavanju mučnine i povraćanja izazvanih hemioterapijom u odnosu na kombinaciju palonosetron, deksametazon, kao i kombinaciju ondansetron, deksametazon. Ista razlika pri primeni antiemetika dobijena je i pri proučavanju kvaliteta života. Zaključci izvedeni ovim ispitivanjem potvrda su drugih radova na ovom polju.</p> / <p>Antiemetic therapy options in chemotherapy induced nausea and vomiting (CINV) is based on knowledge on ethiology, physiology, clinical signes and simptoms, and influence on quality of life (QoL). Also it is needed to understand emetogenic potential of antineoplastics, mechanism of action, indication, uses, dosage, side effects, pharmacokinetics, interaction, and contraindication of three most important groups of drugs which are used in CINV according to international recommendation. The goal were to analyze efficacy of the combination antiemetics ondansetron, dexamethasone, aprepitant and ondansetron, dexamethasone in second line chemotherapy based on fluorouracil, adriamycin, cyclophosphamide in patient with diagnosed carcinoma of the breast, efficacy of the combination antiemetics ondansetron, dexamethasone, aprepitant and palonosetron, dexamethasone and quality of life. Material and methods: the sample consist of patients with diagnosed carcinoma of the breast, on chemotherapy fluorouracil, adriamycin, cyclophosphamide. Patients wich was on antiemetic drugs ondansetron, dexamethasone with chemotherapy induced nausea or vomiting after first cycle of chemotherapy were split in two groups randomly. First group was on antiemetic therapy palonosetron, dexamethasone and second one on ondansetron, dexamethasone and aprepitant. Nausea and vomiting was measured for 5 days, by numeric scale for nausea and counting number of emetic episodes, and it was questionnaire about quality of life. Results: It was statistical important differences between three used combination of antiemetics. The highest efficacy was in combination of ondansetron, dexamethasone and aprepitant than palonosetron, dexamethasone, and the last was ondansetron, dexamethasone. Results were similar for all aspects of quality of life. Conclusion: The combination ondansetron, dexamethasone and aprepitant had the highest efficacy in stopping chemotherapy induced nausea and vomiting. Similar was for quality of life. Conclusion was in accordance with literature data.</p>
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Postoperative Symptoms After Gynaecological Surgery : How They Are Influenced by Prophylactic Antiemetics Sensory Stimulation (P6-Acupressure)Alkaissi, Aidah January 2004 (has links)
Symptoms after surgery and anaesthesia influence the patient´s ability to resume daily activities. If postoperative symptoms are controlled rehabilitation may be accelerated. The aims of this dissertation were to identify disturbing symptoms reported by patients after gynaecological surgery, to investigate what effect prohylactic treatment with antiemetics has on these symptoms and whether or not sensory simulation of the P6-acupressure has an effect on postoperative nausea and vomiting (PONV) and motion sickness. Methods: Total 1138 women participated in three clinical trials (Studies I, II, III) and one experimental study (Study IV). A questionnaire investigating postoperative symptoms was constructed and validated. The questionnaire was used in a prospective, consecutive, doubleblind, randomised, multicentre, and controlled study to identify incidence, and intensity of postoperative symptoms and the effect of common antiemetics (droperidol and granisetron) (Study III). The patients were followed for 24 h. In two studies (I, II) P6-acupressure was compared (prospective, double-blind, ransomised, controlled) with placebo acupressure and a reference group where the effect on PONV was followed over 24 h. The effect of P6-acupressure and placebo acupressure on motion sickness induced by a nauseogenic motion challenge was studied (Study III). Results: A high incidence and severity of postoperative symptoms were found after gynaecological surgery in a group with a high risk (>30%) for PONV. Sixty-four per cent (107/165) of the patients experienced disturbing symptoms after surgery and 46 % (76/165) scored their symptoms as moderate to very severe. Fourty-eight per cent (79/165) had two or more symptoms. A higher incidence of symptoms were reported in the groups with prophylactic treatment, granisetron 74% (123/165) and droperidol 80% (133/165) compared to the control group 41% (69/165) (P <0.05). The relative risk reduction for PONV with granisetron or droperidol prophylaxis is 27% respective 22%. The relative risk increase for headache is 63% after granisetron, and 44% for difficulty with accommodation after droperidol. Less PONV was seen after P6-acupressure, 33% (44/135) compared to reference group 46% (63/136) (p = 0.019), number needed to treat (NNT) was 7 [95% confidence interval (CI) 4- 6]. When comparing laparoscopic and vaginal surgery (subgroup analysis) the main effect was in the vaginal group (day-case surgery), 36% (27/75) in the reference group to 27% (23/86) in the placebo group and to 20% (17/84) in the P6-acupressure group, (P = 0.017), NNT for the vaginal group was 6 [95% CI 3-18]. P6-acupressure increased time to nausea after a laboratory motion challenge and reduced the total number of symptoms reported (p <0.009). Conclusions: There is no clinical efficacy in the form of reduced postoperative symptoms after prophylactic antiemetics (droperidol and granisetron) in females with a high risk (>30%) for PONV undergoing gynaecological surgery. P6-acupressure reduces the incidence of PONV after gynaecological surgery in females with a high (>30%) risk for PONV. The effect seems to be most prominent after vaginal surgery. P6-acupressure increased tolerance to experimental nausogenic stimuli and reduced the total number of symptoms reported in females with a history of motion sickness. / On the day of the public defence the status of article IV was: Submitted.
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Auswirkungen der intraoperativen Gabe von Dexamethason zur PONV-Prophylaxe auf den Blutzucker- und Cortisolspiegel bei normalgewichtigen und adipösen KindernGnatzy, Richard 26 May 2015 (has links)
Background: The incidence of postoperative nausea and vomiting (PONV) can be reduced by dexamethasone. Single dose administration may cause elevated blood glucose levels in obese adults. No data are available for children.
Objective: The aim was to evaluate perioperative blood glucose changes related to body weight in children who received dexamethasone.
Methods: This prospective observational study included 62 children. All patients received total intravenous anesthesia and a single dose of dexamethasone (0.15mg/kg, maximum 8mg). Blood glucose levels were measured up to 6 hours. Standard deviation scores (SDS) were calculated using age- and gender-specific BMI percentiles, p<0.05.
Results: 62 children (11.5±2.9years, median SDS 0.43, 29% overweight/obese) were included. Blood glucose level increased from 5.52±0.52 to 6.74±0.84mmol/l 6h after dexamethasone without correlation to the BMI-SDS.
Conclusions: This study shows an increase of perioperative blood glucose (normoglycemic ranges) after single dose of dexamethasone but no BMI-dependent effect in children. Therefore, low-dose dexamethasone may be used in obese children for PONV prophylaxis.
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La qualité de vie durant la période gestationnelle : impact et prise en charge des nausées et des vomissements de la grossesseLacasse, Anaïs January 2008 (has links)
Thèse numérisée par la Division de la gestion de documents et des archives de l'Université de Montréal.
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La qualité de vie durant la période gestationnelle : impact et prise en charge des nausées et des vomissements de la grossesseLacasse, Anaïs January 2008 (has links)
Thèse numérisée par la Division de la gestion de documents et des archives de l'Université de Montréal
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Omissão do segundo dia da medicação antiemética como estratégia para a redução do custo da profilaxia de náuseas e vômitos induzidos por quimioterapia: resultados de um estudo fase III / The omission of day 2 of Antiemetic Medications is a cost saving strategy for improving chemotherapy-induced nausea and vomiting control: Results of a randomized phase III trialLajolo, Paula Philbert [UNIFESP] 30 July 2008 (has links) (PDF)
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Publico-10756.pdf: 198016 bytes, checksum: b1b248dd88de1aeab5859b81fa05e4c2 (MD5) / INTRODUÇÃO: Os antagonistas 5HT-3 e corticosteróides são drogas importantes no controle da emese induzida por quimioterapia Apresentam controle de 50-80% da emese aguda porém controlam menos de 50% da emese tardia induzida por quimioterapia. Em estudo prévio realizado em nossa instituição, observou-se que o controle da emese tardia poderia ser melhorado com a omissão do segundo dia dos antagonistas 5HT-3. Reportamos aqui os resultados de um estudo fase III confirmando os achados prévios PACIENTES E MÉTODOS: Estudo fase III randomizado e duplo-cego foi realizado na FMABC Santo André/Brasil. Pacientes submetidos a esquemas quimioterápicos alta e moderadamente emetogênicos pela 1ª vez receberam Ondasetron 16mg e Dexametasona 20 mg IV antes da quimioterapia no Dia 1. Foram então randomizados em dois grupos. Grupo A recebeu metoclopramida VO 10mg 8/8hs, Granisetron VO 0,5mg/dia,e dexametasona VO 8mg /dia por 2 dias, a partir do dia 2 (dias 2 e 3). Metoclopramida VO 10 mg 8/8 hs foi continuada no dia 4. Grupo B recebeu placebo no dia 2 e o mesmo esquema de drogas dia 3 e dia 4. Pacientes foram entrevistados no dia 1 e dia 6. RESULTADOS: 73 pacientes foram incluídos no estudo. Os grupos foram bem balanceados em relação as suas características clinicas com exceção ao melhor controle da emese aguda no grupo A (p=0,04). Proteção completa de náuse a e vômito tardios (do dia 2 ao 5 ), foi semelhante em ambos os grupos (30% vs. 32%; p=0.5). Em análise multivariada, tanto a proteção completa da emese aguda (p=0.001) quanto grupo de estudo (p=0.06) estavam independentemente relacionados à proteção completa da náusea e vômito tardios. Selecionando apenas os pacientes que obtiveram controle completo da emese na fase aguda, pacientes do grupo B obtiveram maior proteção da emese tardia (85% vs 50% ,p=0,02). CONCLUSÃO: A omissão da medicação antiemética no dia 2 representa uma estratégia para redução do custo da profilaxia da emese tardia induzida pela quimioterapia. / BACKGROUND: Nausea and vomiting are important symptoms observed in cancer patients. In a previous study we showed that delayed chemotherapyinduced nausea and vomiting (CINV) control could be potentially improved by skipping the administration of a 5HT3-antagonist on day 2. We report here a trial confirming our previous findings. PATIENTS/METHODS: A phase-IIIrandomized- placebo-controlled trial was conducted in which patients received (IV) ondansetron 16mg, dexamethasone 20mg and ranitidine 50mg before highly/moderately emetogenic chemotherapy (day 1).Starting on day 2, all patients received metoclopramide 10mg PO q8 hours (days 2,3 and 4, Dexamethasone 8mg QD (days 2 and 3) and Ranitidine 150mg q12 hours (days 2 and 3). Patients were randomized to receive either Granisetron 0.5mg PO (days 2 and 3) (Group A) or Placebo instead for Granisetron on day 2 and Granisetron 0.5mg on day 3 and 4 (Group B) RESULTS: 73 patients were enrolled. Groups were similar regarding clinical characteristics, despite better control during the acute phase of CINV in group A (p=0.04). Complete delayed protection from nausea/vomiting (DCPNV) from day 2 to 5 was similar in both groups. (30% vs. 32%; p=0.5). Analyzing DCPNV by logistic regression multivariate analyses, acute complete protection from nausea/vomiting (ACPNV) (p=0.001) and study group (p=0.06) were independently associated with DCPNV. Selecting patients who achieved ACPNV, we observed that group B had a superior DCPNV (85% vs 50%, p=0.02). CONCLUSION: DCPNV can be improved just by skipping day 2 of 5HT3- antagonists. Future studies should compare this inexpensive strategy with NK1- antagonists or second generation 5HT3-antagonists. Key words: delayed chemotherapy-induced nausea and vomiting, tachyphylaxis, cost- saving regimen, antiemetics, Granisetron/administration and dosage. / TEDE / BV UNIFESP: Teses e dissertações
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