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Una Glamočlija

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I. Omerhodžić, B. Rovčanin, A. Džurlić, Mirsad Hodžić, Rasim Skomorac, Hakija Bečulić, S. Zahirović, Fahrudin Alić, E. Suljic et al.

OBJECTIVES Brain tumor-related epilepsy management poses significant challenge in clinical practice. Healthcare providers must tailor treatment based on each patient's unique circumstances. Different antiepileptic drugs can be used, including oxcarbazepine. Several studies show this drug's efficacy and safety in brain tumor-related epilepsy. METHODS Observational, prospective study, monitoring the efficacy and safety of the drug oxcarbazepine in the prevention of epileptic seizures, included adult patients of both sexes with a supratentorial tumor and a risk of epileptic seizures after neurosurgery. RESULTS The study included 153 hospitalized patients. The percentages of amplified waves, sharp waves, and spike waves decreased in the second and third compared with the first visit. Significantly lower percentages of sharp waves (P = 0.028) on the second compared with the first measurement and spike waves (P = 0.002) on the third compared with the first measurement were determined. Deterioration from normal to low hemoglobin concentration was observed in 40 (26%) patients at the second visit and 17 (12%) at the third visit, compared with the first visit. However, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration values did not change significantly during the 6 months of follow-up. A transient drop in the number of thrombocytes was observed on the second visit. Adverse reactions to the drug were mild. Therapeutic adherence was low, as measured by the Morisky Medication Adherence Scale (MMAS-4). CONCLUSIONS The drug oxcarbazepine has shown good efficacy and safety in the prevention of epileptic attacks after neurosurgery in patients with supratentorial tumors. Additional education of patients on the importance of taking regular therapy is crucial.

Selma Hrkić, Elvir Mehanović, Alma Tanković, A. Šukalo, Amna Tanović Avdić, M. Mehić, Saša Pilipović, Berina Pilipović, U. Glamočlija

Zdenka Gojković, Jelena Rožić, Nataša Gašpar, A. Šukalo, M. Mehić, Amna Tanović Avdić, U. Glamočlija

Aim: The aim of this study was to examine the effectiveness and safety of lysozyme-based spray in the treatment of oral mucositis in patients undergoing head and neck radiotherapy. Methods: A prospective, open-label study was conducted on patients with ulcerative inflammation of the oral cavity and pharynx mucous membranes clinically assessed for oral mucositis according to the World Health Organization (WHO) Oral Toxicity Scale. Patients were randomly divided into a lysozyme group (using a spray containing lysozyme + cetylpyridinium + lidocaine) and a control group (using a compounded preparation containing gentamicin + dexamethasone + lidocaine). The efficacy and safety of therapy were evaluated on the baseline and three follow-up visits (7, 14, and 21 days after the baseline visit). Results: The total number of participants was 56, of which 26 were in lysozyme and 30 in the control group. The efficacy parameters were similar between the groups and there was no deterioration of symptoms during the follow-up period of 21 days. A significantly lower pain intensity when eating solid food was observed after 21 days in lysozyme compared to the control group. No adverse reactions were observed. Conclusions: This study showed the efficacy and safety of lysozyme-based spray for treating radiotherapy-induced oral mucositis. The availability of new treatment options based on lysozyme, a natural enzybiotic present in the saliva of healthy subjects, could bring added value to the treatment of oral mucositis and the prevention of its complications. However, a larger randomized, blinded study is needed to confirm our results [the study was registered at the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (https://klinicka.almbih.gov.ba/pages/klinicka-registar-javni) under the protocol number LCS-OM-01].

Milkica Glogovac-Kosanović, T. Bućma, Draško Prtina, Aleksandar Gajić, A. Šukalo, M. Mehić, Amna Tanović-Avdić, U. Glamočlija

Background/Aim: Pressure ulcers develop due to prolonged periods of increased pressure on certain parts of the skin and underlying tissue. This study aimed to evaluate the efficacy and safety estimates of lysozyme-based cream in the treatment of pressure ulcers of grade two according to Yarkony-Kirk scale. Methods: Adult patients with neurological diseases and severe functional deficits with grade-two pressure ulcers according to Yarkony-Kirk scale were included. All patients were treated with polarised light. Additionally, the patients were treated twice daily with a cream containing 20 mg/g of lysozyme chloride (lysozyme group) or with povidone-iodine dressings (control group). Visual checks of the ulcer were performed at the baseline and daily until the end of follow-up. Safety was evaluated by the presence of adverse reactions to treatment. Patients were followed for two months or less in case of withdrawal from the study, ulcer healing, or worsening. The Yarkony-Kirk scale grade was determined at the end of follow-up for each patient and one of the four categories was recorded: healed, improved, no changes or worsened. Results: A total of 48 subjects were included, 28 (58 %) in the lysozyme and 20 (42 %) in the control group. Age, sex, pressure ulcer position and duration of follow-up were similar between groups. The percentage of healed pressure ulcers was significantly higher in the lysozyme (71 %) compared to the control (35 %) group (p = 0.005). No adverse reactions to treatments were recorded. Conclusion: The lysozyme-based cream was found to be effective and safe in the treatment of grade-two pressure ulcers. Additional randomised, blinded, larger studies are needed to confirm these findings.

Background: Acute nasopharyngitis is often treated with hypertonic saline that can be combined with additional compounds, such as lysozyme. The aim of this study was to compare efficacy and safety of hypertonic saline solution with or without lysozyme in the treatment of acute nasopharyngitis. Methods: Non-interventional, prospective, multicentre, observational, parallel study was conducted on adult subjects with symptoms of acute nasopharyngitis. Subjects were divided into hypertonic saline or lysozyme group (receiving slightly hypertonic nasal spray with addition of lysozyme). Time until the patency of both nasal passages was measured after the first application of therapy. The congestion severity was assessed by using a visual analogue scale before the therapy application, after 30 minutes, and after seven days. Adverse reactions were monitored and evaluated.   Results: The total number of included subjects was 252 (60 in the hypertonic saline group and 192 in the lysozyme group). In both groups, a significantly better assessment of the severity of the nasal passages’ obstruction was recorded after 30 minutes and seven days from therapy start (for all compared time intervals p<0.001). The lysozyme group had a significantly lower nasal congestion score compared to hypertonic saline 30 minutes after therapy (p<0.001) and seven days from the therapy start (p=0.001). In the hypertonic saline group, a significantly shorter time was observed to establish the patency of the nasal passages after the first therapy application (p<0.001). All adverse events were mild. Conclusions: Addition of lysozyme to slightly hypertonic nasal spray brings added value in the pharmacotherapy of acute nasopharyngitis.

While clear cell renal cell carcinoma (ccRCC) is curable, advanced metastatic (mRCC) remains a clinical challenge. We analyzed clinical, pathohistological, and molecular data (Receptor Interacting Protein 5—RIP5 and Vestigial Like Family Member 4—VGLL4 expression) of 55 mRCC patients treated with first-line treatment with sunitinib. The trend of linear increase in the protein expression of RIP5 was observed with the progression of tumor grade. Overall, 80% of RIP5-positive cells were in the control kidneys and high-grade mRCC. On the contrary, RIP5 displayed low expression in grade 2 mRCC (5.63%). The trend of linear decrease in the expression of VGLL4 was observed with the progression of tumor grade. The highest protein expression of VGLL4 was observed in grade 2 (87.82%) in comparison to grade 3 and 4 and control. High expression of RIP5 mRNA was associated with longer first-line overall survival and longer progression-free survival in mRCC. In addition, a high VGLL4 mRNA expression showed better overall survival in patients with ccRCC. In conclusion, high mRNA expression of RIP5 and VGLL4 are important markers of better survival rates in mRCC patients.

Background: Acute nasopharyngitis is a common condition usually accompanied by nasal congestion. The aim of this study was to compare efficacy and safety of the spray containing xylometazoline and lysozyme with spray containing only xylometazoline in the treatment of acute nasopharyngitis.Methods: Prospective, comparative, post-marketing study was performed on subjects with acute nasopharyngitisdivided into xylometazoline+lysozyme or xylometazoline nasal spray groups. Data collection was performed at the baseline before and 30 minutes after the therapy application and seven days after baseline.Main findings: Out of 173 included subjects, 59 were in the xylometazoline+lysozyme and 114 in the xylometazoline group. In both groups nasal patency was significantly improved 30 minutes after the therapy application (p<0.001). In the xylometazoline+lysozyme group all subjects had nasal decongestion within 20 minutes and this was significantly shorter (p=0.037) compared to xylometazoline group where 16 subjects (14%) needed 20 to 120 minutes for nasal decongestion. All adverse events were mild and there was no significant difference in the number of adverse events between the groups.Principal conclusions: Nasal sprays containing xylometazoline with or without lysozyme were effective and safe in the treatment of acute nasopharyngitis. Nasal spray containing xylometazoline with lysozyme showed a faster effect with significantly shorter time to nose decongestion. All recorded adverse events were mild and there was no difference between the groups in the number of recorded adverse events. Key words: nasopharyngitis, nasal obstruction, lysozyme, xylometazoline,nasal sprays

T. Preradović, S. Miljković, Ljiljana Kos, A. Šukalo, U. Glamočlija, A. Avdić, M. Mehić

Context: Rivaroxaban is an oral direct factor Xa inhibitor reducing the risk of systemic embolism and stroke in patients with nonvalvular atrial fibrillation. Aims: The primary objective was to evaluate the effectiveness of rivaroxaban therapy in reducing the risk of systemic embolism and stroke in patients with nonvalvular atrial fibrillation, whereas secondary objectives were to monitor therapy safety and the patients' adherence to treatment. Settings and Design: The prospective, postmarketing clinical trial was conducted on patients with nonvalvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, and diabetes mellitus, who suffered a stroke or a transient ischemic attack. Subjects and Methods: At the baseline visit, the CHA2DS2 score was determined, and therapy was introduced. At three control visits (1, 3, and 6 months after baseline), systemic embolism, stroke, bruises, or bleeding occurrences were recorded. Furthemore, adverse events were monitored, and the Morisky score (MMAS-8) for treatment compliance was determined. Results were compared to previous studies. Results: The study included 471 patients. The incidence rate in events per 100 patient-years (95% confidence interval) was 2.6 (0.1–5.1) for systemic embolism and 4.3 (1.6–7.0) for stroke. The most common form of bleeding during rivaroxaban therapy was epistaxis. Adverse events were reported in 12 (2.7%) patients. Therapy adherence was in the range of medium adherence for the entire study period, with the average score decreasing significantly from the 1st to 6th months (P < 0.001). Conclusions: Rivaroxaban showed good efficacy and safety in reducing the risk of systemic embolism and stroke in patients with nonvalvular atrial fibrillation including patients with comorbidities.

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