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1.
Account Res ; : 1-6, 2021 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-34615410

RESUMO

Although the underrepresentation of women in publication is a proven fact, there is no information on its counterpart: retractions. Using a previously studied cohort of retractions, the gender of the first author was checked manually to see if there was a similar pattern in the reasons for retraction for women and men authors. Out of 120 retractions, gender was identified for 113 (94.2%). A total of 42 (37.2%) retractions concerned publications authored by women and the reasons for retraction were significantly different between men and women authors. Overall, fraud and plagiarism accounted for 28.6 and 59.2% of women and men-authored retractions, respectively. These findings may have implications as regards training in responsible conduct in research; however, without further investigating larger cohorts and a better understanding of underlying mechanisms, it would be premature to draw any firm conclusions at this stage.

2.
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.

3.
Transpl Int ; 2021 Sep 14.
Artigo em Inglês | MEDLINE | ID: mdl-34519106

RESUMO

The number of patients with a history of melanoma who are awaiting a solid organ transplantation (SOT) is increasing. Few recommendations exist on the timing to transplantation after melanoma diagnosis. The aim of this study was to assess the melanoma recurrence-free survival after pretransplant melanoma (PTM). We conducted a multicenter ambispective observational study. Organ transplant recipients (OTR) with a history of PTM and complete AJCC staging were included. Thirty-seven patients (predominantly men with a renal allograft) were included. Five melanomas were in situ, 21 stage IA, 4 stage IB, 5 stage II, and 2 stage IIIB. The median post-transplantation follow-up time was 4 years. Sixty-two percent of patients were followed up more than 2 years. Recurrence-free survival since melanoma reached 89.9%, but varied significantly according to AJCC staging (P = 0.0129). Three patients presented a recurrence. Despite the rather limited sample size and a wide range of follow-up, our findings concerning the recurrence-free survival appear reassuring for in situ and stage IA PTM; accordingly, we suggest that a waiting time to transplantation is not mandatory in patients with in situ or stage IA PTM, especially whenever SOT is urgently needed. Caution is, however, needed for patients with higher stage.

4.
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
5.
Br J Radiol ; 94(1124): 20210242, 2021 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-34282946

RESUMO

OBJECTIVES: The present multicenter Phase II study evaluated the rate of late grade ≥2 gastrointestinal (GI) toxicities at 3 years, after hypofractionated radiotherapy (HFR) of prostate cancer with injection of hyaluronic acid (HA) between the prostate and the rectum. METHODS: Between 2010 and 2013, 36 patients with low- or intermediate-risk prostate cancer were treated by HFR/IMRT-IGRT. 20 fractions of 3.1 Gy were delivered, 5 days per week for a total dose of 62 Gy. A transperineal injection of 10cc of HA was performed between the rectum and the prostate. Late toxicities were evaluated between 3 and 36 months after the end of treatment (CTCAE v4). RESULTS: Median pretreatment prostate-specific antigen was 8 ng ml-1. Among the 36 included patients, 2 were not evaluated because they withdrew the study in the first 3 months of follow-up, and 4 withdrew between 3 and 36 months, the per protocol population was therefore composed.Late grade ≥2 GI toxicities occurred in 4 (12%) patients with 3 (9%) Grade 2 rectal bleedings and one diarrhoea. Therefore, the inefficacy hypothesis following Fleming one-stage design cannot be rejected. None of the patients experienced late Grade 3-4 toxicities. Among the 30 patients completing the 36 months' visit, none still had a grade ≥2 GI toxicity. Late grade ≥2 genitourinary (GU) toxicities occurred in 14 (41%) patients. The most frequent toxicities were dysuria and pollakiuria. Four patients still experienced a grade ≥2 GU toxicity at 36 months.The biochemical relapse rate (nadir +2 ng ml-1) was 6% (2 patients). Overall, HA was very well tolerated with no pain or discomfort. CONCLUSION: Despite the inefficacy of HA injection was not rejected, we observed the absence of Grade 3 or 4 rectal toxicity as well as a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up. Late urinary toxicities are the most frequent but the rate decreases largely at 3 years. ADVANCES IN KNOWLEDGE: With an injection of HA, hypofractionated irradiation in 4 weeks is well tolerated with no Grade 3 or 4 GI toxicity and a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up.


Assuntos
Gastroenteropatias/prevenção & controle , Ácido Hialurônico/administração & dosagem , Neoplasias da Próstata/radioterapia , Hipofracionamento da Dose de Radiação , Lesões por Radiação/prevenção & controle , Idoso , Gastroenteropatias/epidemiologia , Gastroenteropatias/etiologia , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Lesões por Radiação/complicações , Lesões por Radiação/epidemiologia , Dosagem Radioterapêutica , Fatores de Tempo
6.
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.

7.
Ophthalmol Retina ; 2021 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-33991711

RESUMO

PURPOSE: To evaluate early predictive factors of visual loss in patients treated with anti-vascular endothelial growth factor (VEGF) injections under an as-needed regimen for neovascular age-related macular degeneration (AMD). DESIGN: Post hoc analysis from the randomized controlled trial Groupe d'Evaluation Français Avastin versus Lucentis (GEFAL). PARTICIPANTS: A total of 393 patients with neovascular AMD. METHODS: The present analysis is based on 1-year data from patients included in the study. Patients were separately categorized according to the best-corrected visual acuity (BCVA) change at 3 months and 1 year into 3 trajectories: (1) patients with no vision loss ≥5 letters at 3 months and 1 year (absence of loss ≥5 letters); (2) patients with no vision loss ≥5 letters at 3 months but loss ≥5 letters at 1 year (secondary loss ≥5 letters); and (3) patients with vision loss ≥5 letters at 3 months and 1 year (initial loss ≥5 letters). MAIN OUTCOME MEASURES: The following factors were evaluated at baseline and 3 months: age, sex, BCVA, presence of fluid, central macular thickness, angiographic choroidal neovascularization (CNV) subtype, CNV area measured in disc area on fluorescein angiography, and number of intravitreal injections. RESULTS: An absence of loss ≥5 letters was found in 225 patients (57.3%), a secondary loss ≥5 letters after 3 months was found in 109 patients (27.7%), and an initial loss ≥5 letters was found in 59 patients (15%). Baseline characteristics were comparable among the 3 groups except for the total CNV area, which was larger in the initial and secondary loss groups (P = 0.0412). At 3 months, a significant association was found between presence of subretinal fluid (SRF) (P = 0.0318) and vision loss ≥5 letters, and an even stronger significant association between the presence of intraretinal fluid (IRF) (P = 0.0066) and vision loss ≥5 letters. CONCLUSIONS: In the present study, we found that a large CNV area at baseline was significantly associated with initial or secondary loss of visual acuity ≥5 letters despite anti-VEGF injection. The presence of fluid, both SRF and IRF, at 3 months was found in patients with poorer trajectories.

8.
Eur J Ophthalmol ; : 1120672121999348, 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-33648371

RESUMO

PURPOSE: The principal aim of this pilot study was to investigate the concordance between the different stages of Age-Related Macular Degeneration (AMD), as determined by the simplified classification of the Age Related Eye Disease Study Group (AREDS), and new evaluation criteria using a microperimetry system. METHODS: A complete eye examination and a microperimetry MAIATM (Macular Integrity Assessment, CenterVue, Padova, Italy) examination was performed on 59 eyes with early, intermediate or advanced AMD. We analysed 19 evaluation criteria for every clinical group category. RESULTS: There were 20 female and 12 male participants included with a median age of 74 years (min: 54, max: 87). Thirteen eyes (22%) were classified as category 1, 11 eyes (18.6%) as category 2, 17 eyes (28.8%) as category 3 and 18 eyes (30.6%) as category 4 AMD.All evaluated microperimetry criteria related to retinal sensitivity were found to have a statistically significant difference among the stages (p < 0.05). Fixation stability was unstable in 55.6% of the eyes classified as stage 4 (p = 0.001). The analysis of the distance between the two PRLs - PRL_initial and PRL_final was larger for the stage 4 (p = 0.0258). The mean sensitivity in stages 2 and 3 correlated with the presence or not of reticular pseudodrusen (p = 0.0137). CONCLUSIONS: The mean sensitivity and the categorized sensitivity (set to 25, 15 and 5 dB), the five higher and lower stimuli sensitivity appeared to be the most sensitive criteria to differentiate the four AMD categories. Microperimetry provides a new reproducible method of anatomical-functional macular analysis.

9.
Br J Ophthalmol ; 105(7): 935-940, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32709757

RESUMO

AIMS: To assess vision-related (VR-QOL) and health-related quality of life (HR-QOL) in a large series of patients with de novo uveitis at baseline and 6-month follow-up. METHODS: Non-inferiority, prospective, multicentre, cluster randomised controlled trial registered under the Unique Identifier: NCT01162070. VR-QOL and HR-QOL were assessed by the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) and the Medical Outcomes Study 36-item Short Form Survey (SF-36). RESULTS: At inclusion, 466 patients completed the VFQ-25. The mean composite score was 80.0 (±16.7). In multivariate analysis, higher age, female sex and insidious onset were significantly associated with lower QOL. At 6 months, 138 patients completed the VFQ-25, with a significantly higher mean composite score of 82.6 (±16.7). SF-36 mental component was 42.9 (±11.3) and physical component was 47.2 (±8.5) at inclusion (n=425). HR-QOL improvement at 6 months was not clinically significant. CONCLUSION: QOL seems relatively well preserved in this cohort; only VR-QOL improved significantly at 6 months, especially in patients with low initial visual acuity.

10.
Orphanet J Rare Dis ; 15(1): 254, 2020 09 22.
Artigo em Inglês | MEDLINE | ID: mdl-32962750

RESUMO

BACKGROUND: Hereditary Hemorrhagic Telangiectasia (HHT) is an autosomal dominant disorder characterized by multiple telangiectases and caused by germline disease-causing variants in the ENG (HHT1), ACVRL1 (HHT2) and, to a lesser extent MADH4 and GDF2, which encode proteins involved in the TGF-ß/BMP9 signaling pathway. Common visceral complications of HHT are caused by pulmonary, cerebral, or hepatic arteriovenous malformations (HAVMs). There is large intrafamilial variability in the severity of visceral involvement, suggesting a role for modifier genes. The objective of the present study was to investigate the potential role of ENG, ACVRL1, and of other candidate genes belonging to the same biological pathway in the development of HAVMs. METHODS: We selected 354 patients from the French HHT patient database who had one disease causing variant in either ENG or ACVRL1 and who underwent hepatic exploration. We first compared the distribution of the different types of variants with the occurrence of HAVMs. Then, we genotyped 51 Tag-SNPs from the Hap Map database located in 8 genes that encode proteins belonging to the TGF-ß/BMP9 pathway (ACVRL1, ENG, GDF2, MADH4, SMAD1, SMAD5, TGFB1, TGFBR1), as well as in two additional candidate genes (PTPN14 and ADAM17). We addressed the question of a possible genetic association with the occurrence of HAVMs. RESULTS: The proportion of patients with germline ACVRL1 variants and the proportion of women were significantly higher in HHT patients with HAVMs. In the HHT2 group, HAVMs were more frequent in patients with truncating variants. Six SNPs (3 in ACVRL1, 1 in ENG, 1 in SMAD5, and 1 in ADAM17) were significantly associated with HAVMs. After correction for multiple testing, only one remained significantly associated (rs2277383). CONCLUSIONS: In this large association study, we confirmed the strong relationship between ACVRL1 and the development of HAVMs. Common polymorphisms of ACVRL1 may also play a role in the development of HAVMs, as a modifying factor, independently of the disease-causing variants.


Assuntos
Receptores de Activinas Tipo II , Fígado , Pneumopatias , Telangiectasia Hemorrágica Hereditária , Doenças Vasculares , Receptores de Activinas Tipo II/genética , Endoglina/genética , Feminino , Genótipo , Humanos , Fígado/irrigação sanguínea , Mutação , Telangiectasia Hemorrágica Hereditária/genética , Doenças Vasculares/genética
11.
Eur J Hosp Pharm ; 2020 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-32978218

RESUMO

INTRODUCTION: Adherence to secondary preventive medications is often suboptimal in patients with stroke, exposing them to an increased risk of recurrent cerebral and/or cardiovascular events. Effective actions in the long term to improve adherence to medication are needed. The study will evaluate the efficacy of a collaborative multiprofessional patient-centred intervention conducted by a pharmacist on adherence to secondary preventive medication in stroke survivors. METHODS AND ANALYSIS: This is a multicentre cluster-randomised controlled trial. Two groups of 91 patients (intervention vs standard care) will be recruited. The clinical pharmacist intervention targeting secondary preventive medication will consist of three parts over 1 year: (1) an individual semi-structured interview at hospital discharge; (2) follow-up telephone interviews at 3, 6 and 9 months after discharge; and (3) a final individual semi-structured interview 1 year after discharge. Information on patient follow-up will be shared with the general practitioner and the community pharmacist by sending a report of each interview. The primary outcome is adherence to medication during the 12 months after hospital discharge, assessed using a composite endpoint: the medication possession ratio associated with a self-administered questionnaire. ETHICS AND DISSEMINATION: The local ethics committee, the national committee for use of personal data in medical research and the national data protection agency approved the study. The sponsor has no role in study design; collection, analysis and interpretation of data; or report writing. DISCUSSION: This pharmacist-led educational programme has the potential to significantly improve adherence to medication in stroke survivors which could lead to a decrease in recurrent cerebral and/or cardiovascular events. TRIAL REGISTRATION NUMBER: NCT02611440.

12.
Curr Med Res Opin ; 36(11): 1783-1790, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32847420

RESUMO

BACKGROUND: There is a general perception that research is underdeveloped in rehabilitation professions. However, a PubMed search found that the growth in publications in the rehabilitation field was twice that of the general medical field. Despite this growth, another study focusing on Europe found that the proportion of articles reporting on clinical research in the rehabilitation field remained low (less than 40% of articles). This could be due to lack of teaching about research in rehabilitation schools or the late introduction of such courses. AIMS: Describe the students' perceptions of research: their desire to conduct research, the usefulness of research and research competence. METHODS: Questionnaire survey targeting all French paramedical students (speech therapy, occupational therapy, psychomotricity, audiometry, physiotherapy, orthoptics) in their final year of study in 2018-2019. RESULTS: Overall, 791 students completed the full survey representing a response rate of 36.3% of the students contacted. Only 34.3% of rehabilitation students were willing to conduct research despite finding it useful (98.6%). The main barrier was the preference for their core operational work (cited 444 times, representing 17.6% of citations). There was a significant relation between perceived competence and the attractiveness of research: 84% of the students not interested in research felt they were not competent to conduct research but this figure dropped to 57.6% amongst the students interested in research (OR 4.0; 95% CI 2.9-5.6). Using a multivariate analysis, we confirmed that the main incentive was feeling competent, as well as past contact with research and supervisors who promoted research work. CONCLUSION: Students have little contact with research during their internships, low perceived competence and, consequently, little desire to conduct research.


Assuntos
Atitude do Pessoal de Saúde , Pesquisa Biomédica , Estudantes de Medicina , Adulto , Audiometria , Bolsas de Estudo , Feminino , França , Humanos , Masculino , Terapia Ocupacional/educação , Ortóptica/educação , Percepção , Modalidades de Fisioterapia/educação , Fonoterapia/educação , Estudantes de Medicina/psicologia , Estudantes de Medicina/estatística & dados numéricos , Inquéritos e Questionários , Adulto Jovem
13.
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.

14.
J Clin Med ; 9(3)2020 Mar 06.
Artigo em Inglês | MEDLINE | ID: mdl-32155956

RESUMO

PURPOSE: To describe a five-grade classification of ectopia lentis in Marfan syndrome (MFS) and to evaluate the positive predictive value of the early grades of ectopia lentis. METHODS: We prospectively included MFS patients and their healthy relatives. The anterior segment examination was classified into grades 0 to 5, and we studied the sensitivity, specificity, and positive predictive value of ectopia lentis in this classification. RESULTS: Seventy-four MFS patients and thirty-six healthy controls were examined. In the MFS group, grades 1, 2, 3, and 4 were present in 15, 24, 17, and 7 patients, respectively, whereas 11 patients in this group did not present ectopia lentis. In the control group, grades 0 and 1 were observed in 30 and 6 individuals, respectively. Sensitivity to ectopia lentis of at least grade 2 was 64.9%, with 100% specificity, whereas sensitivity to ectopia lentis of at least grade 1 was 85.1%, with 83.3% specificity. The positive predictive value of ectopia lentis that was greater than or equal to grade 2 was 100%, whereas that of ectopia lentis greater than or equal to grade 1 was 91.3%. CONCLUSION: High positive predictive values s were found to be associated with grades 2 and higher of the five-grade classification of ectopia lentis. This classification should help to harmonize clinical practices for this major feature of MFS.

15.
Int J Hyperthermia ; 37(1): 144-150, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32003300

RESUMO

Purpose: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel approach for delivering intraperitoneal chemotherapy and offers perspective in the treatment of peritoneal carcinomatosis. Concept is based on a 12 mmHg capnoperitoneum loaded with drug changed in microdoplets. It was postulated to guarantee a more homogeneous drug distribution and tissular uptake than hyperthermic intraperitoneal chemotherapy (HIPEC). The aim of this study was to compare cisplatin peritoneal distribution and pharmacokinetic between HIPEC and PIPAC procedures in a healthy swine model.Methods: Two groups of eight pigs underwent either HIPEC with cisplatin (70 mg/m2) at 43 °C for 60 min, or PIPAC with cisplatin (7.5 mg/m2) for 30 min. Postoperatively, peritoneal areas were biopsied allowing peritoneal cavity cartography. Tissular and plasmatic cisplatin concentrations were analyzed.Results: Cisplatin distribution was heterogeneous in both the groups with higher concentrations obtained closed to the delivery sites. Median total platinum peritoneal concentration by pig was higher in the HIPEC group than in the PIPAC group (18.0 µg/g versus 4.3 µg/g, p < .001) but the yield was 2.2 times better with PIPAC. Platinum concentrations were higher in the HIPEC group in all stations. At each time-point, cisplatin plasmatic concentrations were higher in the HIPEC group (p < .001) but beneath the toxicity threshold.Conclusions: With doses used in clinical practice, HIPEC guaranteed a higher cisplatin peritoneal uptake than PIPAC in this swine model. Spatial drug distribution was heterogeneous with both technics, with hotspots closed to the drug delivery sites. Nevertheless, considering the dose ratio, IP drug uptake yield was better with PIPAC.


Assuntos
Antineoplásicos/uso terapêutico , Cisplatino/uso terapêutico , Neoplasias/tratamento farmacológico , Animais , Antineoplásicos/farmacologia , Cisplatino/farmacologia , Suínos
16.
PLoS One ; 15(2): e0228918, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32059021

RESUMO

MAIN OBJECTIVE: To prospectively assess the cost-consequence of a standardized diagnostic strategy as to compared to an open one for the etiological diagnosis of uveitis. DESIGN: This was a prospective, non-inferiority, multicentre, randomized controlled trial. METHODS: We included all consecutive patients with uveitis who had visited at least one of the Departments of Ophthalmology. In the standardized group, patients had a minimal work-up regardless of the type of uveitis (including evaluation of the CBC, ESR, C-reactive protein, tuberculin skin test, syphilis serology and chest X-ray). Depending on ophthalmological findings, further investigations could be performed. In the open strategy, ophthalmologists were free to order any kind of investigation. The main outcome was the mean cost per patient of each strategy. RESULTS: 903 uveitis patients were included from January, 2010 to May, 2013. The mean cost per patient of the standardized strategy was 182.97 euros [CI 95% (173.14; 192.80)], and the mean cost per patient of the open strategy was 251.75 euros [CI 95% (229.24; 274.25)]. Therefore, the mean cost per patient of the standardized strategy was significantly lower than the mean cost per patient of the open strategy (p<0.001). There were significantly fewer visits (p<0.001), fewer radiological procedures (p<0.004) and fewer laboratory investigations (p<0.001) in the standardized group. CONCLUSION: A standardized strategy is a cost-saving approach for the etiological diagnosis of uveitis.


Assuntos
Oftalmologia/normas , Uveíte/diagnóstico , Uveíte/economia , Adulto , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Oftalmologistas , Oftalmologia/economia , Padrões de Prática Médica/economia , Padrões de Prática Médica/normas , Estudos Prospectivos , Uveíte/etiologia
17.
Surg Endosc ; 34(7): 2939-2946, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-31456025

RESUMO

BACKGROUND: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) and hyperthermic intraperitoneal chemotherapy (HIPEC) are technics proposed to treat patients with peritoneal carcinomatosis, in different settings. There is some concern about an over-risk of anastomotic leakage (AL) with PIPAC jeopardizing a combination with cytoreductive surgery. This study used a healthy swine model to compare the postoperative AL rate between PIPAC and HIPEC with digestive resection and to analyze macrocirculation and microcirculation parameters. METHODS: Segmental colonic resection with a handsewn anastomosis was performed on 16 healthy pigs; 8 pigs had a PIPAC procedure with 7.5 mg/m2 cisplatin (PIPAC group), and 8 pigs had a closed HIPEC procedure with 70 mg/m2 cisplatin and 42 °C as the target intraperitoneal temperature (HIPEC group). Pigs were kept alive for 8 days, then sacrificed and autopsied to look for AL, which was defined as local abscess or digestive fluid leakage when pressure was applied to the anastomosis. Food intake, weight, and core temperature were monitored postoperatively. Macrocirculation (heart rate, systolic blood pressure) and microcirculation parameters (percentage of perfused vessels, perfused vessels density, DeBacker score) were evaluated intraoperatively at five timepoints. Results were compared between pigs with AL and those without. RESULTS: The HIPEC group had no AL, but 3 of 8 pigs (37.5%) had AL in the PIPAC group (p = 0.20). Heart rate and core temperature showed perioperative increases in the HIPEC group. Intraoperatively, heart rate was higher in the HIPEC group at the two last timepoints (123 vs. 93 bpm, p = 0.031, and 110 vs. 85 bpm, p = 0.010, at timepoints 3 and 4, respectively). Other macrocirculatory and microcirculatory parameters showed no significant differences. CONCLUSION: In this healthy swine model, PIPAC might have increased AL incidence compared to HIPEC. This potential over-risk did not seem to be related to changes in the microcirculation. PIPAC should probably not be used with digestive resection and should be avoided in cases of perioperative serosal injury.


Assuntos
Fístula Anastomótica/etiologia , Colo/cirurgia , Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Quimioterapia Intraperitoneal Hipertérmica/efeitos adversos , Neoplasias Peritoneais/tratamento farmacológico , Aerossóis/administração & dosagem , Animais , Antibacterianos/farmacologia , Pressão Sanguínea/efeitos dos fármacos , Cisplatino/administração & dosagem , Procedimentos Cirúrgicos de Citorredução/métodos , Frequência Cardíaca/efeitos dos fármacos , Quimioterapia Intraperitoneal Hipertérmica/métodos , Masculino , Microcirculação , Suínos , Resultado do Tratamento
18.
J Med Ethics ; 46(4): 255-258, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31704781

RESUMO

OBJECTIVE: A high prevalence of authorship problems can have a severe impact on the integrity of the research process. We evaluated the authorship practices of clinicians from the same university hospital in 2019 to compare them with our 2003 data and to find out if the practices had changed. METHODS: Practitioners were randomly selected from the hospital database (Hospices Civils de Lyon, France). The telephone interviews were conducted by a single researcher (HM) using a simplified interview guide compared with the one used in 2003. The doctors were informed that their answers would be aggregated without the possibility of identifying the respondents. During the interviews, the researcher ticked the boxes with the answers on a paper file. RESULTS: We interviewed 26 clinicians (mean age 49±8 years) from various medical specialties. They were unfamiliar with the ICMJE (International Committee of Medical Journal Editors) criteria for writing medical articles and felt that these criteria were not well met in general. With regard to ways of reducing the practice of honorary authors, the participants clearly felt that asking for a signature was hypocritical and of little use. The ghost authors were well known; this practice was considered as rather rare. The 'publish or perish' has always been cited as being responsible for bad practices (26/26: 100%). We compared these results with those observed in 2003 and no improvement has been observed in the past 15 years. CONCLUSION: For the second time in France, within a 15-year interval, we have shown that the ICMJE criteria were ignored and that honorary authorship was frequent.

19.
Stroke ; 50(12): 3471-3480, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31765296

RESUMO

Background and Purpose- Flow diverters are used for endovascular therapy of intracranial aneurysms. We did a nationwide prospective study to investigate the safety and effectiveness of flow diversion at 12 months. Methods- DIVERSION was a national prospective cohort study including all flow diverters placement between October 2012 and February 2014 in France. The primary end point was the event-free survival rate at 12 months, defined as the occurrence of morbidity (intracranial hemorrhage, ischemic stroke, noncerebral hemorrhage, or neurological deficit due to mass effect), retreatment, or death within 12 months post-treatment. A quality control was carried out on 100% of the collected data and of at least 10% of the included patients in each center, chosen at random. All reported serious events were adjudicated by an independent Data Safety and Monitoring Board. Satisfactory occlusion was defined as 3 or 4 on Kamran scale by an independent imaging core laboratory at 12 months. Results- We enrolled 398 patients harboring 477 intracranial aneurysms. At least 1 morbidity-mortality event was noted in 95 of 408 interventions representing an event-free survival rate of 75.7% (95% CI, 71.1-79.7). The rate of permanent-related serious events and mortality was 5.9% and 1.2% at 12 months, respectively. Multivariate analysis showed that high baseline blood pressure (hazard ratio, 2.54; 95% CI, 1.35-4.79; P=0.039), diabetes mellitus (hazard ratio, 3.70; 95% CI, 1.60-8.6; P=0.0022), and larger aneurysms (hazard ratio, 1.07; 95% CI, 1.04-1.11; P<0.0001) were associated with the occurrence of a neurological deficit. The satisfactory occlusion rate at 12 months was 79.9%, and the absence of high baseline blood pressure (odds ratio, 2.01; 95% CI, 1.12-3.71; P=0.0193) and postprocedural satisfactory occlusion (odds ratio, 2.75; 95% CI, 1.49-5.09; P=0.0012) were associated with a 12-month satisfactory occlusion. Conclusions- A satisfactory occlusion was achieved in almost 80% of cases after flow diverter treatment with a permanent-related serious event and mortality rates of 5.9% and 1.2% at 12 months, respectively.


Assuntos
Implante de Prótese Vascular , Prótese Vascular , Procedimentos Endovasculares , Aneurisma Intracraniano/cirurgia , Adulto , Idoso , Pressão Sanguínea , Angiografia Cerebral , Estudos de Coortes , Diabetes Mellitus/epidemiologia , Feminino , França , Hemorragia/epidemiologia , Humanos , Hemorragias Intracranianas/epidemiologia , Masculino , Pessoa de Meia-Idade , Mortalidade , Modelos de Riscos Proporcionais , Estudos Prospectivos , Retratamento , Acidente Vascular Cerebral/epidemiologia
20.
Sci Rep ; 9(1): 11986, 2019 08 19.
Artigo em Inglês | MEDLINE | ID: mdl-31427745

RESUMO

Hereditary hemorrhagic telangiectasia is a rare vascular genetic disease. Epistaxis is the most frequent and disabling manifestation, and timolol appears to be a new therapeutic option as non-selective beta-blockers have in vitro and in vivo anti-angiogenic properties. Our main objective was to evaluate the efficacy of TIMOLOL nasal spray as a treatment for epistaxis in hereditary hemorrhagic telangiectasia. This study is a single-center, randomized, phase 2, double-blind placebo-controlled study with an allocation ratio of 1:1. It was proposed to patients with hereditary hemorrhagic telangiectasia monitored at the French Reference Center, and we included patients aged over 18 years, diagnosed with hereditary hemorrhagic telangiectasia and epistaxis. The treatment was self-administered by the patient with a posology of one spray (50 µL) of timolol 0.5% or placebo in each nostril twice a day for 28 consecutive days. The primary efficacy endpoint was mean monthly epistaxis duration, assessed by monitoring epistaxis grids. A total of 58 patients were randomized and treated. The baseline characteristics were similar in the 2 groups. Mean monthly epistaxis duration measured at 3 months was not significantly different in the 26 patients receiving the drug in comparison with the placebo group (p = 0.54). Toxicity was low and no severe adverse events were reported. One limitation is that we included all HHT patients with nosebleeds and did not take into account history of nasal surgery or nasal crusts. Timolol, administered by nasal spray at a dose of 0.25 mg in each nostril twice a day for 28 consecutive days, did not improve epistaxis in patients with hereditary hemorrhagic telangiectasia at 4 months after the beginning of the treatment.


Assuntos
Antagonistas Adrenérgicos beta/administração & dosagem , Epistaxe/tratamento farmacológico , Epistaxe/etiologia , Telangiectasia Hemorrágica Hereditária/complicações , Timolol/administração & dosagem , Antagonistas Adrenérgicos beta/efeitos adversos , Adulto , Idoso , Epistaxe/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sprays Nasais , Recidiva , Telangiectasia Hemorrágica Hereditária/diagnóstico , Telangiectasia Hemorrágica Hereditária/terapia , Timolol/efeitos adversos , Resultado do Tratamento
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