Kaiser H B, Findlay S R, Georgitis J W, Grossman J, Ratner P H, Tinkelman D G, Roszko P, Zegarelli E, Wood C C
University of Minnesota, Minneapolis 55402, USA.
J Allergy Clin Immunol. 1995 May;95(5 Pt 2):1128-32. doi: 10.1016/s0091-6749(95)70217-2.
The purpose of this study was to assess the safety and efficacy of ipratropium bromide nasal spray 0.06% (aqueous solution), 84 micrograms per nostril three times a day, in reducing nasal hypersecretion in the long-term treatment of patients with perennial allergic rhinitis (PAR). This was an open-label 1-year trial. In the first 6 months all patients were treated with two puffs ipratropium bromide nasal spray 0.06%, 84 micrograms per nostril three times per day, unless they were unable to tolerate the dose. In the last 6 months the dose could be reduced to the lowest amount required to control rhinorrhea. Ninety-six patients entered the trial, and 47 completed it. Sixty-three patients completed more than 6 months of treatment. Patient and physician global evaluation suggested that ipratropium bromide nasal spray 0.06% is effective in controlling rhinorrhea associated with PAR and can contribute to control of congestion, postnasal drip, and sneezing. There was also a trend toward reduction of mucosal edema and improvement in quality of life. The most common drug-related adverse events were nasal dryness, epistaxis/nose bleed, and increased rhinitis. Most adverse events were mild and resulted in drug discontinuation in less than 10% of patients. Ipratropium bromide nasal spray was well tolerated and not associated with serious drug-related adverse events or clinically significant anticholinergic side effects. Use of ipratropium bromide nasal spray alone or with other standard medications should be considered in treating patients with PAR.
本研究的目的是评估0.06%异丙托溴铵鼻喷雾剂（水溶液，每侧鼻孔84微克，每日三次）在长期治疗常年性变应性鼻炎（PAR）患者时减少鼻分泌物过多的安全性和有效性。这是一项为期1年的开放标签试验。在最初6个月，所有患者接受0.06%异丙托溴铵鼻喷雾剂每侧鼻孔两喷，每日三次，除非他们无法耐受该剂量。在最后6个月，剂量可减至控制鼻漏所需的最低量。96名患者进入试验，47名完成试验。63名患者完成了超过6个月的治疗。患者和医生的整体评估表明，0.06%异丙托溴铵鼻喷雾剂在控制与PAR相关的鼻漏方面有效，并且有助于控制鼻塞、鼻后滴漏和打喷嚏。黏膜水肿也有减轻趋势，生活质量有所改善。最常见的与药物相关的不良事件是鼻干燥、鼻出血和鼻炎加重。大多数不良事件为轻度，导致停药的患者不到10%。异丙托溴铵鼻喷雾剂耐受性良好，未出现严重的与药物相关的不良事件或具有临床意义的抗胆碱能副作用。在治疗PAR患者时，应考虑单独使用异丙托溴铵鼻喷雾剂或与其他标准药物联合使用。
