Adverse effects associated with favipiravir in patients with COVID-19 pneumonia: a retrospective study

ABSTRACT BACKGROUND: Favipiravir is generally used in treating coronavirus disease 2019 (COVID-19) pneumonia in Turkey. OBJECTIVE: To determine the side effects of favipiravir and whether it is a good treatment option. DESIGN AND SETTING: Retrospective study conducted in Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, Ankara, Turkey. METHODS: 357 patients who completed favipiravir treatment at the recommended dose were included. 37 patients with drug side effects and 320 patients without drug side effects were examined in two groups. RESULTS: Side effects were observed in 37 (10.36%) out of 357 patients using favipiravir. The most common side effect was liver dysfunction, in 26 (7.28%) of the patients. The following other side effects were also observed: diarrhea (1.4%), nausea (0.84%), abdominal pain (0.28%) and thrombocytopenia (0.28%). One patient (0.28%) presented both increased transaminases and nausea. CONCLUSION: In this study, it was determined that favipiravir may constitute an alternative for treating COVID-19 pneumonia given that its side effects are generally well tolerated and not serious.

Risk factors associated with antineoplastic chemotherapy-induced nausea and vomiting / Fatores de risco associados a náuseas e vômitos induzidos por quimioterapia antineoplásica

ABSTRACT OBJECTIVE: To estimate the incidence and to evaluate risk factors for antineoplastic nausea and vomiting with high and moderate emetogenic chemotherapy in adult patients in the first treatment cycle. METHODS: Prospective cohort study with follow-up of 269 adults during the first cycle of antineoplastic chemotherapy. The incidence of nausea and vomiting was evaluated in the acute phase (0-24 hours), in the late phase (24 hours-5th day) and in the total phase (0-5th day). RESULTS: In total, 152 patients underwent high emetogenic chemotherapy and 117 moderate emetogenic chemotherapy. The relative frequency of nausea was higher when compared with vomiting in the acute phase (p < 0.001) and in the late phase (p < 0.001). The risk factors identified were: age group ≤ 49 years (odds ratio = 0.47; 95%CI 0.23-0.95) and 50-64 years (odds ratio = 0.45; 95%CI 0.23-0.87), tobacco use (odds ratio = 0.35; 95%CI 0.14-0.88), and high emetogenic chemotherapy (odds ratio 0.55; 95%CI 0.31-0.95). CONCLUSION: The incidence of nausea was higher than that of vomiting, and adverse effects were more frequent in the late phase. The results suggest the risk factors for chemotherapy-induced nausea and vomiting are tobacco, age (young adults), and high emetogenic chemotherapy.

RESUMO OBJETIVO: Estimar a incidência e avaliar os fatores de risco para náuseas e vômitos induzidos por antineoplásicos com alto e moderado potencial emético em pacientes adultos, no primeiro ciclo de tratamento. MÉTODOS: Estudo de coorte prospectiva, com 269 adultos acompanhados durante o primeiro ciclo de quimioterapia antineoplásica. A incidência de náuseas e vômitos foi avaliada na fase aguda (0-24 horas), na fase tardia (24 horas-5° dia) e na fase total (0-5° dia). RESULTADOS: 152 pacientes foram submetidos a quimioterápico com alto potencial emético e 117 a moderado potencial emético. A frequência relativa de náuseas foi maior quando comparada à de vômitos na fase aguda (p < 0,001) e na fase tardia (p < 0,001). Os fatores de risco identificados foram: faixa etária ≤ 49 anos (odds ratio = 0,47; IC95% 0,23-0,95) e 50-64 anos (odds ratio = 0,45; IC95% 0,23-0,87), uso de tabaco (odds ratio = 0,35; IC95% 0,14-0,88) e alto potencial emético dos quimioterápicos (odds ratio 0,55; IC95% 0,31-0,95). CONCLUSÃO: A incidência de náuseas foi maior do que a de vômitos, e na fase tardia os efeitos adversos foram mais frequentes. Os resultados sugerem que os fatores de risco para náuseas e vômitos induzidos por quimioterapia são o tabaco, a idade (adultos jovens) e o alto potencial emético do quimioterápico.

Síndrome de hiperémesis por cannabinoides: caso clínico / Cannabinoid hyperemesis syndrome: clinical case

Background. The cannabinoid hyperemesis syndrome (CHS) was first described in 2004. It is considered as a functional gastrointestinal syndrome characterized by the presence of nausea, severe and cyclic morning vomiting, epigastric abdominal pain, hot water bathing for symptom relief, in patients that use cannabis regularly and has a resolution of the syndrome after cessation of cannabis consumption. Clinical Case. Report of a 29 year old male, with daily consumption of cannabis, with history of intense epigastric abdominal pain and recurrent vomiting that partially responded to the use of antispasmodics. After 4 visits to the emergency department he was hospitalized for study and treatment. Laboratory and image exploration are carried out without positive results for organic disease. Therefore, a functional gastrointestinal syndrome is thought, and a cannabinoid hyperemesis syndrome was suspected. A psychiatric evaluation is carried out, diagnosing a cannabis use disorder. Discussion and conclusion. CHS is a syndrome that has been described recently and is not usually considered as a differential diagnosis for patients with hyperemesis. However, the current high prevalence of cannabis consumption, will probably lead to a more frequent presentation of the syndrome at different health providers. Therefore, it is important to diffuse and update the knowledge about this syndrome to recognize it and develop a timely treatment, avoiding medical complications from invasive exploratory methods and the use of unnecessary resources. (AU)

Segurança e tolerabilidade de Nintedanibe em pacientes com fibrose pulmonar idiopática no Brasil / Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis in Brazil

RESUMO Objetivo Ensaios clínicos mostraram que 150 mg de Nintedanibe duas vezes ao dia reduzem a progressão da doença em pacientes com Fibrose Pulmonar Idiopática (FPI), com um perfil de efeitos adversos que é controlável para a maioria dos pacientes. Antes da aprovação do Nintedanibe como tratamento para a FPI no Brasil, um Programa de Acesso Expandido (PEA) foi iniciado para fornecer acesso precoce ao tratamento e avaliar a segurança e a tolerância do Nintedanibe para este grupo de pacientes. Métodos Foram elegíveis para participar da PEA pacientes com diagnóstico de FPI nos últimos 5 anos, com capacidade vital forçada (CVF) ≥ 50% do previsto e capacidade de difusão dos pulmões para monóxido de carbono (DLco) 30%-79% do previsto. Os pacientes receberam Nintedanibe 150 mg, 2 vezes ao dia (bid). As avaliações de segurança incluíram eventos adversos que levaram à suspensão permanente do Nintedanibe e eventos adversos graves. Resultados O PEA envolveu 57 pacientes em 8 centros. A maioria dos pacientes era do sexo masculino (77,2%) e brancos (87,7%). No início do estudo, a média de idade foi de 70,7 (7,5) anos e a CVF foi de 70,7 (12,5%) do previsto. A média de exposição ao Nintedanibe foi de 14,4 (6,2) meses; a exposição máxima foi de 22,0 meses. Os eventos adversos frequentemente relatados pelo pesquisador como relacionados ao tratamento com Nintedanibe foram diarreia (45 pacientes, 78,9%) e náusea (25 pacientes, 43,9%). Os eventos adversos levaram à suspensão permanente do Nintedanibe em 16 pacientes (28,1%) que passaram por um evento adverso grave. Conclusões No PEA brasileiro, o Nintedanibe apresentou um perfil aceitável de segurança e tolerância em pacientes com FPI, condizendo com dados de ensaios clínicos.

ABSTRACT Objective Clinical trials have shown that nintedanib 150 mg twice daily (bid) reduces disease progression in patients with idiopathic pulmonary fibrosis (IPF), with an adverse event profile that is manageable for most patients. Prior to the approval of nintedanib as a treatment for IPF in Brazil, an expanded access program (EAP) was initiated to provide early access to treatment and to evaluate the safety and tolerability of nintedanib in this patient population. Methods Patients with a diagnosis of IPF within the previous five years, forced vital capacity (FVC) ≥ 50% predicted and diffusing capacity of the lungs for carbon monoxide (DLco) 30% to 79% predicted were eligible to participate in the EAP. Patients received nintedanib 150 mg bid open-label. Safety assessments included adverse events leading to permanent discontinuation of nintedanib and serious adverse events. Results The EAP involved 57 patients at eight centers. Most patients were male (77.2%) and white (87.7%). At baseline, mean (SD) age was 70.7 (7.5) years and FVC was 70.7 (12.5) % predicted. Mean (SD) exposure to nintedanib was 14.4 (6.2) months; maximum exposure was 22.0 months. The most frequently reported adverse events considered by the investigator to be related to nintedanib treatment were diarrhea (45 patients, 78.9%) and nausea (25 patients, 43.9%). Adverse events led to permanent discontinuation of nintedanib in 16 patients (28.1%). Sixteen patients (28.1%) had a serious adverse event. Conclusion In the Brazilian EAP, nintedanib had an acceptable safety and tolerability profile in patients with IPF, consistent with data from clinical trials.

Diagnóstico de enfermagem "náusea" durante a quimioterapia: análise de conceito / Nursing diagnosis "nausea" during chemotherapy: concept analysis

Estudo com o objetivo de analisar o conceito náusea no tratamento quimioterápico, a fim de aperfeiçoar o diagnóstico de enfermagem "náusea". Utilizados como referencial teórico o modelo proposto por Walker e Avant e uma revisão integrativa realizada nos portais PUBMED, EMBASE, CINAHL e LILACS, sem restrição temporal. Amostra constituída por 30 artigos, identificaram-se 44 antecedentes, sendo 25 relacionados ao paciente/biofísico, oito ao tratamento/fatores farmacológicos e 11 aos fatores psicológicos. Na mesma amostra, foram identificados 17 consequentes, sendo os mais frequentes: "redução na qualidade de vida", "quimioterapia pode ser adiada, alterada, dose reduzida ou tratamento interrompido" e "diminuição da nutrição/má nutrição". Nas definições de náusea, o tratamento quimioterápico não é citado como causa. Os antecedentes deste conceito devem ser investigados na prática clínica de forma individualizada. A avaliação dos consequentes nesta clientela pode permitir intervenções precoces e diminuir os efeitos indesejáveis da náusea.

A study with the objective to analyze the concept nausea in chemotherapeutic treatment, to improve the nursing diagnosis "nausea". We used the model proposed by Walker and Avant as a theoretical reference and, we conducted an integrative review in the databases PUBMED, EMBASE, CINAHL, and LILACS, with no time restriction. Thirty articles composed the sample, we identified 44 antecedents, being 25 related to the patient/biophysical, eight to the treatment/pharmacological factors and, 11 related to psychological factors. In the same sample, we identified 17 consequents, being the most frequent: "reduction of quality of life", "chemotherapy can be cancelled, altered, dose reduced or interrupted treatment" and "decrease of nutrition/bad nutrition". In the nausea definitions, the chemotherapeutic treatment is not cited as a cause. The precendents of this concept should be investigated in the clinical practice in an individualized way. The assessment of the consequents in this clientele can allow early interventions and decrease the undesirable nausea effects.

Integrative review of factors related to the nursing diagnosis nausea during antineoplastic chemotherapy / Revisão integrativa dos fatores relacionados do diagnóstico de enfermagem náusea na quimioterapia antineoplásica / Revisión integradora de los factores relacionados al diagnóstico de enfermería náusea en la quimioterapia antineoplásica

ABSTRACT Objective: to identify factors related to the nursing diagnosis nausea among cancer patients undergoing chemotherapy. Method: integrative review conducted in four electronic databases (PUBMED, EMBASE, CINAHL and LILACS) using the key words: neoplasia, antineoplastic agents and nausea. Results: only 30 out of 1,258 papers identified met the inclusion criteria. The most frequent related factors were: being younger than 50 years old, motion sickness, being a woman, emetogenic potential of the chemotherapy, anxiety, conditioned stimulus, and expecting nausea after treatment. Conclusion: this review's findings, coupled with the incidence of nausea among cancer patients undergoing chemotherapy, reveal an important difference between evidence found and that used by NANDA International, Inc. Even though it provides an appropriate definition of related factors, it does not mention chemotherapy, despite the various studies addressing the topic using different designs and presenting various objectives and outcomes.

RESUMO Objetivo: identificar os fatores relacionados ao diagnóstico de enfermagem náusea entre pacientes oncológicos durante o tratamento quimioterápico. Método: revisão integrativa de quatro bases eletrônicas de dados (PUBMED, EMBASE, CINAHL e LILACS) com as palavras-chaves neoplasia, agentes antineoplásicos e náusea. Resultados: dos 1258 artigos identificados, somente 30 atenderam aos critérios de inclusão. Os fatores relacionados mais frequentes foram: idade abaixo de 50 anos, doença do movimento, sexo feminino, potencial emético do quimioterápico, ansiedade, estímulo condicionado e expectativa de náuseas depois do tratamento. Conclusão: diante dos resultados encontrados e da incidência de náusea entre os pacientes oncológicos em tratamento quimioterápico, observa-se diferença importante entre as evidências encontradas e as utilizadas pela NANDA International, Inc. Apesar da definição estar adequada entre os fatores relacionados, não há menção à quimioterapia mesmo com inúmeros estudos, com diferentes delineamentos, objetivos e desfechos encontrados sobre esta temática.

RESUMEN Objetivo: identificar los factores relacionados al diagnóstico de enfermería náusea entre pacientes oncológicos durante el tratamiento de quimioterapia. Método: revisión integradora de cuatro bases electrónicas de datos (PUBMED, EMBASE, CINAHL y LILACS) con las palabras clave: neoplasia, agentes antineoplásicos y náusea. Resultados: de los 1.258 artículos identificados, solamente 30 atendieron los criterios de inclusión. Los factores relacionados más frecuentes fueron: edad abajo de 50 años, enfermedad del movimiento, sexo femenino, potencial emético de la quimioterapia, ansiedad, estímulo condicionado y expectativa de náuseas después del tratamiento. Conclusión: delante de los resultados encontrados y de la incidencia de náusea entre los pacientes oncológicos en tratamiento de quimioterapia, se observó diferencia importante entre las evidencias encontradas y las utilizadas por la NANDA International, Inc. A pesar de que la definición está adecuada entre los factores relacionados, no se menciona a la quimioterapia, inclusive encontrándose datos sobre esta temática en numerosos estudios con diferentes delineamientos, objetivos y resultados.

Orthodontic approach to treat complex hypodontia using miniscrews in a growing patient

This article reports orthodontic treatment of a case of hypodontia of five premolars in an 11-year-old female patient with a positive tooth size-arch length discrepancy in both dental arches. The patient had a straight profile with balanced facial growth. Setup manufacture revealed the possibility of achieving ideal occlusion by mesializing permanent molars up to 15 mm, in addition to keeping a primary molar in the dental arch. With the aid of absolute anchorage, the proposed mechanics was performed and the occlusion predicted in the setup was achieved, while profile and facial growth pattern were maintained. The use of miniscrews for extensive orthodontic movements was successful. Furthermore, one primary molar was extensively mesialized. The indication of gingivoplasty to correct gingival smile proved effective. This is considered a useful technique for orthodontists.

Este artigo apresenta o tratamento ortodôntico de um caso com hipodontia de cinco pré-molares, em uma paciente, de 11 anos de idade, com discrepância positiva de modelo em ambas as arcadas. A paciente apresentava perfil reto, com crescimento facial equilibrado. Por meio da confecção de set-up, verificou-se a possibilidade de se estabelecer uma oclusão ideal por meio da mesialização, de até 15mm, dos molares permanentes e manutenção de um molar decíduo no arco. Com o auxílio de ancoragem absoluta, foi realizada a mecânica proposta, alcançando-se a oclusão prevista em set-up, além da manutenção do perfil e do padrão de crescimento facial. A utilização de mini-implantes para grandes movimentos ortodônticos foi favorável, incluindo a extensa mesialização de um molar decíduo. A indicação da gengivoplastia para correção do sorriso gengival se mostrou acertada, sendo essa uma técnica de grande auxílio à Ortodontia.

Factors Predictive of Treatment-Emergent Adverse Events of Prucalopride: An Integrated Analysis of Four Randomized, Double-Blind, Placebo-Controlled Trials

BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to experience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. CONCLUSIONS: Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians.

Factors Predictive of Treatment-Emergent Adverse Events of Prucalopride: An Integrated Analysis of Four Randomized, Double-Blind, Placebo-Controlled Trials

BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to experience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. CONCLUSIONS: Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians.

Palonosetron versus granisetron in combination with aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with gynecologic cancer / 부인종양

OBJECTIVE: There is no research regarding the appropriate antiemetic agents for female patients, especially those receiving moderately emetogenic chemotherapy (MEC). We evaluated the antiemetic efficacy of a combination of 5-HT3 receptor with/without aprepitant in patients with gynecological cancer treated with the TC (paclitaxel and carboplatin) regimen of MEC. METHODS: We enrolled 38 patients diagnosed with gynecologic cancer and scheduled to receive the TC regimen. The patients were randomly assigned to receive a 5-HT3 receptor antagonist, either palonosetron in the first cycle followed by granisetron in the second cycle or vice versa. In the third cycle, all patients received a combination of the 5-HT3 receptor and dexamethasone with/without aprepitant. RESULTS: When three drugs were administered, palonosetron consistently produced an equivalent complete response (CR) rate to granisetron in the acute phase (89.5% vs. 86.8%, p=0.87) and delayed phase (60.5% vs. 65.8%, p=0.79). With regard to the change in dietary intake, palonosetron exhibited similar efficacy to granisetron in the acute phase (92.1% vs. 89.4%, p=0.19) and delayed phase (65.7% vs. 68.4%, p=0.14). However, in the delayed phase, the addition of aprepitant therapy with a 5-HT3 receptor antagonist and dexamethasone produced a higher CR rate than a 5-HT3 receptor antagonist with dexamethasone (93.3% vs. 47.8%, p<0.001) and allowed the patients to maintain a higher level of dietary intake (93.3% vs. 56.5%, p<0.001). CONCLUSION: The addition of aprepitant therapy was more effective than the control therapy of a 5-HT3 receptor antagonist, and dexamethasone in gynecological cancer patients treated with the TC regimen.

Incidence and management of chemotherapy-induced nausea and vomiting in women with breast cancer / Incidencia y gestión de náuseas y vómitos en tratamiento quimioterapico en mujeres con cáncer de mama / Ocorrência e manejo de náusea e vômito no tratamento quimioterápico em mulheres com câncer de mama

The objective of this study was to analyze the incidence of chemotherapy-induced nausea and vomiting in women with breast cancer and identify strategies used by them to control these signs and symptoms. Data for this cross-sectional study were collected through interviews during the last cycle of chemotherapy, between August 2011 and March 2012, in a university hospital in the State of São Paulo. The sample consisted of 22 women between the ages of 31 and 70, of whom 77.3% reported nausea and 50% vomiting during treatment. Regarding symptom management, 82% of the women reported having received some information centered on the use of prescribed medication. However, 27.3% did not know what medication they had taken. We concluded that there is a lack of systematic care and institutional protocol to guide professionals in providing standardized information to women so they can better control nausea and vomiting.

Este estudio objetivó analizar la incidencia de náuseas y vómitos en mujeres con cáncer de mama durante la quimioterapia, identificar el manejo utilizado para controlar estos signos y síntomas. Estudio transversal, cuyos datos fueron recolectados por medio de entrevistas en el último ciclo de quimioterapia entre agosto 2011 y marzo 2012 en un hospital universitario en el Estado de São Paulo. La muestra consistió de 22 mujeres, con edades entre 31 y 70 años, que el 77,3% reportó náuseas y el 50% vómitos durante el tratamiento. Cuanto al manejo, el 82% afirmó que habían recibido algún tipo de información centrada en el uso de la medicación prescrita, sin embargo, el 27,3% no supo responder cuál medicación fue utilizada. Se concluye que falta de sistematización de la atención y protocolo institucional para orientar profesionales para ofrecer información estandarizada, posibilitando el seguimiento de las mujeres para tener un mejor control de náuseas y vómitos.

Objetivou-se analisar a ocorrência de náusea e vômito em mulheres com câncer de mama durante a quimioterapia, e identificar o manejo utilizado para o controle desses sinais e sintomas. Pesquisa transversal, cujos dados foram coletados por meio de entrevista, no último ciclo de quimioterapia, entre agosto de 2011 e março de 2012 em um hospital universitário no interior do Estado de São Paulo. A amostra foi composta por 22 mulheres, com idade entre 31 e 70 anos, e 77,3% relataram náusea e 50% vômito, durante o tratamento. Quanto ao manejo, 82% delas afirmaram ter recebido algum tipo de informação que ficou centrada no uso da medicamento prescrito, entretanto, 27,3% não souberam responder qual medicamento usaram. Concluiu-se que há falta de sistematização da assistência e protocolo institucional que norteiem os profissionais a fornecer informações padronizadas, possibilitando o seguimento das mulheres, a fim de terem controle mais adequado da náusea e vômito.

Utilização de experiências musicais como terapia para sintomas de náusea e vômito em quimioterapia / Use of musical experiences as therapy for symptoms of nausea and vomiting in chemotherapy / El uso de experiencias musicales como terapia para los síntomas de las náuseas y los vómitos en quimioterapia

Objetivou-se aplicar as experiências musicais para avaliação dos efeitos terapêuticos em náuseas e vômitos associados à quimioterapia antineoplásica e identificar alterações nos parâmetros vitais dos pacientes que participaram da experiência. Estudo descritivo, transversal, nível II, de abordagem quantitativa, realizado com treze pacientes de um ambulatório de quimioterapia de um hospital particular no município de São Paulo. Foram utilizados dois instrumentos, sendo um deles proposto pela MASCC (Multinational Association on Supportive Care in Cancer). A maior parte da amostra foi composta por pacientes do sexo feminino, com idade entre 40 a 60 anos, casadas e com câncer de mama. Reduziu-se a frequência cardíaca em 77% da amostra; a náusea diminuiu em 100% dos pacientes após a primeira experiência musical, e em 85% após a segunda. Concluiuse ter havido houve redução estatisticamente significativa dos sintomas de náusea e vômito após as experiências musicais.

The study aimed to evaluate the therapeutic effects of musical experiments in nausea and vomiting associated with antineoplastic chemotherapy, and to identify changes in vital parameters of the patients who participated in the experience. This is a descriptive, transversal study, level II, which used a quantitative approach, conducted with thirteen patients from an outpatient chemotherapy unit, of a private hospital in São Paulo City. Two instruments were used, one of them proposed by MASCC (Multinational Association on Supportive Care in Cancer). The participants were predominantly females, aged 40 to 60 years, married and with breast cancer. Heart rate has decreased in 77% of the sample, and the reduction of nausea occurred in 100% of patients after the first musical experience, and in 85% after the second one. Patients reported disbelief in music in relieving nausea and vomiting before the sessions, and relief of nausea after them. It was concluded that there was a statistically significant reduction of the symptoms nausea and vomiting after the musical experiences.

Objetivó-se evaluar los efectos terapéuticos de experimentos musicales en las náuseas y los vómitos asociados con la quimioterapia del cáncer, e identificar cambios en los parámetros vitales de los pacientes sometidos a esa experiencia. Estudio descriptivo, exploratorio, transversal, nivel II, con enfoque cuantitativo, llevado a cabo con 13 pacientes de un ambulatorio de quimioterapia, en un hospital privado en São Paulo. En la recopilación de datos, utilizó-se dos instrumentos, uno que fue propuesto por la MASCC (Multinational Associationon Supportive Care in Cancer). Lla mayoría de los participantes estaba compuesta por pacientes de sexo femenino, con edades entre 40 y 60 años, casados y con cáncer de mama. Con respecto a los signos vitales, hubo reducción de la frecuencia cardíaca en 77%; e de las náuseas en el 100% de los pacientes después de la primera experiencia musical, y en el 85% después de la segunda. Antes de las sesiones, los pacientes reportaron falta de fe en la música para el alivio de las náuseas y los vómitos; y alivio de las náuseas después de las sesiones. En conclusión, hubo una reducción estadísticamente significativa en las puntuaciones de náuseas y vómitos después de las experiencias musicales.

Carbamazepine for prevention of chemotherapy-induced nausea and vomiting: a pilot study / Carbamazepina para prevenção de náusea e vômito induzidos por quimioterapia: um estudo piloto

CONTEXT AND OBJECTIVE: Nausea and vomiting are major inconveniences for patients undergoing chemotherapy. Despite standard preventive treatment, chemotherapy-induced nausea and vomiting (CINV) still occurs in approximately 50% of these patients. In an attempt to optimize this treatment, we evaluated the possible effects of carbamazepine for prevention of CINV. DESIGN AND LOCATION: Prospective nonrandomized open-label phase II study carried out at a Brazilian public oncology service. METHODS: Patients allocated for their first cycle of highly emetogenic chemotherapy were continuously recruited. In addition to standard antiemetic protocol that was made available, they received carbamazepine orally, with staggered doses, from the third day before until the fifth day after chemotherapy. Considering the sparseness of evidence about the efficacy of anticonvulsants for CINV prevention, we used Simon's two-stage design, in which 43 patients should be included unless overall complete prevention was not achieved in 9 out of the first 15 entries. The Functional Living Index-Emesis questionnaire was used to measure the impact on quality of life. RESULTS: None of the ten patients (0%) presented overall complete prevention. In three cases, carbamazepine therapy was withdrawn because of somnolence and vomiting before chemotherapy. Seven were able to take the medication for the entire period and none were responsive, so the study was closed. There was no impact on the patients' quality of life. CONCLUSION: Carbamazepine was not effective for prevention of CINV and also had a deleterious side-effect profile in this population. .

CONTEXTO E OBJETIVO: Náusea e vômito são inconvenientes importantes para pacientes submetidos a quimioterapia. A despeito do tratamento preventivo padrão, náuseas e vômitos induzidos por quimioterapia (NVIQ) ocorrem em aproximadamente 50% dos pacientes. Na tentativa de otimizar este tratamento, avaliamos os possíveis efeitos da carbamazepina na prevenção de náuseas e vômitos induzidos por quimioterapia. TIPO DE ESTUDO E LOCAL: Estudo fase II, prospectivo, não randomizado, aberto, realizado em um serviço público brasileiro de oncologia. MÉTODOS: Recrutaram-se continuamente pacientes alocados para o primeiro ciclo de quimioterapia altamente emetogênica. Além do protocolo anti-emético padrão disponibilizado, os pacientes receberam carbamazepina, por via oral, em doses escalonadas, a partir do terceiro dia anterior até o quinto dia após a quimioterapia. Dada a escassa evidência de eficácia dos anticonvulsivantes na prevenção de NVIQ, adotamos o desenho de Simon em duas fases, que deveria incluir 43 pacientes a não ser que prevenção completa global não fosse alcançada em 9 dos primeiros 15 participantes. O questionário "Functional Living Index-Emesis" foi usado para avaliar o impacto na qualidade da vida. RESULTADOS: Nenhum dos 10 pacientes (0%) apresentou prevenção completa global. Três tiveram a carbamazepina suspensa por sonolência e vômito antes da quimioterapia. Sete foram capazes de tomar a medicação por todo o período proposto e nenhum obteve resposta, sendo então interrompido o estudo. Não houve impacto na qualidade da vida. CONCLUSÃO: Carbamazepina não foi efetiva para prevenção de NVIQ e apresentou perfil deletério de efeitos adversos nesta população. .

A Phase 3, randomized, double-blind study of single-dose fosaprepitant for prevention of cisplatin-induced nausea and vomiting: Results of an Indian population subanalysis.

Context: Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian patients. Aims: This post hoc study assessed the efficacy and safety of fosaprepitant compared with aprepitant for prevention of CINV in the Indian population. A subgroup analysis was performed from data collected in a phase 3 study of intravenous (IV) fosaprepitant or oral aprepitant, plus the 5-HT 3 antagonist ondansetron and the corticosteroid dexamethasone, in cisplatin-naοve patients with solid malignancies. Materials and Methods: Patients scheduled to receive cisplatin (≥70 mg/m 2 ) were administered a single IV dose of fosaprepitant dimeglumine (150 mg) on day 1 or a 3-day dosing regimen of oral aprepitant (day 1:125 mg, days 2 and 3:80 mg) with standard doses of ondansetron and dexamethasone. Patients recorded nausea and/or vomiting episodes and their use of rescue medication and were monitored for adverse events (AEs) and tolerability. Statistical Analysis Used: Differences in response rates between fosaprepitant and aprepitant were calculated using the Miettinen and Nurminen method. Results: In the Indian subpopulation (n = 372), efficacy was similar for patients in both the fosaprepitant or aprepitant groups; complete response in the overall, acute, and delayed phases and no vomiting in all phases were approximately 4 percentage points higher in the fosaprepitant group compared with the aprepitant group. Fosaprepitant was generally well-tolerated; common AEs were similar to oral aprepitant. Conclusions: IV fosaprepitant is as safe and effective as oral aprepitant in the Indian subpopulation and offers an alternative to the oral formulation.

Náuseas, vômitos e qualidade de vida de mulheres com câncer de mama em tratamento quimioterápico / Náuseas, vómitos y calidad de vida en mujeres con cáncer de mama en la quimioterapia / Nausea, vomiting and quality of life in women with breast cancer receiving chemotherapy

Objetivou-se avaliar a qualidade de vida (QV) de mulheres com câncer de mama em tratamento quimioterápico e identificar a ocorrência de náuseas e vômitos durante o tratamento. Os dados foram coletados com a aplicação do instrumento da Organização Europeia de Pesquisa e Tratamento de Câncer, EORTC-QLQ-C30, na versão em português, bem como do módulo para câncer de mama BR-23, aplicados antes, no meio e ao final do tratamento. Das 79 mulheres incluídas, 93% apresentaram náuseas e 87% vômitos pelo menos uma vez durante o tratamento. A QV apresentou pequena diminuição durante o tratamento. O coeficiente alfa de Cronbach para cada aplicação dos questionários foi de 0,890492, 0,936392 e de 0,937639. A disponibilidade de informações sobre o tratamento e de orientações quanto ao manejo da náusea e do vômito é crucial para o gerenciamento adequado das toxicidades da quimioterapia.

Evaluar la calidad de vida (QOL) de las mujeres con cáncer de mama durante la quimioterapia e identificar el acontecimiento de náuseas y vómitos durante el tratamiento. Se recogieron datos con la aplicación del instrumento de la Organización Europea para la Investigación y Tratamiento del Cáncer, EORTC-QLQ-C30 versión en portugués y módulo para el cáncer de mama BR-23 aplicado antes, en la mitad y al final del tratamiento. Se incluyeron 79 mujeres, el 93% tuvo náuseas, el 87% vómitos al menos una vez durante el tratamiento. La QOL presentó una ligera disminución durante el tratamiento. El coeficiente alfa de Cronbach para cada aplicación de los cuestionarios fue 0.890492, 0.936392 y 0.937639. La disponibilidad de informaciones sobre el tratamiento y directrices sobre el manejo de la náusea y vómito es fundamental para la correcta gestión de las toxicidades de la quimioterapia.

The aim of this study was to assess the quality of life (QoL) of women with breast cancer during chemotherapy and to identify the incidence of nausea and vomiting during the treatment. Data were assessed with the application of the instrument of the European Organization for Research and Treatment of Cancer, EORTC-QLQ-C30 Portuguese version and breast cancer module BR-23, which was applied before, in the middle and in the end of the treatment. The participants were 79 women, of which 93% had nausea and 87% had vomited at least once during the treatment. QoL showed a slight decrease during treatment. Cronbach's alpha for each application of the questionnaires was 0.890492, 0.936392 and 0.937639. The availability of treatment information and guidelines on the management of nausea and vomiting is crucial for the proper management of the toxicities of chemotherapy.

Practical Effect of Sorafenib Monotherapy on Advanced Hepatocellular Carcinoma and Portal Vein Tumor Thrombosis

BACKGROUND/AIMS: We investigated the effects of sorafenib monotherapy on advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT) in a clinical setting. METHODS: In total, 143 consecutive patients with unresectable HCC were treated with sorafenib. Among these patients, 30 patients with advanced HCC and PVTT (Vp3 or 4) were treated with sorafenib monotherapy. RESULTS: All patients had a performance status of 1 to 2 (Eastern Cooperative Oncology Group 1/2, 20/10) and Child-Pugh class A or B (A/B, 17/13). Eleven patients had modified Union for International Cancer Control stage IVA tumors, whereas 19 had stage IVB tumors. All patients had PVTT (Vp3, 6; Vp4, 24). Following sorafenib monotherapy, three patients (10.0%) had a partial response with PVTT revascularization, and nine (30.0%) had stable disease, with a disease control rate of 33.3%. The median overall survival was 3.1 months (95% confidence interval [CI], 2.70 to 3.50), and the median progression-free survival was 2.0 months (95% CI, 1.96 to 2.05). Fatigue and hand-foot skin reactions were the most troublesome side effects. CONCLUSIONS: A limited proportion of patients with advanced HCC and PVTT exhibited a remarkable outcome after sorafenib monotherapy, although the treatment results in this type of patient is extremely poor. Further studies to predict good responders to personalized therapy are warranted.

[Effect of music therapy on chemotherapy nausea and vomiting in children with malignancy]

Nausea and vomiting is one of the major side-effects of chemotherapy. Due to complex nature of its management, both medical and non-medical therapies are recommended. This study aimed to investigate the effect of music therapy on chemotherapy nausea and vomiting in children with malignancy. In this quasi-experimental study, 30 children aged 8-12 who were under chemotherapy were recruited. After getting the current treatments, the children listened to a kind of music for 45 minutes at 6, 9, and 12 hours after the beginning of the chemotherapy. Nausea and vomiting was measured using both numerical and descriptive scales every 8 hours for 24 hours after beginning of the chemotherapy. Data were analyzed using Willcoxon and Mcnemar statistical tests in the SPSS, version 11.5. The rate of nausea was declined significantly at the 16[th] and 24[th] hours after music therapy. Assessment of nausea by descriptive scale showed a decline only at 24[th] hours after music therapy. The rate of vomiting did not show any significant difference between two stages. Music therapy could decrease the amount of nausea in children with malignancy under chemotherapy; however, it does not any effect on the rate of vomiting

Intravenous ketamine plus midazolam vs. intravenous ketamine for sedation in lumbar puncture: a randomized controlled trial.

OBJECTIVE: To compare a combined dose of ketamine and midazolam versus ketamine alone in the sedation of children requiring lumbar puncture. STUDY DESIGN: A randomized, controlled study, conducted between January 2004 and December 2006. SETTING: The Pediatric Emergency Department (PED) at Ankara Training and Research Hospital, Turkey. PARTICIPANTS: A random sample of 99 children (59 boys, 40 girls) aged 2-14 years (mean age 6.5+/-3.7) undergoing lumbar puncture. INTERVENTION: Participants were randomized to receive intravenous (IV) ketamine only (1 mg/kg; IVK) (n=51) or ketamine plus midazolam (1 mg/kg ketamine+0.1 mg/kg midazolam; IVKM) (n=48). MAIN OUTCOME MEASURES: The mean time to sedation and adverse events. RESULTS: The mean time to sedation was significantly shorter in the IVKM group than the IVK group (2.6+/-1.1 and 3.4+/-1.7 min, respectively; P=0.01). The parental satisfaction was significantly higher in the IVKM group (P=0.001). Also the fasting time and recovery time did not differ between groups, nor was there a significant difference in nausea/vomiting between groups. Nightmares or crying spells were more common in the IVK group than in the IVKM group (P=0.04). CONCLUSIONS: We conclude that adding midazolam to ketamine did not increase the frequency of adverse events and that the combined sedative was superior to ketamine alone in terms of speed of sedation and parental satisfaction.