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氯己定/苄达明口腔喷雾剂对急性病毒性咽炎疼痛及生活质量的影响:一项前瞻性、随机、双盲、安慰剂对照、多中心研究。

Effects of chlorhexidine/benzydamine mouth spray on pain and quality of life in acute viral pharyngitis: a prospective, randomized, double-blind, placebo-controlled, multicenter study.

作者信息

Cingi Cemal, Songu Murat, Ural Ahmet, Yildirim Muzeyyen, Erdogmus Nagehan, Bal Cengiz

机构信息

Department of Otorhinolaryngology, Osmangazi University Medical Faculty, Eskisehir, Turkey.

出版信息

Ear Nose Throat J. 2010 Nov;89(11):546-9.

PMID:21086279
Abstract

We conducted a prospective, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy of chlorhexidine gluconate/benzydamine HCl mouth spray for reducing pain and improving quality of life in patients with acute viral pharyngitis. Prior to treatment, patients rated the intensity of their pain on a visual analog scale and evaluated their quality of life on the 36-Item Short-Form Health Survey. Patients were then randomized to receive either paracetamol (acetaminophen) plus chlorhexidine/benzydamine or paracetamol plus placebo for 7 days. On days 3 and 7 of treatment, the participants again rated the intensity of their pain, and on day 7, they again rated their quality of life. A total of 164 patients were evaluable at study's end-80 in the chlorhexidine/benzydamine group and 84 in the control group. A comparison of self-evaluations revealed that the active treatment group reported less pain on both day 3 (p < 0.001) and day 7 (p = 0.002). Likewise, the chlorhexidine/benzydamine group reported a significantly better quality of life on day 7 (p < 0.001). Chlorhexidine/benzydamine was well tolerated, and no serious adverse events were observed.

摘要

我们进行了一项前瞻性、随机、双盲、安慰剂对照、多中心研究,以评估葡萄糖酸氯己定/盐酸苄达明口腔喷雾剂对减轻急性病毒性咽炎患者疼痛和改善生活质量的疗效。治疗前,患者用视觉模拟量表对疼痛强度进行评分,并通过36项简短健康调查问卷评估其生活质量。然后,患者被随机分为两组,一组接受对乙酰氨基酚加氯己定/苄达明治疗,另一组接受对乙酰氨基酚加安慰剂治疗,为期7天。在治疗的第3天和第7天,参与者再次对疼痛强度进行评分,在第7天,他们再次对生活质量进行评分。研究结束时,共有164例患者可进行评估,其中氯己定/苄达明组80例,对照组84例。自我评估比较显示,活性治疗组在第3天(p<0.001)和第7天(p = 0.002)报告的疼痛均较轻。同样,氯己定/苄达明组在第7天报告的生活质量明显更好(p<0.001)。氯己定/苄达明耐受性良好,未观察到严重不良事件。

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