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1.
Arch Pediatr ; 22(5): 554-61, 2015 May.
Artigo em Francês | MEDLINE | ID: mdl-25840466

RESUMO

Children suffer most from today's increasing precariousness. In France, access to care is available for all children through various structures and existing measures. The support for foreign children is overseen by specific legislation often unfamiliar to caregivers. Pediatric emergencies, their location, organization, actors, and patient flow are a particular environment that is not always suitable to communication and may lead to situations of abuse. Communication should not be forgotten because of the urgency of the situation. The place of the child in the dialogue is often forgotten. Considering the triangular relationship, listening to the child and involving the parents in care are the basis for a good therapeutic alliance. Privacy and medical confidentiality in pediatric emergencies are governed by law. However, changes in treatments and medical practices along with the variety of actors involved imply both individual and collective limitations, to the detriment of medical confidentiality.


Assuntos
Comunicação , Confidencialidade , Serviços Médicos de Emergência/ética , Ética Médica , Acessibilidade aos Serviços de Saúde/ética , Criança , Confidencialidade/ética , Confidencialidade/legislação & jurisprudência , Serviços Médicos de Emergência/legislação & jurisprudência , França , Humanos , Admissão do Paciente/legislação & jurisprudência , Relações Médico-Paciente/ética , Relações Profissional-Família/ética , Refugiados/legislação & jurisprudência , Cobertura Universal do Seguro de Saúde/ética , Cobertura Universal do Seguro de Saúde/legislação & jurisprudência
2.
Fundam Clin Pharmacol ; 7(8): 435-41, 1993.
Artigo em Inglês | MEDLINE | ID: mdl-8294081

RESUMO

The pharmacokinetics of diacerein (a new anti-inflammatory analgesic antipyretic drug) following a single oral dose of 50 mg was studied in 12 healthy volunteers and two groups of eight patients with mild or severe renal insufficiency. Statistical analysis using a Kruskal-Wallis rank sum test showed a significant difference between the three groups for the following parameters. In severely uraemic patients, median AUC0-infinity was multiplied by a factor of ca 2: 40.5 mg h/l versus 21.3 in healthy subjects, P = 0.04; and t1/2 was prolonged by the same factor: 9.6 h versus 4.3 in the control group, P = 0.003. Apparent drug availability and renal clearance assessed through urinary data decreased with renal failure, respectively: 14.5% and 0.045 l/h versus 35.4% (P = 0.01) and 0.13 l/h (P = 0.008) in healthy subjects. Amounts of glucuro and sulfo conjugates in urine were lower in severely uraemic patients. Intermediate values were observed for mildly uraemic patients. Other parameters: lag-time, Cmax, tmax, Vss/F, urinary glucuro- to sulphoconjugate ratios did not change significantly. Apparent total clearance of rhein was poorly correlated with creatinine clearance and this was related to a decrease of non-renal clearance of rhein in renal insufficiency. It was concluded that, from a pharmacokinetic point of view, a reduction (50%) in the maintenance dosage of diacerein should be considered in severe renal failure.


Assuntos
Antraquinonas/farmacocinética , Anti-Inflamatórios não Esteroides/farmacocinética , Insuficiência Renal/metabolismo , Administração Oral , Adulto , Idoso , Antraquinonas/administração & dosagem , Antraquinonas/sangue , Anti-Inflamatórios não Esteroides/administração & dosagem , Creatinina/sangue , Creatinina/urina , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência Renal/sangue
3.
Pharmacoeconomics ; 13(1 Pt 2): 135-46, 1998 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-10176148

RESUMO

This 9-month pragmatic study compared 2 therapeutic regimens in the management of osteoarthritis of the hip and knee. Patients received either diacerein 100 mg/day plus standard osteoarthritic therapy for 6 months, followed by a 3-month monitoring period without diacerein, or standard therapy alone for the entire 9-month period. A total of 207 patients with osteoarthritis of the knee and hip were enrolled. Improvements in Lequense's functional index and quality-of-life scores (revised Arthritis Impact Measurement Scales Health Status Questionnaire and Nottingham Health Profile), and decreases in nonsteroidal anti-inflammatory drug and analgesic consumption were significantly greater with diacerein plus standard therapy than with standard therapy alone. The overall assessment of therapy by patients was good or excellent for 60% of those who received diacerein plus standard therapy, compared with 26% who received standard therapy alone. Medical and paramedical procedures carried out in addition to those stipulated in the protocol (medical consultations, physiotherapy, nursing, etc.), osteoarthritis-related, were fewer and less costly in the diacerein plus standard therapy group than in the standard therapy group. The average outpatient cost (in 1995 French francs) of osteoarthritis treatment in the standard therapy group was FF2272 compared with FF2360 in the diacerein plus standard therapy group. The cost-effectiveness ratios per point scored on Lequesne's index were FF1893 for the standard therapy group and FF1072 for the diacerein plus standard therapy group, leading to a saving of 43% with diacerein plus standard therapy. The marginal cost (additional cost corresponding to the clinical benefit obtained by adding diacerein to standard treatment) was FF88 per point scored on Lequesne's index.


Assuntos
Antraquinonas/economia , Anti-Inflamatórios não Esteroides/economia , Osteoartrite/economia , Idoso , Antraquinonas/efeitos adversos , Antraquinonas/uso terapêutico , Anti-Inflamatórios não Esteroides/efeitos adversos , Anti-Inflamatórios não Esteroides/uso terapêutico , Análise Custo-Benefício , Diarreia/induzido quimicamente , Método Duplo-Cego , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite/tratamento farmacológico , Estudos Prospectivos , Qualidade de Vida
4.
Rev Mal Respir ; 16(4): 521-8, 1999 Sep.
Artigo em Francês | MEDLINE | ID: mdl-10549062

RESUMO

The clinical efficacy of vectrine (erdosteine) was evaluated in the treatment of chronic bronchitis patients with hypersecretion during a controlled clinical trial having included 170 patients. For inclusion, the bronchitis patients had to be in a stable status (no exacerbation since at least three months). The patients received, in double-blind protocol, vectrine, one capsule b.i.d. or placebo, one similar capsule b.i.d. during a period treatment of 21 days. The results of the main evaluation criteria, the global index of efficacy (frequency of the cough + severity of the cough + difficulty in breathing + dyspnea) but also on the intensity and frequency of the cough were statistically significant in favor of vectrine. The safety of the treatment was excellent.


Assuntos
Bronquite/tratamento farmacológico , Expectorantes/uso terapêutico , Tioglicolatos/uso terapêutico , Tiofenos/uso terapêutico , Administração Oral , Adulto , Idoso , Bronquite/patologia , Doença Crônica , Método Duplo-Cego , Dispneia , Expectorantes/administração & dosagem , Expectorantes/farmacologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Tioglicolatos/efeitos adversos , Tioglicolatos/farmacologia , Tiofenos/efeitos adversos , Tiofenos/farmacologia , Resultado do Tratamento
5.
Rev Rhum Ed Fr ; 60(6 Pt 2): 83S-86S, 1993 Jul.
Artigo em Francês | MEDLINE | ID: mdl-8118457

RESUMO

Diacerhein is an anthraquinone derivative which is the active ingredient in ART 50. Its unique pharmacological activity involves inhibition of interleukin 1 and cartilage-degrading enzymes. In well-known animal models (carrageenin-induced oedema, adjuvant-induced arthritis, post-contusion or post-patellectomy osteoarthritis), diacerhein demonstrated antiinflammatory effects and protected against the development of osteoarthritis. In humans, approximately 30 studies have documented the efficacy of diacerhein in osteoarthritis. In acute exacerbations of osteoarthritis of the hip, efficacy of ART 50 on pain and on the algorfunctional index was significantly greater than that of a placebo and equivalent to that of tenoxicam on the 60th treatment day. ART 50 was as effective as naproxen after two months of treatment. Gastric tolerance has been excellent with diacerhein. Moderate transient diarrhea has been reported. Because of the promising results obtained with diacerhein in vitro and in animal models, a large human study has been designed to confirm the chondroprotective effect of ART 50.


Assuntos
Antraquinonas/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Osteoartrite/tratamento farmacológico , Antraquinonas/efeitos adversos , Antraquinonas/farmacologia , Anti-Inflamatórios não Esteroides/farmacologia , Cartilagem Articular/efeitos dos fármacos , Humanos , Interleucina-1/antagonistas & inibidores , Resultado do Tratamento
6.
Rev Rhum Ed Fr ; 60(6 Pt 2): 77S-81S, 1993 Jul.
Artigo em Francês | MEDLINE | ID: mdl-8118456

RESUMO

The "chondroprotective" activity of a drug must be tested not only in vitro but also in vivo. Because this would require several years in humans, animal models of osteoarthritis are used. A closed contusion of the patella caused by the impact of a 1-kg weight dropped from a height of one meter results in osteoarthritis. Twenty-three adult New Zealand rabbits were sacrificed 49 days after the contusion. Cartilages of both condyles and the patella were studied on 6-mu hematoxylin-eosin-stained serial sections. The morphologic osteoarthritis score (sum of gross and microscopic scores) was determined. Mean score was the mean value of scores for both condyles and the patella, whereas total score was the sum of scores at the three sites. The 23 rabbits were divided into four groups: controls (n = 6), controls + diacerhein (n = 5), contusion (n = 6), and contusion + diacerhein (n = 6). Diacetylrhein was given orally (3.5 mg/kg/d) throughout the 49-day interval between contusion and sacrifice. Mean and total scores showed no significant differences between the control, diacerhein, and diacerhein + contusion groups. Scores were significantly lower in the control group as compared with the contusion group (p < 0.03) and in the diacerhein + contusion group as compared with the contusion group (p < 0.05). Diacetylrhein given in as prophylactic treatment under the experimental conditions used prevented contusion-induced cartilage destruction and exhibited a "chondro-protective" effect.


Assuntos
Antraquinonas/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Cartilagem Articular/patologia , Modelos Animais de Doenças , Osteoartrite/tratamento farmacológico , Animais , Cartilagem Articular/efeitos dos fármacos , Feminino , Traumatismos do Joelho , Coelhos
10.
Ann Rheum Dis ; 65(3): 354-9, 2006 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-16322084

RESUMO

OBJECTIVE: To determine whether systemic markers of bone, cartilage, and synovium can predict structural progression of osteoarthritis (OA). METHODS: Patients with painful hip OA were treated with diacerein or placebo in a multicentre, prospective, double blind, 3 year follow up trial. The following information was collected at entry: demographics, characteristics of hip OA, and 10 markers: N-propeptides of collagen types I and III, cartilage oligomeric matrix protein, YKL-40, hyaluronan (sHA), matrix metalloproteinases-1 and -3, C reactive protein, C-terminal crosslinking telopeptides of collagen types I and II (uCTX-II). Radiographs were obtained at entry and every year. Structural progression was defined as a joint space decrease > or =0.5 mm or requirement for total hip replacement. Grouped survival analysis was performed with time to structural progression as dependent variable, and clinical data, radiographic findings, treatment groups (diacerein versus placebo), and markers as explanatory measures. RESULTS: In the 333 patients in whom all markers were measured, high functional impairment, a joint space width <2 mm, and lateral migration of the femoral head at baseline increased the risk of progression, but diacerein had a protective effect (relative risk = 0.75; 95% confidence interval (CI) 0.54 to 0.96). In addition, patients in whom uCTX-II and sHA were in the upper tertile had a relative risk of progression of 3.73 (95% CI 2.48 to 5.61) compared with patients with markers in the two lower tertiles. CONCLUSION: In this large cohort, combined measurements of uCTX-II and sHA were a new predictor of the structural progression of hip OA.


Assuntos
Cartilagem Articular/metabolismo , Colágeno/urina , Ácido Hialurônico/sangue , Osteoartrite do Quadril/patologia , Sinovite/diagnóstico , Idoso , Artroplastia de Quadril , Biomarcadores/sangue , Biomarcadores/urina , Progressão da Doença , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/diagnóstico por imagem , Osteoartrite do Quadril/metabolismo , Prognóstico , Estudos Prospectivos , Radiografia , Índice de Gravidade de Doença , Sinovite/sangue , Sinovite/urina
11.
Arthritis Rheum ; 37(4): 529-36, 1994 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-8147930

RESUMO

OBJECTIVE: To determine the efficacy and safety of diacerhein, a potential new therapeutic agent with properties differing from those of existing nonsteroidal anti-inflammatory drugs (NSAIDs), and of a combination of diacerhein and an NSAID (tenoxicam) in the treatment of osteoarthritis (OA) of the hip. METHODS: Two hundred eighty-eight patients with painful OA of the hip were enrolled in an 8-week randomized, double-blind, placebo-controlled, 2 x 2 factorial design study. Four treatment groups were defined: 1) diacerhein placebo and tenoxicam placebo, 2) tenoxicam and diacerhein placebo, 3) diacerhein and tenoxicam placebo, and 4) diacerhein and tenoxicam. The daily dosages of diacerhein and tenoxicam were 100 mg and 20 mg, respectively. RESULTS: Analyses of efficacy showed no interaction between diacerhein and tenoxicam in terms of efficacy, a clinically significant rapid (< or = 2 weeks) and persisting effect of tenoxicam during the 8 weeks of the study, and a slow-acting (6 weeks) effect of diacerhein. Moderate, transient diarrhea was the most frequent side effect observed in the diacerhein group (37%) compared with the placebo group (4%). CONCLUSION: Both tenoxicam and diacerhein appear to be superior to placebo, and neither agent appears to significantly enhance or detract from the efficacy of the other when they are administered concomitantly. The onset of action of diacerhein appears to be delayed (> or = 4 weeks).


Assuntos
Antraquinonas/administração & dosagem , Anti-Inflamatórios não Esteroides/administração & dosagem , Osteoartrite do Quadril/tratamento farmacológico , Piroxicam/análogos & derivados , Idoso , Antraquinonas/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos , Diarreia/induzido quimicamente , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Piroxicam/administração & dosagem , Piroxicam/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento
12.
Biopharm Drug Dispos ; 14(5): 401-8, 1993 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-8218958

RESUMO

The pharmacokinetics of diacerein following a single oral dose of 50 mg was studied in 12 healthy volunteers, 10 patients with a mild liver cirrhosis (Child Pugh's grade A), and 6 patients with a more severe liver cirrhosis (Child Pugh's grade B to C). Statistical analysis using a Kruskal-Wallis test showed no significant differences between the three groups for the following parameters: median Cmax was 3.9 mg l-1 for the cirrhotic patients group I (CPI) and 3.2 mg l-1 for the cirrhotic patients group II (CPII) versus 3.2 mg l-1 for the healthy volunteers (HV); median t1/2 was 4.9 h for CPI and 4.3 h for CPII versus 4.3 h for HV; median Cl/F was 2.1 l h-1 for CPI and 2.5 l h-1 for CPII versus 1.6 l h-1 for HV; median Vdss/F was 12.6 l for CPI and 14.0 l for CPII versus 13.21 for HV. The urinary parameters were comparable. It was concluded that, from a pharmacokinetic point of view, no reduction in the initial dosage of diacerein need be proposed in liver cirrhosis.


Assuntos
Antraquinonas/farmacocinética , Cirrose Hepática/metabolismo , Adulto , Antraquinonas/administração & dosagem , Antraquinonas/sangue , Antraquinonas/urina , Cápsulas , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
13.
Ann Rheum Dis ; 55(6): 356-62, 1996 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-8694574

RESUMO

OBJECTIVES: To determine a cut off value for changes in radiological joint space width that allowed definition of radiological progression of hip osteoarthritis not related to measurement method errors and, thereafter, to determine factors predictive of radiological progression of hip osteoarthritis and to evaluate the correlations between clinical and radiological parameters. METHODS: A prospective, longitudinal (one year duration), multicentre study was made of patients with osteoarthritis of the hip (American College of Rheumatology criteria). Data on clinical activity (pain, functional impairment), demographic data (age, gender, body mass index), and femoral head migration (superolateral, superomedial, concentric) were collected when the patient entered the study; radiological grade (joint space width in millimetres at the narrowest point using a 0.1 mm graduated magnifying glass, evaluated by a single observer unaware of the chronology of the films) was recorded at the patient's entry to the study and after one year. RESULTS: Analysis of the means of the differences between two analyses performed by a single observer of 30 pairs of radiographs (one performed after an interval of one year) (0.06 (SD 0.23)) suggested that a change of more than 0.56 mm (2 SD) after a one year follow up could define progression of osteoarthritis of the hip. Of the 508 patients recruited, 461 (91%) completed the one year follow up and radiological progression was observed in 102 (22%). The factors predictive of radiological progression that were identified in the multivariate analysis were: radiological joint space width at entry < or = 2 mm, superolateral migration of the femoral head, female gender, Lequesne's functional index > 10, age at entry > 65 years (odds ratios 2.11, 4.25, 2.51, 2.66, 1.90, respectively). The level of clinical parameters (pain, functional impairment) and the amount of symptomatic treatment required (non-steroidal anti-inflammatory drugs and analgesic intake) accounted for 20% (p < 0.0001) of the variability of the changes in radiological joint space width over the one year study period. CONCLUSION: These data suggest that radiological progression of hip osteoarthritis could be defined by a change in joint space width of at least 0.6 mm after a one year follow up period, is correlated with the changes in clinical status of the patients, and is related not only to demographic data (age, gender), but also to some specific characteristics of osteoarthritis (localisation, radiological severity, clinical activity).


Assuntos
Articulação do Quadril/diagnóstico por imagem , Osteoartrite do Quadril/diagnóstico por imagem , Idoso , Anti-Inflamatórios não Esteroides/uso terapêutico , Progressão da Doença , Feminino , Cabeça do Fêmur/diagnóstico por imagem , Seguimentos , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/tratamento farmacológico , Estudos Prospectivos , Radiografia , Fatores de Risco , Fatores Sexuais
14.
Osteoarthritis Cartilage ; 5(1): 17-22, 1997 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-9010875

RESUMO

The aim of the study was to assess whether radiographic hip joint space thickness was changed by weight-bearing (WB) compared with non weight-bearing (NWB) position, and to evaluate whether radiographs centered on the hip were more sensitive than pelvic X-rays to detect such a change. Anteroposterior radiographs of the pelvis were made in 30 patients with hip osteoarthritis OA (46 OA and 11 normal hips). Osteoarthritic, as well as contralateral normal hips were analyzed. Radiographs centered on OA hip were performed in 28 other patients. X-rays were made in WB and NWB positions using a standardized radiological procedure. Measurements of mean joint space width (MeanJSW) maximum joint space narrowing (MaxJSN) and joint space surface area (JSA), were made using a computerized image analysis system. The joint space width was unaffected by WB in normal joints but decreased with WB in OA joints. The decrease was significant only when considering MaxJSN in patients with a joint space thickness smaller than 2.5mm. The difference between WB and NWB was larger in radiographs centered on the hip than on pelvic X-rays. MeanJSW and JSA were found to be less sensitive than MaxJSN. The decrease of joint space width was inversely correlated with joint space size in WB. These results suggest that WB radiographs of the hip should be used in preference to NWB in studies of hip OA.


Assuntos
Artrografia/métodos , Cartilagem Articular/patologia , Osteoartrite do Quadril/diagnóstico por imagem , Osteoartrite do Quadril/patologia , Idoso , Animais , Feminino , Articulação do Quadril/diagnóstico por imagem , Articulação do Quadril/patologia , Humanos , Masculino , Pessoa de Meia-Idade
15.
Rev Rhum Engl Ed ; 64(12): 795-803, 1997 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-9476268

RESUMO

OBJECTIVES: To evaluate potential radiographic predictors of hip osteoarthritis progression. PATIENTS AND METHODS: A prospective, longitudinal two-year study was conducted in patients meeting American College of Rheumatology criteria for hip osteoarthritis. Hip osteoarthritis progression was defined as a greater than 0.5-mm decrease in joint space width measured using a magnifying glass marked at intervals of 0.1 mm, at the site of maximum joint space narrowing, by a single investigator who was blinded to the chronological order of the radiographs. Radiographic parameters determined at study entry were as follows: presence of osteophytes, osteosclerosis, and subchondral cysts; femoral head migration (superolateral, superomedial, concentric); and severity (joint space width in mm, Kellgren and Lawrence grade, subjective evaluation of joint space narrowing). RESULTS: In the 463 study patients, joint space width decreased from 2.2 +/- 0.8 at baseline to 1.7 +/- 1.0 mm after two years (P < 0.0001). Radiographic progression was seen in 148 patients (32%). Radiologic parameters predictive of disease progression in the multivariate analyses were as follows: CONCLUSION: Our data suggest that a number of baseline radiological features including distribution of joint space loss, subchondral bone production, and severity of joint space loss are predictive of progression of hip osteoarthritis.


Assuntos
Osteoartrite do Quadril/diagnóstico por imagem , Idoso , Artrografia/métodos , Progressão da Doença , Método Duplo-Cego , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Osteoartrite do Quadril/etiologia , Estudos Prospectivos , Índice de Gravidade de Doença
16.
J Rheumatol ; 26(4): 855-61, 1999 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-10229407

RESUMO

OBJECTIVE: To assess if total hip arthroplasty (THA) is a valid outcome measure of hip osteoarthritis (OA), in respect to clinical and radiological assessments. METHODS: A prospective 3 year study of patients who had painful hip OA with an initial radiographic joint space width > or =1 mm at the narrowest point. Dependent variable was THA. Patient data including body mass index, OA structural severity by radiograph, OA symptomatic severity (pain, function), and OA localization were recorded at entry. Pelvic radiographs were obtained before THA, when available, and once yearly during the study. RESULTS: During the study 106 of 506 patients underwent THA. Risk was estimated (Kaplan-Meier method) to be 8+/-1, 16+/-2, and 23+/-2% after 1, 2, and 3 years, respectively. Factors predisposing to requirement for surgery were: age > or =70 years, female sex, superolateral migration of the femoral head, joint space width <2 mm, Kellgren-Lawrence grade > or =3, pain (visual analog scale) > or =50 mm, and Lequesne index > or =10 with a relative risk of 1.65, 1.71, 1.96, 1.85, 1.89, 1.86, and 2.59, respectively. Mean change in joint space width was 0.22+/-0.50 vs 0.97+/-1.35 mm/year in patients without and with THA, respectively (p<0.0001). Changes in radiological joint space width during the first year were highly predictive of requirement for THA during the 2 following years (risk of 5, 13, 25, and 79% in patients with a radiological joint space width worsening during the first year of 0, < or =25, >25 and < or =50, and >50%, respectively). CONCLUSION: These data suggest that THA could be considered as a valid outcome measure in OA. However, further studies should be conducted in other countries with different health care systems to evaluate the inter-country reliability of this measurement.


Assuntos
Artroplastia de Quadril , Osteoartrite do Quadril/diagnóstico , Osteoartrite do Quadril/cirurgia , Avaliação de Resultados em Cuidados de Saúde/métodos , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos Testes , Fatores de Risco , Sensibilidade e Especificidade
17.
Arthritis Rheum ; 44(11): 2539-47, 2001 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-11710710

RESUMO

OBJECTIVE: To evaluate the ability of diacerein, an interleukin-1beta inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis (OA). METHODS: In this randomized, double-blind, placebo-controlled 3-year study, 507 patients with primary OA of the hip (by the American College of Rheumatology criteria) received diacerein (50 mg twice a day) or placebo. The minimal hip joint space width was measured by a central reader on yearly pelvic radiographs, using a 0.1-mm-graduated magnifying glass. RESULTS: Baseline characteristics were comparable in the 2 treatment groups (255 patients receiving diacerein, 252 receiving placebo); 238 patients (47%) discontinued the study, mainly because of adverse events in the diacerein group (25% versus 12% with placebo) and because of inefficacy in the placebo group (14% versus 7% with diacerein). The percentage of patients with radiographic progression, defined by a joint space loss of at least 0.5 mm, was significantly lower in patients receiving diacerein than in patients receiving placebo, both in the intent-to-treat analysis and in the completer analysis (50.7% versus 60.4% [P = 0.036] and 47.3% versus 62.3% [P = 0.007], respectively). In those patients who completed 3 years of treatment, the rate of joint space narrowing was significantly lower with diacerein (mean +/- SD 0.18 +/- 0.25 mm/year versus 0.23 +/- 0.23 mm/year with placebo; P = 0.042). Diacerein had no evident effect on the symptoms of OA in this study. However, a post hoc covariate analysis that took into account the use of analgesics and antiinflammatory drugs showed an effect of diacerein on the Lequesne functional index. Diacerein was well tolerated during the 3-year study. The most frequent adverse events were transient changes in bowel habits. CONCLUSION: This study confirms previous clinical findings indicating that the demonstration of a structure-modifying effect in hip OA is feasible, and shows, for the first time, that treatment with diacerein for 3 years has a significant structure-modifying effect as compared with placebo, coupled with a good safety profile. The clinical relevance of these findings requires further investigation.


Assuntos
Antraquinonas/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Osteoartrite do Quadril/tratamento farmacológico , Doenças do Sistema Digestório/induzido quimicamente , Doenças do Sistema Digestório/fisiopatologia , Método Duplo-Cego , Feminino , Articulação do Quadril/diagnóstico por imagem , Articulação do Quadril/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/diagnóstico por imagem , Osteoartrite do Quadril/fisiopatologia , Dor/tratamento farmacológico , Dor/fisiopatologia , Medição da Dor , Radiografia , Índice de Gravidade de Doença , Dermatopatias/induzido quimicamente , Dermatopatias/fisiopatologia , Resultado do Tratamento , Doenças Urológicas/induzido quimicamente , Doenças Urológicas/fisiopatologia
18.
Rheumatology (Oxford) ; 41(2): 142-7, 2002 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-11886961

RESUMO

OBJECTIVE: To determine a cut-off point above which a change in joint space width (JSW) could be considered as relevant in patients with hip osteoarthritis (OA) on the basis of predicted need for subsequent total hip arthroplasty (THA). METHODS: A multicentre, prospective, longitudinal, 5-yr follow-up study was performed. A pelvic radiograph was obtained at entry and after 1 and 2 yr. For each film, the narrowest JSW was measured using a 0.1 mm graduated magnifying glass. The absolute and relative differences between baseline and 1 and 2 yr of follow-up were calculated. We determined the cut-off points above which an absolute or relative decrease in JSW between baseline and 1 and 2 yr of follow-up could be considered relevant on the basis of the predicted need for THA during the remaining years of the study. The need for THA was categorized as 'yes' or 'no'. Thereafter, for each observed change in JSW (0.1 per 0.1 mm or 1% per 1%), the sensitivity and specificity for subsequent THA were calculated. The choice of cut-off was based on maximal sensitivity and specificity, using the graphic representation of correct classification probabilities. In this way it was possible to obtain the best measured JSW threshold with maximal true positive and minimal false positive results. RESULTS: A total of 423 and 385 patients met the criteria for analysis using the decrease in JSW between baseline and 1 and 2 yr respectively. The best cut-off points were absolute decreases in JSW of 0.2 and 0.4 mm and relative decreases in JSW of 15 and 20% after 1 and 2 yr respectively, with corresponding ranges of sensitivity and specificity of 68-75 and 67-78%. CONCLUSION: This work determined the cut-off above which a change in JSW could be considered clinically relevant in patients with hip OA, on the basis of predicted subsequent need for THA. For validation, similar studies should be conducted in other countries with different health-care systems.


Assuntos
Artroplastia de Quadril/estatística & dados numéricos , Osteoartrite do Quadril/diagnóstico por imagem , Osteoartrite do Quadril/cirurgia , Idoso , Progressão da Doença , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/epidemiologia , Avaliação de Resultados em Cuidados de Saúde , Valor Preditivo dos Testes , Estudos Prospectivos , Radiografia
19.
Rheumatology (Oxford) ; 41(2): 148-52, 2002 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-11886962

RESUMO

AIM: To determine the minimum clinically important difference (MCID) in joint space width (JSW) progression in patients with hip osteoarthritis (OA), based upon evaluation by a panel of clinical experts as a gold standard. METHODS: A sample of 298 patients with hip OA was selected from a multicentre, prospective, longitudinal, 3-yr follow-up study. A pelvic radiograph was obtained at entry and after 3 yr. For each film, the narrowest JSW was measured using a 0.1-mm graduated magnifying glass. The difference between baseline and 3-yr follow-up JSW was calculated. Two senior rheumatologists, who were experts in osteoarthritis, evaluated each pair of films and noted whether a clinically relevant deterioration in osteoarthritis stage occurred at 3 yr compared with baseline. Interobserver reliabilities were evaluated using the kappa coefficient and proportions of agreements. Then, for each measured difference in JSW (0.1 mm per 0.1 mm), the sensitivity and specificity for MCID, defined as the assessment of expert 1, expert 2 or a combination of both, were calculated. This allowed us to obtain, from graphic representations of the correct classification probabilities, the best measured JSW threshold, with the maximal true positive and the minimal false positive results. RESULTS: The mean measured change in JSW was -0.63 +/- 0.74 mm. Experts 1 and 2 considered the decrease in JSW to be clinically relevant in 122 (40.9%) and 100 pairs (33.6%) respectively. The proportion of agreements between the experts was 79.9%, with a kappa coefficient of 0.572. The best measured JSW threshold was -0.4 mm for expert 1, expert 2 and the combination of both; sensitivity and specificity were 0.75 and 0.8, 0.71 and 0.72, and 0.75 and 0.7 respectively. CONCLUSION: This study suggests that a change of at least 0.4 mm in the radiological JSW could be considered clinically relevant. Other studies using other sets of patients and other methods are needed for validation.


Assuntos
Osteoartrite do Quadril/diagnóstico por imagem , Reumatologia/estatística & dados numéricos , Idoso , Progressão da Doença , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Avaliação de Resultados em Cuidados de Saúde , Estudos Prospectivos , Radiografia , Distribuição Aleatória , Sensibilidade e Especificidade
20.
Ann Rheum Dis ; 62(10): 931-4, 2003 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-12972469

RESUMO

OBJECTIVE: To evaluate sex differences in the clinical and structural presentation, and natural history of hip OA. METHODS: A multicentre, prospective, longitudinal, five year follow up study of 508 patients (302 women, 206 men, mean age 63 (7) years) with painful hip OA. Data collected were baseline demographics, symptomatic, therapeutic, and structural variables; symptomatic variables and changes in joint space width (JSW) during the first year's follow up; requirement for total hip arthroplasty (THA) between the end of the first and fifth years. STATISTICAL ANALYSIS: evaluation of sex differences (a) at baseline, in the main characteristics of hip OA using multivariate logistic regression; (b) during the first year of follow up, in the radiological progression of the disease; (c) during the five years of follow up, in the requirement for THA using Kaplan-Meier curves and the log rank test, and of the parameters related to THA, using a multivariate Cox analysis. RESULTS: At entry, women presented more frequently than men with polyarticular OA (mean (SD) articular score 306 (162) v 235 (127)), and superomedial migration of the femoral head (40% v 19%), and had more severe symptomatic disease (patient's overall assessment 46 (23) v 40 (26)). The change in JSW did not differ between women and men after one year, but a greater proportion of women had rapid structural progression (OR=2.34, 95% CI 1.1 to 5.2). THA was performed more often in women. Multivariate analysis suggested that the decision to perform surgery was related more closely to the symptomatic and structural severity of the disease than to the sex of the patient. CONCLUSION: Hip OA in women is more frequently part of a polyarticular OA, and displays greater symptomatic and structural severity.


Assuntos
Artroplastia de Quadril , Osteoartrite do Quadril/cirurgia , Fatores Sexuais , Idoso , Artrografia , Índice de Massa Corporal , Feminino , Seguimentos , Articulação do Quadril/diagnóstico por imagem , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Quadril/diagnóstico por imagem , Seleção de Pacientes , Estudos Prospectivos
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