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Informacje o czasopiśmie
Format
Czasopismo
eISSN
1338-4139
Pierwsze wydanie
03 Jun 2011
Częstotliwość wydawania
3 razy w roku
Języki
Angielski

Wyszukiwanie

Tom 17 (2017): Zeszyt 3 (December 2017)

Informacje o czasopiśmie
Format
Czasopismo
eISSN
1338-4139
Pierwsze wydanie
03 Jun 2011
Częstotliwość wydawania
3 razy w roku
Języki
Angielski

Wyszukiwanie

5 Artykułów
Otwarty dostęp

Quantification of Theophylline in Guinea Pig Plasma by LC-MS/MS Using Hydrophilic Interaction Liquid Chromatography Stationary Phase: Method Development, Validation, and Application in Study

Data publikacji: 20 Feb 2018
Zakres stron: 5 - 15

Abstrakt

Abstract

Theophylline has been used in the treatment of bronchial asthma and chronic obstructive pulmonary disease (COPD) for over 70 years. In order to maximize the effectiveness and safety of theophylline therapy it is important to individualize the dosage of the drug. In our study we focused on determination of theophylline concentrations in guinea pig plasma. A rapid, specific, and reliable LC-MS/MS-based method was developed and validated according to European Medicine Agency (EMA) guidelines. A hydrophilic interaction liquid chromatography (HILIC) separation mode for reduction time of sample preparation was used. The analysed sample was quantified in a positive ionization mode. Multiple reaction monitoring (MRM) using transition m/z 181.06→124.06 and m/z 187.17→127.06 was performed to quantify theophylline with deuterated internal standard ([2H6]-theophylline), respectively. Modification of collision energies was performed in parallel with chromatographic separation to further eliminate interference from the matrix. The method was validated for a range of 0.5 to 30 μg/mL of plasma sample. The intra-day and inter-day precision and accuracy of the quality control samples at low, me dium, and high concentration levels exhibited relative standard deviations (RSD) of less than 10 %. The method was successfully applied for the quantitation of theophylline in guinea pig plasma for better understanding its effects in a model of ovalbumin-induced allergic inflammation.

Słowa kluczowe

  • theophylline
  • HILIC
  • liquid chromatography
  • mass spectrometry
  • guinea pig
  • plasma
Otwarty dostęp

Potential Effect of Pharmacotherapy on Sympathetic Arousal in Autism

Data publikacji: 20 Feb 2018
Zakres stron: 16 - 23

Abstrakt

Abstract

Background: Autism spectrum disorder (ASD) is a serious neurodevelopmental disorder associated with autonomic nervous system (ANS) abnormalities. Moreover, at least 50% of children with ASD suffer from other comorbid diseases such as anxiety, depression, and attention deficit hyperactivity disorder (ADHD) associated with receiving psychotropic medication. From this context we aimed to evaluate changes in sympathetic arousal using analysis of electrodermal activity (EDA) as an index of sympathetic cholinergic activity in treated and non-treated autistic children under resting conditions.

Methods: We examined 23 children with ASD and 14 healthy age- and gender-matched children at the age of 7–15 years. The ASD patients were divided into ASD non-treated group (n=12) and ASD treated group (n=11). The EDA was continuously monitored during resting phase in a supine position. The EDA amplitude (μS) was computed as an average of 5 min baseline period.

Results: We found significantly lower EDA in ASD non-treated subgroup compared to controls indicating subtle abnormalities in the regulation of the sympathetic nervous system. Although no significant differences were found between the ASD treated and non-treated subgroups the ASD treated group showed comparable sympathetic activity relative to controls indicating a potential ameliorated treatment effect on sympathetic arousal in ASD.

Conclusions: These findings could help to determine differences in sympathetic arousal in treated and non-treated children with ASD, which is important for assessment of autism-linked cardiovascular risk depending on pharmacotherapy.

Słowa kluczowe

  • autism spectrum disorder
  • comorbidity
  • pharmacotherapy
  • sympathetic nervous system
  • electrodermal activity
Otwarty dostęp

The comparison of femoral component rotation in the total knee arthroplasty

Data publikacji: 20 Feb 2018
Zakres stron: 24 - 31

Abstrakt

Abstract

Introduction Background: Optimal femoral component rotation in total knee arthroplasty (TKA) is crucial to establish a balanced knee reconstruction. Unbalanced knees can lead to instability, patellofemoral problems, persistent pain, stiffness, and generally poorer outcomes including early failure. There are several methods to achieve the femoral component rotation such as balanced gap technique, measured resection technique, and bone landmarks such as transepicondylar line (TEA) and Whiteside line. The purpose of this study was to compare the balan ced gap technique with the TEA technique.

Materials and Methods: This randomised prospective study compares the femoral component rotation obtained with the use of balanced gap technique and the TEA, as well as compares the differences due to preoperative knee desaxations. The study includes 50 knees, 19 with neutral alignment, 22 with varus, and 9 with valgus desaxation. The femoral component rotation was measured postoperatively on photodocumentation taken after determining the TEA and balanced gap technique line peroperatively. These lines were compared to the posterior femoral condyles obtaining the degree of rotation. In case of transepicondylar line it is condylar twist angle (CTA) and in case of ligament balancer rotation axis it is ligament balancer angle (LBA).

Results: The statistically significant differences in femoral component rotation using the techniques mentioned above as well as differences in individual knee desaxations were observed. The average LBA was 3.42 degrees and average CTA 3.58 in neutral knees group, but in the varus knees the average CTA value was 2.27 degrees and LBA value was 1.05 degrees. The average CTA value in patients with valgus desaxation is 4.78 degrees and LBA value is 5.22 degrees. According to Tukey Post Hoc test a statistically significant difference in LBA value is between neutral and varus knees with a significance level of p = 0.000022 and the most significant difference between varus and valgus knees with a significance level of p = 0.000011.

Conclusion: The statistically significant differences in femoral component rotation using the techniques mentioned above as well as differences in individual knee desaxations were observed.

Słowa kluczowe

  • Transepicondylar axis
  • balanced gap technique
  • rotational alignment
Otwarty dostęp

Efficiency and Limitations of Decompressive Craniectomy in Patients after Traumatic Brain Injury – Preliminary Results

Data publikacji: 20 Feb 2018
Zakres stron: 32 - 38

Abstrakt

Abstract

Introduction: Decompressive craniectomy (DC) has been recently proven effective tier II therapeutic procedure in the treatment of refractory posttraumatic intracranial hypertension. However, its full potential and effectivity is yet to be described and this surgery remains controversial. The goals of our study include analysis of efficiency of DC and description of risk factors associated with unfavourable outcome.

Methods: 24 patients who underwent DC at the Clinic of Neurosurgery, JFM CU in Martin, during years 2015–2016 were prospectively observed. Selected demographic, clinical, and radiographic factors were analysed and compared with patient’s GOS (Glasgow Outcome Scale) at the time of their first ambulatory control (after 3.5 months in average).

Results: We observed mortality of 29.17 %. Good outcome (GOS 4–5) was achieved by 29.17 % of the patients as well. Preoperative GCS ≤ 5 (p = 0.049), intraventricular bleeding (p = 0.0268), midline shift ≥ 15 mm (p = 0.0067), and the volume of intracranial lesion (R = −0.41, p = 0.046), especially its extracerebral component (R = −0.46, p = 0.02), were identified as statistically significant negative prognostic factors.

Conclusion: DC is effective in the management of patients with traumatic brain injury. Good outcome is achieved by 29.17 % of the patients. Described negative prognostic factors (preoperative GCS ≤ 5, intraventricular bleeding, midline shift ≥ 15 mm, and increasing the volume of traumatic mass lesion) could help in targeting this surgery only to patients who are expected to benefit from it.

Słowa kluczowe

  • intracranial hypertension
  • craniectomy
  • traumatic brain injury
  • outcome
Otwarty dostęp

Biosimilar medicines and patient registries – expectations, limitations, and opportunities

Data publikacji: 20 Feb 2018
Zakres stron: 39 - 51

Abstrakt

Abstract

Introduction: Biology therapies in a various medical specializations and for a broad spectrum of indications were launched during last two decades. As a new in class the therapies were obliged to provide additional data re gar ding efficacy and safety after their real medical practice integration. Patient registries, databases collecting various patient data, were introduced to grant data on the treatment effectiveness, safety, and long-term on treatment survival. Satisfactory treatment effect and acceptable safety profile were confirmed after couple of years of careful observation. However, the benefits were usually offered at much higher treatment costs compared to the standard therapies. Biologically similar drugs, so-called biosimilars (B.S), are being launched after original molecule patent protection expiry during recent years. They were expected as an ideal solution to avoid distinct impact on the medical budget: comparable effect for less money. The unsubstantiated doubts about biosimilar efficacy and safety were the reason of the late launch in many markets. Since biosimilars are considered as new therapy entities, the cautiousness to certain extent should be required. Information gained from post-marketing observations and patient registries over several years, confirmed the biosimilar product comparable quality. Healthcare budget savings could secure easier therapy access for more new patients.

Słowa kluczowe

  • biology therapy registries
  • biosimilars
  • biologically similar drugs
  • HTA (health technology assessment)
5 Artykułów
Otwarty dostęp

Quantification of Theophylline in Guinea Pig Plasma by LC-MS/MS Using Hydrophilic Interaction Liquid Chromatography Stationary Phase: Method Development, Validation, and Application in Study

Data publikacji: 20 Feb 2018
Zakres stron: 5 - 15

Abstrakt

Abstract

Theophylline has been used in the treatment of bronchial asthma and chronic obstructive pulmonary disease (COPD) for over 70 years. In order to maximize the effectiveness and safety of theophylline therapy it is important to individualize the dosage of the drug. In our study we focused on determination of theophylline concentrations in guinea pig plasma. A rapid, specific, and reliable LC-MS/MS-based method was developed and validated according to European Medicine Agency (EMA) guidelines. A hydrophilic interaction liquid chromatography (HILIC) separation mode for reduction time of sample preparation was used. The analysed sample was quantified in a positive ionization mode. Multiple reaction monitoring (MRM) using transition m/z 181.06→124.06 and m/z 187.17→127.06 was performed to quantify theophylline with deuterated internal standard ([2H6]-theophylline), respectively. Modification of collision energies was performed in parallel with chromatographic separation to further eliminate interference from the matrix. The method was validated for a range of 0.5 to 30 μg/mL of plasma sample. The intra-day and inter-day precision and accuracy of the quality control samples at low, me dium, and high concentration levels exhibited relative standard deviations (RSD) of less than 10 %. The method was successfully applied for the quantitation of theophylline in guinea pig plasma for better understanding its effects in a model of ovalbumin-induced allergic inflammation.

Słowa kluczowe

  • theophylline
  • HILIC
  • liquid chromatography
  • mass spectrometry
  • guinea pig
  • plasma
Otwarty dostęp

Potential Effect of Pharmacotherapy on Sympathetic Arousal in Autism

Data publikacji: 20 Feb 2018
Zakres stron: 16 - 23

Abstrakt

Abstract

Background: Autism spectrum disorder (ASD) is a serious neurodevelopmental disorder associated with autonomic nervous system (ANS) abnormalities. Moreover, at least 50% of children with ASD suffer from other comorbid diseases such as anxiety, depression, and attention deficit hyperactivity disorder (ADHD) associated with receiving psychotropic medication. From this context we aimed to evaluate changes in sympathetic arousal using analysis of electrodermal activity (EDA) as an index of sympathetic cholinergic activity in treated and non-treated autistic children under resting conditions.

Methods: We examined 23 children with ASD and 14 healthy age- and gender-matched children at the age of 7–15 years. The ASD patients were divided into ASD non-treated group (n=12) and ASD treated group (n=11). The EDA was continuously monitored during resting phase in a supine position. The EDA amplitude (μS) was computed as an average of 5 min baseline period.

Results: We found significantly lower EDA in ASD non-treated subgroup compared to controls indicating subtle abnormalities in the regulation of the sympathetic nervous system. Although no significant differences were found between the ASD treated and non-treated subgroups the ASD treated group showed comparable sympathetic activity relative to controls indicating a potential ameliorated treatment effect on sympathetic arousal in ASD.

Conclusions: These findings could help to determine differences in sympathetic arousal in treated and non-treated children with ASD, which is important for assessment of autism-linked cardiovascular risk depending on pharmacotherapy.

Słowa kluczowe

  • autism spectrum disorder
  • comorbidity
  • pharmacotherapy
  • sympathetic nervous system
  • electrodermal activity
Otwarty dostęp

The comparison of femoral component rotation in the total knee arthroplasty

Data publikacji: 20 Feb 2018
Zakres stron: 24 - 31

Abstrakt

Abstract

Introduction Background: Optimal femoral component rotation in total knee arthroplasty (TKA) is crucial to establish a balanced knee reconstruction. Unbalanced knees can lead to instability, patellofemoral problems, persistent pain, stiffness, and generally poorer outcomes including early failure. There are several methods to achieve the femoral component rotation such as balanced gap technique, measured resection technique, and bone landmarks such as transepicondylar line (TEA) and Whiteside line. The purpose of this study was to compare the balan ced gap technique with the TEA technique.

Materials and Methods: This randomised prospective study compares the femoral component rotation obtained with the use of balanced gap technique and the TEA, as well as compares the differences due to preoperative knee desaxations. The study includes 50 knees, 19 with neutral alignment, 22 with varus, and 9 with valgus desaxation. The femoral component rotation was measured postoperatively on photodocumentation taken after determining the TEA and balanced gap technique line peroperatively. These lines were compared to the posterior femoral condyles obtaining the degree of rotation. In case of transepicondylar line it is condylar twist angle (CTA) and in case of ligament balancer rotation axis it is ligament balancer angle (LBA).

Results: The statistically significant differences in femoral component rotation using the techniques mentioned above as well as differences in individual knee desaxations were observed. The average LBA was 3.42 degrees and average CTA 3.58 in neutral knees group, but in the varus knees the average CTA value was 2.27 degrees and LBA value was 1.05 degrees. The average CTA value in patients with valgus desaxation is 4.78 degrees and LBA value is 5.22 degrees. According to Tukey Post Hoc test a statistically significant difference in LBA value is between neutral and varus knees with a significance level of p = 0.000022 and the most significant difference between varus and valgus knees with a significance level of p = 0.000011.

Conclusion: The statistically significant differences in femoral component rotation using the techniques mentioned above as well as differences in individual knee desaxations were observed.

Słowa kluczowe

  • Transepicondylar axis
  • balanced gap technique
  • rotational alignment
Otwarty dostęp

Efficiency and Limitations of Decompressive Craniectomy in Patients after Traumatic Brain Injury – Preliminary Results

Data publikacji: 20 Feb 2018
Zakres stron: 32 - 38

Abstrakt

Abstract

Introduction: Decompressive craniectomy (DC) has been recently proven effective tier II therapeutic procedure in the treatment of refractory posttraumatic intracranial hypertension. However, its full potential and effectivity is yet to be described and this surgery remains controversial. The goals of our study include analysis of efficiency of DC and description of risk factors associated with unfavourable outcome.

Methods: 24 patients who underwent DC at the Clinic of Neurosurgery, JFM CU in Martin, during years 2015–2016 were prospectively observed. Selected demographic, clinical, and radiographic factors were analysed and compared with patient’s GOS (Glasgow Outcome Scale) at the time of their first ambulatory control (after 3.5 months in average).

Results: We observed mortality of 29.17 %. Good outcome (GOS 4–5) was achieved by 29.17 % of the patients as well. Preoperative GCS ≤ 5 (p = 0.049), intraventricular bleeding (p = 0.0268), midline shift ≥ 15 mm (p = 0.0067), and the volume of intracranial lesion (R = −0.41, p = 0.046), especially its extracerebral component (R = −0.46, p = 0.02), were identified as statistically significant negative prognostic factors.

Conclusion: DC is effective in the management of patients with traumatic brain injury. Good outcome is achieved by 29.17 % of the patients. Described negative prognostic factors (preoperative GCS ≤ 5, intraventricular bleeding, midline shift ≥ 15 mm, and increasing the volume of traumatic mass lesion) could help in targeting this surgery only to patients who are expected to benefit from it.

Słowa kluczowe

  • intracranial hypertension
  • craniectomy
  • traumatic brain injury
  • outcome
Otwarty dostęp

Biosimilar medicines and patient registries – expectations, limitations, and opportunities

Data publikacji: 20 Feb 2018
Zakres stron: 39 - 51

Abstrakt

Abstract

Introduction: Biology therapies in a various medical specializations and for a broad spectrum of indications were launched during last two decades. As a new in class the therapies were obliged to provide additional data re gar ding efficacy and safety after their real medical practice integration. Patient registries, databases collecting various patient data, were introduced to grant data on the treatment effectiveness, safety, and long-term on treatment survival. Satisfactory treatment effect and acceptable safety profile were confirmed after couple of years of careful observation. However, the benefits were usually offered at much higher treatment costs compared to the standard therapies. Biologically similar drugs, so-called biosimilars (B.S), are being launched after original molecule patent protection expiry during recent years. They were expected as an ideal solution to avoid distinct impact on the medical budget: comparable effect for less money. The unsubstantiated doubts about biosimilar efficacy and safety were the reason of the late launch in many markets. Since biosimilars are considered as new therapy entities, the cautiousness to certain extent should be required. Information gained from post-marketing observations and patient registries over several years, confirmed the biosimilar product comparable quality. Healthcare budget savings could secure easier therapy access for more new patients.

Słowa kluczowe

  • biology therapy registries
  • biosimilars
  • biologically similar drugs
  • HTA (health technology assessment)

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