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1.
Encephale ; 45(6): 459-467, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31542210

RESUMO

OBJECTIVES: Schizophrenia entails a considerable humanistic and economic burden. Improved treatment continuity to antipsychotic therapy is paramount to reduce the risk of relapse. The novel three-monthly paliperidone palmitate treatment (PP3M) offers the longest dosing interval currently available in France. This study assesses its cost-effectiveness, versus the currently available one-monthly long-acting treatment (PP1M) in French schizophrenic patients. METHODS: A Markov model with monthly cycles was developed and adapted. It encompassed [a] administration of PP3M or PP1M in first-line, [b] a period where the patient does not receive any active treatment, and [c] a follow-up treatment line consisting of a treatment mix reflecting French clinical practice. Relapse rates in first-line were based on a pivotal non-inferiority head-to-head trial, and treatment discontinuation rates were based on French real-world data. Accounting for differences in drug exposure, time-dependent monthly relapse rates were applied following discontinuation to first line. The impact of a less frequent injection schedule for PP3M in QoL was accounted for through the application of a utility differential. The collective perspective was adopted throughout a 5-year time horizon. Four percent discount rates were applied on costs and outcomes. RESULTS: PP3M was dominant when compared to PP1M, featuring an incremental QALY of 0.123 and a cost saving effect (-669€) resulting from reduced therapy costs (drug acquisition, administration and monitoring) and relapse-related costs. Sensitivity analysis supported the robustness of the results. CONCLUSION: With slightly better QALY outcomes and a cost-saving effect when compared to PP1M, introducing PP3M is an improvement to the current treatment in France.

2.
Eur J Orthop Surg Traumatol ; 29(7): 1451-1460, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31256289

RESUMO

BACKGROUND AND PURPOSE: In a previous study, we investigated the link between the femoral offset (FO) loss by trochanteric impaction (TI) and cut-out complication occurrence after pertrochanteric fractures. Three major factors are likely to drive to failure after intramedullary nailing (IN): fracture stability, reduction quality and osteosynthesis quality. We wanted to investigate the quality of the fracture reduction through the TI and the neck-shaft angle (NSA) measurement and correlate these parameters with the risk of mechanical failure occurrence. MATERIALS AND METHODS: It was a retrospective multicentric one case-one control match design study with age and gender randomization. The cases presented a mechanical failure of nailing: [Formula: see text] in percentage. Femoral rotation was taken into account, and all TI were rotation-corrected (TIcorrected). Rotation-corrected neck-shaft angles (NSAcorrected) were calculated. The neck-shaft angle gap between the fractured and the healthy sides (NSAgap) was a ratio: [Formula: see text] in percentage. The tip-apex distance (TAD) was measured. Absolute values of TIcorrected and NSAgap were analyzed. RESULTS: Twenty-one cases and 21 controls were examined. The average TIcorrected rate was 30% for the cases and 11% for the controls (p = 0.007). A 13% TIcorrected threshold had maximum specificity and sensitivity, equal to 71%. The average TAD was 27 mm for cases and 19 mm for controls (p = 0.004). The average NSAgap rate was 7% for the case group and 4% for the control group (p = 0.009). The areas under the ROC curves for TIcorrected, TAD and NSAgap were 0.73, 0.73 and 0.66, respectively. INTERPRETATION: Closed reduction and exclusive implantation of IN do not seem optimal in case of FO or NSA restoration failure after pertrochanteric fractures. LEVEL OF EVIDENCE: Level III, case-control study.


Assuntos
Pinos Ortopédicos/efeitos adversos , Fixação Intramedular de Fraturas/efeitos adversos , Fraturas do Quadril/cirurgia , Complicações Pós-Operatórias/etiologia , Idoso , Idoso de 80 Anos ou mais , Área Sob a Curva , Estudos de Casos e Controles , Redução Fechada , Feminino , Fraturas do Quadril/diagnóstico por imagem , Articulação do Quadril/fisiopatologia , Humanos , Masculino , Curva ROC , Estudos Retrospectivos , Rotação , Falha de Tratamento
3.
Orthop Traumatol Surg Res ; 104(3): 369-375, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29454973

RESUMO

BACKGROUND: The choice between performing total hip arthroplasty (THA) or hemiarthroplasty (HA) is not straightforward in older patients with femoral neck fracture, particularly when co-morbidities are factored in. This led us to carry out a case-control study to determine (1) the rate of mechanical complications for these two types of implants, and (2) the rate of medical complications and mortality. HYPOTHESIS: THA with dual mobility cup (DM) will result in fewer mechanical complications than HA. PATIENTS AND METHODS: This was a single-center, retrospective case-control study. Between 2010 and 2015, all patients with a femoral neck fracture treated by HA or DM THA were included. The primary outcome was the occurrence of any type of surgical complication. The Charlson Co-morbidity Index (CCI) and the independence during Activities of Daily Living (ADL) score were calculated for every patient. Two subgroups of patients were made based on whether they met frailty criteria. The effect of covariates on 1-year mortality was controlled using Cox's proportional hazards regression model. RESULTS: The cohort consisted of 101 HA and 98 THA procedures in 193 patients (139 women, 54 men) with a mean age of 80.6years (range, 76-101). The mean follow-up was 24.2months (range, 0-83) with a median of 14.5months. Fifteen of the HA hips (15%) had surgical complication, of which 10 were posterior dislocations (10%). Ten patients in the HA cohort had a serious medical complication (10%). Ten of the THA hips (10%) had a mechanical complication, including three posterior dislocations (3%) and four infections (4%). Nine patients in the THA cohort had a medical complication (9%). There were significantly fewer posterior dislocations in the THA hips (p = 0.05). In the subgroup analysis, the 117 patients (58%) who met the frailty criteria had a significantly lower dislocation rate after undergoing THA (p = 0.048). After adjusting on age, ADL and CCI score, the dislocation rate no longer differed significantly between the two groups (p = 0.1). The dislocation rate was lower in the THA hips only in the "frail" patients (Odds ratio = 0.137, 95% CI: [0.003-0.97] (p = 0.04)). There was no difference in the dislocation rate in the "non-frail" patients. The overall 1-year mortality was 85% [95% CI: 78-94%]. It was 78% [95% CI: 69-86%] for the HA hips and 88% [95% CI: 82-95%] for the THA hips (p = 0.01). After factoring in the impact of age, CCI and ADL, the differences in the 1-year mortality between HA and THA were no longer present (p = 0.42). Thus, there is no increased risk of mortality in THA patients. DISCUSSION: When the CCI and independence level are taken into consideration, the frailest patients can undergo DM THA to reduce the dislocation risk, without increasing the mortality rate at 1year. Patients who are not frail will benefit equally from undergoing HA or THA. LEVEL OF EVIDENCE: III, case-control study.


Assuntos
Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/instrumentação , Fraturas do Colo Femoral/cirurgia , Hemiartroplastia/efeitos adversos , Complicações Pós-Operatórias/etiologia , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Feminino , Idoso Fragilizado , Luxação do Quadril/etiologia , Humanos , Masculino , Estudos Retrospectivos , Taxa de Sobrevida
4.
Encephale ; 43(4): 311-320, 2017 Aug.
Artigo em Francês | MEDLINE | ID: mdl-27623123

RESUMO

INTRODUCTION: The course of schizophrenia can vary widely, and patients experience remission phases alternating with relapse episodes, which generally lead to hospitalisation and have a significant impact on the burden of disease. The prevalence of schizophrenia in France is estimated to be approximately 600,000 people, with an incidence of 10,000 new patients per year. Patients with schizophrenia represent the largest group of hospitalised patients in French public institutions and specialised centres, and the French authorities recognise that the management of schizophrenia is a major public health concern. The Haute Autorité de Santé (HAS) and most of the evidence-based guidelines for the maintenance treatment of schizophrenia recommend long-acting injectable (LAI) antipsychotics to be used predominantly in the prevention of relapse for non-compliant patients; however, in clinical practice, the use of LAIs remains low. OBJECTIVE: This analysis aimed to estimate and to compare the cost-effectiveness of the most common antipsychotic strategies in France in the management of schizophrenia. METHODS: A Markov model was developed to simulate the progression of a cohort of patients with schizophrenia through four health states (stable treated, stable non-treated, relapse and death) and considered up to three lines of treatment to account for changes in treatment management. Antipsychotics including aripiprazole LAI (ALAI), olanzapine LAI (OLAI), paliperidone LAI (PLAI), risperidone LAI (RLAI), haloperidol decanoate (HD) and oral olanzapine (OO) were compared in terms of costs and clinical outcomes. Thus, costs, quality-adjusted life-years (QALYs) and number of relapses were assessed over five years based on three-month cycles from a French health insurance perspective with a discount rate of 4 %. Patients were considered to be stabilised after clinical decompensation and would enter the model at an initiation phase, followed by a prevention of relapse phase if successful. Data (e.g. relapse or discontinuation rates) for the initiation phase came from randomised clinical trials, whereas relapse rates in the prevention phase were derived from hospitalisation risks based on French real-life data in order to capture adherence effects. Safety and utility data were derived from international publications. Additionally costs were retrieved from French health insurance databases and publications. Robustness of results was assessed through deterministic and probabilistic sensitivity analyses. RESULTS: First and second generations of LAIs were found to have similar costs over five years; i.e. approximately € 55,000, except for PLAI which was associated with a discounted cost of € 50,880. Oral antipsychotics were found to be less costly (i.e. OO cost € 50,379 after five years) but associated with a lower number of QALYs gained and relapse avoided. PLAI and RLAI were associated with the greatest number of QALYs gained; i.e. PLAI dominated ALAI, OLAI and HD and was associated with an incremental costs-effectiveness ratio (ICER) of € 2411 per QALY gained versus OO. Finally, PLAI and OLAI were associated with the lowest number of relapses; i.e. PLAI dominated RLAI, ALAI and HLAI and was associated with an ICER of € 1782 per avoided relapse compared to OO. OO and HD were found to have led to the highest number of relapses. CONCLUSION: This analysis, to the best of our knowledge, is the first of its kind to assess the cost-effectiveness of antipsychotics based on French observational data. PLAI was associated with the highest probability of being the optimal treatment from the French health insurance perspective.


Assuntos
Antipsicóticos/economia , Antipsicóticos/uso terapêutico , Esquizofrenia/tratamento farmacológico , Esquizofrenia/economia , Assistência Ambulatorial/economia , Estudos de Coortes , Análise Custo-Benefício , Preparações de Ação Retardada , França , Nível de Saúde , Humanos , Cadeias de Markov , Modelos Econômicos , Programas Nacionais de Saúde/economia , Cooperação do Paciente , Anos de Vida Ajustados por Qualidade de Vida , Recidiva
5.
Sci Rep ; 6: 25806, 2016 05 19.
Artigo em Inglês | MEDLINE | ID: mdl-27194388

RESUMO

Human respiratory syncytial virus (hRSV) is a leading cause of acute lower respiratory tract infection in infants, elderly and immunocompromised individuals. To date, no specific antiviral drug is available to treat or prevent this disease. Here, we report that the Smoothened receptor (Smo) antagonist cyclopamine acts as a potent and selective inhibitor of in vitro and in vivo hRSV replication. Cyclopamine inhibits hRSV through a novel, Smo-independent mechanism. It specifically impairs the function of the hRSV RNA-dependent RNA polymerase complex notably by reducing expression levels of the viral anti-termination factor M2-1. The relevance of these findings is corroborated by the demonstration that a single R151K mutation in M2-1 is sufficient to confer virus resistance to cyclopamine in vitro and that cyclopamine is able to reduce virus titers in a mouse model of hRSV infection. The results of our study open a novel avenue for the development of future therapies against hRSV infection.


Assuntos
Vírus Sincicial Respiratório Humano/fisiologia , Transcrição Genética , Proteínas Virais/metabolismo , Replicação Viral/fisiologia , Alcaloides/farmacologia , Animais , Linhagem Celular , RNA Polimerases Dirigidas por DNA/metabolismo , Modelos Animais de Doenças , Farmacorresistência Viral/efeitos dos fármacos , Feminino , Regulação Viral da Expressão Gênica/efeitos dos fármacos , Humanos , Camundongos Endogâmicos BALB C , Modelos Moleculares , Infecções por Vírus Respiratório Sincicial/tratamento farmacológico , Infecções por Vírus Respiratório Sincicial/virologia , Vírus Sincicial Respiratório Humano/efeitos dos fármacos , Receptor Smoothened/metabolismo , Transcrição Genética/efeitos dos fármacos , Veratrum/química , Alcaloides de Veratrum/química , Alcaloides de Veratrum/farmacologia , Alcaloides de Veratrum/uso terapêutico , Replicação Viral/efeitos dos fármacos , Replicação Viral/genética
6.
Orthop Traumatol Surg Res ; 101(8): 903-7, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26498882

RESUMO

BACKGROUND: Damage to the radial nerve in the arm during revision of total elbow arthroplasty is a serious complication; which is still not well documented. The aim of this study was to define a way on how to avoid this complication and to prevent it. PATIENTS AND METHODS: Four patients underwent radial palsy after revision of total elbow arthroplasty. An anatomical study on 20 upper limbs was performed to define landmarks for the radial nerve in the arm and elbow. RESULTS: Radial nerve damage occurred near the proximal tip of the stem in all four patients, due to cement seepage caused by cortical effraction in two patients, and to damage caused by the retractors in the two other patients. The anatomical study made it possible to specify landmarks for the radial nerve in relation to the humerus. A high-risk area located 14cm away from the tip of the olecranon fossa, and 15.5cm from the medial epicondyle, was identified. CONCLUSION: A high-risk area for the radial nerve was defined and suggested targeted landmarks with a posterior proximal counter-incision situated at about 14cm above the olecranon fossa. LEVEL OF EVIDENCE: IV.


Assuntos
Artroplastia de Substituição do Cotovelo/efeitos adversos , Nervo Radial/lesões , Neuropatia Radial/etiologia , Adulto , Idoso , Pontos de Referência Anatômicos , Cimentos para Ossos/efeitos adversos , Cotovelo/inervação , Articulação do Cotovelo/cirurgia , Feminino , Humanos , Úmero/anatomia & histologia , Úmero/cirurgia , Masculino , Pessoa de Meia-Idade , Nervo Radial/anatomia & histologia , Nervo Radial/cirurgia , Neuropatia Radial/prevenção & controle , Reoperação/efeitos adversos , Reoperação/métodos , Instrumentos Cirúrgicos/efeitos adversos , Ulna/anatomia & histologia
7.
Haemophilia ; 21(1): 21-6, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25335191

RESUMO

Although a serious impediment in haemophilia patients, difficulty accessing peripheral veins has received little attention in clinical studies. New peripheral vein visualization devices could potentially ameliorate difficult venous access (DVA), but their utility remains unproved. The study aim was to survey the frequency, causes and clinical manifestations of DVA and evaluate the clinical utility of a near-infrared (NIR) vein visualizer. In this multicentre prospective study, methods, difficulties and outcomes of venous access were assessed for a single venipuncture in consecutive patients. The impact of an NIR vein visualizer on vein localization, the number of venipuncture attempts and patient stress and pain was determined. Among 450 total patients enrolled, venous access was judged to be difficult in 165 (36.7%), most often because of poor vein condition, young patient age, overweight and difficulty in finding veins. Of the patients with DVA, difficulty in locating veins was encountered in 82.4%, and more than one venipuncture attempt was required in 24.8%. Veins were difficult to locate in significantly fewer DVA patients (P = 0.002) when the NIR vein visualizer was used (76.0%) than not used (92.3%). Pain during venipuncture in DVA patients was also significantly less common (P = 0.019) with use of the NIR vein visualizer (34.0% vs. 55.4%). No effect was observed on venipuncture attempts. DVA affects more than one-third of patients at haemophilia treatment centres. An NIR vein visualizer showed significant promise for facilitating vein location and mitigating patient pain in those patients.


Assuntos
Hemofilia A/diagnóstico , Flebotomia/métodos , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Feminino , França , Humanos , Masculino , Estudos Prospectivos , Veias
8.
Chir Main ; 33(1): 63-6, 2014 Feb.
Artigo em Francês | MEDLINE | ID: mdl-24394235

RESUMO

We report the occurrence of a rare injury in a teenager not yet described in the literature: the association of posteromedial elbow dislocation, lateral condyle and coronoid process fractures. The treatment required fixation of lateral condyle and coronoid process thanks to lateral and medial approaches and capsular fixation. This lesion is unstable, such as the terrible triad described in adults. It requires external and anterior stabilization of the elbow. The management of such injuries of the elbow is complex. It must consider both bone and ligament instability, and risk of injury to growth plates.


Assuntos
Articulação do Cotovelo/cirurgia , Fixação Interna de Fraturas , Luxações Articulares/cirurgia , Fraturas do Rádio/cirurgia , Fraturas da Ulna/cirurgia , Adolescente , Articulação do Cotovelo/diagnóstico por imagem , Articulação do Cotovelo/lesões , Humanos , Luxações Articulares/diagnóstico por imagem , Instabilidade Articular/cirurgia , Masculino , Radiografia , Fraturas do Rádio/diagnóstico por imagem , Amplitude de Movimento Articular , Resultado do Tratamento , Fraturas da Ulna/diagnóstico por imagem
10.
Orthop Traumatol Surg Res ; 96(8): 844-8, 2010 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-20822963

RESUMO

INTRODUCTION: Trochanteric fractures are commonly stabilized either by intramedullary nailing or plate and screw fixation after reduction on the orthopaedic surgical table under radiological guidance. HYPOTHESIS: Closed trochanteric fracture anatomic reduction is difficult in the transversal plane. OBJECTIVES: The objective of this prospective study was to assess the rotational malalignment induced after reduction and osteosynthesis of trochanteric fractures. PATIENTS AND METHODS: Prospective study including 40 patients (mean age, 78 years; range, 51-90 years) operated for a trochanteric fracture between January 2007 and September 2008. Fourteen fractures were treated using DHS™ (Synthes™) plate and screw fixation and 26 with intramedullary nailing (trochanteric nail™, Stryker™). All these patients underwent postoperative CT of the pelvis during their hospitalization with measurement of anteversion of the operated and healthy femoral necks at the posterior condyles. The evaluation criterion was whether or not there was malalignment greater than 15° on the operated side compared to the healthy side. RESULTS: The mean anteversion was 14.2° for the healthy side and 23° for the operated side. The mean rotational malalignment was 15.3°. Forty percent of the rotational malalignments were greater than 15°, with a majority of cases showing excess internal rotation (35%) of the distal fragment. CONCLUSION AND DISCUSSION: The rate of internal rotational malalignment of the distal fragment greater than 15° was high (40% of this series). This should encourage surgeons to reduce the excess internal rotation that tends to be attributed to the distal fragment during preoperative reduction of these fractures. LEVEL OF EVIDENCE: Level III. Prospective diagnostic study with no control group.


Assuntos
Mau Alinhamento Ósseo/etiologia , Placas Ósseas , Parafusos Ósseos , Fixação Interna de Fraturas , Fixação Intramedular de Fraturas , Fraturas Fechadas/cirurgia , Fraturas do Quadril/cirurgia , Complicações Pós-Operatórias/etiologia , Anormalidade Torcional/etiologia , Idoso , Idoso de 80 Anos ou mais , Mau Alinhamento Ósseo/diagnóstico por imagem , Feminino , Consolidação da Fratura/fisiologia , Humanos , Processamento de Imagem Assistida por Computador , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico por imagem , Estudos Prospectivos , Tomografia Computadorizada por Raios X , Anormalidade Torcional/diagnóstico por imagem
11.
Haemophilia ; 16(3): 447-54, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-20088955

RESUMO

The activities of 'expert patients' or 'patient tutors', who help educate their peers, are gaining recognition in the health care system. This study investigates the role played by such patients in therapeutic education programmes organized by caregivers to validate the role of patients in implementing the therapeutic education of haemophilic patients and to define the skills required for such activities. This study employs the consensus methodology recommended by France's National Authority for Health. The working group includes seven caregivers from Hemophiliac Treatment Centers (HTCs) and three patients from the French Association of Hemophiliacs (FAH). The role of patients in haemophilia education is recognized. Patients participating in the education of their peers are referred to as 'patient resources'. A patient resource should be an adult, a volunteer and live in the same region as his peers. Candidates are chosen by the FAH and the HTCs to serve based on their motivation to facilitate the education of other patients as well as on their psychological and pedagogical aptitudes. A patient resource participates in the conception and administration of therapeutic education programmes. He also mediates between the caregivers and the patients. He ensures that the patients understand the material and are able to apply their knowledge in daily life. His activities are governed by professional ethics. Seven categories of skills were defined, permitting the group to determine precisely which skills are required to function as a patient resource. Supervision of the patients is planned to reinforce reflexive practices in the patients. Evolution of the health care system has led patients to become involved in therapeutic education. This phenomenon calls for a framework to be developed and an evaluation of its eventual effects.


Assuntos
Hemofilia A/terapia , Hemofilia B/terapia , Educação de Pacientes como Assunto/métodos , Participação do Paciente , Consenso , França , Humanos , Grupo Associado , Papel (figurativo)
12.
Diabetes Metab ; 31(3 Pt 1): 263-71, 2005 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16142017

RESUMO

OBJECTIVE: To compare the Health Related Quality of Life (HRQL) of French diabetic patients with and without foot ulcers and to determine the factors influencing disease-specific HRQL for those with foot ulcers. METHODS: 355 diabetic patients, including 239 with foot ulcers (group 1) and 116 without foot ulcers (group 2) were studied in a cross-sectional setting. Socio-demographic and clinical variables were recorded and HRQL was evaluated using a generic HRQL questionnaire (SF-36) for all subjects. For group 1, the severity of foot ulcers was assessed according to Wagner's classification, and disease-specific HRQL assessed using the Diabetes Foot Ulcer Scale (DFS). RESULTS: HRQL was found to be significantly lower (P = 0.0001) in group 1 than in group 2 for all domains of the SF-36. Independent inverse relationships were found between good HRQL in the DFS domain of Leisure and Wagner grade (OR = 0.136 [0.029-0.467]) as well as the number of foot ulcers (OR = 0.365 [0.191-0.678]). Age was significantly associated with several DFS domains including Daily Activities, Physical Health and Dependence. CONCLUSION: Our findings suggest that the number and severity of foot ulcers are associated with patient HRQL, especially in terms of leisure activity disruption and constraints due to treatment. These findings have implications for the evaluation, planning and management of patient care in diabetic foot disease.


Assuntos
Pé Diabético/fisiopatologia , Pé Diabético/psicologia , Qualidade de Vida , Idoso , Atitude Frente a Saúde , Estudos Transversais , Diabetes Mellitus Tipo 1/fisiopatologia , Diabetes Mellitus Tipo 1/psicologia , Diabetes Mellitus Tipo 2/fisiopatologia , Diabetes Mellitus Tipo 2/psicologia , Angiopatias Diabéticas/fisiopatologia , Angiopatias Diabéticas/psicologia , Neuropatias Diabéticas/fisiopatologia , Neuropatias Diabéticas/psicologia , Feminino , Úlcera do Pé/fisiopatologia , Úlcera do Pé/psicologia , França , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade
13.
Encephale ; 31(2): 235-46, 2005.
Artigo em Francês | MEDLINE | ID: mdl-15959450

RESUMO

UNLABELLED: Schizophrenia is a disease affecting the young adults and amounts to approximately 300,000 people in France. The French public psychiatric sector takes care of approximately 150,000 adults schizophrenics: 50% benefit from ambulatory care, 50% are in partial or full-time hospitalization care. Schizophrenia represents the first diagnosis that psychiatric sectors take in charge. The costs associated with schizophrenia, mainly hospital costs, are important and were estimated at 2% of the total medical costs in France. In the French social welfare system, the social costs (pensions, allowances, managements of custody or guardianship by social workers) are also to be taken into account: it amounts to a third of the global direct cost. Schizophrenia also generates indirect costs (losses of productivity and premature deaths) which would be at least equal, or even more important, than direct medical costs. The non-compliance to the antipsychotic treatment is a major problem with people suffering from schizophrenia. Indeed the lack of compliance to the treatment, estimated at 20 to 40%, is a major handicap for schizophrenic patient stabilization. The poor level of compliance is due to many various causes: adverse effects that are considered unbearable, medicine viewed as persecutory, negation of the disease, nostalgia for the productive phases of the disease, lack of social support, complexity of the prescription, relapse itself. Compliance is thus influenced by the patient's clinical features, local provision of health care and the specific nature of the drug (adverse effects, pharmaceutical formulation). The atypical antipsychotics present fewer extrapyramidal side effects and reduce the cognitive deficits associated with the disease, which results in improved compliance. Long-acting injectable antipsychotics allow a better therapeutic compliance and thus better efficacy of the treatment. Several studies have shown a significant improvement in compliance related to the pharmaceutical formulation of antipsychotics. Hospitalization and relapse risks are lower in compliant than in non-compliant patients. OBJECTIVES: The main objective of this pharmacoeconomic analysis is to evaluate the impact in terms of medical benefits and costs of the following strategies: 1. Risperidone long-acting injection: first long-acting injectable atypical antipsychotic; 2. Haloperidol depot: long-acting injectable conventional neuroleptic; 3. Olanzapine: atypical antipsychotic available commercially in oral formulation. METHODS: The target population defined for the study are young schizophrenic patients treated for at least 1 year and whose disorder has not been diagnosed for longer than 5 years. The time horizon is 2 years. A cost-effectiveness analysis is performed. The perspective adopted is the French Health System. The main hypothesis of the model is that an increase in compliance linked to the use of long-acting injectable formulation could lead to an increased efficacy and a modification of the cost-effectiveness ratio. A decision tree was built. Six periods of follow-up are identified with a duration of 4-months per period. The tree contains 3 principal arms, each one corresponding to a specific treatment: risperidone LA injection, haloperidol decanoate and olanzapine. For each arm, at the chance node, two health states are identified: either the patient responds favourably to the treatment or does not respond favourably and requires a switch to another drug treatment. After a period of response, the patient can either remain in the same state or experiences a clinical deterioration. If the patient presents a clinical deterioration, he can either go back to a positive response state after a period of intensive follow-up or remain in an insufficient response state; in this case, a change of antipsychotic treatment is necessary. In the model, a patient should receive four different treatments before a long-term hospitalization takes put in place. According to the market authorization labelling, clozapine is proposed only as a 2nd or 3rd line therapeutic option, so when at least one or two successive neuroleptics have failed. The efficacy data used in the model are provided by clinical research recently published. These studies estimate the efficacy of oral risperidone, LA risperidone, olanzapine, and treatment by haloperidol. When available data in the literature were insufficient, the opinion of experts was sought. The effectiveness criteria is the rate of patients treated successfully: patients responding to the initial treatment with the possibility of experiencing one or two episodes of clinical deterioration but without requiring a switch to another drug during 2 years of follow-up. The base case is as follows: efficacy for oral risperidone is used for the LA risperidone strategy, increased by 10% within the first 4 months of follow-up; efficacy for oral haloperidol is used for haloperidol depot, increased by 5% within the first 4 months of follow-up; for olanzapine, observed data in clinical trials were applied. The hypotheses for long acting forms are rather conservative because the increase of efficacy which can be expected for the long-acting injectable formulations varies between 5% to more than 30% according to the literature data. The analysis of sensibility includes three scenarios: scenario 1: for LA risperidone, 5% of patients treated successfully improvement in regard to oral risperidone instead of 10% in the base case; scenario 2: for haloperidol depot, 10% of patients treated successfully improvement in regard of oral haloperidol instead of 5% in the base case; scenario 3: the results of an open trial conducted within the framework of the LA risperidone license are used, leading to an increase of up to 13,3% of the rate of successfully treated patients, compared to oral risperidone literature data. As for the side effects, only extrapyramidal symptoms were considered. Other side effects are described in the literature such as the obesity or the occurrence of a diabetes; these effects were not taken into account in the model, their impact on the cove-rage of schizophrenic patients and on resources utilisation being poorly known. Only direct medical costs were considered in the pharmaco-economic analysis. Two types of costs were identified: hospital costs and community care costs. The stays in overnight hospitalisation and day hospitalisation were derived from the Disease Related Groups (DRG) and valued from the data of the National Cost Study (Etude Nationale de Coûts; 1999). The DRGs corresponding to the diagnosis of schizophrenia are the DRG 627 (complete hospitalization) and DRG 819 (day hospitalisation). Ambulatory care: procedures and visits, were valued in euros in reference with the tariffs for reimbursement issued in the Naming General of the Professional Acts (NGAP) and published by the French National Health Insurance (Year 2001). Medication consumption was quantified by using the daily dosage specified in the the MAA and the French prescription database IMS-Dorema. The cost of medicines was valued from tariffs 2001 (SEMPEX). LA risperidone price being not fixed to date, the reserved hypothesis is a 141,62 Euro retail price. As schizophrenia is listed among the diseases reimbursed at a 100% rate by the Health insurance, out of pocket expenses by patient are not considered in the analysis. The cost for the extrapyramidal effects was attributed to all the strategies. This cost was calculated according to the rates of extrapyramidal effects occurrence collected in the literature. Globally, in the published studies, the incidence of the side effects for the patients treated by olanzapine or risperidone is similar. It was thus decided by the experts to use the same rate of occurrence for extrapyramidal effects for olanzapine and risperidone (20%). This rate is 40% for haloperidol decanoate, 10% for oral clozapine. For the cost estimation, the expenses for treating a schizophrenic patient for two years were taken into account. RESULTS: The results show that in two years, LA risperidone is more effective than the two other antipsychotics. After 2 years, the rate of patients treated successfully is 82,7% for LA risperidone, 74,8% for olanzapine and 57,3% for haloperidol depot. The 2 year-cost per patient treated by LA risperidone is 14,055 Euro. This cost is 14,351 Euro and 17,203 Euro respectively for the strategies olanzapine and haloperidol depot. The cost-efficacy ratios per patient successfully treated are 16,995 Euro for the strategy LA risperidone, 19,186 Euro for olanzapine and 30,023 Euro for haloperidol depot. LA risperidone is a dominant strategy compared with both olanzapine and haloperidol depot. Scenario 1 shows that LA risperidone strategy remains the most effective. Indeed, this strategy allows a response increase of 3,5% regarding olanzapine strategy and of 21% regarding haloperidol depot strategy. Under the hypothesis tested in scenario 1, LA risperidone is a partial dominant strategy against olanzapine and a total dominant strategy against haloperidol depot. In scenario 2, as efficacy is improved for haloperidol decanoate (61,10%), a decrease of 1,763 Euro in the cost per patient treated is observed for this strategy. Cost per patient treated successfully and efficacy for LA risperidone and olanzapine are the same than in the base case. LA risperidone is a total dominant strategy against olanzapine and haloperidol decanoate. In scenario 3, the rate of patients treated successfully at 2 years is 88,6% for LA risperidone with a cost per patient of 12,347 Euro. LA risperidone is dominant against olanzapine and haloperidol depot. DISCUSSION AND CONCLUSION: The schizophrenia is a relatively frequent disease. (ABSTRACT TRUNCATED)


Assuntos
Antipsicóticos/administração & dosagem , Antipsicóticos/economia , Assistência ao Paciente/economia , Esquizofrenia/tratamento farmacológico , Esquizofrenia/economia , Meio Social , Antipsicóticos/uso terapêutico , Benzodiazepinas/economia , Benzodiazepinas/uso terapêutico , Análise Custo-Benefício , Esquema de Medicação , Haloperidol/economia , Haloperidol/uso terapêutico , Humanos , Injeções , Olanzapina , Risperidona/economia , Risperidona/uso terapêutico
15.
J Virol Methods ; 123(1): 1-7, 2005 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-15582692

RESUMO

Real-time RT-PCR, combining amplification and detection of virus-specific amplicons, is a promising tool for norovirus detection in environmental or food samples such as shellfish. We developed a real-time RT-PCR assay based on one-step detection using single primer sets and probes for norovirus genogroups I and II. Seventy and seven RT-PCR units of genogroup I and II reference norovirus strains, respectively, were detected in artificially contaminated oysters. Validation of the new method on 150 archived naturally contaminated shellfish confirmed the utility of the genogroup II primer set to detect a large range of different strains circulating in France since 1995, but genogroup I strains were detected infrequently.


Assuntos
Norovirus/isolamento & purificação , Ostreidae/virologia , Frutos do Mar/virologia , Animais , Primers do DNA , Norovirus/classificação , Norovirus/genética , RNA Viral/análise , RNA Viral/isolamento & purificação , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Sensibilidade e Especificidade
16.
Diabetes Metab ; 29(3): 269-77, 2003 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-12909815

RESUMO

OBJECTIVE: To evaluate the cost of foot ulcers in diabetic patients. METHODS: Retrospective pharmacoeconomic study using direct and indirect costs (sick leave days) from the perspective of French social security system. RESULTS: 239 patients were included in the study by 80 physicians who treat diabetic patients suffering from foot ulcers. Initially identified by telephone survey, these physicians were primarily endocrinologists/diabetologists, general practitioners and surgeons. Average monthly costs in the treatment of foot ulcers were 697 euro; for outpatient care, 1556.20 euro; for hospital care (day treatment and short stays), and 34.76 euro; for sick leaves. When hospitalization was required, it represented approximately 70% of the average cost for foot ulcers. The portion of outpatient costs was principally generated by medical and paramedical treatments, and interventions carried out by healthcare personnel. On the other hand, medication only represented 10% of total costs. The initial severity of the pathology was a determinant clinical factor of high healthcare costs. In addition, the more recent the lesion was, the higher the cost of treatment. Amputation and follow-up by specialists were correlated to high costs as well, a logical result of these clinical factors. CONCLUSION: This analysis is the first to evaluate the cost of treating foot ulcers in such a large population of diabetic patients. The economic outcomes should help direct public authorities in their choices, particularly as regards the interest of treating these diabetes-related complications as early as possible.


Assuntos
Pé Diabético/economia , Custos e Análise de Custo , Medicina de Família e Comunidade/economia , Medicina de Família e Comunidade/normas , França , Humanos , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Garantia da Qualidade dos Cuidados de Saúde , Estudos Retrospectivos , Telefone
17.
Nephrologie ; 23(3): 123-30, 2002.
Artigo em Francês | MEDLINE | ID: mdl-12087809

RESUMO

In order to analyze changes in anemia management in the hemodialysis patients, a retrospective survey was performed in 1999 on a representative French sample of patients in hemodialysis treated by EPO since 1992, 1994, 1996, and 1998 respectively. 368 patients were enrolled in 97 centres. At treatment initiation, some patients characteristics have significantly changed: the percentage of type 2 diabetic patients has increased marquedly from 4.5% in 1992 to 22.1% in 1998. The mean time lag between dialysis and EPO treatment initiation has decreased from 3.3 years to 0.9 on the 6-year period. Lastly, the mean hemoglobin level has increased from 73.7 to 78.5 g/l. No significant evolution in the EPO protocol was observed at the initiation as well as in the maintenance phase. An average percentage of 33.7% of patients were treated in i.v. route at initiation with a mean posology of 105.2 IU/kg (respectively 91.4 in s.c.). In the first year of follow-up, the overall mean posology was 84 IU/kg. In conclusion, this survey suggests that anemia management has been optimized over the last 6 years follow-up, including an earlier initiation of EPO treatment and a higher target of hemoglobin while EPO needs were reduced in the same time.


Assuntos
Anemia/tratamento farmacológico , Eritropoetina/uso terapêutico , Falência Renal Crônica/terapia , Diálise Renal/efeitos adversos , Anemia/epidemiologia , Anemia/etiologia , Anemia/prevenção & controle , França/epidemiologia , Humanos , Diálise Peritoneal/efeitos adversos , Diálise Peritoneal/estatística & dados numéricos , Diálise Renal/estatística & dados numéricos
18.
Encephale ; 28(2): 129-38, 2002.
Artigo em Francês | MEDLINE | ID: mdl-11972139

RESUMO

UNLABELLED: In 2000, a one week national survey was conducted among 202 psychiatrists (129 participants) in France, from hospitals and clinics, private or public. The first 20 inpatients and 10 outpatients prescribed at least one antipsychotic drug (age range 18-65), were included. The diagnostic procedure was standardized with a structured interview: the Mini International Neuropsychiatric Interview (MINI). A total 2 068 patients were included, among whom 892 (43.1%) reached the criteria of schizophrenia according ICD-10. We present here data on these latter patients. Mean age was 38.8 years; with 38.8% females. Median duration of current antipsychotic treatment was 0.5 year in inpatients and 2 years in outpatients. Median duration of any antipsychotic treatment was 10 years, without difference between groups. Comorbid situations (anxiety disorder, depression and suicidal risk) were found in 33.1% of schizophrenic patients, with higher frequency among inpatients in private hospitals (54.8%) than in other groups. 46.8% patients were prescribed at least 2 neuroleptics, and 73.6% at least one non-neuroleptic drugs. Cyamemazine accounted for 16.6% of all neuroleptics drugs, and 56% of patients were prescribed an atypical antipsychotic (risperidone, olanzapine, amisulpride or clozapine). Atypical drugs accounted for 59.4% of patients who were prescribed only one neuroleptic drug. Inpatients had more neuroleptics coprescription than outpatients (mean 1.8 vs 1.4 drugs), with higher daily dose. In addition, inpatients had more other psychotropics prescribed (mean 1.5 vs 1.1 drugs). Overall, more other psychotropic drugs were prescribed among patients with -, than those without - comorbid situations (1.7 vs 1.2 drugs). Median time since admission, at the time of the study, were similar in private and public hospitals (107 vs 99 days) but maximal time since admission was respectively 2.8 and 48.9 years. Visit frequency for outpatients was more than one every two weeks for 43.1% in private and 24.7% in public clinics. Among inpatients only we found a difference between private and public hospitals for polypharmacy of non neuroleptics psychotropics, (mean 1.9 vs 1.5). In outpatients, long acting depot accounted for 26.6% of neuroleptics treatments in public clinics and 15.4% in private clinics. Finally, we found that polypharmacy among outpatients increased with duration of antipsychotic treatment. CONCLUSION: in France, important differences are reported in antipsychotic prescription for schizophrenia between in- and outpatients. Current antipsychotic prescription is more recent in inpatients than in outpatients, with similar duration of overall antipsychotic treatment. Inpatients have more drug prescription, antipsychotics and other psychotropics, than outpatients. Differences are less important between private and public providers. Inpatients in private hospitals receive more non neuroleptic drugs than in public hospitals, and depot antipsychotics are more used among patients of public clinics. Long term inpatients are found in public hospitals only. Outpatients follow up is more intensive in private than in public clinics.


Assuntos
Antipsicóticos/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Esquizofrenia/tratamento farmacológico , Adolescente , Adulto , Idoso , Assistência Ambulatorial/estatística & dados numéricos , Tratamento Farmacológico/estatística & dados numéricos , Feminino , França/epidemiologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Esquizofrenia/epidemiologia , Esquizofrenia/reabilitação , Fatores de Tempo
19.
Artigo em Inglês | MEDLINE | ID: mdl-11381706

RESUMO

The rutile-ring method of dielectrically frequency-temperature compensating a high-Q whispering gallery (WG) sapphire resonator is presented. Two and three-dimensional finite element (FE) analysis has been implemented to design and analyze the performance of such resonators, with excellent agreement between theory and experiment. A high-Q factor of 30 million at 13 GHz and compensation temperature of 56 K was obtained. It is shown the frequency-temperature compensation can occur either because the rutile adds a small perturbation to the sapphire resonator or because of a mode interaction with a resonant mode in the rutile. The characteristics of both of these methods are described, and it is shown that for high frequency stability, it is best to compensate perturbatively.

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