Evaluation of the impact of warfarin time in therapeutic range on outcomes of patients with atrial fibrillation in Turkey: Perspectives from the observational, prospective WATER Registry

Background: Warfarin is highly efficacious in reducing stroke risk in patients with atrial fibrillation (AF). However, its safety and efficacy in stroke prevention is markedly influenced by its time in therapeutic range (TTR). The quality of anticoagulant therapy varies considerably among countries. Representative data concerning the quality of anticoagulant therapy and its effects on clinical outcomes in Turkey are lacking. Methods: Warfarin in Therapeutic Range (WATER) registry is a prospective, observational study which followed 572 AF patients (mean age 67.3 ± 12 years; females 60%; 71% non-valvular AF) treated with warfarin. Results: At a median of 22-month follow-up, the mean TTR value was 42.3 ± 18% (median: 40%) for the whole population and lower in non-valvular AF su group than valvular AF subgroup (40.3 ± 18 vs. 46.9 ± 19, respectively, p < 0.001). Death, cardiac hospital­ization and minor bleeding rates were higher in the group with TTR value < 40% than the group with > 40% (3.4% vs. 5.9%; 28.6% vs. 35.4%; 36.5% vs. 41.7%, respectively, all of them p < 0.001). A correlation analysis showed a negative correlation between age and TTR value (r = –0.178, p < 0.001). Mean CHA2DS2VASc score was 3.63 ± 1.5 and mean HASBLED score was 2.38 ± 1.01 in the non-valvular AF group. A negative correlation was observed between TTR levels and CHA2DS2VASc score. Conclusions: WATER provides insight into the anticoagulation control status of AF patients in Turkey. The quality of anticoagulation was poor. Strategies should be undertaken by clinicians and patients to improve TTR. New oral anticoagulant agents may be perfect alternatives for non-valvular AF patients

Critical review of European Medicines Agency (EMA) assessment report and related literature on domperidone

WOS: 000467578900002PubMed ID: 30864085European Medicines Agency (EMA) issued a final decision on September 01, 2014 that restricts the maximum daily dose of domperidone to 30mg and treatment duration to 7days. This paper presents a critical review of the scientific basis of the literatures having a role in the decision of EMA on domperidone with an approach based on statistical and epidemiological perspective. Although observational studies used by EMA were published, the EMA didn't use an algorithm including randomized clinical trials according to evidence-based medicine when presenting their results. In conclusion, the results obtained from published studies are controversial, especially for the bias. From these publications, it cannot be concluded that domperidone exposure definitely increases the risk of sudden cardiac death, death associated with ventricular arrhythmia or ventricular arrhythmia The most concrete result of these studies is that the risk is higher with metoclopramide exposure compared to domperidone exposure

Unusual polypoid malign tumors which occur in vagina of children (Sarcoma botryoides)

[No abstract available

Skin leishmaniasis

[No abstract available

Bronchodilator Efficacy of a Single-Dose 12/400-mu g Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial

YUKSEL, KIVANC/0000-0003-3491-0099; Yildiz, Birsen Pinar/0000-0002-6650-1495; Bayraktaroglu, Mesut/0000-0002-9063-1118WOS: 000487922800009PubMed: 31332649Background and Objectives: A patient-friendly and easy-to-use multi-dose dry powder inhaler, Discair, has been recently developed. the objective of this study was to evaluate the bronchodilator efficacy of a single-dose 12/400-mu g formoterol plus budesonide combination as a dry powder for inhalation delivered by Discair in adult patients with moderate-to-severe, stable, chronic obstructive pulmonary disease. Methods: A total of 33 male patients with moderate-to-severe, chronic obstructive pulmonary disease were included in this single-arm, open-label, phase IV trial. the primary efficacy parameters were the average maximum change in forced expiratory volume in 1 s (FEV1, in L) and time to maximum FEV1 response. Absolute and percent change from baseline in FEV1 and forced vital capacity, maximum change and time to peak forced vital capacity response were also evaluated. Results: the mean post-bronchodilator FEV1 maximum value was significantly higher than the pre-bronchodilator baseline FEV1 value [1.66 (standard deviation 0.43) vs. 1.32 (standard deviation 0.35), p < 0.001], with an absolute change of 0.34 (standard deviation 0.18) and a percent change of 26.0 (standard deviation 0.14) from baseline to maximum response. the average time to peak FEV1 response was 3.94 h (standard deviation 2.75), while the standardized area under the response-time curve from 0 to 12 h for FEV1 was 2.72 (standard deviation 1.84). the FEV1 and forced vital capacity values recorded at each time point during the 12-h post-bronchodilator period were also significantly higher than the baseline values (p < 0.001 for each). Conclusions: Our findings revealed significant changes from baseline in post-bronchodilator peak and average FEV1 and forced vital capacity responses, indicating bronchodilator efficacy of a single-dose 12/400 mu g formoterol plus budesonide dry powder formulation delivered by Discair in patients with chronic obstructive pulmonary disease.Neutec Ar-Ge San & Tic A.S. (Turkey)This study was funded by Neutec Ar-Ge San & Tic A.S. (Turkey)

The Effect of Clinical Knowledge and Surgical Experience on Treatment Choice in Legg-Calve-Perthes Disease: Intra-observer and Inter-observer Reliability Study

WOS: 000522607700001PubMed: 32549963Aim the aim of this study was to evaluate standardized hip radiographs, arthographs, demographic characteristics, physical examination findings, and their effects on treatment choices in leg-calve-perthes disease (LCPD). Intraobserver and interobserver realibility between orthopaedic residents, orthopaedic surgeons, and paediatric orthopaedic surgeons were also investigated. Materials and Methods 47 LCPD patients were included this cross-sectional study. Six separate presentations including different variabilities (clinical findings, standard radiographs, and arthrographs) were evaluated by three different groups (residents, surgeons, paediatric orthopaedic surgeons) and were sent to the observers every other month by hiding patients' personal information. Seven different treatment modalities were introduced for the best treatment modality. Intraobserver and interobserver reliability in these three groups were examined. Percentage aggreement (PA) and intraclass correlation coefficients (ICC) tests were used for this purpose. Results Treatment PA rates between presentations were 29.5-53.6% in residents, 38.3-60.4% in surgeons, and 39.1-59.8% in pediatric orthopaedic surgeons. Conservative methods were mostly preferred as treatment modality in all groups; followed by proximal femoral osteotomies. Pediatric orthopaedic surgeons preferred safe dislocation and femur head and/or neck reconstruction surgery 5-18 times more than residents and orthopaedic surgeons. Intraobserver reliability of treatment modalities was higher among the paediatric orthopaedic surgeons; the results were fair-good (0.483-0.763). Among residents and orthopaedic surgeons, ICC values were poor to good, respectively (- 0.080 to 0.636 and 0.263-0.643). Interobserver reliability among three groups was meanly good. Conclusion As surgical experience increases, both the compliance rates of the treatment modalities and the intra- and inter-group reliability are increased. Knowledge of the demographic data and clinical findings of patients besides hip radiographs or arthrographs increase treatment compliance in paediatric orthopaedic surgeons, however, cause changes in treatment modalities in residents. As surgical experience increases, more difficult surgeries such as safe dislocation and femoral head/neck reconstruction are preferred

Assessing the role of hip arthrography in the treatment decision making for children with Legg-Calve-Perthes disease

WOS: 000583284400012PubMed: 33155565Objective: the aim of this study was to determine the role of hip arthrography in the treatment decision making for children with Legg-Calve-Perthes disease (LCPD). Methods: A total of 47 consecutive children with LCPD (42 boys, 5 girls; mean age=7.5 years; range=6-10 years) who underwent operative treatment were included in the study. the patient demographics, physical examination findings (pain and hip range of motion [ROM]), standard anteroposterior and Lowenstein lateral hip radiographs, and hip arthrography data were retrospectively collected. the arthrographies were performed immediately before the surgery under general anesthesia. the patients were staged according to the Catterall and Herring classifications and examined in terms of head-at-risk signs before the study. Four sets of patient files were established based on the aforementioned data, with each child in a randomized and blinded order. Ten consultant pediatric orthopedic surgeons randomly assessed the patient files on 4 separate occasions (Set 1 vs Set 2 and Set 3 vs Set 4), with a minimum time interval of 4 weeks. in the first and second sets, the demographic and clinical information, including the age, gender, hip ROM, and hip radiographs, were presented. in the third and fourth sets, hip arthrography was presented in addition to the data from Set 1 and Set 2. the observers were instructed to choose the best treatment options. the percent agreement (PA) and Gwet's AC1 statistics were used to establish a relative level of agreement among the observers. Results: the mean intra-observer reliabilities ranged from fair to moderate after adding the hip arthrography data (Gwet's AC1 = 0.36 for Set 1 vs Set 2 and 0.42 for Set 3 vs Set 4). the mean PA was 56.6% (range = 29.8% to 78.7%) with a Gwet's AC1 value of 0.51 (range: 0.21 to 0.77) between Set 1 and Set 3 (moderate intra-observer reliability). the decision for the treatment strategy was changed in 43.4% of the patients. For inter-observer reliability, Gwet's AC1 was computed as 0.48 (moderate reliability). the correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups. Thus, there is a negative correlation with the disease progression. Conclusion: Hip arthrography seems to have a significant role in the treatment decision making for children with LCPD, especially in the advanced stages of the disease

Comparison of the Cytogenetic and Molecular Analyses in the Assessment of Imatinib Response in Chronic Myelocytic Leukemia

We aimed to compare the cytogenetic and molecular analyses in the assessment of imatinib mesylate response in patients suffering the chronic phase of chronic myelocytic leukemia who were refractory to a-interferon treatment. A total of 117 patients in the chronic phase of chronic myelocytic leukemia were included. The patients were treated with 400 mg/day imatinib mesylate. Bone marrow samples were obtained for the cytogenetic and molecular analyses. Patients without the Ph chromosome were defined as complete cytogenetic responders. Partial cytogenetic response was determined when the Ph chromosome was detected in 1-35% of the cells. Molecular response was determined by quantitative real-time reverse transcriptase polymerase chain reaction (QR-PCR) and defined as no detection of BCR-ABL mRNA. The frequencies of complete and partial cytogenetic response were 29% (n = 34) and 15% (n = 18), respectively. No cytogenetic response was achieved in 56% (n = 65) of the patients. Molecular response was achieved in 62% (n = 21) and 33% (n = 6) of the complete and partial cytogenetic responders, respectively. All of the 65 patients with no cytogenetic response were also molecular nonresponders. We conclude that there is reasonable agreement between the cytogenetic and molecular analyses. Both methods are complementary in the assessment of response to therapy