A simple, rapid liquid chromatography/tandem mass spectrometric (LC–MS/MS) assay was developed and validated for the quantification of both unbound and total paclitaxel in plasma following treatment with Abraxane (ABI-007) or Taxol. Accurate and reproducible analysis of ABI-007, an albumin nanoparticle formulation of paclitaxel could not be achieved using previously published methodology designed for Taxol. The final validated method involved protein precipitation followed by vacuum filtration, in a 96-well format for rapid processing. The 4 min run employed gradient elution on a Waters SymmetryShield C8 (2.1 mm × 50 mm, 3.5 μm) column, followed by tandem mass spectrometric detection, in electrospray positive mode. Calibrator samples were prepared daily with paclitaxel and analyzed with both ABI-007 and paclitaxel quality control samples. To measure unbound drug, sample preparation was preceded by ultrafiltration. The assay was linear over the range of 10–2500 ng/mL, with dilution providing measurement up to 50,000 ng/mL. Within-run and between-run precision for all QC samples was less than 5.0% and 10.4%, respectively. Accuracy was high, with deviation of less than 6.1% for all QCs. Measurement of unbound paclitaxel was precise (BRP and WRP <10%).
This paper presents an informatic system (CARDIO) which has been developed in order to improve the quality of the medical service in a cardiovascular clinic and to help the physicians in the continuous surveillance of the patients. The CARDIO system allows an easier access to all information regarding the time spent by a patient in the clinic (complex investigations, disease history, treatments followed, etc.). Each activity of the clinic has its correspondence in the informatic system. The data collections (tables) of the CARDIO database have been structured to correspond to the specified activities carried out in the cardiovascular clinic. Important types of data collection used by the system are catalogues. The role of these catalogues is to classify and identify the diseases, the surgical techniques etc. The CARDIO system has been installed and is being tested at the Cardiovascular Surgery Clinic in Targu Mures.
Atrial fibrillation (AF) is frequently found in association with rheumatic mitral valve disease. To study the interrelation of factors contributing to the risk of AF in patients with mitral stenosis, we examined a cardiac catheterization database of a series of 314 patients. Patients with AF were older, 53.4 +/- 6.1 years versus 51.7 +/- 7.2 years (p = 0.03), and had a lower cardiac index, 2.3 +/- 0.6 L/min/m2 versus 2.6 +/- 0.7 L/min/m2 (p = 0.0002), than patients in sinus rhythm at catheterization. The mitral valve area was significantly smaller in patients with AF than in patients in sinus rhythm, 1.2 +/- 0.5 cm2 versus 1.6 +/- 0.7 cm2 (odds ratio 1.40/0.25 cm2 decrease; p = 0.0001) as was mitral valve index. The pressure-AF association with the highest statistical significance was seen with mean right atrial pressure, 10.6 +/- 4.9 mm Hg versus 7.6 +/- 3.8 mm Hg (odds ratio 2.24; p < 0.0001). Other variables with significant positive associations by univariate analysis were pulmonary artery wedge pressure, pulmonary artery mean pressure, and pulmonary resistance. When stepwise logistic multiple regression analysis was performed, the results indicated that both severity of mitral stenosis and increased right atrial pressure were independently associated with AF in this population with mitral stenosis. After adjustment was performed for these variables, age was not independently associated with AF.