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Objective To establish an assay method for monohydroxy carbamazepine, the active metabolite of oxcarbazepine, in human plasma. Methods Ornidazole was used as the internal standard. Plasma samples were processed with methanol and analyzed by HPLC. The column was ZORBAX Eclipse XDB-C18(150 mm×4.6 mm, 5 μm) with the mobile phase of water-acetonitrile (80∶20, V/V) at a flow rate of 1.0 ml/min. Dual wavelength detection is applied. The detection wavelength of monohydroxy carbamazepine was set at 192 nm and ornidazole at 318 nm. Results There was an excellent liner relationship for monohydroxy carbamazepine from 2 to 50 μg/ml(r= 0.998 6). The limit of quantification was 2 μg/ml with the range of accuracy between 95.57% and 100.59%. The RSD of intra-day and inter-day precisions were less than 15%. The average extraction recovery rate of MHC and internal standard were in the range of 89.62% to 98.76%. The RSD of stability was less than 6%. Conclusion This method is specific, sensitive, and easy to operate. It is suitable for the clinical assay of monohydroxy carbamazepine in human plasma.
RESUMO
Objective To establish an assay method for unbound teicoplanin in plasma by centrifugal ultrafiltration combined with ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). Methods Protein was removed from plasma by a Centrifree® ultrafiltration device. The ultrafiltrate was injected to determine the unbound concentration of teicoplanin. EndeadvorsilTM C18 column (1.8 μm, 50 mm×2.1 mm) was used with gradient elution of acetonitrile and 0.02 mol/L ammonium acetate solution (containing 0.1% formic acid). The detection was performed on a triple-quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM)mode via electro spray ionization (ESI). Results The calibration curve of unbound teicoplanin in plasma was linear over the range of 0.10 to 8.00 μg/ml (r=0.999). The intra-assay precision and the inter-assay precision of samples didn't exceed 7.00%. The average relative recovery ratio was 97.9%, and the matrix effect factor was 0.97. The samples had good stability after being stored at room temperature for 10 h or at −20 ℃ for 15 days, and freeze-thawed 3 times (RSDs were all within 6.50%). Conclusion This method is convenient, fast, sensitive and accurate. It provided a basis for clinical development of teicoplanin unbound concentration monitoring.
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Objective Based on the data of gemcitabine adverse reactions (ADR), the characteristics and patterns of ADR occurrence were analyzed. The guidance for the rational clinical use of gemcitabine was provided. Methods From our information system, the patients treated by gemcitabine chemotherapy from September 2008 to September 2018 were selected and their related ADRs were summarized and statistically analyzed by using SPSS 18.0. Results Among the 750 cases, there were 312 ADRs related to gemcitabine treatment, of which the incidence of ADR was higher in female patients than in male patients (48.68% vs 36.77%) and the highest incidence in the age group of 50-69 years (44.14%). The patients with lower status (KPS) scores were more sensitive to chemotherapeutic drugs, and more likely to develop ADR. During the combination therapy, gemcitabine+paclitaxel chemotherapy had the highest incidence of ADR (61.54%) and the highest incidence of ADR in thymic carcinoma (62.50%), followed by hematological and reproductive system tumors (58.62% and 57.14%, respectively); ADR involvement in organs/systems is mainly caused by hematological toxicity. The bone marrow suppression is common, followed by digestive system damage. The major clinical symptoms were nausea and vomit. Conclusion Gemcitabine-related ADR has a large individualized difference and is affected by many factors. Chemotherapy should be used according to individual conditions to improve clinical safety and rational use of drugs.
