From the 1Instituto de Immunología, Universidad Central de Venezuela; and 2Policlínica Metropolitana, Caracas, Venezuela; 3Universidad Peruana Cayetano Heredia, Lima, Perú; 4Centro Especializado San Fernando, Panamá City, Panamá; 5Hospital Angeles Pedregal, Mexico City; and 6Allergy and Clinical Immunology Department, Hospital Universitario, Monterrey, Mexico; and 7Hospital Universitario del Río, Universidad del Azuay, Cuenca, Ecuador.
World Allergy Organ J. 2009 Apr;2(4):42-8. doi: 10.1097/WOX.0b013e31819cdfdb.
: To determine the effectiveness of desloratadine syrup in relieving symptoms of allergic rhinitis (AR) among children in Latin America.
: In an open-label trial conducted in 5 Latin American countries, 455 children aged 6 to 12 years with seasonal or perennial AR were treated with desloratadine syrup 2.5 mg/d for 6 weeks. Thirty percent of subjects were concomitantly taking corticosteroids, and 21.3% had a history of asthma. Efficacy was measured by improvement in the Total Symptom Severity 4 questionnaire and decrease in severity of individual nasal symptoms of congestion, rhinorrhea, pruritus, and sneezing. Physicians and subjects' caregivers rated symptom improvement in a separate assessment at final visit.
: Treatment with desloratadine led to a significant decrease in mean Total Symptom Severity 4 score, from 7.54 at baseline to 1.96 at study end (P < 0.0001), and in individual symptom scores, including congestion (P < 0.0001 for all). Similar improvements were found in groups receiving desloratadine monotherapy and desloratadine plus corticosteroids. Allergic rhinitis symptoms were rated "better" or "much better" by 94% of caregivers. Incidence of adverse events was 6%.
: Desloratadine, with or without concomitant corticosteroids, was efficacious and safe in the treatment of AR in this group of Latin American children.
评估地氯雷他定糖浆在缓解拉丁美洲儿童变应性鼻炎(AR)症状方面的疗效。
在拉丁美洲 5 个国家进行的一项开放标签试验中,455 名年龄在 6 至 12 岁、患有季节性或常年性 AR 的儿童接受地氯雷他定糖浆 2.5mg/d 治疗,疗程为 6 周。30%的受试者同时服用皮质类固醇,21.3%有哮喘病史。通过总症状严重度 4 问卷(Total Symptom Severity 4 questionnaire)改善和鼻塞、流涕、瘙痒和打喷嚏等单个鼻部症状严重度降低来评估疗效。在最后一次就诊时,医生和受试者的护理人员对症状改善情况进行了单独评估。
地氯雷他定治疗可显著降低平均总症状严重度 4 评分,从基线时的 7.54 降至研究结束时的 1.96(P<0.0001),且单个症状评分(包括鼻塞)也显著降低(所有症状均 P<0.0001)。接受地氯雷他定单药治疗和地氯雷他定加皮质类固醇治疗的组均观察到类似的改善。94%的护理人员认为过敏症状得到“改善”或“明显改善”。不良事件发生率为 6%。
地氯雷他定联合或不联合皮质类固醇治疗在该组拉丁美洲儿童的 AR 治疗中是有效且安全的。