Department of Allergy, Asthma, and Rhinosinusitis, AAADRS Clinical Research Center, Coral Gables, Florida 33134, USA.
Am J Rhinol Allergy. 2011 Nov-Dec;25(6):383-7. doi: 10.2500/ajra.2011.25.3668.
Allergic rhinitis is commonly treated with antihistamines. Monitoring improvement of airway inflammation noninvasively using nasal nitric oxide (nNO) would be clinically useful. To determine the anti-inflammatory effect of oral levocetirizine dihydrochloride (LC), we measured nNO and nasal eosinophils (nEos) in perennial allergic rhinitis (PAR) subjects.
A randomized double-blind placebo-controlled crossover design was used. Inclusion criteria consisted of subjects having a PAR history, exam and diary scores consistent with active symptoms, and positive skin testing. Subjects taking allergy medications 1 month before the study were not enrolled. After consenting, 31 subjects (24 female subjects; mean age, 29 years) were randomized to either oral LC (5 mg) or matching placebo for 2 weeks. After 2 week washout, subjects started the other 2-week treatment. At each visit, nNO was measured by aspiration at each nare using a nasal kit from NIOX (Aerocrine, Sweden) in parts per billion; nEos was collected from nasal smears and measured by microscopy using the scoring system (0-4+) and symptoms were self-reported using the allergic Rhinitis Quality of Life Questionnaire (RQLQ). Daily allergy symptom scores (total symptom score [TSS] 4) were collected at each visit.
During LC, mean baseline nNO was 807 ± 317 parts per billion (ppb; left) and 831 ± 332 ppb (right) and decreased significantly to 688 ± 266 ppb and 702 ± 286 ppb, respectively (p < 0.05). No significance was found during placebo treatment (778 ± 270 ppb, 808 ± 299 ppb to 802 ± 271 ppb, 813 ± 273 ppb). The mean nNO change was also significant compared with placebo (-125 ppb versus +14 ppb; p < 0.05). There was a significant decrease in nEos with LC compared with placebo (3.1-2.5 versus 2.9-2.6; p < 0.05). RQLQ scores were significantly improved with LC only. In TSS-4 scoring, a trend toward improvement during LC and significant worsening during placebo was found. Baseline nNO predicted changes in nasal eosinophils (nEos) and RQLQ.
We showed that oral LC therapy decreased objective markers of rhinitis inflammation, nNO and nEos, in patients with PAR. Improvement in symptom scoring was also found with LC treatment.
过敏性鼻炎通常采用抗组胺药物治疗。使用鼻一氧化氮(nNO)无创监测气道炎症的改善将具有临床意义。为了确定口服左西替利嗪二盐酸盐(LC)的抗炎作用,我们对常年性过敏性鼻炎(PAR)患者进行了 nNO 和鼻嗜酸性粒细胞(nEos)的测量。
采用随机双盲安慰剂对照交叉设计。纳入标准包括有 PAR 病史、检查和日记评分符合活跃症状以及皮肤测试阳性的患者。在研究前 1 个月服用过敏药物的患者不被纳入。同意后,31 名受试者(24 名女性;平均年龄 29 岁)被随机分配接受口服 LC(5mg)或匹配安慰剂治疗 2 周。经过 2 周的洗脱期后,受试者开始接受另外 2 周的治疗。每次就诊时,使用 Aerocrine 公司的 NIOX(瑞典)鼻腔试剂盒通过鼻腔抽吸测量 nNO,以十亿分之几(ppb)为单位;从鼻腔涂片收集 nEos 并通过显微镜使用评分系统(0-4+)进行测量,并使用过敏性鼻炎生活质量问卷(RQLQ)自我报告症状。每次就诊时均收集每日过敏症状评分(总症状评分[TSS]为 4)。
在 LC 期间,左鼻基线 nNO 为 807±317ppb,右鼻为 831±332ppb,分别显著下降至 688±266ppb 和 702±286ppb(p<0.05)。在安慰剂治疗期间未发现显著变化(778±270ppb,808±299ppb 至 802±271ppb,813±273ppb)。与安慰剂相比,nNO 的平均变化也具有显著意义(-125ppb 与+14ppb;p<0.05)。与安慰剂相比,LC 组 nEos 也显著减少(3.1-2.5 与 2.9-2.6;p<0.05)。只有 LC 组的 RQLQ 评分显著改善。在 TSS-4 评分中,发现 LC 组有改善趋势,而安慰剂组则明显恶化。基线 nNO 可预测 nEos 和 RQLQ 的变化。
我们表明,口服 LC 治疗可降低 PAR 患者鼻炎炎症的客观标志物,包括 nNO 和 nEos。LC 治疗还发现症状评分有改善。