Keith Paul K, Luciuk George
McMaster University, Hamilton, Ontario, Canada.
Clin Ther. 2007 Mar;29(3):419-26. doi: 10.1016/s0149-2918(07)80080-4.
Seasonal allergic rhinitis (SAR) is an inflammatory response to seasonal allergens. Desloratadine, a once-daily selective histamine H(1)-receptor antagonist, has been reported to be efficacious in relieving symptoms of SAR in controlled clinical trials. However, to assess the actual effectiveness of a drug, it is important to examine information about its use in routine clinical practice.
The Partners in Allergy Control and Therapy (PACT) study examined the effectiveness of desloratadine in patients with SAR symptoms receiving treatment in a community setting of primary care physicians in Canada.
Patients with symptoms of SAR received desloratadine 5 mg once daily for 7 days during the spring-summer allergy season (April-July 2002). Patients rated their SAR symptoms along with their physicians by completing a questionnaire at baseline and day 7. Nasal, ocular, respiratory, and overall symptoms were rated on a scale of 0 (no symptoms evident) to 3 (severe/interfere with activities of daily living and/or sleeping). Physicians were asked to keep a record of adverse events reported by patients. The Wilcoxon signed-rank test was used to evaluate symptom severity scores. A 2-way (time x treatment), repeated measures, mixed analysis of variance (ANOVA) model was constructed to assess differences in variables over time.
A total of 6829 patients participated in the study. Patients reported nasal stuffiness/congestion as their most severe symptom. Just over half (50.1%) of patients were receiving another medication for SAR at study entry; 29.7% were receiving an intranasal corticosteroid. After 7 days of treatment with desloratadine, individual symptom scores and overall symptom scores were significantly reduced compared with baseline (all scores, P<0.001). An improvement in nasal/stuffiness/ congestion was reported by 88.0% of patients. The ANOVA detected a statistically significant incremental benefit with desloratadine and an intranasal corticosteroid compared with desloratadine monotherapy (P<0.001). No severe adverse events were reported.
Desloratadine 5 mg once daily was associated with significant improvement in symptoms of SAR, and appeared to provide additional benefit in relieving moderate to severe nasal stuffiness/congestion in 6786 patients receiving 7-day treatment in an actual practice setting of primary care physicians in Canada.
季节性变应性鼻炎（SAR）是对季节性变应原的一种炎症反应。地氯雷他定是一种每日服用一次的选择性组胺H(1)受体拮抗剂，在对照临床试验中已报道其对缓解SAR症状有效。然而，为评估一种药物的实际有效性，考察其在常规临床实践中的使用信息很重要。
变应性疾病控制与治疗合作组织（PACT）研究考察了地氯雷他定在加拿大基层医疗医生社区环境中接受治疗的有SAR症状患者中的有效性。
有SAR症状的患者在2002年春夏变应性疾病季节（4月至7月）期间每日一次服用5mg地氯雷他定，共7天。患者在基线和第7天通过填写问卷对其SAR症状以及与其医生一起进行评分。鼻、眼、呼吸道和总体症状按0（无明显症状）至3（严重/干扰日常生活活动和/或睡眠）进行评分。要求医生记录患者报告的不良事件。采用Wilcoxon符号秩检验评估症状严重程度评分。构建一个双向（时间×治疗）重复测量混合方差分析（ANOVA）模型以评估变量随时间的差异。
共有6829例患者参与了该研究。患者报告鼻阻塞/充血是其最严重的症状。刚好超过一半（50.1%）的患者在研究入组时正在接受另一种治疗SAR的药物；29.7%的患者正在接受鼻用糖皮质激素治疗。用地氯雷他定治疗7天后，与基线相比，个体症状评分和总体症状评分均显著降低（所有评分，P<0.001）。88.0%的患者报告鼻/阻塞/充血有所改善。ANOVA检测到与地氯雷他定单药治疗相比，地氯雷他定与鼻用糖皮质激素联合使用有统计学显著增加的益处（P<0.001）。未报告严重不良事件。
在加拿大基层医疗医生的实际临床实践环境中，6786例接受7天治疗的患者中，每日一次服用5mg地氯雷他定与SAR症状的显著改善相关，并且在缓解中度至重度鼻阻塞/充血方面似乎提供了额外益处。
