Common Cold Centre & Healthcare Clinical Trials, Cardiff School of Biosciences, Cardiff University, Cardiff, UK.
Curr Med Res Opin. 2010 Apr;26(4):889-99. doi: 10.1185/03007991003648015.
Common cold is one of the most prevalent conditions that family doctors encounter. One of the first symptoms to occur is nasal congestion, which can have a negative impact on daily life and prompts many patients to seek treatment for relief. Xylometazoline nasal spray (Otrivin*) is a topical decongestant that has been used successfully for many years and is generally recognized as an effective and safe therapy. However, most studies have investigated its clinical efficacy in healthy patients and few have included patients with common cold.
To review the published clinical efficacy and safety of xylometazoline alone and in combination in the management of nasal congestion in patients with common cold. Literature searches of PubMed and the Cochrane Library were conducted to obtain published open or blinded, randomized, placebo- or active-controlled studies on the use of xylometazoline hydrochloride for the symptomatic relief of nasal congestion in patients with common cold. Searches included papers published in English only, up to September 2009.
Despite the small number of studies identified in common cold (n = 4), as per search criteria defined, intranasal xylometazoline quickly and effectively relieved nasal congestion. When used alone, xylometazoline had a clinically relevant decongestant effect that was significantly superior for up to 10 hours compared with placebo. The superior decongestant effect with xylometazoline led to high patient satisfaction with treatment. When used in combination with ipratropium bromide, nasal congestion and rhinorrhoea were treated simultaneously, leading to significantly higher patient general impression scores compared with either agent used alone. Xylometazoline was well tolerated, with generally mild to moderate nasal-related side effects (e.g. epistaxis in 3.4% of patients, and blood-tinged mucus in 10-26% of patients) that were easily resolved; the most frequently reported non-nasal AEs were headache (3.4%) and period pain (10.3%); no cases of sedation were reported. As expected, no rhinitis medicamentosa or rebound congestion was noted with short-term use (<10 days). No clinically important differences in ciliary motility and mucociliary clearance were observed. Xylometazoline does not result in sympathomimetic systemic side effects seen with oral decongestants (e.g. pseudoephedrine, phenylephrine).
The few studies available in common cold suggest that intranasal xylometazoline provides fast and effective relief of nasal congestion and is well tolerated. When xylometazoline is used in combination with ipratropium, patients with common cold experience the additive benefit of nasal congestion and rhinorrhoea being treated simultaneously.
普通感冒是家庭医生最常遇到的病症之一。最先出现的症状之一是鼻塞，这会对日常生活造成负面影响，促使许多患者寻求治疗以缓解症状。羟甲唑啉鼻喷剂（欧托品*）是一种局部减充血剂，已成功使用多年，通常被认为是一种有效且安全的疗法。然而，大多数研究都调查了它在健康患者中的临床疗效，很少有研究包括普通感冒患者。
回顾羟甲唑啉单独和联合治疗普通感冒患者鼻塞的已发表临床疗效和安全性。通过对 PubMed 和 Cochrane 图书馆进行文献检索，获得了关于盐酸羟甲唑啉用于缓解普通感冒患者鼻塞症状的已发表的开放或双盲、随机、安慰剂对照或阳性对照研究。检索包括仅用英语发表的论文，截止到 2009 年 9 月。
尽管根据搜索标准确定的普通感冒研究数量很少（n = 4），但鼻内羟甲唑啉能迅速且有效地缓解鼻塞。单独使用羟甲唑啉具有临床相关的减充血作用，与安慰剂相比，其作用可持续长达 10 小时。羟甲唑啉的优越减充血作用使患者对治疗非常满意。当与异丙托溴铵联合使用时，可同时治疗鼻塞和鼻漏，与单独使用任何一种药物相比，患者的总体印象评分显著更高。羟甲唑啉耐受性良好，通常仅有轻度至中度与鼻相关的副作用（例如，3.4%的患者出现鼻出血，10%至 26%的患者出现带血黏液），这些副作用很容易解决；最常报告的非鼻副作用是头痛（3.4%）和经期疼痛（10.3%）；未报告镇静作用。如预期的那样，在短期（<10 天）使用中未观察到鼻炎药物性或反弹性充血。未观察到纤毛运动和黏液纤毛清除率有临床意义的差异。羟甲唑啉不会导致口服减充血剂（例如伪麻黄碱、苯肾上腺素）引起的拟交感神经全身副作用。
普通感冒中可用的少数研究表明，鼻内羟甲唑啉可快速有效缓解鼻塞，且耐受性良好。当羟甲唑啉与异丙托溴铵联合使用时，普通感冒患者同时受益于鼻塞和鼻漏的治疗。
