Schwetz Swetlana, Olze Heidi, Melchisedech Silvia, Grigorov Alexandre, Latza Reinhard
Institute of Immunology, Federal Scientific Research Center, Moscow, Russia.
Arch Otolaryngol Head Neck Surg. 2004 Aug;130(8):979-84. doi: 10.1001/archotol.130.8.979.
To assess the efficacy and safety of a pollen blocker crème for prophylaxis of symptoms in patients with seasonal or perennial allergic rhinitis.
Double-blind, randomized, placebo-controlled, crossover study conducted from November 2001 through September 2002 in 2 outpatient centers in Germany and 1 in Russia. Ninety-one patients aged 18 to 55 years with at least a 2-year history of seasonal or perennial allergic rhinitis confirmed by history and positive skin test results were randomly assigned to receive pollen blocker cream (n = 43) or carboxymethylcellulose in gel (placebo) (n = 48) applied sparingly to the lower internal nose region 4 times daily for a total of 9 days. The efficacy of treatment was assessed by means of nasal provocation testing. The investigators assessed the nasal symptom severity scores (range, 0-6), and the changes in nasal airflow after allergen application were measured by anterior rhinomanometry.
The median score fell from 4 to 1 after application of the pollen blocker cream (P<.001) and from 4 to 3 in the placebo group (P<.05). The difference between the 2 groups after the second provocation was highly significant (P<.001). The increase in airflow in response to treatment was roughly 20% in the blocker group compared with only about 10% in the placebo group, relative to an airflow rate (299 mL/s) measured after provocation on day 1.
The blocker was significantly more effective than placebo and reduced the typical symptoms of allergic rhinitis in response to nasal challenge with allergen by nearly 60% (placebo reduced symptoms by 25%). The pollen blocker cream did not produce any adverse effects. Therefore, the efficacy of the investigational product can be rated as good.
评估一种花粉阻断乳膏对季节性或常年性变应性鼻炎患者症状预防的疗效和安全性。
2001年11月至2002年9月在德国的2个门诊中心和俄罗斯的1个门诊中心进行的双盲、随机、安慰剂对照、交叉研究。91例年龄在18至55岁、有至少2年季节性或常年性变应性鼻炎病史且经病史和皮肤试验阳性结果证实的患者被随机分配接受花粉阻断乳膏（n = 43）或凝胶状羧甲基纤维素（安慰剂）（n = 48），每天4次少量涂抹于鼻内下部区域，共9天。通过鼻激发试验评估治疗效果。研究者评估鼻症状严重程度评分（范围为0 - 6），并通过前鼻测压法测量过敏原应用后鼻气流的变化。
应用花粉阻断乳膏后，中位数评分从4降至1（P <.001），安慰剂组从4降至3（P <.05）。第二次激发后两组间差异非常显著（P <.001）。相对于第1天激发后测量的气流速率（299 mL/s），阻断剂组治疗后气流增加约20%，而安慰剂组仅约10%。
该阻断剂比安慰剂显著更有效，在过敏原鼻激发试验中使变应性鼻炎的典型症状减少近60%（安慰剂使症状减少25%）。花粉阻断乳膏未产生任何不良反应。因此，该研究产品的疗效可评为良好。
