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异丙托溴铵鼻喷雾剂治疗非变应性常年性鼻炎的双盲研究

Double-blind study of intranasal ipratropium bromide in nonallergic perennial rhinitis.

作者信息

Druce H M, Spector S L, Fireman P, Kaiser H, Meltzer E O, Boggs P, Wood C C, Paluch E P

机构信息

Department of Internal Medicine, St. Louis University School of Medicine, Missouri.

出版信息

Ann Allergy. 1992 Jul;69(1):53-60.

PMID:1385682
Abstract

We undertook this trial to determine whether ipratropium bromide nasal spray 0.03% (IB) reduced the nasal hypersecretion associated with nonallergic perennial rhinitis (NAPR) without causing excessive dryness or irritation of the nasal mucosa. We compared two drug doses of IB (21 micrograms and 42 micrograms per nostril) to a placebo, administered as two sprays to each nostril twice daily. The study design consisted of a 1-week screening period without treatment, a 1-week single-blind placebo period, a 4-week double-blind treatment comparison period, and a 1-week follow-up period without medication to evaluate nasal rebound. One hundred fifty-two patients were entered and 140 completed the trial. Both doses of IB reduced the severity and duration of rhinorrhea compared with placebo (P = .05 and .03, respectively). Treatment differences were noticeable during the first week of therapy, continued to widen during the second week, and then remained stable throughout the next 2 weeks. There was no evidence of nasal rebound observed during the week after treatment. The drug was well tolerated with side effects limited to infrequent nasal adverse events of nasal dryness, blood-tinged mucus, and epistaxis occurring in 2% to 6% of patients. We conclude that IB is a safe and effective therapy for control of rhinorrhea associated with NAPR.

摘要

我们进行了这项试验,以确定0.03%异丙托溴铵鼻喷雾剂(IB)是否能减少与非过敏性常年性鼻炎(NAPR)相关的鼻分泌物过多,同时又不会引起鼻黏膜过度干燥或刺激。我们将两种剂量的IB(每侧鼻孔21微克和42微克)与安慰剂进行比较,每天向每个鼻孔喷两次,每次喷两下。研究设计包括1周的无治疗筛查期、1周的单盲安慰剂期、4周的双盲治疗比较期以及1周的无药物随访期,以评估鼻反弹情况。152名患者进入试验,140名完成了试验。与安慰剂相比,两种剂量的IB均降低了鼻漏的严重程度和持续时间(P值分别为0.05和0.03)。治疗差异在治疗的第一周就很明显,在第二周继续扩大,然后在接下来的两周内保持稳定。治疗后一周内未观察到鼻反弹的证据。该药物耐受性良好,副作用仅限于2%至6%的患者出现的偶尔的鼻部不良事件,如鼻干、带血黏液和鼻出血。我们得出结论,IB是控制与NAPR相关鼻漏的一种安全有效的疗法。

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Double-blind study of intranasal ipratropium bromide in nonallergic perennial rhinitis.异丙托溴铵鼻喷雾剂治疗非变应性常年性鼻炎的双盲研究
Ann Allergy. 1992 Jul;69(1):53-60.
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