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1.
Ann Chir Plast Esthet ; 68(2): 152-161, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35987670

RESUMO

BACKGROUND: Combining fat graft with platelet derived products is now common practice in regenerative surgery. We proposed to assess the safety and efficacy of Platelet-Rich Plasma (PRP) addition to a micro-lipofilling protocol for facial treatment of patients suffering from Systemic Sclerosis (SSc). OBJECTIVE: Main objective was to evaluate the improvement of the Mouth Handicap In Systemic Sclerosis (MHISS) scale score at 6 months post-therapy. METHOD: Included SSc patients had a MHISS score equal or up to 20. Surgery was performed under general anesthesia. Micro-fat and PRP (CCA-NA from DEPA Classification) were mixed in a 70/30 ratio, before injection in peri-oral sites according to a specific protocol. Efficacy criteria were recorded at baseline, 3 and 6 months. Moreover, we compared this cohort (current study) to a former (2015) non-enriched micro-lipofilling cohort in the same indication, using the same protocol. RESULTS: Thirteen women patients with mean age of 53.2 years (±14.3) have been included. At baseline, mean MHISS score was 29.5 (±8.7) and significantly decreased to 22.5 (±7.8) at 6 months (P=0.016), corresponding to a 22.0% of improvement from baseline, with a mean decrease of 6.5 points (±7.5) at 6 months. Patients received a mean volume of 30.8ml PRP-micro-fat (±8.1ml). CONCLUSION: PRP addition appeared beneficial, however, controlled studies are required to determine its superiority to facial micro-lipofilling.


Assuntos
Plasma Rico em Plaquetas , Escleroderma Sistêmico , Humanos , Feminino , Pessoa de Meia-Idade , Estudos Prospectivos , Escleroderma Sistêmico/cirurgia , Face/cirurgia , Boca , Resultado do Tratamento
2.
Clin Exp Dermatol ; 47(4): 709-716, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34859487

RESUMO

BACKGROUND: During isotretinoin treatment, special attention is required to detect any symptom or change in the mental health of patients. The monitoring is complex for adolescents because of confounding factors such as mood changes associated with adolescence and puberty and the higher psychosocial impairment due to the acne itself. AIM: To determine the utility of the Adolescent Depression Rating Scale (ADRS) for monitoring symptoms in adolescents before and during isotretinoin treatment in dermatology real-life practice. METHODS: This was a national, multicentre prospective study that enrolled a random sample of dermatologists treating adolescents. An algorithm including ADRS score and its changes between consecutive visits was used. At each visit, dermatologists rated their satisfaction with ADRS and its ease of use, while patients rated the acceptability of the ADRS. RESULTS: In total, 70 dermatologists used the algorithm for 1227 visits of 283 adolescents receiving isotretinoin. Of these 70 dermatologists, 80.8% were satisfied/very satisfied with the ADRS, 82.7% considered the use of the ADRS in clinical practice to be easy/very easy and 75% considered that the ADRS enabled them to discuss more easily the risk of depression with their patients. For the patients, acceptability of the ADRS was considered good by 93.8%. CONCLUSIONS: The implementation of the ADRS could be valuable in dermatology practice, optimizing the monitoring of patients and the good use of isotretinoin.


Assuntos
Acne Vulgar , Transtorno Depressivo , Fármacos Dermatológicos , Acne Vulgar/tratamento farmacológico , Acne Vulgar/psicologia , Adolescente , Depressão/diagnóstico , Depressão/tratamento farmacológico , Depressão/etiologia , Transtorno Depressivo/diagnóstico , Transtorno Depressivo/tratamento farmacológico , Transtorno Depressivo/etiologia , Fármacos Dermatológicos/efeitos adversos , Fármacos Dermatológicos/uso terapêutico , Dermatologistas , Humanos , Isotretinoína/efeitos adversos , Isotretinoína/uso terapêutico , Projetos Piloto , Estudos Prospectivos
3.
Br J Surg ; 108(3): 296-301, 2021 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-33793719

RESUMO

BACKGROUND: Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is used increasingly when performing a prophylactic mastectomy. Few prospective studies have reported on complication rates. This complementary trial to the French prospective multicentre MAPAM trial aimed to evaluate the nipple-areola complex (NAC) necrosis rate in prophylactic NSM with IBR. METHODS: Patient characteristics and surgical data were recorded. Morbidity after prophylactic NSM with a focus on NAC necrosis was analysed. RESULTS: Among 59 women undergoing prophylactic NSM, 19 (32 per cent) of the incisions were partly on the NAC. Reconstructions were performed with 46 definitive implants and 13 expanders. The crude rate of postoperative complications was 25 per cent (15 patients). Complete NAC necrosis was reported in two women (3 per cent) and partial or total necrosis in nine (15 per cent). No NAC resection was necessary. Median BMI was lower in women with total or partial NAC necrosis compared with the others (20.0 versus 21.3 kg/m2 respectively; P = 0.034). CONCLUSION: Results of this prospective study confirm that prophylactic NSM with IBR is associated with a low risk of total NAC necrosis.


Assuntos
Mamoplastia , Necrose , Mamilos/patologia , Tratamentos com Preservação do Órgão , Mastectomia Profilática , Adulto , Idoso , Índice de Massa Corporal , Neoplasias da Mama/prevenção & controle , Feminino , França , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto Jovem
4.
Ann Surg Oncol ; 25(2): 535-541, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29159738

RESUMO

BACKGROUND: Pelvic exenteration remains one of the most mutilating procedures, with important postoperative morbidity, an altered body image, and long-term physical and psychosocial concerns. This study aimed to assess quality of life (QOL) during the first year after pelvic exenteration for gynecologic malignancy performed with curative intent. METHODS: A French multicentric prospective study was performed by including patients who underwent pelvic exenteration. Quality of life by measurement of functional and symptom scales was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3.0) and the EORTC QLQ-OV28 questionnaires before surgery, at baseline, and 1, 3, 6, and 12 months after the procedure. RESULTS: The study enrolled 97 patients. Quality of life including physical, personal, fatigue, and anorexia reported in the QLQ-C30 was significantly reduced 1 month postoperatively and improved at least to baseline level 1 year after the procedure. Body image also was significantly reduced 1 month postoperatively. Global health, emotional, dyspnea, and anorexia items were significantly improved 1 year after surgery compared with baseline values. Unlike younger patients, elderly patients did not regain physical and social activities after pelvic exenteration. CONCLUSIONS: Therapeutic decision on performing a pelvic exenteration can have a severe and permanent impact on all aspects of patients' QOL. Deterioration of QOL was most significant during the first 3 months after surgery. Elderly patients were the only group of patients with permanent decreased physical and social function. Preoperative evaluation and postoperative follow-up evaluation should include health-related QOL instruments, counseling by a multidisciplinary team to cover all aspects concerning stoma care, sexual function, and long-term concerns after surgery.


Assuntos
Imagem Corporal , Neoplasias dos Genitais Femininos/cirurgia , Exenteração Pélvica/psicologia , Exenteração Pélvica/reabilitação , Qualidade de Vida , Adulto , Idoso , Feminino , Seguimentos , Neoplasias dos Genitais Femininos/patologia , Neoplasias dos Genitais Femininos/psicologia , Humanos , Pessoa de Meia-Idade , Período Pós-Operatório , Prognóstico , Estudos Prospectivos , Inquéritos e Questionários
5.
Rev Med Liege ; 73(9): 435-438, 2018 Sep.
Artigo em Francês | MEDLINE | ID: mdl-30188027

RESUMO

The use of gynecological pessary to put back up prolapsed organs to their normal position appears to be as effective as surgical management to relieve symptoms related to uro-genital prolapse and restore body image. This millenary device can be used temporarily, awaiting a surgical solution or as a therapeutic test (mimicking the effect of a surgical procedure to predict its functional outcome or identifying a masked urinary incontinence). It can also represent an alternative to surgery (patient choice, women who wish to complete childbearing or who are unsuitable for surgery because of medical comorbidities) and thus can be used in first intention. Pessary can also be used to confirm or deny the responsibility of pelvic organ prolapse for atypical symptomatology as pelvic heaviness or pain. However, this use requires adjuvant treatment. In this paper, we highlight an original effective process not yet published to optimize the tolerance of pessary.


L'utilisation du pessaire gynécologique afin de réintégrer les organes prolabés dans l'enceinte pelvienne est une alternative efficace dans le soulagement des symptômes liés au prolapsus uro-génital et la restauration tant de l'image corporelle que de l'estime de soi. Ce dispositif millénaire peut être utilisé temporairement, dans l'attente d'une intervention chirurgicale, à titre de test thérapeutique préopératoire (prédiction du résultat fonctionnel attendu, identification d'une possible incontinence urinaire masquée par le prolapsus, confirmation de la responsabilité du trouble de la statique pelvienne quant à une symptomatologie inhabituelle à type de pesanteur pelvienne ou de douleurs). Le pessaire peut aussi être considéré en alternative définitive à la chirurgie (choix de la patiente, désir de grossesse, terrain récusant une intervention). Cette alternative nécessite toutefois un traitement adjuvant. Nous mettons en lumière un procédé original, non encore publié, optimisant la tolérance dudit pessaire.


Assuntos
Guias como Assunto , Prolapso de Órgão Pélvico/terapia , Pessários , Assistência Ambulatorial , Feminino , Humanos
6.
Ann Chir Plast Esthet ; 63(1): 31-40, 2018 Feb.
Artigo em Francês | MEDLINE | ID: mdl-29157877

RESUMO

OBJECTIVE: Emulsified fat injection showed its interest in aesthetic facial surgery. The adipose tissue harvested is mechanically emulsified and filtered. The suspension obtained is injected into the dermis through small diameter needles (27 to 30 gauges). The objective of our study was to evaluate the biological composition of emulsified fat and its clinical effectiveness in the treatment of peri-oral wrinkles in 4 patients aged 50 to 59 years. MATERIAL AND METHOD: Each patient received an intradermal injection of emulsified fat in the peri-oral wrinkles prepared from abdominal fat under local anesthesia. The cell viability, stromal vascular fraction (FVS) composition in emulsified fat and the adipocyte differentiation capacity of mesenchymal stem cells (MSC) were studied. The clinical results were evaluated by standardized photographs, 3D microphotography, confocal microscopy, and self-evaluation of patient satisfaction over a period of 4 months. RESULTS: The biological study of the emulsified fat found a lysis of all the adipocytes. The mean number of FVS cells was 126,330±2758 cells by cc of emulsified fat with preserved cell viability (85.1±6.84 %) and a good proportion of regeneratives cells (18.77±6.2 %). The clinical study found a tendency to decrease the volume of wrinkles on standardized photography and 3D microphotography no significative. Patients were satisfied with treatment with an average score of 7±1.15/10 to 4 months. CONCLUSION: Intradermal injection of emulsified fat seems to be an interesting treatment of face wrinkles. Our study has shown its safety, but additional studies seems necessary to confirm its clinical efficacy.


Assuntos
Tecido Adiposo/transplante , Lábio , Satisfação do Paciente , Rejuvenescimento , Ritidoplastia , Envelhecimento da Pele/efeitos dos fármacos , Feminino , Humanos , Injeções Intradérmicas/métodos , Pessoa de Meia-Idade , Fotografação/métodos , Ritidoplastia/métodos , Resultado do Tratamento
7.
Reprod Biomed Online ; 24(3): 321-30, 2012 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-22285245

RESUMO

Sperm banking is an important procedure to preserve fertility before cancer therapy. The aim of this study was to comprehensively analyse cryopreservation activity retrospectively for 1080 patients referred to the sperm bank for sperm cryopreservation before cancer treatment. This study included 1007 patients diagnosed with testicular cancer (TC) (41.7%), lymphoma (26%), other haematological cancers (9.4%) or other types of cancer (22.8%); of these, 29 patients did not produce any semen sample and cryopreservation was impossible for 67 patients. Semen characteristics before treatment were within normal ranges, except moderate asthenospermia. Sperm concentration was significantly lower in TC than in non-TC. Straws from 57 patients (6.3%) were used in assisted reproductive technologies, which led to a 46.8% cumulative birth rate. Straws were destroyed for 170 patients (18.7%) and 140 patients performed semen analyses after cancer therapy. After an average delay of 22.5 months after the end of therapy, 43 patients (30.7%) exhibited azoospermia. This study of a large population of cancer patients revealed a high level of successful sperm storage. Utilization of cryopreserved spermatozoa led to good chances of fatherhood. Nevertheless, sperm banks should be aware of the low rates of straw use and straw destruction by cancer patients.


Assuntos
Criopreservação/métodos , Preservação da Fertilidade/estatística & dados numéricos , Neoplasias/terapia , Espermatozoides , Adolescente , Adulto , Doença de Hodgkin/complicações , Doença de Hodgkin/terapia , Humanos , Infertilidade Masculina/etiologia , Masculino , Neoplasias/complicações , Estudos Retrospectivos , Análise do Sêmen , Neoplasias Testiculares/complicações , Neoplasias Testiculares/terapia
9.
Prog Urol ; 21(5): 333-40, 2011 May.
Artigo em Francês | MEDLINE | ID: mdl-21514536

RESUMO

No study on side effects had showed that conformal radiation therapy for prostate cancer is more harmful in patients older than 70 years to patients younger. The aim of this study was to evaluate acute and late toxicities of conformal radiotherapy, with high dose for localized prostate cancer in patients older than 70 years and compared to patients younger than 70 years. Between 1996 and 2009, 104 patients were treated with radiation therapy and hormonal therapy for localized cancer prostate. Median follow-up was 105 months (9-300). Acute (occurred at ≤ three months) and late side effects of 55 patients older than 70 years (median age: 75 [71-92]) were graded according to the CTCAE 3.0 criteria and compared to the younger population. Median dose to the prostate was 75.6 Gy (67-80) in both groups. There were no significant differences in acute and late side effects between age groups. For patients above 70 years, the incidence of grade II or higher acute and late side effects were respectively 27 and 22% for urologic symptoms and 13 and 16% for rectal symptoms. The frequency of grade III late symptoms was low and ranged between 0 and 6% for the evaluated symptoms, irrespective of age group. Older patients had a better biochemical recurrence-free survival than younger patients (86 versus 77% at four years, P=ns). High dose 3D conformal radiotherapy for localized prostate cancer was well tolerated in patients older than 70 years. Age is not a limiting factor for conformal radiation therapy and hormonotherapy for older patients.


Assuntos
Neoplasias da Próstata/radioterapia , Radioterapia Conformacional/efeitos adversos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Antagonistas de Androgênios/uso terapêutico , Terapia Combinada , Contraindicações , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias da Próstata/tratamento farmacológico , Radioterapia Conformacional/métodos , Estudos Retrospectivos , Fatores de Tempo
10.
Arch Pediatr ; 28(1): 39-46, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33309119

RESUMO

BACKGROUND: Since the law of February 11, 2005, in France, the number of children with disabilities enrolled in ordinary schools has increased steadily. As a result, the amount of personal support provided by a special needs assistant (personal support) is also increasing. The aim of the study was to describe the diseases and impairments of disabled children aged 2-6, enrolled in mainstream schools and benefiting from personal support for schooling by special needs assistants in the Bouches-du-Rhône (France) in 2014. METHODS: A cross-sectional descriptive study was performed. Children included were benefiting from either an individual or shared personal support. Physicians from the territorial organization in charge of disability coded diseases and deficiencies using the International Classification of Diseases, 10th revision, and nomenclature inspired by the International Classification of Functioning, Disability and Health. RESULTS: Medical data were coded for 990 children out of 1260 of the total population. These young disabled children were most frequently children with pervasive developmental disorders (23.3%), lack of expected normal physiological development (19.9%), or mixed specific developmental disorders (13.5%), and most often had behavioral, personality, and relational skills disorders (61.8%), psychomotor function impairments (51.9%), or written or oral language learning impairment (43.2%). Finally, the two main types of impairments most represented among these children were psychological impairments (86.7%) and language and speech impairments (79.8%). The children were most often supported by an individual personal support (for one child only) than by a shared personal support (60% vs. 40%). They were mainly boys (almost 75%). CONCLUSION: This study provides working guidelines for the management of health policies relating to disability at the territorial or even national level.


Assuntos
Crianças com Deficiência/educação , Transtornos da Linguagem/reabilitação , Inclusão Escolar/estatística & dados numéricos , Transtornos do Neurodesenvolvimento/reabilitação , Distribuição por Idade , Criança , Pré-Escolar , Estudos Transversais , Crianças com Deficiência/psicologia , Crianças com Deficiência/reabilitação , Crianças com Deficiência/estatística & dados numéricos , Feminino , França/epidemiologia , Política de Saúde , Humanos , Transtornos da Linguagem/epidemiologia , Transtornos da Linguagem/psicologia , Inclusão Escolar/métodos , Masculino , Transtornos do Neurodesenvolvimento/epidemiologia , Transtornos do Neurodesenvolvimento/psicologia , Prevalência , Instituições Acadêmicas , Distribuição por Sexo
11.
Arch Pediatr ; 28(1): 1-6, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33342682

RESUMO

We aimed to describe the real-life role of high-flow nasal cannula (HFNC) for bronchiolitis in infants under 3 months of age admitted to three general pediatric departments during the 2017-2018 epidemic period. We retrospectively assessed the clinical severity (Wang score) for every 24-h period of treatment (H0-H24 and H24-H48) according to the initiated medical care (HFNC, oxygen via nasal cannula, or supportive treatments only), the child's discomfort (EDIN score), and transfer to the pediatric intensive care unit (PICU). A total of 138 infants were included: 47±53 days old, 4661±851.9 g, 70 boys (50.7%), 58 with hypoxemia (42%), Wang score of 6.67±2.58, 110 (79.7%) staying for 48 consecutive hours in the same ward. During the H0-H24 period, only patients treated with HFNC had a statistically significant decrease in the severity score (n=21/110; -2 points, P=0.002) and an improvement in the discomfort score (n=15/63; -3.8 points, P<0.0001). There was no difference between groups during the H24-H48 period. The rate of admission to the PICU was 2.9% for patients treated for at least 24 h with HFNC (n=34/138, 44% with oxygen) versus 16.3% for the others (P=0.033). Early use of HFNC improves both clinical status and discomfort in infants younger than 3 months admitted for moderately severe bronchiolitis, whatever their oxygen status.


Assuntos
Bronquiolite/terapia , Oxigenoterapia/métodos , Doença Aguda , Bronquiolite/diagnóstico , Cânula , Feminino , Departamentos Hospitalares , Hospitalização , Humanos , Lactente , Recém-Nascido , Masculino , Oxigenoterapia/instrumentação , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
12.
Cancer Radiother ; 24(1): 64-66, 2020 Feb.
Artigo em Francês | MEDLINE | ID: mdl-32044159

RESUMO

Intra-operative radiotherapy for breast cancer has been developed throughout the last two decades. It is already well-established regarding local control and toxicity for intra-operative radiotherapy using electrons as we now have the necessary background knowledge. However, very few data on later toxicity are available for intra-operative radiotherapy using low-energy photons. We report here the case of a 36-year-old woman who experienced rib fracture following intra-operative and external radiotherapy. This patient has been included in the Targit-boost trial. The intra-operative irradiation has been operated with an INTRABEAM device delivering low-energy photons of 50-kV.


Assuntos
Neoplasias da Mama/radioterapia , Cuidados Intraoperatórios , Fraturas das Costelas/etiologia , Adulto , Neoplasias da Mama/cirurgia , Carcinoma Ductal de Mama/radioterapia , Carcinoma Ductal de Mama/cirurgia , Feminino , Humanos , Excisão de Linfonodo , Mastectomia Segmentar , Fraturas das Costelas/diagnóstico
13.
HIV Clin Trials ; 10(1): 33-40, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19362994

RESUMO

PURPOSE: We previously reported a beneficial effect of benfluorex (BFL) on oral glucose tolerance test (OGTT) and visceral fat mass in an open-label study conducted in 60 HIV-infected patients. The objective of this study was to assess whether administration of BFL compared to placebo (PBO) improves insulin resistance (IR) in HIV+ patients with HAART- induced lipodystrophy. METHOD: 22 HIV-infected patients with IR or impaired glucose tolerance were double-blind randomly assigned to receive BFL 3 tablets/day or PBO for 24 weeks. Efficacy assessments included OGTT, abdominal computed tomography, and the measurement of fasting lipids. RESULTS: Change of median insulin AUC was -53.0 microIU/mL (IQR, -126.0 to -12.7) in the BFL group vs. +33.6 microIU/mL (IQR, 7.0 to 115.6) (p = .01) in PBO group. Weight decreased significantly in the BFL group (-2 kg +/- 2.6; IQR, -6.8 to 2.0) compared to the PBO group (0.8 kg +/- 1.7; IQR, -2.0 to 0.5) (p = .02). No significant changes in visceral or subcutaneous fat mass and plasma lipid level were observed between the two groups. CONCLUSION: Added to antiretroviral therapy, a 6-month therapy with BFL improved insulin sensitivity but is not sufficient to reduce significantly visceral fat mass.


Assuntos
Fenfluramina/análogos & derivados , Intolerância à Glucose/tratamento farmacológico , HIV-1 , Síndrome de Lipodistrofia Associada ao HIV/tratamento farmacológico , Hipolipemiantes/uso terapêutico , Resistência à Insulina , Adulto , Terapia Antirretroviral de Alta Atividade/efeitos adversos , Método Duplo-Cego , Feminino , Fenfluramina/uso terapêutico , Síndrome de Lipodistrofia Associada ao HIV/induzido quimicamente , Humanos , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
14.
Gynecol Obstet Fertil Senol ; 46(6): 540-549, 2018 06.
Artigo em Francês | MEDLINE | ID: mdl-29786534

RESUMO

OBJECTIVES: The use of pessary to put back up prolapsed organs to their normal position dates back prior to several millennia. This work aims to discuss its place in our clinical practice through an updated bibliographic review and emphasizes a hands-on approach to pessary fitting and management in terms of indication, pessary type selection, device' size, insertion, removal, follow-up visits and care. METHODS: A review of the literature, in the light of the latest publications and recommendations of French and international learned societies, as well as our own experience, were analyzed. RESULTS: This device appears to be as effective as surgical management to relieve symptoms related to urogenital prolapse and restore body image. It can be used temporarily, awaiting a surgical solution or as a therapeutic test (mimicking the effect of a surgical procedure to predict its functional outcome or identifying a masked urinary incontinence). It can also represent an alternative to surgery (patient choice, women who wish to complete childbearing or who are unsuitable for surgery because of medical comorbidities) and thus can be used in first intention. However, despite its moderate cost and its harmlessness, this device remains somewhat little known as regards the practical modalities of its use, which, moreover, appear not consensual. CONCLUSION: A guide intended for the attention of the patients as well as a film relating to the practical modalities of the device' use were elaborated to improve the knowledge of both professionals and users in order to optimize and secure the care pathway.


Assuntos
Prolapso de Órgão Pélvico/terapia , Pessários , Feminino , Humanos , Prolapso de Órgão Pélvico/cirurgia , Pessários/efeitos adversos , Resultado do Tratamento , Incontinência Urinária/terapia
15.
Contemp Clin Trials ; 68: 109-115, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29608972

RESUMO

BACKGROUND: In medical oncology, changes in practices are almost always based on randomized trials but medical history shows that it is different in surgical oncology. In the past, many surgical procedures were routinely performed without a rigorous evaluation of the risk-benefit. To highlight the complexity of developing randomized surgical trials, disquisitions on methodology presented in the medical literature. This is particularly true when we consider breast reconstruction after surgical treatment for breast cancer. It is illusory to perform and conduct a randomized clinical trial (RCT) when a surgical procedure is routinely used by most surgeons. METHODS: As a case study, we present the scientific rationale and the design of the MAPAM01 trial which evaluates the security of the nipple sparing mastectomy. Other alternative approaches, such as propensity score and CUSUM, are presented. RESULTS: In this situation, to design surgical trials using alternative methodological approaches present a particularly important challenge both for surgeons and methodologists. Alternative approach to randomized trials can be useful to evaluate surgical procedures routinely used. CONCLUSION: Close collaboration between surgeons and methodologists is needed to propose appropriate and well-designed surgical trials.


Assuntos
Neoplasias da Mama/cirurgia , Mamoplastia/métodos , Mastectomia/métodos , Tratamentos com Preservação do Órgão/métodos , Projetos de Pesquisa/normas , Pesquisadores , Cirurgiões , Adulto , Feminino , França , Humanos , Colaboração Intersetorial , Oncologia/métodos , Oncologia/normas , Mamilos , Estudos Observacionais como Assunto , Melhoria de Qualidade , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Eur J Endocrinol ; 179(5): 307-317, 2018 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-30108093

RESUMO

OBJECTIVE: Glucocorticoid excess is one of the most important causes of bone disorders. Bone marrow fat (BMF) has been identified as a l new mediator of bone metabolism. Cushing syndrome (CS), is a main regulator of adipose tissue distribution but its impact on BMF is unknown. The objective of the study was to evaluate the effect of chronic hypercortisolism on BMF. DESIGN: This was a cross-sectional study. Seventeen active and seventeen cured ACTH-dependent CS patients along with seventeen controls (matched with the active group for age and sex) were included. METHODS: the BMF content of the femoral neck and L3 vertebrae were measured by 1H-MRS on a 3-Tesla wide-bore magnet. BMD was evaluated in patients using dual-energy X-ray absorptiometry. RESULTS: Active CS patients had higher BMF content both in the femur (82.5±2.6%) and vertebrae (70.1±5.1%) compared to the controls (70.8±3.6%, p=0.013 and 49.0±3.7% p=0.005, respectively). In cured CS patients (average remission time of 43 months), BMF content was not different from controls at both sites (72.3±2.9% (femur) and 46.7%±5.3% (L3)). BMF content was positively correlated with age, fasting plasma glucose, HbA1c, triglycerides and visceral adipose tissue in the whole cohort and negatively correlated with BMD values in the CS patients . CONCLUSIONS: Accumulation of BMF is induced by hypercortisolism. In remission patients BMF reached values of controls. Further studies are needed to determine whether this increase in marrow adiposity in CS is associated with bone loss.


Assuntos
Tecido Adiposo/diagnóstico por imagem , Adiposidade/fisiologia , Densidade Óssea/fisiologia , Medula Óssea/diagnóstico por imagem , Síndrome de Cushing/diagnóstico por imagem , Absorciometria de Fóton , Adulto , Estudos Transversais , Feminino , Colo do Fêmur/diagnóstico por imagem , Humanos , Vértebras Lombares/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Espectroscopia de Prótons por Ressonância Magnética
17.
Encephale ; 33(2): 169-78, 2007.
Artigo em Francês | MEDLINE | ID: mdl-17675912

RESUMO

OBJECTIVES: The objective of this study is to evaluate the validity of a new self questionnaire: the "ESQ" (Emotional State Questionnaire). BACKGROUND: This novel instrument possesses a number of original attributes: first of all, it is designed to assess a general emotional profile, in opposition to other similar scales which can only be applied to the emotional reactions provoked by specific stimuli. Secondly, this scale is composed of several emotional dimensions. The ESQ has been constructed according to four components: recognition, expression, internal emotional experience and social context. The first three dimensions were selected because of their wide use through behavioral experiments. Indeed, contrary to most scales used in this field, which only assess the emotional experience, we wanted to propose an instrument also able to assess the subject's impression of his own capacities to encode and decode emotions. We hypothesized that these three dimensions could not be dissociated from a fourth dimension, the social context, which therefore also figures in this scale. The emotions explored were the five fundamental emotions indicated by Izard (fear, happiness, sadness, disgust and surprise) to which we added a neutral feeling that we considered as a basic emotion. STUDY DESIGN: To establish this instrument, a first conceptual phase was conducted by a group of experts. These experts all worked in the psychological field. They proposed the scale on the base of their clinical experience and after study of the literature. The scale was then validated in a population of 218 healthy volunteers, aged between 15 and 88 years. Subjects were not included if they presented depression (score above 16 in the Beck Depression Scale) or pathological anxiety (score above 5 in the Spieberger State Anxiety Inventory). The psychometric characteristics tested were: the item analysis, the item-dimension correlation, the factor analysis and the internal consistency reliability. RESULTS: The population studied was equally distributed according to gender (sex ratio: 0.97), the mean age was of 36.2 2 +/- 16.1 years. Acceptability was good with less than 5% of data missing. The analysis of items revealed no floor or ceiling effect and a low correlation between items. Item-dimension correlation ranged from 0.23 to 0.62, with most scores above 0.4. The items were always better correlated to their dimension than to other dimensions, except for one item. The 4 dimensions (recognition, expression, internal emotional experience and social context of emotions) explained 42% of the total variance. Finally, the scale showed good internal consistency with Cronbach coefficients, equal or above 0.84 for the total score, the recognition and the expression dimensions. This coefficient reached 0.77 for the feeling dimension but only 0.58 for the social context dimension. CONCLUSION: All together, results showed satisfactory characteristics in regard of the complexity of the notion measured. However, an important drawback is the lack of an external instrument to assess convergent validity. This instrument can be of great interest in the emotional characterization of healthy volunteers. More-over, if validated in psychiatric populations, this scale could be most useful in psychopathological assessment and also in comparison with behavioral evaluations of emotion.


Assuntos
Afeto , Inquéritos e Questionários , Adolescente , Adulto , Idoso , Análise Fatorial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria/estatística & dados numéricos , Reprodutibilidade dos Testes
18.
Clin Neurophysiol ; 128(2): 357-364, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28068522

RESUMO

OBJECTIVE: The detection of upper motor neuron (UMN) dysfunction is necessary for the diagnosis of amyotrophic lateral sclerosis (ALS). However, signs of UMN dysfunction may be difficult to establish. This study aimed to determine whether motor-evoked potential (MEP) gain (MEP area/background electromyographic activity) represents an efficient alternative to assess UMN dysfunction. METHODS: MEP area, MEP/compound muscle action potential (CMAP) area ratio, and MEP gain were tested at different force levels in healthy control subjects and ALS patients. Receiver operating characteristic (ROC) curve analyses was used to determine the diagnostic utility of MEP gain and compare it to alternative techniques, namely, diffusion tensor imaging (DTI) and the triple stimulation technique (TST). RESULTS: MEP gain revealed a significant difference between the patients and healthy control subjects in contrast to MEP area and MEP/CMAP area ratio. The diagnostic utility of MEP gain was comparable with that of TST and superior to that of DTI. CONCLUSION: MEP gain can distinguish ALS patients from control subjects and may be helpful for the diagnosis of ALS. SIGNIFICANCE: MEP gain appears to be a useful adjunct test and noninvasive method for the assessment of corticospinal dysfunction.


Assuntos
Esclerose Lateral Amiotrófica/diagnóstico , Eletromiografia/métodos , Potencial Evocado Motor , Tratos Piramidais/fisiopatologia , Esclerose Lateral Amiotrófica/diagnóstico por imagem , Esclerose Lateral Amiotrófica/fisiopatologia , Imagem de Tensor de Difusão/métodos , Eletromiografia/instrumentação , Feminino , Humanos , Masculino
19.
Cancer Radiother ; 21(3): 216-221, 2017 May.
Artigo em Francês | MEDLINE | ID: mdl-28461029

RESUMO

Radiotherapy's main skin toxicities are now well-separated, acute (acute radiation dermatitis) or chronic complications (chronic radiation dermatitis, induced cutaneous carcinoma, aesthetic sequelae). Exceptionally, radiotherapy may induce, by isomorphic reaction or Koebner's phenomenon, some specific dermatosis. In this article, we report five new observations of these unusual complications of radiation therapy, occurring in very variable time after breast irradiation and remaining strictly localized in the irradiated field (cutaneous mastocytosis, Sweet syndrome, lichen planus, vitiligo). These cases emphasize the need to realize a systematic histological exam if any atypical skin lesion appears after radiotherapy, even long after.


Assuntos
Neoplasias da Mama/radioterapia , Lesões por Radiação/etiologia , Dermatopatias/etiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos
20.
Curr Res Transl Med ; 65(1): 40-43, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28340695

RESUMO

INTRODUCTION: Hand involvement confers a substantial handicap in work and daily activities in patients with Systemic sclerosis (SSc). Autologous adipose-derived stromal vascular fraction is as an easily accessible source of cells with regenerative effects. We previously performed a phase I open-label clinical trial (NTC01813279) assessing the safety of subcutaneous injection of autologous adipose-derived stromal vascular fraction. Six and 12-month data have been reported. As patients were followed in our medical centre, we report their longer-term outcome beyond the end of the trial. PATIENTS AND METHOD: Twelve females, mean age 54.5±10.3 years, initially enrolled in the clinical trial were assessed during a scheduled medical care, which took place between 22 and 30months after treatment. RESULTS: Multiple patient-reported outcomes showed sustained improvement, in comparison with the assessment performed just before surgery: 62.5% in the Cochin Hand Function Scale, 51.1% in the Scleroderma Health Assessment Questionnaire, 33.1% in hand pain, and 88.3% in the Raynaud Condition Score. A decrease in the number of digital ulcers number was noted. Mobility, strength and fibrosis of the hand also showed improvement. None of the 8 patients who had previously received iloprost infusion required new infusion. CONCLUSION: Despite the limits of an open label study, the data are in favour of the long-term safety of the adipose-derived stromal vascular fraction injection. Two randomized double blind, placebo-controlled trials of this therapeutic agent are ongoing in the USA (NCT02396238) and in France (NCT02558543) and will help determine the place of this innovative therapy for SSc patients.


Assuntos
Tecido Adiposo/citologia , Dedos , Doença de Raynaud/terapia , Escleroderma Sistêmico/terapia , Células Estromais/transplante , Adulto , Idoso , Fracionamento Celular , Células Endoteliais/citologia , Células Endoteliais/transplante , Feminino , Dedos/patologia , Seguimentos , Mãos , Humanos , Injeções Subcutâneas , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Doença de Raynaud/etiologia , Escleroderma Sistêmico/complicações , Úlcera Cutânea/etiologia , Úlcera Cutânea/terapia , Transplante Autólogo , Resultado do Tratamento
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