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1.
Stud Health Technol Inform ; 264: 793-797, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31438033

RESUMO

Potentially inappropriate prescribing of direct oral anticoagulants is frequent with the most common errors being dosage, administration, and duration of therapy. We developed RecosDoc-MTeV, a documentary-based clinical decision support system (CDSS) for the management of direct oral anticoagulant prescription to prevent and treat venous thromboembolism. Simultaneously, the network of Parisian public hospitals (AP-HP, France) developed narrative clinical practice guidelines (CPGs) and a companion smartphone application to enhance medication and patient safety related to direct oral anticoagulant prescription. To assess the effectiveness of these CDS tools, we performed a retrospective review of 274 random patients hospitalized in 2017, which were either at risk of venous thromboembolism or actually treated for the disease. Consistency between the two CDS tools was measured at 96.7%. Administered treatments were compliant in 67.2% and 72.3% of the cases, with AP-HP CPGs and RecosDoc-MTeV, respectively. These results support that implementing CDSSs for the prescription of direct oral anticoagulants may ensure safe prescribing of high-risk medications.


Assuntos
Anticoagulantes/uso terapêutico , Tromboembolia Venosa , Administração Oral , França , Humanos , Estudos Retrospectivos , Tromboembolia Venosa/tratamento farmacológico
2.
J Chemother ; 28(6): 494-499, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27535294

RESUMO

INTRODUCTION: The active clinical research programme of trabectedin continues to improve knowledge on the therapeutic activity and toxicity of the drug in the treatment of soft tissue sarcomas (STS). In contrast, limited number of data is available on its use outside of clinical trials. PATIENTS AND METHODS: We retrospectively analysed efficacy and safety of trabectedin when given in daily practice to patients with advanced/recurrent STS. Outcomes were compared with previously published works including clinical and retrospective studies. RESULTS: Forty-five patients received trabectedin between January 2005 and May 2014. Sarcomas were histologically heterogeneous in our cohort (37.9% of other types of sarcomas than L-sarcomas). Our patients had poor baseline health status (ECOG ≥ 2 [17.8%]) and had received multiple previous lines of chemotherapy. Patients received a median of five cycles of treatment (1-22). The objective response rate was statistically superior in our study (37.8%) compared to the other works. However, median PFS was similar. Trabectedin-related serious adverse events (AEs) induced hospitalizations and treatment discontinuation in 22 and 15% of patients. CONCLUSION: This analysis confirms the efficacy of trabectedin in clinical practice (with a third of patients experiencing prolonged disease control) and highlighted the importance of its administration as early line therapy to allow the best management of serious AEs.


Assuntos
Antineoplásicos Alquilantes/uso terapêutico , Dioxóis/uso terapêutico , Sarcoma/tratamento farmacológico , Tetra-Hidroisoquinolinas/uso terapêutico , Dioxóis/administração & dosagem , Dioxóis/efeitos adversos , Intervalo Livre de Doença , França , Humanos , Estudos Retrospectivos , Sarcoma/diagnóstico , Tetra-Hidroisoquinolinas/administração & dosagem , Tetra-Hidroisoquinolinas/efeitos adversos , Trabectedina
3.
Expert Opin Pharmacother ; 14(9): 1241-53, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23614756

RESUMO

INTRODUCTION: Levofloxacin , the l-isomer of ofloxacin has become one of the cornerstones of antibiotic therapy of pyelonephritis since its introduction in the 1990s, thanks to its exceptional pharmacokinetic (PK) and pharmacodynamic (PD) profile, broad-spectrum antibacterial action and satisfactory tolerance. However, the emergence of widespread fluoroquinolone resistance over the past decade, has prompted to re-examine its place in the treatment of urinary tract infection. AREAS COVERED: This review covers the medical literature in any language through December 2012, on 'levofloxacin'. To identify relevant articles, the search terms 'pyelonephritis', 'urinary tract infections', 'levofloxacin', 'levaquin' and 'ofloxacin' were obtained through PubMed, MEDLINE and Clinicaltrials.gov queries. The authors focus on clinical trials, articles related to the PK and PD properties of levofloxacin as well as recent development in the mechanisms and prevalence of levofloxacin resistance. Major points stemming from international guidelines are also reviewed. EXPERT OPINION: Levofloxacin has achieved satisfactory bacterial eradication rates and clinical success across all available trials, similar to the antibiotic comparator. High-dose (750 mg) orally administrated levofloxacin over a short 5-day course is a reasonable option for patients eligible for outpatient management. Levofloxacin is no longer a suitable option for first-line empirical treatment of pyelonephritis in areas where resistance rates are high (> 10%) when pyelonephritis is hospital-acquired. Efforts to promote fluoroquinolone-sparing agents should be encouraged and its prescription should be performed in compliance with antimicrobial guidelines.


Assuntos
Antibacterianos/uso terapêutico , Levofloxacino/uso terapêutico , Pielonefrite/tratamento farmacológico , Administração Oral , Assistência Ambulatorial , Antibacterianos/efeitos adversos , Antibacterianos/farmacologia , Farmacorresistência Bacteriana , Humanos , Levofloxacino/efeitos adversos , Levofloxacino/farmacologia , Guias de Prática Clínica como Assunto , Pielonefrite/microbiologia , Infecções Urinárias/tratamento farmacológico , Infecções Urinárias/microbiologia
4.
Eur Urol ; 59(1): 148-54, 2011 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-21030144

RESUMO

BACKGROUND: Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP). OBJECTIVE: To establish the superiority of duloxetine over placebo in SUI after RP. DESIGN, SETTING, AND PARTICIPANTS: We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80mg of duloxetine daily or matching placebo for 3 mo. MEASUREMENTS: The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events. RESULTS AND LIMITATIONS: Thirty-one patients were randomised to either the treatment (n=16) or control group (n=15). Reduction in IEF was significant with duloxetine compared to placebo (mean±standard deviation [SD] variation: -52.2%±38.6 [range: -100 to +46] vs +19.0%±43.5 [range: -53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0-101.4; p<0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p=0.006, p=0.02, p=0.0004, and p=0.003, respectively). Both treatments were well tolerated throughout the study period. CONCLUSIONS: Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP.


Assuntos
Inibidores da Captação Adrenérgica/uso terapêutico , Prostatectomia/efeitos adversos , Inibidores de Captação de Serotonina/uso terapêutico , Tiofenos/uso terapêutico , Incontinência Urinária/prevenção & controle , Inibidores da Captação Adrenérgica/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Distribuição de Qui-Quadrado , Método Duplo-Cego , Cloridrato de Duloxetina , Humanos , Masculino , Pessoa de Meia-Idade , Paris , Projetos Piloto , Efeito Placebo , Estudos Prospectivos , Qualidade de Vida , Inibidores de Captação de Serotonina/efeitos adversos , Inquéritos e Questionários , Tiofenos/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Incontinência Urinária/etiologia
5.
Bull Cancer ; 95 FMC Onco: F37-43, 2008 May 28.
Artigo em Francês | MEDLINE | ID: mdl-18511365

RESUMO

Few elderly cancer patients are included in clinical trials, resulting insuffisant data of the effectiveness and tolerance of anticancer drugs in this patient population. The aim of this study was to analyse the studies concerning the effectiveness and tolerance of chemotherapy prescribed for elderly patients treated for colorectal, breast and lung cancer. The data of this population showed that the older patients are less likely to receive chemotherapy than the younger. The age is considered as significant important factor for the decision of chemotherapy of this population. However elderly patients seem to have the same benefit as compared with younger patients. Rather than the criteria of age, comorbidities should be considered. It is necessary to develop specific geriatric assessment and development of clinical trials specifically including elderly patients remains a necessity.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Quimioterapia Adjuvante , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Fase III como Assunto , Neoplasias Colorretais/patologia , Feminino , Humanos , Masculino
6.
J Clin Oncol ; 25(24): 3732-8, 2007 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-17704423

RESUMO

PURPOSE: This randomized, 2 x 2 factorial study compared a semimonthly regimen (fluorouracil [FU] and leucovorin [LV] semi-monthly is LV5FU2) with a monthly regimen of FU and LV (mFU/LV) as well as 24 weeks versus 36 weeks of each regimen as adjuvant treatment of stage II and III colon cancer. PATIENTS AND METHODS: LV5FU2 was administered semimonthly for 2 days as racemate (dl) or levogyre (l-; 200 or 100 mg/m(2)) as a 2-hour infusion, followed by 400 mg/m(2) FU bolus and a 600-mg/m(2) FU 22-hour continuous infusion. FU and LV were administered monthly (mFU/LV) for 5 days as dl- or l-LV 15-minute infusion, followed by a 400 mg/m(2) FU 15-minute infusion. The primary end point was disease-free survival (DFS). RESULTS: Between September 1996 and November 1999, 905 patients with stage II (43%) and III (57%) colon cancer were enrolled. The median follow-up was 6 years. There was no statistically significant difference between mFU/LV and LV5FU2 in terms of DFS (150 v 148 events; hazard ratio [HR],1.01; 95% CI, 0.806 to 1.269; P = .94) and overall survival (OS; 104 v 103 events; HR,1.02; 95% CI, 0.77 to 1.34; P = .91). No statistical difference was observed between 24 or 36 weeks of chemotherapy. Median survival from metastatic relapse was 24 months. The survival of patients with metastatic relapse (n = 243) was significantly longer for patients with a longer time from random assignment to relapse (< 1, 1 to 2, >or= 2 years; log-rank test for trend P, .0497). CONCLUSION: DFS and OS were not statistically different between treatment groups and treatment durations. These data confirm the value of LV5FU2 as control arm in the Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer and Pan-European Trials in Adjuvant Colon Cancer studies.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias do Colo/tratamento farmacológico , Quimioterapia Adjuvante , Neoplasias do Colo/mortalidade , Neoplasias do Colo/patologia , Intervalo Livre de Doença , Esquema de Medicação , Fluoruracila/administração & dosagem , Seguimentos , Humanos , Leucovorina/administração & dosagem , Recidiva Local de Neoplasia , Prognóstico , Taxa de Sobrevida
8.
Presse Med ; 36(5 Pt 1): 786-93, 2007 May.
Artigo em Francês | MEDLINE | ID: mdl-17303370

RESUMO

INTRODUCTION: Heparin-induced thrombocytopenia (HIT) is a serious immune complication of heparin therapy and presents a risk of severe thromboembolic events. Withdrawal of heparin together with administration of an alternative antithrombotic agent is always necessary in patients with suspected HIT. Diagnosis of this complication, however, is often difficult, particularly in hospitalized patients. The aim of this study was to evaluate the impact of multidisciplinary consultation on the appropriate prescription of danaparoid, widely used as an alternative antithrombotic treatment in HIT. MATERIAL AND METHODS: Multidisciplinary consultation between clinician, hematologist, and pharmacist called for reassessment of the HIT diagnosis at day 3 and between day 3 and 10 after the beginning of danaparoid treatment. Continuation or stopping treatment depended on their joint conclusion. All danaparoid prescriptions were evaluated according to this procedure for one year. RESULTS: HIT was suspected in 26 in-patients. The multidisciplinary approach made it possible to reassess the HIT diagnosis on day 3 and stop the alternative treatment in 42.3% of cases. Danaparoid use decreased by 52% compared with the previous year. CONCLUSION: Multidisciplinary consultations between clinician, hematologist, and pharmacist appear useful for minimizing inappropriate prescription of this alternative treatment in cases of suspected HIT.


Assuntos
Anticoagulantes/uso terapêutico , Sulfatos de Condroitina/uso terapêutico , Dermatan Sulfato/uso terapêutico , Prescrições de Medicamentos , Fibrinolíticos/uso terapêutico , Heparina/efeitos adversos , Heparitina Sulfato/uso terapêutico , Trombocitopenia/induzido quimicamente , Trombocitopenia/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Heparina/imunologia , Heparina/uso terapêutico , Hospitalização , Humanos , Pessoa de Meia-Idade , Equipe de Assistência ao Paciente , Contagem de Plaquetas , Probabilidade , Encaminhamento e Consulta , Estudos Retrospectivos , Trombocitopenia/sangue , Trombocitopenia/etiologia , Trombocitopenia/prevenção & controle , Fatores de Tempo
9.
Bull Cancer ; 91(10): 769-77, 2004 Oct.
Artigo em Francês | MEDLINE | ID: mdl-15556877

RESUMO

Anticancer drugs off label used in Tenon hospital were analysed by a panel of 12 experts not working at Tenon hospital. They distinguished 3 groups of off-label prescribing according to scientific evidence, labelling anticancer drugs alternative in presence and patient's characteristics: justified off label used (62%), unjustified off label used (26%) and prescriptions for which no consensus had been reached between the experts (12%). Nineteen per cent of unjustified off label used had labelling alternative and 7% did not have anticancer drugs labelling alternative. Questions who experts had to answer to analyse drugs prescribing could be systematically asked when a chemotherapy is prescribed. It could allowed to take into account scientific, economic and ethical requirements. This method proposed by the local drug committee could be used to regulate economic resources and to justify financing of some expensive anticancer drugs.


Assuntos
Antineoplásicos/uso terapêutico , Rotulagem de Medicamentos , Neoplasias/tratamento farmacológico , Prescrições de Medicamentos , Humanos , Auditoria Médica , Comitê de Farmácia e Terapêutica
10.
Bull Cancer ; 91(5): 437-43, 2004 May.
Artigo em Francês | MEDLINE | ID: mdl-15281283

RESUMO

A practice survey was performed in Tenon hospital on 396 consecutive patients treated for solid tumors during 4 weeks in november 2002. 33% of anticancer drugs were off label used. The wording heterogeneity of the different anticancer drugs approved labeling and the lack of anticancer drugs in a number of cancers can explain those results. On one hand, randomised comparative clinical trial, considered as the best level of evidence to obtain a label used, is not always possible in cancerology, especially for rare tumors. One the other hand, pharmaceutical firm are not obliged to asked a label used for an anticancer drugs in spite of high level of evidence. So, label used can not be the own references for anticancer drugs prescribing, therapeutic advanced can be realised and disseminated before their taking into account in the label used.


Assuntos
Antineoplásicos/uso terapêutico , Revisão de Uso de Medicamentos , Neoplasias/tratamento farmacológico , Rotulagem de Medicamentos , Humanos
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