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].
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.
Introduction: Benign prostatic hyperplasia (BHP) is one of the most common, progressive diseases in elderly men. It is very important to diagnose this disease in its early stages. The international prostate symptom score (IPSS) is a very helpful tool to be used for this purpose. Aims: The main goal of this study was to analyze the signs and symptoms of benign prostatic hyperplasia and its impact on a patient's quality of life. Patients and Methods: This descriptive randomized study included 112 male examinees aged 50-70 years. We used IPSS as a survey tool. Results: The average age of the examinees was 61.02 (± 6,18). 56.3% of examinees had mild symptoms, 31.3% had moderate symptoms and 12.5% of our examinees had severe lower urinary tract symptoms. Nocturia was the most common symptom. Irritative symptoms were present in 76.8% of examinees compared to obstructive symptoms which occurred in 8.9%, and 14.3% had both types of symptoms. Hypertension was the most common comorbidity (in 50.9% of cases). The majority of examinees answered that they would be satisfied with their quality of life if their symptoms do not change in the future. Conclusions: Assessment of symptoms and signs of benign prostatic hyperplasia using IPSS in clinical practice has proven to be useful in the timely approach of clinical physicians.
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
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.
Background Although migraine is among the most common disabling conditions worldwide, it is rarely accurately diagnosed. This study aimed to categorize and compare patients suffering from migraines without aura (MWA) or other types of headaches in primary health care facilities. Material and Methods We conducted a prospective, cross-sectional, epidemiological, and non-interventional study at 46 primary health care facilities in Bosnia and Herzegovina. The validated Balkan Migraine Screening Questionnaire (BMSQ) was used to classify patients into MWA or non-MWA groups. Results The study comprised 1,366 patients categorized into MWA (n =896, 65.6 %) and non-MWA (n =470, 34.4 %) groups. Seven hundred thirty-four patients with MWA were newly identified. The patients in the MWA group were significantly younger, at 49.9 ± 13.7 years, compared to the non-MWA group at 52.0 ± 14.4 years (p =0.008). The MWA group documented less alcohol consumption (11.0 % vs 18.7 % for the non-MWA group, p <0.001) and experienced more severe headaches [headache intensity on Visual Analogue Scale (VAS), with a median score of 7, interquartile range (IQR): 6-8 vs 5 (IQR: 4-7) for the non-MWA group, p <0.001)]. The MWA group had a higher proportion of women (80.1 % vs 64.3 % for the non-MWA group, p <0.001). Compared to the non-MWA group, patients in the MWA group experienced more frequent headache attacks (more than six attacks in the preceding six months: 50.6 % vs 28.1 %, p <0.001), needed additional headache treatment (using two or more classes of antiheadache therapy 41.3 % vs 26.4 %, p <0.001), and had a positive family history of migraine (46.9 % vs 23.0 %, p <0.001). The binomial regression model identified two positive predictors (family history of migraines and headache intensity) and one negative predictor (alcohol consumption) for the BMSQ classification of patients into the MWA group. Conclusion More than half the patients in this study were newly classified as having MWA, indicating a high prevalence of undiagnosed migraine. Categorization of patients with headaches is of crucial importance for appropriate treatment and should be utilized in everyday practice in primary health care settings. HIPPOKRATIA 2023, 27 (2):99-105.
Background: Acute gastroenteritis remains an extremely common problem among the general population. In Western countries, an average person will probably face one or two episodes of gastrointestinal infections every year. Objective: The aim of this study was to compare the efficacy of nifuroxazide and probiotic preparation containing lactic acid bacteria in the treatment of acute diarrheal syndrome. Methods: The study was prospective, comparative study. Patients who suffered from acute infective diarrhoea for ≤72 hours and had ≥3 unformed stools per day, with no administration of antibiotics during 10 days before enrolment were divided into two groups: nifuroxazide group and the lactic acid probiotic group. All patients received therapies four times a day for three days. Data was collected at the baseline visit (before the initiation of the treatment) and two follow-up examinations on the third and seventh day from the treatment start. Results: The study included 61 patients, 36 in nifuroxazide group and 25 in probiotic group. Nifuroxazide group compared to probiotic group showed faster improvement of patients’ condition with lower number of stools three and seven days after therapy start (p=0.001 and p<0.001 respectively) and faster stool consistency normalization. On the seventh day from therapy start medium mushy stool consistency was observed in the majority of patients in nifuroxazide group (n=31, 86%) and only in small number of patients in probiotic group (n=5, 20%). Patients were feeling better and there was a trend of reporting better therapy efficacy in nifuroxazide group. Subjective assessment of therapy tolerability was also better in nifuroxazide group. Compliance to therapy and recommended dietary regime was similar between groups and there were no significant differences between groups regarding age, gender, elevated body temperature, abdominal pain, cramps, nausea and vomiting. Conclusion: Although probiotics are sometimes used in the treatment of acute diarrheal syndrome, nifuroxazide has better efficacy and greater patients’ satisfaction. Nifuroxazide can be recommended as the first choice empirical treatment in adult patients with the acute diarrheal syndrome.
Objective. The objective of this non-interventional post-marketing clinical trial was to analyze the antihypertensive effect and safety of a fixed combination of perindopril and indapamide in the treatment of unregulated essential hypertension. Patients and Methods. The prospective clinical trial included patients aged 20 to 75 years with essential hypertension and blood pressure values ≥140/90 mmHg at baseline. On the basis of the investigator’s decision, patients received 2 mg perindopril + 0.625 mg indapamide (group 2+0.625) or 4 mg perindopril + 1.25 mg indapamide (group 4+1.25). Results. The study included 1173 patients (426 patients in group 2+0.625 and 747 patients in group 4+1.25) at 27 investigational centers in Bosnia and Herzegovina. Mean blood pressure values at baseline and visits after nine months were significantly higher in the 4+1.25 group compared to the 2+0.625 group. There was a significant drop in systolic and diastolic blood pressure in both groups. The target values of systolic and diastolic blood pressure, according to the European Society of Cardiology (2018), were reached after nine months of therapy by more than 80% of patients in the 2+0.625 group, and this number was significantly higher compared to the 4+1.25 group where more than 60% of patients reached target values. Newly diagnosed patients had a better response to therapy. The percentage of patients receiving additional antihypertensive therapy decreased by the end of the study. Age, gender and the existence of diabetes mellitus were identified as negative predictors of target blood pressure achievement. The therapy showed a good safety profile. Conclusion. A fixed combination of perindopril and indapamide was effective and safe in the treatment of unregulated essential hypertension.
Ova stranica koristi kolačiće da bi vam pružila najbolje iskustvo
Saznaj više