ABSTRACT
PURPOSE: Paclitaxel-coated balloon catheters inhibit restenosis after coronary and peripheral angioplasty (PCI,PTA). The aim of this study was to investigate paclitaxel plasma levels and laboratory parameters following PTA with paclitaxel-coated balloons (PCB) in peripheral arteries. MATERIALS AND METHODS: This single treatment arm, multicenter study included 14 patients with Rutherford stage 1 - 5 with occlusions of up to 5 cm or ≥ 70 % diameter stenosis of the superficial femoral or popliteal arteries (SFA, PA). PTA was performed using up to three PCB catheters. The paclitaxel plasma levels and safety laboratory parameters were determined by collecting blood samples pre-intervention, immediately post-intervention, at 0.5, 1, 2, 4, 8, 24 hours and 1 and 4 weeks post-intervention (p. i.). Vital signs were monitored to assess clinical safety. RESULTS: PTA was performed successfully in all patients. Paclitaxel plasma levels were always below a level and duration known to cause systemic side effects. A mean peak paclitaxel plasma level (40 ng/ml) was reached immediately p. i. and decreased rapidly below detectable levels in more than half of the patients already 2 hours p. i. The paclitaxel plasma concentrations returned to values below detectable levels at 24 hours p. i. in all patients. Laboratory parameters and vital signs did not give any reason for safety concerns. No adverse events associated with balloon coating were observed. CONCLUSION: The results of 14 patients with peripheral arterial occlusive disease show no systemic bioavailability of paclitaxel > 24 hours after PTA with one or more PCB catheters, indicating that the PCB catheter is safe with regard to possible systemic effects.
Subject(s)
Antineoplastic Agents, Phytogenic/administration & dosage , Antineoplastic Agents, Phytogenic/pharmacokinetics , Arterial Occlusive Diseases/blood , Arterial Occlusive Diseases/therapy , Catheterization/instrumentation , Coated Materials, Biocompatible , Drug Delivery Systems/instrumentation , Drug Delivery Systems/methods , Femoral Artery , Paclitaxel/administration & dosage , Paclitaxel/pharmacokinetics , Popliteal Artery , Aged , Antineoplastic Agents, Phytogenic/adverse effects , Biological Availability , Dose-Response Relationship, Drug , Equipment Safety , Female , Humans , Male , Metabolic Clearance Rate , Middle Aged , Paclitaxel/adverse effectsABSTRACT
The purpose of this study was to correlate magnetic resonance imaging (MRI)-based lesion load assessment with clinical disability in early relapsing remitting multiple sclerosis (RRMS). Seventeen untreated patients (ten women, seven men; mean age 33.0 +/- 7.9 years) with the initial diagnosis of RRMS were included for cross-sectional as well as longitudinal (24 months) clinical and MRI-based assessment in comparison with age-matched healthy controls. Conventional MR sequences, MR spectroscopy (MRS) and magnetisation transfer imaging (MTI) were performed at 1.5 T. Lesion number and volume, MRS and MTI measurements for lesions and normal appearing white matter (NAWM) were correlated to clinical scores [Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC)] for monitoring disease course after treatment initiation (interferon beta-1a). MTI and MRS detected changes [magnetisation transfer ratio (MTR), N-acetylaspartate (NAA)/creatine ratio] in NAWM over time. EDSS and lesional MTR increases correlated throughout the disease course. Average MTR of NAWM raised during the study (p < 0.05) and correlated to the MSFC score (r = 0.476, p < 0.001). At study termination, NAA/creatine ratio of NAWM correlated to the MSFC score (p < 0.05). MTI and MRS were useful for initial disease assessment in NAWM. MTI and MRS correlated with clinical scores, indicating potential for monitoring the disease course and gaining new insights into treatment-related effects.
Subject(s)
Biomarkers/analysis , Magnetic Resonance Imaging/methods , Magnetic Resonance Spectroscopy/methods , Multiple Sclerosis/diagnosis , Multiple Sclerosis/metabolism , Nerve Fibers, Myelinated/pathology , Adolescent , Adult , Arteriovenous Fistula , Brain/metabolism , Brain/pathology , Cross-Sectional Studies , Female , Humans , Longitudinal Studies , Male , Middle Aged , Recurrence , Remission, Spontaneous , Reproducibility of Results , Sensitivity and Specificity , Young AdultABSTRACT
BACKGROUND: The diagnostic value of perfusion CT in dementia patients was retrospectively evaluated in comparison to the Mini-Mental State Examination (MMSE). MATERIAL AND METHODS: The perfusion CT database of 55 subjects was investigated. All patients underwent an unenhanced, contrast-enhanced, and perfusion CT of the head. The clinical evaluation of the degree of dementia was performed with the MMSE. In the perfusion CT data, 24 ROI were marked. Then blood volume (BV), blood flow (BF), and mean transit time (MTT) were calculated and compared with the ipsilateral and contralateral regions and with the degree of dementia. RESULTS: With increasing degree of dementia, a significant decrease of the occipital and temporal BV was found. A significant decrease of the BF in the frontal lobe, basal ganglia, and occipital region was found. Concurrently, the MTT increased significantly in the basal ganglia region. The group with Alzheimer's disease showed significant regional hypoperfusion compared with the group of cognitively normal subjects in the frontal, basal ganglia, occipital, and temporal region. CONCLUSIONS: The cerebral perfusion decreased with increasing degree of dementia. The inexpensive and widely available perfusion CT reveals information about regional differences of cerebral perfusion, which may be useful in differentiating severity and types of dementia.
