Major iatrogenic bile duct injury during elective cholecystectomy: a Czech population register-based study.

PURPOSE: Bile duct injury (BDI) remains the most serious complication following cholecystectomy. However, the actual incidence of BDI in the Czech Republic remains unknown. Hence, we aimed to identify the incidence of major BDI requiring operative reconstruction after elective cholecystectomy in our region despite the prevailing modern 4 K Ultra HD laparoscopy and Critical View of Safety (CVS) standards implemented in daily surgical practice among the Czech population. METHODS: In the absence of a specific registry for BDI, we analysed data from The Czech National Patient Register of Reimbursed Healthcare Services, where all procedures are mandatorily recorded. We investigated 76,345 patients who were enrolled for at least a year and underwent elective cholecystectomy during the period from 2018-2021. In this cohort, we examined the incidence of major BDI following the reconstruction of the biliary tract and other complications. RESULTS: A total of 76,345 elective cholecystectomies were performed during the study period, and 186 major BDIs were registered (0.24%). Most elective cholecystectomies were performed laparoscopically (84.7%), with the remaining open (15.3%). The incidence of BDI was higher in the open surgery group (150 BDI/11700 cases/1.28%) than in laparoscopic cholecystectomy (36 BDI/64645 cases/0.06%). Furthermore, the total hospital stays with BDI after reconstruction was 13.6 days. However, the majority of laparoscopic elective cholecystectomies (57,914, 89.6%) were safe and standard procedures with no complications. CONCLUSION: Our study corroborates the findings of previous nationwide studies. Therefore, though laparoscopic cholecystectomy is reliable, the risks of BDI cannot be eliminated.

Protection by Vaccines and Previous Infection Against the Omicron Variant of Severe Acute Respiratory Syndrome Coronavirus 2.

BACKGROUND: The Omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) evades immunity conferred by vaccines and previous infections. METHODS: We used a Cox proportional hazards model and a logistic regression on individual-level population-wide data from the Czech Republic to estimate risks of infection and hospitalization, including severe states. RESULTS: A recent (≤2 months) full vaccination reached vaccine effectiveness (VE) of 43% (95% confidence interval [CI], 42%-44%) against infection by Omicron compared to 73% (95% CI, 72%-74%) against Delta. A recent booster increased VE to 56% (95% CI, 55%-56%) against Omicron infection compared to 90% (95% CI, 90%-91%) for Delta. The VE against Omicron hospitalization of a recent full vaccination was 45% (95% 95% CI, 29%-57%), with a recent booster 87% (95% CI, 84%-88%). The VE against the need for oxygen therapy due to Omicron was 57% (95% CI, 32%-72%) for recent vaccination, 90% (95% CI, 87%-92%) for a recent booster. Postinfection protection against Omicron hospitalization declined from 68% (95% CI, 68%-69%) at ≤6 months to 13% (95% CI, 11%-14%) at >6 months after a previous infection. The odds ratios for Omicron relative to Delta were 0.36 (95% CI, .34-.38) for hospitalization, 0.24 (95% CI, .22-.26) for oxygen, and 0.24 (95% CI, .21-.28) for intensive care unit admission. CONCLUSIONS: Recent vaccination still brings substantial protection against severe outcome for Omicron.

What are the specifics of diabetic foot syndrome and why we need interdisciplinary recommendations for its diagnosis and treatment?

The care of patients with diabetic foot syndrome (DFS) requires interdisciplinary cooperation, and therefore interdisciplinary recommendations focused on the diagnosis and treatment and prevention of DFS are in place. We also need these recommendations because DFS has its own specifics that affect its diagnosis, therapy, but also the prognosis of patients. These include, for example, the different course of infection and PAD in patients with diabetes, the diagnosis of neuropathic Charcot osteoarthropathy, and the frequent association with end stage kidney disease, which worsens the course of SDN and increases its risk. Last but not least, the specifics of DFS include the issue of amputations with a significantly worse prognosis than in people without diabetes. The creation of an interdisciplinary team in foot clinics, providing comprehensive care for patients with DFS according to the recommended procedure, is associated with improved prognosis of patients with DFS, especially the reduction of amputations.

Prospective evaluation of contrast-enhanced ultrasound of breast BI-RADS 3-5 lesions.

BACKGROUND: To determine the benefit of contrast-enhanced ultrasound (CEUS) in the assessment of breast lesions. METHODS: A standardized contrast-enhanced ultrasound was performed in 230 breast lesions classified as BI-RADS category 3 to 5. All lesions were subjected to qualitative and quantitative analysis. MVI (MicroVascular Imaging) technique was used to derive qualitative analysis parameters; blood perfusion of the lesions was assessed (perfusion homogeneity, type of vascularization, enhancement degree). Quantitative analysis was conducted to estimate perfusion changes in the lesions within drawn regions of interest (ROI); parameters TTP (time to peak), PI (peak intensity), WIS (wash in slope), AUC (area under curve) were obtained from time intensity (TI) curves. Acquired data were statistically analyzed to assess the ability of each parameter to differentiate between malignant and benign lesions. The combination of parameters was also evaluated for the possibility of increasing the overall diagnostic accuracy. Biological nature of the lesions was verified by a pathologist. Benign lesions without histopathological verification (BI-RADS 3) were followed up for at least 24 months. RESULTS: Out of 230 lesions, 146 (64%) were benign, 67 (29%) were malignant, 17 (7%) lesions were eliminated. Malignant tumors showed statistically significantly lower TTP parameters (sensitivity 77.6%, specificity 52.7%) and higher WIS values (sensitivity 74.6%, specificity 66.4%) than benign tumors. Enhancement degree also proved to be statistically well discriminating as 55.2% of malignant lesions had a rich vascularity (sensitivity 89.6% and specificity 48.6%). The combination of quantitative analysis parameters (TTP, WIS) with enhancement degree did not result in higher accuracy in distinguishing between malignant and benign breast lesions. CONCLUSIONS: We have demonstrated that contrast-enhanced breast ultrasound has the potential to distinguish between malignant and benign lesions. In particular, this method could help to differentiate lesions BI-RADS category 3 and 4 and thus reduce the number of core-cut biopsies performed in benign lesions. Qualitative analysis, despite its subjective element, appeared to be more beneficial. A combination of quantitative and qualitative analysis did not increase the predictive capability of CEUS.

Laryngeal mask airway Unique™ position in paediatric patients undergoing magnetic resonance imaging (MRI): prospective observational study.

BACKGROUND: Laryngeal mask UNIQUE® (LMAU) is supraglottic airway device with good clinical performance and low failure rate. Little is known about the ideal position of the LMAU on the magnetic resonance imaging (MRI) and whether radiological malposition can be associated with clinical performance (audible leak) in children. The primary aim of the study was to evaluate incidence of the radiologic malposition of the LMAU according to size. The secondary outcome was the clinical performance and associated complications (1st attempt success rate, audible leak) in LMAUs in correct position vs. radiologically misplaced LMAUs. METHODS: In prospective observational study, all paediatric patients undergoing MRI of the brain under general anaesthesia with the LMAU were included (1.9.2016-16.5.2017). The radiologically correct position: LMAU in hypopharynx, proximal cuff opposite to the C1 or C2 and distance A (proximal cuff end and aditus laryngis) ≤ distance B (distal cuff end and aditus laryngis). Malposition A: LMAU outside the hypopharynx. Malposition B: proximal cuff outside C1-C2. Malposition C: distance A ≥ distance B. We measured distances on the MRI image. Malposition incidence between LMAU sizes and first attempt success rate in trainees and consultant groups was compared using Fisher exact test, difference in incidence of malpositions using McNemar test and difference in leakage according to radiological position using two-sample binomial test. RESULTS: Overall 202 paediatric patients were included. The incidence of radiologically defined malposition was 26.2% (n = 53). Laryngeal mask was successfully inserted on the 1st attempt in 91.1% (n = 184) cases. Audible leak was detected in 3.5% (n = 7) patients. The radiologically defined malposition was present in 42.9% (n = 3) cases with audible leak. The rate of associated complications was 1.5% (n = 3): laryngospasm, desaturation, cough. In 4.0% (n = 8) the LMAU was soiled from blood. Higher incidence of radiological malposition was in LMAU 1.0, 1.5 and LMAU 3, 4 compared to LMAU 2 or LMAU 2.5 (p < 0.001). CONCLUSION: Malposition was not associated with impaired clinical performance (audible leak, complications) of the LMAU or the need for alternative airway management. TRIAL REGISTRATION: Clinicaltrials.gov  (NCT02940652) Registered 18 October 18 2016.

Motion and emotion: anxiety-axial connections in Parkinson's disease.

Anxiety is a serious and frequent complication in Parkinson's disease (PD) that significantly affects the quality of life of patients. Multiple neuroanatomical, experimental, and clinical studies suggest its close association with axial disturbances. However, whether this relation applies for PD patients (commonly suffering from axial difficulties, such as balance and gait disturbance) has not been properly tested yet. The purpose of this study was to determine whether PD patients suffering from axial symptoms have higher levels of anxiety than others and to identify other factors associated with anxiety-axial connections. In this questionnaire study, 212 patients with PD were assessed by standardized scales, such as Hamilton Anxiety Scale, Montgomery-Asberg Depression Rating Scale, Montreal Cognitive Assessment, examining their mood and cognitive status. These data were correlated to dominant motor symptoms of these patients, such as tremor, rigidity, bradykinesia, and axial symptoms. Unlike other motor symptoms, only axial symptoms showed to be significantly related to higher levels of anxiety. The patients suffering from anxiety and axial problems have also shown significantly higher depression levels. Axial disturbances are related to higher anxiety levels in PD patients. It is crucial to pay high attention to symptoms of anxiety in patients having postural instability or gait disorder. Further clinical studies are desirable to investigate new, practical implications of anxiety-axial connection to provide complex management options of these serious symptoms.

Terminally differentiated memory T cells are increased in patients with common variable immunodeficiency and selective IgA deficiency.

INTRODUCTION: Previous studies showed that several lymphocyte abnormalities seen in the most frequent symptomatic immunoglobulin deficiency, common variable immunodeficiency (CVID), were also observed in a genetically related asymptomatic disorder - selective IgA deficiency (IgAD). In this study we searched for abnormalities in the differentiation stages of T cells as well as for similarities of these abnormalities in CVID and IgAD patients. MATERIAL AND METHODS: Using flow cytometry in 80 patients with IgAD, 48 patients with CVID, and 80 control persons we determined T-lymphocyte subsets: both CD4 and CD8 were divided into the naïve CD45RO-CD27+, early differentiated CD45RO+CD27+, late differentiated CD45RO+CD27- and fully differentiated effector CD45RO-CD27- memory T cells, as well as Treg cells, defined as CD4+CD25highCD127low T cells. RESULTS: An increase of CD4+ and CD8+ late differentiated memory cells was observed comparing CVID patients to controls, as well as comparing IgAD patients to controls. In CVID patients an increase of CD4+ early differentiated memory cells, a decrease of CD8+ intermediate memory cells, and CD4+ and CD8+ naïve cells were found as well. The abnormalities in IgAD patients might be explained by higher CMV seropositivity observed in our IgAD. We confirmed the repeatedly published decrease of Treg cells in CVID patients, while Treg cells in IgAD patients were increased compared to controls. CONCLUSIONS: Our results show T-cell activation not only in CVID, but also in IgAD patients. The increase in IgAD patients may be influenced by a more frequent CMV infection in our group of IgAD patients.

Low-Dose or High-Dose Rocuronium Reversed with Neostigmine or Sugammadex for Cesarean Delivery Anesthesia: A Randomized Controlled Noninferiority Trial of Time to Tracheal Intubation and Extubation.

BACKGROUND: Rocuronium for cesarean delivery under general anesthesia is an alternative to succinylcholine for rapid-sequence induction of anesthesia because of the availability of sugammadex for reversal of neuromuscular blockade. However, there are no large well-controlled studies in women undergoing general anesthesia for cesarean delivery. The aim of this noninferiority trial was to determine whether rocuronium and sugammadex confer benefit in time to tracheal intubation (primary outcome) and other neuromuscular blockade outcomes compared with succinylcholine, rocuronium, and neostigmine in women undergoing general anesthesia for cesarean delivery. METHODS: We aimed to enroll all women undergoing general anesthesia for cesarean delivery in the 2 participating university hospitals (Brno, Olomouc, Czech Republic) in this single-blinded, randomized, controlled study. Women were randomly assigned to the ROC group (muscle relaxation induced with rocuronium 1 mg/kg and reversed with sugammadex 2-4 mg/kg) or the SUX group (succinylcholine 1 mg/kg for induction, rocuronium 0.3 mg/kg for maintenance, and neostigmine 0.03 mg/kg for reversal of the neuromuscular blockade). The interval from the end of propofol administration to tracheal intubation was the primary end point with a noninferiority margin of 20 seconds. We recorded intubating conditions (modified Viby-Mogensen score), neonatal outcome (Apgar score <7; umbilical artery pH), anesthesia complications, and subjective patient complaints 24 hours after surgery. RESULTS: We enrolled 240 parturients. The mean time to tracheal intubation was 2.9 seconds longer in the ROC group (95% confidence interval, -5.3 to 11.2 seconds), noninferior compared with the SUX group. Absence of laryngoscopy resistance was greater in the ROC than in the SUX groups (ROC, 87.5%; SUX, 74.2%; P = 0.019), but there were no differences in vocal cord position (P = 0.45) or intubation response (P = 0.31) between groups. No statistically significant differences in incidence of anesthesia complications or in neonatal outcome were found (10-minute Apgar score <7, P = 0.07; umbilical artery pH, P = 0.43). The incidence of postpartum myalgia was greater in the SUX group (ROC 0%; SUX 6.7%; P = 0.007). The incidence of subjective complaints was lower in the ROC group (ROC, 21.4%; SUX, 37.5%; P = 0.007). CONCLUSIONS: We conclude that rocuronium for rapid-sequence induction is noninferior for time to tracheal intubation and is accompanied by more frequent absence of laryngoscopy resistance and lower incidence of myalgia in comparison with succinylcholine for cesarean delivery under general anesthesia.

Efficacy of bevacizumab and chemotherapy in the first-line treatment of metastatic colorectal cancer: broadening KRAS-focused clinical view.

BACKGROUND: The aim of the present retrospective study was to analyze clinical outcome and risk factors associated with treatment outcomes according to KRAS status in patient with metastatic colorectal cancer (mCRC) treated with bevacizumab (bev) plus chemotherapy in the first-line setting. METHODS: We performed observational study on 1622 patients with mCRC treated with bev plus oxaliplatin- or irinotecan-based chemotherapy, and correlated treatment outcomes with KRAS mutation status. The primary endpoint was progression-free survival (PFS) and additionally overall survival (OS). Adverse events of bevacizumab and risk factors including location of metastases were evaluated. RESULTS: Mutation in KRAS was present in 40.6% of mCRC cases. The median PFS in patients with wild-type KRAS (wtKRAS) vs mutant KRAS was 11.5 vs 11.4 months, respectively. The median OS was 30.7 vs 28.4 months (p = 0.312). Patients with KRAS mutation had lung metastases more frequently than wtKRAS individuals (32.0% vs 23.8%; p = 0.001). We observed no difference in clinical outcome between hepatic and extrahepatic metastatic disease. CONCLUSION: KRAS mutation does not interfere with clinical benefit from first-line treatment with bevacizumab plus chemotherapy in mCRC patients.

[The mortality of patients with diabetes mellitus using oral antidiabetic drugs in the Czech Republic decreased over the decade of 2003-2013 and came closer to the population average]. / Mortalita pacientu s diabetes mellitus lécených perorálními antidiabetiky v Ceské republice poklesla behem let 2003-2013 a priblízila se populacnímu prumeru.

INTRODUCTION: Every year official data is published which describes the care of patients with diabetes mellitus in the Czech Republic. An overall number of individuals with diabetes, the number of newly reported cases and the number of patient deaths is always specified. However this data does not allow us to identify the differences in mortality between the individual cohorts of diabetic patients in relation to therapy. GOAL: Comparison of the mortality development in the periods of 2002-2006 and 2010-2013 in a representative sample of the patient population with type 2 diabetes mellitus using oral antidiabetic drugs, kept in the database of the General Health Insurance Company of the Czech Republic (VZP) which provided health care coverage for 63% of Czech population in 2013. METHODOLOGY: A retrospective epidemiologic analysis. We identified all individuals in the VZP database who had a record of DM diagnosis (E10-E16 based on ICD 10) or who had any antidiabetic therapy prescribed (ATC group A10) in the periods of 2002-2008 and 2009-2013. We only selected those patients for the analysis who were treated with oral antidiabetic medicines (in the given year or the preceding years they had a record of treatment with at least one medicine from A10B group, while having no record of treatment with medicines from A10A group within both years). 237,665 individuals met the selected criteria in 2003 and 315,418 individuals in 2013. RESULTS: Mortality rates dropped for all age groups (from 2003-2013): for 50-59 year olds by 1.2%-0.7%; in 60-69 year olds by 2.6%-1.6%; for 70-79 year olds by 5.8%-3.5%. In 2013 mortality rates came close to the general population where for the same age groups they reached 0.6%, 1.5% and 3.4% respectively. When expressed in relative terms, the mortality among 50-59 year olds declined by 42% (Czechia by 25%), among 60-69 year olds by 39% (Czechia by 17%) and among 70-79 year olds by 40% (Czechia by 28%) from the year 2003. The decline in mortality among the patients with DM treated with oral antidiabetic medicines was greater in both absolute and relative terms in the period of 2003-2013 than among the general population in the Czech Republic. CONCLUSION: The analysis of mortality among the patients treated with oral antidiabetic medicines, registered in the VZP database, has shown a clearly favourable trend of mortality decline which is faster than among the general population. The fact that mortality among this cohort is getting closer to that among the general population of the corresponding age is a finding of critical importance. There is a justified expectation that mortality, with increasingly extensive utilization of the present therapeutic procedures, will continue to decrease.

[Incidence of amputations among patients with diabetes mellitus in the Czech Republic from 2010 to 2014]. / Incidence amputací u pacientu s diabetes mellitus v Ceské republice v letech 2010-2014.

INTRODUCTION: Information about the incidence of organ-affecting complications of diabetes, including the diabetic foot syndrome, can be obtained from the documents of the Institute of Health Information in the Czech Republic. GOAL: Assessment of the development of high amputations and minor surgical procedures on the lower limb from 2010 to 2014 in a representative sample of the population of patients with DM kept in the General Health Insurance Company of the Czech Republic database. METHODOLOGY: We identified all individuals in the VZP database who had a record of DM diagnosis (E10-E16 based on ICD 10) or any antidiabetic therapy prescribed (ATC group A10) in the period of 2010-2014. A set of patients who had an agent from A10 group prescribed at least once in the given year was extracted for analysis. In the next step we identified individuals, who in the period of 2010-2014 also underwent a surgical procedure on the lower limb due to diabetic foot. RESULTS: An absolute number of lower limb amputations remains at a stationary level. CONCLUSION: The submitted analysis presents the first assessment of the development of surgical treatment of diabetic foot in the Czech Republic. The amount of surgical procedures on the diabetic foot remains stable, regarding both high amputations and lower limb minor surgical procedures. In the context of an absolute increase of patients treated for diabetes mellitus, the stationary state is an indication of a relative decrease, which is favourable in particular with regard to the amputation of long bones.

[The PROROK project results after 6 months of intervention (Prospective observation project focusing on the relevance of the difference between fasting blood glucose levels and postprandial blood glucose for estimation of success of type 2 diabetes therapy)]. / Výsledky projektu PROROK po 6 mesících intervence (Prospektivní observacní projekt významu diference glykemie nalacno a postprandiální glykemie pro odhad úspesnosti terapie diabetu 2. typu).

INTRODUCTION: The PROROK project (Prospective observation project focusing on the relevance of the difference between fasting and postprandial blood glucose levels for the estimation of success of type 2 diabetes therapy) had a character of non-interventional, prospective, multicentric observation study lasting 6 months, whose goal was to quantify the relevance of the difference between fasting and postprandial blood glucose levels to the success of the treatment with GLP1 receptor agonists, resp. the treatment with basal, premixed insulin, or a combination of basal-bolus insulin. Physicians chose a therapy for patients with insufficiently compensated problems as they considered appropriate; 4,972 patients were included. GOAL: Evaluation of the intervention results for the patients included in the PROROK observation project with a focus on the choice of therapy by the treating diabetologist after 6 months of observation. RESULTS: An average improvement of the glycated hemoglobin values in the whole cohort reached 1.6%, the median of the resulting glycated hemoglobin reached 5.9% and 5.8% resp. (basal insulin). Statistically significant was the change in the median weight in the cohort treated with GLP-1 receptor agonists, from 105 kg to 100 kg; this did not significantly change in the other cohorts. The change of waist circumference over time in all patients and in the individual cohorts was consistent with the change of weight. The median change of fasting blood glucose levels in the whole cohort was -1.7 mmol/l after 3 months and -2.4 mmol/l (p<0.001) after 6 months. The greatest absolute decrease was recorded in the cohort treated with basal insulin (-2.8 mmol/l). The median change of postprandial blood glucose levels was -2.4 mmol/l after 3 months and -3.3 mmol/l (p<0.001) after 6 months. The greatest absolute decrease was recorded in the branch treated with a combination of prandial and basal insulin (-3.9 mmol/l). All differences p<0.001. CONCLUSION: The choice of therapy in the PROROK project is in agreement with the basic findings in pathophysiology of type 2 diabetes and with the options of an individually chosen targeted intervention involving antidiabetic therapy. The results of the six-month observation have proven the individual choice of therapy correct. In the cohort of diabetic patients differing at the beginning in weight, waist circumference, fasting blood glucose and the difference between fasting and postprandial glucose levels, an individually chosen therapy led to the same final result, while an absolute change in the followed parameters differed in the individual groups.

[Do diabetologists choose a therapy rationally? Basic results of the PROROK project (a prospective observation project to assess the relevance of the difference between fasting glycemia and postprandial glycemia to estimation of success of type 2 diabetes therapy)]. / Volí diabetologové terapii racionálne? Základní výsledky projektu PROROK (Prospektivní observacní projekt významu diference glykemie nalacno a postprandiální glykemie pro odhad úspesnosti terapie diabetu 2. typu).

INTRODUCTION: The PROROK project (A prospective observation project to assess the relevance of the difference between fasting glycemia and postprandial glycemia to estimation of success of type 2 diabetes therapy) had a character of a non-interventional, prospective, multicentric observation project conducted for a period of 6 months, whose aim was to quantify the relevance of the difference between fasting and postprandial glycemia to the success of GLP1 receptor agonist treatment, or insulin therapy with basal or premixed insulin, or a combination of basal and bolus insulin. Physicians chose therapy for inadequately compensated patients at their own discretion, with 4 972 patients included. AIM: The study aimed at the assessment of the differences in basic anthropometric and biochemical parameters between the patient cohorts included in the PROROK project with regard to the therapy selected by the treating diabetologist. METHODOLOGY AND RESULTS: The patients treated with GLP1 receptor agonists were quite young, they have suffered from diabetes for a shorter period of time and at the same time were more obese and had the highest concentration of triacylglycerols. The patients who underwent basal insulin therapy, had the highest fasting glycemia. The patients for whom premixed insulin therapy or basal/bolus insulin regimen were chosen, manifested the highest postprandial glycemia, those with basal/bolus insulin regimen had the highest initial glycated haemoglobin. The difference between fasting and postprandial glycemia was the smallest in the cohort for which basal insulin therapy was chosen and the greatest in the cohort chosen for the therapy with premixed insulin, or with the basal/bolus insulin combination. Average improvement in glycated haemoglobin values reached 1.6 % within the whole cohort, a median of the resulting glycated haemoglobin reached 5.9 % or 5.8 % (GLP1 receptor agonist treatment). All the differences amounted to p < 0.001. CONCLUSION: Bearing in mind that the differences established in the parameters describing the cohorts, although statistically relevant, are of smaller clinical relevance, we regard as an important finding that the choice of therapy is in accordance with the basic knowledge about the pathophysiology of type 2 diabetes and possibilities of an individually chosen targeted intervention with antidiabetic therapy. We may conclude that most of the physicians participating in the PROROK project choose their therapy in a rational manner.

[Analysis of the development of metformin and sulfonylurea prescriptions in the Czech Republic]. / Analýza vývoje preskripce metforminu a sulfonylurey v Ceské republice.

INTRODUCTION: In the Czech Republic, patients with diabetes mellitus (DM) are followed and treated predominantly by specialists (approx. 80% at a specialist diabetology clinic), a minor part by general practitioners (up to 20%). Long-term development of the changes in prescribing metformin and sulfonylurea in the Czech Republic and its concordance with recommended procedures has not been evaluated until now. GOAL: Comparison of the development of metformin (MET) and sulfonylurea (SU) prescriptions in the period of 2002-2006 with that of 2010-2014 in a representative sample of the patient population with DM kept in the database of the General Health Insurance Company of the Czech Republic (VZP) which provided health care coverage for 63% of Czech Republic population in 2014. METHODOLOGY: We identified all individuals in the VZP database who had a record of DM diagnosis (E10-E16 based on ICD 10) or who had any antidiabetic therapy prescribed (ATC group A10) in the periods of 2002-2006 and 2010-2014. A cohort of patients was extracted for analysis, who had an agent from A10 group prescribed at least once in a relevant year (n=308,962 in 2002; n=426,695 in 2014). A number of patients was evaluated for each year, who had at least once MET or SU prescribed. The number of patients treated with MET or SU was then expressed as a percentage of all who had any therapy from A10 group prescribed in the year in question. RESULTS: Metformin prescriptions have linearly risen from 43% to 77%, while sulfonylurea prescriptions have linearly decreased from 65% to 37%. CONCLUSION: The analysis presents the first evaluation of the development of metformin prescriptions conducted in the Czech Republic and evaluation of its concordance with the recommended procedures for the treatment of DM. The amount of metformin prescribed in the Czech Republic increased from 43% to 77% while the amount of SU prescribed decreased from 65% to 37% between 2002 and 2014. This development and the current ratio between the prescribed amounts of MET and SU demonstrate the implementation of the recommended procedures into practice and prove the high quality of care for patients with DM2T in specialists--diabetologists surgeries.

[Monitoring of diabetes compensation in patients treated with an insulin pump in the Czech Republic]. / Monitorování kompenzace diabetu u pacientu lécených inzulinovou pumpou v Ceské republice.

INTRODUCTION: Insulin pump treatment (IP) is one of the ways of intensive insulin therapy, designed preferentially for patients with type 1 diabetes. The price of the treatment is higher than that of the conventional basalbolus and insulin regimens using repeated insulin application with a dose selector. GOAL: Quality assessment of IP therapy monitoring in patients with DM in a representative sample of the patient population with DM kept in the database of the General Health Insurance Company of the Czech Republic (VZP) which provided health care coverage for 63% of Czech population in 2014. METHODOLOGY: We identified all individuals in the VZP database who had a record of DM diagnosis (E10-E16 based on ICD 10) or who had any antidiabetic therapy prescribed (ATC group A10) in the period of 2009-2013. Over the whole period of 2009-2014 there were overall n=4,002 unique patients with DM identified in the VZP data, who were treated with IP within the assessment period. Incidence for the year 2014 (the newly treated with an insulin pump): all patients who had IP recorded in 2014 while in the preceding period of 2009-2013 they had no record of IP use. Prevalence for the year 2014 (all treated with an insulin pump): all the patients who for the period of 2010-2014 had at least once insulin pump use recorded and who did not die before 2014. Quality control parameters (HbA1c examination and consumption of glucose level test strips) for patients treated with IP were only assessed in detail for the year 2014, namely for all patients undergoing insulin pump treatment in 2014 throughout the year (i.e. from 1 January 2014 to 31 December 2014), i.e. in n=3,189 patients in all. RESULTS: In 2014 there were 247 incident patients and 3 794 prevalent patients. IP was newly introduced for almost 50% of the patients aged 20-39 years. In 2014 an average frequency of HbA1c examination equaled 3.38 per patient and 98.5% patients were examined for HbA1c at least once. An average consumption of glucose level testing strips per patient was 879 pieces. CONCLUSION: The pilot project of assessment of quality parameters for IP therapy monitoring shows that the patients treated with IP have glycated hemoglobin checked quite frequently (3.38 checkups per patient in 2014) and they measure their blood glucose 2-3 times a day on average.

[Hypolipidemic and antihypertensive therapy in diabetic patients in the Czech Republic: notes on the VZP (General Health Insurance Company) Data]. / Terapie diabetiku hypolipidemiky a antihypertenzivy v Ceské republice: poznámky k datum VZP.

Diabetes mellitus and in particular type 2 diabetes mellitus is one of the most important risk factors of cardiovascular disease. To influence cardiovascular risk there is enormous important not only positive influence of glycemia, but also the treatment of diabetic dyslipidemia and hypertension. The present work provides an analysis of lipid-lowering and antihypertensive therapy for all diabetics registered with General Health Insurance Company in the period 2010-2013. In this time 866,570 patients with diabetes mellitus registered with General Health Insurance Company were treated, the majority of them were diabetics independent on insulin. Approximately half of the patients were observed by dialectologists and half of them by the doctors of other specialization. Out of antihypertensive medi-cation, patients were most often treated by drugs that affect the renin-angiotensin system, as well as beta-blockers and diuretics. Prescription of the lipid-lowering therapy, especially prescription of statins, in accordance with the guidelines, is increasing, but remains insufficient (at 2013 43.6% diabetics treated by dialectologists and 51.3% diabetics treated by GP´s didn´t have lipid lowering therapy). Inadequate use of combination lipid-lowering therapy was recorded too, still represented mainly by combination of statin and fibrate, but in coming years we expect (based on the positive results of the subanalysis IMPROVE-IT study), an increase of combination therapy statin and ezetimibe.

Bevacizumab with 5-fluorouracil, leucovorin, and oxaliplatin versus bevacizumab with capecitabine and oxaliplatin for metastatic colorectal carcinoma: results of a large registry-based cohort analysis.

BACKGROUND: Data from the Czech national registry were analysed retrospectively to describe treatment outcomes for capecitabine and oxaliplatin (XELOX) regimen with bevacizumab versus 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) regimen with bevacizumab in the first-line therapy for metastatic colorectal cancer (mCRC). METHODS: A national registry containing anonymised individual data on patients treated with targeted therapies was used as a data source. In total, 2,191 mCRC patients who received a first-line therapy with bevacizumab combined with either FOLFOX regimen (n = 1,218, 55.6%) or XELOX regimen (n = 973, 44.4%) were included in the present analysis. RESULTS: No statistically significant difference in survival was observed between the two groups, with median overall survival (OS) of 27.0 months (95% confidence interval [CI] 24.6-29.5 months) and 30.6 months (95% CI 27.8-33.4 months) for FOLFOX/bevacizumab and XELOX/bevacizumab, respectively (p = 0.281). Median progression-free survival (PFS) was 11.4 months (95% CI 10.7-12.1 months) for FOLFOX/bevacizumab and 11.5 months (95% CI 10.8-12.3 months) for XELOX/bevacizumab (p = 0.337). The number of metastatic sites was identified as the most significant predictor of PFS and, together with the presence/absence of metastatic disease at diagnosis, also for OS. CONCLUSIONS: According to this large registry-based analysis, XELOX and FOLFOX regimens have similar effectiveness for use in combination with bevacizumab in the first-line treatment of mCRC. Multiple metastatic sites and the presence of metastatic disease at diagnosis were the strongest negative predictors of OS regardless of backbone chemotherapy regimen.

Efficacy and safety of bevacizumab in elderly patients with metastatic colorectal cancer: results from the Czech population-based registry.

BACKGROUND: Patients aged 65 years and older represent the majority of patients with metastatic colorectal cancer (mCRC). However, this patient population is often underrepresented in clinical trials and probably undertreated in the clinical practice. METHODS: We have analysed the outcomes of 3,187 mCRC patients treated with first-line bevacizumab based on data from the Czech national registry of mCRC patients aiming to compare the treatment efficacy and safety according to the age categories. RESULTS: In total, 2,126 (66.7%), 932 (29.2%), and 129 (4.0%) patients were aged <65 years, 65 to 75 years, and 75+ years, respectively. Median progression-free survival (PFS) was 11.4, 11.3, and 11.8 months for patients aged <65 years, 65 to 75 years, and 75+ years, respectively (p = 0.94). Median overall survival (OS) was 26.9, 27.5, and 25.1 months for patients aged <65 years, 65 to 75 years, and 75+ years, respectively (p = 0.73). Using multivariable Cox model for both PFS and OS, the patient age was not significantly associated with either PFS or OS. No increase in bevacizumab-related toxicity was observed among the elderly mCRC patients with the exception of hypertension, which was observed in 71 (3.3%), 34 (3.6%), and 10 (7.8%) patients aged <65 years, 65 to 75 years, and 75+ years, respectively. CONCLUSIONS: The results of the present study suggest similar outcome in terms of OS and PFS with bevacizumab-containing therapy in elderly mCRC patients fit for chemotherapy combined with targeted therapy compared to younger patients. Thus, chronological age should not be considered to represent a limitation in prescribing bevacizumab-containing therapy in mCRC patients.

[Ph-negative myeloproliferative diseases with thrombocythemia in the context of Thromboreductin® treatment, data from registry 2013]. / Ph-negativní myeloproliferativní onemocnení s trombocytemií ve svetle úcinku lécby prípravkem Thromboreductin® v datech registru ke konci roku 2013.

Czech Working Group for Ph-negative Myeloproliferative diseases (CZEMP) recommends anagrelid (Thromboreductin®) for the treatment of Ph-negative chronic myeloproliferative disease (MPO) with thrombocythemia accompanying. To evaluate the efficacy of this treatment, the patient registry with essential thrombocythemia and/or thrombocytosis accompanying other Ph-negative myeloproliferative diseases was established. The beginnings of data collection go back to 2001, registry itself is maintained from 2005 and the aim is to archive the medical records with detailed physical and laboratory examination, safety patient profile included. The longest follow-up monitors 150 months period. Registry database contained 1,325 patients in the end of 2013, with an annual increase of anagrelid therapy as a drug of first choice in accordance with CZEMP guidelines approved by the Czech Society of Hematology of Czech Medical Association of J. E. Purkyne. Indication criteria contribute to this trend as anagrelid is the first choice agent in 65 years old patients, instead previous 60 years of age. Often, we can observe the combined treatment, especially, in older patients and in patients with primary myelofibrosis and polycythemia vera. There have been founded 543 thrombotic events in 413 patients and 63 bleeding events in 58 patients of study group by the end of 2013. During treatment, thrombosis was diagnosed 225 times in 171 patients and bleeding was observed 139 times in 104 patients. The therapeutic response is achieved after 3 months in 77% and after 6 months in 83% of subjects, but after 12 months, the treatment still fails in 12,5% of patients. It might be caused by slow titration of Thromboreductin®. One of the most important indicators of treatment success is the effect on clinical symptoms presentation, especially the occurrence of thrombotic events. The proof of a good treatment efficacy is demonstrated by 1.8 fold decrease in arterial thrombosis, more than 1.5 fold decrease in microvascular thrombosis and even 6.2 fold decrease in venous thromboembolism events. Bleeding is observed in about double more patients in comparison to the period before inclusion in the systematic monitoring, but the bleedings are clinically insignificant.Key words: anagrelid (Thromboreductin®) - Ph-myeloproliferative diseases - registry - thrombosis.

Current survival measures reliably reflect modern sequential treatment in CML: correlation with prognostic stratifications.

Using the data of 723 chronic myeloid leukemia (CML) patients in the chronic phase, we analyzed the prognostic value of the Sokal, Euro, and EUTOS scores as well as the level of BCR-ABL1 and the achievement of complete cytogenetic response (CCgR) at 3 months of imatinib therapy in relation to the so-called current survival measures: the current cumulative incidence (CCI) reflecting the probability of being alive and in CCgR after starting imatinib therapy; the current leukemia-free survival (CLFS) reflecting the probability of being alive and in CCgR after achieving the first CCgR; and the overall survival. The greatest difference between the CCI curves at 5 years after initiating imatinib therapy was observed for the BCR-ABL1 transcripts at 3 months. The 5-year CCI was 94.3% in patients with BCR-ABL1 transcripts ≤ 10% and 57.1% in patients with BCR-ABL1 transcripts > 10% (P = 0.005). Therefore, the examination of BCR-ABL1 transcripts at 3 months may help in early identification of patients who are likely to perform poorly with imatinib. On the other hand, CLFS was not significantly affected by the considered stratifications. In conclusion, our results indicate that once the CCgR is achieved, the prognosis is good irrespective of the starting prognostic risks.