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依克多因含片治疗急性病毒性咽炎:一项前瞻性、活性对照临床研究。

Ectoine lozenges in the treatment of acute viral pharyngitis: a prospective, active-controlled clinical study.

作者信息

Dao Van-Anh, Overhagen Sabrina, Bilstein Andreas, Kolot Carina, Sonnemann Uwe, Mösges Ralph

机构信息

CRI-Clinical Research International Ltd., Cologne, Germany.

bitop AG, Dortmund, Germany.

出版信息

Eur Arch Otorhinolaryngol. 2019 Mar;276(3):775-783. doi: 10.1007/s00405-019-05324-9. Epub 2019 Feb 9.

Abstract

PURPOSE

Acute pharyngitis is an uncomfortable disorder mostly caused by viruses and for which antibiotics are unwarranted. This study compared lozenges containing ectoine, a natural extremolyte, with hyaluronic acid lozenges and hypertonic saline gargle for symptomatic treatment of acute viral pharyngitis.

METHODS

This prospective, controlled clinical study, recruited 90 patients with moderate-to-severe pharyngitis symptoms who chose to use either ectoine (n = 35), hyaluronic acid (n = 35), or saline gargle (n = 20). Patients applied their 7-day treatment from the inclusion visit (V1) until the end-of-study visit (V2). Patients' pharyngitis symptoms, general health, general treatment effectiveness and tolerability, and patient compliance were assessed by investigators and patients.

RESULTS

The sum score for three primary symptoms (pain on swallowing, urge to cough, and hoarseness) decreased by 79.5% (ectoine), 72.2% (hyaluronic acid), and 44.8% (saline gargle). Both lozenges were significantly superior to saline gargle (P < 0.05). Regarding general health improvement, ectoine was significantly superior to saline gargle (72.5% vs. 45.2%, P < 0.05), but hyaluronic acid (63.3%) was not. At V2, 65.7% of patients receiving ectoine reported "very good" general health vs. 48.6% of those receiving hyaluronic acid and 20.0% using saline gargle. Ectoine was significantly superior (P < 0.05) to both hyaluronic acid and saline gargle in terms of tolerability and patient compliance. No patients taking ectoine reported unpleasant sensations while applying their treatment, whereas almost half of patients using hyaluronic acid lozenges and saline gargle did.

CONCLUSION

Treatment with ectoine lozenges significantly relieves moderate-to-severe symptoms of acute viral pharyngitis and is more effective and tolerable than treatments with hyaluronic acid lozenges and hypertonic saline gargle.

摘要

目的

急性咽炎是一种令人不适的疾病,主要由病毒引起,使用抗生素并无必要。本研究比较了含有依克多因(一种天然极端微生物保护剂)的含片、透明质酸含片和高渗盐水漱口对急性病毒性咽炎的症状治疗效果。

方法

这项前瞻性对照临床研究招募了90名有中度至重度咽炎症状的患者,他们选择使用依克多因(n = 35)、透明质酸(n = 35)或盐水漱口(n = 20)。患者从纳入访视(V1)开始进行为期7天的治疗,直至研究结束访视(V2)。研究者和患者对患者的咽炎症状、总体健康状况、总体治疗效果和耐受性以及患者依从性进行评估。

结果

三种主要症状(吞咽疼痛、咳嗽冲动和声音嘶哑)的总分下降情况分别为:依克多因组下降79.5%,透明质酸组下降72.2%,盐水漱口组下降44.8%。两种含片均显著优于盐水漱口(P < 0.05)。在总体健康改善方面,依克多因显著优于盐水漱口(72.5%对45.2%,P < 0.05),但透明质酸(63.3%)则不然。在V2时,接受依克多因治疗的患者中有65.7%报告总体健康状况“非常好”,而接受透明质酸治疗的患者为48.6%,使用盐水漱口的患者为20.0%。依克多因在耐受性和患者依从性方面显著优于透明质酸和盐水漱口(P < 0.05)。使用依克多因治疗的患者在治疗过程中均未报告有不适感,而使用透明质酸含片和盐水漱口的患者中几乎有一半报告有不适感。

结论

依克多因含片治疗可显著缓解急性病毒性咽炎的中度至重度症状,且比透明质酸含片和高渗盐水漱口治疗更有效且耐受性更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/555c/6411829/cf9d5bdea4ba/405_2019_5324_Fig1_HTML.jpg

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