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1.
Zhonghua Wai Ke Za Zhi ; 58(5): 350-355, 2020 May 01.
Artigo em Chinês | MEDLINE | ID: mdl-32393001

RESUMO

Objective: To examine the overall status of the Jiangsu Province Coronary Artery Bypass Grafting Registry database. Methods: The patients date of Jiangsu Province Coronary Artery Bypass Grafting Registry database from October 2017 to December 2019 was collected retrospectively.Risk factors, history, cardiac function (New York Heart Association class), extent of coronary artery lesion, European system for cardiac operative risk evaluation Ⅱ (EuroSCORE Ⅱ), cardiopulmonary bypss, arterial grafts, the numbers and flow of grafts and postoperative major adverse cardiac and cerebrovascular event(MACCE) information were analyzed. The clinical data of patients underwent on-pump CABG(ONCABG) or off-pump CABG (OPCAB) were compared by t test or χ(2) test. Results: Up till December 2019, the database enrolled 7 138 patients, in which 4 661 patients receiving primary isolated CABG. There were 3 486 males and 1 175 females with the age of (64.6±8.1) years (range:31 to 87 years). There were coronary left main disease in 960 patients, triple vessel disease in 3 934 patients, both left main and triple vessel disease in 837 patients, ejection fraction>50% in 3 841 patients, cardiac function class Ⅲ to Ⅳ in 1 664 patients. EuroSCORE Ⅱ was (2.3±0.7)% (range: 0.5% to 35.8%). There were 2 731 patients (58.59%) underwent ONCABG and 1 930 patients (41.41%) underwent OPCAB. There were 4 144 patients (88.91%) for whom the left internal thoracic artery was harvested. Seven centers (2 centers routinely) used left radial artery, 5 centers (3 centers routinely) used the transit time flow meter. The graft was 3.4±0.7 (range:1 to 7), the aortic crossclamp time was (65.0±20.4) minutes (range: 21 to 196 minutes), the cardiopulmonary bypass time was (90.0±24.2) minutes (range: 33 to 227 minutes). In-hospital death ocurred in 84 patients(1.80%), while re-operation in 93 patients (2.00%), myocardial infarction in 71 patients (1.52%), cerebral infarction in 33 patients (0.71%) and dialysis in 56 patients (1.20%). There were 2 936 patients prescribed with secondary prevention drugs(62.99%).Comparing with OPCAB group, ONCABG group had younger age, more female, more diabetes mellitus, more history of myocardial infarction and percutaneous transluminal coronary angioplasty, poorer cardiac function and coronary lesions, higher EuroSCORE Ⅱ, preoperatively (all P<0.05), and was associated with higher MACCE (135/2 731 vs. 71/1 930, χ(2)=4.280, P=0.039), and of more grafts, transfusion and intra-aortic balloon counterpulsation application (all P<0.05). Conclusions: Jiangsu Province Coronary Artery Bypass Grafting Registry database is generally in good operation, and some parameters still need to be improved. Comparing with OPCAB group, ONCABG has more severe preoperative general conditions, while the outcomes is acceptable.


Assuntos
Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/cirurgia , Sistema de Registros , Idoso , China , Ponte de Artéria Coronária/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
2.
Zhonghua Wai Ke Za Zhi ; 58(5): 356-362, 2020 May 01.
Artigo em Chinês | MEDLINE | ID: mdl-32393002

RESUMO

Objective: To examine the short and long-term clinical outcomes of total arterial coronary artery bypass grafting. Methods: Clinic data of 208 patients with left main and multiple vessel coronary artery disease and undertaken total arterial coronary artery bypass grafting from February 2009 to December 2019 in Department of Cardiac Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine were analyzed retrospectively. There were 188 males and 20 females with an age of (54.7±10.7) years (range: 32 to 79 years). The harvest of arterial conduits and grafting strategies were depended upon the individual patient characteristics and surgeon's experience. Left internal thoracic artery (LITA) was applied in 207 cases, right internal thoracic artery (RITA) in 38 cases (bilateral internal thoracic artery (BITA) in 37 cases), and radial artery (RA) in 187 cases (188 grafts). The graft number per case was 2.6±0.7 (range: 2 to 4). Surgical procedures was completed with off-pump technique in 98.1% patients (204/208). Subgroup analysis was carried out between subgroup BITA (n=37) and subgroup SITA (single ITA+RA) (n=171). The t test, χ(2) test or Fisher exact test were used to compare the clinic characteristics between the two subgroups. The Kaplan-Meier curve was used to estimate the rate of late mortality, major adverse cardiac cerebrovascular event (MACCE), and target vessel revascularization (TVR). A Cox proportional hazards model was used to identify the independent prognosis factors of late mortality. Results: The overall mortality within 30 days postoperatively was 1.4%(3/208). The incidences of perioperative MACCE, re-operation for bleeding and deep sternal wound infection (DSWI) were 1.9%(4/208), 0.5%(1/208) and 1.4%(3/208), respectively. Perioperative myocardial infarction and TVR were not observed. There was no significant difference of 30-day mortality, MACCE, bleeding and DSWI between subgroup BITA and SITA+RA (all P>0.05). In a follow-up period of (5.4±2.8)years (range: 0.2 to 10.9 years), the incidence of all-cause mortality at 1-, 5- and 10-year was 2.3%, 3.4% and 6.9%, respectively. The incidence of MACCE was 3.9%,11.2% and 28.5%, respectively. The rate of TVR was 0.4%, 3.7% and 11.9%, respectively. Age>65 was an independent prognosis factor of late mortality (HR=1.125, 95% CI:1.050 to 1.205, P<0.01). Conclusions: Total arterial coronary bypass grafting is safe and achievable with proper patient selection and surgical strategies. It significantly decreases the risks of late mortality and repeated revascularization.


Assuntos
Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/cirurgia , Artéria Torácica Interna/transplante , Adulto , Idoso , China , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
3.
Zhonghua Wai Ke Za Zhi ; 58(5): 363-368, 2020 May 01.
Artigo em Chinês | MEDLINE | ID: mdl-32393003

RESUMO

Objective: To examine the safety and efficacy of minimally invasive coronary surgery-coronary artery bypass grafting (MICS-CABG). Methods: From the first case in November 2015 to November 2019, a total of 244 cases of MICS-CABG were performed in Department of Cardiovascular Surgery, Peking University Third Hospital. There were 197 males and 47 females, aging (62.3±8.7)years (range: 36 to 88 years). The operations were performed via the 5(th) intercostal space of left thoracic lateral incision (length: 4 to 5 cm extended for 8 to 10 cm), and were performed under off-pump, with the help of the chest wall suspension device and cardiac fixator. The proximal anastomosis on ascending aorta and the distal anastomosis of left anterior descending branch, circumflex branch and right coronary system were completed according to procedure. In all 244 cases, the proportion of 2 grafts was 53.7% (131 cases), 3 grafts was 36.1% (88 cases), 4 grafts was 9.8% (24 cases) and 5 grafts was 0.4% (1 case). The average of grafts was 2.6±0.7 (range: 2 to 5). The proportion of hybrid was 14.3% (35 cases), sequential bypass procedure was 43.0% (105 cases) and multiple artery grafts was 25.4% (62 cases). The perioperative complications of the patients were collected, the patency rate of the grafts was evaluated by coronary angiography or CT within 7 days after the operation, and main adverse cardiovascular and cerebrovascular events (MACCE) were followed up. The survival curve was drawn by Kaplan-Meier method, and the 1-year MACCE rate was calculated by survival analysis. Results: All cases had no transition to thoracotomy and cardiopulmonary bypass procedure, and no cases needed intra aortic balloon pumping and extracorporeal membrane oxygenation during the operation.There were 2 cases of poor incision healing, and reoperation was performed in 10 cases (6 cases of postoperative bleeding, 2 cases of incision debridement, and 2 cases of grafts problems). The rate of MACCE in 30 days was 2.6% (10 cases), which contained 3 cases of death (2 cases of grafts occlusion, 1 case of serious hemorrhage after thoracic puncture drainage), 3 cases of stroke and 5 cases of non-fatal myocardial infarction. By the re-examination of angiography in 7 days after operation, the overall patency of the grafts was 96.1%, and the patency of the left anterior descending was 98.6%. Kaplan-Meier survival analysis was conducted for 235 patients (96.3%) with 1 to 36 months follow-up results, and the 1-year MACCE rate was 5.6% (95%CI: 4.2% to 7.0%) . There was no significant difference among the incidences of MACCE at each stage of learning curve. Surgeon could reduce the operation time and complete more anastomosis with the accumulation of experience after the early 30 cases. Conclusions: MICS-CABG can safely achieve completed revascularization, which has good operative effects in short and medium-long term. There is no significant risk in the early cases of learning curve.


Assuntos
Ponte de Artéria Coronária sem Circulação Extracorpórea/métodos , Doença da Artéria Coronariana/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Idoso , Ponte de Artéria Coronária sem Circulação Extracorpórea/efeitos adversos , Ponte de Artéria Coronária sem Circulação Extracorpórea/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Grau de Desobstrução Vascular
4.
Ren Fail ; 42(1): 495-512, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32434422

RESUMO

Background: We aimed to evaluate the acute kidney injury (AKI) incidence and its associated risk of mortality in patients with implantable left ventricular assist devices (LVAD).Methods: A systematic literature search in Ovid MEDLINE, EMBASE, and Cochrane Databases was conducted through January 2020 to identify studies that provided data on the AKI incidence and AKI-associated mortality risk in adult patients with implantable LVADs. Pooled effect estimates were examined using random-effects, generic inverse variance method of DerSimonian-Laird.Results: Fifty-six cohort studies with 63,663 LVAD patients were enrolled in this meta-analysis. The pooled incidence of reported AKI was 24.9% (95%CI: 20.1%-30.4%) but rose to 36.9% (95%CI: 31.1%-43.1%) when applying the standard definition of AKI per RIFLE, AKIN, and KDIGO criteria. The pooled incidence of severe AKI requiring renal replacement therapy (RRT) was 12.6% (95%CI: 10.5%-15.0%). AKI incidence did not differ significantly between types of LVAD (p = .35) or indication for LVAD use (p = .62). While meta-regression analysis did not demonstrate a significant association between study year and overall AKI incidence (p = .55), the study year was negatively correlated with the incidence of severe AKI requiring RRT (slope = -0.068, p < .001). The pooled odds ratios (ORs) of mortality at 30 days and one year in AKI patients were 3.66 (95% CI, 2.00-6.70) and 2.22 (95% CI, 1.62-3.04), respectively. The pooled ORs of mortality at 30 days and one year in severe AKI patients requiring RRT were 7.52 (95% CI, 4.58-12.33) and 5.41 (95% CI, 3.63-8.06), respectively.Conclusion: We found that more than one-third of LVAD patients develop AKI based on standard definitions, and 13% develop severe AKI requiring RRT. There has been a potential improvement in the incidence of severe AKI requiring RRT for LVAD patients. AKI in LVAD patients was associated with increased 30-day and 1 year mortality.


Assuntos
Lesão Renal Aguda/etiologia , Ventrículos do Coração/fisiopatologia , Coração Auxiliar/efeitos adversos , Lesão Renal Aguda/epidemiologia , Humanos , Incidência , Função Ventricular Esquerda
9.
Lancet ; 395(10235): 1496-1505, 2020 05 09.
Artigo em Inglês | MEDLINE | ID: mdl-32386593

RESUMO

BACKGROUND: Head-to-head trials in psoriatic arthritis are helpful in guiding clinical decision making. The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab as first-line biological monotherapy for 52 weeks in patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response. METHODS: This parallel-group, double-blind, active-controlled, phase-3b, multicentre (168 sites in 26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis. Eligible patients were randomly assigned (1:1) by means of interactive response technology to receive secukinumab or adalimumab. Patients, investigators, site personnel, and those doing the assessments (except independent study drug administrators) were masked to study assignment. 300 mg secukinumab was administered subcutaneously at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks until week 48 as a pre-filled syringe. Adalimumab was administered every 2 weeks from baseline until week 50 as 40 mg per 0·4 mL citrate free subcutaneous injection. The primary outcome was the proportion of patients with at least 20% improvement in the ACR response criteria (ACR20) at week 52. Patients were analysed according to the treatment to which they were randomly assigned. Safety analyses included all safety data reported up to and including the week 52 visit for each patient who received at least one dose of study drug. The trial is registered at ClinicalTrials.gov, NCT02745080. FINDINGS: Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive secukinumab (n=426) or adalimumab (n=427). 709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50. 61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101 (24%) of 427 patients in the adalimumab group. The primary endpoint of superiority of secukinumab versus adalimumab for ACR20 response at week 52 was not met. 67% of patients in the secukinumab group achieved an ACR20 response at week 52 versus 62% of patients in the adalimumab group (OR 1·30, 95% CI 0·98-1·72; p=0·0719). The safety profiles of secukinumab and adalimumab were consistent with previous reports. Seven (2%) of 426 patients in the secukinumab group and six (1%) of 427 patients in the adalimumab group had serious infections. One death was reported in the secukinumab group due to colon cancer and was assessed as not related to the study drug by the investigator. INTERPRETATION: Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52. However, secukinumab was associated with a higher treatment retention rate than adalimumab. This study provides comparative data on two biological agents with different mechanisms of action, which could help guide clinical decision making in the management of patients with psoriatic arthritis. FUNDING: Novartis Pharma.


Assuntos
Adalimumab/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Adulto , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Antirreumáticos/administração & dosagem , Antirreumáticos/efeitos adversos , Tomada de Decisão Clínica , Método Duplo-Cego , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Segurança , Resultado do Tratamento
10.
Am Surg ; 86(4): 284-292, 2020 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-32391751

RESUMO

Progress in the arena of cancer immunotherapy has been immense in recent years. The fact remains that most of the cancer resections in the United States are performed by general surgeons and not oncologic specialists. A busy practice in general surgery will invariably make it difficult to keep pace with such rapid advancement. This review offers a concise summary of the major concepts and trials that have driven the immunotherapy revolution and their implications for surgeons who deliver cancer care.


Assuntos
Imunoterapia , Melanoma/tratamento farmacológico , Receptor de Morte Celular Programada 1/antagonistas & inibidores , Neoplasias Cutâneas/tratamento farmacológico , Antígeno CTLA-4/antagonistas & inibidores , Antígeno CTLA-4/imunologia , Carcinoma Hepatocelular/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Quimioterapia Adjuvante , Neoplasias Gastrointestinais/tratamento farmacológico , Humanos , Imunoterapia/efeitos adversos , Neoplasias Hepáticas/tratamento farmacológico , Receptor de Morte Celular Programada 1/imunologia
11.
Am Surg ; 86(4): 300-307, 2020 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-32391753

RESUMO

As bariatric surgery increases, there is a growing population of patients with biliary obstruction and anatomy which precludes transoral access through endoscopic retrograde cholangiopancreatography (ERCP). Minimally invasive transgastric ERCP (TG-ERCP) offers a feasible alternative for the treatment. A retrospective review was performed of all patients who underwent laparoscopic or robotic-assisted TG-ERCP between 2010 and 2017. Chart abstraction collected demographics, procedural details, success rate, and postoperative outcomes. Forty patients were identified, of which 38 cases were performed laparoscopically and two robotically. Median operative time was 163 minutes, with an estimated blood loss of 50 cc. TG-ERCP was performed successfully in 36 cases (90%); sphincterotomy was completed in 35 patients (97%). Sixty per cent already had a cholecystectomy; in the remaining patients, it was performed concurrently. Major complications included stomach perforation (n = 1), pancreatitis (n = 3), and anemia requiring transfusion (n = 2). In patients with biliary obstruction and anatomy not suitable for ERCP, TG-ERCP can be performed in a minimally invasive fashion, with a high rate of technical success and low morbidity. We describe a stepwise, reproducible technique because it is an essential tool for the shared armamentarium of endoscopists and surgeons.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica/métodos , Coledocolitíase/cirurgia , Cálculos Biliares/cirurgia , Derivação Gástrica/efeitos adversos , Adulto , Idoso , Coledocolitíase/etiologia , Feminino , Cálculos Biliares/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/cirurgia , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos , Esfinterotomia Endoscópica/métodos , Resultado do Tratamento
12.
Am Surg ; 86(4): 334-340, 2020 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-32391757

RESUMO

Different kinds of complications after splenectomy in hepatolenticular degeneration patients with hypersplenism have been reported in the past decades, but studies on pancreatic fistula and the corresponding targeted prevention and treatment after splenectomy still remain much unexplored. The present work investigated the pathogenic factors of pancreatic fistula after splenectomy and the variation tendency of amylase in drainage fluid, aiming to verify the significance of monitoring amylase in the abdominal drainage fluid in the early diagnosis of pancreatic fistula after splenectomy. One hundred sixty-seven patients with hepatolenticular degeneration and hypersplenism who underwent splenectomy in the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine from January 2016 to August 2018 were selected and analyzed. The amylase in the abdominal drainage fluid was monitored routinely after splenectomy. We also conducted the statistics on the incidence of different types of pancreatic fistula and analyzed the influence factors of pancreatic fistula formation. After splenectomy, biochemical fistula occurred in 11 patients (6.6%), grade B fistula in six patients (3.6%), grade C fistula in one patient (0.6%), and the incidence of pancreatic fistula was 4.2 per cent (biochemical fistula excluded). The amylase in the peritoneal drainage fluid was closely concerned with the incidence of pancreatic fistula according to our statistics. Furthermore, by analyzing the different influence factors of pancreatic fistula, Child-Pugh grading of liver function (P = 0.041), pancreatic texture (P = 0.029), degree of splenomegaly (P = 0.003), and operative method (P = 0.001) were supposed to be closely related to the formation of pancreatic fistula. Monitoring of amylase in peritoneal drainage fluid is regarded as an important physiological parameter in the early diagnosis of pancreatic fistula after splenectomy, which provides effective clinical reference and plays a significant role in preventing the occurrence and development of pancreatic fistula.


Assuntos
Amilases/análise , Líquido Ascítico/química , Degeneração Hepatolenticular/cirurgia , Fístula Pancreática/etiologia , Complicações Pós-Operatórias/epidemiologia , Esplenectomia/efeitos adversos , Esplenomegalia/cirurgia , Adolescente , Adulto , Idoso , Biomarcadores/análise , Criança , Drenagem , Feminino , Degeneração Hepatolenticular/complicações , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica , Fístula Pancreática/epidemiologia , Fístula Pancreática/prevenção & controle , Esplenomegalia/etiologia , Adulto Jovem
13.
Am Surg ; 86(4): 369-376, 2020 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-32391762

RESUMO

This study evaluated the safety of early anti-factor Xa assay-guided enoxaparin dosing for chemoprophylaxis in patients with TBI. We hypothesized that assay-guided chemoprophylaxis would be comparable in the risk of intracranial hemorrhage (ICH) progression to fixed dosing. An observational analysis of adult patients with blunt traumatic brain injury (TBI) was performed at a Level I trauma center from August 2016 to September 2017. Patients in the assay-guided group were treated with an initial enoxaparin dose of 0.5 mg/kg, with peak anti-factor Xa activity measured four hours after the third dose. Prophylactic range was defined as 0.2 to 0.5 IU/mL with a dose adjustment of ± 10 mg based on the assay result. The assay-guided group was compared with historical fixed-dose controls and to a TBI cohort from the most recent Trauma Quality Improvement Project dataset. Of 179 patients included in the study, 85 were in the assay-guided group and 94 were in the fixed-dose group. Compared with the fixed-dose group, the assay-guided group had a lower Glasgow Coma Score and higher Injury Severity Score. The proportion of severe (Abbreviated Injury Score, head ≥3) TBI, ICH progression, and venous thromboembolism rates were similar between all groups. The assay-guided and fixed-dose groups had chemoprophylaxis initiated earlier than the Trauma Quality Improvement Project group. The assay-guided group had the highest percentage of low molecular weight heparin use. Early initiation of enoxaparin anti-factor Xa assay-guided venous thromboembolism chemoprophylaxis has a comparable risk of ICH progression to fixed dosing in patients with TBI. These findings should be validated prospectively in a multicenter study.


Assuntos
Anticoagulantes/administração & dosagem , Lesões Encefálicas Traumáticas/complicações , Enoxaparina/administração & dosagem , Tromboembolia Venosa/prevenção & controle , Doença Aguda , Adulto , Idoso , Anticoagulantes/efeitos adversos , Quimioprevenção , Enoxaparina/efeitos adversos , Inibidores do Fator Xa/sangue , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tempo para o Tratamento , Índices de Gravidade do Trauma
15.
BMJ ; 369: m1309, 2020 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-32404430

RESUMO

OBJECTIVES: To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery. DESIGN: Open, multicentre, randomised, controlled, non-inferiority trial. SETTING: Seven National Health Service tertiary hospitals in the United Kingdom. PARTICIPANTS: 1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate. INTERVENTION: Participants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS. OUTCOME MEASURES: The primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality. RESULTS: Between May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval -0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior. CONCLUSIONS: For patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery. TRIAL REGISTRATION: ISRCTN13911492.


Assuntos
Anticoagulantes/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Complicações Pós-Operatórias/prevenção & controle , Meias de Compressão , Tromboembolia Venosa/prevenção & controle , Adjuvantes Farmacêuticos , Adulto , Idoso , Terapia Combinada , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento , Tromboembolia Venosa/etiologia
17.
Lancet ; 395(10236): 1547-1557, 2020 05 16.
Artigo em Inglês | MEDLINE | ID: mdl-32416780

RESUMO

BACKGROUND: Atezolizumab can induce sustained responses in metastatic urothelial carcinoma. We report the results of IMvigor130, a phase 3 trial that compared atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in first-line metastatic urothelial carcinoma. METHODS: In this multicentre, phase 3, randomised trial, untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries, were randomly assigned to receive atezolizumab plus platinum-based chemotherapy (group A), atezolizumab monotherapy (group B), or placebo plus platinum-based chemotherapy (group C). Patients received 21-day cycles of gemcitabine (1000 mg/m2 body surface area, administered intravenously on days 1 and 8 of each cycle), plus either carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin (70 mg/m2 body surface area administered intravenously) on day 1 of each cycle with either atezolizumab (1200 mg administered intravenously on day 1 of each cycle) or placebo. Group B patients received 1200 mg atezolizumab, administered intravenously on day 1 of each 21-day cycle. The co-primary efficacy endpoints for the intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival and overall survival (group A vs group C) and overall survival (group B vs group C), which was to be formally tested only if overall survival was positive for group A versus group C. The trial is registered with ClinicalTrials.gov, NCT02807636. FINDINGS: Between July 15, 2016, and July 20, 2018, we enrolled 1213 patients. 451 (37%) were randomly assigned to group A, 362 (30%) to group B, and 400 (33%) to group C. Median follow-up for survival was 11·8 months (IQR 6·1-17·2) for all patients. At the time of final progression-free survival analysis and interim overall survival analysis (May 31, 2019), median progression-free survival in the intention-to-treat population was 8·2 months (95% CI 6·5-8·3) in group A and 6·3 months (6·2-7·0) in group C (stratified hazard ratio [HR] 0·82, 95% CI 0·70-0·96; one-sided p=0·007). Median overall survival was 16·0 months (13·9-18·9) in group A and 13·4 months (12·0-15·2) in group C (0·83, 0·69-1·00; one-sided p=0·027). Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24). Adverse events that led to withdrawal of any agent occurred in 156 (34%) patients in group A, 22 (6%) patients in group B, and 132 (34%) patients in group C. 50 (11%) patients in group A, 21 (6%) patients in group B, and 27 (7%) patients in group C had adverse events that led to discontinuation of atezolizumab or placebo. INTERPRETATION: Addition of atezolizumab to platinum-based chemotherapy as first-line treatment prolonged progression-free survival in patients with metastatic urothelial carcinoma. The safety profile of the combination was consistent with that observed with the individual agents. These results support the use of atezolizumab plus platinum-based chemotherapy as a potential first-line treatment option for metastatic urothelial carcinoma. FUNDING: F Hoffmann-La Roche and Genentech.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Antineoplásicos/administração & dosagem , Carboplatina/administração & dosagem , Carcinoma de Células de Transição/tratamento farmacológico , Cisplatino/administração & dosagem , Neoplasias Urológicas/tratamento farmacológico , Administração Intravenosa , Adulto , Idoso , Anticorpos Monoclonais Humanizados/efeitos adversos , Antineoplásicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carboplatina/efeitos adversos , Carcinoma de Células de Transição/mortalidade , Cisplatino/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Intervalo Livre de Progressão , Modelos de Riscos Proporcionais , Neoplasias Urológicas/mortalidade
18.
Lancet ; 395(10236): 1558-1568, 2020 05 16.
Artigo em Inglês | MEDLINE | ID: mdl-32416781

RESUMO

BACKGROUND: Nivolumab and ipilimumab, alone or in combination, are widely used immunotherapeutic treatment options for patients with advanced-ie, unresectable or metastatic-melanoma. This criterion, however, excludes patients with stage IV melanoma with no evidence of disease. We therefore aimed to evaluate the safety and efficacy of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus a placebo in this patient population. METHODS: We did a randomised, double-blind, placebo-controlled, phase 2 trial in 20 German academic medical centres. Eligible patients were aged 18-80 years with stage IV melanoma with no evidence of disease after surgery or radiotherapy. Key exclusion criteria included uveal or mucosal melanoma, previous therapy with checkpoint inhibitors, and any previous immunosuppressive therapy within the 30 days before study drug administration. Eligible patients were randomly assigned (1:1:1), using a central, interactive, online system, to the nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab every 3 weeks for four doses, followed by 3 mg/kg of nivolumab every 2 weeks), nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo during weeks 1-12), or double-matching placebo group. The primary endpoint was the recurrence-free survival in the intention-to-treat population. The results presented in this report reflect the prespecified interim analysis of recurrence-free survival after 90 events had been reported. This study is registered with ClinicalTrials.gov, NCT02523313, and is ongoing. FINDINGS: Between Sept 2, 2015, and Nov 20, 2018, 167 patients were randomly assigned to receive nivolumab plus ipilimumab (n=56), nivolumab (n=59), or placebo (n=52). As of July 2, 2019, at a median follow-up of 28·4 months (IQR 17·7-36·8), median recurrence-free survival was not reached in the nivolumab plus ipilimumab group, whereas median recurrence-free survival was 12·4 months (95% CI 5·3-33·3) in the nivolumab group and 6·4 months (3·3-9·6) in the placebo group. The hazard ratio for recurrence for the nivolumab plus ipilimumab group versus placebo group was 0·23 (97·5% CI 0·12-0·45; p<0·0001), and for the nivolumab group versus placebo group was 0·56 (0·33-0·94; p=0·011). In the nivolumab plus ipilimumab group, recurrence-free survival at 1 year was 75% (95% CI 61·0-84·9) and at 2 years was 70% (55·1-81·0); in the nivolumab group, 1-year recurrence-free survival was 52% (38·1-63·9) and at 2 years was 42% (28·6-54·5); and in the placebo group, this rate was 32% (19·8-45·3) at 1 year and 14% (5·9-25·7) at 2 years. Treatment-related grade 3-4 adverse events were reported in 71% (95% CI 57-82) of patients in the nivolumab plus ipilimumab group and in 27% (16-40) of those in the nivolumab group. Treatment-related adverse events of any grade led to treatment discontinuation in 34 (62%) of 55 patients in the nivolumab plus ipilimumab group and seven (13%) of 56 in the nivolumab group. Three deaths from adverse events were reported but were considered unrelated to the study treatment. INTERPRETATION: Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease. The rates of grade 3-4 treatment-related adverse events in both active treatment groups were higher than the rates reported in previous pivotal trials done in advanced melanoma with measurable disease. FUNDING: Bristol-Myers Squibb.


Assuntos
Antineoplásicos Imunológicos/administração & dosagem , Antineoplásicos Imunológicos/efeitos adversos , Ipilimumab/administração & dosagem , Melanoma/tratamento farmacológico , Nivolumabe/administração & dosagem , Neoplasias Cutâneas/tratamento farmacológico , Adjuvantes Imunológicos/administração & dosagem , Adjuvantes Imunológicos/efeitos adversos , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Humanos , Ipilimumab/efeitos adversos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Nivolumabe/efeitos adversos , Intervalo Livre de Progressão
19.
J Wound Care ; 29(5): 245-259, 2020 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-32421479

RESUMO

The 2019 novel coronavirus disease (COVID-19) pandemic has brought the effects of device-related pressure ulcers (DRPU) into sharp focus. With the increased use of personal protective equipment (PPE), including face masks, continuous positive airway pressure (CAPP) masks and other devices, the incidence of DRPUs among health professionals and patients alike has risen starkly. As such, the Journal of Wound Care (JWC) consensus document, Device-related pressure ulcers: SECURE prevention, published in February 2020, is more relevant than ever. To help support patients and frontline health professionals, JWC is republishing the consensus in a digital format, along with a new introductory article outlining the DRPU risks posed by PPE and other medical devices used by patients and health professionals during the pandemic, and how the skin damage can be avoided. The aim is to provide frontline staff with a clear, simple strategy on how to prevent the risk of personal skin damage and/or DRPU during the pandemic, as well as point them in the direction of more indepth guidance on long-term strategies for prevention, for both themselves and patients.


Assuntos
Infecções por Coronavirus/prevenção & controle , Equipamentos e Provisões/efeitos adversos , Controle de Infecções/normas , Máscaras/efeitos adversos , Pandemias/prevenção & controle , Equipamento de Proteção Individual/efeitos adversos , Pneumonia Viral/prevenção & controle , Lesão por Pressão/prevenção & controle , Infecções por Coronavirus/etiologia , Infecções por Coronavirus/transmissão , Transmissão de Doença Infecciosa/prevenção & controle , Traumatismos Faciais/etiologia , Traumatismos Faciais/prevenção & controle , Humanos , Controle de Infecções/métodos , Pneumonia Viral/etiologia , Pneumonia Viral/transmissão , Lesão por Pressão/etiologia , Pele/lesões , Dermatopatias/etiologia , Dermatopatias/prevenção & controle
20.
Isr Med Assoc J ; 22(5): 289-293, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32378820

RESUMO

BACKGROUND: Behçet's disease is a multi-systemic chronic relapsing inflammatory disease, classified among the vasculitides. The heterogeneity of clinical manifestations challenges the disease management. OBJECTIVES: To assess efficacy and safety of adalimumab in patients with active persistent Behçet's arthritis who did not respond to disease-modifying anti-rheumatic drugs and to assess the impact of treatment on the cytokine milieu. METHODS: Our cohort comprised 10 patients with active arthritis who received adalimumab in a 24-week investigator-initiated prospective open-label study. Patients who relapsed within 12 weeks following adalimumab discontinuation could enter a 3-year extension study. The patients underwent a comprehensive assessment including questionnaires and measurement of inflammatory cytokines, adalimumab serum levels, and anti-drug antibodies. RESULTS: A significant improvement was observed in arthritis, disease activity visual analogue scales, Behçet's disease current activity form, and interleukin-6 (IL-6) levels, but not in health assessment questionnaire and functional assessment of chronic illness therapy fatigue scale questionnaire. Resolution of oral and urogenital ulcers was achieved in all patients. Significant reduction of pain was reported by 40% of patients. The disease relapsed in 9 of 10 patients, within 2-6 weeks following adalimumab discontinuation. Of the 7 patients who continued the study, arthritis was resolved in 5. Two patients with high neutralizing antidrug antibodies titer relapsed. CONCLUSIONS: Adalimumab treatment achieved a significant improvement in arthritis, mucocutaneous manifestations, and IL-6 levels in all study patients but only 40% reported significant pain reduction. The arthritis relapsed in 90% of patients following adalimumab discontinuation and long-term treatment was required.


Assuntos
Adalimumab/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Artrite/tratamento farmacológico , Síndrome de Behçet/tratamento farmacológico , Adalimumab/efeitos adversos , Adulto , Anti-Inflamatórios/efeitos adversos , Artrite/sangue , Artrite/etiologia , Síndrome de Behçet/sangue , Síndrome de Behçet/complicações , Síndrome de Behçet/diagnóstico , Citocinas/sangue , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento
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