Estudo de fase II de pregabalina para prevenção de náuseas e vômitos induzidos por quimioterapia / Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting

Para avaliar o papel da pregabalina na proteção das náuseas e vômitos induzidos pela quimioterapia, foi realizado um ensaio clínico de fase II, aleatorizado, duplamente cego, controlado por placebo, para investigar se a pregabalina poderia melhorar o controle completo das náuseas e vômitos (desfecho primário). Inscrevemos 82 pacientes virgens de quimioterapia, programados para receber quimioterapia moderadamente e altamente emetogênica. Todos os doentes receberam ondansetron 8mg por via intravenosa, dexametasona 10mg antes da quimioterapia no primeiro dia e, dexametasona 4 mg por via oral, b.d., nos dias dois e três. Os doentes foram distribuídos aleatoriamente para tomar pregabalina 75 mg ou placebo, bd, desde a noite anterior à quimioterapia até ao quinto dia. A resposta completa global não foi estatisticamente significativa entre os grupos (53,7 versus 48,8%, respetivamente, no grupo da pregabalina e no grupo de controlo (P=0,65)). Também não houve diferença estatística significativa durante a fase aguda (primeiras 24 horas) e a fase tardia (24-120h): 80,5% versus 82,9% (P=0,77), 53,7 versus 51,2% (P=0,82), respectivamente. Neste estudo não foi identificada ação da pregabalina na prevenção de náuseas e vômitos induzidos por quimioterapia. Número de registo no Clinicaltrial.gov: NCT04181346.

To evaluate the role of pregabalin in the protection of chemotherapy-induced nausea and vomiting, we performed a phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin could improve the complete control of nausea and vomiting (primary end point). We enrolled 82 chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy. All patients received IV ondansetron 8mg, dexamethasone 10mg before chemotherapy on day one and oral dexamethasone 4mg, b.d., on days two and three. Patients were randomly assigned to take pregabalin 75mg or placebo, bd, from the night before chemotherapy to day five. The overall complete response was not statistically significant between the groups (53.7 versus 48.8%, respectively, in the pregabalin group and the control group (P=0.65)). There was also no significant difference during the acute phase (first 24 hours) and delayed phase (24-120h): 80.5% versus 82.9% (P=0.77), 53.7 versus 51.2% (P=0.82), respectively. There is no role for pregabalin preventing chemotherapy-induced nausea and vomiting. Clinicaltrial.gov registration number: NCT04181346.

Post-operative nausea and vomiting prophylaxis: A meta-review on systematic reviews and meta-analyses

Introduction: Postoperative nausea and vomiting (PONV) are common complications in surgical patients undergoing general anesthesia, and multiple strategies have been suggested to prevent them. Objective: To describe the available evidence on the effectiveness of pharmacological and non-pharmacological strategies for preventing PONV in adults undergoing surgery under general anesthesia, as reported in previous meta-analyses and systematic reviews. Methodology: An overview of systematic reviews and meta-analyses was conducted. Searches were performed in PubMed, EBSCO, EMBASE, Cochrane Database, Science Direct, and Scopus, without restrictions as to gender, clinical condition, or date of publication, including articles in Spanish, French, and English only. Two reviewers independently and in duplicate did the screening, data extraction, quality evaluation, and risk of bias assessment according to AMSTAR-2. The PRISMA and PRIOR statements were followed for reporting. PROSPERO registration number CRD42021251999. Results: Out of 80 candidate articles, three were viable for meta-analysis. 1.5 mg to 18 mg doses of Dexamethasone showed a significant reduction in the risk of PONV, with a RR of 0.48 (95 % CI 0.41-0.57; p<0.001), I2=63 % (p=0.07), and a NNTc of 5 and 7. Other effective strategies included the use of acoustic stimulation/acupuncture/acupressure, 5HT3 antagonists, NK1 antagonists, gabapentinoids, haloperidol, droperidol, metoclopramide, midazolam, mirtazapine, among others. The risk of publication bias was low. Conclusion: Different strategies are effective for PONV prophylaxis in surgeries under general anesthesia. Dexamethasone shows the best available evidence at the moment. The documented methodological quality suggests the need for better studies to establish the effectiveness of the strategies.

Introducción: Las náuseas y el vómito posoperatorios (NVPO) son comunes en pacientes quirúrgicos bajo anestesia general y se han planteado múltiples estrategias para prevenirlos. Objetivo: Describir la evidencia disponible sobre la efectividad de las estrategias farmacológicas y no farmacológicas para prevenir las NVPO en adultos sometidos a cirugía bajo anestesia general, según lo descrito en metaanálisis y revisiones sistemáticas previas. Metodología: Se realizó una metarrevisión de revisiones sistemáticas y metaanálisis. Se ejecutaron búsquedas en PubMed, EBSCO, Embase, Cochrane Database, ScienceDirect y Scopus, sin restricción por sexo, condición clínica ni fecha de publicación, solo de artículos en español, francés e inglés. Dos revisores llevaron a cabo tamizaje, extracción de datos, evaluación de calidad y riesgo de sesgo según AMSTAR-2, de manera independiente y en duplicado. Se siguieron las declaraciones PRISMA y PRIOR para el reporte, previo registro en Prospero CRD42021251999. Resultados: De 80 artículos candidatos, se seleccionaron tres viables para realización de metaanálisis. La dexametasona entre 1,5 mg y 18 mg mostró un RR=0,48 (IC95 % [0,41-0,57]; p<0,001), I2=63 % (p=0,07) y un NNTc 5 y 7. Otras estrategias efectivas incluyen el uso de acuestimulación/acupuntura/acupresión, antagonistas 5HT3, antagonistas NK1, gabapentinoides, haloperidol, droperidol, metoclopramida, midazolam, mirtazapina, entre otras. El riesgo de sesgo de las publicaciones fue bajo. Conclusión: Diferentes estrategias son efectivas para profilaxis NVPO en cirugías con anestesia general. Dexametasona presenta la mejor evidencia disponible al momento. La calidad metodológica documentada sugiere la necesidad de realizar mejores trabajos para determinar la efectividad de las estrategias.

What are the effects of drugs for nausea and vomiting prevention following general anesthesia? Summary and comments regarding a Cochrane Collaboration network meta-analysis

The aim of this special article is to summarize and discuss, from an anesthesia perspective, the network meta-analysis on drugs used for the prevention of postoperative nausea and vomiting after general anesthesia, in agreement with the Cochrane Colombia collaboration and within the framework of the Cochrane Corners strategy. Through the combination of indirect comparisons and based on the evidence, the use of aprepitant, ramosetron, granisetron, dexamethasone and ondansetron is recommended with a high degree of certainty for the reduction of postoperative nausea and vomiting.

Este artículo especial tiene el objetivo de resumir y discutir desde la perspectiva de la anestesiología, el metaanálisis en red sobre fármacos para prevenir náuseas y vómito posoperatorio luego de anestesia general, en acuerdo con la colaboración Cochrane Colombia y en el marco de la estrategia Cochrane Corners. Mediante la combinación de la evidencia y el uso de comparaciones indirectas, se ha recomendado con alto grado de certeza el uso de aprepitant, ramosetrón, granisetrón, dexametasona y ondansetrón para la reducción de náuseas y vómito posoperatorio.

El paciente con estado migrañoso en urgencias / Patient with status migrainosus in emergency department

RESUMEN Se presentan dos casos de la práctica diaria, de pacientes con migraña con y sin aura que evolucionan a estado migrañoso (SM) y requieren atención hospitalaria. El manejo hospitalario es necesario luego de que se agotaran todas las medidas de manejo ambulatorio indicadas. Se describen los criterios diagnósticos del SM actuales por la ICDH-3, su fisiopatología y la reciente propuesta del SM episódico. Se ofrecen algunas sugerencias del manejo actual de acuerdo con la evidencia disponible que pueden ser de utilidad en la práctica diaria.

SUMMARY We describe two cases with migraine with and without aura who evolves to Migrainous State (MS) requiring hospital care. Admision for management is necessary after all outpatient management measures were exhausted. The current criteria for the diagnosis of MS by the ICDH -3, its pathophysiology and the recent proposal of episodic MS were described. We propose some suggestions of current management according to the available evidence that may be useful for daily practice.

Effect of palonosetron, ondansetron and dexamethasone in the prevention of postoperative nausea and vomiting in video cholecystectomy with total venous anesthesia with propofol-remifentanil - randomized clinical trial / Efeito da palonosetrona, ondansetrona e dexametasona na prevenção de náusea e vômito pós-operatório em videocolecistectomia com anestesia venosa total com propofol-remifentanil - ensaio clínico randomizado duplo cego

Abstract Introduction and objectives: The incidence of Postoperative Nausea and Vomiting (PONV) after video cholecystectomy is high. Progress in pharmacological PONV prophylaxis includes a new generation of 5-HT3 antagonists. This study aims to assess the effect of the 5-HT3 antagonist in postanesthetic antiemetic management of patients submitted to laparoscopic cholecystectomy with total intravenous anesthesia. Methods: Sixty individuals who underwent video cholecystectomy were randomized into three groups of 20 individuals according to the treatment administered: 0.125 mg of palonosetron (Group 1); 4 mg of ondansetron associated with 4 mg of dexamethasone (Group 2); 4 mg of dexamethasone (Group 3). General intravenous anesthesia was performed with propofol, remifentanil and rocuronium. The group to which the participant belonged was concealed from the investigator who assessed drug effect. PONV was assessed using the Rhodes Scale at 12 and 24 hours after surgery. Rescue medication was 0.655 to 1.5 mg of droperidol. Results: Group 1 presented a lower incidence of PONV and required less rescue medication in the first postoperative hour. There was no significant difference among the three groups regarding PONV incidence in the first 12 postoperative hours. Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours. Group 1 showed significantly superior nausea control in the first 12 postoperative hours. Conclusions: The present study showed evidence that palonosetron is superior to the drugs compared regarding a protracted antiemetic effect and less requirement of rescue drugs, mainly related to its ability to completely inhibit the uncomfortable symptom of nausea.

Resumo Justificativa e objetivo: Náuseas e Vômitos no Pós-Operatório (NVPO) têm alta incidência após videocolecistectomia. Avanços na profilaxia farmacológica de NVPO incluem a nova geração de antagonista 5-HT3. O objetivo deste estudo foi avaliar o efeito do antagonista 5-HT3 no controle antiemético pós-anestésico em videocolecistectomia com anestesia venosa total. Método: Estudo realizado no HC-UFU (Hospital Terciário). Sessenta indivíduos submetidos a videocolecistectomia foram randomizados em três grupos de igual número, sendo administrados 0,125 mg de palonosetrona (Grupo 1); 4 mg de ondasetrona e 4 mg de dexametasona (Grupo 2); ou 4 mg de dexametasona (Grupo 3). A anestesia geral venosa foi realizada com propofol, remifentanil e rocurônio. O avaliador do efeito da droga desconhecia o grupo ao qual o indivíduo pertencia. NVPO foi avaliada aplicando a Escala de Rhodes após 12 e 24 horas do término da cirurgia. Para resgate terapêutico, foi estabelecido 0,655−1,5 mg de droperidol. Resultado: Observou-se no Grupo 1 menor incidência de NVPO e de resgate terapêutico na primeira hora de PO. Não foi observada diferença significativa entre os três grupos com relação a ocorrência de NVPO nas primeiras 12 horas de pós-operatório. Os grupos 1 e 2 foram superiores ao Grupo 3 no que se refere ao controle de NVPO de 12 a 24 horas e após o resgate de 12−24 horas. Observou-se que o controle de náuseas nas primeiras 12 horas de pós-operatório do Grupo 1 foi significantemente superior. Conclusão: O presente estudo mostrou evidências da superioridade da palonosetrona às demais drogas empregadas no que se refere ao efeito antiemético prolongado e menor necessidade de resgate, principalmente na capacidade de inibir completamente o desconfortável sintoma de náusea.

Effect of Intra-Operative Intravenous Crystalloid Infusion on Post-Operative Nausea and Vomiting after Diagnostic Gynaecological Laparoscopy- Comparison of 30 mL/Kg & 15 mL/Kg.

Laparoscopic procedures have the advantages of minimal incision, early recovery, lesser post-operative pain and early ambulation. However, they are associated with an increased incidence of post-operative nausea and vomiting (PONV), which is all the more frequent in gynaecological laparoscopic surgeries. In our study, we have evaluated the effectiveness of intra-operative intravenous crystalloid infusion on post-operative nausea and vomiting after diagnostic gynaecological laparoscopy.METHODSInformed consent was obtained and patients were randomly divided into two groups. Group 1 received 30 mL/Kg intravenous crystalloid infusion intra operatively and group 2 received 15 mL/Kg intravenous crystalloid infusion. Incidence of nausea, incidence of emesis (retching or vomiting), the amount of rescue antiemetic used, and the haemodynamic parameters were noted in the postoperative period for 12 hours for both the groups.RESULTSIncidence of PONV was much more in group 2 in 0, 1, 2, 3, 4, 6 hours post operatively and rescue antiemetic use was much more in group 2 in total 12 hours post-operative period. There was no statistically significant difference in hemodynamic parameters between Group 1 and Group 2.CONCLUSIONSIntra-operative administration of 30 mL/Kg of crystalloid infusion significantly reduces the incidence of PONV and rescue antiemetic use compared to 15 mL/Kg crystalloid infusion in diagnostic gynaecological laparoscopy. So, it can be used as a non-pharmacological method for prophylaxis of PONV.

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.

Extrapiramidalismo por antieméticos / Extrapyramidal Side Effects of Antiemetics / Reações extrapiramidais causadas por antieméticos

Resumen: Los antieméticos son usados frecuentemente por diversas áreas de la medicina, aunque existe una tendencia a subestimar sus efectos adversos neurológicos. El objetivo del presente estudio de revisión fue revisar la literatura sobre la fisiología, farmacología, factores predisponentes, clínica y manejo del extrapiramidalismo por antieméticos. Se realizó una búsqueda en la literatura de artículos de revistas científicas, libros y trabajos de grado. Se utilizaron los buscadores Medline, LILACS, PubMed, EMBASE, Current contents y Google Scholar con las siguientes palabras claves: deshidratación, gastroenteritis, vómitos, antieméticos, distonía, dopamina, hipertermia, citocromo, meto-clopramida y domperidona. Se obtuvieron 252 artículos, de los cuales 50 fueron considerados aptos para la revisión. A partir del análisis, se concluyó que el uso de antieméticos es de uso frecuente por medicina general y especialidades como anestesiología y pediatría, por lo cual un conocimiento sobre los efectos extrapiramidales permitirá un diagnóstico y manejo temprano.

Abstract: Antiemetics are frequently used by various areas of medicine, although there is a tendency to underestimate their neurological adverse effects. This paper aims to review the literature on the physiology, pharmacology, predisposing factors, clinical picture, and management of the extrapyramidal side effects of antiemetics. Scientific journal articles, books, and dissertations were searched. The search engines Medline, LILACS, PubMed, EMBASE, Current Contents, and Google Scholar were used with the following keywords: dehydration, gastroenteritis, vomit, antiemetics, dystonia, dopamine, hyperthermia, cytochrome, metoclopramide, and domperidone. Two hundred and fifty-two articles were obtained, 50 of which were considered suitable for review. From the analysis, it was concluded that antiemetics are often used by general medicine and specialties such as anesthesiology and pediatrics; therefore, knowledge of the extrapyramidal effects will allow early diagnosis and treatment.

Resumo: Os antieméticos são frequentemente usados por diversas áreas da medicina, embora possamos constatar uma tendência a subestimar seus efeitos adversos neurológicos. O objetivo do presente estudo é revisar a literatura sobre a fisiologia, a farmacologia, os fatores predisponentes, a clínica e o tratamento de reações extrapiramidais causadas por antieméticos. Foi realizada uma busca na literatura por artigos de revistas científicas, livros e monografias. Os mecanismos de busca Medline, LILACS, PubMed, EMBASE, Current contents e Google Scholar foram utilizados com as seguintes palavras-chave: desidratação, gastroenterite, vómito, antieméticos, distonia, dopamina, hipertermia, citocromo, metoclopramida e domperidona. Foram encontrados 252 artigos, dos quais 50 foram considerados aptos para a revisão. A partir da análise, concluiu-se que os antieméticos são frequentemente utilizados pela medicina geral e especialidades, como anestesiologia e pediatria, portanto, o conhecimento dos efeitos extrapiramidais possibilitará um diagnóstico e tratamento precoces.

Prospective randomized trial of standard antiemetic therapy with yoga versus standard antiemetic therapy alone for highly emetogenic chemotherapy-induced nausea and vomiting in South Asian population

Aim/Background: Chemotherapy-induced nausea and vomiting (CINV) is one of the most distressing side effects of highly emetogenic chemotherapy regimens. There have been continuous efforts in the direction to control CINV by many investigators. Materials and Methods: Randomly selected patients were those receiving highly emetogenic chemotherapy regimen grouped into yoga and standard antiemetic therapy (n = 50) just before receiving chemotherapy and continued for the following days and other group (n = 50) received only the standard antiemetic agent. Both the groups were assessed, followed for acute and delayed onset of chemotherapy-induced and anticipatory nausea and vomiting using radiation therapy oncology group grading for the same. We also assessed the quality of life of the patient using the Functional Assessment of Cancer Therapy-General questionnaire. Results: The median age group of the patients was 51 years with male:female ratio 2:1, The Eastern Cooperative Oncology Group (ECOG) performance status was 0/1 in 38% of the selected population, while ECOG 2 in 62% of the patients. In yoga arm, insignificant reduction in chemotherapy-induced nausea (90% vs. 78%, P = 0.35) and but significant reduction in vomiting (42% vs. 22%, P =0.01) was observed as compared to the standard antiemetics only arm. There was a significant reduction in Grade 2 and 3 nausea (84% vs. 38% P < 0.01) and vomiting (14% vs. 0% P < 0.01). Quality of life is also significantly improved in the yoga arm, especially in the ECOG 2 performance status. Conclusions: This study concludes that yoga along with standard antiemetic medication should be a part of the management plan for the cancer patients receiving highly emetogenic chemotherapy

Single-dose Intravenous Ondansetron in Children with Gastroenteritis: A Randomized Controlled Trial

Objective: To evaluate the efficacy of ondansetron for thetreatment of vomiting and thus reducing the need for intravenous(IV) rehydration in children with gastroenteritis.Design: Double-blind, placebo-controlled, randomized trial.Setting: Pediatric ward of An Giang General Hospital, SouthVietnam, between December 2013 and June 2014.Participants: 61 inpatient children (age 11-60 mo) suffering fromgastroenteritis with vomiting. Exclusion criteria were: underlyingchronic conditions, immunodeficiency, malnutrition or history ofallergy to ondansetron.Intervention: Single bolus of IV ondansetron at a dose of 0.2 mg/kg or placebo.Outcome measures: Proportion of patients who needed IVrehydration, proportion of patients with cessation of vomiting,amount of oral rehydration solution intake, duration of diarrheaand the length of hospital stay.Results: After drug administration, 22 (73%) of the 30 patients inthe ondansetron group had complete cessation of vomitingcompared with 7 (23%) of the 31 patients in the placebo group(RR 0.32; 95% CI 0.16 to 0.63, P<0.001). 3 (10%) patients inthe ondansetron group required IV rehydration as comparedwith 12 (39%) in the placebo group (RR 0.51; 95% CI 0.33 to0.79, P=0.009). The median amount of oral rehydration solutionintake in 24 hours was significantly greater in the ondansetrongroup (450 mL vs 350 mL, P=0.019).The duration of diarrheaand the length of hospital stay were not different between the twogroups.Conclusion: In hospitalized children having gastro-enteritisassociated with emesis, ondansetron is effective in the cessationof episodes of vomiting and in lowering the rates of IV rehydration,without reducing the duration of diarrhea and hospital stay

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy: Results of the Korean South West Oncolog / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: Data on the efficacy of olanzapine in patients receiving moderately emetogenic chemotherapy (MEC) are limited. This study aimed to evaluate and compare the efficacy of olanzapine versus placebo in controlling nausea and vomiting in patients receiving MEC. MATERIALS AND METHODS: We conducted a randomized, double-blind, placebo-controlled study to determine whether olanzapine can reduce the frequency of chemotherapy-induced nausea and vomiting (CINV) and improve the quality of life (QOL) in patients receiving palonosetron and dexamethasone as prophylaxis for MEC-induced nausea and vomiting. The primary end point was complete response for the acute phase (0-24 hours after chemotherapy). The secondary end points were complete response for the delayed (24-120 hours) and overall phase (0-120 hours), proportion of significant nausea (visual analogue scale ≥ 25 mm), use ofrescue medications, and effect on QOL. RESULTS: Fifty-six patients were randomized to the olanzapine (n=29) and placebo (n=27) groups. Complete response rates were not significantly different between the olanzapine and placebo groups in the acute (96.5% vs. 88.0%, p=0.326), delayed (69.0% vs. 48.0%, p=0.118), and overall phases (69.0% vs. 48.0%, p=0.118). However, the percentage of patients with significant nausea (17.2% vs. 44.0%, p=0.032) and the use of rescue medications (0.03±0.19 vs. 1.88±2.88, p=0.002) were lower in the olanzapine group than in the placebo. Furthermore, the olanzapine group demonstrated better QOL (p=0.015). CONCLUSION: Olanzapine combined with palonosetron and dexamethasone significantly improved QOL and vomiting control among previously untreated patients receiving MEC, although the efficacy was limited to the reduction of the frequency of CINV.

Cost-effectiveness of newer anti-emetics in the prevention of chemotherapy induced nausea and vomiting: a pharmaco-economic study analysis

Background: Chemotherapy induced Nausea and Vomiting (CINV) is one the most common adverse effects associated with chemotherapeutic management of carcinoma breast. Preventing CINV becomes a vital part in treatment of these cancer patients for better compliance. The conventional regimen of newer 5-HT3 receptor antagonist and dexamethasone along with newer agents - Aprepitant, a NK-1 receptor antagonist and a recently approved atypical antipsychotic, Olanzapine have shown better control of CINV. These newer agents are effective but also very expensive.Methods: The study included carcinoma breast patients scheduled for chemotherapy (n = 55 in each group) who either received aprepitant or olanzapine or a combination of both as the anti-emetic regimen. Considering Cost-Effectiveness Analysis (CEA), the cost included was the cost of anti-emetic agents (sponsor’s perspective) and outcome measured as control of nausea and vomiting - as Complete Protection (CP), Complete Response to Best (CRB) and Incomplete Response (IR) for acute (0-24 hours) and delayed (24-120 hours) phases. The cost effectiveness(CE) ratio for emesis and CINV free days were calculated.Results: CP was seen better during the acute period than the delayed period. With Aprepitant, delayed CRB and IR was seen with 13 (23.6%) and 10 (18.2%) subjects. 16 (29.1%) showed IR with Olanzapine during the delayed period.The average number of Emesis and CINV free days were 4.65, 4.51, 4.89 and 3.38, 3.96, 4.15 for the three groups respectively. The cost required to achieve 1 emesis and 1 CINV free day per subject in the 3 groups was INR 351.19, INR 27.20, INR 339.54 and INR 483.36, INR 30.94, INR 400.60 respectively.Conclusions: The newer anti-emetic even though being expensive at cost, pharmacoeconomically provide better outcomes and seem to have better control rates than the conventional regimen.

Bromopride, metoclopramide, or ondansetron for the treatment of vomiting in the pediatric emergency department: a randomized controlled trial / Bromoprida, metoclopramida ou ondansetrona no tratamento de vômito no departamento de emergência pediátrica: ensaio controlado randomizado

Abstract Objective: To compare the effectiveness of a single intramuscular dose of bromopride, metoclopramide, or ondansetron for treating vomiting. Methods: Randomized controlled trial including children 1-12 years of age presenting with acute vomiting at the pediatric emergency department. Outcomes: Number of children that stopped vomiting at one, six, and 24 h following treatment; episodes of diarrhea; acceptance of oral liquids; intravenous rehydration; return to hospital and side effects. Results: There were 175 children who completed the study. Within the first hour after treatment, all drugs were equally effective, with ondansetron preventing vomiting in 100%, bromopride in 96.6%, and metoclopramide in 94.8% of children (p = 0.288). Within six hours, ondansetron was successful in preventing vomiting in 98.3% of children, compared to bromopride and metoclopramide, which were successful in 91.5% and 84.4% of patients, respectively (p = 0.023). Within 24 h, ondansetron was superior to both other agents, as it remained efficacious in reducing vomiting in 96.6% of children, as opposed to 67.8% and 67.2% with bromopride and metoclopramide, respectively (p = 0.001). The ondansetron group showed better acceptance of oral liquids (p = 0.05) when compared to the bromopride and metoclopramide. The ondansetron group did not show any side effects in 75.9% of cases, compared to 54.2% and 53.5% in the bromopride and metoclopramide groups, respectively. Somnolence was the most common side effect. Conclusions: A single dose of ondansetron is superior to bromopride and metoclopramide in preventing vomiting six hours and 24 h following treatment. Oral fluid intake after receiving medication was statistically better with Ondansetronwhile also having less side effects compared to the other two agents.

Resumo Objetivo: Para comparar a eficacia de uma unica dose intramuscular de bromoprida, metoclopramida ou ondansetrona no tratamento de vomito. Métodos: Ensaio controlado randomizado incluindo crianc¸as de 1 a 12 anos de idade que apresentam vomito agudo no departamento de emergencia pediatrica. Desfechos: Numero de crianças que pararam de vomitar 1, 6 e 24 horas apos o tratamento; episodios de diarreia; aceitac¸ao de liquidos orais; reidratac¸ao intravenosa, retorno ao hospital e efeitos colaterais. Resultados: 175 crianças concluiram o estudo. Na primeira hora apos o tratamento, todos os medicamentos foram igualmente eficazes, sendo que a ondansetrona preveniu vomito em 100%, a bromoprida em 96,6% e metoclopramida em 94,8% das crianças (p = 0,288). Em 6 horas, a ondansetrona mostrou sucesso na prevençao do vomito em 98,3% das crianças, em comparac¸ao a bromoprida e a metoclopramida, que mostraram sucesso em 91,5% e 84,4% dos pacientes, respectivamente (p = 0,023). Em 24 horas, a ondansetrona foi superior aos dois outros agentes, pois ela continuou eficaz na reduçao do vomito em 96,6% das crianças, diferente de 67,8% e 67,2% com bromoprida e metoclopramida, respectivamente (p = 0,001). O grupo de ondansetrona mostrou melhor aceitaçao de liquidos orais (p = 0,05) em comparaçao a bromoprida e metoclopramida. O grupo de ondansetrona nao mostrou efeitos colaterais em 75,9% dos casos, em comparaçao a 54,2% e 53,5% dos grupos de bromoprida e metoclopramida. O efeito colateral mais comum foi sonolencia. Conclusões: Uma unica dose de ondansetrona e superior a bromoprida e metoclopramida no tratamento de vomito 6 horas e 24 horas apos o tratamento. A ingestao de fluidos orais apos receber medicaçao foi estatisticamente melhor com ondansetrona, ao mesmo tempo em que tambem apresentando menos efeitos colaterais em comparaçao aos outros dois agentes.

Prophylaxis of postoperative nausea and vomiting after cardiac surgery in high-risk patients: A randomized controlled study

Context: The role of prophylaxis for postoperative nausea and vomiting (PONV) in cardiac surgery is under debate. Aims: To study the risk factors for PONV after cardiac surgery and the role of betamethasone with or without droperidol for its prevention. Setting and Design: Randomized open-label controlled study comparing standard care with PONV prophylaxis from February to November 2016. Methods: Five hundred and two patients with planned nonemergent cardiac surgery were included. Interventions: In the intervention arm, PONV prophylaxis (4 mg betamethasone with/without 0.625 mg droperidol) was administered in high-risk patients (two or more risk factors). Patients in the control arm were treated as per routine hospital practices. Results: Female sex, past history of PONV, and migraines were associated with a significantly increased risk of PONV, while motion sickness, smoking status, and volatile anesthetics were not. Pain and treatment with nefopam or ketoprofen were associated with an increased risk of PONV. PONV was less frequent in the active arm compared to controls (45.5% vs. 54.0%, P = 0.063; visual analogic scale 10.9 vs. 15.3 mm, P = 0.043). Among the 180 patients (35.6%) with ≥2 risk factors, prophylaxis was associated with reduced PONV (intention-to-treat: 46.8% vs. 67.8%, P = 0.0061; per-protocol: 39.2% vs. 69%, P = 0.0002). In multivariate analysis, prophylaxis was independently associated with PONV (odds ratio [OR]: 0.324, 95% confidence interval: 0.167–0.629, P = 0.0009), as were female sex, past history of PONV, and migraines (OR: 3.027, 3.031, and 2.160 respectively). No drug-related side effects were reported. Conclusion: Betamethasone with/without droperidol was effective in decreasing PONV in high risk cardiac surgical patients without any side effect.

Comparison of Ramosetron Dose in Patients with Postoperative Nausea and Vomiting Who Received Oxycodone-Based Intravenous Patient-Controlled Analgesia after Undergoing Gynecological Laparoscopic Surgery

OBJECTIVE: Pain that occurs following gynecological laparoscopic surgery is a main cause for prolonged hospitalization. As a solution, various intravenous patient-controlled analgesia (IV PCA) systems have been used to control postoperative pain. This study explored the relationship between the dose of the ramosetron used to control postoperative nausea and vomiting (PONV) and its effect when oxycodone was used as the IV PCA. METHODS: Ninety-two patients (age, 18–70 years) undergoing gynecological laparoscopic surgery received oxycodone as IV PCA and were divided into the RB and RM group. Towards the end of surgery, the RB group patients were given 0.3 mg ramosetron as an IV bolus, and those in the RM group were given 0.3 mg ramosetron plus and additional 0.6 mg as IV PCA. The degree of PONV, postoperative pain, and pain felt during coughing were observed for 0.5, 2, 4, 8, 24, and 48 hours postoperatively. Patient satisfaction and comfort were assessed at 24 and 48 hours. RESULTS: No differences in operation time, anesthesia period, or amounts of propofol and remifentanil used were observed between the groups. IV PCA demand, severity of PONV, postoperative pain, and coughing pain were also similar between the groups. Patient comfort was similar between the groups at 24 and 48 hours postoperatively. CONCLUSION: No difference in the incidence of PONV was detected between patients who used only 0.3 mg ramosetron as an intravenous bolus and those who received an additional 0.6 mg ramosetron mixed in IV PCA when oxycodone was offered as the IV PCA after undergoing gynecological laparoscopic surgery.

Cyclophosphamide administration routine in autoimmune rheumatic diseases: a review / Rotina de administração de ciclofosfamida em doenças autoimunes reumáticas: uma revisão

Abstract Cyclophosphamide is an alkylating agent widely used for the treatment of malignant neoplasia and which can be used in the treatment of multiple rheumatic diseases. Medication administration errors may lead to its reduced efficacy or increased drug toxicity. Many errors occur in the administration of injectable drugs. The present study aimed at structuring a routine for cyclophosphamide use, as well as creating a document with pharmacotherapeutic guidelines for the patient. The routine is schematized in three phases: pre-chemotherapy, administration of cyclophosphamide, and post-chemotherapy, taking into account the drugs to be administered before and after cyclophosphamide in order to prevent adverse effects, including nausea and hemorrhagic cystitis. Adverse reactions can alter laboratory tests; thus, this routine included clinical management for changes in white blood cells, platelets, neutrophils, and sodium, including cyclophosphamide dose adjustment in the case of kidney disease. Cyclophosphamide is responsible for other rare - but serious - side effects, for instance, hepatotoxicity, severe hyponatremia and heart failure. Other adverse reactions include hair loss, amenorrhea and menopause. In this routine, we also entered guidelines to post-chemotherapy patients. The compatibility of injectable drugs with the vehicle used has been described, as well as stability and infusion times. The routine aimed at the rational use of cyclophosphamide, with prevention of adverse events and relapse episodes, factors that may burden the health care system.

Resumo A ciclofosfamida (CFM) é um agente alquilante vastamente usado para o tratamento de neoplasias malignas e pode ser usado no tratamento de diversas doenças reumatológicas. O erro de administração de medicamentos pode levar à diminuição da eficácia ou ao aumento da toxicidade medicamentosa. Diversos erros ocorrem na administração de medicamentos injetáveis. O trabalho objetivou a estruturação de uma rotina do uso de ciclofosfamida, bem como a criação de um documento de orientações farmacoterapêuticas para o paciente. A rotina foi esquematizada em três fases, a pré-quimioterapia (pré-QT), a administração da ciclofosfamida e a pós-quimioterapia (pós-QT), que levaram em consideração os medicamentos que devem ser administrados antes e depois da ciclofosfamida para prevenção aos efeitos adversos, incluindo náusea e cistite hemorrágica. As reações adversas podem alterar os exames laboratoriais e a rotina incluiu manejo clínico para alteração clínica dos leucócitos, das plaquetas, dos neutrófilos e do sódio incluindo o ajuste de dose de ciclofosfamida em caso de insuficiência renal. A ciclofosfamida é responsável por outras reações adversas raras, mas sérias, como hepatotoxicidade, hiponatremia severa e falência cardíaca. Outras reações adversas incluem perda de cabelo, amenorreia e menopausa. A rotina foi composta também por orientações ao paciente pós-QT. A compatibilidade dos medicamentos injetáveis com o veículo foi descrita, bem como o tempo de estabilidade e o tempo de infusão. A rotina visou ao uso racional da ciclofosfamida e prevenir os efeitos adversos e os episódios de recidiva, os quais podem onerar o sistema de saúde.

Prevención y tratamiento de pacientes con náuseas y vómitos postoperatorios / Prevention and treatment of patients with postoperative nausea and vomiting

Resumen Las náuseas y vómitos postoperatorios (NVPO) son un problema frecuente en los pacientes quirúrgicos. Cuando no son prevenidos adecuadamente pueden provocar mayor morbilidad, estadía prolongada en la unidad de recuperación postoperatoria y hospitalización no planificada. El objetivo del equipo quirúrgico debe ser la profilaxis de las NVPO más que su tratamiento, con el fin de disminuir significativamente su incidencia y complicaciones asociadas. Los principales factores de riesgo para NVPO son: sexo femenino, historia de NVPO en cirugías previas y/o cinetosis, no fumar, uso de opioides sistémicos en el postoperatorio, someterse a ciertos tipos de cirugía (como colecistectomía, cirugía laparoscópica y cirugía ginecológica), utilizar anestésicos volátiles y/u óxido nitroso intraoperatorios, y duración de la cirugía. Sugerimos objetivar el riesgo de NVPO utilizando las escalas de riesgo de NVPO de Apfel o Koivuranta. Los principales fármacos antieméticos usados como profilaxis y tratamiento en el período perioperatorio son dexametasona, ondansetrón y droperidol. Existen estrategias generales que se pueden utilizar para reducir el riesgo quirúrgico basal de NVPO como evitar la anestesia general, privilegiando la anestesia regional, utilizar propofol para la inducción y mantención de la anestesia, evitar el uso de óxido nitroso y/o anestésicos inhalatorios, minimizar el uso postoperatorio de opioides sistémicos y recibir una hidratación intravenosa abundante durante la cirugía. La etiología de las NVPO es multifactorial, por lo que la prevención y tratamiento deben incluir diferentes clases de antieméticos, que actúen sobre los diferentes receptores de náuseas y/o vómitos hasta el momento conocidos, junto con las estrategias generales antes mencionadas.

Abstract Postoperative nausea and vomiting (PONV) are a common problem in surgical patients. When not properly prevented, they can lead to increased morbidity, prolonged stay in the postoperative recovery unit and unplanned hospitalization. The objective of the surgical team should be the prophylaxis of PONV rather than its treatment, in order to significantly reduce its incidence and associated complications. The main risk factors for PONV are: female sex, history of PONV in prior surgeries and/or motion sickness, non-smoking, use of systemic opioids postoperatively, undergo certain types of surgery (such as cholecystectomy, laparoscopic surgery and gynecological surgery), use volatile anesthetics and/or intraoperative nitrous oxide, and duration of surgery. We suggest to objectify the risk of PONV using the Apfel or Koivuranta PONV risk scales. The main anti-emetic drugs used as prophylaxis and treatment in the perioperative period are dexamethasone, ondansetron and droperidol. There are general strategies that can be used to reduce the baseline surgical risk of PONV such as avoiding general anesthesia, favoring regional anesthesia, using propofol for induction and maintenance of general anesthesia, avoiding the use of nitrous oxide and/or inhalational anesthetics, minimizing the postoperative use of systemic opioids and to receive an abundant intravenous hydration during surgery. The etiology of PONV is multifactorial, so prevention and treatment should include different classes of antiemetics, acting on the different receptors of nausea and/or vomiting so far known, together with the general strategies mentioned above.

Analysis of the Utilization of Antiemetics in Cancer Patients of 87 Hospitals from 2012 to 2014 / 中国药房

OBJECTIVE:To provide reference for rational use of antiemetics in cancer patients. METHODS:The utilization of antiemetics in cancer outpatients and inpatients from 87 hospitals involved inHospital Prescription Analysisproject during 2012-2014 was analyzed statistically by time or by hospital category. RESULTS:14 antiemetics were used in 87 hospitals during 2012-2014. The consumption sum and person number of antiemetics in cancer outpatients were 5763000 yuan and 34000 persons [22000 yuan/(year·hospital),133.1 person/(year·hospital) in average];those of cancer inpatients were 61711000 yuan and 515000 persons [256000 yuan/(year·hospital),2137.9 person/(year·hospital) in average];those of outpatient were lower than those of inpatient. The ratio of consumption sum of antiemetics in cancer outpatients and inpatients were 5.2‰-34.0‰;the ratio of person number ranged 2.9%-10.9%. Those of inpatient were higher than those of outpatient;those of special hospital were higher than those of comprehensive hospital. Main drugs included ondansetron,tropisetron,metoclopramide and palonosetron. CONCLU-SIONS:Antiemetics are frequently used in cancer patients,especially for 5-HT3 receptor antagonists and metoclopramide.

Analysis of Rationality and Therapeutic Efficacy of Antiemetics in Cancer Patients of Our Hospital / 中国药房

OBJECTIVE:To provide reference for rational use of antiemetics in cancer patients. METHODS:Two thousand six hundred and sixteen pieces of medical orders of patients receiving antiemetics were collected from oncology department of our hospital via EMRS during Oct. 2015-Jun. 2016. RESULTS:Among 2 616 cases surveyed,1 301 cases conformed to inclusion and exclusion criteria,of which irrational use of drugs were found in 595 cases,760 times in total. Main manifestations were unsuitable drug selection(33.82%),irrational usage and dosage(25.26%),unsuitable drug combination(34.08%)and non-standard medication course(6.84%). The incidence of nausea in female was higher than male,with statistical sighificance(P=0.003),but gender had no significant effect on the incidence of nausea(P>0.05). Age had no significant effect on both nausea and vomiting(P>0.05). The control rate of nausea/vomiting in rational drug use group was higher than irrational drug use group. Average cost of antiemetic treatment of different emetic risk chemotherapy drugs in rational drug use group were all lower than irrational drug use group, indicating therapeutic efficacy could be guaranteed and economic burden was reduced in rational drug use group. CONCLUSIONS:The antiemetic plan should be selected rationally according to emetic risk degree of chemotherapy drugs. Patients receiving combined chemotherapy should select antiemetic plan according to highest emetic risk degree of chemotherapy drugs,and strictly master usage, dosage and duration. At the same time,treatment cost should be considered when selecting antiemetic plan to guarantee the safe, effective,economical and rational use of drugs.

Additive effect of rikkunshito, an herbal medicine, on chemotherapy-induced nausea, vomiting, and anorexia in uterine cervical or corpus cancer patients treated with cisplatin and paclitaxel: results of a randomized phase II study (JORTC KMP-02) / 부인종양

OBJECTIVE: Rikkunshito, an herbal medicine, is widely prescribed in Japan for the treatment of anorexia and functional dyspepsia, and has been reported to recover reductions in food intake caused by cisplatin. We investigated whether rikkunshito could improve chemotherapy-induced nausea and vomiting (CINV) and anorexia in patients treated with cisplatin. METHODS: Patients with uterine cervical or corpus cancer who were to receive cisplatin (50 mg/m² day 1) and paclitaxel (135 mg/m² day 0) as first-line chemotherapy were randomly assigned to the rikkunshito group receiving oral administration on days 0–13 with standard antiemetics, or the control group receiving antiemetics only. The primary endpoint was the rate of complete control (CC: no emesis, no rescue medication, and no significant nausea) in the overall phase (0–120 hours). Two-tailed p<0.20 was considered significant in the planned analysis. RESULTS: The CC rate in the overall phase was significantly higher in the rikkunshito group than in the control group (57.9% vs. 35.3%, p=0.175), as were the secondary endpoints: the CC rate in the delayed phase (24–120 hours), and the complete response (CR) rates (no emesis and no rescue medication) in the overall and delayed phases (63.2% vs. 35.3%, p=0.095; 84.2% vs. 52.9%, p=0.042; 84.2% vs. 52.9%, p=0.042, respectively), and time to treatment failure (p=0.059). Appetite assessed by visual analogue scale (VAS) appeared to be superior in the rikkunshito group from day 2 through day 6. CONCLUSION: Rikkunshito provided additive effect for the prevention of CINV and anorexia.