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首页> 外文期刊>Journal of Pharmacy and Pharmaceutical Sciences >Randomised, Double-Blind, Placebo-Controlled Study of a Single Dose of an Amylmetacresol/2,4-dichlorobenzyl Alcohol Plus Lidocaine Lozenge or a Hexylresorcinol Lozenge for the Treatment of Acute Sore Throat Due to Upper Respiratory Tract Infection
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Randomised, Double-Blind, Placebo-Controlled Study of a Single Dose of an Amylmetacresol/2,4-dichlorobenzyl Alcohol Plus Lidocaine Lozenge or a Hexylresorcinol Lozenge for the Treatment of Acute Sore Throat Due to Upper Respiratory Tract Infection

机译：随机，双盲，安慰剂对照研究单剂量淀粉酰氯/ 2,4-二氯苄醇和Liatocaine锭剂或己基丙烯醇锭剂，用于治疗由于上呼吸道感染引起的急性疼痛

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Purpose: Sore throat is a frequent reason for seeking medical care but few prescription options are available. Lozenges are effective in delivering active ingredients to the throat. This study was conducted to determine the analgesic efficacy of two lozenges ? one containing amylmetacresol (AMC)/2,4-dichlorobenzyl alcohol (DCBA) and lidocaine and one containing hexylresorcinol ? versus placebo in patients with acute sore throat due to upper respiratory tract infection (URTI). Methods: This was a multicentre, randomised, double-blind, parallel group, placebo-controlled study. In total, 190 patients were randomised 1:1:1 to a single dose of AMC/DCBA + lidocaine, hexylresorcinol or placebo lozenge. Subjective ratings of throat soreness, difficulty swallowing, swollen throat, numbing, and sore throat relief were obtained up to 2 hours post dose. Patient and investigator global ratings and a consumer questionnaire were also collected. The primary endpoint was the change from baseline in severity of throat soreness for both lozenges versus placebo at 2 hours post dose. Results: The hexylresorcinol lozenge demonstrated superiority over placebo for primary and secondary efficacy variables including those related to throat soreness, sore throat relief and difficulty swallowing; the AMC/DCBA + lidocaine lozenge was also superior to placebo for secondary endpoints at various time points but did not reach significance for the primary efficacy variable. Both lozenges had a rapid onset of action from 1–10 minutes post dose for the AMC/DCBA + lidocaine lozenge and 1–5 minutes post dose for the hexylresorcinol lozenge. Numbness was reported from 1 minute post dose with the AMC/DCBA + lidocaine lozenge and was greatest at 15 minutes. Numbness was reported from 5 minutes post dose with the hexylresorcinol lozenge and was greatest at 10 minutes. Both lozenges were well tolerated. Conclusions: Both AMC/DCBA + lidocaine and hexylresorcinol lozenges provided rapid and effective sore throat relief in patients with URTI. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on on the issue’s contents page.
机译：目的：喉咙痛是寻求医疗保健的常见原因，但有很少的处方选项。锭剂有效地将活性成分递送到喉咙。进行了这项研究以确定两种锭剂的镇痛效果？一种含有淀粉酰氯（AMC）/ 2,4-二氯苄醇（DCBA）和LIDOCAIN和含有己基甲酰氯酚的一种含有氨基丙酮（AMC）/ 2,4-二氯苄醇吗？由于上呼吸道感染（URTI），急性疼痛患者的与安慰剂。方法：这是多期，随机，双盲，并行组，安慰剂对照研究。总共，190名患者随机1：1：1至单剂量的AMC / DCBA + LIDOCAINE，己基丙烯酰酚或安慰剂锭剂。咽喉疼痛的主观评级，吞咽困难，咽喉肿胀，麻木和喉咙痛缓解，剂量后2小时。还收集了患者和调查员全球评级和消费者问卷。主要终点是从2小时后喉部患者的喉咙疼痛严重程度的基线变化。结果：己基苯酚锭剂含有对初级和二次疗效变量的安慰剂的优越性，包括喉咙痛，喉咙痛缓解和吞咽困难; AMC / DCBA +利多卡因锭剂在各个时间点的次要终点中也优于安慰剂，但对初级疗效变量没有达到意义。锭剂均为AMC / DCBA + Lidocaine锭剂的1-10分钟的发布剂量迅速发作，为己基硼丙烯酚锭剂的1-5分钟给药。据报道麻木是从AMC / DCBA + Lidocaine锭剂的1分钟后剂量，并且在15分钟内最大。据报道麻木用己酰甲酸含水含量5分钟，10分钟最大。锭剂都耐受良好。结论：AMC / DCBA +利多卡因和己基丙啶醇锭剂在URTI患者中提供了快速有效的喉咙痛。本文对发布后审查开放。注册读者（参见“对于读者”）可以通过单击“问题的内容”页面进行评论。

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