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1.
Soins ; 64(838): 20-24, 2019 Sep.
Artigo em Francês | MEDLINE | ID: mdl-31542113

RESUMO

Peripheral venous catheters are the most commonly used vascular devices in hospitals. The ageing population and the increase in comorbidities makes their insertion more complex. A survey carried out in surgical units describes the factors contributing to failures. It is important to improve the identification of patients with difficult venous access, to offer access to various techniques and devices, as well as to the expertise of a specialised team.


Assuntos
Cateterismo Periférico , Idoso , Comorbidade , Pesquisas sobre Serviços de Saúde , Hospitalização , Humanos , Fatores de Risco , Centro Cirúrgico Hospitalar , Falha de Tratamento
2.
N Engl J Med ; 381(11): 1035-1045, 2019 09 12.
Artigo em Inglês | MEDLINE | ID: mdl-31509674

RESUMO

BACKGROUND: Previous studies have suggested that maternal supplementation with n-3 long-chain polyunsaturated fatty acids may reduce the incidence of preterm delivery but may also prolong gestation beyond term; however, more data are needed regarding the role of n-3 long-chain polyunsaturated fatty acids in pregnancy. METHODS: We performed a multicenter, double-blind, randomized trial in which women who were pregnant with single or multiple fetuses were assigned to receive either fish-oil capsules that contained 900 mg of n-3 long-chain polyunsaturated fatty acids (n-3 group) or vegetable-oil capsules that contained trace n-3 long-chain polyunsaturated fatty acids (control group) daily, beginning before 20 weeks of gestation and continuing to 34 weeks of gestation or delivery, whichever occurred first. The primary outcome was early preterm delivery, defined as delivery before 34 completed weeks of gestation. Other pregnancy and neonatal outcomes were also assessed. RESULTS: A total of 5544 pregnancies in 5517 women were randomly assigned at six centers in Australia; 5486 pregnancies were included in the primary analysis. Early preterm delivery occurred in the case of 61 of 2734 pregnancies (2.2%) in the n-3 group and 55 of 2752 pregnancies (2.0%) in the control group; the between-group difference was not significant (adjusted relative risk, 1.13; 95% confidence interval [CI], 0.79 to 1.63; P = 0.50). There were no significant differences between the groups in the incidence of interventions in post-term (>41 weeks of gestation) deliveries, in adverse events, or in other pregnancy or neonatal outcomes, except that a higher percentage of infants born to women in the n-3 group than in the control group were very large for gestational age at birth (adjusted relative risk, 1.30; 95% CI, 1.02 to 1.65). Percentages of serious adverse events did not differ between the groups. Minor gastrointestinal disturbances were more commonly reported in the n-3 group than in the control group. CONCLUSIONS: Supplementation with n-3 long-chain polyunsaturated fatty acids from early pregnancy (<20 weeks of gestation) until 34 weeks of gestation did not result in a lower incidence of early preterm delivery or a higher incidence of interventions in post-term deliveries than control. (Funded by the Australian National Health and Medical Research Council and the Thyne Reid Foundation; ORIP Australian New Zealand Clinical Trials Registry number, ACTRN12613001142729.).


Assuntos
Suplementos Nutricionais , Ácidos Graxos Ômega-3/uso terapêutico , Nascimento Prematuro/prevenção & controle , Adulto , Método Duplo-Cego , Feminino , Macrossomia Fetal , Idade Gestacional , Humanos , Incidência , Recém-Nascido , Análise de Intenção de Tratamento , Óleos Vegetais/uso terapêutico , Gravidez , Resultado da Gravidez , Nascimento Prematuro/epidemiologia , Cuidado Pré-Natal , Falha de Tratamento
4.
Anticancer Res ; 39(9): 5203-5207, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31519634

RESUMO

BACKGROUND: A retrospective analysis was performed to investigate the survival outcomes in pediatric acute lymphoblastic leukemia (ALL) based on time period. We hypothesized that improvement has been obtained with the time-dependent therapeutic era and rise in the gross domestic product (GDP) and Human Development Index (HDI). MATERIALS AND METHODS: Data from 710 children who were treated for ALL between 1958 and 2018 at a single pediatric center were analyzed for probability of 5-year overall survival (pOS), event-free survival (pEFS) and relapse risk (pRR). Time periods were defined by the treatment protocols used in seven consecutive therapeutic eras. RESULTS: Over the 60-year period analyzed, pOS increased from 1.2% to 90.7%, pEFS from 1.2% to 86.6%, and pRR decreased from 98.8% to 9.9% for patients treated in the past decade. Risk of mortality for patients who received chemotherapy and hematopoietic cell transplant was reduced to 9.9% in the recent era, however, no statistically significant survival difference was found between patients treated with stem cell transplant and those not. CONCLUSION: The therapeutic era, related to improved GDP and HDI, was a statistically significant predictor of increased OS from ALL.


Assuntos
Leucemia-Linfoma Linfoblástico de Células Precursoras/epidemiologia , Adolescente , Biomarcadores Tumorais , Biópsia , Criança , Pré-Escolar , Feminino , Pesquisas sobre Serviços de Saúde , Humanos , Lactente , Recém-Nascido , Masculino , Avaliação de Resultados (Cuidados de Saúde) , Leucemia-Linfoma Linfoblástico de Células Precursoras/diagnóstico , Leucemia-Linfoma Linfoblástico de Células Precursoras/mortalidade , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Estudos Retrospectivos , Fatores de Risco , Falha de Tratamento , Resultado do Tratamento
6.
N Engl J Med ; 381(8): 716-726, 2019 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-31433919

RESUMO

BACKGROUND: Serelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy. Previous studies have suggested that treatment with serelaxin may result in relief of symptoms and in better outcomes in patients with acute heart failure. METHODS: In this multicenter, double-blind, placebo-controlled, event-driven trial, we enrolled patients who were hospitalized for acute heart failure and had dyspnea, vascular congestion on chest radiography, increased plasma concentrations of natriuretic peptides, mild-to-moderate renal insufficiency, and a systolic blood pressure of at least 125 mm Hg, and we randomly assigned them within 16 hours after presentation to receive either a 48-hour intravenous infusion of serelaxin (30 µg per kilogram of body weight per day) or placebo, in addition to standard care. The two primary end points were death from cardiovascular causes at 180 days and worsening heart failure at 5 days. RESULTS: A total of 6545 patients were included in the intention-to-treat analysis. At day 180, death from cardiovascular causes had occurred in 285 of the 3274 patients (8.7%) in the serelaxin group and in 290 of the 3271 patients (8.9%) in the placebo group (hazard ratio, 0.98; 95% confidence interval [CI], 0.83 to 1.15; P = 0.77). At day 5, worsening heart failure had occurred in 227 patients (6.9%) in the serelaxin group and in 252 (7.7%) in the placebo group (hazard ratio, 0.89; 95% CI, 0.75 to 1.07; P = 0.19). There were no significant differences between the groups in the incidence of death from any cause at 180 days, the incidence of death from cardiovascular causes or rehospitalization for heart failure or renal failure at 180 days, or the length of the index hospital stay. The incidence of adverse events was similar in the two groups. CONCLUSIONS: In this trial involving patients who were hospitalized for acute heart failure, an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo. (Funded by Novartis Pharma; RELAX-AHF-2 ClinicalTrials.gov number, NCT01870778.).


Assuntos
Doenças Cardiovasculares/mortalidade , Insuficiência Cardíaca/tratamento farmacológico , Relaxina/uso terapêutico , Vasodilatadores/uso terapêutico , Doença Aguda , Idoso , Pressão Sanguínea/efeitos dos fármacos , Progressão da Doença , Método Duplo-Cego , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Hospitalização , Humanos , Incidência , Infusões Intravenosas , Masculino , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/farmacologia , Proteínas Recombinantes/uso terapêutico , Relaxina/efeitos adversos , Relaxina/farmacologia , Falha de Tratamento , Vasodilatadores/efeitos adversos
7.
Arq Bras Cir Dig ; 32(2): e1440, 2019 Aug 26.
Artigo em Inglês, Português | MEDLINE | ID: mdl-31460600

RESUMO

BACKGROUND: Re-fundoplication is the most often procedure performed after failed fundoplication, but re-failure is even higher. AIM: The objectives are: a) to discuss the results of fundoplication and re-fundoplication in these cases, and b) to analyze in which clinical situation there is a room for gastrectomy after failed fundoplication. METHOD: This experience includes 104 patients submitted to re-fundoplication after failure of the initial operation, 50 cases of long segment Barrett´s esophagus and 60 patients with morbid obesity, comparing the postoperative outcome in terms of clinical, endoscopic, manometric and 24h pH monitoring results. RESULTS: In patients with failure after initial fundoplication, redo-fundoplication shows the worst clinical results (symptoms, endoscopic esophagitis, manometry and 24 h pH monitoring). In patients with long segment Barrett´s esophagus, better results were observed after fundoplication plus Roux-en-Y distal gastrectomy and in obese patients similar results regarding symptoms, endoscopic esophagitis and 24h pH monitoring were observed after both fundoplication plus distal gastrectomy or laparoscopic resectional gastric bypass, while regarding manometry, normal LES pressure was observed only after fundoplication plus distal gastrectomy. CONCLUSION: Distal gastrectomy is recommended for patients with failure after initial fundoplication, patients with long segment Barrett´s esophagus and obese patients with gastroesophageal reflux disease and Barrett´s esophagus. Despite its higher morbidity, this procedure represents an important addition to the surgical armamentarium.


Assuntos
Esôfago de Barrett/cirurgia , Fundoplicatura/efeitos adversos , Gastrectomia/métodos , Obesidade Mórbida/cirurgia , Anastomose em-Y de Roux , Monitoramento do pH Esofágico , Humanos , Manometria , Reoperação , Falha de Tratamento
8.
Medicine (Baltimore) ; 98(32): e16357, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31393344

RESUMO

Achieving and maintaining viral suppression in young adults (18-24 years) living with HIV is challenging. Overall HIV viral suppression rates are lower in young as compared to older adults. Longitudinal data provide valuable insight on dynamics of viral suppression and variables of potential influence on HIV virological failure (VF), but is scarce in young adults living with HIV on combination antiretroviral therapy (cART). We evaluated longitudinal virological outcomes of behaviorally young adults (18-24 years) living with HIV in the Netherlands over a period of 15 years.We analyzed data from the Dutch national HIV database of 816 young adults living with HIV on cART in the Netherlands from 2000 to 2015. VF was defined as 2 consecutive detectable plasma HIV-1 viral load (VL) measurements > 200 copies/ml. Generalized linear mixed model analyses were used to assess HIV VF over time and identify risk factors associated with VF.VF during the study follow-up occurred at least once in 26% of cases. The probability of experiencing VF decreased over the study period per calendar year (OR 0.78, 95% confidence interval [CI];0.72; 0.85). Factors significantly associated with VF were being infected through heterosexual contact (OR 5.20, CI 1.39;19.38) and originating from Latin America or the Caribbean (OR 6.59, CI 2.08;20.92). Smaller, yet significant risk factors for VF were being infected through a blood transfusion or a needle accident (OR9.93, CI 1.34;73.84, and having started with cART with a nadir CD4 count >500 cells/µl (OR 11.36, CI 2.03;63.48).In our large cohort of young adults, the risk of VF has diminished over 15 years. Specific subgroups were identified to be at risk for suboptimal treatment.


Assuntos
Antirretrovirais/uso terapêutico , Infecções por HIV/tratamento farmacológico , Adolescente , Antirretrovirais/administração & dosagem , Contagem de Linfócito CD4 , Grupos de Populações Continentais , Quimioterapia Combinada , Feminino , Infecções por HIV/etiologia , HIV-1 , Humanos , Estudos Longitudinais , Masculino , Países Baixos , Fatores de Risco , Comportamento Sexual , Falha de Tratamento , Carga Viral , Adulto Jovem
9.
JAMA ; 322(8): 736-745, 2019 08 27.
Artigo em Inglês | MEDLINE | ID: mdl-31454046

RESUMO

Importance: Few studies have assessed the effects of daily vitamin D doses at or above the tolerable upper intake level for 12 months or greater, yet 3% of US adults report vitamin D intakes of at least 4000 IU per day. Objective: To assess the dose-dependent effect of vitamin D supplementation on volumetric bone mineral density (BMD) and strength. Design, Setting, and Participants: Three-year, double-blind, randomized clinical trial conducted in a single center in Calgary, Canada, from August 2013 to December 2017, including 311 community-dwelling healthy adults without osteoporosis, aged 55 to 70 years, with baseline levels of 25-hydroxyvitamin D (25[OH]D) of 30 to 125 nmol/L. Interventions: Daily doses of vitamin D3 for 3 years at 400 IU (n = 109), 4000 IU (n = 100), or 10 000 IU (n = 102). Calcium supplementation was provided to participants with dietary intake of less than 1200 mg per day. Main Outcomes and Measures: Co-primary outcomes were total volumetric BMD at radius and tibia, assessed with high resolution peripheral quantitative computed tomography, and bone strength (failure load) at radius and tibia estimated by finite element analysis. Results: Of 311 participants who were randomized (53% men; mean [SD] age, 62.2 [4.2] years), 287 (92%) completed the study. Baseline, 3-month, and 3-year levels of 25(OH)D were 76.3, 76.7, and 77.4 nmol/L for the 400-IU group; 81.3, 115.3, and 132.2 for the 4000-IU group; and 78.4, 188.0, and 144.4 for the 10 000-IU group. There were significant group × time interactions for volumetric BMD. At trial end, radial volumetric BMD was lower for the 4000 IU group (-3.9 mg HA/cm3 [95% CI, -6.5 to -1.3]) and 10 000 IU group (-7.5 mg HA/cm3 [95% CI, -10.1 to -5.0]) compared with the 400 IU group with mean percent change in volumetric BMD of -1.2% (400 IU group), -2.4% (4000 IU group), and -3.5% (10 000 IU group). Tibial volumetric BMD differences from the 400 IU group were -1.8 mg HA/cm3 (95% CI, -3.7 to 0.1) in the 4000 IU group and -4.1 mg HA/cm3 in the 10 000 IU group (95% CI, -6.0 to -2.2), with mean percent change values of -0.4% (400 IU), -1.0% (4000 IU), and -1.7% (10 000 IU). There were no significant differences for changes in failure load (radius, P = .06; tibia, P = .12). Conclusions and Relevance: Among healthy adults, treatment with vitamin D for 3 years at a dose of 4000 IU per day or 10 000 IU per day, compared with 400 IU per day, resulted in statistically significant lower radial BMD; tibial BMD was significantly lower only with the 10 000 IU per day dose. There were no significant differences in bone strength at either the radius or tibia. These findings do not support a benefit of high-dose vitamin D supplementation for bone health; further research would be needed to determine whether it is harmful. Trial Registration: ClinicalTrials.gov Identifier: NCT01900860.


Assuntos
Densidade Óssea/efeitos dos fármacos , Colecalciferol/administração & dosagem , Suplementos Nutricionais , Vitaminas/administração & dosagem , Absorciometria de Fóton , Administração Oral , Idoso , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Análise de Elementos Finitos , Resistência à Flexão , Humanos , Masculino , Pessoa de Meia-Idade , Rádio (Anatomia)/anatomia & histologia , Rádio (Anatomia)/diagnóstico por imagem , Tíbia/anatomia & histologia , Tíbia/diagnóstico por imagem , Falha de Tratamento , Vitamina D/análogos & derivados , Vitamina D/sangue
10.
BMC Infect Dis ; 19(1): 599, 2019 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-31288748

RESUMO

BACKGROUND: Second-line Antiretroviral Therapy (ART) regimens are used when patients develop treatment failure for first-line drug regimens. It is costly unaffordable and it is not widely available for patients in resource limiting setting, there is a need to maximizing the duration of stay on second-line regimen. This study was conducted to estimate the incidence rate of second-line treatment failure and to identify its predictors among adults living with HIV in the Amhara region. METHODS: An institution based retrospective follow-up study was conducted from May to June 2017. A total of 1,011 adults on second-line ART who were enrolled between February 2008 and April 2016 were included for final analysis. Kaplan-Meier estimator curves were used to describe the survival function. Semi-parametric proportional hazard model was fitted to identify the predictors of treatment failure. RESULTS: The overall incidence of second-line treatment failure was 9.86 per 100 person-years. It was high during the first and the last year of follow-up. The rate of second-line treatment failure was higher for patients who didn't change second-line regimens (HR: 1.55, 95%CI: 1.18-2.04), who had poor ART adherence (HR: 1.40, 95%CI: 1.06-1.85), and not taking INH (HR: 1.68, 95%CI: 1.23-2.30) as compared to their counter group. The rate of treatment failure for patients who were under WHO clinical stage III at switch (HR: 0.68, 95%CI: 0.50-0.91) was also lower as compared to clients who were under WHO clinical stage I. Furthermore, the rate of treatment failure was higher for clients who were under second-line regimen "TDF-3TC-LPV/r" (HR: 1.55, 95%CI: 1.03-2.32) and "AZT-3TC-LPV/r" (HR: 3.00, 95%CI: 1.86-4.85) as compared to patients under "ABC-ddI-LPV/r" regimens. CONCLUSIONS: A high incidence rate of second-line treatment failure was noticed in the study setting. The rate of second-line treatment failure was higher for patients who didn't change drug regimens, who had poor ART adherence, and who were not taking INH. Therefore, addressing significant predictors to prevent treatment failure among ART patients is essential and sustainable monitoring to reduce the risk of treatment failure is also desirable.


Assuntos
Antirretrovirais/uso terapêutico , Infecções por HIV/tratamento farmacológico , Adolescente , Adulto , Etiópia/epidemiologia , Feminino , Seguimentos , Infecções por HIV/epidemiologia , Infecções por HIV/mortalidade , Infecções por HIV/patologia , Humanos , Incidência , Estimativa de Kaplan-Meier , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Índice de Gravidade de Doença , Falha de Tratamento , Adulto Jovem
11.
Zhonghua Wei Zhong Bing Ji Jiu Yi Xue ; 31(6): 689-693, 2019 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-31315724

RESUMO

OBJECTIVE: To investigate the characteristics and failure risk factors of sequential high-flow nasal cannula oxygen therapy (HFNC) after weaning from invasive ventilation. METHODS: The patients who received sequential HFNC after weaning from invasive ventilation admitted to surgical intensive care unit (ICU) of Peking University People's Hospital from June 1st 2016 to May 31st 2018 were retrospectively analyzed. Clinical variables, respiratory therapy parameters, respiratory variables, cardiac variables and outcomes were reviewed and analyzed. Treatment characteristics of HFNC after weaning was analyzed. Patients were divided into HFNC success group and HFNC failure group according to the failure of HFNC, and the differences between the two groups were compared. The independent risk factors of HFNC treatment failure were analyzed by Logistic regression analysis. The value of predictive treatment failure of risk factors and regression models were analyzed by receiver operating characteristic (ROC) curve. RESULTS: A total of 99 patients were included, 61 men, and the median age was 67.0 (57.0, 76.0) years old. The medianinitial HFNC flow was 50 (50, 60) L/min, and inspired oxygen concentration (FiO2) was 0.50 (0.40, 0.60). Eighteen patients experienced HFNC failure (18.2%). Compared with the HFNC success group, the sequential organ failure assessment (SOFA) score in the HFNC failure group was higher [4 (3, 5) vs. 2 (1, 3), P < 0.01], B type natriuretic peptide (BNP) before HFNC therapy were significant higher [ng/L: 647.2 (399.2, 1 331.3) vs. 127.2 (55.2, 369.5), P < 0.01], and respiratory frequency (RR) and heart rate (HR) were significant faster, mean arterial pressure (MAP) was significant higher, oxygen index (PaO2/FiO2) was significant lower after 30 minutes HFNC treatment [RR (times/min): 26 (22, 28) vs. 19 (17, 21), HR (bpm): 105 (97, 107) vs. 85 (77, 90), MAP (mmHg, 1 mmHg = 0.133 kPa): 104.3 (101.7, 110.7) vs. 92.3 (88.3, 97.7), PaO2/FiO2 (mmHg): 207.3 (185.8, 402.8) vs. 320.2 (226.2, 361.5), all P < 0.05]. It was shown by multiple Logistic regression analysis that the SOFA score [odds ratio (OR) = 2.818, P = 0.022, ß = 1.036], BNP before HFNC treatment (OR = 1.002, P = 0.033, ß = 0.002) and HR after HFNC treatment 30 minutes (OR = 1.140, P = 0.032, ß = 0.131) were independent risk factors for HFNC treatment failure. It was shown by ROC curve that the area under the ROC curve (AUC) for the prediction of HFNC failure was 0.840, 0.859, 0.860 and 0.962 for SOFA, BNP before HFNC treatment, HR after HFNC treatment 30 minutes, and regression model, all had good forecast values (all P < 0.01). CONCLUSIONS: HFNC is one of the commonly used oxygen therapy methods in the ICU, but not all patients who are treated as a sequential therapy after invasive mechanical ventilation weaning can benefit from it. SOFA score, BNP before HFNC treatment and HR after 30 minutes HFNC treatment were independent risk factors of HFNC failure. Each independent risk factor and regression model can predict the success of HFNC treatment.


Assuntos
Cânula , Oxigenoterapia/métodos , Desmame do Respirador , Idoso , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Centro Cirúrgico Hospitalar , Falha de Tratamento
12.
BMC Infect Dis ; 19(1): 569, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31262272

RESUMO

BACKGROUND: Antiretroviral therapy (ART) was rolled-out in Ethiopia in 2005, but there are no reports on outcome of ART and human immunodeficiency virus drug resistance (HIVDR) at national level. We described acquired drug resistance mutations in pol gene and performed a viral genome wide association study in virologic treatment failure patients who started first line ART during 2009-2011 in the first large countrywide HIV cohort in Ethiopia. METHODS: The outcome of tenofovir (TDF)- and zidovudine (ZDV)-based ART was defined in 874 ART naïve patients using the on-treatment (OT) and intention-to-treat (ITT) analyses. Genotypic resistance testing was done in patients failing ART (> 1000 copies/ml) at month 6 and 12. Near full-length genome sequencing (NFLG) was used to assess amino acid changes in HIV-1 gag, pol, vif, vpr, tat, vpu, and nef genes between paired baseline and month 6 samples. RESULTS: High failure rates were found in ITT analysis at month 6 and 12 (23.3%; 33.9% respectively). Major nucleoside and non-nucleoside reverse transcriptase (NRTI/NNRTI) drug resistance mutations were detected in most failure patients at month 6 (36/47; 77%) and month 12 (20/30; 67%). A high rate of K65R was identified only in TDF treated patients (35.7%; 50.0%, respectively). No significant difference was found in failure rate or extent of HIVDR between TDF- and ZDV- treated patients. All target regions of interest for HIVDR were described by NFLG in 16 patients tested before initiation of ART and at month 6. CONCLUSION: In this first Ethiopian national cohort, a high degree of HIVDR was seen among ART failure patients, independent on whether TDF- or ZDV was given. However, the major reason to ART failure was lost-to-follow-up rather than virologic failure. Our NFLG assay covered all relevant target genes for antiretrovirals and is an attractive alternative for HIVDR surveillance.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Farmacorresistência Viral/genética , Infecções por HIV/virologia , HIV-1/genética , Mutação , Adulto , Estudos de Coortes , Farmacorresistência Viral/efeitos dos fármacos , Etiópia , Feminino , Estudo de Associação Genômica Ampla , Genótipo , Infecções por HIV/tratamento farmacológico , Integrase de HIV/genética , HIV-1/efeitos dos fármacos , Humanos , Masculino , Inibidores da Transcriptase Reversa/uso terapêutico , Tenofovir/uso terapêutico , Falha de Tratamento , Zidovudina/uso terapêutico
13.
Medicine (Baltimore) ; 98(26): e15886, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31261497

RESUMO

There is limited information about the effects of corticosteroids on severe drug-induced liver injury (DILI). This study aimed to investigate the efficacy and safety of prednisone in severe DILI.Ninety patients with severe DILI were enrolled and studied retrospectively. They were divided into prednisone (n = 66) and control groups (n = 24), undergoing the same treatment regimen except that patients in the prednisone group received a median daily dose of 40 mg prednisone. The primary endpoint was severity reduction (serum total bilirubin [TBIL] <86 µmol/L).During the study, the cumulative rates of severity reduction at 4-, 8-, and 12 days were comparable between the 2 groups (prednisone versus control: 7.6%, 33.3%, and 60.6% versus 12.5%, 37.5%, and 66.7%, P = .331), and were markedly lower in the high-dose group than in the low-dose group (0%, 28.6%, and 35.7% versus 9.6%, 34.6%, and 67.3%, P = .012) or in the control group (0%, 28.6%, and 35.7% versus 12.5%, 37.5%, and 66.7%, P = .023). The 30-day overall survival rate in the prednisone group was significantly higher than in the control group (100% versus 91.7%, P = .018). Serum bilirubin and transaminase values gradually decreased in both groups, which were not significantly different mostly. Cox-regression models revealed that baseline TBIL (hazard ratio: 0.235; 95% confidence interval: 0.084-0.665; P = .006) was the only predictor for severity reduction. No severe adverse event was noted in both groups.Prednisone therapy is safe but not beneficial, and even detrimental at a daily dose > 40 mg for the treatment of severe DILI.


Assuntos
Doença Hepática Induzida por Substâncias e Drogas/tratamento farmacológico , Glucocorticoides/uso terapêutico , Prednisona/uso terapêutico , Adolescente , Adulto , Idoso , Bilirrubina/sangue , Biomarcadores/sangue , Doença Hepática Induzida por Substâncias e Drogas/sangue , Doença Hepática Induzida por Substâncias e Drogas/mortalidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Estudos Retrospectivos , Índice de Gravidade de Doença , Análise de Sobrevida , Falha de Tratamento , Adulto Jovem
14.
Braz J Cardiovasc Surg ; 34(3): 297-304, 2019 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-31310468

RESUMO

OBJECTIVES: To investigate the association between clinical hematologic parameters and saphenous vein graft failure after on-pump coronary artery bypass surgery. METHODS: A total of 1950 consecutive patients underwent isolated on-pump coronary artery surgery between November 2010 and February 2013. Of these, 284 patients met our inclusion criteria; their preoperative clinical hematological parameters were retrospectively obtained for this cohort study. And of them, 109 patients underwent conventional coronary angiography after graft failure was revealed by coronary computed tomography angiography. The primary endpoint was to catch at least one saphenous vein graft stenosis or occlusion following the coronary angiogram. We then analyzed risk factors for graft failure. In sequential or T grafts, each segment was analyzed as a separate graft. RESULTS: In logistic regression analysis, older age, platelet distribution width, and diabetes mellitus were identified as independent predictors of saphenous vein graft failure (P<0.). In contrast, preserved ejection fraction value favored graft patency (P<0.001). CONCLUSION: Increased platelet distribution width is easily measurable and can be used as a simple and valuable marker in the prediction of saphenous vein graft failure.


Assuntos
Plaquetas/fisiologia , Ponte de Artéria Coronária/efeitos adversos , Veia Safena/transplante , Grau de Desobstrução Vascular/fisiologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Angiografia Coronária/métodos , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/etiologia , Ecocardiografia , Feminino , Testes Hematológicos , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Contagem de Plaquetas , Valor Preditivo dos Testes , Curva ROC , Valores de Referência , Estudos Retrospectivos , Fatores de Risco , Veia Safena/fisiopatologia , Estatísticas não Paramétricas , Falha de Tratamento
15.
Braz J Cardiovasc Surg ; 34(3): 318-326, 2019 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-31310471

RESUMO

OBJECTIVES: This study sought to evaluate the impact of prosthesis-patient mismatch (PPM) on the risk of early-term mortality after transcatheter aortic valve implantation (TAVI). METHODS: Databases (Medical Literature Analysis and Retrieval System Online [MEDLINE], Excerpta Medica dataBASE [EMBASE], Cochrane Controlled Trials Register [CENTRAL/CCTR], ClinicalTrials.gov, Scientific Electronic Library Online [SciELO], Latin American and Caribbean Literature on Health Sciences [LILACS], and Google Scholar) were searched for studies published until February 2019. PPM after TAVI was defined as moderate if the indexed effective orifice area (iEOA) was between 0.85 cm2/m2 and 0.65 cm2/m2 and as severe if iEOA ≤ 0.65 cm2/m2. RESULTS: The search yielded 1,092 studies for inclusion. Of these, 18 articles were analyzed, and their data extracted. The total number of patients included who underwent TAVI was 71,106. The incidence of PPM after TAVI was 36.3% (25,846 with PPM and 45,260 without PPM). One-year mortality was not increased in patients with any PPM (odds ratio [OR] 1.021, 95% confidence interval [CI] 0.979-1.065, P=0.338) neither in those with moderate PPM (OR 0.980, 95% CI 0.933-1.029, P=0.423). Severe PPM was separately associated with high risk (OR 1.109, 95% CI 1.041-1.181, P=0.001). CONCLUSION: The presence of severe PPM after TAVI increased early-term mortality. Although moderate PPM seemed harmless, the findings of this study cannot not rule out the possibility of it being detrimental, since there are other registries that did not address this issue yet.


Assuntos
Próteses Valvulares Cardíacas/efeitos adversos , Falha de Prótese/efeitos adversos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Humanos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Falha de Tratamento
16.
Braz J Cardiovasc Surg ; 34(3): 361-365, 2019 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-31310476

RESUMO

Prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (SAVR) is an issue that has been overlooked (not to say neglected). Cardiac surgeons must bear in mind that this is a real problem that we must tackle. The purpose of this paper is to be a wake-up call to the surgical community by giving a brief overview of what PPM is, its incidence and impact on the outcomes. We also discuss the increasing role played by imaging for predicting and assessing PPM after SAVR (with which surgeons must become more acquainted) and, finally, we present some options to avoid PPM after the surgical procedure.


Assuntos
Próteses Valvulares Cardíacas/efeitos adversos , Falha de Prótese/efeitos adversos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Humanos , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/mortalidade , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/mortalidade , Falha de Tratamento
17.
Medicine (Baltimore) ; 98(28): e16297, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31305414

RESUMO

AIM: Accumulating evidence has explored the effect of mesalazine on irritable bowel syndrome (IBS). However, these studies remain inconsistent. Thus, a meta-analysis was conducted to estimate the role of mesalazine on IBS. METHODS: PubMed, Medline, Embase, Web of Science, and the Cochrane Library Database were searched for all relevant randomized, controlled, blinded trials on mesalazine in patients with IBS between January 1980 and October 2018. All statistical analyses were performed using Revman 5.3 software. A fixed-effects model was adopted, 95% confidence intervals for SMD was calculated. Heterogeneity was evaluated by χ test and I statistic. RESULTS: Five studies involving 387 participants were finally included in this meta-analysis. The results showed that the SMD for clinical efficacy on abdominal pain in IBS patients treated with mesalazine in comparison to placebo was 0.19 (95% CI = -0.01 to 0.39, P = .06), which was statistically non-significant but clinically important. For beneficial effect of abdominal bloating, the SMD was 0.05 (95% CI = -0.20 to 0.30, P = .70), which was statistically non-significant. In regard to clinical efficacy on defecation frequency per day, the results revealed that the SMD was 0.29 (95% CI = -0.14 to 0.73, P = .18), which was statistically non-significant but clinically important. As for beneficial effect of general well-being, we found that the SMD was 0.41 (95% CI = -0.75 to 1.58, P = .49), which was statistically non-significant. With respect to stool consistency, the SMD was 0.01 (95% CI = -0.31 to 0.33, P = .96), which was statistically non-significant. For the effect of defecation urgency severity in IBS patients treated with mesalazine in comparison to placebo, we detected a surprising result with an SMD of 0.54 (95% CI = 0.05-1.04, P = .03), which was statistically significant. There was no significant difference between mesalazine group and placebo group on total mucosal immune cell counts of the patients with IBS with an SMD of -1.64 (95% CI = -6.17 to 2.89, P = .48) and there was also no significant difference in adverse reactions between two groups with an SMD of 1.05 (95% CI = 0.76-1.46 P = .77). CONCLUSION: Mesalazine is not superior to placebo in relieving clinical symptoms of abdominal pain, abdominal bloating, and general well-being of IBS and has no advantage of reducing defecation frequency per day and immune cell infiltration and improving stool consistency though without adverse reactions of mesalazine compared with placebo. For defecation urgency severity, placebo is even superior to mesalazine for IBS patients. Thus, mesalazine might be a cost burden to patients without providing good effectiveness. In view of the small sample size of the current study and the differences in every experimental designs, this study has high heterogeneity and requires subsequent verification.


Assuntos
Fármacos Gastrointestinais/uso terapêutico , Síndrome do Intestino Irritável/tratamento farmacológico , Mesalamina/uso terapêutico , Humanos , Falha de Tratamento
18.
N Engl J Med ; 381(4): 328-337, 2019 07 25.
Artigo em Inglês | MEDLINE | ID: mdl-31259488

RESUMO

BACKGROUND: Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known. METHODS: In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met. RESULTS: The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients. CONCLUSIONS: Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter. (Funded by the Medical Research Foundation of Royal Perth Hospital and others; Australian New Zealand Clinical Trials Registry number, ACTRN12614000963628.).


Assuntos
Embolia Pulmonar/prevenção & controle , Filtros de Veia Cava , Ferimentos e Lesões/terapia , Adulto , Angiografia por Tomografia Computadorizada , Humanos , Incidência , Escala de Gravidade do Ferimento , Estimativa de Kaplan-Meier , Perna (Membro)/diagnóstico por imagem , Pulmão/diagnóstico por imagem , Pessoa de Meia-Idade , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/epidemiologia , Embolia Pulmonar/mortalidade , Risco , Falha de Tratamento , Ultrassonografia , Trombose Venosa/diagnóstico por imagem , Ferimentos e Lesões/mortalidade
19.
N Engl J Med ; 381(1): 36-46, 2019 07 04.
Artigo em Inglês | MEDLINE | ID: mdl-31269364

RESUMO

BACKGROUND: B-cell anomalies play a role in the pathogenesis of membranous nephropathy. B-cell depletion with rituximab may therefore be noninferior to treatment with cyclosporine for inducing and maintaining a complete or partial remission of proteinuria in patients with this condition. METHODS: We randomly assigned patients who had membranous nephropathy, proteinuria of at least 5 g per 24 hours, and a quantified creatinine clearance of at least 40 ml per minute per 1.73 m2 of body-surface area and had been receiving angiotensin-system blockade for at least 3 months to receive intravenous rituximab (two infusions, 1000 mg each, administered 14 days apart; repeated at 6 months in case of partial response) or oral cyclosporine (starting at a dose of 3.5 mg per kilogram of body weight per day for 12 months). Patients were followed for 24 months. The primary outcome was a composite of complete or partial remission of proteinuria at 24 months. Laboratory variables and safety were also assessed. RESULTS: A total of 130 patients underwent randomization. At 12 months, 39 of 65 patients (60%) in the rituximab group and 34 of 65 (52%) in the cyclosporine group had a complete or partial remission (risk difference, 8 percentage points; 95% confidence interval [CI], -9 to 25; P = 0.004 for noninferiority). At 24 months, 39 patients (60%) in the rituximab group and 13 (20%) in the cyclosporine group had a complete or partial remission (risk difference, 40 percentage points; 95% CI, 25 to 55; P<0.001 for both noninferiority and superiority). Among patients in remission who tested positive for anti-phospholipase A2 receptor (PLA2R) antibodies, the decline in autoantibodies to anti-PLA2R was faster and of greater magnitude and duration in the rituximab group than in the cyclosporine group. Serious adverse events occurred in 11 patients (17%) in the rituximab group and in 20 (31%) in the cyclosporine group (P = 0.06). CONCLUSIONS: Rituximab was noninferior to cyclosporine in inducing complete or partial remission of proteinuria at 12 months and was superior in maintaining proteinuria remission up to 24 months. (Funded by Genentech and the Fulk Family Foundation; MENTOR ClinicalTrials.gov number, NCT01180036.).


Assuntos
Ciclosporina/uso terapêutico , Glomerulonefrite Membranosa/tratamento farmacológico , Imunossupressores/uso terapêutico , Rituximab/uso terapêutico , Administração Oral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ciclosporina/efeitos adversos , Esquema de Medicação , Feminino , Humanos , Fatores Imunológicos/uso terapêutico , Imunossupressores/efeitos adversos , Infusões Intravenosas , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Proteinúria/tratamento farmacológico , Indução de Remissão , Rituximab/efeitos adversos , Falha de Tratamento , Adulto Jovem
20.
Cochrane Database Syst Rev ; 7: CD001911, 2019 07 18.
Artigo em Inglês | MEDLINE | ID: mdl-31318037

RESUMO

BACKGROUND: This is an update of a Cochrane Review first published in 2002 and last updated in 2017. This review is one in a series of Cochrane Reviews investigating pair-wise monotherapy comparisons.Epilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy with a single antiepileptic drug in monotherapy.Worldwide, carbamazepine and phenytoin are commonly-used broad spectrum antiepileptic drugs, suitable for most epileptic seizure types. Carbamazepine is a current first-line treatment for focal onset seizures in the USA and Europe. Phenytoin is no longer considered a first-line treatment, due to concerns over adverse events associated with its use, but the drug is still commonly used in low- to middle-income countries because of its low cost. No consistent differences in efficacy have been found between carbamazepine and phenytoin in individual trials; however, the confidence intervals generated by these trials are wide, and therefore, synthesising the data of the individual trials may show differences in efficacy. OBJECTIVES: To review the time to treatment failure, remission and first seizure with carbamazepine compared with phenytoin when used as monotherapy in people with focal onset seizures (simple or complex focal and secondarily generalised), or generalised onset tonic-clonic seizures (with or without other generalised seizure types). SEARCH METHODS: For the latest update, we searched the following databases on 13 August 2018: the Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy's Specialised Register and CENTRAL; MEDLINE; the US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov); and the World Health Organization International Clinical Trials Registry Platform (ICTRP). We handsearched relevant journals and contacted pharmaceutical companies, original trial investigators, and experts in the field. SELECTION CRITERIA: Randomised controlled trials comparing monotherapy with either carbamazepine or phenytoin in children or adults with focal onset seizures or generalised onset (tonic-clonic) seizures. DATA COLLECTION AND ANALYSIS: This was an individual participant data (IPD) review. Our primary outcome was time to treatment failure. Our secondary outcomes were time to first seizure post-randomisation, time to six-month remission, time to 12-month remission, and incidence of adverse events. We used Cox proportional hazards regression models to obtain trial-specific estimates of hazard ratios (HRs), with 95% confidence intervals (CIs), using the generic inverse variance method to obtain the overall pooled HR and 95% CI. MAIN RESULTS: IPD were available for 595 participants out of 1102 eligible individuals, from four out of 11 trials (i.e. 54% of the potential data). For remission outcomes, a HR greater than 1 indicates an advantage for phenytoin; and for first seizure and withdrawal outcomes, a HR greater than 1 indicates an advantage for carbamazepine. Most participants included in analysis (78%) were classified as experiencing focal onset seizures at baseline and only 22% were classified as experiencing generalised onset seizures; the results of this review are therefore mainly applicable to individuals with focal onset seizures.Results for the primary outcome of the review were: time to treatment failure for any reason related to treatment (pooled HR adjusted for seizure type for 546 participants: 0.94, 95% CI 0.70 to 1.26, moderate-certainty evidence); time to treatment failure due to lack of efficacy (pooled HR adjusted for seizure type for 546 participants: 0.99, 95% CI 0.69 to 1.41, moderate-certainty evidence); both showing no clear difference between the drugs and time to treatment failure due to adverse events (pooled HR adjusted for seizure type for 546 participants: 1.27, 95% CI 0.87 to 1.86, moderate-certainty evidence), showing that treatment failure due to adverse events may occur earlier on carbamazepine than phenytoin, but we cannot rule out a slight advantage to carbamazepine or no difference between the drugs.For our secondary outcomes (pooled HRs adjusted for seizure type), we did not find any clear differences between carbamazepine and phenytoin: time to first seizure post-randomisation (582 participants): 1.15, 95% CI 0.94 to 1.40, moderate-certainty evidence); time to 12-month remission (551 participants): 1.00, 95% CI 0.79 to 1.26, moderate-certainty evidence); and time to six-month remission (551 participants): 0.90, 95% CI 0.73 to 1.12, moderate-certainty evidence).For all outcomes, results for individuals with focal onset seizures were similar to overall results (moderate-certainty evidence), and results for the small subgroup of individuals with generalised onset seizures were imprecise, so we cannot rule out an advantage to either drug, or no difference between drugs (low-certainty evidence). There was also evidence that misclassification of seizure type may have confounded the results of this review, particularly for the outcome 'time to treatment failure'. Heterogeneity was present in analysis of 'time to first seizure' for individuals with generalised onset seizures, which could not be explained by subgroup analysis or sensitivity analyses.Limited information was available about adverse events in the trials and we could not compare the rates of adverse events between carbamazepine and phenytoin. Some adverse events reported on both drugs were abdominal pain, nausea, and vomiting, drowsiness, motor and cognitive disturbances, dysmorphic side effects (such as rash). AUTHORS' CONCLUSIONS: Moderate-certainty evidence provided by this systematic review does not show any differences between carbamazepine and phenytoin in terms of effectiveness (retention) or efficacy (seizure recurrence and seizure remission) for individuals with focal onset or generalised onset seizures.However, some of the trials contributing to the analyses had methodological inadequacies and inconsistencies, which may have had an impact on the results of this review. We therefore do not suggest that results of this review alone should form the basis of a treatment choice for a person with newly-onset seizures. We did not find any evidence to support or refute current treatment policies. We implore that future trials be designed to the highest quality possible, with consideration of masking, choice of population, classification of seizure type, duration of follow-up, choice of outcomes and analysis, and presentation of results.


Assuntos
Anticonvulsivantes/uso terapêutico , Carbamazepina/uso terapêutico , Epilepsia/tratamento farmacológico , Fenitoína/uso terapêutico , Anticonvulsivantes/efeitos adversos , Carbamazepina/efeitos adversos , Criança , Humanos , Fenitoína/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Convulsões/prevenção & controle , Falha de Tratamento , Resultado do Tratamento
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