de Mey Christian, Peil Hubertus, Kölsch Stephan, Bubeck Jürgen, Vix Jean-Michel
ACPS--Applied Clinical Pharmacology Services, Mainz-Kastel, Germany.
Arzneimittelforschung. 2008;58(11):557-68. doi: 10.1055/s-0031-1296557.
Sore throat is the hallmark of acute pharyngitis. Although usually caused by viral infections, it is frequently treated with antibiotics. Such inappropriate use of antibiotics might best be challenged by offering efficacious and safe symptomatic pain relief instead. However, there is need for robust evidence to support such alternatives. Presently, the evidence from randomised, placebo-controlled, double-blind clinical trials (RCT) with the local anaesthetic ambroxol (CAS 23828-92-4) in the treatment of sore throat is being reviewed. This relates to five RCT in 1,772 patients; 1,713 were evaluable with regard to efficacy. Treatment with ambroxol lozenges was statistically significantly superior to placebo in reducing sore throat pain intensity with a high level of consistency of the estimated effect across the different studies. The effect had an early onset and lasted up to at least 3 h after a single first lozenge. The pain relief was associated with a statistically superior regression of pharyngeal redness and inflammation; with ambroxol, the overall efficacy was more frequently rated as at least "good". Treatment with the ambroxol lozenges was well tolerated. There was heterogeneity in reporting adverse events: in one later study with less severe baseline pain intensity there was more frequent reporting of hypoaesthesia of the oral cavity and tongue as an untoward phenomenon. In patients with more severe baseline pain this reflection of the medication's pharmacological action was only rarely reported as untoward. It is concluded that lozenges containing 20 mg ambroxol are a safe and efficacious treatment for acute uncomplicated sore throat of recent onset in adult patients.
喉咙痛是急性咽炎的标志。虽然通常由病毒感染引起，但经常使用抗生素进行治疗。通过提供有效且安全的对症止痛措施来挑战这种对抗生素的不当使用或许是更好的做法。然而，需要有力的证据来支持此类替代方法。目前，正在对局部麻醉剂氨溴索（CAS 23828 - 92 - 4）治疗喉咙痛的随机、安慰剂对照、双盲临床试验（RCT）的证据进行综述。这涉及1772例患者的5项RCT；其中1713例可评估疗效。在减轻喉咙痛疼痛强度方面，氨溴索含片治疗在统计学上显著优于安慰剂，且不同研究中估计效果的一致性较高。效果起效早，在首次含服一片含片后至少持续3小时。疼痛缓解与咽部发红和炎症在统计学上更显著的消退相关；使用氨溴索时，总体疗效更常被评为至少“良好”。氨溴索含片治疗耐受性良好。不良事件报告存在异质性：在一项基线疼痛强度较轻的后期研究中，口腔和舌头感觉减退作为不良现象的报告更频繁。在基线疼痛较严重的患者中，这种药物药理作用的表现很少被报告为不良事件。结论是，含20毫克氨溴索的含片是治疗成年患者近期发作的急性非复杂性喉咙痛的一种安全有效的方法。
