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首页> 外文期刊>Pulmonary therapy. >A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis
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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis

机译：一种随机，双盲，安慰剂对照研究，评估急性咽炎患者氨溴含量含量的疗效和安全性

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IntroductionThe aim of this study was to evaluate the efficacy and safety of a new hard-boiled lozenge formulation containing ambroxol 20?mg versus placebo for the relief of sore throat in patients with acute pharyngitis. MethodsThis was a phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter trial conducted between June and September 2018 in South Africa. Patients with a diagnosis of acute pharyngitis, onset?≤?72?h, and sore throat pain of at least moderate intensity were randomized to receive either ambroxol 20?mg or placebo hard-boiled lozenges. The primary efficacy endpoint was the normalized time-weighted sum of pain intensity differences (SPID) from baseline over 3?h following administration of the first lozenge (SPIDsubnorm,0–3h/sub). Secondary efficacy endpoints included SPID 24?h after the first lozenge intake (SPIDsubnorm,0–24h/sub) and patient assessment of efficacy at 3 and 24?h after the first lozenge. ResultsOf 422 patients from 11 centers, 390 were randomized to one of the two treatment groups ( n =?196, ambroxol; n =?194, placebo) and 388 were analyzed (modified intention-to-treat). The mean?±?standard deviation SPIDsubnorm,0–3h/sub values were ?0.386 (0.259) and ?0.366 (0.243) in the ambroxol and placebo groups, respectively, and the adjusted mean?±?standard error SPIDsubnorm0–3h/sub difference between ambroxol and placebo was ?0.020 (0.025) ( p =?0.443). Comparable results between treatment groups were also found for SPIDsubnorm,0–24h/sub and patient assessment of efficacy at 3 and 24?h after the first lozenge. The incidence of treatment-emergent adverse events (TEAEs) was similar between treatment groups (11.7% for ambroxol versus 9.3% for placebo). ConclusionAlthough marked pain relief was observed over the first 3?h of treatment, superiority of ambroxol 20?mg hard-boiled lozenges versus placebo was not demonstrated in this study. Trial RegistrationNCT03583658. FundingSanofi-Aventis Group.
机译：介绍本研究的目的是评估含有氨溴激素20βMG与安慰剂的新的硬煮含卵巢配方的疗效和安全性，以缓解急性咽炎患者的喉咙痛。方法是，2018年6月至9月在南非之间进行了3阶段，随机，双盲，安慰剂控制，并行组多中心试验。患者诊断急性咽炎，发作≤α72≤H，并且喉咙痛至少适中强度的疼痛被随机接受氨布氧咯醇20？Mg或安慰剂硬沸腾的锭剂。初级疗效终点是在施用第一个锭剂（Spid Norm，0-3H ）后，从基线到基线的归一化时间加权差异（Spid）。次级疗效终点包括在第一个锭剂摄入后的SPID 24？H（Spid 符号，0-24h ）和第3和24次患者的疗效评估在第一个锭剂之后。结果422名从11个中心，390名患者被随机分析到两个治疗组中的一种（n = 196，氨溴罗; n = 194，安慰剂）和388（修改意向治疗）。平均值？±α？标准偏差Spid 范数，0-3h 值分别是α0-386（0.259）和α0.366（0.243），分别在Ambroxol和安慰剂组中，调整后的平均值？标准误差spd norm0-3h ambroxol和安慰剂之间的差异为0.020（0.025）（p = 0.443）。还发现了治疗组之间的可比较结果，用于SPID 标准，0-24h ，患者在第一个锭剂后3和24的疗效评估。治疗组（茶叶）的发生率（茶叶）在治疗基团（氨溴激素11.7％）之间相似（安慰剂的9.3％）。结论虽然在前3次治疗中观察到显着的疼痛浮雕，但在本研究中未在氨溴氧咯醇20的优越性中进行过沸腾的洛杉矶和安慰剂。试验登录INCT03583658。 Fundingsanofi-Aventis集团。

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