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1.
Medicine (Baltimore) ; 98(44): e17745, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31689827

RESUMO

The aim of this study was to analyze the clinical manifestations of adverse reactions after the use of SonoVue contrast agent from a large retrospective database, and to evaluate the nursing care strategies and the efficacy of standardized procedure for adverse reactions of SonoVue (SPARS).From January 1, 2012 to December 30, 2018, 34,478 cases of contrast-enhanced ultrasonography were performed in our center. The clinical manifestations of adverse reactions after the use of SonoVue contrast agent were identified and analyzed. The nursing care strategies were evaluated and the outcomes of patients with moderate and severe adverse reactions before and after the application of SPARS were compared.Of the 34,478 cases, 40 cases (0.12%) of adverse reactions after the use of SonoVue were identified. Adverse reactions included anaphylatic shock, skin allergies, nausea or vomiting, dizziness or headache, numbness, chest distress, back pain, and local reactions of the injection site. Most of the adverse reactions were mild and self-limited. Only 3 cases of anaphylatic shock and 2 cases of severe rash underwent further treatments. The 3 patients who were managed by SPARS recovered quicker and spent less comparing with the other 2 patients who were not.SonoVue was a safe contrast agent, with few and mostly mild adverse reactions. SPARS may be an efficient way in tackling moderate to severe adverse reactions, although of which the incidence was rare.


Assuntos
Meios de Contraste/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/enfermagem , Cuidados de Enfermagem/estatística & dados numéricos , Fosfolipídeos/efeitos adversos , Hexafluoreto de Enxofre/efeitos adversos , Ultrassonografia/efeitos adversos , Idoso , Bases de Dados Factuais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Ultrassonografia/métodos
2.
Zhonghua Zhong Liu Za Zhi ; 41(10): 775-781, 2019 Oct 23.
Artigo em Chinês | MEDLINE | ID: mdl-31648501

RESUMO

Objective: To evaluate the efficacy and safety of apatinib combined with chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) with negative driving genes. Methods: From January 2016 to March 2018, 62 advanced NSCLC patients with negative driving genes diagnosed at Xuzhou Cancer Hospital were randomly divided into study group (30 cases) and control group (32 cases), respectively. The patients in the study group were treated with standard first-line chemotherapy combined with apatinib, while those in control group were treated with chemotherapy alone. Results: The disease control rate (DCR) and objective remission rate (ORR) in the study group were 60.0% and 16.7%, respectively, higher than 46.9% and 9.3% in the control group, but without statistical difference (P>0.05). The median progression-free survival (PFS) of study group and control group were 6.4 months and 4.9 months, respectively (P=0.004), and the median overall survival (OS) were 11.3 months and 9.2 months, respectively (P=0.006). Multivariate survival analysis indicated that treatment regimen (P=0.001) was the independent prognostic factor of PFS, and PS score (P=0.002), clinical stage (P=0.02) and treatment regimen (P<0.001) were the independent prognostic factors of OS. After treatment, the incidence of hypertension and hand-foot syndrome in the study group were 46.7% and 53.3%, respectively, significantly higher than 3.3% and 0 in the control group, respectively (P<0.05). The incidence of grade 3-4 adverse drug reactions (ADRs) in the study group was 26.7% (8/30), mainly including hypertension, hand-foot syndrome and bone marrow suppression. The incidence of grade 3-4 ADRs in the control group was 15.6% (5/32), all of which were bone marrow suppression, without significant difference (P=0.286). There was no difference in serum levels of VEGF and CEA between the two groups before treatment. After treatment, the serum level of VEGF in the study group was (169.3±10.1) pg/ml, lower than (211.8±16.7) pg/ml of the control group (P<0.05). Conclusion: Apatinib combined with first-line chemotherapy for advanced NSCLC patients with negative driving genes is safe and beneficial for survival. This therapeutic strategy can significantly prolong the PFS and OS, and further improvement and application can be considered as a choice in the clinical treatment.


Assuntos
Antineoplásicos/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Complicações Pós-Operatórias/epidemiologia , Inibidores de Proteínas Quinases/uso terapêutico , Antineoplásicos/efeitos adversos , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/patologia , China/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Síndrome Mão-Pé/complicações , Síndrome Mão-Pé/epidemiologia , Humanos , Hipertensão/complicações , Hipertensão/epidemiologia , Incidência , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Inibidores de Proteínas Quinases/administração & dosagem , Inibidores de Proteínas Quinases/efeitos adversos , Piridinas/administração & dosagem , Piridinas/efeitos adversos , Piridinas/uso terapêutico , Análise de Sobrevida , Resultado do Tratamento
3.
Expert Rev Clin Pharmacol ; 12(10): 921-930, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31544557

RESUMO

Introduction: In each section of the human gastrointestinal (GI) tract we may find bacteria that are adapted to local conditions and fulfill an important role in the proper functioning of the body. The gut microorganisms are crucial in human physiology in areas as diverse as the brain and the immune system functions. Therefore, there is a close relationship between the intestinal microbiota, its metabolic activity, and health of the host. Areas covered: In this review, we explore the host-microbiome interactions and characterize the role they may play in drug metabolism and toxicity. The study is based on pertinent papers that were retrieved by a selective search using relevant keywords in PubMed and ScienceDirect databases. Expert opinion: Increasing unhealthy eating habits, stress, antibiotic therapy, unfavorable environmental factors, and genetic predisposition contribute to imbalances in the composition and function of the GI tract microbes and the initiation and progression of disease processes. Restoration of the balanced gut microbiota composition is possible by oral administration of probiotics.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Microbioma Gastrointestinal/fisiologia , Preparações Farmacêuticas/metabolismo , Administração Oral , Animais , Progressão da Doença , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/microbiologia , Trato Gastrointestinal/microbiologia , Humanos , Preparações Farmacêuticas/administração & dosagem , Probióticos/administração & dosagem
4.
Anticancer Res ; 39(8): 4555-4560, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31366559

RESUMO

BACKGROUND/AIM: Treatments for controlling delayed nausea after chemotherapy are inadequate, potentially inciting malnutrition. We sought to determine the incidence of nausea, anorexia, and food intake after chemotherapy. PATIENTS AND METHODS: Subjects were females with gynecological cancers who underwent chemotherapy between 2008 and 2013. Nausea, anorexia, and food intake in the acute (day 1) and delayed phases (days 2 and 3) were retrospectively evaluated. RESULTS: Subjects included 156 females. Chemotherapies were highly (HEC; n=24) and moderately emetogenic (MEC; n=132). There were no significant between-group differences for anorexia control during either the acute or the delayed phase and both groups demonstrated significantly worse control of nausea during the delayed phase. In the HEC group, food intake was significantly reduced on days 2 and 3 compared with day 1. CONCLUSION: Rates of nausea, anorexia, and food intake significantly worsened over time, particularly in the MEC group. Current supportive therapies appear inadequate and should be improved.


Assuntos
Anorexia/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Ingestão de Alimentos , Neoplasias dos Genitais Femininos/tratamento farmacológico , Adulto , Idoso , Anorexia/patologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Neoplasias dos Genitais Femininos/complicações , Neoplasias dos Genitais Femininos/epidemiologia , Neoplasias dos Genitais Femininos/patologia , Humanos , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Náusea/epidemiologia , Náusea/patologia , Vômito/induzido quimicamente , Vômito/epidemiologia , Vômito/patologia
5.
Farm. hosp ; 43(4): 128-133, jul.-ago. 2019. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-183899

RESUMO

Objetivo: Describir un programa de farmacovigilancia llevado a cabo por un servicio de farmacia y analizar las sospechas de reacciones adversas a medicamentos recogidas. Método: Estudio observacional, longitudinal, de nueve años de duración (2008-2016). El programa de farmacovigilancia está liderado por el servicio de farmacia, que realiza farmacovigilancia prospectiva, retrospectiva, intensiva y voluntaria en el paciente hospitalizado y ambulatorio (urgencias, hospital de día, consultas externas y centros sociosanitarios). Las reacciones adversas se incorporan en la historia clínica electrónica del paciente y se añade una alerta que indica su presencia. Resultados: Se recogieron 2.631 reacciones adversas a medicamentos en 2.436 pacientes (52% varones) con una media [rango] de edad de 63,3 [0-98] años. El 92,8% de las reacciones fueron notificadas por el farmacéutico y el 7,2% por médicos, enfermería y técnicos. El 63,7% se notificaron en hospitalización, el 19,2% en urgencias, el 10,6% en consultas externas, el 6,2% en hospital de día y el 0,3% en radiología. Se observó un incremento de notificación por farmacovigilancia prospectiva e intensiva. Los grupos terapéuticos mayoritariamente implicados fueron: antineoplásicos (21,3%), antibacterianos (12,3%), antitrombóticos (7,7%), analgésicos (6,7%), corticosteroides (5,2%), psicolépticos (5,2%), diuréticos (4,9%), antivirales (4,9%), antiinflamatorios y antirreumáticos (4,2%) e inmunosupresores (3,3%). Las reacciones adversas detectadas afectaron mayoritariamente a la piel y anejos (19,7%) y al tracto gastrointestinal (19,1%). Respecto a su gravedad, el 38,7% fueron leves, el 30,8% graves y el 30,5% moderadas. El 60,9% de los pacientes se recuperaron de las reacciones adversas y el 31,7% se encontraban en proceso de recuperación. Se interrumpió el tratamiento en el 65% de los casos y el 56% de los pacientes recibieron tratamiento específico. Conclusiones: La incorporación del programa de farmacovigilancia en la rutina diaria del farmacéutico de hospital aporta un valor añadido a la seguridad de la farmacoterapia del paciente


Objective: To describe our pharmacovigilance program and to analyze the reported adverse drug reactions. Method: Observational longitudinal study conducted from 2008 to 2016. The Pharmacy Department leads the pharmacovigilance program and performs prospective, retrospective, intensive, and spontaneous reporting of inpatients and outpatients (emergencies, day hospital, external consultations, and nursing homes). Each adverse drug reaction is incorporated in the electronic health record of the patient along with an alert. Results: A total of 2,631 adverse drug reactions were reported in 2,436 patients. Of these patients, 52% were men with a mean age of 63.3 [0-98] years. A total of 92.8% drug events were reported by the pharmacists and 7.2% by doctors, nurses, and technicians. A total of 63.7% were reported in inpatients, 19.2% in emergencies, 10.6% in external consultations, 6.2% in the day hospital, and 0.3% in diagnostic radiology. There was an increase in adverse drug reactions detected by prospective and intensive pharmacovigilance. Principal therapeutic groups involved in adverse drug events were antineoplastic agents (21.3%), antibacterials (12.3%), antithrombotics (7.7%), analgesics (6.7%), corticosteroids (5.2%), psycholeptics (5.2%), diuretics (4.9%), anti virals (4.9%), antiinflammatories and antirheumatics (4.2%), and immunosupressants (3.3%). Adverse drug reactions mainly affected the skin and appendages (19.7%) and gastrointestinal tract (19.1%). Adverse drug reactions were mild (38.7%), severe (30.8%), and moderate (30.5%). In total, 60.9% of patients recovered from drug events and 31.7% were in recovery. The most frequent response was treatment interruption in 65% of cases and the patients received additional specific treatment in 56% of cases. Conclusions: The incorporation of the pharmacovigilance program within the daily routine of the hospital pharmacist provides added value to the safety and pharmacotherapy of the patient


Assuntos
Humanos , Masculino , Feminino , Recém-Nascido , Lactente , Pré-Escolar , Criança , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Serviço de Farmácia Hospitalar/métodos , Serviço de Farmácia Hospitalar/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Antibacterianos , Fibrinolíticos , Antineoplásicos , Hospitalização/estatística & dados numéricos , Emergências/epidemiologia , Serviços Médicos de Emergência/estatística & dados numéricos , Corticosteroides , Diuréticos
6.
Medicine (Baltimore) ; 98(33): e16785, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415382

RESUMO

Data regarding the safety of anti-vascular endothelial growth factor (anti-VEGF) treatment is limited.To compare the adverse events (AEs) induced by aflibercept and ranibizumab using a spontaneous reporting system and determine the signals.We used data from the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD), collected between 2007 and 2016. Differences in patient demographics, report type, reporter, causality, and serious-AEs between aflibercept and ranibizumab were compared. Metrics including proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC), were used to compare signals with the AEs on the drug labels in the United States of America and Korea. Logistic regression analysis was performed to identify AEs that are more likely to occur with drug use.A total of 32 aflibercept and 103 ranibizumab cases of AEs were identified. The proportion of AEs that were reported voluntarily was higher with aflibercept (50.5%) use than ranibizumab (4.9%), whereas the AEs reported by post-marketing surveillance were higher with ranibizumab (46.6%) use than aflibercept (31.3%). The percentage of AEs in patients >60 years old, reports by consumers, and the ratio of SAEs to AEs associated with aflibercept (84. %, 9.4%, and 75.0%, respectively) were higher than those of ranibizumab (77.7%, 1.9%, and 19.4%, respectively). The number of newly detected AEs after aflibercept and ranibizumab treatment was 3 and 8, respectively. Among these, conjunctivitis and medicine ineffective were not included on the aflibercept and ranibizumab labels, respectively. Endophthalmitis (OR 6.96, 95% CI 2.74-17.73) was more likely to be reported in patients with aflibercept than in patients without aflibercept, whereas medicine ineffective (OR 18.49, 95% CI 2.39-143.29) and retinal disorder (OR 7.03, 95% CI 1.60-30.96) were more likely to be reported in patients with ranibizumab than in patients without ranibizumab.New signals have been identified for aflibercept and ranibizumab. Further research is necessary to evaluate the causality of AEs that were detected as signals in this study.


Assuntos
Inibidores da Angiogênese/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Ranibizumab/efeitos adversos , Proteínas Recombinantes de Fusão/efeitos adversos , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Receptores de Fatores de Crescimento do Endotélio Vascular , República da Coreia/epidemiologia , Adulto Jovem
7.
Rev Med Chil ; 147(4): 416-425, 2019 Apr.
Artigo em Espanhol | MEDLINE | ID: mdl-31344202

RESUMO

BACKGROUND: Medication related adverse events are an important cause of hospital admission or prolonged stay. AIM: To assess medication related adverse events in a hospital discharge database. MATERIAL AND METHODS: Revision of the Chilean hospital discharge database from 2010 to 2017 searching for ICD- 10 diagnostic codes corresponding to medication related adverse events. RESULTS: The number of medication related adverse events was stable across the studied time lapse, but admission length increased. Between 34 and 111 people died every year due to medication related adverse events. Lactating babies, toddlers, adolescents and people over 80 years of age are at greater risk of experiencing these events. CONCLUSIONS: Medication related adverse events are more common than expected.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Hospitalização/estatística & dados numéricos , Adolescente , Adulto , Distribuição por Idade , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Chile/epidemiologia , Feminino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Fatores de Risco , Distribuição por Sexo , Fatores Sexuais , Fatores de Tempo , Adulto Jovem
8.
Expert Rev Clin Pharmacol ; 12(9): 875-883, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31269818

RESUMO

Introduction: Drug-induced liver injury (DILI) has become the most frequent cause of acute liver failure in high-income countries. However, little is known about the determinants of DILI in sub-Saharan Africa (SSA), where the prescription of antimicrobials and the use of potentially hepatotoxic traditional medicine are common. Areas covered: Based on an extensive literature search, we summarize current data available on the epidemiology and risk factors of DILI in SSA. We discuss the most likely causes of DILI in the region, including antimicrobial therapies and traditional medicine. We also highlight research gaps as well as barriers to diagnosis and management of the condition, and explore ways to address these important challenges. Expert opinion: DILI is underestimated in SSA and several factors challenge its early diagnosis, including lack of information on the causes of DILI in the region, sub-optimal knowledge about the condition among clinicians, and structural difficulties faced by health care systems. In order to better prevent the occurrence of DILI and its complications, it is crucial to enhance awareness among health care providers and patients, adapt drug prescription habits and regulations, and improve current knowledge on the main risk factors for DILI, including host genetic and environmental determinants.


Assuntos
Anti-Infecciosos/efeitos adversos , Doença Hepática Induzida por Substâncias e Drogas/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , África ao Sul do Saara , Anti-Infecciosos/administração & dosagem , Doença Hepática Induzida por Substâncias e Drogas/diagnóstico , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Humanos , Medicina Tradicional Africana/efeitos adversos , Medicina Tradicional Africana/métodos , Fatores de Risco
9.
Expert Opin Drug Saf ; 18(10): 993-999, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31315002

RESUMO

Objectives: The objectives were to identify drugs related with anemia in children and evaluate the novelty of these correlations. Methods: The authors established a two-step method for detecting the relationship between drugs and anemia using electronic medical records (EMRs), which were obtained from 247,136 patients in Beijing Children's Hospital between 2007 and 2017. The authors extracted potential drugs by mining cases for hemoglobin abnormalities from the EMR and then performed a retrospective cohort study to correlate them with anemia by calculating the matched odds ratios and 95% confidence interval using unconditional logistic regression analysis. Results: In total, nine positive drug-anemia associations were identified. Among them, the correlations of drugs fluconazole (OR 3.95; 95%CI: 2.65-5.87) and cefathiamidine (OR 3.49; 95%CI: 2.94-4.15) with anemia were considered new signals in both children and adults. Three associations of drugs, vancomycin, cefoperazone-sulbactam and ibuprofen, with anemia were considered new signals in children. Conclusion: The authors detected nine signals of drug-induced anemia, including two new signals in children and adults and three new signals in children. This study could serve as a model for using EMR and automatic mining to monitor adverse drug reaction signals in the pediatric population.


Assuntos
Anemia/induzido quimicamente , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Registros Eletrônicos de Saúde/estatística & dados numéricos , Anemia/epidemiologia , Pequim , Criança , Estudos de Coortes , Mineração de Dados , Hemoglobinas/metabolismo , Hospitais Pediátricos , Humanos , Modelos Logísticos , Estudos Retrospectivos
10.
J Cancer Res Clin Oncol ; 145(9): 2335-2342, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31286241

RESUMO

PURPOSE: Clinical stage (CS) 1 testicular seminoma is cured in almost 100% of cases following either retroperitoneal radiotherapy, carboplatin monotherapy, or surveillance strategies. Little is known about potential long-term effects of carboplatin. We, therefore, examined late sequelae of this drug in seminoma patients. PATIENTS AND METHODS: We retrospectively identified 451 patients with CS1 testicular seminoma treated between 1994 and 2014, of whom 243 underwent carboplatin therapy [median follow-up (F/U) 96 months], 81 received radiotherapy (median F/U 142 months), and 127 underwent surveillance (median F/U 40 months). Satisfaction regarding management, as well as the following events during F/U, were analysed by questionnaire: subsequent malignant neoplasms (SMNs), cardiovascular events, arterial hypertension, peptic ulcer, tinnitus, peripheral neuropathy, hypogonadism, and infertility. The relative frequencies of the events were analysed using descriptive statistics. The frequency of observed SMNs was compared with the expected number. RESULTS: Patients receiving carboplatin tolerated the treatment less well (71.2%) than those under surveillance (81.9%). After carboplatin, 12 SMNs (5.0%) were noted vis-a-vis 5.0 expected. There were three cases of prostatic cancer and 3 melanomas among the SMNs. Half of these SMNs occurred early after treatment. Among the other health events, only reported hypogonadism (13.2%) appeared to be marginally increased in frequency. CONCLUSIONS: This study found a 2.4-fold higher than expected rate of SMN-and a slightly increased rate of hypogonadism-in the long-term period following carboplatin treatment. Although further studies are needed to confirm these preliminary findings, these results are probably informative for clinicians caring for seminoma patients.


Assuntos
Carboplatina/administração & dosagem , Seminoma/tratamento farmacológico , Seminoma/radioterapia , Neoplasias Testiculares/tratamento farmacológico , Neoplasias Testiculares/radioterapia , Adolescente , Adulto , Idoso , Carboplatina/efeitos adversos , Quimioterapia Adjuvante , Terapia Combinada , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Transtornos de Início Tardio/induzido quimicamente , Transtornos de Início Tardio/epidemiologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Segunda Neoplasia Primária/epidemiologia , Radioterapia Adjuvante , Estudos Retrospectivos , Seminoma/patologia , Neoplasias Testiculares/patologia , Resultado do Tratamento , Conduta Expectante , Adulto Jovem
12.
Cancer Invest ; 37(4-5): 209-215, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31179764

RESUMO

This study aimed to determine incidence, risk factors of unplanned hospital visits children receiving chemotherapy. The study was conducted with 65 children. Data were collected using form consisting of questions regarding causes of their unplanned hospital visits. Chi-square test were used analysis of data. Three quarters of children receiving chemotherapy were determined to have unplanned hospital visits, majority of them were found to be admitted. Knowing high-risk factors for unplanned hospital visits and admissions of children receiving chemotherapy and applying appropriate interventions for discharge education and home care regarding these factors may contribute to reduce unplanned hospital visits.


Assuntos
Antineoplásicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Hospitalização/estatística & dados numéricos , Neoplasias/tratamento farmacológico , Adolescente , Criança , Pré-Escolar , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/terapia , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Educação de Pacientes como Assunto , Estudos Retrospectivos , Fatores de Risco , Turquia/epidemiologia
13.
BMC Cancer ; 19(1): 548, 2019 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-31174493

RESUMO

BACKGROUND: Vascular endothelial growth factor (VEGF), tyrosine kinase (TK) and mechanistic target of rapamycin kinase (mTOR) inhibitors are common first-line (1 L) treatments for metastatic renal cell carcinoma (mRCC). Despite treatment availability, the 5-year survival rate in patients diagnosed at the metastatic stage is only ≈ 10%. To gain contemporary insights into RCC treatment trends that may inform clinical, scientific and payer considerations, treatment patterns and adverse events (AEs) associated with 1 L therapy were examined in a retrospective, longitudinal, population-based, observational study of patients with mRCC. METHODS: US administrative claims data (Truven Health MarketScan Commercial Databases) were used to assess trends in 1 L treatment initiation in mRCC (2006-2015) and characterize patterns of individual 1 L treatments, baseline characteristics, comorbidities and treatment-related AEs from 2011 through 2015. Outcomes were evaluated by drug class and route of administration. RESULTS: Ten-year trend analysis (n = 4270) showed that TK/VEGF-directed therapy rapidly became more common than mTOR-directed therapy, and oral treatments were favored over intravenous (IV) treatments. Overall, 1992 eligible patients initiated 1 L treatment for mRCC from 2011 through 2015: 1752 (88%) received TK/VEGF-directed agents and 233 (12%) received mTOR-directed agents; 1674 (84%) received oral treatments, and 318 (16%) received IV treatments. The most common 1 L treatment was sunitinib (n = 849), followed by pazopanib (n = 631), temsirolimus (n = 157) and bevacizumab (n = 154). Patient characteristics and comorbidities, including age, diabetes and congestive heart failure, were independent predictors of 1 L mRCC treatment choice. The three most common potentially 1 L treatment-related AEs were nausea/vomiting (128.2 per 100 patient-years [PY]), hypertension (69 per 100 PY) and renal insufficiency (44.6 per 100 PY). A wide variety of agents were used as second-line (2 L) therapy. Substantial latency of onset was observed for several potentially treatment-related toxicities in patients treated with TK/VEGF- or mTOR-directed agents. CONCLUSIONS: In the US, 1 L TK/VEGF inhibitor uptake in recent years appears largely in line with national approvals and guidelines, with varied 2 L agent use. Although retrospective evaluation of claims data cannot assess underlying causality, insights from these real-world RCC treatment and AE patterns will be useful in informing medical and payer decisions.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carcinoma de Células Renais/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Neoplasias Renais/epidemiologia , Padrões de Prática Médica , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Carcinoma de Células Renais/patologia , Estudos Transversais , Bases de Dados Factuais , Feminino , Pesquisas sobre Serviços de Saúde , Humanos , Neoplasias Renais/tratamento farmacológico , Neoplasias Renais/patologia , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Terapia de Alvo Molecular , Estados Unidos/epidemiologia
15.
J Dermatol ; 46(8): 641-651, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31206779

RESUMO

We evaluated the efficacy of efinaconazole 10% topical solution in long-term use, for up to 72 weeks, for onychomycosis, including severe cases. Among 605 participants, 219 patients diagnosed as having onychomycosis were evaluated for the efficacy of efinaconazole. The treatment success rate (<10% clinical involvement of the target toenail) at the final assessment time point was 56.6%, the complete cure rate was 31.1% and the mycological cure rate was 61.6%, all of which increased over time, demonstrating that continuous application contributed to the improvement of cure rate. Even in severe cases, reduction of the affected nail area was observed, showing the potential efficacy of the treatment. Responses to a quality of life questionnaire among patients with onychomycosis, OnyCOE-t, suggested that efinaconazole treatment improved the patients' quality of life. The incidence of adverse drug reaction in the patients eligible for the assessment was 6.3%, and this developed only in the administration site in all cases. No systemic adverse event was observed. In addition, no increase in the incidence of adverse drug reaction due to long-term use was found. Efinaconazole therapy was proved to exhibit excellent balance between efficacy and safety, and thus may serve as a useful treatment option for onychomycosis.


Assuntos
Antifúngicos/administração & dosagem , Dermatoses do Pé/tratamento farmacológico , Onicomicose/tratamento farmacológico , Triazóis/administração & dosagem , Administração Tópica , Idoso , Antifúngicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Dermatoses do Pé/diagnóstico , Humanos , Incidência , Assistência de Longa Duração/métodos , Masculino , Pessoa de Meia-Idade , Onicomicose/diagnóstico , Qualidade de Vida , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Triazóis/efeitos adversos
16.
Rev Assoc Med Bras (1992) ; 65(5): 611-617, 2019 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-31166436

RESUMO

INTRODUCTION: Drug interaction is an important cause of global morbidity. It is of particular importance in cancer patients since they are often in use of polypharmacy, related to interactions between the drugs and the chemotherapeutics used. OBJECTIVE: To evaluate the drug interaction between chemotherapy and other drugs in cancer patients. METHODS: a cross-sectional study carried out in the outpatient oncology department of a public tertiary hospital. Two hundred thirty-five patients were included, and the drugs they were using were identified. Using the MedScape and Epocrates database, we evaluated the interactions between medications and chemotherapy by defining their frequency and dividing their severity from interaction into mild, close monitoring necessity and severe. RESULTS: 161 patients had some drug interaction. We identified 9 types of mild interactions, 23 types of interactions with close monitoring necessity, and 2 types of serious interactions. The most frequent interactions were between fluorouracil and leucovorin (32 cases) and cyclophosphamide and doxorubicin (19 cases). Serious interactions were between aspirin and pemetrexed; and leucovorin and Bactrim. CONCLUSION: In the present study, drug interactions were frequent, including serious interactions with a potential increase in morbidity and mortality. Thus, it is necessary for oncologists to draw up a therapeutic plan considering potential interactions between prescribed chemotherapy and current medications in use by patients.


Assuntos
Antineoplásicos/efeitos adversos , Interações de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Brasil/epidemiologia , Estudos Transversais , Feminino , Hospitais Públicos , Humanos , Masculino , Pessoa de Meia-Idade , Polimedicação , Fatores de Risco , Índice de Gravidade de Doença , Centros de Atenção Terciária
17.
Einstein (Sao Paulo) ; 17(3): eAO4521, 2019 May 30.
Artigo em Inglês, Português | MEDLINE | ID: mdl-31166484

RESUMO

OBJECTIVE: To characterize severe potential drug interactions in maternal intensive care, and to determine their frequency, risk factors and potential risk medications. METHODS: An observational and longitudinal study conducted between December 2014 and December 2015 in a maternal intensive care unit. Clinical data were collected and severe potential drug interactions were identified on pregnant inpatients. The drug interactions were classified by type, prevalence and exposure rate. A multivariate logistic regression model was used to identify the severe potential drug interactions and the related drugs (p<0.05). RESULTS: A total of 95.1% of patients were exposed to, at least, one potential drug interaction; in that, 91.7% 33.9% were related to, respectively, moderate and severe potential drug interactions. The patients were exposed, on average, on 69.2% of days they were in the intensive care unit. The main drugs involved in more severe drug interactions were magnesium sulfate, metoclopramide, propranolol and diazepam. CONCLUSION: The severe potential drug interactions were observed in almost all patients of the study, and, approximately one third of those interactions were related to greater severity and resulted in exposure during long hospital stay. The higher number of prescribed drugs and its previous use of medications at home increase the occurrence of severe potential drug interactions.


Assuntos
Interações de Medicamentos , Unidades de Terapia Intensiva/estatística & dados numéricos , Gravidez/efeitos dos fármacos , Medição de Risco/métodos , Adolescente , Adulto , Brasil/epidemiologia , Estudos Transversais , Diazepam/farmacologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Modelos Logísticos , Sulfato de Magnésio/farmacologia , Metoclopramida/farmacologia , Análise Multivariada , Prevalência , Propranolol/farmacologia , Fatores de Risco , Índice de Gravidade de Doença , Adulto Jovem
18.
Expert Opin Drug Saf ; 18(8): 745-752, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31232612

RESUMO

Objectives: Adverse drug reactions (ADRs) are a pervasive global problem, and its management is integral to patient safety and healthcare quality. Pharmacists play a pivotal role in monitoring and reporting ADRs, which has a direct impact on patient care. The aim of this study was to identify potential factors that facilitate pharmacists in community and hospital settings to report ADRs. Methods: A cross-sectional, online survey using a validated questionnaire was administered to pharmacists working in community and hospital pharmacies in Saudi Arabia. Results: 1,717 community and 153 hospital pharmacists participated in this study. Only 10.2% and 26.8% of community and hospital pharmacists, respectively, admitted ever reporting an ADR. The most reported factors that may facilitate ADRs reporting have included ongoing improvements in therapeutic knowledge about ADRs, attending educational programs with continuous medical education credits, the seriousness of the experienced ADRs and accessibility to patients' medical profile. The impact of peers by seeing colleagues reporting ADRs and ADRs due to herbal or traditional medicine were the least important factors reported by pharmacists. Conclusion: The study identified factors that can effectively address the under-reporting of ADRs by pharmacists. A multi-stakeholder, multi-pronged approach of ADR reporting is needed to develop greater awareness of this issue among pharmacists.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Conhecimentos, Atitudes e Prática em Saúde , Farmacêuticos/estatística & dados numéricos , Adulto , Serviços Comunitários de Farmácia/organização & administração , Estudos Transversais , Feminino , Humanos , Masculino , Farmacovigilância , Serviço de Farmácia Hospitalar/organização & administração , Papel Profissional , Arábia Saudita , Inquéritos e Questionários
19.
Zhongguo Zhong Yao Za Zhi ; 44(7): 1497-1502, 2019 Apr.
Artigo em Chinês | MEDLINE | ID: mdl-31090310

RESUMO

To understand the characteristics of adverse reactions and find early warning signs after intake of Guizhi Fuling Capsules. The 1 500 adverse reaction(ADR) cases of Guizhi Fuling Capsules obtained by spontaneous reporting system(SRS) from 2008 to 2017 were analyzed by proportional reporting ratios method(PRR), Bayesian confidence propagation neural network method(BCPNN) and propensity score method. The number of ADR reports increased year by year, and reached the peak in the fourth quarter of 2014. A total of 1 500 ADR cases were monitored, including 10 severe ADR cases. There were a total of 934 cases aged between 18-44 years old, accounting for 62.27%. All patients were orally administered. Among them, 1 398 patients received a single dose according to the package insert, and 57.4% had ADR within 24 h. The top five clinical manifestations of ADR were gastric dysfunction, abdominal pain, nausea, vomiting and rash, which mainly damaged the digestive system. The ADR signals were analyzed. PRR suggested that "gastric dysfunction" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. BCPNN suggested that "nausea" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. After the propensity score weighting method was used to control the confounding factors, the warning signals remained unchanged. The results show that Guizhi Fuling Capsules has fewer adverse reactions and is relatively safe. This study provides a basis for studying ADR of Guizhi Fuling Capsules, and guidance for drug vigilance and risk management of Guizhi Fuling Capsules.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Medicamentos de Ervas Chinesas/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Teorema de Bayes , Cápsulas , Humanos , Gestão de Riscos , Adulto Jovem
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