Study types and reliability of Real World Evidence compared with experimental evidence used in Polish reimbursement decision-making processes.

OBJECTIVES: The aim of this study was to identify the relationship and impact between Real World Evidence (RWE) and experimental evidence (EE) in Polish decision-making processes for the drugs from selected Anatomical Therapeutic Chemical (ATC) groups. STUDY DESIGN: Descriptive study. METHODS: A detailed analysis was performed for 58 processes from five ATC code groups in which RWE for effectiveness, or effectiveness and safety were cited in Agency for Health Technology Assessment and Tariff System's (AOTMiT) documents published between January 2012 and September 2015: Verification Analysis of AOTMiT, Statement of the Transparency Council of AOTMiT, and Recommendation of the President of AOTMiT. RESULTS: In 62% of the cases, RWE supported the EE and confirmed its main conclusions. The majority of studies in the EE group showed to be RCTs (97%), and the RWE group included mainly cohort studies (89%). There were more studies without a control group within RWE compared with the EE group (10% vs 1%). Our results showed that EE are more often assessed using Jadad, NICE or NOS scale by AOTMiT compared with RWE (93% vs 48%). When the best evidence within a given decision-making process is analysed, half of RWE and two-thirds of EE are considered high quality evidence. CONCLUSIONS: RWE plays an important role in the decision-making processes on public funding of drugs in Poland, contributing to nearly half (45%) of all the evidence considered. There exist such processes in which the proportion of RWE is dominant, with one process showing RWE as the only evidence presented.

Evaluation of arterial stiffness and cardiac function in patients with vascular erectile dysfunction: acute effects of phosphodiesterase-5 inhibitor tadalafil.

This study aimed to detect endothelial dysfunction in erectile dysfunction (ED) patients free from cardiovascular diseases or atherosclerotic risk factors and to evaluate acute effects of phosphodiesterase-5 inhibitor tadalafil on endothelial dysfunction and cardiac function. Thirty ED patients and 20 healthy male subjects (mean ages: 48.7±11.7 and 48.3±8.7 years, respectively) were enrolled. Endothelium functions were assessed by applanation tonometry. Aortic stiffness and cardiac function were evaluated by transthoracic echocardiography. Pulse pressure was greater in the ED group (P<0.05), whereas aortic strain and aortic distensibility were significantly lower (P<0.001). Treatment with tadalafil reduced pulse pressure (P=0.0179), systolic blood pressure (P=0.001) and diastolic blood pressure (P=0.054) and increased aortic distensibility (P=0.001) and aortic strain (P=0.003) in the ED group. Tadalafil administration also increased large artery and small artery elasticity indices that were reduced in the ED group at baseline (P=0.02 and 0.003, respectively). Systemic vascular disease and compromised left ventricular diastolic function (LVDF) were present in ED patients with no known atherosclerotic risk factors and cardiac diseases. Tadalafil positively affected arterial stiffness and LVDF.

Spread of carbapenem-resistant international clones of Acinetobacter baumannii in Turkey and Azerbaijan: a collaborative study.

Epidemic clones of Acinetobacter baumannii, described as European clones I, II, and III, are associated with hospital epidemics throughout the world. We aimed to determine the molecular characteristics and genetic diversity between European clones I, II, and III from Turkey and Azerbaijan. In this study, a total of 112 bloodstream isolates of carbapenem-resistant Acinetobacter spp. were collected from 11 hospitals across Turkey and Azerbaijan. The identification of Acinetobacter spp. using conventional and sensitivity tests was performed by standard criteria. Multiplex polymerase chain reaction (PCR) was used to detect OXA carbapenemase-encoding genes (bla OXA-23-like, bla OXA-24-like, bla OXA-51-like, and bla OXA-58-like). Pulsed-field gel electrophoresis (PFGE) typing was used to investigate genetic diversity. The bla OXA-51-like gene was present in all 112 isolates, 75 (67 %) carried bla OXA-23-like, 7 (6.2 %) carried bla OXA-58-like genes, and 5 (4.5 %) carried bla OXA-24-like genes. With a 90 % similarity cut-off value, 15 clones and eight unique isolates were identified. The largest clone was cluster D, with six subtypes. Isolates from clusters D and I were widely spread in seven different geographical regions throughout Turkey. However, F cluster was found in the northern and eastern regions of Turkey. EU clone I was grouped within J cluster with three isolates found in Antalya, Istanbul, and Erzurum. EU clone II was grouped in the U cluster with 15 isolates and found in Kayseri and Diyarbakir. The bla OXA-24-like gene in carbapenemases was identified rarely in Turkey and has been reported for the first time from Azerbaijan. Furthermore, this is the first multicenter study in Turkey and Azerbaijan to identify several major clusters belonging to European clones I and II of A. baumannii.

Comparison between dexmedetomidine and remifentanil infusion in emergence agitation during recovery after nasal surgery: A randomized double-blind trial.

BACKGROUND: Postoperative emergency agitation (EA) is a common problem. Dexmedetomidine and remifentanil may be used to prevent this problem. Our primary aim was to compare dexmedetomidine, remifentanil, and placebo with respect to their effectiveness in preventing postoperative EA. MATERIAL AND METHODS: Ninety patients undergoing nasal surgery were randomized into three groups. The dexmedetomidine group (group D, n = 30) received dexmedetomidine infusion at a rate of 0.4 µg kg(-1 ) h(-1); the remifentanil group (group R, n = 30) received remifentanil infusion at a rate of 0.05 µg kg(-1) min(-1) from induction of anesthesia until extubation; and the control group (group S, n = 30) received a volume-matched normal saline infusion as a placebo. Propofol (1.5-2 mg kg(-1)) and fentanyl (1 µg kg(-1)) were used to initiate anesthesia, and desflurane was used to maintain anesthesia. The incidence of agitation, hemodynamic parameters, and recovery characteristics were evaluated during emergence. RESULTS: The incidence of EA was significantly higher in group S (46.7%) compared with groups R and D (3.3 and 20%, respectively; p < 0.001). The lowest incidence of EA was detected in group R (p = 0.046). Residual sedation in the post-anesthesia care unit (PACU) was similar in all groups (p = 0.947). The incidence of nausea or vomiting was significantly lower in group D than in groups R and S (p = 0.043). Administration of analgesics in the PACU was higher in group R than in groups S and D (p = 0.015). CONCLUSION: Anesthetic maintenance with either remifentanil or dexmedetomidine infusion until extubation provided a more smooth and hemodynamically stable emergence, without complications after nasal surgery. While remifentanil was superior to dexmedetomidine with regard to avoiding EA, dexmedetomidine was more effective than remifentanil regarding vomiting and pain.

Modest correlation between serum neopterin levels and Gensini scores in a cohort of patients undergoing coronary angiography.

OBJECTIVE: We initially tried to study the possible correlation between the severity of coronary artery disease (CAD) and serum neopterin levels in stable coronary artery disease patients. Also we tried to investigate the neopterin as an indicator for the extent of CAD using the Gensini score. METHODS: A total of 40 patients with stable angina pectoris who are chosen for coronary angiography were selected for the study. Before the angiography procedure, blood samples were taken for the measurement of serum neopterin levels and the results of the coronary angiography were scored according to the Gensini scoring system. RESULTS: Neopterin levels were correlated with the Gensini scores [p = 0.010, ρ = 0.401] and a correlation between the age of patient population and Gensini score was also observed in the study [p = 0.016, ρ = 0.380]. CONCLUSION: By the guidance of our results, we can confidently state that there is a correlation between serum neopterin levels and the severity and extent of CAD in stable coronary artery disease patients.

Efficacy and safety comparison of rapid-acting insulin aspart and regular human insulin in the treatment of type 1 and type 2 diabetes mellitus: a systematic review.

BACKGROUND: Insulin aspart (IAsp) is one of the three rapid-acting insulin analogues (RAAs) registered for the treatment of diabetes. However, there is an ongoing debate concerning the efficacy and safety of RAAs. For this reason, a systematic review-based study was performed to compare clinical outcomes of treatment with IAsp and regular human insulin (RHI) as well as biphasic insulin aspart and premixed human insulin in type 1 and type 2 diabetes (T1DM, T2DM) patients. METHODS: Relevant articles were identified by a systematic search through the electronic medical databases (MEDLINE, EMBASE, CENTRAL) up to July 2009. RESULTS: A total of 28 trials fulfilled the inclusion criteria, including 17 studies of T1DM, 10 of T2DM and one study of both. For T1DM, pooled data for HbA(1c) (13 studies) demonstrated lower levels with IAsp than with RHI (WMD=-0.11%; 95% CI: -0.16 to -0.06). In addition, meta-analysis revealed statistically significant differences in favour of IAsp for postprandial glucose (PPG) after breakfast, lunch and dinner, but not for fasting glucose (FG). The Diabetes Treatment Satisfaction Questionnaire evaluating treatment flexibility showed IAsp benefits compared with RHI (WMD=0.31; 95% CI: 0.15 to 0.47). Safety analyses (three studies) showed a significant reduction in nocturnal hypoglycaemia risk with IAsp (RR=0.67; 95% CI: 0.54 to 0.83), and no difference in severe hypoglycaemias and a slight increase in any hypoglycaemic episodes with RAAs (RR=1.06; 95% CI: 1.01 to 1.10). For T2DM, a meta-analysis of nine studies revealed no significant differences between IAsp and RHI in HbA(1c) (WMD=-0.04%; 95% CI: -0.10 to 0.03), whereas PPG was significantly lower in the IAsp group (WMD=-1.18 mmol/L; 95% CI: -1.88 to -0.47). No studies of treatment satisfaction or quality of life were identified. CONCLUSION: Analyses based on a systematic review showed that treatment with IAsp in T1DM patients resulted in moderately better metabolic control and treatment satisfaction than RHI. In T2DM patients, meta-analysis showed improvement in PPG, but not in any other outcomes.

Dyskeratosis congenita: clinical report and review of the literature.

Dyskeratosis congenita (DKC) is an inherited disorder that usually presents in males, consisting of the triad of leukoplakia of the mucous membranes, nails dystrophy and skin pigmentation. Oral and dental abnormalities may also be present. Most cases are X-linked autosomal dominant, but recessive forms have also been reported. This study describes herein a case in which the classic triad of signs was present, along with the development of leukoplakia in the buccal mucosa. Our patient, a 25-year-old man, presented with several characteristic systemic features of this condition, together with the following oral features: hypodontia, delayed dental eruption, short blunt roots, extensive caries, gingival inflammation and bleeding, loss of alveolar bone and buccal mucosa with leukoplakia and irregular ulcers. The patient was given full preventive care. The primary teeth were extracted under local anaesthesia. After establishing optimal oral health, oral hygiene instructions were given to the patient and he was rehabilitated with fixed and removable partial denture. Prosthetic treatments were carried out after establishing optimal oral health. This treatment option appears beneficial in this patient, resulting in rehabilitation of occlusion and less mechanical irritation to the oral mucosa.

IL-6 and IL-8 levels in GCF of the teeth supporting fixed partial denture.

OBJECTIVES: To evaluate the gingival crevicular fluid (GCF) contents of interleukin-6 (IL-6) and interleukin-8 (IL-8) and the clinical parameters of the teeth supporting fixed partial denture (FPD) and the contralateral teeth and to assess the effect of scaling and root planning (SRP) on clinical parameters and the GCF levels of cytokines. MATERIALS AND METHODS: The study population included 23 patients. Probing depth (PD), clinical attachment level (CAL), plaque index (PI), and gingival index (GI) were recorded, and GCF samples were collected for analysis of cytokine levels from the teeth with FPD (Test Group), the contralateral teeth (Control Group) of each participant at baseline. After initial measurements, all participants received primary phase of non-surgical treatment including oral hygiene instruction and scaling and root planning (SRP). At the 1st month and the 3rd month after SRP, these procedures were repeated. RESULTS: In both groups, all clinical parameters and the total amount of IL-8 showed decreases from initial to the 3rd month (P < 0.05), but from the 1st month to the 3rd month; PD, PI, and GI values significantly increased in the test group (P < 0.05). CONCLUSION: The non-surgical periodontal treatment reduced the total amount of IL-8, not IL-6, and the clinical parameters of the teeth with FPD and contralateral teeth. But, there was a trend to the higher levels of PD, PI, and GI in the teeth with FPD. Therefore, a regular program for dental prophylaxis is also important for the maintenance of periodontal health in patients with FPD.

Postoperative regression of clubbing at an unexpected rate in a patient with aortic and mitral valve replacement due to infective endocarditis.

Pulmonary diseases such as malignancies, empyema, bronchiectasis, digestive tract malignancies, inflammatory bowel diseases, cyanotic congenital heart diseases and infective endocarditis can cause clubbing. We present a 63-year-old female patient with infective endocarditis, who had clubbing that resolved very rapidly after cardiac surgery due to rupture of the mitral papillary muscle. She had persistent fever and in her echocardiographic examination rupture of the papillary muscle of the anterior mitral valve and significant aortic regurgitation was noted. She was scheduled for emergency operation and had debridement and replacement of the mitral and the aortic valves. During the follow-up, she had complaints of pain in the distal parts of the fingers. The convex shape of the nails changed and basal portions were apparently thinner and paler than the previous thickened and discoloured, hyperkeratotic nails. This newly growing tissue rapidly replaced the old thick nails in 3 days.

Effects of Origanum onites on endothelial function and serum biochemical markers in hyperlipidaemic patients.

The effects of Origanum onites on endothelial function and antioxidative status were investigated in 48 patients with mild hyperlipidaemia who required no drug therapy. All participants were given lifestyle and low-fat dietary advice, however 32 of the patients (study group) were also prescribed 25 ml of aqueous distillate of Origanum onites to be taken after each meal for 3 months. The remaining 16 patients were the control group. Various biochemical markers and endothelial function parameters were measured at baseline and after 3 months. A significantly greater increase in high density lipoprotein-cholesterol and significantly greater decreases in low density lipoprotein-cholesterol, apolipoprotein B, lipoprotein(a) and high sensitivity C-reactive protein occurred in the study group compared with the control group over the 3-month study period. Paraoxonase and arylesterase activities, and flow- and nitroglycerine-mediated dilatation of the brachial artery showed significantly greater increases in the study group compared with the changes in the control group. In conclusion, consumption of Origanum onites distillate had beneficial effects on lipid profiles, antioxidant status and endothelial function in patients with mild hyperlipidaemia.

Distortion of symmetrical introgression in a hybrid zone: evidence for locus-specific selection and uni-directional range expansion.

The fate of species integrity upon natural hybridization depends on the interaction between selection and dispersal. The relative significance of these processes may be studied in the initial phase of contact before selection and gene flow reach equilibrium. Here we study a hybrid zone of two salamander species, Lyciasalamandra antalyana and Lyciasalamandra billae, at the initial phase of hybridization. We quantify the degree and mode of introgression using nuclear and mtDNA markers. The hybrid zone can be characterized as an abrupt transition zone, the central hybrid zone being only c. 400 m, but introgressed genes were traced up to 3 km. Introgression was traced in both sexes but gene flow may be slightly male-biased. Indirect evidence suggests that hybrid males are less viable than females. Introgression occurred at two levels: (1) locus-specific selection led to different allelic introgression patterns independent of species, while (2) asymmetrical species-level introgression occurred predominately from L. antalyana to L. billae due to range expansion of the former. This indicates that foreign genes can be incorporated into novel genomic environments, which in turn may contribute to the great diversity of morphological variants in Lyciasalamandra.

Prognostic value of viable myocardium in patients with non-Q-wave and Q-wave myocardial infarction.

This study assessed the amount and prognostic value of myocardial viability in patients with non-Q-wave myocardial infarction (NQMI) and Q-wave myocardial infarction (QMI). A total of 175 patients with MI and an ejection fraction < or = 45% underwent dobutamine stress echocardiography. On the basis of clinical criteria and myocardial viability, 110 patients were revascularized. The amount of viable myocardium and the clinical outcome were compared in the NQMI and QMI groups. Patients with NQMI exhibited a larger amount of viable myocardium compared with those with QMI. The mortality rate was 6% in patients with NQMI with viable myocardium and subsequent revascularization, 33% in patients with NQMI without viable myocardium or revascularization, 27% in patients with QMI with viable myocardium and subsequent revascularization, and 33% in patients with QMI without viable myocardium or revascularization. In conclusion, our data suggest that patients with NQMI and viable myocardium have the best prognosis after revascularization.

Tissue Doppler echocardiography and myocardial performance index in patients with scleroderma.

In this study, left and right ventricular functions were examined echocardiographically in 22 patients with scleroderma and 22 healthy volunteers. Conventional and tissue Doppler echocardiography and myocardial performance indexes were used as measures of right and left ventricular global functions. Mitral early diastolic E wave deceleration time, isovolumetric contraction time and left ventricular myocardial performance index and peak tricuspid A wave velocity were significantly higher in the scleroderma group compared with the control group. Mitral and tricuspid E/A ratios were significantly lower in patients with scleroderma. In addition, mitral annular and tricuspid annular isovolumetric relaxation times and the tricuspid E/E' ratio were significantly increased in scleroderma patients compared with the control group. In conclusion, in scleroderma patients the global left ventricular functions were depressed and diastolic function abnormalities were seen in both right and left ventricles. In addition, longitudinal muscle functions of the ventricles were depressed in scleroderma patients, as shown by tissue Doppler imaging parameters.

[Pigments of green sulfur bacteria isolated from reservoirs of Iavoriv sulfur deposit]. / Pihmenty zelenykh sirkobakterii, vydilenykh iz vodoim Iavorivs'koho sirchanoho rodovishcha.

The enormous amount of hydrogen sulfide (up to 11 mg/ml) is present in the Yavoriv sulfur deposit reservoirs owing to sulfur reductive bacteria activity. As a consequence the ecological situation is badly affected and requires recovering. The biological H2S decomposition by photosynthetic sulfur bacteria, which use the hydrogen sulfide as electron donor during photosynthesis, can be one of the possible ways of this toxic substance destruction. The qualitative and quantitative analysis of photosynthetic pigments composition that derived from green photosynthesizing sulfur bacteria from reservoirs of Yavoriv sulfur deposit is carried out. It was fixed that Pelodictyon sp., Chlorobium sp. and isolated consortia "Pelochromatium sp." contain the bacteriochlorophyll c and d. All the isolated cultures contained bacteriochlorophyll a in trace amounts. The obtained photosynthetic pigments (bacteriochlorophylls, carotenoids) were recognized by their absorption spectra in the visible and far-red region and by their quantity. The difference was not essential. All investigated cultures of isolated bacteria contain some carotenoid the Chlorobium sp. and obtained consortia possesses isorenieratene. The absorption maxima of extracted pigments from young cultures of isolated green sulfur bacteria are more definitely displayed than those from old cultures. Investigations of phototrophic sulfur bacteria were carried out in Ukraine up to now. Ecological problem that occurred in the Yavoriv sulfur deposit as a result of the deposit exploitation caused a necessity of the investigation of photosynthetic sulfur bacteria and bacterial photosynthesis mechanism. The photosynthetic pigments nature identification will promote the fast and precise identification of the new forms of photosynthetic sulfur bacteria and will extend our knowledge about their role in the anoxygenic photosynthesis.

Palaeoclimatic changes explain Anatolian mountain frog evolution: a test for alternating vicariance and dispersal events.

Holarctic biodiversity has been influenced by climatic fluctuations since the Pliocene. Asia Minor was one of the major corridors for postglacial invasions in the Palearctic. Today this area is characterized by an extraordinarily rich fauna with close affiliation to European, Asian and Indo-African biota. However, exact scenarios of range expansion and contraction are lacking. Using a phylogeographical approach we (i). identify monophyletic lineages among Anatolian mountain frogs and (ii). derive a spatio-temporal hypothesis for the invasion process in Anatolia. We sequenced 540 bp of the mitochondrial 16S rRNA gene from 40 populations of mountain frogs from Anatolia, the Elburz Mountains and the Caucasus. Our samples comprise all known species and subspecies: Rana macrocnemis macrocnemis, R. m. tavasensis, R. m. pseudodalmatina, R. camerani and R. holtzi. They include the type localities of four of these taxa. We used a nested clade analysis (NCA) to infer historical and recurrent events that account for the observed geographical distribution of haplotypes. None of the extant species is monophyletic. Based on a molecular clock calibration using homologous sequences of Western Palearctic water frogs of the same genus, we estimated that a basic radiation into three lineages c. 2 Mya was followed by several dispersal and fragmentation events. The geographical distribution of resident and widespread haplotypes allows us to infer and date scenarios of range expansion and fragmentation that are aligned with dramatic climatic oscillations that have occurred during the last 600000 years. Consequently, Pliocene and Pleistocene climatic oscillations triggered the evolution of Anatolian mountain frogs through an interplay of vicariance and dispersal events.

Lumbalgia y deporte / Lumgalgia and sports

La lumbalgia es uno de los motivos de consulta mas frecuentes en la practica medica diaria, se estima que entre el 60 y el 90 por ciento de la poblacion adulta la padece en algun momento de su vida, siendo la incidencia anual del 5 por ciento; sin embargo solo el 1 por ciento de los pacientes con dolor lumbar agudo, sintomas de compromiso radicular. En estos datos estadisticos, incluimos a los deportistas no solo de alta competencia, sino tambien aquellos que lo practican como recreacion de tiempo libre. Lumbalgia no significa nada mas que dolor lumbar, y es un sintoma que puede depender de numerosas causas

[A pressure gravity-diffusive effect for flat polymeric membrane and ternary non-electrolyte solutions]. / Cisnieniowy efekt grawidyfuzyjny dla plaskiej membrany polimerowej trójskladnikowych roztworów nieelektrolitów.

In this paper the pressure gravidiffusive model equation in a single-membrane osmotic-diffusive cell is elaborated. In this cell the flat, microporous and symmetric polymeric membrane so-called Nephrophane positioned horizontally separated water and binary (aqueous glucose or aqueous ethanol) or ternary (glucose in 0.2 mol.l-1 aqueous ethanol or ethanol in 0.05 mol.l-1 aqueous glucose) non-electrolyte solutions. The calculations of pressure gravidiffusive effects for the configurations A and B of the single-membrane osmotic-diffusive cell were elaborated. In configuration A solution was placed in compartment below membrane and in configuration B--above membrane. The calculated result are interpreted in terms of the convective instability that increases the diffusive permeability coefficient of complex: concentration boundary layer/membrane/concentration boundary layer.