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1.
J Clin Med ; 10(14)2021 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-34300299

RESUMO

Pharmaco-electroencephalography (pharmaco-EEG) is a technique used to assess the effects of psychotropic medications on the bioelectrical activity of the brain. The purpose of this study was to assess the treatment response with the use of the Hamilton Depression Rating Scale (HDRS) and via EEG. Over an 8-week period, we analyzed electroencephalographic tracings of 91 patients hospitalized for major depression at the Medical University of Warsaw. Thirty-nine of those patients received tricyclic antidepressants (TCAs), 35 received fluoxetine, and 17 received fluoxetine augmented with magnesium (Mg) ions. All patients had their serum drug levels monitored. The highest proportion of patients (88.2%) who showed adequate responses to treatment was observed in the fluoxetine+Mg group, whereas the lowest rates of treatment response were observed in the TCA group (58.3%). This difference was statistically significant (p = 0.029, Phi = 0.30). Our study demonstrated a relationship between achieving remission (HDRS ≤ 6 at week 8 of treatment) and obtaining a positive pharmaco-EEG profile 6 h after administration of the first dose in the group receiving fluoxetine augmented with Mg ions (p = 0.035, Phi = 0.63).

2.
Front Pharmacol ; 10: 1279, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31827433

RESUMO

Objective: To review the reimbursement recommendations issued by selected European health technology assessment agencies for orphan drugs and the reimbursement status of these drugs; to assess the relationship between the type of recommendation and reimbursement status. Methods: The list of orphan drugs to be included in the analysis was obtained from the European Medicines Agency and Orphanet. Seven European states were included in the analysis: Belgium, England, France, Germany, Poland, Scotland, and Spain. For all identified orphan drugs, relevant data on the reimbursement status and type of recommendation were collected for each country. The relationship between the type of recommendation and reimbursement status was evaluated separately for each considered country, using Cohen's kappa coefficient for the measurement of agreement; sub-analyses for oncology and metabolic drugs were performed. Results: Most reimbursement recommendations for orphan drugs were positive (71%), while approximately 17% were negative and almost 13% were conditional. The highest percentage of positive reimbursement recommendations was observed in Spain (97%) and France (95%) and the highest percentage of negative reimbursement recommendations was revealed for Poland (49%). On average, 65% of the 163 analyzed orphan drugs were reimbursed from public funds. The highest number of reimbursed orphan drugs was observed in Germany (n = 148), while the lowest, in Poland (n = 41). Considering all analyzed drugs, the highest agreement between recommendations and reimbursement status was observed for Spain (value of 1), and the lowest, for Germany (κ = -0.03). Conclusions: On average, more than 60% of identified orphan drugs were reimbursed from public funds in the included countries, and the majority of reimbursement recommendations were found to be positive. The agreement between reimbursement recommendations and reimbursement status differed between the countries, but overall, it did not show any patterns, as it ranged from -0.03 to 1 (κ coefficient).

3.
Artigo em Inglês | MEDLINE | ID: mdl-30473786

RESUMO

Background: The problem of inappropriate use of antibiotics and the resulting growth in antimicrobial resistance (AMR) has implications for Poland and the world. The objective of this paper was to compare and contrast antibiotic resistance and antibiotic utilisation in Poland in recent years versus other European countries, including agreed quality indicators, alongside current AMR patterns and ongoing policies and initiatives in Poland to influence and improve antibiotic prescribing. Methods: A quantitative ten-year analysis (2007-2016) of the use of antibiotics based on European Centre for Disease Prevention and Control (ECDC) data combined with a literature review on AMR rates and antimicrobial stewardship initiatives. Results: The system of monitoring AMR and appropriate strategies to address AMR rates remain underdeveloped in Poland. The role of microbiological diagnostics and efforts to prevent infections is currently underestimated by physicians. Overall, Poland had one of the highest rates of total consumption of antibiotics in the analysed European countries. Total consumption of antibacterials for systemic use and relative consumption of beta-lactamase sensitive penicillins were characterized by small but statistically significant average annual increases between 2007 and 2016 (from 22.2 DIDs to 23.9 DIDs and from 0.8 to 1.3%, respectively). Conclusions: The integrated activities around appropriate antibiotic prescribing in the pre- and post-graduate training of physicians and dentists seem to be particularly important, as well as changes in policies on prescribing antibiotics within ambulatory care. AMR and appropriate prescribing of antibiotics should be the focus of health policy actions in Poland.


Assuntos
Antibacterianos , Prescrições de Medicamentos/estatística & dados numéricos , Farmacorresistência Bacteriana , Uso de Medicamentos/estatística & dados numéricos , Antibacterianos/farmacologia , Odontólogos , Farmacorresistência Bacteriana/efeitos dos fármacos , União Europeia , Política de Saúde , Humanos , Penicilinas/farmacologia , Médicos , Polônia , Padrões de Prática Odontológica , Padrões de Prática Médica , beta-Lactamases
4.
Front Pharmacol ; 9: 1263, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30483124

RESUMO

Objective: To assess shares of reimbursed orphan drugs and agreement in reimbursement decision-making in different European Union member states as well as to define odds for reimbursement influenced by the presence of conditional approval or exceptional circumstances granted by the European Medicines Agency (EMA) or by type of the disease. Methods: The list of authorized drugs with current orphan designations was collected from the website of the EMA. For each drug, the information regarding conditional approval or approval under exceptional circumstances was collected. The reimbursement statuses were available on national reimbursement or HTA agencies websites. The agreement for reimbursement decisions between selected countries was assessed using the κ coefficient for the measurement of agreement. The impact of the EMA's conditional approval as well as approval under exceptional circumstances was assessed using the logistic regression and presented as odds ratio. Results: The percentage of reimbursed orphan drugs varied significantly from 27% in Poland to 88% in Denmark, with an average value of 51% (p < 0.0001). Regarding the reimbursement status, the highest, substantial agreement was observed between Spain and Italy, and the lowest agreement was observed between Germany and England, with κ of 0.64 and 0.01, respectively. Conditional approval status significantly decreased the chance for reimbursement in France, Italy, and Spain by 77-80%; however, approval granted under exceptional circumstances had significant impact only in Germany with 85% decrease in chances for reimbursement. The type of the disease (oncology or metabolic) was significantly associated with both conditional approval (p of 0.03-oncology drugs were more likely to be conditionally approved then the rest of analyzed drugs) and exceptional circumstances (p of 0.02-drugs for metabolic diseases were more likely to be approved under exceptional circumstances). Conclusions: Access to reimbursed orphan drugs varies significantly across EU countries. The highest, substantial agreement in reimbursement decisions was observed between Italy and Spain and the lowest between Germany and England. Conditional approval and approval under exceptional circumstances were significant negative predictors of reimbursement in some countries and they were significantly associated with the type of the disease (oncology or metabolic).

5.
Pharmacoeconomics ; 36(7): 853-865, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29667146

RESUMO

OBJECTIVE: The aim was to evaluate the cost-effectiveness of Crohn's disease (CD) treatment with vedolizumab and ustekinumab after failure of therapy with tumor necrosis factor-α antagonists (anti-TNFs). METHODS: The Markov model incorporated the lifetime horizon, synthesis-based estimates of biologics' efficacy in relation to anti-TNF exposure, and administration of biologics reflecting clinical practice (e.g., sequence of biologics, retreatment, 12-month treatment). The utilities, non-medical costs and indirect costs were derived from a study of 200 adult patients with CD, while the healthcare costs were from a study of 1393 adults with CD who used biologics in Poland. The quality-adjusted life years (QALYs) and costs (the societal perspective) were discounted with the annual rates of 3.5 and 5%, respectively. RESULTS: The addition of vedolizumab (ustekinumab) to the sequence of available anti-TNFs (after first-line infliximab or after second-line adalimumab) led to a gain of 0.364 (0.349) QALYs at an additional cost of €5600.24 (€6593.82). The incremental cost-effectiveness ratios (ICERs) were €15,369 [95% confidence interval (CI) 7496-61,354] and €18,878 (95% CI 9213-85,045) per QALY gained with vedolizumab and ustekinumab, respectively. Sensitivity analyses revealed a high impact on the ICERs of the relapse rate after discontinuation of biologic treatment. The highest value of vedolizumab/ustekinumab was estimated after the failure of therapies with both anti-TNFs. CONCLUSIONS: CD treatment with ustekinumab or vedolizumab after failure of anti-TNF therapy appears to be cost-effective at a threshold of €31,500. The replacement of the second-line anti-TNF with ustekinumab/vedolizumab and the course of the disease after discontinuation of biologics are influential drivers of the cost-effectiveness.


Assuntos
Anticorpos Monoclonais Humanizados/economia , Análise Custo-Benefício , Doença de Crohn/economia , Ustekinumab/economia , Adalimumab/economia , Adalimumab/uso terapêutico , Anticorpos Monoclonais/economia , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Efeitos Psicossociais da Doença , Doença de Crohn/tratamento farmacológico , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Infliximab/economia , Infliximab/uso terapêutico , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Falha de Tratamento , Ustekinumab/uso terapêutico
6.
Prz Gastroenterol ; 12(1): 60-65, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28337239

RESUMO

INTRODUCTION: Ulcerative colitis (UC) require expensive, lifelong treatment, which generates huge direct costs and has a significant impact on the quality of life, especially in the active state of the disease. AIM: To assess the indirect costs, health-related quality of life, and clinical characteristics of patients with UC in Poland. Additionally, we investigated the association between activity of UC and productivity loss of patients in a Polish setting. MATERIAL AND METHODS: A questionnaire survey was conducted using the Patient Simple Clinical Colitis Activity Index (P-SCCAI) to assess disease activity, as well as the modified Work Productivity and Activity Impairment Questionnaire to assess productivity loss. The quality of life was presented as utility calculated with the EQ-5D-3L questionnaire. Indirect costs were assessed with the Human Capital Approach and were expressed in Polish zlotys (PLN) as well as in euros (€). Correlations were presented using the Spearman coefficient. RESULTS: We performed our analysis based on 202 full questionnaires collected. Mean patient age and age at disease onset were 33.14 years (standard deviation (SD): 9.90) and 26.35 years (SD: 8.89), respectively. The mean P-SCCAI score in the analysed group of patients was 8.26, and the mean utility was 0.8651. Average and median annual indirect costs per working person were €2043 and €1389 (8543 PLN and 5808 PLN), respectively, calculated using the gross domestic product, as well as €4791 and €3257 (20,026 PLN and 13,615 PLN), respectively, calculated using the gross value added. Total productivity loss was significantly correlated with the disease activity. CONCLUSIONS: Ulcerative colitis causes a decrease in the quality of life as well as patients' productivity loss associated with both absenteeism and with presenteeism.

7.
Front Pharmacol ; 8: 892, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29326583

RESUMO

Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries. Methods: A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. A review of requirements for reimbursement and implications of Health Technology Assessment (HTA) was performed to compare the issues in above-mentioned countries. For each specified country, data for reimbursement costs, total pharmaceutical budget, and total public health care budget in the years 2014 and 2015 were also collected. Questionnaires were distributed via emails and feedback data were obtained in the same way. Additional questions, if any, were also submitted to respondents by email. Pricing and reimbursement data were valid for March 2017. Results: The survey revealed that the relation of drug reimbursement costs to total public healthcare spending ranged from 0.12 to 0.21 in the year 2014 and 2015 (median value). It also revealed that pricing criteria for drugs, employed in the CEE countries, were quite similar. External reference pricing as well as internal reference pricing were common in mentioned countries. Positive reimbursement lists were valid in all countries of the CEE region, negative ones were rarely used; reimbursement decisions were regularly revised and updated in the majority of countries. Copayment was common and available levels of reimbursement differed within and between the countries and ranged from 20 to 100%. Risk-sharing schemes were often in use, especially in the case of innovative, expensive drugs. Generic substitution was also possible in all analyzed CEE countries, while some made it mandatory. HTA was carried out in almost all of the considered CEE countries and HTA dossier was obligatory for submitting a pricing and reimbursement application. Conclusions: Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries.

8.
Expert Rev Pharmacoecon Outcomes Res ; 17(4): 385-400, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27882823

RESUMO

BACKGROUND: The appropriate access to public information is very important for healthcare system stakeholders. The goal of this study was to examine how the execution of the formally existing right to public information on the HTA-based recommendations on reimbursement of new health technologies from public funds has been changing in Poland. METHODS: All recommendations published within two predefined equal periods of time between 2013 and 2015 were analyzed. The gathered data was subjected to statistical analysis. RESULTS: The frequency and intensity of censoring the published HTA-based recommendations on the pharmaceutical reimbursement has diminished. The text readability and clarity of message has improved, although the degree of decisiveness of the recommendations has dropped. CONCLUSION: The positive changes in the public communication policy should be continued. The transparency of the HTA-based recommendations should be increased further in some areas in the future.


Assuntos
Acesso à Informação , Atenção à Saúde/organização & administração , Mecanismo de Reembolso , Avaliação da Tecnologia Biomédica , Comunicação , Atenção à Saúde/economia , Humanos , Preparações Farmacêuticas/economia , Polônia , Política Pública
9.
PLoS One ; 11(12): e0168586, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27992531

RESUMO

BACKGROUND AND AIMS: Evidence on indirect cost of Crohn's disease (CD) is available but typically provides information on the loss of productivity at paid work of patients. In the present study, the quality of life and indirect costs of CD patients were assessed (overall and by disease severity). METHODS: A self-report questionnaire-based study among adult Polish patients with CD was performed. We collected data on patients' characteristics, quality of life, loss of productivity, consumption of medical resources, and out-of-pocket expenses. The disease severity was determined using the patient's version of the Harvey-Bradshaw index. Productivity costs were assessed from the social perspective, using a human capital approach. The cost of absenteeism, presenteeism and permanent work disability was valuated using the gross domestic product per worker. The patients' productivity loss at unpaid work was measured by time inputs of others to assist patients. The productivity loss among informal caregivers and patients' productivity loss at unpaid work were valuated with the average wage in Poland. The results were adjusted for confounders. RESULTS: The responses from 200 patients (47% in remission) were analysed. The mean utility index was 0.839 (SD 0.171). The total indirect cost was estimated at €462.47 per patient per month (24.0%, absenteeism; 35.0%, work disability; 30.4%, presenteeism; 0.4%, productivity loss at unpaid work; and 10.4%, informal care). A significant correlation of the quality of life and productivity losses with disease severity was observed. Compared with active disease, the remission subgroup had a higher utility index by 16% (p<0.001) and lower indirect costs by 71% (p = 0.003) for absenteeism, 41% (p = 0.030) for presenteeism, 76% (p<0.001) for productivity loss at unpaid work, and 75% (p<0.001) for informal care. CONCLUSIONS: Our study revealed the social burden of CD and high dependency of indirect costs and quality of life on the severity of CD in Poland.


Assuntos
Efeitos Psicossociais da Doença , Doença de Crohn/economia , Doença de Crohn/psicologia , Gastos em Saúde/estatística & dados numéricos , Qualidade de Vida/psicologia , Absenteísmo , Adulto , Eficiência , Feminino , Humanos , Masculino , Polônia , Autorrelato , Licença Médica , Adulto Jovem
10.
Orphanet J Rare Dis ; 11(1): 122, 2016 09 06.
Artigo em Inglês | MEDLINE | ID: mdl-27600717

RESUMO

BACKGROUND: The aim of this study was to review and compare types of reimbursement recommendations for orphan drugs issued by eight European health technology assessment (HTA) agencies and the reimbursement status of these drugs in the corresponding countries. Separate calculations were also performed for three sub-groups: ultra-orphan drugs, oncology orphan drugs and other (non-ultra, non-oncology) orphan drugs. RESULTS: We reviewed drugs authorized by the European Medicine Agency (EMA) between 1 November 2002 and 30 September 2015. Among these, we identified 101 orphan drugs. Seventy-nine of them were assessed by eight European HTA agencies. The average rates of positive, conditional and negative reimbursement recommendations issued by these agencies were 55.7 %, 15.3 % and 29.0 %, respectively. On average, 21.2 % of EMA-authorized orphan drugs were reimbursed in the eight European countries studied: 49.0 % of those with positive, 53.6 % of those with conditional, and 16.0 % of those with negative reimbursement recommendations. In addition, 5.4 % of orphan drugs that had not been assessed by any of the eight HTA agencies were also reimbursed. The shares of oncology, ultra, and other orphan drugs that were assessed by HTA agencies were similar, with the lowest share observed in ultra-orphan drugs (72 %) and the highest in other orphan drugs (80 %). In terms of reimbursement, 20 % of oncology orphan drugs, 25 % of ultra-orphan drugs and 21 % of other orphan drugs were reimbursed. CONCLUSIONS: Reimbursement of orphan drugs does not always correspond to the type of HTA recommendation. While the highest rate of reimbursement is observed (unsurprisingly) among drugs with positive or conditional recommendation, a high rate of reimbursement (11 %) is also observed among ultra-orphan drugs that had never been assessed by any HTA agency.


Assuntos
Produção de Droga sem Interesse Comercial/economia , Avaliação da Tecnologia Biomédica/normas , Tomada de Decisões , Europa (Continente) , Política de Saúde , Humanos , Produção de Droga sem Interesse Comercial/legislação & jurisprudência , Produção de Droga sem Interesse Comercial/normas , Mecanismo de Reembolso/normas , Mecanismo de Reembolso/estatística & dados numéricos , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
11.
Eur J Clin Pharmacol ; 72(11): 1319-1325, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27497991

RESUMO

PURPOSE: Until recently, surgery was the only remaining choice for moderate to severe chronic ulcerative colitis patients who failed standard treatment or when it was not tolerated. Anti-TNFα treatment is a new, non-invasive option for the management of ulcerative colitis. The objective of this study was to assess the cost-effectiveness of induction and maintenance treatment up to 1 year of ulcerative colitis with adalimumab/standard care and standard care alone in Poland. METHODS: A Markov model was used to estimate the expected costs and effects of adalimumab/standard care and a standard care alone. For each treatment option, the costs and quality adjusted life years were calculated to estimate the incremental cost-utility ratio. The analysis was performed from the perspective of the Polish public payer and society over a 30-year time horizon. Different direct and indirect costs and utility values were assigned to the various model health states. RESULTS: The treatment of ulcerative colitis patients with adalimumab/standard care up to 1 year instead of a standard care alone resulted in 0.14 additional years of life with full health (QALYs). The incremental cost-utility ratio of adalimumab/standard care compared to the standard care alone is estimated to be 76,120 €/QALY gained from NHF perspective and 71,457 €/QALY gained from social perspective. CONCLUSIONS: The biologic treatment of ulcerative colitis patients with adalimumab/standard care is more effective but also more costly compared with standard care alone.


Assuntos
Adalimumab/economia , Anti-Inflamatórios/economia , Colite Ulcerativa/economia , Adalimumab/uso terapêutico , Adulto , Anti-Inflamatórios/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Análise Custo-Benefício , Feminino , Humanos , Masculino , Cadeias de Markov , Modelos Econômicos , Polônia , Anos de Vida Ajustados por Qualidade de Vida
12.
PLoS One ; 11(8): e0160444, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27494322

RESUMO

OBJECTIVE: The objective of this study was to assess the cost-effectiveness of induction and maintenance treatment up to 1 year of ulcerative colitis with golimumab/standard care and standard care alone in Poland. METHODS: A Markov model was used to estimate the expected costs and effects of golimumab/standard care and a standard care alone. For each treatment option the costs and quality adjusted life years were calculated to estimate the incremental cost-utility ratio. The analysis was performed from the perspective of the Polish public payer and society over a 30-years time horizon. The clinical parameters were derived mainly from the PURSUIT-SC and PURSUIT-M clinical trials. Different direct and indirect costs and utility values were assigned to the various model health states. RESULTS: The treatment of ulcerative colitis patients with golimumab/standard care instead of a standard care alone resulted in 0.122 additional years of life with full health. The treatment with golimumab/standard care was found to be more expensive than treatment with the standard care alone from the public payer perspective and from social perspective. The incremental cost-utility ratio of golimumab/standard care compared to the standard care alone is estimated to be 391,252 PLN/QALY gained (93,155 €/QALYG) from public payer perspective and 374,377 PLN/QALY gained (89,137 €/QALYG) from social perspective. CONCLUSIONS: The biologic treatment of ulcerative colitis patients with golimumab/standard care is more effective but also more costly compared with standard care alone.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/economia , Fármacos Gastrointestinais/uso terapêutico , Anticorpos Monoclonais/economia , Análise Custo-Benefício , Fármacos Gastrointestinais/economia , Humanos , Cadeias de Markov , Modelos Econômicos , Polônia , Qualidade de Vida , Resultado do Tratamento
13.
Rheumatol Int ; 36(9): 1223-30, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27339273

RESUMO

The aim of the study was to assess the indirect costs, health-related quality of life and clinical characteristics of patients with psoriatic arthritis (PsA), measured using a PsA disease activity index in Poland. Additionally, we aimed to investigate the association between the activity, utility of PsA-affected patients and productivity loss in a Polish setting. A questionnaire survey was conducted to assess disease activity, as well as productivity loss, and a paper version of the EuroQoly-5D-3L questionnaire was used to assess productivity loss and the quality of life. Indirect costs were assessed with the human capital approach employing the gross domestic product (GDP) per capita, gross value added (GVA) and gross income (GI) per worker in 2014 in Poland and were expressed in Polish zlotys (PLN) as well as in euros. The correlation was presented using the Spearman correlation coefficient. Our analysis was performed on the basis of 50 full questionnaires collected. We observed a mean utility value of 0.6567. The mean number of days off work was 2.88 days per month, and mean on-the-job productivity loss was 24.1 %. Average monthly indirect costs per patient were €206.7 (864.01 PLN) calculated using the GDP; €484.56 (2025.46 PLN) calculated using the GVA; and €209.70 (876.56 PLN) calculated using the GI. PsA reduces the patients' quality of life as well as their productivity loss associated with both absenteeism and presenteeism. Total indirect costs were negatively correlated with utility. The greater the disease activity, the lower the utility and the greater the indirect costs.


Assuntos
Artrite Psoriásica/diagnóstico , Efeitos Psicossociais da Doença , Emprego , Custos de Cuidados de Saúde , Qualidade de Vida , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Artrite Psoriásica/economia , Artrite Psoriásica/psicologia , Eficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polônia , Índice de Gravidade de Doença , Inquéritos e Questionários , Adulto Jovem
14.
Pharmacotherapy ; 36(5): 472-81, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-27007213

RESUMO

STUDY OBJECTIVE: To assess the cost-effectiveness of infliximab with standard care (e.g., azathioprine, prednisolone, mesalazine, and 6-mercaptopurine) versus standard care alone for induction and maintenance treatment of patients with ulcerative colitis (UC) in Poland. DESIGN: Cost-utility decision analytic model. MEASUREMENTS AND MAIN RESULTS: A Markov model was used to estimate the expected costs and effects of infliximab/standard care and standard care alone. For each treatment option, costs and quality-adjusted life-years (QALYs) were calculated to estimate the incremental cost-utility ratio. The target population consisted of a hypothetical cohort of adult patients with moderately to severely active UC who had an inadequate response to standard treatment, including corticosteroids and 6-mercaptopurine or azathioprine, or who were intolerant to or had medical contraindications to such therapies. The analysis was performed from the perspective of the Polish public payer over a 30-year time horizon. The clinical parameters were derived mainly from the Active Ulcerative Colitis Trial (ACT) 1 and ACT 2 and from the Ulcerative Colitis Long-term Remission and Maintenance with Adalimumab (ULTRA) 2 clinical trial. Different costs and utility values were assigned to the various health states in the model; utility values were derived from a previously published study. Treatment of patients who received infliximab/standard care instead of standard care alone resulted in 0.174 additional QALYs. Treatment with infliximab/standard care was found to be more expensive than treatment with standard care alone from the Polish National Health Fund perspective. The incremental cost-utility ratio of infliximab/standard care compared with standard care alone was estimated to be 402,420 Polish zlotys (PLN)/QALY gained (95% confidence interval [CI] 253,936-531,450 PLN/QALY gained), which is equivalent to $106,743 (U.S. dollars)/QALY gained (95% CI $67,357-140,968 [U.S. dollars]/QALY gained). CONCLUSION: Treatment with infliximab/standard care instead of standard care alone resulted in additional QALYs but also additional costs. The incremental cost per QALY gained of infliximab/standard care compared with standard care alone exceeded the willingness-to-pay threshold in Poland (equivalent to ~$33,400).


Assuntos
Colite Ulcerativa/economia , Análise Custo-Benefício/estatística & dados numéricos , Infliximab/economia , Colite Ulcerativa/tratamento farmacológico , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Infliximab/uso terapêutico , Cadeias de Markov , Polônia , Anos de Vida Ajustados por Qualidade de Vida
15.
Pharmacol Ther ; 157: 10-27, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26549541

RESUMO

In this review, we aim to present, discuss and clarify our current understanding regarding the prediction of possible antipsychotic effects of metabotropic glutamate (mGlu) receptor ligands. The number of preclinical trials clearly indicates, that this group of compounds constitutes an excellent alternative to presently used antipsychotic therapy, being effective not only to positive, but also negative and cognitive symptoms of schizophrenia. Although the results of clinical trials that were performed for the group of mGlu2/3 agonists were not so enthusiastic as in animal studies, they still showed that mGlu ligands do not induced variety of side effects typical for presently used antipsychotics, and were generally well tolerated. The lack of satisfactory effectiveness towards schizophrenia symptoms of mGlu2/3 activators in humans could be a result of variety of uncontrolled factors and unidentified biomarkers different for each schizophrenia patient, that should be taken into consideration in the future set of clinical trials. The subject is still open for further research, and the novel classes of mGlu5 or mGlu2/3 agonists/PAMs were recently introduced, including the large group of compounds from the third group of mGlu receptors, especially of mGlu4 subtype. Finally, more precise treatment based on simultaneous administration of minimal doses of the ligands for two or more receptors, seems to be promising in the context of symptoms-specific schizophrenia treatment.


Assuntos
Antipsicóticos/uso terapêutico , Receptores de Glutamato Metabotrópico/metabolismo , Esquizofrenia/tratamento farmacológico , Animais , Humanos , Ligantes , Esquizofrenia/metabolismo
16.
Pol Merkur Lekarski ; 37(217): 43-8, 2014 Jul.
Artigo em Polonês | MEDLINE | ID: mdl-25154199

RESUMO

UNLABELLED: Until recently, the cytostatic drugs were being prepared at the Polish hospitals by the nursing staff on hospital wards, however according to the Pharmaceutical Law, preparation of cytostatic drugs, as a pharmaceutical service, should be performed by the pharmacists, who possess appropriate qualifications and experience in working within aseptic conditions and who are trained in professional handling with harmful substances. The aim of this paper has been to assess the impact, which establishment of the cytostatic drugs unit at the hospital pharmacy of the big oncologic hospital, located in southern Poland, had on the overall costs of cytostatic drugs utilization. MATERIAL AND METHODS: The analysis of drugs consumption, as well as determining the size of losses of particular active substances, prepared by the cytostatic drugs unit, have been based on statistical reports, provided by the hospital pharmacy. In order to calculate the level of consumption and losses of active substances in the chemotherapy ward, in framework of the previous modality of function, the estimations have been done, taking into consideration the same needs of particular patients, as those included within reports provided by the pharmacy. The actual prices of drugs from year 2012 have been applied in the assessment of costs of drug utilization. The calculations have been done with Excel and SPSS v.21 software. The methods of descriptive statistics and the comparison of groups, using the Student's t-test for dependent samples have been applied. RESULTS: Due to functioning of the centralized modality of cytostatic drugs preparation within the specialized unit, the decline of overall cytostatic drug consumption, amounting to 9.73% has been observed. The reduction in losses, on stage of preparation of drugs, has been achieved and the share of these losses within overall consumption of drugs has dropped by 77.28%. The dissolution of cytostatic drugs in the cytostatic drugs unit, instead of the chemotherapy ward, allows the hospital to achieve the yearly savings, exceeding PLN 572,276.07. CONCLUSIONS: Establisment of the cytostatic drugs unit, at the hospital pharmacy of the specialist oncologic hospital, not only allowed for increasing quality of pharmacotherapy, but also for substantial savings, when compared with the previously used method of dissolving and preparing cytostatic drugs by the nurses, instantly at the chemotherapy wards.


Assuntos
Citostáticos/uso terapêutico , Composição de Medicamentos/economia , Uso de Medicamentos/economia , Uso de Medicamentos/estatística & dados numéricos , Serviço de Farmácia Hospitalar/economia , Composição de Medicamentos/enfermagem , Composição de Medicamentos/estatística & dados numéricos , Papel do Profissional de Enfermagem , Serviço de Farmácia Hospitalar/organização & administração , Polônia
17.
Pharmacol Rep ; 62(6): 1204-10, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-21273679

RESUMO

In this study, the neuropathological changes induced by chronic unpredictable stress (CUS) and chronic mild stress (CMS) in calbindin D-28K (CB) and parvalbumin (PV) immunoreactive neurons in the rat hippocampus were demonstrated. We used immunohistochemical techniques to quantify the numerical density and morphological changes of PV immunoreactive and CB immunoreactive neurons in the dentate gyrus (DG) and the CA1 and CA3 regions of the hippocampus. We also assessed cell proliferation (Ki-67) and apoptotic processes (active caspase-3) in the DG. We found a significant decrease (16.6% for CUS and 13.3% for CMS) in the numerical density of granule cells (GC), alterations in the CB immunoreactive cells of the GC in the DG and an impairment of mossy fiber CB immunolabelling in the CA3. These changes were not accompanied by a decrease in Ki-67 labeling or the level of caspase-3 in the DG. These data indicate a stress-induced reduction of calcium binding neuron parameters, which may be related to the behavioral paradigms exhibited in these models.


Assuntos
Cálcio/metabolismo , Depressão/patologia , Transtorno Depressivo/patologia , Hipocampo/patologia , Transtornos Mentais/patologia , Neurônios/patologia , Animais , Calbindinas , Caspase 3/metabolismo , Giro Denteado/metabolismo , Giro Denteado/patologia , Depressão/metabolismo , Transtorno Depressivo/metabolismo , Modelos Animais de Doenças , Hipocampo/metabolismo , Masculino , Transtornos Mentais/metabolismo , Neurônios/metabolismo , Parvalbuminas/metabolismo , Ratos , Ratos Wistar , Proteína G de Ligação ao Cálcio S100/metabolismo
18.
Arch Immunol Ther Exp (Warsz) ; 56(6): 381-4, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-19043671

RESUMO

In large, mostly English-speaking countries, where the "critical mass" of scientists working in different subfields of science is achieved, the peer review system may be sufficient to assess the quality of scientific research. However, in smaller countries, outside the Anglo-American circle, it is important to introduce different systems to identify research of high quality. In Poland, a parametric system for assessing the quality of research has been introduced. It was largely based on the impact factor of scientific journals. While the use of this indicator to assess research quality is highly questionable, the implementation of the system in the Polish reality is even worse. Therefore it is important to change and improve the system currently used by the Ministry of Science and Higher Education to both evaluate and, more importantly, finance science in Poland. Here, a system based on three factors, i.e. the impact factor, the institutional h-index, and the institutional number of citations, is proposed. The scientific quality of institutions in Division VI: Medical Sciences of the Polish Academy of Sciences were evaluated and the results were compared with the existing system. Moreover, a method to identify high-quality researchers and institutions at the national level based on the quantity of highly cited papers is shown. Additionally, an attempt to identify the highest quality Polish research on an international level is proposed. This is based on the number of individual citations, the individual h-index, the number of publications, and the priority of the discovery.


Assuntos
Bibliometria , Fator de Impacto de Revistas , Publicações Periódicas como Assunto , Bibliografias como Assunto , Bases de Dados Bibliográficas , Humanos , Sistemas de Informação , Revisão por Pares , Polônia , Editoração , Pesquisa/tendências , Projetos de Pesquisa , Apoio à Pesquisa como Assunto , Universidades
19.
Pharmacol Rep ; 57(6): 861-6, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-16382209

RESUMO

Magnetic resonance diffusion anisotropy imaging (DAI) of the rat spinal cord after contusion using weight-drop method was used to study the neuroprotecting effect of 2-methyl-6-(phenylethynyl)-pyridine (MPEP), an mGluR5 receptor antagonist. Eighteen rats were used, divided into 3 groups of 6 animals: a reference group without any operation, a control group with injury and a test group with injury and MPEP. DAI was performed at 4.7 T at 1 h, 24 h, 48 h and 7 day after the injury. Locomotor function was evaluated using Basso, Beattie and Bresnahan (BBB) open field locomotor activity test each day starting one day after the injury. DAI results confirm positive effect of MPEP on the limitation of secondary excitotoxic injury in the spinal cord.


Assuntos
Imagem de Difusão por Ressonância Magnética , Fármacos Neuroprotetores/farmacologia , Piridinas/farmacologia , Receptores de Glutamato Metabotrópico/antagonistas & inibidores , Traumatismos da Medula Espinal/tratamento farmacológico , Medula Espinal/efeitos dos fármacos , Animais , Anisotropia , Imagem de Difusão por Ressonância Magnética/métodos , Modelos Animais de Doenças , Masculino , Atividade Motora/efeitos dos fármacos , Fármacos Neuroprotetores/uso terapêutico , Piridinas/uso terapêutico , Ratos , Ratos Wistar , Receptor de Glutamato Metabotrópico 5 , Receptores de Glutamato Metabotrópico/metabolismo , Medula Espinal/metabolismo , Medula Espinal/patologia , Traumatismos da Medula Espinal/metabolismo , Traumatismos da Medula Espinal/patologia , Fatores de Tempo
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