Lysozyme addition to slightly hypertonic nasal spray in the treatment of acute nasopharyngitis: a prospective post-marketing study

Zumreta Pintol, A. Šukalo, Meliha Mehić, Amna Tanović Avdić, R. Baljic, U. Glamočlija
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Abstract

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.
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溶菌酶添加到微量高渗鼻腔喷雾剂中治疗急性鼻咽炎:上市后前瞻性研究
背景:急性鼻咽炎通常采用高渗盐水治疗,高渗盐水可与溶菌酶等其他化合物结合使用。本研究旨在比较高渗盐水加或不加溶菌酶治疗急性鼻咽炎的疗效和安全性:方法:对有急性鼻咽炎症状的成年受试者进行非干预性、前瞻性、多中心、观察性、平行研究。受试者被分为高渗盐水组和溶菌酶组(接受添加溶菌酶的微高渗鼻腔喷雾)。在首次使用疗法后,测量直至双侧鼻腔通畅的时间。治疗前、30 分钟后和 7 天后,使用视觉模拟量表评估鼻塞的严重程度。对不良反应进行了监测和评估。 研究结果受试者总数为 252 人(高渗盐水组 60 人,溶菌酶组 192 人)。两组受试者在治疗开始 30 分钟后和 7 天后的鼻腔阻塞严重程度评估结果均明显优于对照组(所有时间间隔的比较结果均为 P<0.001)。溶菌酶组在治疗后 30 分钟(P<0.001)和治疗开始后 7 天(P=0.001)的鼻塞评分明显低于高渗盐水组。在高渗盐水组中,观察到首次治疗后建立鼻腔通畅的时间明显更短(p<0.001)。所有不良反应均为轻微:结论:在微量高渗鼻腔喷雾剂中添加溶菌酶可为急性鼻咽炎的药物治疗带来更多价值。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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