Strandell B, Norgren-Holst E, Tran N, Jakobsen H B, Chen S
Orebro University Hospital, Orebro, Sweden.
Int J Clin Pharmacol Ther. 2009 Dec;47(12):744-51. doi: 10.5414/cpp47744.
Combination of xylometazoline and ipratropium in a nasal spray provides fast, effective symptomatic relief of nasal congestion and rhinorrhea in adults with common cold.
To gather data in a non-prescription setting regarding the safety, pattern of use, patients' general assessment of treatment and suitability of making available without medical prescription of this topical combination nasal spray.
Post-marketing, non-interventional, non-controlled study reflecting normal over-the-counter (OTC) use of the spray in adults with common cold (n = 1,019). Main outcome measures included pattern of use (patient-reported effectiveness, compliance with treatment) and safety (adverse drug reaction (ADR) reports).
Over 92% of patients used the product for the intended indication, 81.4% used it 2 - 3 times/day and the median duration of treatment was 6 days. In total, 39.7% of patients reported 585 ADRs (mean 1.45 ADR/patient) while 60.3% reported no ADRs. Most common side effects were nasal dryness (12.4%), blood tinged mucus (9.3%), nasal discomfort (6.2%), epistaxis (4.2%), generally harmless and of mild severity. Patients who used the product outside the approved indication did not seem to have a higher risk of ADRs. Mean general impression score was 3.4, with 79% of patients rating treatment as "good" to "excellent".
The topical combination nasal spray (xylometazoline plus ipratropium) for the symptomatic relief of nasal congestion and rhinorrhea in adults with common cold has a good safety profile and results in high patient satisfaction in an OTC setting. No reasons could be found to oppose the assertion that the combination spray is suitable for classification as a product not subject to medical prescription.
在鼻腔喷雾剂中联合使用赛洛唑啉和异丙托溴铵可快速、有效地缓解普通感冒成人患者的鼻塞和流涕症状。
在非处方环境中收集有关该局部联合鼻腔喷雾剂安全性、使用模式、患者对治疗的总体评估以及无需医生处方即可使用的适用性的数据。
上市后非干预性、非对照研究，反映普通感冒成人患者（n = 1019）对该喷雾剂的正常非处方使用情况。主要结局指标包括使用模式（患者报告的疗效、治疗依从性）和安全性（药物不良反应报告）。
超过92%的患者将该产品用于预期适应症，81.4%的患者每天使用2 - 3次，治疗的中位持续时间为6天。共有39.7%的患者报告了585例药物不良反应（平均每位患者1.45例），而60.3%的患者未报告药物不良反应。最常见的副作用是鼻干（12.4%）、带血黏液（9.3%）、鼻部不适（6.2%）、鼻出血（4.2%），一般无害且严重程度较轻。在批准适应症以外使用该产品的患者似乎没有更高的药物不良反应风险。总体印象评分平均为3.4分，79%的患者将治疗评为“良好”至“优秀”。
用于缓解普通感冒成人患者鼻塞和流涕症状的局部联合鼻腔喷雾剂（赛洛唑啉加异丙托溴铵）具有良好的安全性，在非处方环境中患者满意度较高。没有理由反对将该联合喷雾剂归类为无需医生处方的产品这一主张。
