Effect of Blood Groups on Clinical Presentations and Treatment Outcomes in Immune Thrombotic Thrombocytopenic Purpura Patients with Severe ADAMTS13 Deficiency: A Multi-Center Experience.

Introduction: Thrombotic thrombocytopenic purpura (TTP) is a thrombotic microangiopathy caused by accumulation of ultra-large von Willebrand factor (vWF) due to the significantly reduced activity ADAMTS13. Limited studies have been published examining the blood group as an epidemiological factor that can contribute to development of TTP. It has been suggested that due to low vWF levels, the distribution of the "O" blood group among TTP patients may be lower than anticipated compared to the blood group distribution rates in the normal population. The aim of this study was to explore the relationship between blood groups and the clinical outcome of immune TTP (iTTP). Methods: Thirty patients with iTTP with severe ADAMTS13 deficiency were enrolled. Data collection commenced in January 2011 and was completed by June 2020. It was analyzed whether there was a difference between the blood groups in terms of frequency of iTTP, response to treatment, frequency of relapse, and clinical and laboratory results. Results and Conclusions: The distribution of group "A" among patients with iTTP was higher than expected. Although not statistically significant, patients with blood group "O" required more TPE for the treatment and relapse rate was statistically higher than other blood groups. Mortality rate in all patients was 6.7%. Although blood group "A" is a risk factor for iTTP, the frequency of relapse is higher in the blood group "O."

[The Role of Anti-HBc Testing on Donor Selection and Its Contribution to Current Alghorithms; Can the Gülhane Experience Be a Model for Turkey?] / Anti-HBc Testinin Bagisçi Seçimindeki Rolü, Güncel Algoritmaya Katkisi; Gülhane Deneyimi Türkiye için Örnek Model Olur Mu?

Additional or different test procedures can be applied to maximize transfusion safety by reducing the risk of transfusion-transmitted infections. Antibodies to hepatitis B core antigen (anti-HBc) is one of the most commonly used serologic marker in this context. The aim of the study was to analyse anti-Hbc test results performed within the scope of routine screening tests in our center and to examine the effect of the donor re-entry protocol established. A total of 57191 people who applied to Gülhane Regional Blood Center to donate blood between 2014-2019 were included in the study. All blood donations were screened for anti-HBc by chemiluminescense immunoassay (Architect i2000 SR, AXSYM, Abbott, IL, USA). Hepatitis B surface antibody (anti-HBs) and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) (ABI Prism 7500 Real time PCR system, Applied Biosystems, USA) tests were performed in accordance with the donor recovery protocol for those who could be reached among those with positive for anti-HBc test results. Samples with > 100 IU/ml of anti-HBs levels and negative for HBV DNA test were included in the donor pool. Of the 57 191 blood donors involved in the study, 5125 (8.5%) were found as positive for anti-HBc. Of the donors, 54 035 (94.4%) were male and 3156 (5.5%) were female. The difference was found to be statistically significant in terms of gender distribution between the years of the study (p<0.001). The highest anti-HBc positivity rate (35.7%) was in the age group of 60 years and over while the lowest positivity rate (3.8%) was in the age group of 18-30 years (r= 0.549, p= 0.0001). The year with the highest anti-HBc seroprevalance (10.1%) was 2017, while the year with the lowest (7.9%) was 2014. The distribution of seropositivity over the years was statistically significant (p<0.001). In the study, anti-HBs and HBV-DNA test results of 439 donors were accessible and of which 301 (68.5%) were considered eligible to donate again according to the re-entry protocol. The isolated anti-HBc positivity and HBV-DNA positivity rates were 7.5% (33/430) and 0.2% (1/439) respectively,in blood donors to whom re-entry protocol was performed. The seroprevalance of anti-HBc below 10% during the six-year period in which the study was conducted is a critical data for the evaluation of this test within the scope of routine microbiological screening tests. Moreover, we have observed that donor losses due to the antiHBc testing can be significantly reduced with the implementation of donor re-entry protocols. Anti-HBc screening strategy should be decided by considering of HBV epidemiology, cost-effectivity and possible blood donor losses.

Evaluation of Second Primary Cancer Risk Among Chronic Lymphocytic Leukemia Patients: Multicenter Study.

BACKGROUND: Patients with chronic lymphocytic leukemia (CLL) have an increased risk of developing second primary cancers (SPC). The aim of this study is to determine the frequency of SPC in CLL patients and determine the relationship between these cancers and their treatment status, cytogenetic factors, and other risk factors. METHODS: The study was designed as multicenter and retroprospective. The sample comprised 553 subjects with a CLL diagnosis. Data collection commenced in August 2016, and completed at May 2021. RESULTS: Fifty one of 553 patients followed for CLL, had a history of SPC. SPC development rate was 9.2%. Epithelial tumors were mostly observed. According to the incidence skin, lymphoma, renal, breast, lung, gastrointestinal system, thyroid, malignant melanoma, prostate, Kaposi's sarcoma, neuroendocrine tumor, ovarian, larynx and salivary gland cancers were detected respectively. The 13q deletion was the most common genetic abnormality in those who developed SPC, and the frequency of 13q deletion was found to be increased statistically significant in those with malignancy, compared to those who did not. CONCLUSION: In CLL patients with SPC, the age of diagnosis, 13q and CD38 positivity, and treatment rates with fludarabine and monoclonal antibodies were found to be higher. Also, we determined that SPC frequency increased independently from hemogram values (except hemoglobin values), ß2 microglobulin level on admission, number of treatment lines, and genetic mutations other than 13q, in CLL patients. In addition, the mortality rate was higher in CLL patients with SPC and they were prone to be in advanced stages at the time of diagnosis.

What Will Be the Economic Impact of the New Medical Device Regulation? An Interrupted Time-Series Analysis of Foreign Trade Data.

OBJECTIVES: To date, the economic effects of medical device directives compared with the clinical and regulatory effects have not been sufficiently studied. We believe that the financial obligations and responsibilities imposed on the stakeholders by the legal regulations have a corresponding economic indicator in the medical device market. METHODS: In this study, we selected 2 crucial legal regulations on medical devices in Turkey: the Medical Device Directive that has been harmonized from the European Union and the Medical Device Sales, Advertising, and Promotion Directive. The impacts of these regulations on foreign trade were investigated using interrupted time-series analysis. Turkey's monthly medical device export and import data from 2008 to 2019 were obtained under 56 6-digit custom codes. RESULTS: The results show that the selected directives have significantly affected the foreign trade trend level, and they may be breakpoints in the Turkey's foreign trade trend curve. We also reported the significant differences between the Medical Device Directive and the European Union's new medical device regulation (MDR) (2017/745 MDR). CONCLUSIONS: We concluded that the MDR, which has more strict requirements, will result in increased costs for economic operators in comparison with the current directive and would further increase the import of medical devices by the importing countries. To prevent this, Turkey should aim to have a manufacturer's position by improving their clinical trial capabilities and manufacturing infrastructures with innovation-based approaches.

Comparison of the efficacy of mud-pack and hot-pack treatments in chronic non-specific neck pain: A single-blind, randomized-controlled study.

Objectives: This study aims to compare the short-term efficacy of mud-pack (MP) and hot-pack (HP) treatments with the same temperature and duration on sleep, function, depression, and quality of life for chronic non-specific neck pain (CNNP) patients. Patients and methods: Between December 2018 and September 2019, a total of 70 patients with CNNP diagnosis (12 males, 58 females; mean age: 50.2±9.4 years; range, 24 to 65 years) were included. The patients were divided into two groups. The MP group (n=35) had a total of 15 sessions of MP for 20 min + transcutaneous electrical nerve stimulation (TENS) for 20 min + home exercise (HE) on five days per week for three weeks. The HP group (n=35) had 15 similar sessions of HP for 20 min + TENS for 20 min + HE. The patients were assessed with the Visual Analog Scale (VAS-pain), VAS physician's and patient's global assessments, modified Neck Disability Index (mNDI), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Short Form-36 (SF-36) measures before treatment, at the end of post-treatment third week and one month later. Results: In the MP group, there were statistically significant improvements in all parameters at the end of treatment three-week and one-month follow-up (p<0.05), apart from SF-36 Vitality/Energy (SF-36V/E) at the end of treatment and SF-36 General Health (SF-36GH) at one month. In the HP group, there were statistically significant improvements observed for all parameters (p<0.05), apart from the SF-36 Physical Role and SF-36GH at the end of treatment third week and SF-36V/E at the first-month assessment. The VAS-pain(p<0.001), mNDI (p=0.019), BDI (p=0.002), SF-36GH (p<0.001), SF-36V/E (p<0.001) and SF-36 mental health (p<0.001) showed statistically significantly superior improvements in the MP group (p<0.05). Conclusion: In CNNP patients, both MP and HP treatments are effective. However, MP therapy has more positive effects on pain, function, depression, and quality of life parameters. The MP treatment may be used in addition to TENS treatment for CNNP patients.

Cost Evaluation of Inhaler Therapies Used in Respiratory Diseases: 1998--2015 Period in Turkey.

BACKGROUND: With the rise in life expectancy, the burden of chronic diseases, including obstructive pulmonary diseases, has increased throughout the world. OBJECTIVES: To evaluate the sales trends of inhaler pharmaceuticals. METHODS: The changes in box sales and sales amounts (in Turkish lira) of inhaler pharmaceuticals during the period 1998 to 2015 were examined and sales were projected for the next 3 years. Pharmaceuticals were classified according to form and pharmacological groups. RESULTS: The sales of inhaler pharmaceuticals have increased rapidly since 2008. The fastest increase in consumption has occurred in short-acting ß2 agonist preparations and nebulizer pharmaceuticals. Inhaled corticosteroid and long-acting ß2 agonist combination sales have been the highest since 2002, when these products entered the Turkish market. CONCLUSIONS: The inhaler pharmaceutical market has grown over the years, and this growth will continue in the future. The increased use of short-acting preparations, which should be used as symptom relievers, indicates that treatment management continues to be inadequate.