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J Pharm Biomed Anal ; 150: 15-24, 2018 Feb 20.
Artigo em Inglês | MEDLINE | ID: mdl-29202304


A fast analytical method for the simultaneous detection of 24 ß2-agonists in human urine was developed and validated. The method covers the therapeutic drugs most commonly administered, but also potentially abused ß2-agonists. The procedure is based on enzymatic deconjugation with ß-glucuronidase followed by SPE clean up using mixed-phase cartridges with both ion-exchange and lipophilic properties. Instrumental analysis conducted by UHPLC-MS/MS allowed high peak resolution and rapid chromatographic separation, with reduced time and costs. The method was fully validated according ISO 17025:2005 principles. The following parameters were determined for each analyte: specificity, selectivity, linearity, limit of detection, limit of quantification, precision, accuracy, matrix effect, recovery and carry-over. The method was tested on real samples obtained from patients subjected to clinical treatment under chronic or acute therapy with either formoterol, indacaterol, salbutamol, or salmeterol. The drugs were administered using pressurized metered dose inhalers. All ß2-agonists administered to the patients were detected in the real samples. The method proved adequate to accurately measure the concentration of these analytes in the real samples. The observed analytical data are discussed with reference to the administered dose and the duration of the therapy.

Agonistas de Receptores Adrenérgicos beta 2/urina , Cromatografia Líquida de Alta Pressão/métodos , Espectrometria de Massas em Tandem/métodos , Adolescente , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Limite de Detecção , Masculino , Inaladores Dosimetrados , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Adulto Jovem
Lung Cancer ; 89(3): 350-6, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26164208


OBJECTIVES: To analyze changes in pulmonary function and quality of life (QoL) at different time points after Stereotactic Ablative Radiotherapy (SABR) for early stage inoperable lung cancer, and potential correlations between radiation dose-volume parameters and pulmonary toxicity or changes in pulmonary function tests (PFT) and QoL. MATERIALS AND METHODS: From July 2012 to October 2013, 30 patients were enrolled in this prospective observational study. Complete PFT were performed and Lung Cancer Symptoms Scale (LCSS) questionnaire administered prior to SABR; all patients then underwent Computed Tomography (CT) scan and PFT at 45, 135, 225 and 315 days after SABR, together with LCSS questionnaire. Clinical lung toxicity and radiological toxicity (acute and late) were prospectively recorded by using the Radiation Therapy Oncology Group (RTOG) scoring system. RESULTS: A decline in Slow Vital Capacity (SVC), Forced Expiratory Volume in 1s (FEV1), Single-breath lung diffusing capacity (DLCO) and blood partial pressure of oxygen (PaO2) was seen at 135 days post-SABR. PaO2 values rescued to normal levels at 315 days. None of the baseline PFT parameters resulted to be associated with the occurrence of pulmonary toxicity or with late radiological changes. Mean V5, V10, and V20 and MLD2Gy were higher in patients who developed radiation pneumonitis, even if not significantly associated at Cox regression analysis. LCSS QoL showed a significant worsening of the single item fatigue at 135 days after SABR. CONCLUSIONS: A small (mean 10%) but significant decline in lung volumes and DLCO was recorded after SABR, with clinical impact of such change difficult to estimate in individual patients. Global QoL was not significantly impaired. Dose-volume parameters did not emerge as significantly predictive of any clinical, radiological or functional toxicity.

Carcinoma Pulmonar de Células não Pequenas/epidemiologia , Carcinoma Pulmonar de Células não Pequenas/fisiopatologia , Neoplasias Pulmonares/epidemiologia , Neoplasias Pulmonares/fisiopatologia , Qualidade de Vida , Testes de Função Respiratória , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Feminino , Humanos , Estimativa de Kaplan-Meier , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/cirurgia , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Estudos Prospectivos , Radiocirurgia/efeitos adversos , Radiocirurgia/métodos , Fatores de Risco , Resultado do Tratamento
J Neurol ; 255(9): 1315-23, 2008 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-18825438


We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFNbeta-1b) 375 microg (subcutaneously [sc] every other day [eod]) in relapsing-remitting multiple sclerosis (RRMS) patients with a suboptimal response to IFNbeta-1b 250 microg, i.e., with MRI activity or relapses. The OPTimization of Interferon for MS (OPTIMS) study was a prospective multicenter randomized phase 2 trial comprising a 6-month run-in phase (to identify suboptimal responders) and a 6-month randomized phase of open-label clinical and blinded MRI follow-up. During run-in all patients were treated with IFNbeta-1b 250 microg sc eod; during the study phase suboptimal treatment responders were randomized either to IFNbeta-1b 250 or 375 microg sc eod. Primary outcome was the proportion of patients without MRI activity during study Months 9-12 according to the intention-to-treat principle. 216 RRMS patients entered the study: 83 suboptimal responders were identified and randomized, 7 refused to continue treatment, 76 were included in the analysis. More patients treated with 375 microg had no MRI activity at Months 9-12 (30/36 vs.16/40; relative risk, 0.28; 95 % confidence interval, 0.08-0.47; p = 0.0001). Sensitivity analysis ("worst case scenario") confirmed the results. No new or unexpected adverse events were observed, but there was a trend towards more withdrawals in the 375 microg group. Increasing the dose of IFNbeta-1b from 250 microg to 375 microg is a successful strategy for reducing subclinical signs of disease activity in RRMS patients. Further studies are needed to show whether this dose may also improve clinical efficacy.

Interferon beta/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Adjuvantes Imunológicos/administração & dosagem , Adjuvantes Imunológicos/efeitos adversos , Adjuvantes Imunológicos/uso terapêutico , Adolescente , Adulto , Relação Dose-Resposta a Droga , Esquema de Medicação , Seguimentos , Humanos , Injeções Subcutâneas , Interferon beta-1b , Interferon beta/administração & dosagem , Interferon beta/efeitos adversos , Imageamento por Ressonância Magnética/métodos , Pessoa de Meia-Idade , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Estudos Prospectivos , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
J Neurol Sci ; 259(1-2): 104-8, 2007 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-17376486


Adherence to long-term therapy has always been a problem in all fields of medicine. In multiple sclerosis (MS), treatment consists of parenteral administration of immune-modulating drugs once or several times weekly for an as yet undetermined length of time. Different studies on the MS patients' compliance showed that the most frequent cause of stopping treatment is the perceived lack of efficacy and that most treatment withdrawals occur during the first year of treatment. A trial aimed to identify the minimum effective IFNbeta dose showed that some patients had disease activity after switching to a lower IFNbeta dose. OPTIMS (OPTimization of Interferon dose for MS study) was a multicenter study, involving 24 Italian MS centers, 216 patients, aimed to identify a treatment response indicator allowing the early identification of poorly responding patients. A single active scan during the first 6 months of IFN treatment had a significant positive predictability of 59% (95% confidence interval, 41-76; p=0.05) on the presence of clinical signs of disease activity during the further 2-year follow-up.

Adjuvantes Imunológicos/uso terapêutico , Interferon beta/uso terapêutico , Esclerose Múltipla/tratamento farmacológico , Resultado do Tratamento , Humanos