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首页> 外文期刊>BMC Family Practice >A multicentre, randomised, double-blind, single-dose study assessing the efficacy of AMC/DCBA Warm lozenge or AMC/DCBA Cool lozenge in the relief of acute sore throat
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A multicentre, randomised, double-blind, single-dose study assessing the efficacy of AMC/DCBA Warm lozenge or AMC/DCBA Cool lozenge in the relief of acute sore throat

机译：一项多中心，随机，双盲，单剂量研究，评估AMC / DCBA温热锭剂或AMC / DCBA凉爽锭剂缓解急性咽喉痛的功效

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Background Clinically proven over-the-counter (OTC) treatment options are becoming increasingly important in the self-management of acute sore throat. The aim of this study was to determine the analgesic and sensorial benefits of two different amylmetacresol/2,4-dichlorobenzyl alcohol (AMC/DCBA) throat lozenge formulation variants, AMC/DCBA Warm lozenge and AMC/DCBA Cool lozenge, compared with an unflavoured, non-medicated placebo lozenge in the relief of acute sore throat due to upper respiratory tract infections. Methods In this multicentre, randomised, double-blind, single-dose study, 225 adult patients with acute sore throat were randomly assigned to receive either one AMC/DCBA Warm lozenge (n = 77), one AMC/DCBA Cool lozenge (n = 74) or one unflavoured, non-medicated lozenge (matched for size, shape and demulcency; n = 74). After baseline assessments, patients received their assigned lozenge and completed four rating assessments at 11 timepoints from 1 to 120 minutes post dose. Analgesic properties were assessed by comparing severity of throat soreness and sore throat relief ratings. Difficulty in swallowing, throat numbness, functional, sensorial and emotional benefits were also assessed. Results Both the AMC/DCBA Warm and AMC/DCBA Cool lozenge induced significant analgesic, functional, sensorial and emotional effects compared with the unflavoured, non-medicated lozenge. Sore throat relief, improvements in throat soreness and difficulty in swallowing, and throat numbness were observed as early as 1-5 minutes, and lasted up to 2 hours post dose. Sensorial benefits of warming and cooling associated with the AMC/DCBA Warm and AMC/DCBA Cool lozenge, respectively, were experienced soon after first dose, and in the case of the latter, it lasted long after the lozenge had dissolved. Emotional benefits of feeling better, happier, less distracted and less frustrated were reported in those taking either of the AMC/DCBA throat lozenge variants, with no differences in adverse events compared with the unflavoured, non-medicated lozenge. Conclusions AMC/DCBA Warm and AMC/DCBA Cool lozenges are well-tolerated and effective OTC treatment options, offering functional, sensorial and emotional benefits to patients with acute sore throat, over and above that of the rapid efficacy effects provided. Trial registration ISRCTN: ISRCTN00003567
机译：背景技术临床证明的非处方（OTC）治疗选择在急性喉咙痛的自我管理中变得越来越重要。这项研究的目的是确定两种不同的戊基间苯二酚/ 2,4-二氯苄醇（AMC / DCBA）咽喉锭剂配方变体（AMC / DCBA温暖锭剂和AMC / DCBA凉爽锭剂）的镇痛和感官益处，非药物安慰剂锭剂可缓解上呼吸道感染引起的急性咽喉痛。方法在这项多中心，随机，双盲，单剂量研究中，将225名成年急性咽喉炎患者随机分配为接受一种AMC / DCBA保暖锭剂（n = 77），一种AMC / DCBA保冷锭剂（n = 74）或一种无味，无药的锭剂（尺寸，形状和乳化度匹配; n = 74）。在进行基线评估后，患者接受了分配的锭剂，并在给药后1至120分钟的11个时间点完成了四个评估评估。通过比较喉咙痛的严重程度和喉咙疼痛的缓解程度来评估镇痛作用。还评估了吞咽困难，咽喉麻木，功能，感觉和情绪方面的益处。结果与无味，无药的锭剂相比，AMC / DCBA保暖片和AMC / DCBA Cool锭剂均具有明显的镇痛，功能，感官和情感效果。早在1-5分钟即可观察到咽喉疼痛缓解，咽痛改善和吞咽困难以及咽喉麻木，并持续至服药后2小时。分别在AMC / DCBA Warm和AMC / DCBA Cool锭剂中分别获得了温暖和凉爽的感官益处，在第一次给药后不久，对于后者，锭剂溶解后就持续了很长时间。据报道，服用AMC / DCBA咽喉锭剂的人，感觉更好，更幸福，分散注意力和沮丧感的情感益处，与无味，非药物锭剂相比，不良事件没有差异。结论AMC / DCBA Warm和AMC / DCBA Cool锭剂具有良好的耐受性和有效的OTC治疗选择，对急性咽喉炎患者提供功能，感官和情感上的好处，远远超过所提供的快速疗效。试用注册ISRCTN：ISRCTN00003567

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