Finn A F, Aaronson D, Korenblat P, Lumry W, Settipane G, Spector S, Woehler T, Drda K, Wood C C
National Allergy, Asthma and Urticaria Centers of Charleston P.A., SC 29406, USA.
Am J Rhinol. 1998 Nov-Dec;12(6):441-9. doi: 10.2500/105065898780707919.
Medical treatment of perennial rhinitis is aimed at providing symptomatic relief of individual symptoms. Multiple agents are administered when no single agent provides complete relief. Studies assessing the benefit/risk of combined therapy are important, especially for newly available agents such as ipratropium bromide nasal spray, a topical anticholinergic agent approved for the treatment of rhinorrhea in allergic and nonallergic perennial rhinitis. The objective was to determine whether the combined use of ipratropium bromide nasal spray 0.03% (42 mcg per nostril) administered three times daily with a nonsedating antihistamine (terfenadine, 60 mg administered twice daily) is safe and provides greater clinical benefit than use of the placebo nasal spray plus terfenadine. Our method was a multicenter, 6-week, double-blind, randomized, active-controlled, crossover trial of 205 patients with perennial rhinitis (114 allergic and 91 nonallergic), 18 to 75 years of age, who had clinically significant rhinorrhea. After a 1-week run-in period, patients were treated for 2 weeks with one of the two treatment regimens, followed by a 1-week washout period, and then were treated for another 2 weeks with the other treatment regimen. Daily diary symptoms scores of rhinorrhea, congestion, and sneezing were obtained, as well as biweekly patient and physician global assessments of treatment effectiveness of each of the nasal symptoms. Ipratropium bromide nasal spray plus terfenadine was more effective than vehicle plus terfenadine in reducing the average severity (38% versus 28%) and duration (46% versus 30%) of rhinorrhea during the 2 weeks of treatment from baseline (p < 0.05). The advantage of ipratropium bromide nasal spray plus terfenadine was evident by the second day of treatment and continued throughout the 2-week treatment period. Of patients who responded more to one treatment than another, 69% responded to ipratropium bromide nasal spray plus terfenadine, compared to 31% to vehicle plus terfenadine (p < 0.05). Both physicians and patients rated control of rhinorrhea and sneezing by ipratropium bromide nasal spray plus terfenadine as superior to vehicle plus terfenadine (p < 0.05). The symptom of congestion was controlled equally well by both treatments. Combined active therapy was well tolerated with no increase in adverse events over that seen previously with ipratropium bromide nasal spray alone. The combination of ipratropium bromide nasal spray with terfenadine is more effective than vehicle plus terfenadine for the treatment of rhinorrhea, and does not result in a potentiation of adverse drug reactions.
常年性鼻炎的药物治疗旨在缓解个体症状。若单一药物无法完全缓解症状，则使用多种药物。评估联合治疗的获益/风险的研究很重要，特别是对于新上市的药物，如异丙托溴铵鼻喷雾剂，这是一种经批准用于治疗变应性和非变应性常年性鼻炎鼻漏的局部抗胆碱能药物。目的是确定0.03%（每侧鼻孔42微克）的异丙托溴铵鼻喷雾剂每日三次与非镇静性抗组胺药（特非那定，每日两次，每次60毫克）联合使用是否安全，以及是否比使用安慰剂鼻喷雾剂加特非那定能带来更大的临床益处。我们的方法是对205例年龄在18至75岁、有临床显著鼻漏的常年性鼻炎患者（114例变应性和91例非变应性）进行一项多中心、为期6周的双盲、随机、活性药物对照、交叉试验。在1周的导入期后，患者用两种治疗方案之一治疗2周，随后是1周的洗脱期，然后再用另一种治疗方案治疗2周。获得了每日鼻漏、鼻塞和打喷嚏症状的日记评分，以及每两周患者和医生对每种鼻部症状治疗效果的总体评估。在治疗的2周内，从基线开始，异丙托溴铵鼻喷雾剂加特非那定在降低鼻漏的平均严重程度（38%对28%）和持续时间（46%对30%）方面比赋形剂加特非那定更有效（p<0.05）。异丙托溴铵鼻喷雾剂加特非那定的优势在治疗的第二天就很明显，并在整个2周的治疗期间持续存在。在对一种治疗反应比另一种治疗更好的患者中，69%对异丙托溴铵鼻喷雾剂加特非那定有反应，而对赋形剂加特非那定有反应的为31%（p<0.05）。医生和患者都认为异丙托溴铵鼻喷雾剂加特非那定对鼻漏和打喷嚏的控制优于赋形剂加特非那定（p<0.05）。两种治疗对鼻塞症状的控制效果相同。联合活性治疗耐受性良好，不良事件没有比之前单独使用异丙托溴铵鼻喷雾剂时增加。异丙托溴铵鼻喷雾剂与特非那定联合使用治疗鼻漏比赋形剂加特非那定更有效，且不会导致药物不良反应增强。
