Centers In Hungary Research Articles

Drug persistence and need for dose intensification to adalimumab therapy; the importance of therapeutic drug monitoring in inflammatory bowel diseases

BackgroundTherapeutic drug monitoring (TDM) aid therapeutic decision making in patients with inflammatory bowel disease (IBD) who lose response to anti-TNF therapy. Our aim was to evaluate the frequency and predictive factors of loss of response (LOR) to adalimumab using TDM in IBD patients.MethodsOne hundred twelve IBD patients (with 214 TDM measurements, CD/UC 84/28, male/female 50/62, mean age CD/UC: 36/35 years) were enrolled in this consecutive cohort from two referral centres in Hungary. Demographic data were comprehensively collected and harmonized monitoring strategy was applied. Previous and current therapy, laboratory data and clinical activity were recorded at the time of TDM. Patients were evaluated either at the time of suspected LOR or during follow-up. TDM measurements were determined by commercial ELISA (LISA TRACKER, Theradiag, France).ResultsAmong 112 IBD patients, LOR/drug persistence was 25.9%/74.1%. The cumulative ADA positivity (>10 ng/mL) and low TL (<5.0 μg/mL) was 12.1% and 17.8% after 1 year and 17.3% and 29.5% after 2 years of adalimumab therapy. Dose intensification was needed in 29.5% of the patients. Female gender and ADA positivity were associated with LOR (female gender: p < 0.001, OR:7.8 CI 95%: 2.5–24.3, ADA positivity: p = 0.007 OR:3.6 CI 95%: 1.4–9.5).ConclusionsADA development, low TL and need for dose intensification were frequent during adalimumab therapy and support the selective use of TDM in IBD patients treated with adalimumab. ADA positivity and gender were predictors of LOR.

The Antihypertensive Efficacy of the Triple Fixed Combination of Perindopril, Indapamide, and Amlodipine: The Results of the PETRA Study.

The etiology of essential hypertension is multifactorial. Therefore, treatment with combinations of antihypertensive agents acting on multiple targets is necessary for successful therapy in the majority of patients. According to the experience and clinical data accumulated so far, combination therapy with three agents from different pharmacological classes is required in approx. 30% of patients in order to achieve long-term blood pressure control. The primary objective of the PETRA study was to evaluate the efficacy of blood pressure (BP) control with once daily administration of the different dosage strengths of the once-daily, triple fixed combination of perindopril, indapamide, and amlodipine. The evaluation was based on office BP readings and ambulatory blood pressure monitoring (ABPM) data gathered in routine clinical practice. Data from 11,209 hypertensive patients (the proportion of female subjects was 47.6%) were processed and interpreted in a 3-month-long prospective, observational, non-interventional, open-label study conducted in 997 centers in Hungary. Mean baseline office BP was 156.58±16.10/91.56±9.33mmHg (mean±SD), whereas the mean duration of hypertension was 9.48±7.19years. Mean office BP decreased by 24.81±15.47/11.41±9.90mmHg after switching to the triple fixed combination of perindopril, indapamide, and amlodipine (p<0.0001). At the final visit 45.1% of patients took the 5/1.25/5mg, 33.5% of them 10/2.5/5mg, and 21.4% of them 10/2.5/10mg strength of the perindopril/indapamide/amlodipine triple fixed combination. The 24-h blood pressure was obtained in 76 subjects. The mean 24-h BP decreased from 155.51±17.43/85.28±11.48 to 134.63±12.51/77.83±8.99mmHg (p<0.0001). Statistically significant (p<0.0001) and clinically relevant improvement of a number of metabolic parameters-including total cholesterol (-8.6%), LDL-cholesterol (-11.4%), triglyceride (-12.1%), and fasting blood glucose (-6.6%) levels-was observed over the 3-month study period. During the 3months of the PETRA study, the outstanding 24-h antihypertensive efficacy of the triple fixed combination of perindopril, indapamide, and amlodipine was confirmed both by office BP readings and by ABPM recordings. This combination may offer a new therapeutic option for hypertensive patients who have failed to achieve the desired BP target on their previous dual combination therapy. EGIS Pharmaceuticals PLC.

A comprehensive training program for professionals working in mental health promotion centers in Hungary

BackgroundIn a 12 month long mental health promotion pilot programme funded by the Norway Grants, 6 mental health promotion centers (MHPCs) are being set up in various locations in Hungary, employing 2 mental health professionals each, whose main commitment is to develop a local network of key stakeholders. The aim of the project is to enable MHPC professionals to perform network building tasks involving knowledge transfer and attitude changes regarding the following key areas: depression, suicide, dementia, stress and risk assessment.ObjectiveTo measure the effectiveness of the training and education process by using indicators for feedback, knowledge transfer and attitude changes.MethodsThe comprehensive TTT (train the trainers) process of MHPC professionals targets 3 main domains:– improving presentation skills;– knowledge transfer (measured with tests);– elaborative workshops about mental health problems (measured by attitudes at baseline, post-training and 3 months post-training).ResultsThe satisfaction assessment of the initial 3 days long training averaged 4.73 on a 5-point Likert-scale. Altogether, 12 (2/centres) knowledge transfer trainings are being delivered evaluated by attitude change and general satisfaction questionnaires. One elaborating workshop per center has been delivered during the study period. Being a process still underway, the outcome results will only be available by the conference.ConclusionThis procedure enables professionals to disseminate trainings and build networks for mental health promotion in their micro-regions. The optimized version of this pilot program will be delivered on a national level in future projects.Disclosure of interestThe authors have not supplied their declaration of competing interest.

A single-centre review of suspected sudden infant death cases.

This study aimed to establish the number of deaths in infants under 1 year of age that were being reported for medico-legal examination at a single large academic centre in Hungary, as well as the method of these investigations with special emphasis on histopathology, ancillary techniques and the adherence of our current practice to international recommendations. A single-centre, retrospective audit was conducted on all suspected sudden infant death cases. After the review there were eight infectious background sudden infant death syndrome (SIDS) cases, infectious respiratory tract disease in 14 cases, cardiac septal tumour in one case, and hepatic, possibly metabolic, disorder in one case. Our study has highlighted that even in a single institution there is a huge heterogeneity of approaches which needs standardisation. A reclassification of infant cases according to the San Diego definition resulted in a decreased number of SIDS cases in our material. The San Diego definition and related international recommendations were found to be practical and the classification provides a guide to the standardisation of current practice.

The effects of synthetic cannabinoids on executive function.

There is a growing use of novel psychoactive substances (NPSs) including synthetic cannabinoids. Synthetic cannabinoid products have effects similar to those of natural cannabis but the new synthetic cannabinoids are more potent and dangerous and their use has resulted in various adverse effects. The purpose of the study was to assess whether persistent use of synthetic cannabinoids is associating with impairments of executive function in chronic users. A total of 38 synthetic cannabinoids users, 43 recreational cannabis users, and 41 non-user subjects were studied in two centers in Hungary and Israel. Computerized cognitive function tests, the classical Stroop word-color task, n-back task, and a free-recall memory task were used. Synthetic cannabinoid users performed significantly worse than both recreational and non-cannabis users on the n-back task (less accuracy), the Stroop task (overall slow responses and less accuracy), and the long-term memory task (less word recall). Additionally, they have also shown higher ratings of depression and anxiety compared with both recreational and non-users groups. This study showed impairment of executive function in synthetic cannabinoid users compared with recreational users of cannabis and non-users. This may have major implications for our understanding of the long-term consequences of synthetic cannabinoid based drugs.

Allogén vérképzőőssejt-átültetés Magyarországon

The publication summarizes the 2548 stem cell transplantations performed in the period of 1993-2015 in Szent Laszló Hospital, Budapest and provides a detailed discussion of the 425 allogeneic transplantations during 2007-2013. The analysis explains the major steps of the evolution of allogeneic stem cell transplantation and compares the results of the unique Hungarian allogeneic center. The significant shift in the transplantation indications from chronic myeloid leukemia to myelodysplastic syndromes and the rising age of the recipients are in line with world wide tendencies. The latter one is the consequence of the introduction and improvement of the concept of reduced intensity conditioning regimens, originally arising from the idea of Endre Kelemen. The most limiting factor, the donor availability seems to be resolved with the use of a new immunomodulating regimen, the application of posttransplantation cyclophosphamide, which allows the transplantation through HLA barriers with haploidentical family donors with comparable results to the HLA matched volunteer unrelated donors. The above mentioned tendencies result the wider use of allogeneic stem cell transplantation less dependent from recipient age, comorbidities and even donor availability. The publication highlights the need of expanding the stem cell transplantation budget and the involvement of new centers in Hungary in allogeneic of stem cell transplantation. Orv. Hetil., 2017, 158(8), 291-297.

A Retrospective Analysis of the First 41 mCRPC Patients with Bone Pain Treated with Radium-223 at the National Institute of Oncology in Hungary.

Radium-223 dichloride is an alpha-emitting radiopharmaceutical which significantly prolongs overall survival in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases. This was a retrospective analysis of the efficacy and safety of Radium-223 in the first 41 patients treated at a single center in Hungary. Radium-223 was given at a dose of 50kBq/kg intravenously every 4weeks for up to 6cycles. Between 23rd July 2014 and 23rd February 2016, 41 patients were treated. Patient demographics, laboratory values, treatment outcomes and adverse events were collected from medical records. The mean age was 72.2years (SD: 7.1). 24 patients received Radium-223 as first-line treatment (58%), 7 patients as second (17%), 3 as third (7.3%), 6 as (14.6%), and 1 as fifth-line therapy (2.4%). The mean number of cycles administered was 5.5 (SD: 1.1). The most common side effects were anemia (32% grade 1-3), nausea (28%, grade 1), diarrhea (4%, grade 2), thrombocytopenia (4%, grade 3). The mean baseline PSA level was 307.2ng/ml (SD: 525.7), which increased to a mean value of 728.5ng/ml (SD: 1277) by the end of treatment. The baseline mean ALP of 521.1U/L (SD: 728) decreased to 245.1U/L (SD: 283.5). The majority of patients experienced a decrease (37%) or complete cessation (43%) of bone pain intensity. In our symptomatic prostate cancer patient population, Radium-223 proved to be efficient in terms of pain relief, with moderate side effects. No PSA response was detected, while alkaline phosphatase levels significantly decreased.

Right-wing radicalism and factors of xenophobic social practice in Hungary and Slovakia: comparative analysis

Article retracted Abstract: In Hungary and Slovakia during 2010-2015 there has been an increase in xenophobic attitudes in society; rightwing and extremist groups are activating there as well. The purpose of this article is to compare the most signifi cant factors which encourage xenophobia. Previously we have identifi ed the types of right-wing organizations and found out their electoral characteristics. We assume that the activities of right-wing extremist organizations infl uence the formation of xenophobic social practices in Hungary and Slovakia, which arise from the range of factors. In this article we used empirical data gained as a result of public opinion polls conducted by the leading research centers in Hungary and Slovakia, by international organizations, as well as statistics of public authorities and civil society institutions. By means of factor analysis, we identifi ed the main directions and forms of activity of right-wing radicals; determined the value of socio-economic dynamics of the country's development; characterized the attitude of society, the law and the ruling elite to the problems of xenophobia and right-wing radicalism. Among the most infl uential factors we identifi ed: open propaganda of nationalist ideas; constitutional priority of the ethnic majority interests; parliamentary status of rightwing parties; condoning the activities of right-wing radicals by the ruling elite, the courts and the police. The comparison of factors stimulating xenophobic practices in Hungary and Slovakia didn’t confi rm the hypothesis of common signifi cant infl uence of the economic crisis, lack of education and political passivity on the formation of xenophobic practices among young people. The professional frustration of provincial youth discovered itself as a cumulative socioeconomic factor.

Correcting crime rates for touristic centers based on the number of guests

Incorporating data on the number of tourists, the author attempts to conduct an objective analysis of crime data in touristic centers in Hungary.

An Open-Label Extension Study of Parathyroid Hormone Rhpth(1-84) in Adults with Hypoparathyroidism

Hypoparathyroidism is characterized by inadequate parathyroid hormone (PTH), resulting in hypocalcemia, hyperphosphatemia, and bone abnormalities. Adults with hypoparathyroidism treated with recombinant human PTH, rhPTH(1-84), in the 24-week, phase III REPLACE study maintained serum calcium despite reductions in oral calcium and active vitamin D. This study assessed the long-term efficacy and safety of rhPTH(1-84) for hypoparathyroidism. This was a 24-week, open-label, flexible-dose extension study of REPLACE (REPEAT) conducted in 3 outpatient centers in Hungary. Patients who previously completed or enrolled in REPLACE received 50 μg/day rhPTH(1-84), escalated to 75 and then to 100 μg/day, if needed, to reduce active vitamin D and oral calcium. The primary endpoint was ≥50% reduction in oral calcium (or ≤500 mg/day) and active vitamin D (or calcitriol ≤0.25 μg/day or alfacalcidol ≤0.50 μg/day) with normocalcemia. Twenty-four patients (n = 16 previously treated with rhPTH[1-84]; n = 8 rhPTH[1-84]-naïve) were enrolled and completed the study. At Week 24, 75% of patients (95% confidence interval [CI], 53.3-90.2%) achieved the study endpoint; 58% eliminated oral calcium and active vitamin D. Urinary calcium, serum phosphate, and calcium × phosphate (Ca × P) product decreased by Week 24. Mean serum bone turnover markers increased with rhPTH(1-84). Treatment-emergent adverse events (TEAEs) were reported by 92% of patients. No serious adverse events (AEs) occurred. This study used a simplified treatment algorithm intended to better mimic typical clinical practice and demonstrated the extended efficacy and safety of rhPTH(1-84) in patients with hypoparathyroidism and confirmed the REPLACE findings. Sustained rhPTH(1-84) efficacy up to 48 weeks was observed despite treatment interruption between studies.

Liver transplantation in Central Europe.

IntroductionTransplant hepatologists convened in Warsaw on 20-21 November 2015 at a meeting of the Initiative Group for Central European Hepatologic Collaboration to exchange their experience in liver transplantation in their respective countries.Material and methodsThe description is based on narration of individual country representatives, supplemented by data from additional queries, and from publicly accessible sources.ResultsLiver transplantation programs were launched, in the Czech Republic in 1983, in Poland in 1990 (paediatric) followed by the adult program 1994; the first liver transplant in Hungary was performed in 1995, with Slovakia launching its liver transplantation program in 2008. Currently, there are 2 centres for liver transplantation in Slovakia, 1 centre in Hungary, 6 centres in Poland, and 2 centres in the Czech Republic. The rates of liver transplantation correspond to the number of cadaveric donations being the highest in the Czech Republic (15.8 per million population) and the lowest in Slovakia (4.2 per million population) (2014 data). Live donation is utilized systematically in Poland. Indications vary from country to country, but the 3 most frequent ones include hepatitis C and B cirrhosis, alcoholic cirrhosis, and cholestatic liver disorders. There is a growing incidence of hepatocellular carcinoma among adult liver transplant recipients. Biliary atresia and hereditary diseases are the most frequent indications among children. Hungary became a member of Eurotransplant, other countries are not a part of any international organization for organ sharing.ConclusionsDespite some differences, liver transplant programs seem to be compatible honouring the same values and principles universal to liver transplant programs in most parts of the world.

Development of the registry for Philadelphia-negative chronic myeloproliferative neoplasia in Hungary

The establishment and operation of disease registry can be used to collect data on epidemiology cases. In addition, the registry can help to work out medical and health economical and political decisions for longer term. The aim of the authors was to collect and analyse data of patients with Philadelphia negative neoplasia in Hungary and draw conclusions about the basic types and features of the relevant disease. An online electronic data collection system has been established, based on the permission of the Regional and Institutional Committee of Science and Research Ethics obtained in April 8, 2013. Data collection has been initiated by hematology centres in Hungary. In addition to collection of the epidemiologic data, blood and bone marrow analysis data have been collected, as well. Also, based on cardiovascular factors, risk stratification has been established. Finally, the authors have investigated the method and practice of patient treatment in Hungary. Data of 901 patients from 15 Hungarian haematology centres have been recorded up to the date of June 30, 2015. After clarification of the data, 426 polycythaemia vera, 350 essential thrombocythaemia and 82 myelofibrosis cases were used for analysis. An online registry has been established which helps to clarify and analyse the basic features of certain medical cases and their treatment in Hungary. Including additional medical centres could help to improve the accuracy of medical analysis.

Pressure wave propagation phenomena in the pipe system of a nuclear power plant

The aim of this research is to compare the experimental data obtained by using PMK-2 test facility which was equipped as an experimental apparatus for water hammering of the pipe system in the KFKI research center in Hungary with some results of numerical calculations (V&V test) based on WAHA3 code on the pressure wave propagation phenomena in a pipe system of a nuclear power plant. In order to simulate pressure wave propagation in the two-phase flow by using WAHA3 code, we used two node systems for numerical calculations: For the first preliminary calculation, we used a simplified node system by assuming all the same area in the entire pipe system. But for the second calculations, we differently used a fully described node system for a real PMK-2 test facility. And then, we finally compare the calculated results using WAHA3 code with the experimental data produced by PMK-2 test facility.

Antibiotic susceptibility of sulfamethoxazole-trimethoprim resistant Stenotrophomonas maltophilia strains isolated at a tertiary care centre in Hungary.

Sulfamethoxazole-trimethoprim (SXT) is the drug-of-choice in Stenotrophomonas maltophilia caused infections. There has been an increase in resistance to SXT of S. maltophilia over recent years. In this study 30 S. maltophilia clinical isolates resistant to SXT were investigated. Antibiotic susceptibilities for ciprofloxacin, moxifloxacin, levofloxacin, doxycycline, tigecycline, ceftazidime, colistin and chloramphenicol were determined by broth microdilution method. None of the strains were susceptible to ciprofloxacin, tigecycline, ceftazidime or colistin. Only 37% of the isolates were susceptible to levofloxacin or moxifloxacin. Two isolates resistant to all tested antibiotic agents and two others susceptible only to doxycycline were further investigated: susceptibility for combinations of antibiotics was analyzed by checkerboard technique. According to the fractional inhibitory concentration indices calculated, moxifloxacin plus ceftazidime combination was found to be synergistic in each case. Genetic testing revealed the predominance of sul1 gene. Our study concluded that the range of effective antibiotic agents is even more limited in infections caused by SXT-resistant S. maltophilia. In these cases, in vitro synergistic antibiotic combinations could be potential therapeutic options.

Prevalence, significance and predictive value of antiphospholipid antibodies in Crohn's disease.

To assess the prevalence and stability of different antiphospholipid antibodies (APLAs) and their association with disease phenotype and progression in inflammatory bowel diseases (IBD) patients. About 458 consecutive patients [Crohn's disease (CD): 271 and ulcerative colitis (UC): 187] were enrolled into a follow-up cohort study in a tertiary IBD referral center in Hungary. Detailed clinical phenotypes were determined at enrollment by reviewing the patients' medical charts. Disease activity, medical treatment and data about evolvement of complications or surgical interventions were determined prospectively during the follow-up. Disease course (development f complicated disease phenotype and need for surgery), occurrence of thrombotic events, actual state of disease activity according to clinical, laboratory and endoscopic scores and accurate treatment regime were recorded during the follow-up, (median, 57.4 and 61.6 mo for CD and UC). Sera of IBD patients and 103 healthy controls (HC) were tested on individual anti-β2-Glycoprotein-I (anti-β2-GPI IgA/M/G), anti-cardiolipin (ACA IgA/M/G) and anti-phosphatidylserine/prothrombin (anti-PS/PT IgA/M/G) antibodies and also anti-Saccharomyces cerevisiae antibodies (ASCA IgA/G) by enzyme-linked immunosorbent assay (ELISA). In a subgroup of CD (n = 198) and UC patients (n = 103), obtaining consecutive samples over various arbitrary time-points during the disease course, we evaluated the intraindividual stability of the APLA status. Additionally, we provide an overview of studies, performed so far, in which significance of APLAs in IBD were assessed. Patients with CD had significantly higher prevalence of both ACA (23.4%) and anti-PS/PT (20.4%) antibodies than UC (4.8%, P < 0.0001 and 10.2%, P = 0.004) and HC (2.9%, P < 0.0001 and 15.5%, P = NS). No difference was found for the prevalence of anti-β2-GPI between different groups (7.2%-9.7%). In CD, no association was found between APLA and ASCA status of the patients. Occurrence of anti-β2-GPI, ACA and anti-PS/PT was not different between the group of patients with active vs inactive disease state according to appropriate clinical, laboratory and endoscopic scores in CD as well as in UC patients. All subtypes of anti-β2-GPI and ACA IgM status were found to be very stable over time, in contrast ACA IgG and even more ACA IgA status showed significant intraindividual changes. Changes in antibody status were more remarkable in CD than UC (ACA IgA: 49.9% vs 23.3% and ACA IgG: 21.2% vs 5.8%). Interestingly, 59.1% and 30.1% of CD patients who received anti-TNF therapy showed significant negative to positive changes in ACA IgA and IgG antibody status respectively. APLA status was not associated with the clinical phenotype at diagnosis or during follow-up, medical therapy, or thrombotic events and it was not associated with the probability of developing complicated disease phenotype or surgery in a Kaplan-Meier analysis. The present study demonstrated enhanced formation of APLAs in CD patients. However, presence of different APLAs were not associated with the clinical phenotype or disease course.

Infection and colonization by Stenotrophomonas maltophilia: antimicrobial susceptibility and clinical background of strains isolated at a tertiary care centre in Hungary.

BackgroundStenotrophomonas maltophilia is an important opportunistic, mainly nosocomial pathogen that emerged in the last decades worldwide. Due to its inherent extended antibiotic resistance, therapeutic options are strongly limited. New resistance mechanisms in S. maltophilia make antibiotic therapy even more difficult. The aim of our study was to investigate the antimicrobial resistance of S. maltophilia isolates collected in our laboratory and to reveal related clinical background.MethodConsecutive non-duplicate S. maltophilia isolates (n = 160) were collected in a three-year period. Conventional methods, automated identification system and MALDI-TOF MS was used for identification, ERIC-PCR for genetic relationship analysis and broth microdilution method to determine the susceptibility for trimethoprim/sulfamethoxazole (SXT), ciprofloxacin, levofloxacin, moxifloxacin, colistin, doxycycline and tigecycline. Clinical final reports were used retrospectively to collect clinical information.ResultsERIC-PCR revealed large heterogeneity. Trimethoprim/sulfamethoxazole, moxifloxacin and levofloxacin were found to be the most effective agents with MIC50/MIC90 0.5/1, 0.25/1, 1/2 mg/l, respectively. Seventy percent of patients with S. maltophilia infection were treated in intensive care units. All-cause mortality rate was 45%. Nearly 70% of the isolates were collected from polymicrobial infections/colonizations.ConclusionsTrimethoprim/sulfamethoxazole is the most potent antibiotic agent against S. maltophilia. In case of SXT hypersensitivity, intolerance or resistance, fluoroquinolones are alternative therapeutic options. Missing clinical breakpoints, consensus antibiotic susceptibility testing guidelines and clinical trials make the interpretation of antibiotic susceptibility testing results difficult. The indirect pathogenicity of S. maltophilia in polymicrobial infections or colonizations has to be taken into consideration.

Empirical research about IT shared service centers in Hungary

In Hungary the two most important service areas in the business service centers are the information technologies and the finance. Nowadays there is more and more information technologies service centers that deliver services for internal or external corporate partners as an outsourcing or a shared service center. However it is a robust trend in the Hungarian information technologies sector in the last two decades that these companies employ the most newly graduates of higher education but there are very few information about these centers. For example not only the growing headcount is important but these service centers are typically affiliates of big global companies that use new information technologies solutions as well. This research tries to get an overall picture about the players of information technologies business service sector in Hungary. Due to a comprehensive questionnaire and the research is based on the answers of 27 information technologies service centers on its strategic and operational work.

How long does a myeloma patient currently wait for the diagnosis in Hungary?

Long delays with the diagnosis of myeloma are common. So far there has not been a comprehensive study on this issue in Hungary. The aim of the authors was to analyze the waiting time from their first symptoms to the diagnosis of myeloma. 193 myeloma patients treated in one large tertiary referral hematology centre in Hungary were included. The median time was 4.1 months (0-35.4) until diagnosis, and 5.2 months (0-35.4) until treatment. The delay was longer in patients with better prognosis (early stage, low cytogenetic risk), in nonsecretory disease and in 5 patients with amyloidosis. There was no significant relationship between the delay and the survival. Considering the results of the present study and earlier literature data, the authors look for possibilities to improve the diagnostic delay. They think that the key to an earlier diagnosis is in the hands of the primary care physicians as they see the patients first and decide whether it is necessary to refer them to further test and to which specialty. Helping them with diagnostic algorithms, clear referring pathways, fast tracking patients with urgent problems, and making serum electrophoresis universally available in the primary care could help to reduce the time that myeloma patients spend waiting.

Characteristics of infertility-specific quality of life in Hungarian couples

Experiencing involuntary childlessness has a great impact on couples' quality of life. The aim of the authors was to examine the correlations among infertility-specific quality of life and depression on the level of individuals and couples. 126 couples in five fertility centers in Hungary filled out the FertiQoL and Beck Depression Inventory and answered some sociodemographic questions. In gender comparison, women reported about more depressive symptoms and poorer quality of life than men. Both in men and women, the higher depression level correlated with lower level of quality of life. Moreover, the presence of more depressive symptoms in women was related to men's poorer quality of life. The results show that differences may exist in affective responses to infertility between women and men and that female affective problems take effects on the level of the couple relationship. These findings may be useful in psychosocial support of the couples facing infertility, especially in couple counselling or couple therapy.

Peripheral Blood Stem Cell Mobilization and Engraftment after Autologous Stem Cell Transplantation with Biosimilar rhG-CSF

Biosimilar versions of filgrastim [recombinant human granulocyte colony-stimulating factor (rhG-CSF)] are now widely available. To date, biosimilar rhG-CSF has demonstrated a comparable quality, safety and efficacy profile to the originator product (filgrastim [Neupogen(®)], Amgen Inc., CA, USA) in the prevention and management of neutropenia. Biosimilar rhG-CSFs have also been used to induce peripheral blood stem cell (PBSC) mobilization in patients undergoing autologous stem cell transplantation (AHSCT). The authors have examined the effectiveness of a biosimilar rhG-CSF (Zarzio(®), Sandoz Biopharmaceuticals, Holzkirchen, Germany) in two retrospective studies across two medical centers in Hungary. In Study 1, 70 patients with hematological malignancies scheduled to undergo AHSCT received chemotherapy followed by biosimilar rhG-CSF (2 × 5 μg) for facilitating neutrophil, leukocyte, and platelet engraftment. In study 2, 40 additional patients with lymphoid malignancies and planned AHSCT received chemotherapy followed by biosimilar rhG-CSF for PBSC mobilization. The effectiveness of treatment was assessed by the average yield of cluster of differentiation (CD) 34+ cells and the number of leukaphereses required. In Study 1 (patients undergoing AHSCT), the median age was 56 years and most patients were male (60%). The conditioning regimens were mainly high-dose melphalan (n = 41) and carmustine (BiCNU(®), Bristol-Myers Squibb, NJ, USA), etoposide, cytarabine and melphalan BEAM (n = 21). Median times to absolute neutrophil and leukocyte engraftment were 9 (range 8-11 days) and 10 (8-12) days, respectively. Median time to platelet engraftment was 10.5 days (7-19 days). In Study 2, the patients' median age was 54 years and the majority (57.5%) were female. The median time interval between day 1 of mobilizing chemotherapy and first leukapheresis was 12 (9-27) days. In the autologous PBSC grafts, the median number of CD34+ cells harvested was 5.2 × 10(6)/kg (2.22-57.07 × 10(6)/kg). The median yield of CD34+ cells per leukapheresis product was 2.47 × 10(6)/kg. In total, 58 leukaphereses were performed in 40 successfully harvested patients. In line with previous studies with originator rhG-CSF, the findings of this study indicate that biosimilar rhG-CSF following AHSCT is effective and generally well tolerated in the engraftment setting. In addition, biosimilar rhG-CSF is comparable to the originator rhG-CSF in terms of kinetics of PBSC mobilization and yield of CD34+ cells. In conclusion, the authors have demonstrated that the use of biosimilar rhG-CSF is effective and safe in autologous PBSC mobilization and engraftment after AHSCT.