Survey on request form content and result reporting in therapeutic drug monitoring service among laboratories in Czechia and Slovakia.

INTRODUCTION: The aim of the study was to investigate current practice and policies of therapeutic drug monitoring (TDM) service requesting and result reporting in Czechia and Slovakia. MATERIALS AND METHODS: All 149 laboratories that measure plasma drug concentrations were given an online questionnaire during a regular external quality assessment TDM cycle. The questionnaire consisted of 17 questions. The optimal TDM practice was defined as the application of all elements (age, body weight, time of sampling, date of the first administration, time of the last dose administration, the dose, the dosing interval, the route of administration, information on reason of testing, and information on other co-administered drugs) needed for reporting a recommendation for further drug dosing (positive response to question number 16). RESULTS: The response rate was 69%, 103 out of 149 laboratories measuring drug concentrations. Only 12% (12 out of 103 laboratories) of the laboratories implemented all elements needed for optimal TDM practice and reported a recommendation. Both paper and electronic request forms were used by 77 out of 103 (75%) laboratories. A total of 69 out of 103 laboratories (67%) specified the type of sampling tube on their request form. Cystatin C was used for prediction of renal drug elimination by 24% (25 out of 103) of participants. CONCLUSIONS: Small number of laboratories implemented all elements needed for optimal TDM practice and report a recommendation on further dosing. Further efforts in education on optimal TDM practice as well as harmonization of service are desirable.

Prolonged burst as a new method for cardioverter-defibrillator testing.

AIM: To find out whether it is possible to anaesthetize patients safely without analgesia and sedation, using burst pacing prolonged until the patient becomes unconscious. METHODS: One hundred and four patients undergoing implantation or reimplantation of a cardioverter-defibrillator were included. Patients randomized into Group B underwent prolonged burst pacing without analgesia and sedation. Patients in Group T underwent a T-wave shock under analgesia and sedation. Blood samples for measurement of serum neuron-specific enolase were taken before surgery and 6, 24, and 48 h after the procedure. RESULTS: From the 104 patients, 51 were randomly assigned to Group B and 53 to Group T. Four patients from Group B were switched to Group T (ventricular fibrillation not induced by burst pacing). The clinical characteristics of both groups were similar. The mean total time of cardiac arrest was significantly longer in Group B (23.0 ± 4.4 s, median 22.7) vs. Group T (10.3 ± 3.0 s, median 10.0), P < 0.0001 (Mann-Whitney U-test). The effectiveness of both induction methods was similar (92.1% in Group B and 100% in Group T). The mean neuron-specific enolase levels after 6, 24, and 48 h were similar in Groups B and T (13.1 ± 6.3 and 11.6 ± 5.8 mg/L, 14.5 ± 7.5 and 13.4 ± 6.0 mg/L, and 14.9 ± 5.9 and 12.2 ± 6.0 mg/L, respectively) as were these levels compared with baseline neuron-specificenolase levels (14.0 ± 5.9 and 13.4 ± 4.0 mg/L, respectively), P = NS for all. CONCLUSION: Despite a longer time of total cardiac arrest, prolonged burst pacing appears to be a safe and effective method for induction of ventricular fibrillation during cardioverter-defibrillator testing, which enables omission of analgesia and sedation or general anaesthesia.

Time-course evaluation of oxidative stress-related biomarkers after renal transplantation.

Patients with chronic renal disease have a high prevalence of oxidative stress (OS), which is associated with the cardiovascular complications occurring in this population. The restoration of kidney function after kidney transplantation (KT) can lead to reduction in the metabolic abnormalities and elimination of the OS. Time-dependent changes in OS-related markers and specific kidney function and metabolic parameters were evaluated in patients (N = 39; 23 males; 16 females; mean age = 57 ± 10 years) before (day 0) and after KT (day 1, 7, 30, 90, and 180) to monitor the graft. In particular, total antioxidant capacity (TAC), levels of advanced oxidation protein products (AOPP), lipid peroxidation as thiobarbituric acid-reactive substances (TBARS) and reduced glutathione (GSH); activities of glutathione peroxidase, catalase, and superoxide dismutase; and kidney function markers were measured. AOPP, TAC, and TBARS were significantly decreased, whereas GSH was significantly increased after KT. Antioxidant enzyme activities were not significantly changed during the monitored period after KT. Apropos specific kidney function markers and glomerular filtration significantly increased and creatinine level significantly decreased after transplantation. Changes in high-density lipoprotein cholesterol were also found. Our results show that successful KT results in normalization of the antioxidant status and lipid metabolism that is connected with both improved renal function and reduced cardiovascular complications.

Interlaboratory study of free monoclonal immunoglobulin light chain quantification.

BACKGROUND: Quantification of monoclonal immunoglobulin free light chains (FLCs) in serum is used increasingly in clinical practice for the diagnosis, prognostic assessment, and treatment monitoring of monoclonal gammopathies. It is used as an adjunct to standard serum protein electrophoresis and immunofixation. However, methods for FLC quantification need further standardization and validation. METHODS: The Czech Myeloma Group and the Czech Society of Clinical Biochemistry have initiated an interlaboratory study where six laboratories collaborating with the primary myeloma treatment centres measured FLC concentrations in 12 serum samples from patients with monoclonal gammopathies. RESULTS: Repeatability of the measurements in five laboratories was calculated based on differences between the results of duplicate measurements. We found that repeatability depended more on the laboratory than on the device used for measurement. CONCLUSIONS: The study revealed several weak points in the methodology, including the need for a uniform sample dilution procedure. Interlaboratory reproducibility was comparable with values achieved in the NEQAS programme. Because the κ/λ ratio cannot be measured with high precision, κ and λ FLC concentrations should be used where possible. Due to its impact on the clinical management of patients with gammopathy, FLC quantification needs to become a part of the regular quality control cycle in myeloma centres.

Prognostic factors in patients with esophageal carcinoma treated with chemoradiation: single center experience.

BACKGROUND/AIMS: The trimodality therapy including chemotherapy, external beam radiation and surgery is widely accepted as the standard of care in patients with locoregional esophageal carcinoma. METHODOLOGY: We have performed a retrospective analysis of patients with locoregional esophageal carcinoma treated with chemoradiation. RESULTS: One-hundred and fifty-two consecutive patients with non-metastatic adenocarcinoma or squamous cell esophageal carcinoma treated with chemoradiation were included in the present analysis. The median survival of the whole group was 12 months. The estimated 3- and 5-year survival rates were 24% and 19%, respectively. On multivariate analysis, female sex, weight loss and serum albumin were independent negative predictors of survival. Among 140 patients who survived more than 3 months, weight loss, female sex and therapy with paclitaxel were negatively associated with prognosis, and among 109 patients surviving more than 6 months the dose of cisplatin and surgery were independent prognostic factors. Pathologic complete response was not predictive of prognosis. CONCLUSIONS: Long-term survival is obtained in only about 20% of patients with carcinoma of the esophagus treated with chemoradiation. Female sex, weight loss and low serum albumin are independent indicators of poor prognosis. Among treatment-related factors, higher dose of cisplatin and esophagectomy were independent predictors of better prognosis, while administration of paclitaxel was associated with poor prognosis.

The correlation of serum immunoglobulin free light chain levels and selected biological markers in multiple myeloma.

AIMS: the presented study is aimed at the evaluation of correlation of free light chains serum levels - kappa, lambda and their relation (K/L ratio) and serum levels of selected biological markers in a group of patients with multiple myeloma examined at the time of the diagnosis. METHODS: 102 patients with multiple myeloma were included in this prospective study. Free light chains serum levels were determined by Freelite Binding Site system, for determination of serum levels of selected parameters the following methods were used: REA thymidinekinase (TK), RIA (beta(2)microglobulin (beta(2)m), ICTP, PINP), enzymoimmunoassay (sIL-6R, sVCAM-1, sICAM-1, sOPG) and quantitative enzymatic immunoassay (sHGF, sVEGF, sSyndecan-1 (sSyn-1) a sFas). RESULTS: There was found a correlation in the kappa-group of the dominant kappa chain and serum readings of beta(2)m (r = 0.344, p = 0.005), TK (r = 0.263, p = 0.035), ICTP (r = 0.402, p = 0.001), PINP (r = 0.264, p = 0.039), sOPG (r = 0.328, p = 0.028), sSyn-1 (r = 0.255, p = 0.046) and sFas (r = 0.418, p = 0.001). In case of K/L ratio there was found a statistically significant association of levels of beta(2)m (r = 0.316, p = 0.01), TK (r = 0.274, p = 0.027), ICTP (r = 0.346, p = 0.006), PINP (r = 0.261, p = 0.042), sSyn-1 (r = 0.283, p = 0.026) and sFas (r = 0.377, p = 0.002). In the lambda-group the analysis confirmed mutual dependence of the dominant lambda chain levels on beta(2)m (r = 0.476, p = 0.003), ICTP (r = 0.375, p = 0.022), sVCAM-1 (r = 0.383, p = 0.019), sHGF (r = 0.441, p = 0.006) and sFas (r = 0.334, p = 0.040). In addition we ascertained a correlation of L/K ratio and levels of beta(2)m (r = -0.473, p = 0.003), TK (r = -0.412, p = 0.011), ICTP (r = -0.331, p = 0.045), PINP (r = -0.409, p = 0.012), sHGF (r = -0.357, p = 0.028), sSyn-1 (r = -0.449, p = 0.005) a sFas (r = - 0.371, p = 0.022). CONCLUSIONS: The study confirmed mutual correlation of FLC serum levels and the levels of several selected biological markers, in particular beta(2)m, TK, ICTP, PINP, sSyn-1 a sFas at time of the diagnosis. It referred to the mutual relation of bone marrow microenvironment, biological qualities of clonal plasmocytes and the intensity of the free light chains production by the tumour cell population.

Correlation of the IgG index and oligoclonal bands in the cerebrospinal fluid of patients with multiple sclerosis.

AIMS: The aim of this study was to assess the correlation between IgG index values and the number of the oligoclonal IgG bands (OCB) in the cerebrospinal fluid (CSF) of patients with multiple sclerosis (MS). MATERIAL AND METHODS: The set of 150 patients consisted of 41 males and 109 females (aged 18-68, mean 36.6 +/- 10.1 years). The CSF collected by a lumbar puncture was examined evaluating intrathecal synthesis using the IgG index and determining OCB. The number of alkaline OCB in the CSF was assessed using the method of isoelectric focusing. Pearson's correlation analysis, and homogeneity chi(2) test, Mann-Whitney test, paired-sample t-test (parametric) and Wilcoxon signed-ranks test (nonparametric) were used to evaluate the statistical significance of the results. RESULTS: No positive correlation between the IgG index and the number of OCB was found. Mann-Whitney test also failed to demonstrate any significant difference of the IgG index values in patients both with the OCB number > or = 2 and < 2. CONCLUSION: This study did not confirm any correlation between the IgG index values and the OCB number in the CSF of MS patients.