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.
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: 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.
Objective. This study aimed to evaluate the efficacy and safety of lysozyme-based oral antiseptic in the therapy of non-infectious sore throat in teachers. Materials and Methods. A non-interventional, prospective, pilot study was conducted with two examinations. The first was performed as part of a general medical examination. If a non-infectious sore throat was confirmed by clinical checkup and all other inclusion and non-exclusion criteria confirmed, patients were offered to be enrolled in the study. After signing the informed consent form, patients were advised to use lysozyme-based lozenges, six times a day, for a period of five days. A telephone call follow-up examination was performed within 24 hours from the therapy completion. Results. This was a pilot study involving 25 adult patients of both genders. Lysozyme-based lozenges showed positive effects in relieving the symptoms of non-infectious sore throat in teachers. At the same time, the lozenges showed excellent tolerability, and no side effects were reported during the study. 92% of patients confirmed they would take the same medicine again due to the same problem. Conclusion. The results of this “proof-of-concept” study indicated that lysozyme-based antiseptic could be effective and safe in the treatment of non-infectious sore throat in teachers and should be further evaluated as treatment option in this condition.
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