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1.
Retina ; 2021 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-34620799

RESUMO

PURPOSE: To evaluate mean change in visual acuity at 52-weeks in patients with idiopathic choroidal neovascularization (iCNV) treated with aflibercept. METHODS: We conducted a prospective non-comparative open-label phase-II trial. The dosage regimen evaluated in this study was structured into two periods: (1) from inclusion to 20-weeks: a treat-and-extend period composed of three mandatory intravitreal injections, and complementary intravitreal injections performed if needed; (2) from 21-weeks to 52-weeks: a pro re nata period composed of intravitreal injections performed only if needed. RESULTS: A total of 19 patients were included and 16 completed the 52-weeks study. At baseline, mean BCVA was 66.56 (±20.72) letters (≈20/50 Snellen equivalent), and mean CRT was 376.74µm (±93.77). At 52-week, the mean change in BCVA was +19.50 (±19.36) letters [95%CI=+9.18-+29.82]. None of the patients included lost ≥15-letters at 24-weeks or 52-weeks. Mean change in CRT was -96.78µm (±104.29) at 24-weeks and -86.22µm (±112.27) at 52-weeks. The mean number of intravitreal injections was 5.4 (±3.0) at 52-weeks. No ocular serious adverse events related to the treatment were reported. CONCLUSIONS: The present analysis shows clinically significant functional and anatomical treatment effect of aflibercept in case of iCNV. The treat-and-extend regimen proposed after the first injection seems adequate to treat the majority of neovessels.

2.
Nutrients ; 13(7)2021 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-34371859

RESUMO

Almost two in three patients who are aged 75 years and older and scheduled for surgery for colorectal cancer (CRC) are undernourished. Despite evidence that perioperative nutritional management can improve patients outcomes, international guidelines are still insufficiently applied in current practice. In this stepped-wedge cluster-randomized study of five surgical hospitals, we included 147 patients aged 70 years or older with scheduled abdominal surgery for CRC between October 2013 and December 2016. In the intervention condition, an outreach team comprising a geriatrician and a dietician visited patients and staff in surgical wards to assist with the correct application of guidelines. Evaluation, diagnosis, and prescription (according to nutritional status) were considered appropriate and strictly consistent with guidelines in 39.2% of patients in the intervention group compared to only 1.4% in the control group (p = 0.0002). Prescription of oral nutritional supplements during the perioperative period was significantly improved (41.9% vs. 4.1%; p < 0.0001). However, there were no benefits of the intervention on surgical complications or adverse events. A possible benefit of hospital stay reduction will need to be confirmed in further studies. This study highlights the importance of the implementation of quality improvement interventions into current practice for the perioperative nutritional management of older patients with CRC.


Assuntos
Avaliação Geriátrica/métodos , Desnutrição/terapia , Terapia Nutricional/métodos , Complicações Pós-Operatórias/prevenção & controle , Cuidados Pré-Operatórios/métodos , Idoso , Idoso de 80 Anos ou mais , Neoplasias Colorretais/complicações , Neoplasias Colorretais/fisiopatologia , Neoplasias Colorretais/cirurgia , Suplementos Nutricionais , Feminino , Humanos , Masculino , Desnutrição/complicações , Política Nutricional , Terapia Nutricional/normas , Estado Nutricional , Complicações Pós-Operatórias/etiologia , Cuidados Pré-Operatórios/normas , Período Pré-Operatório , Melhoria de Qualidade , Resultado do Tratamento
3.
Can J Surg ; 64(3): E330-E338, 2021 06 04.
Artigo em Inglês | MEDLINE | ID: mdl-34085510

RESUMO

Background: Increased preoperative delay in patients with hip fractures may be responsible for increased morbidity and mortality. We hypothesized that a strategy of reversal of vitamin K antagonist (VKA) by prothrombin complexes concentrates (PCCs), as compared to vitamin K, is safe and reduces preoperative delay and hospital length of stay (LOS). Methods: In this pilot study, we reviewed the records of patients admitted to a university-affiliated hospital for hip fracture between Jan. 1, 2012, and Dec. 31, 2016, who were taking VKA. Patients were stratified according to reversal strategy (vitamin K v. PCC). Adverse effects, time to surgery, LOS and mortality were collected from the electronic medical record and were compared between the 2 study groups and a control group not treated with VKA. Results: A total of 141 patients were included in the study: 65 in the vitamin K group, 26 in the PCC group and 50 in the control group. The median preoperative delay in the PCC group (20 h [interquartile range (IQR)] 13-25 h]) and the control group (20 h [IQR 15-33 h]) was lower than that in the vitamin K group (45 h [IQR 31-52 h]) (p < 0.001). Patients in the PCC group had a shorter median hospital LOS than those in the vitamin K group (6 d [IQR 4-9 d] v. 8 d [IQR 6-11 d], p < 0.05). No difference was observed in the proportion of patients who received a red blood cell transfusion, or had thrombotic or hemorrhagic complications. No difference in mortality at 12 months was observed between the groups. Conclusion: In patients with hip fracture, the use of PCCs as compared to vitamin K to reverse the effect of VKA significantly reduced preoperative delay and hospital LOS, and was not associated with an increase in the rates of thrombotic or hemorrhagic complications. Prospective studies involving a greater number of patients are required to confirm these promising results.

4.
Sci Rep ; 10(1): 11004, 2020 07 03.
Artigo em Inglês | MEDLINE | ID: mdl-32620866

RESUMO

The objective of the study was to demonstrate the non-inferiority of low-frequency spa therapy combined with rehabilitation (Spa-rehab) versus standard spa therapy at 6 months for symptomatic knee osteoarthritis (KOA). A prospective, randomized, monocenter, non-inferiority trial with recruitment of community-based symptomatic KOA patients was performed. Standard spa therapy comprised standardized spa treatment, 6 days a week for 3 weeks, and Spa-rehab therapy comprised spa sessions, 3 days a week for 3 weeks, followed by a dedicated rehabilitation program, 3 days a week for 3 weeks. The primary endpoint was achieving at 6 months a minimal clinically important improvement (MCII) for pain on a visual analog scale and/or an MCII for function on the WOMAC index and no knee surgery (composite MCII). Secondary endpoints were composite MCII at 3 months and achieving a Patient Acceptable Symptom State (PASS) for pain and function at 3 and 6 months. Among 283 patients included, 145 were allocated to standard spa therapy and 138 to Spa-rehab therapy. We could not demonstrate the non-inferiority of Spa-rehab therapy for the primary endpoint: difference for responders - 0.08 [90% CI (- 0.18 to 0.02), p = 0.14]. However, the difference test between the groups was not significant (p = 0.18). Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months. Spa-rehab therapy can reasonably be proposed to patients with symptomatic KOA. This protocol may be more cost-effective than standard spa therapy and avoid absenteeism from work and accommodation costs for patients who live close to a centre.


Assuntos
Balneologia/métodos , Terapia por Exercício/métodos , Osteoartrite do Joelho/terapia , Idoso , Terapia Combinada , Feminino , Academias de Ginástica , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Satisfação do Paciente , Estudos Prospectivos , Resultado do Tratamento
5.
J Clin Med ; 9(5)2020 Apr 26.
Artigo em Inglês | MEDLINE | ID: mdl-32357559

RESUMO

Hereditary hemorrhagic telangiectasia is a rare but ubiquitous genetic disease. Epistaxis is the most frequent and life-threatening manifestation and tacrolimus, an immunosuppressive agent, appears to be an interesting new treatment option because of its anti-angiogenic properties. Our objective was to evaluate, six weeks after the end of the treatment, the efficacy on the duration of nosebleeds of tacrolimus nasal ointment, administered for six weeks to patients with hereditary hemorrhagic telangiectasia complicated by nosebleeds, and we performed a prospective, multicenter, randomized, placebo-controlled, double-blinded, ratio 1:1 phase II study. Patients were recruited from three French Hereditary Hemorrhagic Telangiectasia (HHT) centers between May 2017 and August 2018, with a six-week follow-up, and we included people aged over 18 years, diagnosed with hereditary hemorrhagic telangiectasia and epistaxis (total duration > 30 min/6 weeks prior to inclusion). Tacrolimus ointment 0.1% was self-administered by the patients twice daily. About 0.1 g of product was to be administered in each nostril with a cotton swab. A total of 50 patients was randomized and treated. Mean epistaxis duration before and after treatment in the tacrolimus group were 324.64 and 249.14 min, respectively, and in the placebo group 224.69 and 188.14 min, respectively. Epistaxis duration improved in both groups, with no significant difference in our main objective comparing epistaxis before and after treatment (p = 0.77); however, there was a significant difference in evolution when comparing epistaxis before and during treatment (p = 0.04). Toxicity was low and no severe adverse events were reported. In conclusion, tacrolimus nasal ointment, administered for six weeks, did not improve epistaxis in HHT patients after the end of the treatment. However, the good tolerance, associated with a significant improvement in epistaxis duration during treatment, encouraged us to perform a phase 3 trial on a larger patient population with a main outcome of epistaxis duration during treatment and a longer treatment time.

6.
J Neurol Sci ; 392: 65-68, 2018 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-30025235

RESUMO

BACKGROUND: Off state toe dystonia (TD) is a symptom frequently encountered in Parkinson's disease (PD), but little is known about its evolution after subthalamic nucleus deep brain stimulation (STN-DBS). OBJECTIVE: To analyze the prevalence and the evolution of TD in PD patients candidate to STN-DBS. METHODS: Individual data of consecutive 130 PD patients who underwent STN-DBS between 2010 and 2015 were collected. RESULTS: Data were successfully collected in 95 patients. TD affect 45.3% of the patients in our cohort. TD was present in 32.7% of patients before surgery and was alleviated by STN-DBS in 48% of the cases. Motor improvement provided by STN-DBS, levodopa-equivalent treatment diminution after surgery, disease duration or age at the time of surgery were not predictive of TD evolution. A younger age at PD diagnosis was significantly associated with TD resolution. CONCLUSION: STN-DBS is partially efficient for TD but its evolution seems independent of significant predictive factors.


Assuntos
Estimulação Encefálica Profunda/métodos , Distonia/etiologia , Distonia/terapia , Doença de Parkinson/complicações , Núcleo Subtalâmico/fisiologia , Dedos do Pé/fisiopatologia , Adulto , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
7.
Ther Adv Urol ; 10(8): 223-233, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30034541

RESUMO

Background: The aim of our study was to compare perioperative and functional outcomes of two different prostatic laser enucleation techniques performed in two high-volume centers: 100 W holmium laser enucleation of the prostate (HoLEP) (Lyon, France) and 110 W thulium laser enucleation of the prostate (ThuLEP) (Varese, Italy). Materials and Methods: A nonrandomized, observational, retrospective and matched-pair analysis was performed on two homogeneous groups of 117 patients that underwent prostate laser enucleation in the HoLEP or ThuLEP centers between January 2015 and April 2017, following the classical 'three lobes' enucleation technique. The American Society of Anesthesiologists (ASA) score and prostate volume were the main parameters considered for matching the patients between the two groups. Patients on anticoagulant therapy, with documented detrusor hypoactivity or hyperactivity or with the finding of concurrent prostate cancer were excluded from the study. Follow up was assessed at 3, 6 and 12 months after surgery. Results: Median enucleation and morcellation time was 75.5 and 11.5 min, respectively, in the HoLEP group versus 70.5 and 12 min, respectively, in the ThuLEP group (p = 0.001 and 0.49, respectively). Enucleated adenoma weight was comparable (44 g versus 45.6 g, p = 0.60). Energy index (3884.63 versus 4137.35 J/g, p = 0.30) and enucleation index (0.57 versus 0.6 g/min, p = 0.81) were similar in the two groups. Catheterization time was comparable (1 versus 1 day; p = 0.14). The International Prostate Symptom Score and Quality of Life score significantly decreased, as well as maximal urinary flow rate. Median prostate-specific antigen (PSA) drop 1 year after surgery was 2.1 ng/ml in the HoLEP group (-52.83%) versus 1.75 ng/ml in the ThuLEP group (-47.85%) (p = 0.013). Conclusion: Both HoLEP (100 W) and ThuLEP (110 W) relieve lower urinary tract symptoms in a comparable way with high efficacy and safety, with negligible clinical differences.

8.
Semin Arthritis Rheum ; 47(6): 797-804, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29224976

RESUMO

OBJECTIVE: To analyze the associations between body composition, notably low lean mass, and clinical symptoms [pain, physical function, quality of life (QoL)] in patients with symptomatic hip and/or knee OA. METHODS: Cross-sectional study using data from the 3-year follow-up visit of the Knee and Hip OsteoArthritis Long-term assessment (KHOALA) cohort. Skeletal muscle and fat mass were measured by dual X-ray absorptiometry (DXA). Fat mass index (FMI) was defined as total fat mass/height2. Appendicular lean mass was adjusted on body mass index (ALM/BMI), and low lean mass was defined according to the definition of FNIH Sarcopenia Project recommendations. Pain and function were measured by the WOMAC index and QoL by the SF-36. RESULTS: In total, 358 patients underwent DXA (67% women, mean [SD] age 63.4 [8.4] years, mean BMI 29.5 [5.6]kg/m2). The visual analog scale (0-100) pain score was 38.0 [24.7] and 25.4% had hip and 74.6% knee OA. Low lean mass and ALM/BMI were associated with impaired QoL and WOMAC scores on bivariate analysis (all p ≤ 0.001) but not on multivariate analysis after adjustment for FMI. For patients with normal BMI, mean [SD] WOMAC scores were higher (greater impairment) with low lean mass than normal body composition (WOMAC function 33.4 [23.3] and 24.0 [17.4], p = 0.02), and mean SF-36 physical component score was lower (greater impairment) 40.3 [10.2] and (44.3 [8.4], p = 0.04). Among patients with obesity, low lean mass had no additional effect. CONCLUSION: For patients with OA and normal BMI, QoL and function were more impaired for those with than without low lean mass. Conserving muscle mass in people with OA could have functional and antalgic benefits especially for those with normal BMI.


Assuntos
Composição Corporal/fisiologia , Osteoartrite do Quadril/diagnóstico , Osteoartrite do Joelho/diagnóstico , Qualidade de Vida , Absorciometria de Fóton , Idoso , Índice de Massa Corporal , Densidade Óssea/fisiologia , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/diagnóstico por imagem , Osteoartrite do Joelho/diagnóstico por imagem , Avaliação de Sintomas
9.
Ann Surg ; 264(5): 731-737, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27429039

RESUMO

OBJECTIVES: The aim of this study was to compare nasojejunal early enteral nutrition (NJEEN) with total parenteral nutrition (TPN), after pancreaticoduodenectomy (PD), in terms of postoperative complications. BACKGROUND: Current nutritional guidelines recommend the use of enteral over parenteral nutrition in patients undergoing gastrointestinal surgery. However, the NJEEN remains controversial in patients undergoing PD. METHODS: Multicenter, randomized, controlled trial was conducted between 2011 and 2014. Nine centers in France analyzed 204 patients undergoing PD to NJEEN (n = 103) or TPN (n = 101). Primary outcome was the rate of postoperative complications according to Clavien-Dindo classification. Successful NJEEN was defined as insertion of a nasojejunal feeding tube, delivering at least 50% of nutritional needs on PoD 5, and no TPN for more than consecutive 48 hours. RESULTS: Postoperative complications occurred in 77.5% [95% confidence interval (95% CI) 68.1-85.1] patients in the NJEEN group versus 64.4% (95% CI 54.2-73.6) in TPN group (P = 0.040). NJEEN was associated with higher frequency of postoperative pancreatic fistula (POPF) (48.1% vs 27.7%, P = 0.012) and higher severity (grade B/C 29.4% vs 13.9%; P = 0.007). There was no significant difference in the incidence of post-pancreatectomy hemorrhage, delayed gastric emptying, infectious complications, the grade of postoperative complications, and the length of postoperative stay. A successful NJEEN was achieved in 63% patients. In TPN group, average energy intake was significantly higher (P < 0.001) and patients had an earlier recovery of oral feeding (P = 0.0009). CONCLUSIONS: In patients undergoing PD, NJEEN was associated with an increased overall postoperative complications rate. The frequency and the severity of POPF were also significantly increased after NJEEN. In terms of safety and feasibility, NJEEN should not be recommended.


Assuntos
Nutrição Enteral , Neoplasias Pancreáticas/cirurgia , Pancreaticoduodenectomia/efeitos adversos , Nutrição Parenteral Total , Cuidados Pós-Operatórios , Complicações Pós-Operatórias/epidemiologia , Idoso , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Neoplasias Pancreáticas/complicações , Neoplasias Pancreáticas/patologia , Estudos Prospectivos , Recuperação de Função Fisiológica , Resultado do Tratamento
10.
Ann Surg Oncol ; 23(4): 1261-70, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26628435

RESUMO

PURPOSE: The aim of this study was to identify the risk factors and causes of unresectability in a large cohort of patients with peritoneal carcinomatosis (PC) selected for cytoreductive surgery (CRS), and to assess the contribution of the different imaging modalities to the patient-selection process. METHODS: The pre- and intraoperative data of 533 consecutive patients with PC planned for CRS at a single institution were reviewed. All patients underwent computed tomography (CT) magnetic resonance imaging and/or positron emission tomography/CT within the 2 days prior to surgery. RESULTS: Among the 533 patients, 436 (82 %) underwent complete CRS, 86 (16 %) underwent exploratory laparotomy without CRS because of multiple small-bowel involvement (n = 31), invasion of different digestive segments (n = 15), an elevated PC index (n = 14), invasion of the mesenteric root (n = 12), or another cause (n = 14), and 11 (2 %) did not undergo laparotomy because of disease progression on preoperative imaging findings. On univariate analysis, elevated levels of tumor markers and a short delay between the last cycle of chemotherapy and the scheduled surgery were identified as predictors of unresectability for the colonic PC population, while a younger age was identified in patients with gastric PC. Multivariate analysis disclosed the use of neoadjuvant chemotherapy and a younger age as independent predictors of unresectability in the colonic PC population. CONCLUSIONS: The current modalities for the assessment of PC resectability, including functional imaging examinations, have a low impact on patient selection for CRS. New tools are needed to decrease the rate of open-close procedures.


Assuntos
Procedimentos Cirúrgicos de Citorredução , Imageamento por Ressonância Magnética/métodos , Neoplasias Peritoneais/diagnóstico por imagem , Neoplasias Peritoneais/cirurgia , Tomografia por Emissão de Pósitrons/métodos , Tomografia Computadorizada por Raios X/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Peritoneais/secundário , Prognóstico , Estudos Prospectivos , Estudos Retrospectivos , Taxa de Sobrevida , Adulto Jovem
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