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OBJECTIVE: Ayahuasca, an entheogen from the Amazon rainforest, has garnered growing interest for treating substance dependence. To date, there is little research concerning the act of ayahuasca-related purging (mainly vomiting), which is considered to be central to healing during ayahuasca rituals. This study explored practitioner perspectives on purging during ayahuasca rituals at the Takiwasi Center in Peru. METHOD: We conducted in-depth interviews with curanderos (healers), plant preparers, and psychotherapists (N = 11) at the Takiwasi Center between August and October 2021. Interviews were conducted and transcribed in Spanish. Interviews were analyzed using a thematic analysis approach. RESULTS: Participants described purging as a fluid concept that went beyond the act of vomiting. Participant narratives around purging were organized into three central themes or accounts: spiritual-oriented, which highlighted the relationship between purging and spiritual development; Amazonian-oriented, which emphasized purging as a cathartic expulsion of embodied cargas (loads) that are perceived to lead to sickness; and clinical-oriented, which stressed that purging generates a range of empirically observable therapeutic benefits. All of these explanatory models emphasized the pivotal interconnection between purging and healing during ayahuasca-assisted treatment for substance dependence at Takiwasi. CONCLUSIONS: This study highlights practitioner perspectives on purging at the Takiwasi Center, who offer three main explanatory models for this aspect of healing during ayahuasca-assisted therapy for substance dependence. This research contributes to the limited literature on the role of purging in ayahuasca-related healing, which may inform further investigation into differential understandings of the role of purging for therapeutic benefits.

Asunto(s)

Banisteriopsis , Conducta Ceremonial , Investigación Cualitativa , Trastornos Relacionados con Sustancias , Humanos , Perú , Femenino , Masculino , Trastornos Relacionados con Sustancias/tratamiento farmacológico , Adulto , Centros de Tratamiento de Abuso de Sustancias , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Persona de Mediana Edad

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OBJECTIVE: Anticipatory nausea and vomiting are unpleasant symptoms observed before undergoing chemotherapy sessions. Less is known about the occurrence of symptoms since the advent of the new neurokinin-1 antagonist. METHODS: This prospective cohort study was performed at a single Brazilian Institution. This study included breast cancer patients who received doxorubicin and cyclophosphamide chemotherapy and an appropriate antiemetic regimen (dexamethasone 10 mg, palonosetron 0.56 mg, and netupitant 300 mg in the D1 followed by dexamethasone 10 mg 12/12 h in D2 and D4). Patients used a diary to record nausea, vomiting, and use of rescue medication in the first two cycles of treatment. The prevalence of anticipatory nausea and vomiting was assessed before chemotherapy on day 1 of C2. RESULTS: From August 4, 2020, to August 12, 2021, 60 patients were screened, and 52 patients were enrolled. The mean age was 50.8 (28-69) years, most had stage III (53.8%), and most received chemotherapy with curative intent (94%). During the first cycle, the frequency of overall nausea and vomiting was 67.31%, and that of severe nausea and vomiting (defined as grade>4 on a 10-point visual scale or use of rescue medication) was 55.77%. Ten patients had anticipatory nausea and vomiting (19.23%). The occurrence of nausea and vomiting during C1 was the only statistically significant predictor of anticipatory nausea and vomiting (OR=16, 95%CI 2.4-670.9, p=0.0003). CONCLUSION: The prevalence of anticipatory nausea is still high in the era of neurokinin-1 antagonists, and failure of antiemetic control in C1 remains the main risk factor. All efforts should be made to control chemotherapy-induced nausea or nausea and vomiting on C1 to avoid anticipatory nausea.

Asunto(s)

Antieméticos , Neoplasias de la Mama , Náusea , Humanos , Femenino , Neoplasias de la Mama/tratamiento farmacológico , Persona de Mediana Edad , Estudios Prospectivos , Adulto , Antieméticos/uso terapéutico , Anciano , Náusea/inducido químicamente , Prevalencia , Brasil/epidemiología , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Ciclofosfamida/efectos adversos , Ciclofosfamida/uso terapéutico , Doxorrubicina/efectos adversos , Vómito Precoz , Vómitos/inducido químicamente , Vómitos/epidemiología , Dexametasona/uso terapéutico , Palonosetrón/uso terapéutico

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OBJECTIVE: To identify clinical characteristics that distinguish cannabinoid hyperemesis syndrome (CHS) from cyclic vomiting syndrome (CVS), 2 conditions marked by episodes of nausea, vomiting, and abdominal pain. STUDY DESIGN: We performed a retrospective chart review of patients admitted to a large children's health care system from 2015 through 2022. Patients with CHS and CVS were identified by the electronic medical record using International Classification of Diseases, Ninth and Tenth Revision codes. RESULTS: Of 201 patients screened, 125 were included. Patients with CHS were older than those with CVS (mean [SD] 18.06 [1.41] vs 14.50 [2.91] years, P < .001). There were no significant differences in sex, race, ethnicity, or hospital length of stay between groups. Patients with CHS were more likely to have a positive urine drug screen (86% vs 2.9%, P < .001), lower mean (SD) serum potassium (3.62 [0.77] vs 3.88 [0.49], P < .001), and greater mean (SD) serum creatinine (0.83 (0.41) vs 0.63 (0.17), P < .001). The average (SD) systolic blood pressure was significantly greater in patients with CHS (systolic blood pressure 124.46 [10.66] vs 118.55 [10.99], P = .032) compared with children of comparable age range with CVS. Imaging was obtained in 36% of all patients, and only 2.4% had abnormalities. CONCLUSIONS: Clinical features including older age, greater systolic blood pressure, positive urine drug screen, and select electrolyte findings might distinguish CHS from CVS. Abdominal imaging in both conditions is of low yield. These findings may allow for early recognition and appropriate therapy in CHS patients.

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Síndrome de Hiperemesis Cannabinoide , Vómitos , Adolescente , Niño , Femenino , Humanos , Masculino , Síndrome de Hiperemesis Cannabinoide/diagnóstico , Cannabinoides/efectos adversos , Diagnóstico Diferencial , Náusea/inducido químicamente , Estudios Retrospectivos , Vómitos/inducido químicamente , Vómitos/diagnóstico

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OBJECTIVE: To evaluate the effect of ginger with P6 acupressure in preventing and treating chemotherapy-induced nausea and vomiting (CINV) in cancer patients. METHOD: A total of 172 participants were randomly divided into the control, ginger, acupressure, and joint groups, who were hospitalized in the Affiliated Hospital of Xuzhou Medical University from February and September 2022. The baseline characteristics, nausea, vomiting, and retching, benefit finding, functional living index-emesis, treatment satisfaction, and adverse reaction, were used in data collection. RESULTS: No significant difference was found in benefit finding and adverse reactions among the four groups (P > 0.05). Ginger significantly improved delayed CINV and function living index-nausea (P < 0.05) but had no significant effect on acute CINV, retching, and delayed vomiting, functional living index-emesis, and treatment satisfaction (P>0.05). Acute nausea and retching, delayed nausea, vomiting, and retching, functional living index-emesis, and treatment satisfaction were effectively improved in the acupressure and joint groups (P < 0.05). CONCLUSION: Ginger with P6 acupressure may contribute to improving CINV in patients undergoing chemotherapy.

Asunto(s)

Acupresión , Antineoplásicos , Zingiber officinale , Humanos , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Náusea/prevención & control , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Vómitos/prevención & control , Antineoplásicos/efectos adversos

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BACKGROUND: Natural and synthetic cannabinoids are being used worldwide to treat various symptoms in cancer patients. This study aims to map the therapeutic benefits and adverse effects associated with the use of cannabis-based drugs in these outcomes. METHODS: Following Joanna Briggs Institute guidelines a scoping review was conducted. The study protocol was available in the Open Science Framework public repository. An extensive search strategy involving databases like Cochrane Library, Embase, CINAHL, Medline/PubMed, Lilacs, Google Scholar, and Open Gray for gray literature analysis was executed by a skilled librarian. The inclusion criteria were primary studies (observational and randomized) that evaluated the efficacy and safety of cannabinoids in cancer patients. The review encompassed studies of diverse designs, publication years, and types, as long as they addressed cannabinoids' impact in oncology. RESULTS: Twenty-nine (82.86%) out of total of 35 were randomized and 6 (14.14%) were non-randomized. About 57.1% of studies utilized registered products as interventions, with THC being the most natural cannabinoid cited in variable doses and administration routes. Moreover, 62.85% of studies specified the cancer types (breast, lung, sarcomas, hematological and reproductive system), while only one study detailed cancer staging. The evaluated outcomes encompassed nausea and vomiting (77.14%), appetite (11.43%), pain (8.57%), and tumor regression (2.86%) across different proportions of studies. CONCLUSION: Cannabinoids show promise in managing pain, emesis, and anorexia/cachexia linked to cancer progression. New randomized clinical trials with a larger number of participants and observational studies on long-term safety are crucial to affirm their medicinal utility for cancer patients unresponsive to conventional drugs.

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Cannabinoides , Marihuana Medicinal , Neoplasias , Humanos , Marihuana Medicinal/uso terapéutico , Marihuana Medicinal/efectos adversos , Neoplasias/tratamiento farmacológico , Cannabinoides/uso terapéutico , Cannabinoides/efectos adversos , Vómitos/inducido químicamente , Ensayos Clínicos Controlados Aleatorios como Asunto , Náusea/inducido químicamente

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INTRODUCTION: Despite preventive strategies, vomiting is an adverse event affecting patients with cancer. However, literature on the incidence and risk factors for vomiting in pediatric patients with cancer are scarce. AIM: To assess the incidence and risk factors for vomiting within 24 h and goodness of fit for the Eberhart score in pediatric patients with hematologic cancers after receiving intrathecal chemotherapy under deep sedation. METHODS: This prospective cohort study included patients under 20 years of age with hematologic cancers who were scheduled to undergo intrathecal chemotherapy under anesthesia. The primary outcome was the occurrence of vomiting within 24 h after the end of anesthesia. Sociodemographic and procedure data and underlying diseases were collected. Patients were monitored during the procedure, in the postanesthesia care unit, and the day after (by phone call). RESULTS: A total of 139 patients were included, and the incidence of vomiting was 30.9% within 24 h after intrathecal chemotherapy under anesthesia, with 90.7% of vomiting prior to 6 h. Prophylactic ondansetron was administered prior to the procedure to 45.3% of patients. Risk factors for vomiting were female gender (hazard ratio: 2.47, 95% confidence interval: 1.35-4.53, p: .003), consolidation phase of treatment (hazard ratio: 2.16, 95% confidence interval: 1.10-4.24, p: .025), and history of kinetosis (hazard ratio: 2.49, 95% confidence interval: 1.31-4.70, p: .005). Incidence of vomit was higher than estimated by the Eberhart score distribution (observed incidence in patients with a score of zero: 33.3%; with a score of one: 28.8%; with a score of two: 60%). CONCLUSION: A high incidence of vomiting was observed within 24 h after intrathecal chemotherapy under propofol deep sedation. Risk factors for this outcome were established (being female, consolidation phase of treatment, and previous kinetosis), and evidence suggested that the Eberhart score was not suitable for the studied population.

Asunto(s)

Anestesia , Antieméticos , Neoplasias Hematológicas , Neoplasias , Humanos , Niño , Femenino , Masculino , Antieméticos/uso terapéutico , Estudios de Cohortes , Estudios Prospectivos , Vómitos/inducido químicamente , Vómitos/epidemiología , Ondansetrón/uso terapéutico , Neoplasias Hematológicas/tratamiento farmacológico , Neoplasias/tratamiento farmacológico , Método Doble Ciego

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OBJECTIVE: evaluate the efficacy of Zingiber Officinale in the management of nausea and vomiting induced by treatment with cisplatin associated with radiotherapy in patients with uterine cervical neoplasms. METHODS: a triple-blind, randomized, placebo-controlled trial. Interventions: Comparing the effects of ginger with institutional antiemetic therapy (ondansetron with dexamethasone). Patients with cervical cancer who started treatment with cisplatin with an indication of 40 mg/m² associated with radiotherapy, aged over 18 years, and with the ability to tolerate swallowing a capsule were recruited and equally allocated (1:1:1) into 3 groups of 16 patients each (the ginger capsules 250 mg group, ginger capsules 500 mg group, and placebo group). Nausea and vomiting were measured on baseline, 7 days after the first dose of medication and every seven consecutive days during a treatment break. RESULTS: The 250 mg ginger group had an 8.0% greater chance of experiencing nausea within 24 h after the chemotherapy infusion than the placebo group, although there is no statistical significance (P = .92986). The 500 mg ginger group showed a 63.9% reduction in nausea under the same conditions (P = .40460). No change was detected in the occurrence of nausea episodes during the 6 weeks (P = .8664) or between the groups (P = .2817). No change was detected in acute or late vomiting during the 6 weeks (P = .3510) or between the groups (P = .8500 and P = .5389, respectively). CONCLUSION: Ginger supplementation does not reduce the intensity of acute and late nausea and vomiting. REBEC (RBR-47yx6p9).

Asunto(s)

Neoplasias del Cuello Uterino , Zingiber officinale , Femenino , Humanos , Adulto , Persona de Mediana Edad , Cisplatino/efectos adversos , Método Doble Ciego , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Náusea/inducido químicamente , Náusea/tratamiento farmacológico

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OBJECTIVE: To evaluate the effectiveness of acupuncture and auriculotherapy protocol in relieving chemotherapy-induced nausea and vomiting in cancer patients compared to the antiemetic protocol. METHOD: Pilot study of a pragmatic two-arm clinical trial: an acupuncture group received systemic acupuncture, auriculotherapy, and antiemetic protocol; a control group used antiemetic protocol. The sample consisted of 42 patients with cancer of the gastrointestinal system or multiple myeloma. The outcome was assessed using the Chemotherapy-Induced Nausea and Vomiting Assessment Tool and the patient's diary. RESULTS: There was no statistically significant difference between groups according to the assessment of the patient's diary and the Assessment Tool of chemotherapy-induced nausea and vomiting. The patients were 60 years old on average and the groups were homogeneous, except for marital status. In the diary, there was no statistical difference between groups and sessions for days of nausea (p = 0.873) and vomiting episodes (p = 0.993). CONCLUSION: The protocol of acupuncture and auriculotherapy as a complementary treatment of chemotherapy-induced nausea and vomiting was ineffective, considering the limitations of the study.

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Terapia por Acupuntura , Antieméticos , Antineoplásicos , Auriculoterapia , Neoplasias , Humanos , Persona de Mediana Edad , Proyectos Piloto , Vómitos/inducido químicamente , Vómitos/terapia , Náusea/inducido químicamente , Náusea/terapia , Antineoplásicos/efectos adversos

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INTRODUCTION: Uterine cervix tumors have an invasive nature, with the capacity to proliferate to surrounding organs such as the vagina, bladder, and rectum, as well as the capacity for dissemination and involvement of structures distant from its place of origin. According to the International Federation of Gynecology and Obstetrics, patients with stages IB I, IB I microscopic (small dimension <4 cm) are indicated for radiotherapy or adjuvant chemoradiotherapy with cisplatin (40 mg/m2). However, cisplatin has side effects such as hematological implications (anemia, neutropenia, and thrombocytopenia), gastrointestinal disorders (nausea, vomiting, diarrhea, constipation), and fatigue. Zingiber officinale contains bioactive compounds that act on pregnancy and postoperative nausea, chemotherapy-induced nausea and vomiting, and also in the management of fatigue, myalgia, and insomnia. This study aimed to evaluate the effects of ginger on chemotherapy-induced nausea and vomiting in patients with cervical cancer undergoing treatment with cisplatin and radiotherapy. METHODS AND ANALYSES: A randomized intervention clinical and controlled trial with a triple-blind design is described, comparing the effects of institutional antiemetic therapy alone, as well as in combination with 2 different ginger concentrations. ETHICS AND DISSEMINATION: Due to the nature of the study, we obtained approval from the Division Ethics Committee of Liga Contra o Câncer. All participants signed an informed consent form prior to randomization. The results of this study will be published in peer-reviewed journals. The data collected will also be available in a public repository of data. TRIAL REGISTRATION NUMBER: This study is registered in the Brazilian Registry of Clinical Trials under number RBR-47yx6p9. This study was approved by the Division Ethics Committee of Liga Contra o Câncer under CAAE 40602320.0.0000.5293.

Asunto(s)

Antieméticos , Antineoplásicos , Neoplasias del Cuello Uterino , Zingiber officinale , Antineoplásicos/uso terapéutico , Cisplatino/efectos adversos , Fatiga/inducido químicamente , Femenino , Zingiber officinale/química , Humanos , Náusea y Vómito Posoperatorios/tratamiento farmacológico , Embarazo , Neoplasias del Cuello Uterino/tratamiento farmacológico , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Vómitos/prevención & control

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Among the side effects of anticancer treatment, chemotherapy-induced nausea and vomiting (CINV) is one of the most feared given its high prevalence, affecting up to 40% of patients. It can impair patient's quality of life and provoke low adherence to cancer treatment or chemotherapy dose reductions that can comprise treatment efficacy. Suffering CINV depends on factors related to the intrinsic emetogenicity of antineoplastic drugs and on patient characteristics. CINV can appear at different times regarding the administration of antitumor treatment and the variability of risk according to the different antitumor regimens has, as a consequence, the need for a different and adapted antiemetic treatment prophylaxis to achieve the desired objective of complete protection of the patient in the acute phase, in the late phase and in the global phase of emesis. As a basis for the recommendations, the level of emetogenicity of anticancer treatment is considered and they are classified as high, moderate, low and minimal emetogenicity and these recommendations are based on the use of antiemetic drugs with a high therapeutic index: anti 5-HT, anti-NK and steroids. Despite having highly effective treatments, clinical reality shows that they are not applied enough, so evidence-based recommendations are needed to show the best options and help in decision-making. To cover all the antiemetic prophylaxis options, we have also included recommendations for oral treatments, multiday regimens and radiation-induced emesis prevention.

Asunto(s)

Antieméticos , Antineoplásicos , Neoplasias , Antieméticos/efectos adversos , Antieméticos/uso terapéutico , Antineoplásicos/efectos adversos , Humanos , Náusea/inducido químicamente , Náusea/prevención & control , Neoplasias/tratamiento farmacológico , Calidad de Vida , Vómitos/inducido químicamente , Vómitos/prevención & control

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OBJECTIVE: To evaluate the effects of pre- and intraprocedural opioids on adverse events in children undergoing procedural sedation with ketamine in the emergency department (ED). STUDY DESIGN: We conducted a retrospective cohort study of all children aged 0-18 years who underwent procedural sedation with intravenous ketamine alone, or in combination with an opioid, at a tertiary-care pediatric ED between June 1, 2018, and August 31, 2020. We explored predictors of serious adverse events (SAEs), desaturation or respiratory intervention, and vomiting. RESULTS: Of 1164 included children (694 male, 59.6%; median age 5.0 years [IQR 2.0-8.0]), 80 (6.8%) vomited, 63 (5.4%) had a desaturation or required respiratory interventions, and 6 (0.5%) had SAEs. Pre- and intraprocedural opioids were not independent predictors of sedation-related adverse events. A concurrent respiratory illness (aOR 3.73; 95% CI 1.31-10.60, P = .01), dental procedure (aOR 3.05; 95% CI 1.25-7.21, P = .01), and a greater total ketamine dose (aOR 1.75; 95% CI 1.21-2.54, P = .003) were independent predictors of desaturation or respiratory interventions. A greater total ketamine dose (aOR 1.86; 95% CI 1.16-2.98, P = .01) and older age (aOR 1.15; 95% CI 1.07-1.24, P < .001), were independent predictors of vomiting. CONCLUSIONS: Pre- and intraprocedural opioids do not increase the likelihood of sedation-related adverse events. SAEs are rare during pediatric procedural sedation with ketamine in the ED.

Asunto(s)

Ketamina , Analgésicos Opioides/efectos adversos , Niño , Preescolar , Sedación Consciente/efectos adversos , Sedación Consciente/métodos , Servicio de Urgencia en Hospital , Femenino , Humanos , Hipnóticos y Sedantes , Ketamina/efectos adversos , Masculino , Estudios Prospectivos , Estudios Retrospectivos , Vómitos/inducido químicamente , Vómitos/epidemiología

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PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) is a very common side effect of pediatric cancer therapy. High-quality, evidence-based, pediatric-specific guidelines for prophylaxis and treatment of CINV are available. At many centers, guideline-concordant care is uncommon. We formed a multidisciplinary quality improvement team to implement guideline-concordant care for CINV prophylaxis at our center. We present the results following the first year of our interventions. METHODS: We planned and implemented a multipronged approach in three key phases: (1) developing and publishing an acute CINV prophylaxis pathway, (2) education of providers, and (3) updating the computerized provider order entry system. We used iterative, sequential Plan-Do-Study-Act cycles and behavioral economic strategies to improve adherence to guideline-concordant CINV prophylaxis. We focused on aprepitant usage as a key area for improvement. RESULTS: At the beginning of the study period, < 50% of patients were receiving guideline-concordant CINV prophylaxis and < 15% of eligible patients were receiving aprepitant. After 1 year, more than 60% of patients were receiving guideline-concordant care and 50% of eligible patients were receiving aprepitant. CONCLUSION: We describe the development and implementation of a standardized pathway for prevention of acute CINV in pediatric oncology patients. With a multidisciplinary, multifaceted approach, we demonstrate significant improvements to guideline-congruent CINV prophylaxis.

Asunto(s)

Antieméticos , Antineoplásicos , Neoplasias , Antieméticos/farmacología , Antieméticos/uso terapéutico , Aprepitant/efectos adversos , Niño , Humanos , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Náusea/prevención & control , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológico , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Vómitos/prevención & control

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PURPOSE: Proper monitoring and management of chemotherapy-induced nausea and vomiting (CINV) with antiemetics is crucial for cancer patients. This study aimed to evaluate the use of antiemetics for the treatment of highly emetogenic chemotherapy (HEC) including carboplatin in the real-world setting in Spain. METHODS: A representative panel of cancer specialists was asked to collect information about the antiemetic treatments provided to patients receiving chemotherapy. Records formed part of the Global Oncology Monitor© database (Ipsos Healthcare, London, UK). Chemotherapy data were extrapolated using Ipsos Healthcare's projection methodology. RESULTS: A total of 73 experts were finally included. Data from 9519 patients, estimated to be representative of 202,084 patients, were collected. HEC (and carboplatin-based chemotherapy) was administered to 73,118 (36%) patients, cisplatin-based therapy being the most frequent treatment (n = 34,649, 47.38%). Neurokinin-1 receptor antagonists (NK1RAs) alone or in combination were used as prophylaxis for CINV in 14,762 (20%) patients, while the combination of NK1RA with 5-hydroxytryptamine-3 receptor antagonist (5-HT3RAs) and dexamethasone as recommended by the international guidelines was used in 5849 (8%) patients only. No antiemetic prophylaxis was administered to 8.46% of the patients receiving HEC (n = 6189). Physicians classified cisplatin-, anthracycline-cyclophosphamide (AC-), and carboplatin-based regimens as HEC in 63%, 22% and 4% of the cases, respectively. CONCLUSIONS: The use of NK1RA-containing regimens for CINV prevention in patients treated with HEC was less than expected, suggesting poor adherence to international antiemetic guidelines.

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Antieméticos/uso terapéutico , Antineoplásicos/efectos adversos , Náusea/prevención & control , Vómitos/inducido químicamente , Vómitos/prevención & control , Antraciclinas/efectos adversos , Carboplatino/efectos adversos , Cisplatino/efectos adversos , Consenso , Ciclofosfamida/efectos adversos , Bases de Datos Factuales , Dexametasona/uso terapéutico , Adhesión a Directriz , Encuestas de Atención de la Salud/métodos , Humanos , Náusea/inducido químicamente , Antagonistas del Receptor de Neuroquinina-1/uso terapéutico , Antagonistas del Receptor de Serotonina 5-HT3/uso terapéutico , España

RESUMEN

BACKGROUND: Intra-arterial chemotherapy is a new retinoblastoma treatment associated with high rates of globe salvage that has been widely adopted for primary treatment of retinoblastoma but is less frequently used as secondary treatment for refractory retinoblastoma. This systematic review aims to summarize the reported outcomes of intra-arterial chemotherapy for refractory retinoblastoma. METHODS: We conducted a systematic review of studies published on PubMed, Medline, and Embase from 2011 to 2021 reporting globe salvage rates following intra-arterial chemotherapy for secondary treatment of refractory retinoblastoma. RESULTS: Our search yielded 316 studies, and 24 met inclusion criteria. The 24 included studies were comprised of 1366 patients and 1757 eyes. Among these, 1184 (67%) eyes received secondary indication treatment, and globe salvage was achieved for 776 of these 1184 eyes (64%). Sixteen studies reported cannulation success rates from 71.8 to 100%. Pooled analysis of subjects revealed 21 patients (2.6%) with metastatic disease and 26 deaths (3%) during study follow-up periods (7-74 months). The most common ocular complications were vitreous hemorrhage (13.2%), loss of eyelashes (12.7%), and periocular edema (10.5%). The most common systemic complications were nausea/vomiting (20.5%), neutropenia (14.1%), fever (8.2%), and bronchospasm (6.2%). CONCLUSIONS: Intra-arterial chemotherapy is associated with high rates of globe salvage and low rates of serious complications in patients with refractory retinoblastoma. Unfortunately, current literature is predominantly comprised of retrospective case studies, and further high-quality evidence is necessary to inform clinical practice.

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Resistencia a Antineoplásicos , Neoplasias de la Retina/tratamiento farmacológico , Retinoblastoma/tratamiento farmacológico , Terapia Recuperativa/métodos , Antineoplásicos/administración & dosificación , Espasmo Bronquial/inducido químicamente , Carboplatino/administración & dosificación , Edema/inducido químicamente , Pestañas/efectos de los fármacos , Neutropenia Febril/inducido químicamente , Humanos , Infusiones Intraarteriales/efectos adversos , Infusiones Intraarteriales/métodos , Melfalán/administración & dosificación , Metotrexato/administración & dosificación , Náusea/inducido químicamente , Neoplasias de la Retina/mortalidad , Neoplasias de la Retina/radioterapia , Retinoblastoma/mortalidad , Retinoblastoma/radioterapia , Terapia Recuperativa/efectos adversos , Terapia Recuperativa/estadística & datos numéricos , Topotecan/administración & dosificación , Hemorragia Vítrea/inducido químicamente , Vómitos/inducido químicamente

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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.

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Antineoplásicos/efectos adversos , Náusea/inducido químicamente , Neoplasias/tratamiento farmacológico , Vómitos/inducido químicamente , Adulto , Anciano , Anciano de 80 o más Años , Antieméticos/uso terapéutico , Antineoplásicos/uso terapéutico , Brasil/epidemiología , Estudios de Cohortes , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Náusea/tratamiento farmacológico , Náusea/epidemiología , Estudios Prospectivos , Factores de Riesgo , Vómitos/tratamiento farmacológico , Vómitos/epidemiología

RESUMEN

BACKGROUND: Methotrexate (MTX) intolerance is frequent, and its early identification may impact treatment, leading to timely changes in medication that may promote patient compliance and better control of rheumatoid arthritis (RA). The objective of this study was to identify the frequency of, and risk factors for, MTX intolerance using the Brazilian Portuguese version of the Methotrexate Intolerance Severity Score (MISS) questionnaire in patients with RA. METHODS: This cross-sectional study was performed between April 2018 and April 2019 and enrolled patients with RA in regular use of oral or subcutaneous MTX for at least 3 months. Patients were invited to answer the Brazilian Portuguese version of the MISS questionnaire, and MTX intolerance was defined by a score ≥ 6 points. Age, sex, disease duration, time of MTX use, dose, route of administration, concomitant medications, comorbidities, smoking, and Disease Activity Score for 28joint (DAS28) data were collected from institutional medical records. RESULTS: Among 120 patients, 103 (85.8%) were female, the mean age was 61 (±12.5) years, the mean duration of disease was 16 (±10.3) years, and the average duration of MTX use was 7 (±5.5) years. The frequency of MTX intolerance was 21.6%. The most frequent symptoms reported after the use of MTX were nausea (92.3%), abdominal pain (46.1%), and vomiting (30.7%). Behavioral symptoms occurred in 96.1% of patients with MTX intolerance, the most frequent being restlessness and irritability. Patients who used corticosteroids were more likely to develop MTX intolerance than those not using corticosteroids (odds ratio = 2.73; 95% confidence interval, 1.06 to 7.06; p = 0.038). Conversely, increasing age showed marginally significant association with decreased risk of MTX intolerance (p = 0.059). CONCLUSIONS: The use of the MISS questionnaire disclosed high frequencies of anticipatory, associative, and behavioral symptoms in MTX-intolerant patients, and the use of corticosteroid increases the risk of MTX intolerance. We suggest that the MISS questionnaire be used routinely in clinical practice.

Asunto(s)

Antirreumáticos , Artritis Reumatoide , Metotrexato , Anciano , Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Femenino , Humanos , Masculino , Metotrexato/efectos adversos , Persona de Mediana Edad , Náusea/inducido químicamente , Oportunidad Relativa , Factores de Riesgo , Vómitos/inducido químicamente

RESUMEN

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.

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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.

Asunto(s)

Humanos , Masculino , Femenino , Adulto , Anciano , Anciano de 80 o más Años , Vómitos/inducido químicamente , Náusea/inducido químicamente , Neoplasias/tratamiento farmacológico , Antineoplásicos/efectos adversos , Vómitos/tratamiento farmacológico , Vómitos/epidemiología , Brasil/epidemiología , Incidencia , Estudios Prospectivos , Factores de Riesgo , Estudios de Cohortes , Persona de Mediana Edad , Antieméticos/uso terapéutico , Náusea/tratamiento farmacológico , Náusea/epidemiología , Antineoplásicos/uso terapéutico

RESUMEN

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.

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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.

Asunto(s)

Fibrosis Pulmonar Idiopática/tratamiento farmacológico , Indoles/administración & dosificación , Inhibidores de Proteínas Quinasas/administración & dosificación , Anciano , Algoritmos , Aspartato Aminotransferasas/análisis , Brasil , Enfermedad Hepática Inducida por Sustancias y Drogas/etiología , Diarrea/inducido químicamente , Tolerancia a Medicamentos , Femenino , Humanos , Indoles/efectos adversos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Inhibidores de Proteínas Quinasas/efectos adversos , Reproducibilidad de los Resultados , Factores de Tiempo , Transaminasas/análisis , Resultado del Tratamiento , Capacidad Vital/efectos de los fármacos , Vómitos/inducido químicamente

RESUMEN

BACKGROUND: Due to the worldwide rise in cancer incidence, and therefore the rise in the need for antineoplastic chemotherapy, it is important for both healthcare professionals and patients alike that the side effects of chemotherapy, such as chemotherapy-induced nausea and vomiting (CINV), are treated and prevented. Auriculotherapy is a type of acupuncture and may be a low-cost and safe antiemetic measure to control the side effects of chemotherapy. The goal of this systematic review is to synthesize the available evidence in the literature regarding the auriculotherapy effects to treat CINV in people with cancer. METHODS: The review will only include randomized controlled trials (RCTs) that compare the clinical effects of the auriculotherapy intervention (used alone or as an add-on), with sham auriculotherapy, routine treatment with antiemetic drugs, or other non-pharmacological interventions in patients with cancer with CINV who are undergoing chemotherapy. The outcomes to be evaluated are nausea and vomiting: in acute, delayed, or anticipated stages, when induced by chemotherapy. A comprehensive search for studies will be carried out in these databases: MEDLINE via PubMed, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, ICTRP, LILACS, CUMED, IBECS, BVS MTCI Americas, Web of Science, Scopus, PEDro, CNKI, and CBMdisc up until December 31, 2018. Only articles in English, Portuguese, and Spanish will be selected. Two independent reviewers will evaluate full texts, extract data, and assess the risk of bias of eligible articles. The quality of evidence will be assessed using Grading of Recommendations, Assessment, Development and Evaluation (GRADE). A meta-analysis will be undertaken to assess the interventions and outcomes' homogeneity, assessing statistical heterogeneity using the Cochran's Q test and quantified using Higgins' inconsistency index. If there is insufficient data for a meta-analysis, a narrative synthesis will be presented. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. DISCUSSION: The results of this systematic review will summarize the strength of evidence for the use of auriculotherapy in the control of CINV of patients with cancer and will be used to identify evidence gaps. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018117513.

Asunto(s)

Antineoplásicos/efectos adversos , Auriculoterapia , Náusea/terapia , Vómitos/terapia , Protocolos Clínicos , Humanos , Náusea/inducido químicamente , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Vómitos/inducido químicamente , Revisiones Sistemáticas como Asunto

RESUMEN

BACKGROUND: Chemotherapy-induced nausea and vomiting are concerning adverse events resulting from cancer treatment, and current guidelines recommend the use of neurokinin-1-selective antagonists, such as fosaprepitant, in highly emetogenic schemes. However, the implementation of this strategy may be limited by the cost of treatment. GSTP1 c.313A>G genotype was recently described as a predictor of vomiting related to high-dose cisplatin. We hypothesized that the inclusion of routine GSTP1 c.313A>G screening may be promising in financial terms, in contrast to the wide-spread use of fosaprepitant. METHODS: A cost-minimization analysis was planned to compare GSTP1 c.313A>G genotyping versus overall fosaprepitant implementation for patients with head and neck cancer under chemoradiation therapy with high-dose cisplatin. A decision analytic tree was designed, and conditional probabilities were calculated under Markov chain Monte Carlo simulations using the Metropolis-Hastings algorithm. The observed data included patients under treatment without fosaprepitant, while priors were derived from published studies. RESULTS: To introduce screening with real-time polymerase chain reaction, an initial investment of U$ 39,379.97 would be required, with an amortization cost of U$ 7,272.97 per year. The mean cost of standard therapy with fosaprepitant is U$ 243.24 per patient, and although the initial cost of routine genotyping is higher, there is a tendency of progressive minimization at a threshold of 155 patients (Credible interval-CI: 119 to 216), provided more than one sample is incorporated for simultaneous analysis. A resulting reduction of 35.83% (CI: 30.31 to 41.74%) in fosaprepitant expenditures is then expected with the implementation of GSTP1 c.313A>G genotyping. CONCLUSION: GSTP1 c.313A>G genotyping may reduce the use of preventive support for chemotherapy induced nausea and lower the overall cost of treatment. Despite the results of this simulation, randomized, interventional studies are required to control for known and unknown confounders as well as unexpected expenses.

Asunto(s)

Cisplatino/efectos adversos , Gutatión-S-Transferasa pi/genética , Náusea/inducido químicamente , Náusea/prevención & control , Vómitos/inducido químicamente , Vómitos/prevención & control , Algoritmos , Antieméticos/economía , Antieméticos/uso terapéutico , Antineoplásicos/efectos adversos , Teorema de Bayes , Quimioradioterapia/efectos adversos , Simulación por Computador , Costos y Análisis de Costo , Árboles de Decisión , Costos de los Medicamentos , Neoplasias de Cabeza y Cuello/terapia , Humanos , Cadenas de Markov , Método de Montecarlo , Morfolinas/economía , Morfolinas/uso terapéutico , Náusea/genética , Antagonistas del Receptor de Neuroquinina-1/economía , Antagonistas del Receptor de Neuroquinina-1/uso terapéutico , Pruebas de Farmacogenómica/economía , Reacción en Cadena en Tiempo Real de la Polimerasa/economía , Vómitos/genética